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Welcome to the Whittington & Associates e-Newsletter! Visit and bookmark our web site today: http://www.WhittingtonAssociates.com This
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Only 1 in 20 organizations registered to a 1994 version of ISO 9001, ISO 9002, or ISO 9003 have completed the move to ISO 9001:2000. The International Accreditation Forum (IAF) has issued a statement warning organizations that time is running out. Since 1994 certificates expire at midnight on December 14, 2003, only about half of the original 3 year transition period is remaining. The IAF consists of many of the world's best known accreditation bodies, including the National Accreditation Program in the United States. Their statement said if organizations postpone the transition to the latter part of next year, registrars may be overloaded and unable to schedule the extra audit days. Organizations are being encouraged to begin the transition process as soon as possible. Three years sounded
like a long time when the transition period was first announced. The deadline
now seems much closer. Read my article, Ten Tips for Moving to ISO
9001:2000, in the April 2002 issue of Quality Digest. Also see a copy
in Resources
at our web site.
A March 2002 article in Quality System Update (and the April 2002 issue of Quality Progress) described survey results for organizations that have completed registration to ISO 9001:2000. One quarter of the respondents said they needed an extra audit day from their registrar to complete the registration. Another quarter reported it took them two extra audit days. Three or more additional days were needed by one fifth of the surveyed organizations. About one third said they completed the transition process without requiring any extra audit days. The benefits most commonly attributed to ISO 9001:2000 were:
A new edition of ISO/TS 16949 has been published for international automotive suppliers. An ISO press release stated that the technical specification is expected to become the common and unique basis for the automotive industry's quality management system requirements worldwide, gradually replacing the multiple national specifications now used by the sector (e.g., QS-9000, AVSQ, VDA6.1, and EAQF). The official title is: ISO/TS 16949:2002, Quality management systems - Particular requirements for the application of ISO 9001:2000 for automotive production and relevant service part organizations. The new document was developed by a partnership comprised of the International Automotive Task Force (IATF) and the Japan Automobile Manufacturers Association (JAMA), with the support of ISO technical committee ISO/TC 176, which is responsible for the ISO 9000 family of quality management standards Henry Gryn, leader of the IATF delegation, commented, "The IATF is pleased to announce the release of ISO/TS 16949:2002 for the global automotive supply chain. This technical specification is a value-adding document for the automotive sector. The process for completion was fast and involved participation by original equipment manufacturers, suppliers, and ISO/TC 176 members. We believe that this technical specification, when coupled with its accompanying registration scheme, has significant benefits for the suppliers to whom it is applicable and for subscribing OEM's." Pierre Caillibot, chairman of ISO/TC 176, observed, "The publication of the second edition of ISO/TS 16949 marks an important step for the automotive industry worldwide. It confirms that the profound changes made to ISO 9001 in its year 2000 edition have not diminished its relevance as the undisputed foundation standard for quality management systems. This is good news for the hundreds of thousands of organizations which have elected over the years to implement the ISO 9000 standards. The anticipated use of ISO/TS 16949:2002 by the automotive industry worldwide also signals that the goal of converging sector-specific initiatives on to the foundation of ISO 9001:2000 is a realistic one." ISO/TS 16949:2002 can be used to develop a system that continually improves, emphasizes defect prevention, and reduces variation and waste in the supply chain. Incorporating the requirements of ISO 9001:2000, it also includes detailed, sector-specific requirements for employee competence, awareness and training, design and development, production and service provision, control of monitoring and measuring devices, and measurement, analysis, and improvement. The individual OEM members of the IATF, including DaimlerChrysler, General Motors, Ford, Fiat, PSA Peugeot Citroën, Renault, BMW, and Volkswagen, are now in the process of formulating or announcing their policies for implementation of the technical specification by their respective supply bases. The QS-9000 Supplier
Quality Requirements Task Force (DaimlerChrysler, Ford, and General Motors)
has reached an agreement with ISO that will permit them to use the ISO
9001:1994 requirements as part of QS-9000:1998 until December 14, 2006.
This three year extension beyond the withdrawal date for ISO 9001:1994
will allow the Task Force to develop plans for an orderly transition to
ISO/TS 16949:2002.
You can order a copy of ISO/TS 16949:2002 by calling the Automotive Industry Action Group (AIAG) at 248-358-3003 and asking for publication code TS-2. The price of the document is $25 for AIAG members and $75 for non-AIAG members. Supporting documents will include: ISO/TS 16949:2002
Guidance Supplement (TS-GS): Provides guidance and clarifications
for application of ISO /TS 16949:2002.
The International Accreditation Forum (IAF) has published Issue 2 of their guidance document on the application of ISO Guide 62. The guidance will be adopted by the accreditation bodies by July 1, 2002 and become part of their general rules of operation. ISO Guide 62 specifies the criteria for registrars that operate assessment and registration of quality management systems. The IAF guidance is used by the accreditation bodies to ensure consistent accreditation of registrars. Annex 2 provides
guidance to registrars on the amount of time required to assess organizations
of differing sizes and complexities. The auditor time chart shows the
average number of auditor days (initial audit) for organizations with
different numbers of employees.
The table entries continue in the guidance document for up to 10700 employees (22 auditor days). A note says to follow the depicted progression of auditor days for organizations over 10700 employees. The guidance reminds the reader that the listed auditor days are an average based on experience. The chart is used as a starting point and days are added or subtracted according to audit factors such as: More Time Needed
Surveillance audit days per year are about 1/3 of the time spent on the initial audit. Of course, the surveillance days must reviewed over time to account for any changes to the organization and its related audit factors. The IAF guidance
document for Guide 62 is available to download for free at <http://www.accreditationforum.com>.
