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May, 2002

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May Articles
Training Spotlight
1. Transition Deadline for ISO 9001:2000

2. Feedback from Early Movers to ISO 9001:2000

3. New Edition of ISO/TS 16949:2002 Published

4. Documents Available for ISO/TS 16949:2002

5. Revised Guidance for Accreditation of Registrars

6. ISO 9001:2000 and Quality Management Principles

7. Class Schedule: May, 2002 - July, 2002

8. Schedule of Quality Events

To see previous articles, go to Newsletter Archives.

Atlanta, Georgia

ISO 9001:2000 Internal Auditor
June 17-19, 2002

ISO 9001:2000 Lead Auditor
May 20-24, 2002

July 22-26, 2002

ISO 9001:2000 Auditor Transition
May 16-17, 2002

Implementing ISO 9001:2000
June 10-11, 2002

Quality System Documentation
June 12-13, 2002

Training Classes in Other Cities

1. Transition Deadline for ISO 9001:2000

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.
 
2. Feedback from Early Movers to ISO 9001:2000 

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:

  • Use of data for business management
  • Improved customer satisfaction
  • Increased management commitment
  • More effective management reviews
  • Improved customer communication
The survey performed by the Product Support Initiative is sponsored by the US Technical Advisory Group to ISO TC 176 and the American Society for Quality. To complete the survey for your organization, go to: <http://www.asq.org/mr/psisurvey.html>.
 
3. New Edition of ISO/TS 16949:2002 Published

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.
 
4. Documents Available for 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.
QSA Checklist to ISO/TS 16949:2002 (TS-QSA2): Similar to the QS-9000 checklist. Registrar auditors must cover all the entries.

 
5. Revised Guidance for Accreditation of Registrars 

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.
 
Employees
Days
1-10
2
11-25
3
26-45
4
46-65
5
66-85
6
86-125
7
126-175
8
176-275
9
276-425
10
426-625
11
626-875
12

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

  • Complicated logistics (multiple buildings or locations)
  • Staff speaking more than one language (interpretation)
  • High degree of regulation (food and drugs; aerospace)
  • Highly complex processes or many unique activities
  • Combinations of hardware, software, process, or service
Less Time Needed
  • Reduced scope due to exclusions (e.g., not design responsible)
  • Registrar knowledge of system (registered to another standard)
  • Very small site for number of employees (only office complex)
  • Processes involve only a single general activity (e.g., service)
  • High percentage of employees perform the same simple tasks
If a registrar adjusts the auditor days for an initial audit, sufficient records must be kept to justify the variation. The IAF guidance states it is unlikely the adjustments would reduce the time by more than 30% from the listed auditor days.

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.
 
6. ISO 9001:2000 and Quality Management Principles

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
(communicate importance of meeting customer requirements)

5.2 - Management Responsibility - Customer Focus
(ensure customer requirements are determined and met)

5.5.1 - Management Responsibility - Management Representative
(ensure promotion of awareness of customer requirements)

5.6.2 - Management Responsibility - Management Review - Review Input
(include information on customer feedback)

6.1.b - Resource Management - Provision of  Resource
(provide resources to enhance customer satisfaction)

7.2 - Product Realization - Customer-Related Processes
(determine and review the customer requirements)

(implement effective communication with customers)

7.5.4 - Product Realization - Production and Service Provision - Customer Property
(exercise care with customer property)

8.2.1 - Measurement, Analysis, and Improvement - Customer Satisfaction
(monitor customer perception as to how well you are meeting requirements)

8.4.a - Measurement, Analysis, and Improvement  - Analysis of Data
(analyze data to provide information on customer satisfaction)

8.5.2.a - Measurement, Analysis, and Improvement - Corrective Action
(define the requirements for reviewing customer complaints)

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
(provide evidence of commitment to the effectiveness of the system)

5.3 - Management Responsibility - Quality Policy
(establish and communicate the quality policy to the organization)

5.4.1 - Management Responsibility - Planning - Quality Objectives
(establish measurable quality objectives within the organization)

5.5.2. - Management Responsibility - Responsibility, Authority, and Communication - Management Representative
(appoint member of management to be responsible for system)

5.5.3 - Management Responsibility - Responsibility, Authority, and Communication - Internal Communication
(ensure communication within the organization on system effectiveness)

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
(communicate importance of meeting customer requirements)

5.5.1 - Responsibility, Authority, and Communication - Responsibility and Authority
(define and communicate responsibilities and authority within the organization)

6.2.2.b - Resource Management - Competence, Awareness, and Training
(train personnel in order to meet the competency needs of the organization)

6.2.2.d - Resource Management - Competence, Awareness, and Training
(ensure personnel are aware of relevance and importance of their activities)

(ensure they are aware of how they contribute to achievement of objectives)

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
(identify the processes needed for the quality management system)

7.1 - Product Realization - Planning of Product Realization
(plan and develop the processes needed for product realization)

