ISO 9000 Quality Manual System

Quality Management System To Improve Business Performance

2011-05-23T06:19:00.000-07:00

The intent of the Quality Management Standard is to encourage the adoption of the process approach to manage an organisation.

A process is any activity or set of activities that uses resources to transform inputs to outputs. For organisations to function effectively, they have to identify and manage numerous interrelated and interacting processes. The “Process Approach” is the systematic identification and management of the processes employed within an organisation and particularly the interactions between such processes.

In order to lead and operate an organisation successfully, it is necessary to manage in a systematic and transparent manner. Success can result from implementing and maintaining a management system that is designed to continually improve performance while addressing the needs of all interested parties.

Eight quality management principles that can be used by management in order to lead the organisation towards improved performance are outlined below:

Customer focus

Organisations depend on their customers and therefore should understand current and future customer needs, meet customer requirements and strive to exceed customer expectations.

Leadership

Leaders establish the purpose and direction of the organisation. They should create and maintain the internal environment in which people can become fully involved in achieving the organisation’s objectives.

Involvement of people

People at all levels are the essence of an organisation and their full involvement enables their abilities to be used for the benefit of the organisation.

Process approach

A desired result is achieved more efficiently when activities and related resources are managed as a process.

System approach to management

An organisation’s effectiveness and efficiency in achieving its objectives is attributed to the identifying, understanding and managing interrelated processes.

Continual improvement

Continual improvement of the organisation’s overall performance should be a permanent objective of the organisation.

Factual approach to decision making

Effective decisions are based on the analysis of data and information.

Mutually beneficial supplier relationships

An organisation and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.

These eight quality management principles form the basis for the quality management system standards within the ISO 9000 family.

More information on Quality Management, please go to http://www.iso9001store.com

Training In ISO 9001 Standards

2011-05-23T06:18:00.000-07:00

Implementing ISO 9001 in any organization first requires the development of the necessary knowledge, skills and understanding to enable the practical application of the standard. At this stage organizations often seek the help of a consultant but this is often unnecessary since the required understanding can easily be sought for free.

The training section provided by ISO 9001 Checklist is intended to give any business a knowledgeable foundation that ensures their quality management system is highly robust. It could save you £0000′s in consultancy fees.

The Concept behind ISO 9001 Training

ISO 9001 training is a unique internet browser based tutorial solution that provides expert practical guidance for businesses wishing to interpret ISO 9000 fundamentals to help better understand and implement the requirements of ISO 9001:2008. It could help your business to get the most out of your quality management system, and it’s free to use!

The ISO 9001 training section represents a body of knowledge which explains the requirements of the standard in plain English coupled with practical guidance and interpretation. The online ISO 9001 training section divides the standard into four sections that follow the Plan, Do, Check and Act cycle. The page menu then subdivides each section into Principles, Base Clauses and Requirements for easy comparison. Each stage of the cycle then relates each clause of ISO 9001:2008 to the key concepts that lie at the heart of quality management.

How does it Work?

Simple, it encourages the use of the PDCA cycle as a means to implement your quality management system by prompting the user to:

PLAN your quality system’s high level processes, define your quality policy and establish your quality objectives in accordance with the expected output. Consider; how will the quality management system be documented, what resources will be needed, who will have responsibility for what and how will the effectiveness of the system be evaluated and communicated.

DO carry out day-to-day activities by performing the necessary processes in accordance with any planned arrangements. Gather performance information by undertaking audits and other measurements as planned.

CHECK the results and analyse the information gathered through various measurements and monitoring activities to determine whether the quality management system has achieved what it set out to do.

ACT by using the results from internal audits, preventive actions and management reviews to ensure the continual improvement of your quality management system; continual improvement should be the organization’s permanent objective.What Happens after Implementation?

You need to choose a registrar. The registrar is a third party certification auditor who will assess your quality management system and issue a certificate if it meets the requirements of ISO 9001:2008. In choosing a registrar you should consider their industry experience, geographic coverage, price and service level offered. The key is to find a registrar who can meet your requirements. For further information regarding national accredited certification bodies, please visit UKAS.

Pre-assessment by your registrar normally takes place about 6 weeks before registration. The purpose of the pre-assessment audit is to identify areas where you may not be operating in accordance with the standard. This allows you to correct any deficiencies before registration.

Prior to registration, you should arrange an initial assessment with your registrar. At this point the registrar will review your quality management system (by interviewing staff, observing activities and checking records) to decide whether you should be recommended for registration.

The ISO 9001 Standards Training DVD can be obtained at http://www.iso9001store.com

Active Implication Of The Implementation Of Quality Management System

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Active Implication Of The Implementation Of Quality Management System

Successful implementation of a quality management system is conditioned by implication of the top management of SME. ISO 9001 gives a special importance of the commitment of the top management obviously defining its role in the quality management system. It is underlined the promoting the leadership principle in practice as a base for operational the others principles of the quality management system.

The commitment and active implication of the top management are essential for developing, implementation and maintaining an efficient and efficacy quality system management, having as a final purpose ensuring an increasing clients’ satisfaction.

To achieve such a desideratum, top management must consider the following actions:

· defining the visions, policies and strategic objectives of SME;

· direct participation of the management to improving projects;

· obtaining the feedback regarding efficiency and efficacy of the processes of making the products;

· developing an environment that encourages the involving of the personnel;

· ensuring the necessary resources for achieving the objectives.

Top management defines the methods of the performances of SME to determine the stage of achievement the objectives.

These methods must allow the evaluation:

· financial performances of SME;

· performances of the processes of SME;

· client’s satisfaction, personnel’s and other interested parts’ satisfaction;

· other success factors identified by management.

Information that results from such evaluations are used as incoming elements for the analysis done by management for continue improving of the quality management system, that must ensure the base for improving

the performances of SME.

In this way, top management can demonstrate its commitment through:

· understanding the necessities and present expectations and client’s perspective;

· promoting policies and objectives for increasing the awareness and implication of the personnel in SME;

· adopting the principle of continue improving as a base principle for the processes of SME.

· Rigorous planning of all processes of SME and to operate the changes;

· ensuring an adequate background to satisfy the requirements of the interested parts.

Top management has to involve directly in identification the processes of fabrication the products because these are directly tied by SME’s success. Also, a special attention must be paid on identification of those reliance processes that affects either the efficacy and efficiency of the processes of fabrication of the products of SME, or the necessities and expectations of the interested parts.

The management of SMEs should ensure that the processes are carried out as an efficacious and efficient net. For this it should be analyzed and got at its best the interaction of all processes. In this purpose it must consider the following aspects:

· ensuring the sequence and interaction between processes are in that way designed so they allow getting the desired results;

· ensuring that incoming and outgoing elements are obvious defined and are kept under control;

· monitoring the incoming and outgoing elements to check if the processes are correlated and carried out efficacious and efficient;

· identification and administrate the risks and to turn to account the opportunities of improving

performances;

· doing the analysis of the information for continuously improving of the processes;

· designating the responsible of the processes;

· ensuring that every process is managed so that it allows the achievement of the established objectives;

· defining the necessities and expectations of the interested parts.

Top management can present proves regarding its commitment for developing and implementation of the quality management system as well as for continuously improving of its efficacy through:

· communication of the importance of satisfaction of the clients’ requirements in SME, as well as legal requirements;

· defining the policy and objectives regarding the quality;

· managing the analysis of the quality management system;

· ensuring the necessary resources for the achievement of the objectives.

One of the main tasks that top management has to accomplish refers to defining the policy in the quality field. There is no form of standard presentation, but the policy must be in such way formulated so it ensure:

· getting client’s satisfaction as a main goal;

· clarifying the way in which it is ensured the quality of the products and services of SME;

· explicit commitment of the management regarding continue improving of the quality;

· assuming by the management the responsibility regarding the achievement of the objectives regarding quality.

Policy will be implemented through the objectives regarding the quality, that should be measurable. The more participation of the top management is more direct and more visible, the more the necessary period will be shorter for establishing and implementation of the quality system management, on one hand because of the availability of the resources and on the other hand because of a less bureaucratic approach that top management of SME has in this case.

When it is decided the implementation of a quality management system or it is approved an improving schedule of this, it is vital to exist an obvious understanding of the estimated duration and necessary resources from the management. Often, the initiatives regarding the quality management system fail because of this commitment is missing, especially from the top management.

Why is ISO 9001:2008 Certification Important?

2010-10-09T15:16:00.000-07:00

Why is ISO 9001:2008 Certification Important?

First of all it provides a system for managers and organizations to achieve excellence and opens the door for American manufacturers and/or service organizations seeking a larger role in both international trade and with other American organizations. Many organizations require their suppliers to be certified or at a minimum to be working toward certification on ISO 9001:2008 to do business.

Consider the facts (source MORI/SGS-ICS) that with ISO 9001 certification:

83% realized improved management control
82% realized improved customer satisfaction
62% said it improved the ability to win work
61% stated a more motivated workforce
60% realized improved productivity
60% saw reduced waste
52% stated it improved marketing
50% had reduced costs
49% realized increased market share

ISO 9000 AND THE CONSTRUCTION INDUSTRY

2010-10-09T15:15:00.000-07:00

ISO 9000 AND THE CONSTRUCTION INDUSTRY

formal quality management system at a construction firm, there has to be direct demands from their customers, whose requirement for quality is essential for doing business. Most of the construction organizations will not enter into the cost and allocation of resources to implement a quality management system unless they will be compensated. There is a general movement towards making implementation of a quality management system a contractual requirement. Small to medium sized organizations can always argue that they ‘operate to a quality system’ although this is not formalized. However, since the existence of such ‘informal’ quality systems are

difficult to justify, the International Standards Organization, (ISO) has come up with ISO 9001 series of standards that are applicable to all organizations irrespective of size or nature of business.

ISO 9000 refers to a set of quality management standards. Standards present an opportunity for an organization to develop a quality management system that meets the requirements specified by ISO 9001:2000, which are

recognized internationally, making the organization competitive. ISO 9001 family of standards is undeniably the most prolific of all formal standards. This could be due to the worldwide applicability standardization and

flexibility with which the standards are associated, even though there are some experts that still question the standards’ applicability in the construction industry. It is important to note that ISO 9001:2000 has replaced ISO 9001:1994, ISO 9002:1994 and ISO 9003:1994, while the old ISO 9002 and ISO 9003 standards have been discontinued.

A formal quality management system has the potential to change attitudes, cultures, and work procedures at any construction firm in a way the organization has never experienced before. In most cases, in order to set up aformal quality management system at a construction firm, there has to be direct demands from their customers,whose requirement for quality is essential for doing business. Most of the construction organizations will not enterinto the cost and allocation of resources to implement a quality management system unless they will becompensated. There is a general movement towards making implementation of a quality management system acontractual requirement. Small to medium sized organizations can always argue that they ‘operate to a qualitysystem’ although this is not formalized.

However, since the existence of such ‘informal’ quality systems aredifficult to justify, the International Standards Organization, (ISO) has come up with ISO 9001 series of standardsthat are applicable to all organizations irrespective of size or nature of business. ISO 9000 refers to a set of quality management standards. Standards present an opportunity for an organization todevelop a quality management system that meets the requirements specified by ISO 9001:2000, which arerecognized internationally, making the organization competitive. ISO 9001 family of standards is undeniably themost prolific of all formal standards. This could be due to the worldwide applicability standardization andflexibility with which the standards are associated, even though there are some experts that still question thestandards’ applicability in the construction industry. It is important to note that ISO 9001:2000 has replaced ISO9001:1994, ISO 9002:1994 and ISO 9003:1994, while the old ISO 9002 and ISO 9003 standards have been discontinued.

What Is ISO 14001 Standards?

2010-10-09T15:11:00.000-07:00

What Is ISO 14001 Standards?

The ISO 14001 aims to reduce the environmental carbon footprints that many businesses leave behind today because of not taking the right steps to be environmental sustainable. This standard promotes the decrease in the waste of necessary business resources and also reduces the pollution that can sometimes be a by product of a business.
About ISO 14001
The most updated version of the ISO 14001 was released in the year 2004 by the International Organisation of Standardization (ISO), which was attended by members from all the committees from around the world. In order for a company to be awarded the ISO 14001 standard certificate, an external auditor has to audit the company by an audit body that has been accredited by an accreditation body. The certification auditors are required to be accredited by the International Registrar of Certification Auditor and the certification body has to be accredited by the Registrar Accreditation Board in the USA or by the National Accreditation Board in Ireland.
The structure of ISO 14001 is very much like the ISO 9000, which is management standard, so these two standards can be implemented side by side to achieve the best results. As a part of the ISO 14000 family, which deals with different aspects of environmental issues, ISO 14001:2004 and ISO 14002 deal with environmental management system (EMS). ISO 14001 gives the requirements for the
EMS and ISO 14002 gives the basic guidelines for EMS.
Environmental Management System with ISO 14001:2004
The EMS, as per the requirements of the ISO 14001, enables the company, may it be of any size, location and income to:
It helps the company improve its environmental strategy and this positively affects their environmental performance.
It helps in identifying and controlling the environmental impact that the activities, services or products of the company might have.
And it helps in carrying out a systematic approach to set environmental targets and objectives, to achieve these and also to demonstrate that they have been achieved.
How does it work?
ISO 14001 does not specify or chalk out a definite level that each business has to reach. If the performance was determined, then it would have to be done for every specific business. But that is not how it works and has a very different approach, like:
The ISO has various standards dealing with environmental issues. ISO 14001 deals with a framework provided for a strategic and holistic approach to the businesses environmental policy, actions and plans.
It gives the general requirements for the EMS.
This also states the reference to the communication requirements for the communication of the environmental management issues between the company, stakeholders, the public and the regulators.
As these standards are not company specific, any and every business can undertake them as long as they are dedicated to the continued and improved environmental performance and they have a commitment to comply with the set norms.

Improve your performance management with new version of ISO 9001

2010-06-28T07:46:00.001-07:00

A quality management system enables you to manage your business processes effectively:

it is much more than a set of rules and procedures. When properly implemented and maintained, a QMS addresses the needs of your organisation and delivers tangible business benefits.

