Transitioning to ISO 9001:2000

[Marc]

Transition to ISO9001: Year 2000

Subject: FYI: Transition to new 9001/Vianna
Date: Tue, 22 Sep 1998 13:17:38 -0600
From: ISO Standards Discussion

From: "Vianna, Sidney"
Subject: FYI: Transition to new 9001/Vianna

Concerning the transition to the new Edition of the ISO 9000 Standards, I believe that it is important for us to remember that the 1994 Edition brought "minor changes", as compared to the 1987 Edition. The 2000 Edition, by design is supposed to be a major change to the Standards, to incorporate, amongst other things, feedback from the users of such Standards. In connection with this issue, the following was extracted from the ISO Web site:

"...Smooth transition to improved ISO 9000 standards

Change-over to the improved ISO 9000 standards, which ISO aims to publish in November 2000, will be a smooth one for the businesses around the world which are implementing the current versions.

"A major requirement of the ISO 9000 revision process is that organizations which have implemented the current ISO 9000 standards will find it easy to transition to the revised standards," says ISO, adding, "Transition planning guidance is being produced."

ISO (International Organization for Standardization) gives the assurances in a recent document, "Introduction to the revision of the ISO 9000 standards". An estimated 200 000-plus ISO 9000-based quality management systems are being operated worldwide by organizations of all types in order to ensure their efficiency and their ability to meet their customers' requirements. As a result, interest in the Year 2000 revisions of the standards is intense and ISO is keen to keep current and future ISO 9000 users up to date on developments.

The Introduction document summarizes the reasons for revising the ISO 9000 standards and outlines the direction the revisions are taking. In fact, all ISO standards (currently more than 11 500) are reviewed at least every five years to ensure that they remain the state of the art. The ISO 9000 series was published in 1987 and lightly revised in 1994. The Year 2000 revisions will be much more thorough-going, taking into account the considerable international experience of implementing them.

However, ISO says that the revised standards, like the current ones, will impose no rules on the presentation of a quality manual. It states, "This will allow organizations to continue to document their quality management systems in a manner which reflects their own ways of doing business. The revision of the ISO 9000 standards will not require the rewriting of an organization's quality management system documentation."

In order to ensure that the revised standards will be of maximum benefit, ISO has conducted an international survey of user requirements. In addition, it has an ongoing process which allows for direct feedback from users and customers at key points during the development of the revisions. This is helping to determine how well user requirements are being met in the documents under development and to identify opportunities for improving them further before publication as ISO standards.

The revised standards, ISO 9001 and ISO 9004, are currently at the stage of "Committee Drafts" (CD's), which normally are internal documents circulated for comment only to the ISO members directly participating in their development, before their release to ISO's membership as a whole as Draft International Standards, which are publicly available documents. Due to the huge interest in the ISO 9000 revisions, orders for the CD's of ISO 9001 and ISO 9004 may be addressed to ISO national members and to ISO Central Secretariat. However, it should be understood that the documents are dynamic ones which will certainly evolve before they reach the status of International Standards.

ISO/TC 176/SC 2, the ISO technical body responsible for developing the revised standards, has established a WWW site to provide information. Users who would like to give input or to participate in the validation of the standards may contact ISO/TC 176/ SC 2 directly via the WWW site:

http://www.bsi.org.uk/iso-tc176-sc2/

Information may also be obtained from ISO's national members, as well as being posted on ISO's own WWW site, ISO Online: http://www.iso.ch/

For more information: Roger Frost
Press OfficerTel. + 41 22 749 01 11
Fax + 41 22 733 34 30
E-mail [email protected]. . ."

Thanks and regards,

Sidney Vianna
DNV Certification - Long Beach, CA
Tel. 562/435-1908 ext. 209
[email protected]
http://www.dnvcert.com

 

[Marc]

From the ISO.CH site:

Secretariat of ISO/TC 176/SC 2
Date: 30 July 1998

1. Introduction to the revision of the ISO 9000 standards

1.1 Objective

The objective of this paper is to summarize the reasons for revising the ISO 9000 standards along with the directions the revisions are taking.

1.2 Formal standards review

Under ISO protocols, all standards are required to be reviewed at least every five years to determine whether they should be confirmed, revised or withdrawn.

In 1990, ISO/TC 176 adopted a two-phase revision process. The first phase allowed limited change to the standards and was completed in 1994. In 1996, ISO/TC176 reaffirmed the two-phase revision process. The second, more thorough revision phase is ongoing at this time.

