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!
Thursday, August 27, 2009
Tuesday, August 25, 2009
ISO 9000 Series and Six Sigma
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.
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.
Monday, August 24, 2009
The Development of EMS Standards
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)
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
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.
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.
Saturday, August 22, 2009
ISO 9000 Document Audit Software
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
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
Monday, August 17, 2009
ISO 14001 Auditing and Registration
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.
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.
Saturday, August 15, 2009
Implementing ISO 9000 Quality Management System
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.
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.
Subscribe to:
Posts (Atom)