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Secretariat of ISO/TC 176/SC 2 Date: DecSeptember 1999
To the Members of ISO/TC 176/SC 2 - Quality Management and Quality Assurance/Quality Systems

Transition Planning Guidance for ISO/DIS 9001:2000

Please find attached a copy of the above Transition Planning Guidance. This supersedes the (Draft) Transition Planning Guidance, that was circulated for comment as document ISO/TC 176/SC 2/N 439.

This has been prepared by ISO/TC 176/SC 2/WG 18 to give advice to users of the ISO 9000 standards on possible transition arrangements that should be considered, when preparing for the advent of the year 2000 ISO 9000 family of standards.

It is strongly recommended that this document be read in conjunction with document ISO/TC 176/SC 2/N 475 Product Introduction Planning Guidance for ISO/DIS 9000:2000, ISO/DIS 9001:2000 and ISO/DIS 9004:2000.

Both these documents are also available from the web site

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

(It should be noted that the Product Introduction Planning Guidance is not given as a single document on the above web site, but may be accessed by going to "Information package" under "Latest Update on ISO 9000 revisions", which will lead enquirers though a series of pages, that together constitute N 475.)

This document is being circulated primarily for information at this time. However, WG 18 would welcome comments against this draft, which will be reviewed at the meeting planned for July 2000. In order to allow for processing of any comments in advance of that meeting, we would request that they be submitted to the Secretariat of ISO/TC 176/SC 2 by:

15 May 2000

Yours sincerely

Charles Corrie

for BSI Secretariat

ISO/TC 176/SC 2

1.0 INTRODUCTION

2.0 EXPLANATION OF TRANSITION PERIOD

2.1 Pre-publication period – Phase One

2.2 Co-existence period – Phase Two

2.2.1 Duration of Phase 2

2.2.2 ISO/TC 176 – IAF – ISO/CASCO

2.3 Definitions of User Groups affected by the Transition Periods

2.3.1 Current Users

2.3.1.1 Users

2.3.1.2 Industry Sector Schemes

2.3.2 Transitional / Intermediate Users

2.3.3 New Users

3.0 TRANSITION GUIDELINES FOR USER GROUPS

3.1 Current Users

3.1.1 Organizations

3.1.2 Industry Sector Schemes and Quality Awards

3.1.3 National Standards Bodies

3.1.4 Accreditation Bodies

3.1.5 Certification/Registration Bodies

3.1.6 Training Bodies and Consultants

3.2 Transitional / Intermediate Users

3.3 New Users

4.0 FREQUENTLY ASKED QUESTIONS

6.0 ISO 9001:1994 / ISO 9001:2000 COMPARISON OF REQUIREMENTS

6.1 Requirements correlation table

6.2 Permissible exclusions

6.3 Correspondence between ISO/DIS 9001:2000 and ISO 9001:1994

6.4 Summarised analysis of key enhancements

1.0 INTRODUCTION

Several of the key standards within the current ISO 9000 family of Quality Management and Quality Assurance standards are being revised to form the core of the future year 2000 ISO 9000 family of standards. These revisions will include:. It is intended that:

The merging of ISO 9001:1994, ISO 9002:1994 and ISO 9003:1994 into a single ISO 9001:2000 standard.

The merging of ISO 8402 and part of the content of ISO 9000-1 into a new ISO 9000:2000 standard.

The revision of ISO 9004-1 into a new ISO 9004:2000 standard.

The merger of ISO 10011 (Parts 1, 2 and 3) with ISO 14010, ISO 14011 and ISO 14012 into a new guidelines standard for quality and environmental management system auditing (to be numbered ISO 19011).

The other 20 or so documents within the current ISO 9000 family of standards will also be formally reviewed by ISO Technical Committee ISO/TC 176, to determine whether they should be revised, amended, or withdrawn from the ISO 9000 family etc., in light of the above revisions.