1.3 Reasons for a more thorough revision of the ISO 9000 standards

Customer needs are the force driving the revision of these standards. In 1997, ISO/TC 176 conducted a large global survey of 1 120 users and customers to better understand their needs. This was accomplished using a questionnaire covering:

attitudes towards the existing standards requirements for the revised standards the relationship of the quality management system standards to the environmental management system standards.

The following significant user and customer needs were determined from the analysis of these questionnaires:

The revised standards should have increased compatibility with the ISO 14000 series of Environmental Management System Standards The revised standards should have a common structure based on a Process model Provision should be made for the tailoring of ISO 9001 requirements to omit requirements that do not apply to an organization ISO 9001 requirements should include demonstration of continuous improvement and prevention of non-conformity ISO 9001 should address effectiveness while ISO 9004 should address both efficiency and effectiveness ISO 9004 should help achieve benefits for all interested parties, i.e. customers, owners, employees, suppliers and society The revised standards should be simple to use, easy to understand, and use clear language and terminology The revised standards should facilitate self-evaluation The revised standards should be suitable for all sizes of organizations, operating in any economic or industrial sector, and the manufacturing orientation of the current standards should be removed

To ensure that the revised standards satisfy these user and customer needs, a validation process has been implemented. The validation process allows for direct feedback from users and customers at key milestones during the revision process to determine how well these needs are being met and to identify opportunities for improvement.

1.4 Re-structuring and consolidation of the ISO 9000 family of standards

The current ISO 9000 family of standards contains some 20 standards and documents. This proliferation of standards has been a particular concern of ISO 9000 users and customers. To respond to this concern, ISO/TC 176 has agreed that the year 2000 ISO 9000 family of standards will consist of four primary standards supported by a number of technical reports. To the extent possible, the key points in the current 20 standards will be integrated into the four primary standards, and sector needs will be addressed while maintaining the generic nature of the standards. The four primary standards will be:

ISO 9000: Quality management systems – Concepts and vocabulary
ISO 9001: Quality management systems – Requirements
ISO 9004: Quality management systems – Guidelines
ISO 10011: Guidelines for auditing quality systems

The current ISO 8402 Quality vocabulary standard is being revised to become the future ISO 9000 standard. This standard will include an introduction to quality concepts, as well as a revised vocabulary. The revised vocabulary is being developed using a formal approach to the definition of terms.

The current ISO 9001, ISO 9002 and ISO 9003 standards will be consolidated into the single revised ISO 9001 standard. Tailoring of the ISO 9001 requirements will be permitted to omit requirements that do not apply to an organization. Tailoring may be used by those organizations who would today seek registration to ISO 9002 or ISO 9003.

The revised ISO 9001 and ISO 9004 standards are being developed as a "consistent pair" of standards. Whereas the revised ISO 9001 more clearly addresses the quality management system requirements for an organization to demonstrate its capability to meet customer requirements, the revised ISO 9004 is intended to lead beyond ISO 9001 towards the development of a comprehensive quality management system. In particular, the revised ISO 9004 will not be an implementation guide to the revised ISO 9001. The revised ISO 9004 is based on eight quality management principles: customer focus, leadership, involvement of people, process approach, system approach to management, continual improvement, factual approach to decision making, and mutually beneficial supplier relationships.

A draft of the revised ISO 10011 is not available at this time.

1.5 Structure of the revised standards

The revised ISO 9001 and ISO 9004 standards are being developed using a simple process-based structure. This is a departure from the current 20-element structure used in ISO 9001. The new process-based structure is more generic than the current 20-element structure and adopts the process management approach widely used in business today. Also the new process-based structure is consistent with the Plan-Do-Check-Act improvement cycle used in the ISO 14000 standards on environmental management systems. The 20 elements in the current ISO 9001 will be clearly identifiable in the new processed-based structure. The major clause titles in the revised standards will be:

Management responsibility (policy, objectives, planning, quality management system, management review) Resource management (human resources, information, facilities) Process management (customer satisfaction, design, purchasing, production) Measurement, analysis and improvement (audit, process control, continual improvement).

ISO 9001 does not specify requirements on the layout or structure of an organization's quality management system documentation (e.g. it imposes no rules on the presentation of a quality manual), and neither will the revision. This will allow organizations to continue to document their quality management systems in a manner which reflects their own ways of doing business. The revision of the ISO 9000 standards will not require the rewriting of an organization's quality management system documentation. A major requirement of the ISO 9000 revision process is that organizations which have implemented the current ISO 9000 standards will find it easy to transition to the revised standards. Transition planning guidance is being produced.