The new version of ISO 9001 has recently been published. One of the main aims of ISO 9001:2008 is to facilitate integration with other standards. Although there are no new requirements as such, there are some key clarifications to be taken into account.

There are three main objectives to the new standard:

Detail, clarify, improve the understanding of ISO 9001:2000 (previous version)

Improve compatibility with ISO 14001:2004 Simplify the way in which ISO 9001 can be integrated with other management system standards (such as OHSAS 18001)

There are no new requirements in the new standard:

The title, scope, and structure of the standard are unchanged

The process approach is confirmed

Compatibility with the latest revision of ISO 14001:2004 is maintained and improved upon

Preservation of the quality management principles included in ISO 9000:2000

There are five main areas to note. The relevant sections of the standard are noted in brackets.

1. A reinforcement of the notion of product conformity

2. Compatibility with other standards is evolving

3. A better understanding of outsourced processes

4. An editorial clarification of some requirements – for instance;

A reinforcement of the notion of product conformity2.3.4.

An editorial clarification of some requirements – for instance;A better understanding of outsourced processesCompatibility with other standards is evolving

• (6.4) work environment, including an explanatory note on work environment giving examples,

to help meet product conformity requirements

• (8.2.1) measurement of customer satisfaction, including a note broadening the scope beyond

satisfaction surveys to include other channels such as customer feedback5.

• (Introduction) the notion of risk

• (5.5.2) appointment of a management représentative

• (6.2.2) assessing the effectiveness of achieving compétence

• (8.5.2 et 3) assessing the effectiveness of corrective and preventive actions?

Some additional explanations regarding the requirements of the standard;An editorial clarification of some requirements – for instance;A better understanding of outsourced processesCompatibility with other standards is evolvingA reinforcement of the notion of product conformity

ISO 9001 Standards Video

2010-05-30T06:16:00.000-07:00

ISO 9000 Standards - ISO 9000 Standard Software
The term ISO9000 Standards refers to a set of quality management standards. ISO9000 currently includes three quality standards: ISO 9000:2005, ISO 9001:2000, and ISO 9004:2000. ISO 9001:2000 presents requirements, while ISO 9000:2005 and ISO 9004:2000 present guidelines. All of these are process standards (not product standards).

ISO 9001 Standard 's purpose is to facilitate international trade by providing a single set of standards that people everywhere would recognize and respect.

The ISO 9001 Standards apply to all kinds of organizations in all kinds of areas. Some of these areas include manufacturing, processing, servicing, printing, forestry, electronics, steel, computing, legal services, financial services, accounting, trucking, banking, retailing, drilling, recycling, aerospace, construction, exploration, textiles, pharmaceuticals, oil and gas, pulp and paper, petrochemicals, publishing, shipping, energy, telecommunications, plastics, metals, research, health care, hospitality, utilities, pest control, aviation, machine tools, food processing, agriculture, government, education, recreation, fabrication, sanitation, software development, consumer products, transportation, design, instrumentation, tourism, communications, biotechnology, chemicals, engineering, farming, entertainment, horticulture, consulting, insurance, and so on.

Business benefits of ISO 14001 Standards

2010-05-02T05:53:00.000-07:00

Business benefits of ISO 14001 Standards

Any manager will try to avoid pollution that could cost the company a fine for infringing environmental legislation. But better managers will agree that doing only just enough to keep the company out of trouble with government inspectors is a rather weak and reactive approach to business in today’s increasingly environment-conscious world.
There is a better way. The ISO 14000 way. The ISO 14000 standards are practical tools for the manager who is not satisfied with mere compliance with legislation – which may be perceived as a cost of doing business. They’re for the proactive manager with the breadth of vision to understand that implementing a strategic approach can bring return on investment in environmentrelated measures. Implementing an ISO 14000-basedenvironmental management system, and using other tools from the ISO 14000 family, will give you far more than just confidence that you are complying with legislation.
The ISO 14000 approach forces you to take a hard look at all areas where your business has an environmental impact. And this systematic approach can lead to benefits like the following:
a. Reduced cost of waste managementb. Savings in consumption of energy and materialsc. Lower distribution costsd. Improved corporate image among regulators, customers and the publice. Framework for continuous improvement of your environmental performance.
The manager who is “too busy managing the business” to listen to good senseabout environmental management could actually be costing the business plenty. Just think, for example, of the lost opportunities for achieving benefits like those above.
The ISO 14000 standards are management tools that will help your businessachieve environmental goals that go way beyond acquiring a mere “green sheen”.

The ISO 9001 & ISO 14001 Standards and the environment

2010-05-02T05:52:00.000-07:00

The ISO 9001 & ISO 14001 Standards and the environment

The ISO 14000 family of International Standards on environmental management is a relative newcomer to ISO’s portfolio – but enviroment-related standardization is far from being a new departure for ISO.

In fact, ISO has two-pronged approach to meeting the needs of business, industry, governments, non-governmental organizations and consumers in the field of the environment.

On the one hand, it offers a wideranging portfolio of standardized sampling, testing and analytical methods to deal with specific environmental challenges. It has developed more than 350 International Standards (out of a total more
than 12000) for the monitoring of such aspects as the quality of air, water and soil. These standards are means of providing business and government with scientifically valid data on the environmental effects of economic activity.

They also serve in a number of countries as the technical basis for environmental regulations.

ISO is leading a strategic approach by developing environmental management system standards that can be implemented in any type of organization in either public or private sectors (companies, administration, public utilities). To spearhead this strategic approach, ISO establish a new technical commitee, ISO /TC 207, Environmental management, in

1993. This followed ISO’s successful pioneering experience in management system standardization with the ISO 9000 series for quality management.

ISO’s direct involvement in environmental management stemmed from an intensive consultation process, carried out within the framework of a Strategic Advisory Group on Environment (SAGE),set up in 1991, in which 20 countrie, 11 international organizations and more than 100 environmental experts participated in defining the basic requirements of a new approach to environment-related standards.

This pioneering work was consolidated with ISO’s commitment to support the objective of “sustainable development” dicussed at the United Nations Conference on Environment and Development in Rio de Janeiro in 1992.

Today, delegations of business and government experts from 55 countries have participate actively within TC 207,

and another 16 countries have observer status. These delegations are chosen by the national standars institute concerned and they are required to bring to TC 207 a national consensus on issue being addressed by the commitee.

This national consensus is derived from a process of consultation with interested parties.

From its beginning, it was recognized that ISO/TC 207 should have close cooperation with ISO/TC 176, Quality management and quality assurance, in the areas of management systems, auditing and related terminology. Active efforts are under way to ensure compatibility of ISO environmental management and quality management standards, for the benefit of all organizations wishing to implement them.

ISO 9001:2008 Requirements – Management Responsibility

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ISO 9001:2008 Requirements - Management Responsibility

All requirements in clause 5 are the responsibility of top management.
5.1 Management Commitment
Provide evidence of management commitment to develop and implement the quality management system, as well as, continually improve its effectiveness by:
? Expressing the importance of meeting requirements
? Establishing the quality policy and quality objectives
? Conducting management reviews
? Ensuring the availability of necessary resources

5.2 Customer Focus
Ensure customer requirements are determined and met in order to improve customer satisfaction.
5.3 Quality Policy
Ensure the quality policy is:
? Appropriate to the purpose of the organization
? Focused on meeting requirements and continual improvement
? Used as a framework for quality objectives
? Communicated and understood at appropriate levels
? Reviewed for continuing suitability
5.4 Planning
5.4.1 Quality Objectives
Ensure quality objectives, including those needed to meet product requirements, are established at the relevant functions and levels within the organization. Ensure quality objectives are measurable and consistent with the quality policy.
5.4.2 Quality Management System Planning
Ensure that planning for the quality management system:
? Meets the general requirements (4.1), as well as, quality objectives (5.4.1)
? Maintains the system integrity when changes are planned and implemented
5.5 Responsibility, Authority, and Communication
5.5.1 Responsibility and Authority
Ensure responsibilities and authorities are defined and communicated within the organization.

5.5.2 Management Representative
Appoint a member of your management who, irrespective of other duties, has the responsibility and authority to:
? Ensure the needed processes are established, implemented, and maintained
? Report to top management on quality management system performance
? Report to top management on any need for improvement
? Ensuring the promotion of awareness of customer requirements
NOTE: The responsibility of a management representative can include being the liaison with external parties on matters relating to the quality management system.
5.5.3 Internal Communication
Ensure the appropriate communication processes are established and carried out within the organization regarding the effectiveness of the system.
5.6 Management Review
5.6.1 General
Review the quality management system at planned intervals to:
? Ensure a suitable, adequate, and effective system
? Assess possible opportunities for improvement
? Evaluate the need for any changes to the system
? Consider the need for changes to the quality policy and objectives
Maintain records of the management reviews.
5.6.2 Review Input
Inputs for management review must include information on:
? Results of audits
? Customer feedback
? Process performance and product conformity
? Status of preventive and corrective actions
? Follow-up actions from earlier reviews
? Changes that could affect the quality system
? Recommendations for improvement

5.6.3 Review Output
Outputs from the management review must include any decisions and actions related to:
? Improvement of the effectiveness of the quality management system and its processes
? Improvement of product related to customer requirements
? Resource needs

Quality Management System Requirements

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Quality Management System Requirements
The ISO 9001:2008 standard is meant to be generic and applicable to all kinds of organizations. Therefore, organizations from both the public and private sectors, including non-governmental organizations can benefit from the ISO 9001 quality management system model, regardless of whether they are small, medium or large organizations. The immediate benefit that can be realized from the implementation of ISO 9001 is the collective alignment of the activities of internal processes that are focused towards the enhancement of customer satisfaction which will result in many other benefits, whether internal or external. The magnitude of these benefits are determined by how effective the processes are in achieving its objectives.

Preparing ISO 9000 Quality Manual

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Preparing ISO 9000 Quality Manual

Quality characteristics in ISO 9000 Standards

2009-11-27T04:45:00.002-08:00

Quality characteristics in ISO 9000 Standards

Any feature or characteristic of a product or service that is needed to satisfy customer needs or achieve fitness for use is a quality characteristic. When dealing with products the characteristics are almost always technical characteristics, whereas service quality characteristics have a human dimension. Some typical quality characteristics are given below.

Product characteristics

1. Accessibility Functionality Size

2. Availability Interchangeability Susceptibility

3. Appearance Maintainability Storability

4. Adaptability Odour – Strength

5. Cleanliness Operability -Taste

6. Consumption Portability – Testability

7. Durability Producibility Traceability

8. Disposability Reliability – Toxicity

9. Emittance Reparability Transportability

10. Flammability Safety – Vulnerability

11. Flexibility Security – Weight

Service quality characteristics

1. Accessibility Credibility – Honesty

2. Accuracy Dependability Promptness

3. Courtesy Efficiency - Responsiveness

4. Comfort Effectiveness Reliability

5. Competence Flexibility – Security

These are the characteristics that need to be specified and their achievement controlled, assured, improved, managed and demonstrated. These are the characteristics that form the subject matter of the product requirements referred to in ISO 9000. When the value of these characteristics is quantified or qualified they are termed product requirements. We used to use the term quality requirements but this caused a division in thinking that resulted in people regarding quality requirements as the domain of the quality personnel and technical requirements being the domain of the technical personnel. All requirements are quality requirements – they express needs or expectations that are intended to be fulfilled by a process output that possesses inherent characteristics. We can therefore drop the word quality. If a modifying word is needed in front of the word requirements it should be a word that signifies the subject of the requirements. Transportation system requirements would be requirements for a transportation system, Audio speaker design requirements would be requirements for the design of an audio speaker, component test requirements would be requirements for testing components, and management training requirements would be requirements for training managers. ISO 9000 requirements are often referred to as quality requirements as distinct from other types of requirements but this is misleading. ISO 9000 is no more a quality requirement than is ISO 1000 on SI units, ISO 2365 for Ammonium nitrate or ISO 246 for Rolling Bearings. The requirements of ISO 9000 are quality management system requirements – requirements for a quality management system.

Establishing Quality Policy In ISO 9000 Standards

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Establishing Quality Policy In ISO 9000 Standards

The standard requires that top management establish

the quality policy.

ISO 9001 defines a quality policy as the overall

intentions and direction of an organization related to

quality as formally expressed by top management. It

also suggests that the policy be consistent with the

overall policy of the organization and provide a

framework for setting quality objectives. Further-

more ISO 9001 advises that the eight quality manage-

ment principles be used as a basis for forming the quality policy. The quality

policy can therefore be considered as the values, beliefs and rules that guide

actions, decisions and behaviours. A value may be ‘integrity’ and expressed as:

We will be open and honest in our dealings with those inside and outside the

organization. A rule may be ‘confidentiality’ and expressed as Company

information shall not be shared with those outside the organization. Both these are

also beliefs because it might be believed that deceiving people only leads to

failure in the long run. It might also be believed that disclosing confidential

information fuels the competition and will drive the organization out of

business. Both values guide actions, decisions and behaviours and hence may

be termed policies. They are not objectives because they are not achieved – they

are demonstrated by the manner in which actions and decisions are taken and

the way your organization behaves towards others.

The detail of quality policy will be addressed later. What is important in this

requirement is an understanding of why a quality policy is needed, what is

required to establish a quality policy and where it fits in relation to other

policies.

Defining the purpose or mission of the business is one thing but without

some guiding policies, the fulfilment of this mission may not happen unless

effort is guided in a common direction. If every manager chooses his or her

direction, and policies, the full potential of the organization would not be

realized. A shared vision is required that incorporates shared values and

shared policies.

The purpose of corporate policies is to influence the short and long-term

actions and decisions and to influence the direction in which the mission will

be fulfilled. If there were policies related to the organization’s customers, they

could be fulfilled at the expense of employees, shareholders and society. If

there were policies related to profit, without other policies being defined, profit

is positioned as a boundary condition to all actions and decisions. Clearly this

may not direct the organization towards its mission.

