Document: ISO/TC 176/SC 2/N
435
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Secretariat of ISO/TC 176/SC 2 To the Members of ISO/TC 176/SC 2 Quality Management and Quality Assurance/ Quality Systems
Date:
25 March 1999
Validation programme for ISO/CD2 9001:2000 and ISO/CD2 9004:2000
1.Introduction ISO/CD2 9001:2000 and ISO/CD2 9004:2000 have recently been circulated for comment and ballot (as document ISO/TC 176/SC 2/N 434). Member bodies are now invited to participate in a programme to validate the CD2s against user requirements. The attached paper is now provided to guide member bodies in organizing and conducting their own validation programmes. The results from each individual validation programme will be merged into the overall SC2 programme. Member bodies are requested to ensure that their validation programmes are conducted effectively, that results are processed speedily, and that programme deadlines are met (see section 4). We recognize that this will require a high level of commitment by member bodies for the validation programme to be successful. The key features of this validation programme require that selected candidate organizations: - conduct an impact assessment of ISO/CD2 9001:2000 (including some assessment of ISO/CD2 9004:2000) - complete a questionnaire on ISO/CD2 9001 and ISO/CD 2 9004. Section 5 of this paper has been designed so that it may be detached and used directly by member bodies for their validation programmes. Member bodies are requested to collate and return their validation programme results by
15 July 1999
to Mme Marie-Helene Notis at AFNOR.
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The results of the overall validation programme will be circulated to member bodies later this year. These results will also provide important input to the drafting teams in producing the next drafts of these standards. It should be noted that this validation programme follows work that was conducted on the earlier CD1 versions of the draft standards, and on the WD3 versions, including the use of a questionnaire. The results of that work have been analyzed and have influenced the design of the enclosed questionnaire. We hope that you are able to accept this invitation, and look forward to receiving your validation programme results. Yours sincerely
Charles Corrie for BSI Secretariat ISO/TC 176/SC 2
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2. Guidance to member bodies on managing the ISO/CD2 9001:2000 and ISO/CD2 9004:2000 Validation Programme
2.1 Translation of CDs and validation guidance
Member bodies may need to have the CD2s, the impact assessment process for ISO/CD2 9001 (see 5.3) and the validation questionnaire translated (see5.4), in order for effective responses to be obtained. This may need to be carried out in parallel with establishing the validation programme (see 2.2).
2.2 Appointment of a Project Leader for the validation programme team
Member bodies should appoint a Project Leader to be responsible for the management of their validation programme and to ensure that the results are processed in a timely fashion. Depending on the numbers of organizations participating in the validation programme, it may be necessary for the member body to appoint a validation team to assist the Project Leader.
2.3 Selection of potential participants for the validation of the CD2s
Potential participants should be selected according to the criteria given in section 3, to ensure that a wide range of users of the future standards is consulted.
2.4 Introduction of the programme to potential participants
Potential participants will need to be advised of the objectives of the validation programme and the benefits they can expect to derive from participating. (For example, participants will have an advanced opportunity to prepare for transition to the revised standards with the assistance of member body experts.)
2.5 Selection of participants
Member bodies should select organizations from their listings of potential participants. Member bodies should ensure that programme participants have access to the following information and documents: Impact Assessment Process for ISO/CD2 9001:2000 (see 5.3) Validation questionnaire (see 5.4) ISO/CD2 9001 : Quality management systems - Requirements ISO/CD2 9004: Quality management systems – Guidance for performance improvement. ISO/TC176/SC2 N376 on Quality management principles and guidelines on their application Notification of the deadlines for the submission of the results of their impact assessments and for the return of completed validation questionnaires
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2.6 Provision of extra assistance to SME´s.
The validation programme requires participants to carry out a study of the CD2s and their quality management systems. This could present a barrier to the participation of small and medium sized enterprises (SME´s) due to their lack of resources, including technical expertise. This may require the provision of additional assistance by member bodies to ensure participation by SMEs in their validation programmes.
2.7 Interim meetings.
It may be useful to set up a series of interim meetings at which representatives from the participant organizations can meet and discuss their individual validation programmes. The value of these meetings to participants would be enhanced by the attendance of the Project Leader and the member body's experts to ISO/TC 176/SC 2/WG 18, who could give further supporting advice. These meetings also provide a way of monitoring progress of the validation programme (see 2.8).
2.8 Monitor Progress.
In order to ensure that the validation programme is effective and that programme deadlines are met, member bodies should maintain contact with participants during the programme and monitor progress. Experience with these types of programmes in other areas has shown that participants need ongoing encouragement and support if the programme is to be successful.