Click on the Documentation tab to see the list of available IAF guidance
documents.
Clause 0.1 - Introduction to ISO 9001:2000 says the eight quality management principles stated in ISO 9000:2000 and ISO 9004:2000 were considered in the development of ISO 9001:2000. According to ISO 9000:2000, these principles can be used by management to lead an organization towards improved performance. Now the big question: Will the registrar assess the degree to which your organization has applied these principles? In a fashion, yes - because the quality management principles were used to develop the requirements of ISO 9001:2000. If your system is in conformity with the standard, there will be evidence you have adopted the principles (although the principles are not stated as requirements). 1. Customer Focus Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer. requirements, and strive to exceed customer expectations. This principle is addressed by: 5.1.a - Management
Responsibility - Management Commitment 5.2 - Management
Responsibility - Customer Focus 5.5.1 - Management
Responsibility - Management Representative 5.6.2 - Management
Responsibility - Management Review - Review Input 6.1.b - Resource
Management - Provision of Resource 7.2 - Product
Realization - Customer-Related Processes 7.5.4 - Product
Realization - Production and Service Provision - Customer Property
8.2.1 - Measurement,
Analysis, and Improvement - Customer Satisfaction 8.4.a - Measurement,
Analysis, and Improvement - Analysis of Data 8.5.2.a - Measurement,
Analysis, and Improvement - Corrective Action 2. Leadership Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization's objectives. This principle is addressed by: 5.1 - Management
Responsibility - Management Commitment 5.3 - Management
Responsibility - Quality Policy 5.4.1 - Management
Responsibility - Planning - Quality Objectives 5.5.2. - Management
Responsibility - Responsibility, Authority, and Communication - Management
Representative 5.5.3 - Management
Responsibility - Responsibility, Authority, and Communication - Internal
Communication 3. Involvement of People People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization's benefit. This principle is addressed by: 5.1.a - Management
Responsibility - Management Commitment 5.5.1 - Responsibility,
Authority, and Communication - Responsibility and Authority
6.2.2.b - Resource
Management - Competence, Awareness, and Training 6.2.2.d - Resource
Management - Competence, Awareness, and Training 4. Process Approach A desired result is achieved more efficiently when activities and related resources are managed as a process. This principle is addressed by: 4.1.a - Quality
Management System - General Requirements 7.1 - Product
Realization - Planning of Product Realization 7.3 - Product
Realization - Design and Development - Design and Development Planning
7.5 - Product
Realization - Production and Service Provision 8.1 - Measurement,
Analysis, and Improvement - General 5. System Approach to Management Identifying, understanding, and managing interrelated processes as a system contributes to the organization's effectiveness and efficiency in achieving its objectives. This principle is addressed by: 4.1.a - Quality
Management System - General Requirements 4.1.b - Quality
Management System - General Requirements 4.1.c - Quality
Management System - General Requirements 4.1.d - Quality
Management System - General Requirements 4.1.e - Quality
Management System - General Requirements 4.1.f - Quality
Management System - General Requirements 4 - Quality Management
System - General Requirements 4.2.2.c - Quality
Management System - Documentation Requirements - Quality Manual
6. Continual Improvement Continual improvement of the organization's overall performance should be a permanent objective of the organization. This principle is addressed by: 4.1.f - Quality
Management System - General Requirements 5.3.b - Management
Responsibility - Quality Policy 8.1.c - Measurement,
Analysis, and Improvement - General 8.5.1 Improvement
- Continual Improvement 7. Factual Approach to Management Effective decisions are based on the analysis of data and information. This principle is addressed by: 5.6.2 - Management
Responsibility - Management Review - Review Input 5.6.3 - Management
Responsibility - Management Review - Output 8.4 - Measurement,
Analysis, and Improvement - Analysis of Data 8.5.1 - Measurement,
Analysis, and Improvement - Continual Improvement 8. Mutually Beneficial Supplier Relationships An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value. This principle is addressed by: 7.4.1 - Product
Realization - Purchasing - Purchasing Process 7.4.2 - Product
Realization - Purchasing - Purchasing Information 8.4.d - Measurement,
Analysis, and Improvement - Analysis of Data In summary, the
requirements of ISO 9001:2000 are based on the eight quality management
principles. The clauses listed are examples.. I'm sure you can find others
that demonstrate the application of these principles in your system.
To enroll in any of these public classes, go to the Class Schedule at our web site, or call us at 800-404-7585. The classes taught by Larry Whittington are shown in gold. ISO 9001:2000
Lead Auditor (ANSI/RAB-NAP Accredited) - CEEM, Inc.
ISO 9001:2000
Internal Auditor (ANSI/RAB-NAP Accredited) - CEEM, Inc.
ISO 9001:2000
Auditor Transition (RAB-Approved)
Implementing
ISO 9001:2000 (for New Systems)
ISO 9001:2000
Conversion (for Existing Systems)
Quality System
Documentation (Revised for ISO 9001:2000)
To arrange an
economical on-site class, please call us at 800-404-7585.
56th Annual
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Congress 22nd Southeastern
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for Advancement of Material and Process Engineering Customer-Supplier
Division Conference 57th Annual
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