As stated above, the quality policy is the corporate policy and such policies

exist to channel actions and decisions along a path that will fulfil the

organization’s purpose and mission. A goal of the organization may be the

attainment of ISO 9001 certification and thus a quality policy of meeting the

requirements of ISO 9001 would be consistent with such a goal, but goals are not

the same as purpose as indicated in the box to the right. Clearly no organization

would have ISO 9000 certification as its purpose because certification is not a

reason for existence – an objective maybe but not a purpose.

Policies expressed as short catchy phrases such as “to be the best” really do

not channel actions and decisions. They become the focus of ridicule when the

organization’s fortunes change. There has to be a clear link from mission to

policy.

Policies are not expressed as vague statements or emphatic statements using

the words may, should or shall, but clear intentions by use of the words ‘we will’

– thus expressing a commitment or by the words ‘we are, we do, we don’t, we

have’ expressing shared beliefs. Very short statements tend to become slogans

which people chant but rarely understand the impact on what they do. Their

virtue is that they rarely become outdated. Long statements confuse people

because they contain too much for them to remember. Their virtue is that they

not only define what the company stands for but how it will keep its

promises.

In the ISO 9001 definition of quality policy it is suggested that the eight

quality management principles be used as a basis for establishing the policy.

One of these principles is the Customer Focus principle. By including in the

quality policy the intention to identify and satisfy the needs and expectations

of customers and other interested parties and the associated strategy by which

this will be achieved, this requirement would be fulfilled. The inclusion of the

strategy is important because the policy should guide action and decision.

Omitting the strategy may not ensure uniformity of approach and direction.

The standard requires that top management establish the quality policy.

ISO 9001 defines a quality policy as the overall intentions and direction of an organization related to quality as formally expressed by top management. It also suggests that the policy be consistent with the overall policy of the organization and provide a framework for setting quality objectives. Furthermore ISO 9001 advises that the eight quality management principles be used as a basis for forming the quality policy. The quality policy can therefore be considered as the values, beliefs and rules that guide actions, decisions and behaviours. A value may be ‘integrity’ and expressed as:

We will be open and honest in our dealings with those inside and outside the organization. A rule may be ‘confidentiality’ and expressed as Company information shall not be shared with those outside the organization. Both these are also beliefs because it might be believed that deceiving people only leads to failure in the long run. It might also be believed that disclosing confidential information fuels the competition and will drive the organization out of business. Both values guide actions, decisions and behaviours and hence may be termed policies. They are not objectives because they are not achieved – they are demonstrated by the manner in which actions and decisions are taken and the way your organization behaves towards others.

The detail of quality policy will be addressed later. What is important in this requirement is an understanding of why a quality policy is needed, what is required to establish a quality policy and where it fits in relation to other policies.

Defining the purpose or mission of the business is one thing but without some guiding policies, the fulfilment of this mission may not happen unless effort is guided in a common direction. If every manager chooses his or her direction, and policies, the full potential of the organization would not be realized. A shared vision is required that incorporates shared values and shared policies.

The purpose of corporate policies is to influence the short and long-term actions and decisions and to influence the direction in which the mission will be fulfilled. If there were policies related to the organization’s customers, they could be fulfilled at the expense of employees, shareholders and society. If there were policies related to profit, without other policies being defined, profit is positioned as a boundary condition to all actions and decisions. Clearly this may not direct the organization towards its mission.

As stated above, the quality policy is the corporate policy and such policies exist to channel actions and decisions along a path that will fulfil the organization’s purpose and mission. A goal of the organization may be the attainment of ISO 9001 certification and thus a quality policy of meeting the requirements of ISO 9001 would be consistent with such a goal, but goals are not the same as purpose as indicated in the box to the right. Clearly no organization would have ISO 9000 certification as its purpose because certification is not a reason for existence – an objective maybe but not a purpose.

Policies expressed as short catchy phrases such as “to be the best” really do not channel actions and decisions. They become the focus of ridicule when the organization’s fortunes change. There has to be a clear link from mission to policy.

Policies are not expressed as vague statements or emphatic statements using the words may, should or shall, but clear intentions by use of the words ‘we will’ – thus expressing a commitment or by the words ‘we are, we do, we don’t, we have’ expressing shared beliefs. Very short statements tend to become slogans which people chant but rarely understand the impact on what they do. Their virtue is that they rarely become outdated. Long statements confuse people because they contain too much for them to remember. Their virtue is that they not only define what the company stands for but how it will keep its promises.

In the ISO 9001 definition of quality policy it is suggested that the eight quality management principles be used as a basis for establishing the policy.

One of these principles is the Customer Focus principle. By including in the quality policy the intention to identify and satisfy the needs and expectations of customers and other interested parties and the associated strategy by which this will be achieved, this requirement would be fulfilled. The inclusion of the strategy is important because the policy should guide action and decision.

Omitting the strategy may not ensure uniformity of approach and direction.

Establishing Quality Objectives In ISO 9000 Standards

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Establishing Quality Objectives In ISO 9000 Standards

The ISO 9000 Standard requires that top management ensure that quality objectives are established.

ISO 9001 defines quality objectives as results sought or aimed for related to quality. It also suggests that these

objectives be based on the quality policy and be specified at different levels in the organization, being

quantified at the operational level. As with quality policy the details will be addressed later and here we

will focus on what it means to establish qualityobjectives and how they relate to other objectives.

As the quality policy equates to the corporate policy, it follows that quality objectives equate to corporate objectives. All of the organization’s objectives should in some way serve to fulfil requirements of customers and other interested parties. It is also interesting to note that inISO 9000, the term requirement is defined as a need or expectation that is stated, customarily implied or obligatory. While an investor may not specify a requirement for growth in share value, it would certainly be an expectation. While an employee does not express requirements for salary increases when profits rise, it would certainly be an expectation and while society has no way other than to protest or invoke the law to impose its desires upon an organization, it certainly has the power to make organization’s comply and even change the law in extreme cases. So quality objectives do equate to corporate objectives.

Management needs to ensure that the objectives are established as a basis for action. All work serves an objective and it is the objective that stimulates action.

The reason for top management setting the objectives is to ensure that everyone channels their energies in a positive direction that serves the organizations purpose and mission.

For an objective to be established it has to be communicated, translated into action and become the focus of all achievement. Objectives are not wish lists. The starting point is the purpose and mission statement and the factors

identified as affecting the ability of the organization to accomplish its mission. It is in these areas the organization needs to excel and therefore they become the focus for action and consequently the setting of objectives. Although ISO 9001 suggests that the quality objectives should be based on the quality policy, it is more likely to be current performance, competition and opportunities arising from new technology that drive the objectives.

An objective is a result that is aimed for and is expressed as a result that is to be achieved. Objec-

tives are therefore not policies. The requirement should also not be interpreted as applicable only to

organizational functions and levels. Objectives are required at levels within the organization not levels

within the organization structure. This is clarified by the requirement for objectives to include those

needed to meet requirements for product. There are therefore five levels at which control and improve-

ment objectives need to be established:

Corporate level where the objectives are for the whole enterprise to enable it to fulfil its vision

Process level where the objectives are for specific processes to enable them to fulfil corporate goals

Product or service level where the objectives are for specific products/services or ranges of products/services to enable them to fulfil or create customer needs and expectations

Departmental or function level where the objectives are for an organizational component to enable it to fulfil corporate goals Personal level where the objectives are for the development of individual competency

A management system is not a static system but a dynamic one and if properly designed and implemented can drive the organization forward towards world class quality. All managerial activity is concerned either with maintaining performance or with making change. Change can retard or advance performance. That which advances performance is beneficial. In this regard, there are two classes of quality objectives, those serving the control of quality

(maintaining performance) and those serving the improvement of quality (making beneficial change).

maintain or to prevent from deteriorating. To maintain your performance and your position in the market you will have to continually seek improvement.

Remaining static at whatever level is not an option if your organization is to survive. Although you will be striving for improvement it is important to avoid slipping backwards with every step forwards. The effort needed to prevent

regression may indeed require innovative solutions. While to the people working on such problems, it may appear that the purpose is to change the status quo, the result of their effort will be to maintain their present position not raise it to higher levels of performance. Control and improvement can therefore be perceived as one and the same thing depending on the standards being aimed for and the difficulties in meeting them.

The statements of objectives may be embodied within business plans, product development plans, improvement plans, process descriptions and even procedures.

Achievable objectives do not necessarily arise from a single thought even when the policies provide a framework. There is a process for establishing objectives.

At the strategic level, the subjects that are the focus for setting objectives are the factors that affect the organization’s ability to accomplish its mission – the critical success factors such as marketing, innovation, human resources,

physical and financial resources, productivity and profit. There may be other factors such as the support of the community, of unions, of the media as certain businesses depend on continued support from society. Customer needs, regulations, competition and other external influences shape these objectives and cause them to change frequently. The measures arise from an analysis of current performance, the competition and there will emerge the need for either improvement or control. The steps in the objective setting process are as follows:

Identifying the need

Drafting preliminary objectives

Proving the need to the appropriate level of management in terms of:

whether the climate for change is favourable

the urgency of the improvement or controls

the size of the losses or potential losses

the priorities

Identifying or setting up the forum where the question of change or control is discussed Conducting a feasibility study to establish whether the objective can be achieved with the resources that can be applied Defining achievable objectives for control and improvement

Communicating the objectives

The standard does not require that objectives be achieved but it does require that their achievement be planned and resourced. It is therefore prudent to avoid publishing objectives for meeting an unproven need and which has not

been rigorously reviewed and assessed for their feasibility. It is wasteful to plan for meeting objectives that are unachievable and it diverts resources away from more legitimate uses.

Objectives are not established until they are understood and therefore communication of objectives must be part of this process. Communication is incomplete unless the receiver understands the message but a simple yes or no is not an adequate means of measuring understanding. Measuring employee understanding of appropriate quality objectives is a subjective process. Through the data analysis carried out to meet the requirements of clause 8.4 you will have produced metrics that indicate whether your quality objectives are being achieved. If they are being achieved you could either assume your employees understand the quality objectives or you could conclude that it doesn’t matter. Results alone are insufficient evidence. The results may have been achieved by pure chance and in six months time your performance may have declined significantly. The only way to test understanding is to check the decisions people make. This can be done with a questionnaire but is more effective if one checks decisions made in the work

place. Is their judgement in line with your objectives or do you have to repeatedly adjust their behaviour?

For each objective you should have a plan that defines the processes involved in its achievement. Assess these processes and determine where critical decisions are made and who is assigned to make them. Audit the

decisions and ascertain whether they were contrary to the objectives. A simple example is where you have an objective of decreasing dependence upon inspection. By examining corrective actions taken to prevent recurrence of

nonconformities you can detect whether a person decided to increase the level of inspection in order to catch the nonconformities or considered alternatives.

Any person found increasing the amount of inspection has clearly not understood the objective.

ISO 14001 Template

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The ISO 14001Template were created to help you to prepare the ISO 14001Quality Manual, ISO 14001 Operating Procedure & ISO 14001 Forms. This ISO 14001 Template contains prewritten Quality Manual, Operating Procedure along with sample forms and checklists included as Microsoft Word & Excel format. It provides sample practical documentation in the proper ISO format required by the latest ISO 14001:2004.

The ISO 14001 Template features:-

• Specifically designed to be very easy to customize so that the entire documentation that is required by ISO 14001 : 2004 can be quickly and easily developed.
• Professional design and layout.
• It is designed to fulfill the ISO 14001 : 2004 requirements. .
• Easy to read, easy to understand, and easy to implement.
• Easy to audit as it follows the structure of ISO 14001: 2004..
• Includes the required Process Flowchart.

The ISO 14001 Template series itself is generic, and is designed to be applicable to any manufacturing or service process. The ISO 14001 Environmental Management System (EMS) Template are consist of:

a. ISO 14001 EMS Manual Template
The Policy is fundamental to meeting the needs of ISO 14001. It essentially defines the rules and requirements of the organization with respect to the standard/EMS and as such is a central plank of the initiative.
ISO 14001 Manual Template Consist of:
• Section 1: General EMS Requirement
• Section 2: Environment Policy – Objectives, Targets & Programmes
• Section 3: EMS Planning
• Section 4: Implementation & Operation
• Section 5: Checking & Monitoring
• Section 6: Management Review

b. ISO 14001 Operating Procedure
The ISO 14001 Operating Procedure Template includes and integrates ISO 14001 EMS requirements, thus containing the most difficult part of the ISO 14001 documentation. The ISO 14001 Operating Procedure Template include the detailed samples of the Operating Procedures to fulfill the ISO 14001 : 2004 requirements for the procedures, making the customization process even easier. The entire manual follows the structure of ISO 14001 : 2004.

ISO 14001 Operating Procedures Consist Of:
• Objective & Targets Procedure
• Environmental Management Program Procedure
• Environmental Aspect & Impact Identification & Evaluation Procedure
• Environmental Monitoring & Measuring Procedure
• Legal & Others Requirement & Evaluation Of Compliance Procedure
• Emergency Preparedness & Response Procedure
• Chemical Control Procedure
• Waste Management Procedure
• 5S House Keeping Procedure

c. ISO 14001 Forms
ISO 14001 Forms Consist Of :
• Environmental Non-Conformance Master List
• Environmental Non-Conformance Notice Form
• Environmental Management Program Form
• Environmental Aspect & Impact Identification Form
• Green Environment Internal Audit Master Plan
• Green Environment Plan & Activities Form
• Green Environment Material Purchase Master List
• ISO 14001:2004 Internal Audit Summary Report
• Equipment Monitoring Master List
• Environment Preventive Action Report (PAR) Master List
• Environment Preventive Action Report (PAR) Form.
• Environmental Responsible Form
• EMS Organization Chart.
• Waste Management Schedule Form
• Totally Abolish Banned Substances & Target Deadline For Total Abolishment Form

For more information, please visit us at:

http://www.e-wia.com
http://www.iso-consults.com
http://www.iso9000-software.com

Free ISO 9000 Standards E-Books

2009-11-03T06:05:00.001-08:00

ISO 14001 Standards – Complying with Environmental Laws and Regulations

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One of the most commonly cited reasons for implementing an ISO 14001 environmental management system is that it helps an organization comply with environmental laws and regulations.
ISO 14001 registration will provide additional assurance to City Council, senior management, regulators and key stakeholders that appropriate procedures have been implemented to identify, track, and communicate environmental laws and regulations. ISO 14001 registration will also provide assurance that our Administration is controlling, monitoring, and improving performance, relative to these laws/regulations.
A strong environmental management system, aimed at legal/regulatory compliance, will serve the City of Edmonton by increasing the likelihood of avoiding convictions, fines and judgments; avoiding internal legal costs; and promoting positive relations with regulators.

