Friday, November 27, 2009

Quality characteristics in ISO 9000 Standards

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

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

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.

Tuesday, November 24, 2009

ISO 14001 Template

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

Tuesday, November 3, 2009

Free ISO 9000 Standards E-Books

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