2.9 Processing of replies
Member bodies should collect and check returned impact assessment reports and validation questionnaires, and resolve any points needing clarification. It is requested that member bodies collate and summarize the comments included in returned impact assessment reports, and translate the results into English. Wherever possible, the summarized comments should make reference to specific clauses in the standards. It is suggested that the summarized comments be collated using the same templates as for the return of member body comments against the CD2s (see document ISO/TC 176/SC 2/N 434), before being submitted to AFNOR. The responses in the questionnaires will be processed by AFNOR, using an established database. Member bodies are requested not to pre-process these responses, to avoid problems of incompatibility of data. Copies of the returned questionnaires should just be forwarded to AFNOR. (However, member bodies are free to process this data for their own use.) Separately, it is requested that member bodies advise AFNOR of any problems that were encountered relating to the clarity of the questionnaire itself.
2.10 Submission address for processed replies
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Member bodies are requested to submit their replies marked for the attention of: Marie-Hélène NOTIS AFNOR Tour Europe 92049 PARIS - LA DÉFENSE CEDEX France or preferably by email: marie-helene.notis@email.afnor.fr
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3. Guidance to member bodies on the selection of participating organizations for validation programmes on ISO/CD2 9001:2000 and ISO/CD2 9004:2000.
3.1 Size.
The sample of participants should be selected to be representative of small (independent), medium and large organizations. Each size of organization should be represented. (It should be noted that where a small organization is a part of a larger organization, it may be able to call on resources which an independent company would not have. It may be preferable to confine the sample of small organizations to those that are independent.)
3.2 Product Category.
Organizations that produce or supply products and/or services in one or more of each of the four generic product categories (hardware, software, processed materials, services) should be represented.
3.3 Experience with QMS.
It is considered that only organizations with experience of formal management systems (quality, environmental, etc.) will be able to give an informed response, after an in-depth analysis of the CD2s. If respondents have limited formal management systems experience, they should be clearly identified.
3.4 Profit (commercial) / Non-profit (voluntary/social).
Because of the differences in the way profit and non-profit organizations operate, and differences in management culture, it would be useful to have some representation from non-profit organizations.
3.5 Previous participation in the validation process.
Those organizations which previously participated in the earlier validation work (against the CD1s and the WD3s) should be invited to participate again, since they are particularly well qualified to comment on the latest revisions.
Important note
It is not important to have a large number of participants. The "quality" of the output from the participants is more important, though obviously the exercise will not be statistically valid if there are insufficient participants.
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4. Outline Schedule for the ISO/TC 176/SC 2 Validation Programme for ISO/CD2 9001:2000 and ISO/CD2 9004:2000
Item 1.
Date 1 April 1999
Action ISO/TC 176/SC2 sends validation programme guidance to member bodies
2.
3. 4. 5. 6. 1 July 1999
7.
15 July 1999
Member bodies translate the CD2s, the impact assessment process and the validation questionnaire Member bodies appoint the Project Leader and validation team Member bodies select participating organizations and check that they have the necessary documents and information. Participating organizations commence their impact assessments of ISO/CD2 9001:2000 Member bodies make interim contact with participants to review progress and determine if additional assistance is needed. Deadline for Participating organizations to return impact assessment reports and completed validation questionnaires to their member bodies Member bodies begin forwarding returned questionnaires to AFNOR, and collating (and translating) the impact assessment responses, as they are received. Final date for return of collated comments and questionnaires to AFNOR by member bodies.
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5. Validation Programme for ISO/CD2 9001:2000 and ISO/CD 2 9004:2000
(March 1999)
5.1 Introduction
This validation programme is being conducted by ISO/TC 176/SC 2 to determine whether the future ISO 9001:2000 and ISO 9004:2000 standards will meet customer requirements. The results of this validation programme against the second committee drafts (CD2s) of these future standards will provide valuable inputs into the development of the next level drafts of these standards (the Draft International Standard or DIS stage) which are expected to be achieved later this year. The results of the validation programme will also be made available at that time. Participating organizations are requested: - to study the CD2 draft standards in detail; - to conduct an impact assessment of the potential effects that ISO/CD2 9001:2000 may have on their quality management system (including some assessment of ISO/CD2 9004:2000); - to complete a validation questionnaire on ISO/CD2 9001 and ISO/CD 2 9004. ISO/TC 176/SC 2 member bodies (e.g. a National Standards Body, or recognized Liaison Body) should be able to clarify or give advice on particular aspects of this validation programme.