Emergency Preparedness and Response In ISO 14001

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Emergency Preparedness and Response In ISO 14001
Under the Emergency Preparedness and Response requirement of ISO 14001:2004 (§4.4.7), the organization is required to establish procedures for identifying the potential for and responding to emergency situations and accidents that can have an impact on the environment.
Identification of Potential Emergency and Accident Situations – Experience indicates that organizations infrequently have a preexisting procedure for identifying potential emergency and accident situations.The norm is to establish emergency and accident responses for a variety of emergency and accident situations irrespective of the potential for their occurrence. But ISO 14001 is specific about requiring a procedure to identify the potential for emergency situations and accidents. Adhering to the requirement of the procedure is a valuable exercise that helps organizations identify weaknesses in their own emergency planning and to plan for that which is most likely to occur.Because many environmental impacts of an emergency or accident situation are secondary in nature, it appears that all potential emergency or accident situations need to be identified before a determination of environmental impacts can be made. An organization that attempts to identify potential emergency or accident situations based on a review of its environmental aspects would likely miss the environmental impact potential of, say, an automobile accident.
There are five steps implied by the emergency preparedness and response requirement:
1) Identify the potential for emergency situations and accidents of all kinds;2) Paying particular attention to the potential environmental impacts of accidents and emergency situations, identify how the organization can prevent and mitigate associated adverse environmental impacts;3) Determine how the organization and its employees should respond to emergency situations and accidents;4) Periodically simulate emergency situations to test response capabilities; and,5) Review and revise procedures based on experience derived from actual and simulated emergency situations and accidents.
Accident and Emergency Situation Identification – In order to identify potential for and responding to emergency situations and accidents, the organization should develop a procedure for systematically identifying accident and emergency situations, evaluating their probability of occurrence, their likely consequences, and their severity.Organizations often engage risk management specialists to assist in the identification of potential emergency or accident situations that could lead to human injury, environmental damage, or economic loss. While many checklists are available to facilitate this kind of evaluation, there is virtually no substitute for physical evaluation of facilities by knowledgeable personnel, whether employees or outside professionals.
Emergency Response Procedures – The organization is required to develop procedures for responding to emergency situations and accidents when they occur. Typically, response procedures include identifying public emergency response agencies and their capabilities, identifying individuals within the organization who are trained and able to provide assistance in emergencies, establishing an emergency communications network, and providing emergency lighting, signage, and equipment. Because Emergency Response Procedures are based on identified potential emergency situations and accidents specific to the organization, the emergency response plan will be unique for each organization.
Periodic Testing – The value of conducting emergency response exercises lies not only with simulating situations that could occur but also in identifying flaws in the response plan. Practice drills can be the most effective test of the system to give employees, emergency response personnel, and management the opportunity to walk through the plan and gain familiarity with its procedures. While a full-dress response exercise is valuable, testing of procedures can be effectively done on much smaller scales and still provide the benefits of testing. Above all, the organization should not let the impracticality of a full-dress exercise keep it from testing sub elements of the emergency response plan.
Review and Revise – ISO 14001 calls for continual improvement of the EMS. Periodically reviewing and revising emergency response plans based on the experience gained from the occurrence of emergency situations or accidents or in testing response plans is an example of continual improvement.
Written Response Plans – Many written emergency response plans are too cumbersome to be of value in an emergency situation – their value depends entirely upon previous training of persons who will be called upon to execute them. Yet, many organizations fail to provide the emergency response training necessary to make the plans functional.Keeping in mind that even the simplest, most direct emergency response plan requires training for effective implementation, an alternative for organizations to consider is establishment of abbreviated, readily available Immediate Response Directions established for each kind of potential emergency situation or accident. Such an emergency response plan might consist of a laminated card prepared for each potential emergency situation or accident and providing specific responsibilities and associated actions for employees and visitors, supervisors, emergency coordinators, and emergency directors.

Migration to ISO 9001:2008

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Migration To ISO 9001:2008
The International Accreditation Forum (IAF) and the International Organization forStandardization (ISO) have agreed on an implementation plan to ensure a smooth transition ofaccredited certification to ISO 9001:2008, the latest version of the world’s most widely usedstandard for quality management systems (QMS). The details of the plan are given in the jointcommuniqué by the two organizations which appears below.Like all of ISO’s more than 17 000 standards, ISO 9001 is periodically reviewed to ensure that itis maintained at the state of the art and a decision taken to confirm, withdraw or revise thedocument.ISO 9001:2008, which is due to be published before the end of the year, will replace the year2000 version of the standard which is implemented by both business and public sectororganizations in 170 countries. Although certification is not a requirement of the standard, theQMS of about one million organizations have been audited and certified by independentcertification bodies (also known in some countries as registration bodies) to ISO 9001:2000.ISO 9001 certification is frequently used in both private and public sectors to increaseconfidence in the products and services provided by certified organizations, between partnersin business-to-business relations, in the selection of suppliers in supply chains and in the rightto tender for procurement contracts.ISO is the developer and publisher of ISO 9001, but does not itself carry out auditing andcertification. These services are performed independently of ISO by certification bodies. ISOdoes not control such bodies, but does develop voluntary International Standards toencourage good practice in their activities on a worldwide basis. For example, ISO/IEC17021:2006 specifies the requirements for bodies providing auditing and certification ofmanagement systems.Certification bodies that wish to provide further confidence in their services may apply to be“accredited” as competent by an IAF recognized national accreditation body. ISO/IEC17011:2004 specifies the requirements for carrying out such accreditation. IAF is aninternational association whose membership includes the national accreditation bodies of 49economies.ISO technical committee ISO/TC 176, Quality management and quality assurance, which isresponsible for the ISO 9000 family of standards, is preparing a number of support documentsexplaining what the differences are between ISO 9001:2008 and the year 2000 version, whyand what they mean for users. Once approved, these documents will be posted on the ISOWeb site – probably in October 2008.
ISO (International Organization for Standardization) and the IAF (International AccreditationForum) have agreed an implementation plan to ensure a smooth migration of accreditedcertification to ISO 9001:2008, after consultation with international groupings representingquality system or auditor certification bodies, and industry users of ISO 9001 certificationservices.ISO 9001:2008 does not contain any new requirementsThey have recognized that ISO 9001:2008 introduces no new requirements. ISO 9001:2008only introduces clarifications to the existing requirements of ISO 9001:2000 based on eightyears of experience of implementing the standard world wide with about one millioncertificates issued in 170 countries to date. It also introduces changes intended to improveconsistency with ISO14001:2004The agreed implementation plan in relation to accredited certification is therefore thefollowing:Accredited certification to the ISO 9001:2008 shall not be granted until the publication of ISO9001:2008 as an International Standard.Certification of conformity to ISO 9001:2008 and/or national equivalents shall only be issuedafter official publication of ISO 9001:2008 (which should take place before the end of 2008)and after a routine surveillance or recertification audit against ISO 9001:2008.Validity of certifications to ISO 9001:2000One year after publication of ISO 9001:2008 all accredited certifications issued (newcertifications or recertifications) shall be to ISO 9001:2008.Twenty four months after publication by ISO of ISO 9001:2008, any existing certification issuedto ISO 9001:2000 shall not be valid.

Nonconformity, Corrective Action and Preventive Action in ISO 14001 EMS

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The intent of §4.5.3 is that the organization put in place procedures for 1) identifying actual and potential nonconformities to EMS requirements, 2) taking appropriate corrective or preventive action, and 3) reviewing the effectiveness of corrective or preventive actions taken.The nonconformity requirement of ISO 14001:1996 was a passive requirement in that it was only triggered when a nonconformity came to the attention of the organization through one of the other EMS procedures, such as the EMS audit or management review. ISO 14001:2004, however, requires that the organization establish and maintain procedures to identify actual or potential nonconformities, determine their causes, take action to avoid recurrence or occurrence, record results, and review effectiveness of corrective or preventive actions.
How the organization goes about identifying actual or potential nonconformities is up to it to determine. From the standpoint of registration auditors, it would seem that they would want to see a specific procedure requiring members of the organization to conduct some kind of periodic checklist driven, walk-through inspection for nonconformities. In addition, the procedure should allow for submission of nonconformities by any member of the organization. Actual nonconformities are usually fairly evident and relatively easy to investigate because there is a tangible occurrence with which to deal. The organization should also want to evaluate minor instances of nonconformity that, while not significant in and of themselves, if they occurred under different circumstances, could lead to a significant deviation from the EMS. Such “near misses” could be identified by the occurrence of a sudden, unexpected event, a failure to achieve an objective or target, or a deviation from the Environmental Policy.Potential nonconformities are more difficult to identify and correct. Here, application of Failure Mode and Effects Analysis would be appropriate for organizations having that capability.
When investigating nonconformities, organizations should focus on identifying underlying root causes, not just the immediate manifestation of the problem. If a chemical storage drum leaks, the organization should take action, first, to mitigate the damage and, then, to determine why the leak occurred; e.g., improper or negligent handling, mechanical failure, or lack of a leak detection system. Corrective or preventive actions should then focus on eliminating the cause through training, communication of procedures, use of leak-resistant drums, or installation of a leak detection system.
Other ISO 14001 sections, principally Emergency Preparedness and Response, Internal Audit, and Management Review, are tools that the organization implements in order to help identify instances of actual or potential nonconformity. The underlying principle of these sections is that the identification of nonconformities should be made by the organization through diligent application of these tools, not from the occurrence of an environmental event, a customer or community complaint, or investigation by a regulatory authority. While §4.5.3 does not specifically mention disciplinary action, in many cases disciplinary action or the threat of disciplinary action is appropriate to prevention of future nonconformities. Many organizations have written codes of conduct that give employees notice that deviations from the codes will not be tolerated and that prescribed penalties can result for infractions. These codes can be expanded to include penalties for deviations from the EMS. If so, penalties should be commensurate with the violation itself and should acknowledge the nature of the environmental damage, the degree of negligence, prior conduct, and the forthrightness of the employee being disciplined. Any such code and its remedies should be administered fairly and consistently and should have as its objective correction and prevention of EMS nonconformities, not punishment of employees.Finally, identification, investigation, and correction of nonconformities leads to the need to revise documented procedures.

Evaluation Of Compliance Of ISO 14001 EMS

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The requirement to establish a procedure for periodically evaluating compliance with applicable legal and other requirements falls short of specifically requiring regulatory compliance audits but, in fact, a system of regular regulatory compliance audits may be the most practical means for meeting this requirement of the standard. In the U.S., determination of whether to conduct a compliance audit will be governed in part by the particular jurisdiction’s approach to allowing a legal privilege for the self-assessment audit.
Evaluation vs. Audit – The difference between an evaluation and audit can only be determined by looking outside of ISO 14001. Consulting a dictionary reveals that an evaluation involves a determination of value or worth and that an audit is an examination of accounts done by persons appointed for the purpose. A better definition `is the more specific ISO 19011:2002, Guidelines for Quality and/or Environmental Management Systems Auditing, which defines an audit as a “systematic, independent, and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled.” Many organizations do not have a system for evaluating regulatory compliance other than their own records and the inspections of regulatory officials. This lack of a verification system can be a risky way to operate. Reports of enforcement actions and consent agreements show that many organizations are blindsided by rogue employees who violate rules and falsify documents to cover up environmental misdeeds. Although ISO 14001 does not prescribe a specific approach to evaluation of regulatory compliance, organizations should consider methods for going beyond verification of records by collecting and evaluating physical evidence.

Continual improvement in the quality management In ISO 9001

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Continual improvement in the quality management system and its processes In ISO 9001
The standard requires the organization to continually improve the effectiveness of the quality management system in accordance with the requirements of ISO 9001 and to implement action necessary to achieve planned results andcontinual improvement of the identified processes.
ISO 9000 defines continual improvement as a recurring activity to increase the ability to fulfil requirements. As the organization’s objectives are its requirements, continually improving the effectiveness of the management system means continually increasing the ability of the organization to fulfil its objectives.
This requirement responds to the Continual Improvement principle. If the management system is enabling the organization to accomplish its objectives when that is its purpose, why improve? The need for improvement arises out of a need to become more effective at what you do, more efficient in the utilization of resources so that the organization becomes best in its class. The purpose of measuring process performance is to establish whether or not the objectives are being achieved and if not to take action on the difference. If the performance targets are being achieved, opportunities may well exist to raise standards and increase efficiency and effectiveness.
If the performance of a process parameter is currently meeting the standard that has been established, there are several improvement actions you can take:Raise the standard e.g. if the norm for the sales ratio of orders won to all orders bid is 60%, an improvement programme could be developed for raising the standard to 75% or higherIncrease efficiency e.g. if the time to process an order is within limits, identify and eliminate wasted resources Increase effectiveness e.g. if you bid against all customer requests, by only bidding for those you know you can win you improve your hit rate
You can call all these actions improvement actions because they clearly improve performance. However, we need to distinguish between being better at what we do now and doing new things. Some may argue that improving efficiency is being better at what we do now, and so it is – but if in order to improve efficiency we have to be innovative we are truly reaching new standards. Forty years ago, supervisors in industry would cut an eraser in half in the name of efficiency rather than hand out two erasers. Clearly this was a lack of trust disguised as efficiency improvement and it had quite the opposite effect. In fact they were not only increasing waste but also creating a hostile environment.
Each of the improvement actions is dealt with later in the book and the subject of continual improvement addressed again under Quality planning in Chapter 5. There are several steps to undertaking continual improvement (Juran, J. M., 1995)12 .1 Determine current performance2 Establish the need for change3 Obtain commitment and define the improvement objectives4 Organize diagnostic resources5 Carry out research and analysis to discover the cause of currentperformance6 Define and test solutions that will accomplish the improvementobjectives7 Product improvement plans which specify how and by whom the changeswill be implemented8 Identify and overcome any resistance to change9 Implement the change10 Put in place controls to hold new levels of performance and repeat step one.