7.3 - Product Realization - Design and Development - Design and Development Planning
(determine the design and development stages)

7.5 - Product Realization - Production and Service Provision
(validate any special processes needed for production and service provision)

8.1 - Measurement, Analysis, and Improvement - General
(plan and implement the measurement, analysis, and improvement processes)

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
(identify the application of the processes throughout the organization)

4.1.b - Quality Management System - General Requirements
(determine the sequence and interaction of the processes)

4.1.c - Quality Management System - General Requirements
(determine the criteria and methods for effective process operation)

4.1.d - Quality Management System - General Requirements
(provide resources and information to support the processes)

4.1.e - Quality Management System - General Requirements
(monitor, measure, and analyze the processes)

4.1.f - Quality Management System - General Requirements
(implement actions to achieve the planned results for the processes)

4 - Quality Management System - General Requirements
(manage processes in accordance with ISO 9001:2000 requirements)

4.2.2.c - Quality Management System - Documentation Requirements - Quality Manual
(describe the interaction between the processes of the system)

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
(implement actions for continual improvement)

5.3.b - Management Responsibility - Quality Policy
(include a commitment to continually improve the system)

8.1.c - Measurement, Analysis, and Improvement - General
(evaluate where continual improvement can be made)

8.5.1 Improvement - Continual Improvement
(continually improve the effectiveness of the system)

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
(reviews of quality management system must cover specific information)

5.6.3 - Management Responsibility - Management Review - Output
(recording of management reviews must include decisions and actions)

8.4 - Measurement, Analysis, and Improvement - Analysis of Data
(determine, collect, and analyze data about the system

8.5.1 - Measurement, Analysis, and Improvement - Continual Improvement
(continually improve the system through the analysis of data)

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
(ensure the purchased product conforms to the specified requirements)

(evaluate and select suppliers based on their ability to meet requirements)

7.4.2 - Product Realization - Purchasing - Purchasing Information
(ensure adequacy of requirements before communicating them to suppliers)

8.4.d - Measurement, Analysis, and Improvement - Analysis of Data
(analyze data to provide information about suppliers)

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.
 
7. Class Schedule for May, 2002 - July, 2002

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.
 
May June July
4/29-5/3  Chicago, IL 03-07  San Antonio, TX 08-12  Phoenix, AZ
06-10  San Jose, CA 10-14  San Diego, CA 15-19  Reston, VA
13-17  Orlando, FL 17-21  Charlotte, NC 22-26  Dallas, TX 
20-24  Atlanta, GA  24-28  Chicago, IL 29-02  San Jose, CA

ISO 9001:2000 Internal Auditor (ANSI/RAB-NAP Accredited) - CEEM, Inc.
 
May June July
13-15  San Jose, CA 12-14  Reston, VA July 08-10  Reston, VA
  - -  17-19  Atlanta, GA   - -

ISO 9001:2000 Auditor Transition (RAB-Approved)
* Auditor Refresher (same content as Auditor Transition)

 
May June July
16-17  Atlanta, GA * 10-11  Reston, VA 16-17  Dallas, TX
22-23  Orlando, FL   - -   - -

Implementing ISO 9001:2000 (for New Systems)
 
May June July
20-21  Orlando, FL 10-11  Atlanta 18-19  Dallas, TX
30-31  San Antonio, TX   - -   - -

ISO 9001:2000 Conversion (for Existing Systems)
Note: A two-day Conversion course is available for on-site classes.

 
May June July
01-03  San Jose, CA 05-07  Reston, VA 15-17  Phoenix, AZ 

Quality System Documentation (Revised for ISO 9001:2000)
 
May June July
16-17  San Jose, CA 12-13  Atlanta, GA 11-12  Reston, VA

To arrange an economical on-site class, please call us at 800-404-7585.
 
8. Schedule of Quality Events

56th Annual ASQ Quality Conference
May 20-22, 2002 in Denver, CO

Quality Expo Detroit
June 12-13, 2002 in Novi, MI

Conference On Quality In Commercial Aviation
September 22-25, 2002 in Dallas, TX

11th Annual Service Quality Conference
September 23-24, 2002 in Las Vegas, NV

10th National Quality Education Conference
September 28 - October 1, 2002 in  Columbus, OH

World Quality Congress
September 29 - October 2, 2002 in Harrogate, United Kingdom

22nd Southeastern Quality Conference
October 21-22, 2002 in Atlanta, GA

APICS International Conference and Exposition
October 27-30, 2002 in Nashville, TN

12th International Conference on Software Quality
October 28-30, 2002 in Ottawa, Canada

Society for Advancement of Material and Process Engineering
34th International Technical Conference
November 4-7, 2002 in Baltimore, MD

Customer-Supplier Division Conference
November 5-6, 2002 in Louisville, KY

57th Annual ASQ Quality Conference
May 19-21, 2003 in Kansas City, MO


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