Following extensive consultation with users of the current ISO 9000 standards, a number of significant changes have been incorporated in the new drafts, particularly concerning their underlying concepts and structures.

In summary, these changes will require users to approach quality management systems as a series of processes, and not merely follow, for example, the 20 element discrete quality management system structure given in ISO 9001:1994.

This process management approach is widely used in today’s business world, and has led to the development of a process-based structure for the future standards. This new process-based structure is consistent with the Plan-Do-Check-Act improvement cycle used in the ISO 14000 family of standards on environmental management systems.

This Transition Planning Guidance has been developed to assist users in understanding the issues that need to be considered during the transition from using ISO 9001:1994, ISO 9002:1994, or ISO 9003:1994 to ISO 9001:2000.

In detailing the Transition Planning Guidance it has been found useful to provide specific guidance to distinct User Groups, as follows:

Current Users

Transitional / Intermediate Users

New Users

2.0 EXPLANATION OF TRANSITION PERIOD

The Transition Period has two distinct phases:

a) Phase One

This relates to the period when ISO 9001:2000 is being developed, until the issue of the approved International Standard. The following development stages are included in Phase one:

CD1(completed): The First Committee Draft (released for comment)

CD2 (completed): The Second Committee Draft (released for comment / ballot)

DIS(started Nov 99): Draft International Standard(released for comment / ballot)

FDIS (estiomated to start Q3/2000): Final Draft International Standard (for ballot)

Although the approved International Standard is not expected to been published until the 4^th quarter of the year 2000, that some user groups have already commenced, or will commence, implementation of ISO 9001:2000 based on the CD1, CD2, DIS or FDIS drafts.

b) Phase Two

This is the period after ISO 9001:2000 has been published, and during which accredited certification/registration to the 1994 editions of ISO 9001, ISO 9002, or ISO 9003 continues to be available, in addition to accredited certification/registration to ISO 9001:2000.

The above phases and their relationship with various user groups are illustrated in the Transition Process Model (see Figure 1).

2.1 Pre-publication period - Phase One

This phase has a direct impact on user groups that have already implemented ISO 9001:1994, ISO 9002:1994, ISO 9003:1994 or ISO 9004:1994 regardless of whether they have sought certification/registration (see annex A, items 1 and 3). It is envisagedexpected that the following user groups will be affected during this phase:

Individual organizations using ISO 9001/9002/9003 (including industry associations)

Industry Sector Schemes and Award Schemes

National Standards Bodies (NSBs)

Accreditation Bodies(ABs)

Certification/Registration Bodies(CB/RBs)

Trainers and Consultants

2.2.1 Duration of Phase 2

This phase concerns the co-existence of the availability of accredited certification to the1994 editions of ISO 9001, ISO 9002, or ISO 9003 and to ISO 9001:2000.

This phase will only last for a specific period, during which users will have to upgrade their quality management systems to meet the requirements of ISO 9001:2000.

In acknowledgement of Certification Body interests and the contractual issues relevant to certification/registration in various countries, it is highly recommended that users contact their Certification/Registration Body, or relevant Accreditation Body, for advice regarding the details or time frame for implementing ISO 9001:2000. This is particularly important when their certificate is subject to expiration based on a periodic audit.

2.2.2 ISO/TC 176 – IAF – ISO/CASCO

In September 1999 a joint meeting was held between the International Accreditation Forum (IAF), ISO/TC176 and ISO/CASCO (ISO Committee for conformity assessment), to try and establish common and consistent messages to ensure a smooth transition to the new standards.

As a result of this meeting, a joint communiqué was issued detailing five specific points concerning the transition to ISO 9001:2000. A copy of this communiqué is given in annex A.

One of the five points specifies a maximum period of three years for the co-existence of accredited certification to the 1994 and yaer year 2000 editions of ISO 9001(see annex A, items 1 to 3). The IAF will co-ordinate enforcement of this policy by the Accreditation Bodies.