Preparing the ISO 9001 quality manual

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The standard requires a quality manual to be establishedand maintained that includes the scope of the qualitymanagement system, the documented procedures or refer-ence to them and a description of the sequence andinteraction of processes included in the quality manage-ment system.
ISO 9000 defines a quality manual as a documentspecifying the quality management system of an organi-zation. It is therefore not intended that themanual be a response to the requirements ofISO 9001. As the top-level document describingthe management system it is a system descriptiondescribing how the organization is managed.Countless quality manuals produced to satisfy ISO 9000 :2008, were nomore than 20 sections that paraphrased the requirements of the standard.Such documentation adds no value. They are of no use to managers, staff orauditors. Often thought to be useful to customers, organizations would gainno more confidence from customers than would be obtained from theirregistration certificate.
This requirement responds to the System Approach Principle.A description of the management system is necessary as a means of showinghow all the processes are interconnected and how they collectively deliver thebusiness outputs. It has several uses as :a means to communicate the vision, values, mission, policies and objectivesof the organizationa means of showing how the system has been designeda means of showing linkages between processesa means of showing who does whatan aid to training new peoplea tool in the analysis of potential improvementsa means of demonstrating compliance with external standards and regulations
When formulating the policies, objectives and identifying the processes toachieve them, the manual provides a convenient vehicle for containing suchinformation. If left as separate pieces of information, it may be more difficult tosee the linkages.The requirement provides the framework for the manual. Its content maytherefore include the following:1 Introduction(a) Purpose (of the manual)(b) Scope (of the manual)(c) Applicability (of the manual)(d) Definitions (of terms used in the manual)2 Business overview(a) Nature of the business/organization – its scope of activity, its productsand services(b) The organization’s interested parties (customers, employees, regulators,shareholders, suppliers, owners etc.)(c) The context diagram showing the organization relative to its externalenvironment(d) Vision, values(e) Mission3 Organization(a) Function descriptions(b) Organization chart(c) Locations with scope of activity4 Business processes(a) The system model showing the key business processes and how they areinterconnected(b) System performance indicators and method of measurement(c) Business planning process description(d) Resource management process description(e) Marketing process description(f) Product/service generation processes description(g) Sales process description(h) Order fulfilment process description5 Function matrix (Relationship of functions to processes)6 Location matrix (Relationship of locations to processes)7 Requirement deployment matrices(a) ISO 9001 compliance matrix(b) ISO 14001 compliance matrix(c) Regulation compliance matrices (FDA, Environment, Health, Safety,CAA etc.)8 Approvals (List of current product, process and system approvals)

Scope of the ISO 9001 quality management system

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The standard requires the quality manual to include the scope of the quality management system including details of justification for any exclusion.
The standard addresses activities that may not be relevant or applicable to an organization. The permissible exclusions are explained in section 1.2 of ISO 9001. Here it states that the organization may only exclude requirements that neither affect the organization’s ability, nor its responsibility to provide product that meets customer and applicable regulatory requirements. The requirements for which exclusion is permitted are limited to those in section 7 of the standard.
Under ISO 9000 :2008, it was possible for organizations to exclude functions and processes of their organization that may have been difficult to control or were not part of the order fulfilment cycle. Organizations that designed their own products but not for specific customers could escape bringing these operations into the management system. Marketing was omitted because itoperated before placement of order. Accounting, Administration, Maintenance, Publicity, Public Relations and After Sales Support functions were often omitted because there were no requirements in the standard that specifically dealt with such activities. As there is no function in an organization that does not directly or indirectly serve the satisfaction of interested parties, it is unlikely that any function or process will now be excluded from the management system.
This requirement responds to the System Approach Principle.It is sensible to describe the scope of the management system so as to ensure effective communication. The scope of the management system is one area that generates a lot of misunderstanding particularly when dealing with auditors, consultants and customers. When you claim you have a management system that meets ISO 9001 it could imply that you design, develop, install and service the products you supply, when in fact you may only be a distributor.
Why you need to justify specific exclusions is uncertain because it is more practical tojustify inclusions.
The scope of the management system is the scope of the organization. There is no longer any reason to exclude locations, activities, functions or processes for which there is no requirement in the standard. The reason is because the ISO 9000 family now serves customer satisfaction and is not limited to quality assurance as were the 1994 versions of ISO 9001, ISO 9002 and ISO 9003.
It is not appropriate to address exclusions by inserting pages in the manual corresponding to the sections of the standard and adding justification if not within the scope of the management system – such as ‘We don’t do this!’. It is much more appropriate to use an appendix as indicated previously in the manual contents list. By describing the nature of the business, you are establishing boundary conditions. If in doing so you do not mention that you design products, it will be interpreted that design is not applicable. For exclusions relative to detail requirements, the Compliance Matrix may suffice but for an unambiguous solution, it is preferable to produce an exposition that addresses each requirement of the standard.

Managing processes In ISO 9001 Standard

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The standard requires the organization to manage the identified processes in accordance with the requirements of ISO 9001. The first stage in managing a process is to establish what it is you are trying to achieve, what requirements you need to satisfy, what goals you are aiming at; then establish how you will measure your achievements. The next stage is to define the process you will employ to deliver the results. Managing the process then involves managing all the inherentcharacteristics of the process in such a manner that the requirements of customers and interested parties are fulfilled by the process outcomes. This means:Managing the process inputsManaging the workManaging the physical resourcesManaging the financial resourcesManaging the human resourcesManaging the constraintsManaging the outputs
Process management is therefore much more than managing activities and therefore when describing processes, one needs more than a flow chart of activities. The chart is a diagrammatical representation of a process but only one aspect. One can also add numerical data to the charts to indicate resources, cycle times, delays, costs etc. but the intangible factors of the human environment cannot be reduced to numerical data to add to the charts.
The notes to clause 4.1 of ISO 9001 need some explanation. It is stated that the processes needed for the management system include management activities, provision of resources, product realization and measurement. This note could cause confusion because it suggests that these are the processes that are needed for the management system. It would be unwise to use this as the model and far better to identify the processes from observing how the business operates. The term provision of resources should be Resource Management, which is thecollection of processes covering financial, human and physical resources.
Product realization is also a collection of processes such as design, production, service delivery, etc. Measurement is not a single process but a sub-process within each process. Grouping all the measurement processes together serves no useful purpose except it matches the standard – a purpose of little value in managing the organization.
The second note refers to outsourcing processes although it is difficult to imagine that management activities, product realization or measurement would be outsourced in its entirety. It is likely that market research; design, product verification, equipment calibration and other specialized services may be outsourced. While outsourcing comes under purchasing, it is correct to point out that the organization should control any outsourced processes. The supplier of the process is usually referred to as a subcontractor because they provide services to the organization’s requirements not their own. Control of subcontractors is covered by clause 7.4 but in meeting clause 7.4.3, you need to treat suppliers and subcontractors differently.

ISO 9001 Quality Policy

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On customersWe will listen to our customers, understand and balance their needs andexpectations with those of our suppliers, employees, investors and society andendeavour to give full satisfaction to all parties.On leadershipWe will establish and communicate our vision for the organization and throughour leadership exemplify core values to guide the behaviour of all to achieve ourvision.On peopleWe will involve our people in the organization’s development, utilize theirknowledge and experience, recognize their contribution and provide an environ-ment in which they are motivated to realize their full potential.On processes and systemsWe will take a process approach towards the management of work and manage ourprocesses as a single system of interconnected processes that delivers all theorganization’s objectives.On continual improvementWe will provide an environment in which every person is motivated tocontinually improve the efficiency and effectiveness of our products, processes andour management system.On decisionsWe will base our decisions on the logical and intuitive analysis of data collectedwhere possible from accurate measurements of product, process and systemcharacteristics.On supplier relationshipsWe will develop alliances with our suppliers and work with them to jointlyimprove performance.
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ISO 9001:2008 Quality Management System Standard

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ISO 9001:2008 is the world most successful standard addressing best practice in the application of quality management systems.
The standard is based around the principles of customer satisfaction, continual improvement and the development of a process based quality management system. Although not referenced in the standard itself the ISO 9001:2008 document is underpinned by eight key quality management principles;
a customer focused organisation
leadership
the involvement of people
ensuring a process approach
a systematic approach to management
a factual approach to decision making
mutually beneficial supplier relations
continuous improvement
ISO 9001:2008 has been written to ensure that its guiding principles are equally relevant to all sectors of industry and to all types of organisation. Although containing requirements to control the key processes within an organisation, it only requires six documented procedures. The standard emphasises the need for an organisation to continually monitor their own processes and systems, with many clauses making reference to self monitoring or measurement or both. This emphasis aims for an integrated approach to business processes. Instead of operating to a business plan on one hand and a quality management system on the other, the standard aims to integrate both of these functions into one system.
What is a quality management system?ISO 9001:2008 is a standard that specifies criteria for a quality management system (QMS). A QMS incorporates those elements of an organisations management system that direct and control it with regard to quality. Such a system will need to be supported by top management who will need to be able to demonstrate management commitment.
How do you demonstrate management commitment?Management commitment is one of the cornerstones of ISO 9001:2008, requiring top management to develop and improve the QMS throughout the organisation. This commitment can be demonstrated by a number of methods including creating a quality policy, conducting management reviews and establishing quality objectives.
What is a quality policy?ISO 9001:2008 specifies that an organisation must have a quality policy that documents the organisations overall intentions and direction related to quality as formally expressed by top management. Such a policy will include a commitment to comply with ISO 9001:2008, to continuously improve the QMS and to set and monitor measurable quality objectives.
What are quality objectives?The quality objectives are those targets sought or aimed for by the organisation that are related to quality. These quality objectives must be SMART (suitable, measurable, achievable, reviewed and timely). Examples of quality objectives might be; to reduce machine down time by 20% or to reduce rework costs by ?00 p/m. Whatever quality objectives are chosen they must be meaningful and adequately resourced by the organisation.
What is a management review?A management review is a key element of how the top management of an organisation can assess its performance in terms of the objectives it sets itself, the requirements set by the standard and how its systems are operating. Normally, a management review is a regular meeting of the top management team and uses the information that the organisation? systems have derived. It is a useful forum to review and revise quality objectives.
What are internal audits and why do I need to carry them out?Internal audit is one of the key monitoring processes required by the standard and functions as a check on the organisation? systems. It is the opportunity for an organisation to determine compliance to the systems it has established and maintained to meet the needs of its customers and identify opportunities for improvement. Internal audit can be seen as a ealth check?for an organisation.
The ore?of ISO 9001:2008, Product realisationClause 7 of ISO 9001:2008 contains the core processes that most organisations carry out. Any clause or sub-clause in section 7 can be excluded from an organisations quality management system if it can be justifiably excluded. Examples of common exclusions are clause 7.3 design and development, clause 7.5.3 traceability and clause 7.6 the control of monitoring and measuring devices. Clauses can only be excluded if their exclusion does not affect the company? ability to provide a product or service that meets customer requirements.
These core processes should be managed and controlled via the quality management system, and are evaluated for effectiveness and suitability by the internal audits with feed back into the management review.
This is a clear demonstration of one of the key principles of ISO 9001:2008, continuous improvement by critical self-evaluation. The output from the self-evaluation is fed into a planning stage to determine actions needed to improve the system. Following the planning and consultation comes the action phase where the proposed changes are implemented. Then the cycle starts again by checking that the changes are effective and meaningful by self-evaluation.
Other requirements of section 7 are;Product planning to ascertain and then implement the necessary controls and resources to ensure product realisation.
Purchasing control to verify purchased product against comprehensive purchasing information and the selection and evaluation of suppliers.
Production and service provision to ensure that this activity is carried out in controlled conditions and that any processes that cannot be verified during production are validated to ensure capability. Where appropriate the product must be identified, and if required, traceable at all stages of production. Any customer property must be identified and protected from harm and all products must be stored and handled in such a way to preserve product conformity.
Any monitoring and measuring devices needed to provide evidence of product conformity must be identified and if necessary calibrated.
But what about the customer? All of the clauses in ISO 9001:2008 are in some way focused towards meeting and exceeding the customer? expectations. For example the requirement of management to determine and communicate the importance of customer requirements throughout the organisation, and the review of customer orders to ensure that they can be met. Companies are required to implement methods for effective communication with the client at all stages of the business including ascertaining customer satisfaction after the product or service has been delivered as well as resolving customer complaints.
Finally?ISO 9001:2008 is widely acclaimed as being the pre-eminent specification for quality management systems, it requires a company to look at itself and ask the question, ‘how can we improve?’ An ISO 9001:2008 management system should be an essential part of any business process, requiring continual improvement by self-evaluation with a goal of ensuring that current and future customer expectation can be met and exceeded.
If you have any queries concerning ISO 9001:2008 please visit http://www.iso-consults.com/

Structure Of ISO 9001

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ISO 9001 was first published in 1987. Later, it went through three revisions in 1994, 2000 and 2008. The latest version version of the ISO 9001 standard was published on 14th November 2008. This is the structure of the standard:
Clause 1 Scope
Clause 2 Normative reference
Clause 3 Terms and definitions
Clause 4 Quality management system
Clause 5 Management responsibility
Clause 6 Resource management
Clause 7 Product realization
Clause 8 Measurement, analysis and improvement
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ISO 9001:2008 General Requirements