1.6 Compatibility with the ISO 14000 environmental management system standards

Enhanced compatibility with the ISO 14000 standards is an important customer need. Significant improvements in compatibility of structure, content, language and terminology have been achieved to date, and further improvements will be achieved during the remainder of the ISO 9000 revision cycle and during the upcoming ISO 14000 revision cycle. The goal of this effort is to ensure that common elements of the two series of standards can be readily implemented in a shared manner in whole or in part by organizations without unnecessary duplications or the imposition of conflicting requirements.

1.7 Next steps

The revision work has now produced formal Committee Drafts of the revised standards. These are being circulated to the members of the committee for review. Further formal drafts will be issued during 1999. Information related to the introduction of these revised standards will be provided throughout the remainder of the revision process. Publication of the revised standards is planned for the second half of the year 2000.

 

[Roger Eastin]

This posting is very helpful in understanding the thinking behind the revision. Is there an implementation date (effective date) for the new revision? It looks like it will in the fall of 2000. Is this right?

 

[Marc]

My understanding is late fall or winter of the year 2000.

 

[Marc]

The original is at:

http://www.bsi.org.uk/bsi/services/revisions.htm

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ISO 9000 Revisions

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BSI Briefing Note: Issue 2 September 1998

This communications brief is the second of a series in which we aim to keep you up to date on the proposals and the implications of the revisions to the ISO 9000 standards.

New Timings

The publication schedule has been brought forward slightly to make the revision of ISO 9000 compatible with ISO's proposed review of ISO 14001 in the year 2000.

ISO 9000 Schedule

August 1998 Committee Drafts issued for public comment 1 November 1998 All comments on drafts deadline February 1999 Committee Drafts for ballot

November 1999 Draft of International Standards to be issued

April 2000 Final Draft of International Standards to be issued November 2000 New Standards to be published

New Titles for the Standards

New titles (and definitions) are due to be introduced for the two core standards, ISO 9001 and ISO 9004. These will be:

ISO 9001
Quality Management Systems - Requirements

ISO 9004
Quality Management Systems - Guidelines

There will also be a third ISO 9000 standard entitled:
Quality Management Systems - Concepts and Vocabulary.

Future Standards

A New Standard - ISO 10011 - Guidelines For Auditing Quality Systems is proposed, however, a draft is not yet available. We will advise you in this bulletin when it is published.

Change in Emphasis

The major proposed change is a move from a system-based to a process-based management approach. This is seen as a logical progression in line with other contemporary business management initiatives. There will be greater emphasis placed upon human and physical resources, on customer satisfaction and organizational improvement. A 'process' is defined as: one or more activities, subject to controls, which use different resources to transform inputs into outputs (there is further information on processes in ISO/CD1 9000:1998 3.3 and 4.2.1).

Plan; Do; Check; Act.

The process models for the standards show the four main elements of ISO 9001 and ISO 9004 following the Plan-Do-Check-Act cycle. The correlation is as follows:

Plan = Management Responsibility/Resource Management Do = Process Management Check = Measurement, Analysis/Improvement Act = (Measurement), Analysis/Improvement + Management Responsibility

[iso9000 management responsibility] The diagram above shows the relationship between the four main elements of ISO 9001 and ISO 9004: Management Responsibility, Resource Management, Process Management, Measurement, Analysis and Improvement. The next Briefing Note will begin to explain the changes relating to the four main elements within the Standard.

You can help to shape them

You may want to participate in the process of change. To do so, buy a copy of the Drafts for Public Comment and give us your opinions. Or you can access the BSI website on www.bsi.org.uk/iso-tc176-sc2 and download the comments template (you can also visit the site for regular Standards updates). Add your comments, then e-mail them to Carol Eddleston.

You can prepare now for the changes

We recommend that you do not amend your current quality system documentation, but continue to use the 1994 versions. Meanwhile, read the drafts, attend a seminar and follow up with your registrar.


You will be able to obtain copies, from mid - August, and information by phoning
BSI UK Customer Services 0181 996 9001
BSI Inc +1 703 437 9000
BSI Pacific Limited, Hong Kong +852 2742-5638
BSI Pacific Limited Taiwan Branch +886-2 2585-9810
The next Briefing Note will be issued in February 1999.
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Copyright BSI 1998