ISO/CASCO has also been requested to determine how the current guidelines (ISO/IEC Guide 61 and ISO/IEC Guide 62) that are followed by Certification/Regiatration Registration and Accreditation Bodies are affected by the new ISO 9001:2000. ISO/CASCO will liaise liaise with ISO/TC176 and the IAF during revisions of these these documentsGuides.

<Figure 1>

2.3.1.1 Users of ISO 9001:1994, ISO 9002:1994 or ISO 9003:1994

This user group category is defined as having completed the implementation of ISO 9001:1994, ISO 9002:1994 or ISO 9003:1994, regardless of being certified or not.

(User groups that are in the process of implementing ISO 9001:1994, ISO 9002:1994 or ISO 9003:1994 are addressed as Transitional / Intermediate Users (see 2.3.2)).

2.3.1.2 Users of Industry Sector Schemes, based on ISO 9001:1994, ISO 9002:1994 or ISO 9003:1994

This user group is defined as those using quality management system programmes based on ISO 9001:1994, ISO 9002:1994 or ISO 9003:1994 that include additional quality management system requirements. These form a set of criteria that can either be certified or accredited under the guidelines of a particular Industry Sector Scheme (e.g. ISO/TS 16949 Quality systems – Automotive suppliers – Particular requirements for the application of ISO 9001:1994).

This category of user may be certified or may have no intention to pursue third party certification.

2.3.2 Transitional / Intermediate Users

This user category has been defined as those who are in the process of implementing ISO 9001:1994, ISO 9002:1994 or ISO 9003:1994 and have not yet reached full implementation of the standards' requirements.

It is recognized that this category may also include users who have started to implement quality management systems based on a draft version of the ISO 9001:2000 standard.

This category of user may either be in the process of seeking certification/registration, intending to pursue certification/registration in the near future, or have no intention of becoming certified/registered.

2.3.3 New Users

A New User is defined as an organisation that is either:

Beginning to use ISO 9001:2000 for the first time;

Beginning to implement ISO 9001:1994, ISO 9002:1994 or ISO 9003:1994 for the first time;

Is a potential user.

3.0 TRANSITION GUIDELINES FOR USER GROUPS

3.1.1 Organizations using ISO 9001:1994, ISO 9002:1994 or ISO 9003:1994

Organisations certified to ISO 9001:1994, ISO 9002:1994 or ISO 9003:1994 are recommended to contact their specific Certification Body to discuss the time frame for re-certification or upgrade of current certificates.

to contact their specific Certification Body to discuss the time frame for re-certification or upgrade of current certificates.

To facilitate a smooth transition from ISO 9001:1994, ISO 9002:1994 or ISO 9003:1994 to the ISO 9001:2000 revision (refer figure 2), the following key areas have been identified as important to this user group:

Internal Auditor training (focusing on the changes between the current and the new standards)

Management awareness (focusing on the structure of the new standards and the management role)

General staff awareness programs (to encourage total involvement and understanding)

An understanding of process management

If "permissible exclusions" are applicable to the organization, a clear understanding of the concept and application of "permissible exclusions" will be necessary (see 6.2).

3.1.2 Industry Sector Schemes and Quality Awards

In general, Industry Sector Schemes are based on a relevant 1994 edition of an ISO 9000 standard and are supplemented with additional requirements and/or a higher level of compliance criteria.

In consideration of ISO 9001:2000’s introduction of a process management approach, it is recommended that these user groups commence a strategic plan to assess the continuing suitability or need for supplemental requirements as soon as possible.

At this stage, the evaluation of supplemental requirements should be based on the Draft International Standard (DIS) version of ISO 9001:2000. However, it should be undertaken with full awareness that the Final Draft International Standard (FDIS) may differ from the Draft International Standard (DIS) and similarly, that the International Standard may differ from the Final Draft International Standard (FDIS).