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4.1 General requirements
The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standards. The organization
shall determine the processes needed for the quality management system and their application throughout the organizations,
determine the sequence and interaction of these processes,
determine criteria and methods needed to ensure that both the operation and control of these processes are effective,
ensure the availability of resources and information necessary to support the operation and monitoring of these processes,
monitor, measure (where applicable) and analyze these processes, and
implement actions necessary to achieve planned results and continual improvement of these processes.
These processes shall be managed by the organization in accordance with the requirements of this International Standard.
Where an organization chooses to outsource any process that affects product conformity to requirements, the organization shall ensure control over such processes. The type and extent of control to be applied to these outsourced processes shall be defined within the quality management system.
NOTE 1: Processes needed for the quality management system referred to above include processes for management activities, provision of resources, product realization and measurement, analysis and improvement.
NOTE 2: An outsourced process is identified as one being needed for the organization’s quality management system, but chosen to be performed by a party external to the organization.
NOTE 3: Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory, and regulatory requirements. The type and extent of control to be applied to the outsourced process can be influenced by factors such asa) the potential impact of the outsourced process on the organization’s capability to provide product that conforms to requirements,b) the degree to which the control for the process is shared;c) the capability of achieving the necessary control through the application of clause 7.4.
Clause 4.2 Documentation requirements
4.2.1 General
The quality management system documentation shall includedocumented statements of a quality policy and quality objectives,
a quality manual,
documented procedures and records required by this International Standard,
documents including records, needed determined by the organization to be necessary to ensure the effective planning, operation and control of its processes
NOTE 1: Where the term “documented procedure” appears within this International Standard, this means that the procedure is established, documented, implemented and maintained. A single document may include the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document.
NOTE 2: The extent of the quality management system documentation can differ from one organization to another due to the size of organization and type of activities, the complexity of processes and their interactions, and the competence of personnel.
NOTE 3: The documentation can be in any form or type of medium.
4.2.2 Quality Manual
The organization shall establish and maintain a quality manual that includes the scope of the quality management system, including details of and justification for any exclusions (see 1.2), the documented procedures established for the quality management system, or reference to them, and a description of the interaction between the processes of the quality management.
4.2.3 Control of documents
Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4.
A documented procedure shall be established to define the controls needed
to approve documents for adequacy prior to issue,
to review and update as necessary and re-approve documents,
to ensure that the changes and the current revision status of documents are identified,
to ensure that relevant versions of applicable documents are available at points of use,
to ensure that documents of external origin are identified and their distribution controlled, and
to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.
4.2.4 Control of records
Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled. The organization shall establish a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention, and disposition of records. Records shall remain legible, readily identifiable, and retrievable.

ISO 9001 Management Representative

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The ISO 9001 Management Representative is appointed by the top management of an organization. Irrespective of other responsibilities, he/she is responsible and has the authority in
ensuring that processes needed for the quality management system are established, implemented and maintained,
reporting to top management on the performance of the quality management system and any need for improvement, and
ensuring the promotion of awareness of customer requirements throughout the organization.
The responsibility of the Management Representative also includes liaison with external parties on matters relating to the quality management system.
The Management Representative is usually assisted at the departmental level by Quality Representatives. This position is assumed by the respective Department Managers. The Quality Representatives are responsible for the quality processes which are applicable to their respective departments.
The Quality Representatives head their respective Quality Improvement Teams which are established for the purpose of monitoring processes and identifying opportunities for improvements. Members of the Quality Improvement Teams comprise of key personnel within the departments/process areas who are appointed by the Quality Representative to assist him/her at the process-level.
The Management Representative is also assisted by an appointed Document Controller whose responsibility is to implement the Control of Documents and Control of records procedures.
Collectively, the Management Representative, Quality Representatives and the Document Controller make up the Quality Management System Committee. This committee meets regularly to provide relevant inputs and resolutions for the quality management system. The structure of the Quality Management System Committee is as follows:
Management Representative – Chairman
Document Controller – Secretary
Quality Representatives – Members
[Note: The above is just an example. If you are a small organization, a QMS Committee and Quality Improvement Teams may not be necessary]
To facilitate effecetive communications, the Quality Management System Committee and the Quality Improvement Teams, respectively, meet regularly in order to ensure that communication regarding the effectiveness of the quality management system takes place. Pertinent information regarding the quality management system is then posted by the Management Representative on the Bulletin Board for the benefit of all employees. Employees are generally encouraged to provide their inputs towards the quality management system through suggestion boxes which are located at strategic locations within the organization’s premises.
Note: Some organizations employ this method but results may vary among other organizations. The key is to continually improve on these methods/processes.

Introduction to ISO Certification

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Certification is a way to attest, by the intermediary of a third-party certifier, to a company’s ability to provide a service, product or system in accordance with client requirements and regulation requirements. ISO and IEC give the following definition:
Procedure by which a third party gives written assurancethat a product, process or service complies with the requirementsspecified in a benchmark.The ISO 9000 family of standards corresponds to all the management best practices benchmarks as regards quality, which are defined by ISO (the International Organisation for Standardization).
ISO 9000 standards were originally written in 1987, with revisions taking place in 1994 and 2000. Thus, the 2000 version of the ISO 9001 standard, which is part of the ISO 9000 family, is written “ISO 9001:2000″. The ISO 9001:2000 standard mainly focuses on the processes used to produce a service or product, whereas the ISO 9001:1994 standard was mainly focused on the product itself. Here is an overview of all the different standards in the ISO 9000 family:
ISO 9000: “Quality Management Systems – Basic Principles and Vocabulary”. The ISO 9000 standard describes the principles of a quality management system and defines the terminologyISO 9001: “Quality Management Systems – Requirements”. The ISO 9001 standard describes the requirements relative to a quality management system either for internal use or for contractual or certification purposes. Therefore, this standard is a group of requirements that companies must followISO 9004: “Quality Management Systems – Guidelines for Improving Performance”. This standard, which is intended for internal use and not for contractual purposes, focuses particularly on continually improving performanceISO 10011: “Guidelines for auditing quality management and/or environmental management systems”.

Business benefits of ISO 14000

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Business Benefits Of ISO 14001
Any manager will try to avoid pollution that could cost the company a fine for infringing environmental legislation. But better managers will agree that doing only just enough to keep the company out of trouble with government inspectors is a rather weak and reactive approach to business in today’s increasingly environment-conscious world.
There is a better way. The ISO 14000 way. The ISO 14000 standards are practical tools for the manager who is not satisfied with mere compliance with legislation – which may be perceived as a cost of doing business. They’re for the proactive manager with the breadth of vision to understand that implementing a strategic approach can bring return on investment in environmentrelated measures. Implementing an ISO 14000-basedenvironmental management system, and using other tools from the ISO 14000 family, will give you far more than just confidence that you are complying with legislation.
The ISO 14000 approach forces you to take a hard look at all areas where your business has an environmental impact. And this systematic approach can lead to benefits like the following:
a. Reduced cost of waste managementb. Savings in consumption of energy and materialsc. Lower distribution costsd. Improved corporate image among regulators, customers and the publice. Framework for continuous improvement of your environmental performance.
The manager who is “too busy managing the business” to listen to good senseabout environmental management could actually be costing the business plenty. Just think, for example, of the lost opportunities for achieving benefits like those above.
The ISO 14000 standards are management tools that will help your businessachieve environmental goals that go way beyond acquiring a mere “green sheen”.

ISO 14001 – Specifications With Guidance for Use

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ISO 14001 – Specifications with Guidance For Use
Given the number of international participants involved in the process of developing the ISO 14001 Specifications, it is amazingly brief, consisting of five pages. This includes a Scope, Definitions, and EMS requirements.
The heart of the specification is in the EMS Requirements, the principles of which are summarized below:
Principle #1 – Commitment and Policy Top management must make a commitment to the program.
Principle #2 – Planning To be successful, the program must be organized. This includes an organizational structure, open communications, both internal and external, and a mechanism for identifying issues.
Principle #3 Implementation Program must be undertaken, including training, writing process descriptions, and establishing prevention programs.
Principle #4 Measurement and Evaluation Create a mechanism for assessing performance and progress toward goals.Principle #5 Review and Improvement? ISO 14004, Section 4, Environmental Management System (EMS)
Reference: ISO 14004, Section 4, Environmental Management System (EMS) Principles and Elements.

ISO 14001 – Certification/Registration

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ISO 14001 – Certification/Registration
Similar to the organized approach to problem solving contained in ISO 9000
and ISO 14000, an organized approach is necessary to achieve certification. Although the written requirements contained in ISO 14001 are straightforward and brief, the level of effort required to conform with the requirements should not be underestimated.
If an environmental review of the facility‘s operations has not been conducted, it is important to retain a qualified consultant to conduct the review. which should focus on the requirements of ISO 14000 versus programs currently in use. This activity is known as a Gap Analysis.?E After the Gap Analysis is completed, the environmental status of the operation should be known and the level of effort necessary to develop the ISO 14000 program understood.
It can easily take six months to a year to develop a program that meets EMS requirements. Staff should develop the EMS program as they will ultimately be required to manage it. If staff is inadequate to develop the program, a consultant can be retained to provide guidance to staff as the program is being developed.
But, retaining a consultant will not resolve the problem of long term program maintenance. The ultimate goal of developing the EMS is to obtain certification/registration. Aside from the internal benefits offered by the ISO 14000 series of standards, external benefits may be derived through the certification/registration process. The certification/registration process only applies to ISO 14001, and this is the only standard to which the audit process applies. For the purposes of certification/registration, all other ISO 14000 standards are considered guidance. Certification can either be by a self declaration?Eor by an independent registrar.
Obviously the use of an independent registrar would give more credibility to those looking at an organization from outside.
Registrars have individual preferences about how the requirements should be administered. A registrar should be selected early in the process to help ensure that the program being developed is consistent with the registrars preferences. When the program is fully prepared and implemented, the registrar will be notified and a formal program audit undertaken. This audit will not result in a denial of ISO 14000 certification, but it may result in either approval or a list of deficiencies that must be corrected before certification.

ISO 9001 Standards Software

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ISO 9001 Standards Software
Companies that need quality management systems realize that products like ISO 9001 software are important tools to insure their product safety, consistency and profitability. Using ISO 9001 software can help guarantee that any company can monitor productivity, customer satisfaction and product quality with reports that contain solid information.
This information is now vital to management in order for maximum efficiency in any industry. This is why ISO 9001 software is vital to any sized company. Continuous improvement means continuous profitability. Here are just a few reasons why:
o Companies increase sales because of better performance, quality, and delivery. This propels you ahead of your competition.
o ISO 9001 software helps retain employees and attract more highly qualified employees because they are assured of a controlled and consistent work environment.
o The experience of a more professional workplace boosts employee morale.
o Reduced operating costs dramatically increase your company’s productivity, leading to higher profitability.
o Customer satisfaction and higher profitability expand your market share and demand for your consistently higher product quality.
o When you’re compliant or certified to the appropriate standard, the businesses that work with you know that quality objectives, continuous improvement, and customer satisfaction are your goals.
Many companies require that their suppliers are ISO 9001 compliant; therefore, once you’re certified, your opportunities increase. ISO 9001 software has be utilized and has developed experience of helping manufacturing, service, and distribution organizations to be more efficient and more profitable through continuous improvement programs. We help you to implement the time-tested methods of continuous improvement to measure performance, analyze data, and apply the appropriate process changes. This includes using ISO 9001 software.
ISO 9001 software also offers a suite of modules to enable you to manage the document management and ISO 9001 Compliance Management process. These modules enable complete transparent system measurement with targeted action items ensuring all persons are notified of tasks and carry them out in a prompt and efficient manner. ISO 9001 software provides training in there software and also bring extensive experience in implementing the ISO 9001 software in various environments.

Costs Of Setting Up A Quality Management System

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Costs Of Setting Up A Quality Management System
Common implementation costs that companies incur can be broken down into direct and indirect costs.
The direct costs include, inter alia, the following:
• hiring consultants or external trainers, if required;
• sending personnel for external training;
• acquiring relevant national and international standards of the ISO 9000 family and other related books and publications; and
• acquiring additional equipment, instruments and other resources as identified by the company.
The indirect costs include, inter alia, the following:
• time spent by the management and other staff in developing the system;
• reorganization of the processes, including improvements in the house-keeping, if required;
• external calibration charges for equipment to ensure national and/or international measurement traceability;
• organizing in-house training;
• time spent by internal auditors for periodic internal audits;
• corrective actions, including revision of manuals and procedures, if required; and
• expenditure on word-processing, stationery and other consumables required for the preparation of manuals and documenting procedures, etc.
Some factors can help to lower the above costs. They include:
• having people in the company already conversant with QMS requirements;
• having documented system-related activities such as work instructions, quality plans, procedures, etc. already in place;
• using consultants only for specific activities like gap analysis, training of
auditors, pre-assessment audits, etc., and having in-house staff oversee the remaining activities.
On the other hand, there are factors that can mean higher implementation costs for the company. For example, if your company carries out activities at different locations, or if your company is involved in product design and development, this may increase costs.

Benefits Of Obtaining ISO 9000 Certification

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Benefits Of Obtaining ISO 9000 Certification
Implementing a quality management system brings internal benefits to most organizations, as well as opening up opportunities vis-à-vis the outside world.
Internal benefits to the company include:
• improved customer focus and process orientation within the company;
• improved management commitment and decision-making;
• better working conditions for employees;
• increased motivation of employees;
• reduced cost of internal failures (lower rates of rework, rejection, etc.) and external failures (fewer customer returns, replacements, etc.); and last but not least,
• continual improvement of the quality management system.
The following external benefits are generated:
• customers are more confident that they will receive products conforming to their requirements, which in turn results in higher customer satisfaction;
• an improved image of the company;
• more aggressive publicity, as customers can be informed of the benefits of their doing business with a company that manages the quality of its outputs;
• more confidence that the company’s products meet relevant regulatory
requirements;
• better objective evidence to defend product liability charges if such are brought by customers.
Refer http://www.iso9001-standard.us for more information.

Goal and Scope of an ISO 9000 quality system

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Goal and Scope of an ISO 9000 quality system

The ISO 9000 Standard states its goal in two blunt words: customer satisfaction.How do we achieve customer satisfaction? By meeting customer requirements.The quality management system (QMS) helps us to dothis by:
a. Applying the system. Actually using it. Putting it at the heart of our organization.b. Continually improving the system. The QMS is never done. After all, customer requirements do not stand still—they evolve and grow tougher.So we have to improve continually in order to survive.
(The guidance document, ISO 9004: 2000, sets a compatibleand in some respects more ambitious goal: “improving the processes of an organization to enhance performance.”) Prevention of nonconformity. Prevention is the key term here: prevention,rather than detection. Quality management has longsince evolved away from the old “inspect quality in” approach.Prevention is cheaper, more effective, and more protective of thecustomer. Detection is also a different mindset. It requires a veryhigh degree of process orientation, upstream thinking, and relentlessanalysis.To what types of organizations does the Standard apply? Alltypes. The requirements “are generic and applicable to all organizations,regardless of type and size.” A compliant QMS can be implementedby any organization, producing any product or service,anywhere in the world.Within the organization, the impact of the requirements and theQMS are similarly broad. The Standard “applies to the activities of organizationsfrom the identification of customer requirements, throughall quality management system processes, to the achievement of customer satisfaction.” Every activity within the organization that impactsthe process of creating customer satisfaction is affected by therequirements of the Standard.

ISO 9000 Standards

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ISO 9001 Standards

ISO 9001 is a written set of rules (a “Standard”) published by an internationalstandards writing body (International Organization for Standardization. The rules define practices that are universally recognized and accepted for assuring that organizations consistently understand and meet the needs of their customers.ISO 9001 is also highly generic. Its principles can be applied to any organization providing any product or service anywhere in the world.Since meeting customer needs is one of the (many) definitions of quality, ISO 9001 is often called a quality system or a quality management system. But the rules, referred to as requirements, go beyond quality matters as they are traditionally understood. The requirements fall roughly into the following types:
a. Requirements that help assure that the organization’s output (whether product, service, or both) meets customer specifications. (Making, and keeping, them happy.)
b. Requirements that assure that the quality system is consistently implemented and verifiable. (We must actually do what we say we are supposed to do. This must be verifiable via independent, objectiveaudit.)
c. Requirements for practices that measure the effectiveness of variousaspects of the system. (In God we trust; all others bring data.)
d. Requirements that support continuous improvement of the company’sability to meet customer needs. (We cannot sit still. We must strive to get better all the time, because customers change, and competitors gain strength.)
Nothing in ISO 9000 is new. The first edition, published by ISO in 1987, was drawn almost word for word from a British quality system standard. It in turn evolved from a long succession of written quality system specifications that had their ultimate origin in the defense and arms industries. Most of the practices required by ISO 9001 have been in use in industries of various kinds for decades. One intent of ISO 9001 is to simplify things for organizations. ISO 9000 strives to harmonize the sometimes conflicting, sometimes redundant quality programs that have traditionally been imposed by major corporations on their suppliers. (Note, however, that ISO 9001 is not meant to supersede customer, legal, or regulatory requirements.)
Very often, major customers require or strongly “suggest” that their suppliers implement ISO 9001 systems. Equally often, such customers require independent verification that suppliers are meeting the equirements.
So third-party registration bodies audit suppliers, confirm compliance to the ISO 9001 standard, and register the suppliers. It does not stop there. To stay registered, suppliers must undergo periodic (often semi-annual) surveillance audits, also carried out by their registration body.
Implementing an ISO 9001 quality system is neither cheap, nor easy. How costly and difficult it can be depends on:
a. The level of commitment of senior management. (The single most important factor.)
b. Where you are when you start. If you have already implemented a disciplined, documented quality system, you will have a less difficult time migrating to ISO 9001. (But that does not mean you will waltz to registration, either.)
c. Whether your company (or any part of it) is “design responsible” or not.
d. How much time you have. If you are under the customer’s gun and have merely months to get the job done, the process will be highly stressful.
e. The physical size and configuration of your company.
The bottom line is this. ISO 9001 is a comprehensive set of rules—a business system, really—that can cause the way your organization runs to profoundly change, almost always for the better. Yet, because it is often customer-mandated, many suppliers regard ISO 9001 as “just another hoop to jump through to keep our customers happy.”
They see their choice as swallow hard, pony up, and jump through the hoops; or walk away from the customer. What many do not fully appreciate is that implementing ISO 9001—expensive, exhausting, and annoying as it can be—can also have the salutary effect of improving the performance of your organization. Not just at first, but on an ongoing basis.

ISO 9001 And ISO 14001 Information Site

2009-09-01T15:56:00.001-07:00

ISO 9000 Standard Books & Magazines

2009-08-27T18:12:00.000-07:00

Here are some of the ISO 9000 & ISO 14001 related books & magazines available for online order.
1. ISO Management Systems – English Edition (Magazine Subscription) by Amazon
Format: Magazine
Shipping: Currently, item can be shipped only within the U.S.
Publisher: Iso Central Secretariat
ASIN: B00006KJFO
Iso Focus C-W Iso Management Systems – English ed
2. ISO Focus (Magazine Subscription) by Amazon
Magazine of the International Organization for Standardization providing a panoramic view of what is being done in international standardization, why it has been done and what will be done.
Format: Magazine
Shipping: Currently, item can be shipped only within the U.S.
Publisher: Iso Central Secretariat
ASIN: B0001MS4E6
Iso Focus
3. ISO 9000 Quarterly Report (Magazine Subscription) by Amazon
Format: Magazine
Shipping: Currently, item can be shipped only within the U.S.
Publisher: Rfp Report
ASIN: B00007J7K4
Iso 9000 Quarterly Report
4. A Basic Guide To ISO 14000 – Environment Management System (EMS) provides you with all of the basic information you need in ISO 14000 and ISO 14001:2004.
What is ISO14000
Benefits of ISO 14000
History of ISO 14000
ISO 14000 Certification
ISO 14000 Process Check List
Contents Of ISO 14001:2004
Key Elements Of ISO 14001:2004
Environment Management System Manual
AND MUCH, MUCH MORE!

ISO 9000 Series and Six Sigma

2009-08-25T16:25:00.000-07:00

ISO (International Organization for Standardization) 9000 series standards were first published in 1987, revised in 1994, and re-revised in 2000 by the ISO. The 2000 revision, denoted by ISO 9000:2000, has attracted broad expectations in industry.
As of the year 2001, more than 300,000 organizations world-wide have been certified to the ISO 9000 series standards. It embodies a consistent pair of standards, ISO 9001:2000 and ISO 9004:2000, both of which have been significantly updated and modernized. The ISO 9001:2000 standard specifies requirements for a quality management system for which third-party certification is possible, whereas ISO 9004:2000 provides guide- lines for a comprehensive quality management system and performance improvement through Self-Assessment.
The origin and historical development of ISO 9000 and Six Sigma are very different. The genesis of ISO 9000 can be traced back to the standards that the British aviation industry and the U.S. Air Force developed in the 1920s to reduce the need for inspection by approving the conformance of suppliers’ product quality. These standards developed into requirements for suppliers’ quality assurance systems in a number of western countries in the 1970s. In 1987 they were amalgamated into the ISO 9000 series standards.
Independent of ISO 9000, the same year also saw the launch of Six Sigma at Motorola and the launch of Self-Assessment by means of the Malcolm Baldrige National Quality Award in USA. Both Six Sigma and Self-Assessment can be traced back to Walter A. Shewhart and his work on variation and continuous improvement in the 1920s. It was Japanese industry that pioneered a broad application of these ideas from the 1950s through to the 1970s. When variation and continuous improvement caught the attention of some of the
American business leaders in the late 1980s, it took the form of the Malcolm Baldrige National Quality Award, on a national level, and of Six Sigma at Motorola.
Some people are wondering if the ISO 9000:2000 series standards make Six Sigma superfluous. They typically refer to clause 8 of ISO 9001: It requires that companies install procedures in operations for the measurement of processes and data analysis using statistical techniques with the demonstration of continuous improvement . They also partly refer to the ISO 9004:2000 standards that embody guidelines and criteria for Self-Assessment similar to the national quality awards.
The ISO 9000 series standards have from their early days been regarded and practiced by industry as a minimum set of requirements for doing business. The new ISO 9000:2000 stan
dards do not represent a significant change to this perspective. Six Sigma on the other hand, aims at world-class performance, based on a pragmatic framework for continuous improvement.
The author believes that Six Sigma is superior in such important areas as rate of improvement, bottom-line and top-line results, customer satisfaction, and top-level management commitment. However, considering the stronghold of ISO 9000 in industry, Six Sigma and ISO 9000 are likely to be applied by the same organization, but for very different purposes.

The Development of EMS Standards

2009-08-24T06:51:00.000-07:00

The world’s first standard for environmental management systems (EMS) – BS 7750 – wasdeveloped and published by the British Standards Institution (BSI) in 1992. This standard was the model for the ISO 14000 Series developed by the International Organization for Standardization (ISO). ISO 14001, which establishes the requirements for an EMS, was finalized in 1996. BS 7750 was also the basis for the European Union’s Eco-Management and Audit scheme, known as EMAS.
ISO is an international standard and therefore must incorporate the different interests ofmany countries. This standard clearly has the weakest requirements. By contrast, EMAS is the most stringent and detailed standard reflecting the high environmental standards of German interests and companies which played a key role developing it.
Because ISO 14001 and EMAS are both based on BS 7750, all three standards arequite similar in their approach. If your organization complies with BS 7750 today, little effort will be needed to fullfill the requirements of ISO 14001 or EMAS. Be aware however, that EMAS emphasizes public environmental reporting.
Today there are two major areas in the evaluation of environmental management practice.One area focuses on organizational issues, and the other on products, services and processes.

1. Organization Evaluation
a. Environmental Management Systems (ISO 14001, 14004)
b. Environmental Performance Evaluation (ISO 14014, 14015, 14031)
c. Environmental Auditing (ISO 14010, 14011, 14012, 14013, 14014)

2. Products, Services and Processes

a. Life Cycle Assessment (ISO 14040, 14041, 14042, 14043)

b. Environmental Labeling (ISO 14020, 14021, 14022, 14023, 1402X)

c. Environmental Aspects in Product Standards (ISO 14060)

Measurement and Evaluation In ISO 14001:2004

2009-08-24T06:49:00.000-07:00

After implementing the environmental policy, management needs to measure environmental that the data can be verified by an internal or external auditor.
interventions and their impact on the environment. This is done by building up an environmental effects register (environmental inventory). All equipment used for monitoring and measuring must be accurate and calibrated on a regular basis. To check the compliance status of an organization, additional information about regulations and other requirements is needed. A so called environmental regulations register?Eis often installed and maintained for this purpose. To obtain a better picture about the financial consequences of environmental protection, the accounting system should reflect environmental costs. Therefore, information about environmentally-induced costs and earnings needs to be collected. All this information should be recorded in such a manner.er
Environmental Performance Evaluation Accesses Environment Performance against environmental targets and objectives and against applicable environmental regulations. Responsibilities and authority need to be defined to deal with non-compliance within the EMS. This includes specifying the actions to be taken to correct an undesirable ituation and to prevent future non-compliance.
The analysis of environmental and economic performance leads to eco efficiency, the key component in sustainable business management.
The analysis of environmental and economic performance leads to eco
efficiency, the key component in sustainable business management. The recording of physical environmental data, environmental regulations and environmentally-induced financial information is necessary as a basis for effective decision making. Therefore, financial, legal and ecological data systems must be built up from scratch or adapted to the requirements of the EMS standard.

ISO 9000 Document Audit Software

2009-08-22T16:23:00.000-07:00

ISO 9000 Audit Control Softwares
The ISO 9000 Audit Control Software were designed to handle all aspects of an internal or external audit programme, from planning audits to the follow-up of corrective actions against deficiencies found.The ISO 9000 Audit Control Software increases the accountability and efficiency of your internal/external audits by developing core processes with clearly defined audit plans, step-by-step procedures, and standardized auditor roles and responsibilities. It will help to put you to the right path toward developing a well-organized ISO 9001:2008 internal /external audit system.The ISO 9000 Audit Control Software Provides:-
Audit Schedule – maintains the audit schedule, checklist preparation and all audit info.
Track Non-Conformance – System will help to track all non-conformances found during the audit, including actions & verification.
Corrective Action Report (CAR) – Update of the corrective action.
Security – System provide User Right Control module which enable System Administrator to define the access right to authorized users and activity allowed.
ISO 9000 Audit Control Software comes with:
Unlimited E-mail Support
Help from Real People – Response Time (Within 48 hours)
Fast Download, One-Click Installation
Easy To Use & User Friendly System User Manual

ISO 14001 Auditing and Registration

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ISO 14001 Registration

Aregistration system has grown up around the implementation of the ISO 9000 quality management documents and has formed the basis for a similar system of registration to ISO 14001. At this writing, ISO 14001 is the only specification_ document of the ISO 14000 series and the only standard that is intended to be auditable; all of the other standards are, or will be, guidance documents.

Registrars – Globally, there are 40 – 50 or more organizations established to register organizations to ISO 14001. These registration organizations are accredited by the standards bodies in, for the most part, major industrial nations that have adopted ISO 14001 as their country’s EMS standard. In the U.S., for example, the body that accredits registrars is the ANSI-ASQ National Accreditation Board (ANAB). ANAB passes on the credentials of registrars to register organizations to ISO 14001.

ISO 14001 Audits

First-, second-, or third-party auditors can assess an organization’s conformity to the requirements of the standard. First-party Audits – In the first-party circumstance, the internal auditors of the implementing organization conduct an audit to determine that the EMS has been properly implemented and is being maintained. If the organization passes the internal audit, it may self declare_ its conformity to ISO 14001.

Second-party Audits – In the second-party circumstance, the audit is conducted by a representative of a party interested in the environmental performance of the implementing organization. The interested party_ may be a customer, an environmental regulator, an insurance company, or any other organization affected by the environmental performance of the implementing organization. The second-party audit can be a condition of doing business with the auditor’s organization.