<Figure 2>

While developing supplemental requirements to ISO 9001:2000, it is recommended that the relevant user groups seek:

to ensure consistent interpretation of the ISO 9001:2000 requirements

to establish close relationships with the National Standards Bodies

to establish close relationships with relevant Certification / Registration Bodies or Accreditation Bodies

A consideration for Quality Award related Schemes, or similar programmes, is the role of ISO 9004:2000 in providing guidance for performance improvement and in assisting organizations to move toward TQM.

Although ISO 9004:2000 will be a guideline document, Quality Award Schemes etc. may find it prudent to consider this document in their processes, as ISO 9004:2000 will now include an annex on organizational self-assessment.

 3.1.3 National Standards Bodies

a) Information Focal Point

NSBs will be one of the primary information sources for organizations needing assistance during the transition period.

It is recommended that NSBs establish a focal information point where assistance can be obtained on problems that may be encountered during the initial application of ISO 9001:2000 and related transition issues. These may include, for example, questions relating to transition period timing, legislation issues, withdrawal of ISO 9001:1994, ISO 9002:1994 and ISO 9003:1994, interpretation, permissible exclusions, etc. This will also provide a solid base for consistent communication with all interested parties / user groups.

b) Information output to Users and Interested Parties

In an effort to provide a smooth transition for users and interested parties, information regarding the ISO 9001:2000 revision of the standard should be communicated in a timely manner.

It is recommended that NSBs synchronise their information programmes with the information flows from ISO and ISO/TC 176 (ref. the www.bsi.org.uk/iso-tc176-sc2 web site) and reuse as much first hand information as considered relevant.

The information provided should also advise on the relationship and use of other standards (or documents) in the new ISO 9000:2000 series, especially ISO 9004:2000 and ISO 9000:2000.

c) Translation Issues

If a requirement for translation of the new standards exists, the translation process should be started as early as possible, using the DIS versions of the standardsThis may be of particular importance, given the significance of the changes that have been incorporated into ISO 9001:2000 compared with the previous content of ISO 9001:1994, ISO 9002:1994 and ISO 9003:1994.

(ISO/TC176 will soon be issuing a document "Translation tips" to provide guidance on this subject.)

3.1.4 Accreditation Bodies

Accreditation Bodies should consider the need for reassessment of individual Certification Bodies and their accreditations.

Auditor competence is expected to play a major role during the transition period. Consideration should be given to the criteria that will be used to assess auditor competency in performing audits that verify compliance to ISO 9001:2000.

The recent IAF, ISO/TC 176, ISO/CASCO communiqué has established a policy for consistent accreditation assessment of the competency of Certification/Registration Body personnel with respect to the new standards (see annex A, item 4), in an effort to ensure that all accreditation bodies use uniform criteria.

3.1.5 Certification/Registration Bodies

The changes in the standards are expected to place a relatively heavy burden on the Certification/ Registration Bodies. Not only will they have to plan to meet the changes for their customer organizations, but they will have to plan to address the changes within their own organizations. Many of the items of direct concern to the Certification/ Registration bodies during the transition period have been addressed by the IAF, ISO/TC 176, ISO/CASCO agreement (see annex A).

The following are some of the aspects that should be considered by Certification/ Registration Bodies during the transition process:

Timing of assessment and certification activities based on ISO9001:2000

Arrangement of assessment schedules for existing customer organizations

Training of auditors

Protocols for encouraging users to implement ISO 9001:2000

Timely administration of upgraded certificates

The Certification/Registration bodies will be one of the primary information sources for organizations seeking assistance during the transition period.

It is important that the information they provide is well co-ordinated and consistent with other Certification Bodies. To facilitate this process, it is recommended that the Accreditation Bodies or NSBs participate in this co-ordination task.

Most importantly, Certification Bodies will have the task of informing their existing customer base of certified/registered organisations of the new developments concerning ISO 9001:2000. This should be followed-up by regular communication on the implementation of expected changes in the standard, renewals of certification, individual transition arrangements etc., to avoid any unnecessary confusion.

The competence of their auditors to assess to ISO 9001:2000 should be a major item for consideration by Certification/Registration Bodies during the transition period. It will be necessary to ensure that auditors receive appropriate training to achieve the required levels of competence. It is recommended that Certification/ Registration Bodies start their auditor training programmes as soon as possible.

It is expected that a considerable number of current users will request upgrade audits as soon as possible, to enable them to utilise their audit reports to facilitate their own transition processes. Certification/Registration Bodies should therefore schedule formal assessments to start against the revised ISO 9001 standard at the DIS stage. However, following the IAF, ISO/TC 176, ISO/CASCO agreement, accredited certificates may not be granted until the ISO 9001:2000 standard is published and compliance ensured (see annex A, items 1 –3).

For Certification/Registration Bodies who engage in Certification contracts with their customers, it is recommended that the period of certification is consistent with the impending release of ISO 9001:2000. Ideally, negotiated contract should not support certification to ISO 9001:1994, ISO 9002:1994 or ISO 9003:1994 beyond the publication of ISO 9001:2000. IAF, in consultation with ISO/TC176 and ISO/CASCO recommends limiting certification/registration contracts to the 1994 editions to within one yaer after publication of ISO 9001:2000. Note: Due to the process management approach of ISO 9001:2000, current users who are considering "integrated" management systems may wish to accelerate the implementation of such integrated systems. This in turn will require Certification/ Registration Bodies to respond accordingly and adopt an integrated audit approach.

3.1.6 Training Bodies and Consultants

Training Bodies and consultants have an important role to play in the transition process and are paramount to the success of a smooth transition from ISO 9001:1994, ISO 9002:1994 and ISO 9003:1994 to ISO 9001:2000.

With respect to auditor training, consideration should be given to the currency of existing auditor certification and the protocol to upgrade these auditors in readiness for the release of ISO 9001:2000.

In the past, the 1994 revisions of these standards did not pose the same level of transition complication, due to the minimalist changes that were introduced when compared to the earlier 1987 editions. The ISO 9001:2000 revision however, does provide a number of significant changes that will require sound interpretation of its requirements.

All trainers and consultants should be aware that the issue of a process management approach is the key to the application of ISO 9001:2000.

It is recommended that training bodies start to meet the need for competent auditors and other personnel, by preparing suitable courses based on the available drafts of ISO 9001:2000. The training should be divided into different user applications and be based on factual interpretations and not opinions (see annex A, item 4).

3.2 Transitional / Intermediate Users

Transitional / Intermediate users are those who are currently in the process of implementing ISO 9001:1994, ISO 9002:1994 or ISO 9003:1994.

Due to the change from the current 20 system element structure of the 1994 family of ISO 9000 standards to that of a process management approach, it is strongly recommended that this user group structure their system in accordance with the requirements of ISO 9001:2000. User should not disregard their current system, as parts of it will continue to be required under ISO 9001:2000. However, some system documentation may need to be revised or enhanced to meet the requirements of ISO 9001:2000.

Transitional / Intermediate users should consult with their Certification/Registration Bodies or National Standards Bodies, in order to ensure that their information on the transition of the standards is kept up-to-date.

3.4 New Users

Whilst While new users may be currently considering the implementation of ISO 9001:1994, ISO 9002:1994 or ISO 9003:1994, it is recommended that they also evaluate their quality system objectives with a view to implementing ISO 9001:2000.

Consideration should be given the fact that the 1994 editions of ISO 9001, ISO 9002 and ISO 9003 will be consolidated into the future ISO 9001:2000.

Care should be taken when sourcing training or professional assistance during the implementation of ISO 9001:2000, due to its new structure and process management approach.

New users should commence implementation using the most recent draft available at the time of committing to the implementation of ISO 9001:2000.