Third-party Audits – In the third-party circumstance, an external EMS auditor conducts an audit, usually at the request of the implementing organization, to determine if the organization conforms to the requirements of ISO 14001. The third-party audit is most often for the purpose of certifying_ that the organization is in conformity with the requirements of ISO 14001.

Typically, when a registration is awarded, it is for a period of three years with a provision for the periodic conduct of surveillance_ audits to ensure continuing conformity.

A principal benefit of the third-party audit is that it compels organizations to continually maintain the EMS in order to pass the follow-up surveillance audits; without this, there might be slippage in the maintenance of ISO 14001.

It is not a requirement of implementing ISO 14001 that organizations have a registration audit conducted; this is a decision made by each organization based upon its determination of the commercial value or necessity of certifying. When an ISO 14001 EMS is intended to be audited,

the requirements must be implemented and documented sufficiently for an auditor/registrar to be

able to conduct the audit based on the finding of objective evidence that the organization has implemented an EMS conforming to ISO 14001.

Establishing objective evidence requires a higher level of documentation and record keeping than is required for mere implementation of ISO 14001. The implementation of ISO 14001 is a simpler task for the organization when it is only seeking to implement the policy and sixteen procedures than when it is implementing with the intention or expectation of being audited.

Implementing ISO 9000 Quality Management System

2009-08-15T21:09:00.000-07:00

Implementing ISO 9000 affects the entire organization right from the start. If pursued with total dedication, it results in ‘cultural transition’ to an atmosphere of continuous improvement.
The process of implementing ISO 9000 depends on:
The sophistication of your existing quality program,
The size of your organization, and
The complexity of your process.
The 14 essential steps, briefly described below, are to be followed through in order to implement ISO 9000 quality management system successfully.
Step 1: Top management commitment
Step 2: Establish implementation team
Step 3. Start ISO 9000 awareness programs
Step 4: Provide Training
Step 5. Conduct initial status survey
Step 6: Create a documented implementation plan
Step 7. Develop quality management system documentation
Step 8: Document control
Step 9. Implementation
Step 10. Internal quality audit
Step 11. Management review
Step 12. Pre-assessment audit
Step 13. Certification and registration
Step 14: Continual Improvement
Step 1: Top Management Commitment
The top management (managing director or chief executive) should demonstrate a commitment and a determination to implement an ISO 9000 quality management system in the organization. Without top management commitment, no quality initiative can succeed. Top management must be convinced that registration and certification will enable the organization to demonstrate to its customers a visible commitment to quality. It should realize that a quality management system would improve overall
business efficiency by elimination of wasteful duplication in management system.
The top management should provide evidence of its commitment to the development and implementation of the quality management system and continually improve its effectiveness by:
a. Communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements,
b. Defining the organization’s quality policy and make this known to every employee,
c. Ensuring that quality objectives are established at all levels and functions,
d. Ensuring the availability of resources required for the development and
implementation of the quality management system,
e. Appointing a management representative to coordinate quality management system activities, and Conducting management review.
The top management should also consider actions such as:
1. Leading the organization by example,
2. Participating in improvement projects,
3. Creating an environment that encourages the involvement of people.
This type of top management commitment may be driven by:
1. Direct marketplace pressure: requirements of crucial customers or parent
conglomerates.
2. Indirect marketplace pressure: increased quality levels and visibility among competitors.
3. Growth ambitions: desire to exploit market opportunities.
4. Personal belief in the value of quality as a goal and quality management systems as a means of reaching that goal.
The top management should identify the goals to be achieved through the quality management system. Typical goals may be:
• Be more efficient and profitable
• Produce products and services that consistently meet customers’ needs and
expectations
• Achieve customers satisfaction
• Increase market share
• Improve communications and morale in the organization
• Reduce costs and liabilities
• Increase confidence in the production system
Step 2. Establish Implementation Team
ISO 9000 is implemented by people. The first phase of implementation calls for the commitment of top management – the CEO and perhaps a handful of other key people.
The next step is to establish implementation team and appoint a Management
Representative (MR) as its coordinator to plan and oversee implementation. Its members should include representatives of all functions of the organization -
Marketing, Design and development, Planning, Production, Quality control, etc.
In the context of the standard, the MR is the person within the Organization who acts as interface between organization management and the ISO 9000 registrar. His role is, in fact, much broader than that. The MR should also act as the organization’s “quality management system champion,” and must be a person with:

1. Total backing from the CEO,
2. Genuine and passionate commitment to quality in general and the ISO 9000 quality
management system in particular,
3. The dignity – resulting from rank, seniority, or both – to influence managers and others of all levels and functions,
4. Detailed knowledge of quality methods in general and ISO 9000 in particular.
The members of the implementation team should also be trained on ISO 9000 quality management systems by a professional training organization.

Step 3. Start ISO 9000 Awareness Programs
ISO 9000 awareness programs should be conducted to communicate to the
employees the aim of the ISO 9000 quality management system; the advantage it offers to employees, customers and the organization; how it will work; and their roles and responsibilities within the system. Suppliers of materials and components should also participate in these programs.
The awareness program should emphasize the benefits that the organization expects to realize through its ISO 9000 quality management system. The program should also stress the higher levels of participation and self-direction that the quality management system renders to employees. Such a focus will go far to enlist employee support and commitment.
The programs could be run either by the implementation team or by experts hired to talk to different levels of employees.
Step 4. Provide Training
Since the ISO 9000 quality management system affects all the areas and all personnel in the organization, training programs should be structured for different categories of employees – senior managers, middle-level managers, supervisors and workers. The ISO 9000 implementation plan should make provision for this training. The training should cover the basic concepts of quality management systems and the standard and their overall impact on the strategic goals of the organization, the changed processes, and the likely work culture implications of the system. In addition, initial training may
also be necessary on writing quality manuals, procedures and work instruction; auditing principles; techniques of laboratory management; calibration; testing procedures, etc.
When in-house capacity to carry out such training is not available, it may be necessary to participate in external training courses run by professional training organizations.
Alternatively, an external training institution could be invited to conduct in-house training courses.

Step 5. Conduct Initial Status Survey
ISO 9000 does not require duplication of effort or redundant system. The goal of ISO 9000 is to create a quality management system that conforms to the standard. This does not preclude incorporating, adapting, and adding onto quality programs already in place. So the next step in the implementation process is to compare the organization’s existing quality management system, if there is one — with the requirements of the
standard (ISO 9001:2008).
For this purpose, an organization flow chart showing how information actually flows (not what should be done) from order placement by the customer to delivery to this customer should be drawn up. From this over-all flow chart, a flow chart of activities in each department should be prepared.
With the aid of the flow charts, a record of existing quality management system should be established. A significant number of written procedures may already be in place.
Unless they are very much out of date, these documents should not be discarded.
Rather, they should be incorporated into the new quality management system.
Documents requiring modification or elaboration should be identified and listed. This
exercise is some times referred to as ” gap analysis”. During these review processes,
wide consultation with executives and representatives of various unions and
associations within the organization is required to enlist their active cooperation.
In the review process, documents should be collected, studied and registered for further use, possibly after they have been revised. Before developing new quality management system documentation, you need to consider with which quality requirements or department you should start. The best is to select an area where processes are fairly well organized, running effectively and functioning satisfactorily.
The basic approach is to determine and record how a process is currently carried out.
We can do this by identifying the people involved and obtaining information from them during individual interviews. Unfortunately, it often happens that different people will give different, contradicting versions of a process. Each one may refer to oral instructions that are not accurate or clear. This is why the facts are often not described correctly the first time around, and have to be revised several times.
Once it has been agreed how to describe the current process, this process has to be adapted, supplemented and implemented according to the requirements of the quality standard (ISO 9001:2008). This requires organizational arrangements, the drawing up of additional documents and possible removal of existing documentation (e.g. procedures, inspection/test plans, inspection/test instructions) and records (e.g.
inspection/test reports, inspection/test certificates).
In introducing a quality management system, the emphasis is on the improvement of the existing processes or the re-organization of processes.
In general, the steps to follow are the following:
Ascertain and establish the following:
What is the present operation/process? What already exists?

Analyze the relevant sections of the quality standard – ISO 9001:2008:
What is actually required?
If necessary, supplement and change operational arrangements in accordance with the standard, develop documents and records, and describe operations/processes:
What is the desired operation/process?
Figure 1: Steps in introducing a quality management system
The above gap analysis can be done internally, if the knowledge level is there. Or a
formal pre-assessment can be obtained from any one of a large number of ISO 9000
consulting, implementing, and registration firms.
Step 6. Create a Documented Implementation Plan
Once the organization has obtained a clear picture of how its quality management system compares with the ISO 9001:2008 standard, all non-conformances must be addressed with a documented implementation plan. Usually, the plan calls for identifying and describing processes to make the organization’s quality management system fully in compliance with the standard.
The implementation plan should be thorough and specific, detailing:
???? Quality documentation to be developed
???? Objective of the system
???? Pertinent ISO 9001:2008 section
???? Person or team responsible
???? Approval required
???? Training required
???? Resources required
???? Estimated completion date
These elements should be organized into a detailed chart, to be reviewed and
approved. The plan should define the responsibilities of different departments and personnel and set target dates for the completion of activities. Once approved, the Management Representative should control, review and update the plan as the implementation process proceeds.
Typical implementation action plan is shown in Figure 2. Use ISO 10005:1995 for guidance in quality planning

Step 7. Develop Quality Management System Documentation
Documentation is the most common area of non-conformance among organizations wishing to implement ISO 9000 quality management systems. As one company pointed out: “When we started our implementation, we found that documentation was inadequate. Even absent, in some areas. Take calibration. Obviously it’s necessary, and obviously we do it, but it wasn’t being documented. Another area was inspection and testing. We inspect and test practically every item that leaves here, but our documentation was inadequate”.
Documentation of the quality management system should include:
???? Documented statements of a quality policy and quality objectives,
???? A quality manual,
???? Documented procedures and records required by the standard ISO 9001:2008, and
???? Documents needed by the organization to ensure the effective planning, operation and control of its processes.
Quality documentation is generally prepared in the three levels indicated in the box that follows. Use ISO 10013:1995 for guidance in quality documentation.

In small companies, the above levels of documentation could be presented in one manual; otherwise, separate manuals should be prepared.
A list of the documents to be prepared should be drawn up and the responsibility for writing the documents should be assigned to the persons concerned in various functional departments. They should be advised to prepare the drafts within a specific time frame.
Step 8: Document Control
Once the necessary quality management system documentation has been generated, a documented system must be created to control it. Control is simply a means of managing the creation, approval, distribution, revision, storage, and disposal of the various types of documentation. Document control systems should be as simple and as easy to operate as possible — sufficient to meet ISO 9001:2008 requirements and that is all.
Document control should include:
???? Approval for adequacy by authorized person (s) before issue,
???? Review, updating and re-approval of documents by authorized person (s),
???? Identification of changes and of the revision status of documents,
???? Availability of relevant versions of documents at points of use,
???? Identification and control of documents of external origin,
???? Assurance of legibility and identifability of documents, and
???? Prevention of unintended use of obsolete documents.
The principle of ISO 9000 document control is that employees should have access to the documentation and records needed to fulfil their responsibilities.
Step 9. Implementation
It is good practice to implement the quality management system being documented as the documentation is developed, although this may be more effective in larger firms. In smaller companies, the quality management system is often implemented all at once throughout the organization. Where phased implementation takes place, the effectiveness of the system in selected areas can be evaluated.
It would be a good idea initially to evaluate areas where the chances of a positive evaluation are high, to maintain the confidence of both management and staff in the merits of implementing the quality management system.
The implementation progress should be monitored to ensure that the quality
management system is effective and conforms to the standard. These activities include internal quality audit, formal corrective action and management review.
Step 10. Internal Quality Audit
As the system is being installed, its effectiveness should be checked by regular internal quality audits. Internal quality audits are conducted to verify that the installed quality management system:

???? Conform to the planned arrangements, to the requirements of the standard (ISO 9001:2008) and to the quality management system requirements established by your organization, and
???? Is effectively implemented and maintained.
Even after the system stabilizes and starts functioning, internal audits should be planned and performed as part of an ongoing strategy.
A few staff members should be trained to carry out internal auditing. Use ISO 19011 for guidance in auditing, auditor qualification and programmes.
Step 11. Management Review
When the installed quality management system has been operating for three to six months, an internal audit and management review should be conducted and corrective actions implemented. The management reviews are conducted to ensure the continuing suitability, adequacy and effectiveness of the quality management system.????
The review should include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.
The input to management review should include information on:
???? Results of audits,
???? Customer feed back,
???? Process performance and product conformity,
???? Status of preventive and corrective actions,
???? Follow-up actions from previous management reviews,
???? Changes that could affect the quality management system, and
???? Recommendations for improvements.
Management reviews should also address the pitfalls to effective implementation, including lack of CEO commitment, failure to involve everyone in the process, and failure to monitor progress and enforce deadlines.
Step 12. Pre-assessment Audit
When system deficiencies are no longer visible, it is normally time to apply for certification. However, before doing so, a pre-assessment audit should be arranged with an independent and qualified auditor. Sometimes certification bodies provide this service for a nominal charge. The pre-assessment audit would provide a degree of confidence for formally going ahead with an application for certification.
Step 13. Certification and Registration
Once the quality management system has been in operation for a few months and has stabilized, a formal application for certification could be made to a selected certification agency. The certification agency first carries out an audit of the documents (referred to as an “adequacy audit”). If the documents conform to the requirements of the quality standard, then on-site audit is carried out. If the certification body finds the system to be working satisfactorily, it awards the organization a certificate, generally
for a period of three years. During this three-year period, it will carry out periodic surveillance audits to ensure that the system is continuing to operate satisfactorily.
Step 14: Continual Improvement
Certification to ISO 9000 should not be an end. You should continually seek to improve the effectiveness and suitability of the quality management system through the use of:
???? Quality policy
???? Quality objectives
???? Audit results
???? Analysis of data
???? Corrective and preventive actions
???? Management review
ISO 9004:2008 provides a methodology for continual improvement.