5.2 Information and Documents required
Participants will need to have access to the following information and documents: Impact Assessment Process for ISO/CD2 9001:2000 (see 5.3) Validation questionnaire (see 5.4) ISO/CD2 9001 : Quality management systems - Requirements ISO/CD2 9004: Quality management systems – Guidance for performance improvement. ISO/TC176/SC2 N376 on Quality management principles and guidelines on their application Notification of the deadlines for the submission of the results of impact assessments and for the return of completed validation questionnaires.
5.3 Impact Assessment Process
5.3.1 Introduction Please conduct an impact assessment of the potential effects of the future ISO 9001:2000 standard on your quality management system (this will also include some assessment of ISO/CD2 9004) against the questions detailed below in 5.3.2 - 5.3.5. Please submit a brief report of the results of your assessment. 5.3.2 Particular Impact Please answer each of the following questions for each of clauses 5 to 8 of ISO/CD2 9001:2000. a) b) c) d) Are there any new requirements? What is needed to comply with the new requirements? Will the new standard require you to perform additional activities (functions/tasks)? Will the new standard require you to change the methods of carrying out existing tasks? ISO/TC 176/SC 2/N 435 8
e) Will the new standard require you to expand existing activities? f) Will the new standard require you to reduce existing activities? g) For items a) - f) above, what benefits or disadvantages do you expect from the changes? h) Are new documents required? If so, estimate how many. 5.3.3 General (overall) Impact Estimate what additional resources may be needed to make the changes detailed in ISO/CD2 9001:2000: a) capital investment (e.g. hardware, software) b) time to fully implement the changes required by the new standard, e.g.: - less than 3 months - 3 to 6 months - 6 to 12 months - more than 12 months. c) external expertise, d) training, e) additional personnel f) top management commitment g) documentation: - Approximately what percentage of documents in your current quality management system will need to be significantly changed (e.g. requiring more than 10% of the text to be changed)? - What levels of documentation will be affected (e.g. quality manual, procedures, operating instructions etc.)? There is no need to be too exact in estimating the above resources. The objective here is find out whether the overall effort will be excessive / prohibitive. 5.3.4 ISO 9004 Please indicate which text (clauses, paragraphs) of ISO/CD2 9004 would NOT: a) help you to understand the concepts involved in the relevant section of ISO/CD2 9001, and why. (Please remember that ISO 9004 is NOT intended to give guidance on how to implement the requirements of ISO 9001.) b) enable your organization to further develop and improve its quality management approach, and why. 5.3.5 Other comments Please indicate any other areas or issues where you consider that the changes to the standards may bring benefits or disadvantages to your organization?
5.4 Validation Questionnaire for ISO/CD2 9001:2000 and ISO/CD 2 9004:2000
Please find a copy of the validation questionnaire attached. This questionnaire addresses both ISO/CD2 9001:2000 and ISO/CD2 9004:2000, and has been developed following the results of earlier validation work against the CD1 and WD3 drafts of the standards.
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5.5 Submission of results
Please return the report of your impact assessment and your completed validation questionnaire to your member body no later than:
1 July 1999
Thank you for your support of the ISO 9000 standards and for your participation in this validation programme.
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VALIDATION QUESTIONNAIRE ON QUALITY MANAGEMENT SYSTEMS STANDARDS ISO/CD2 9001 AND ISO/CD2 9004 (Committee Drafts)
Developed by ISO/TC 176/SC 2/WG 18/TG 1.8.2. Please send the completed questionnaire as soon as possible but not later than: 1 July 1999 to your member body of ISO/TC176/SC2. Please type your responses.
Organization Identification
Name of organization Address Country Contact person e-mail phone
fax
Organization profile
1-49 50-249 over 250
Number of employees in the organization (tick applicable box) User category (tick one box only)
- We primarily use the standard(s) in our own organization - We primarily use the standard(s) to assess suppliers/subcontractors - We primarily use the standard(s) for other purposes (e.g. conformity assessment body, consultants, training provider) Intangible products
Tangible products
Type of product provided
Service (tick applicable box(es))
Software Hardware
Processed material
1 General questions related to the Committee Drafts (ISO/CD2 9001 and ISO/CD2 9004) 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8
The purpose of ISO/CD2 9001 is clear. The purpose of ISO/CD2 9004 is clear. ISO/CD2 9001 can be used without ISO/CD2 9004. ISO/CD2 9004 is easy to understand ISO/CD2 9001 translates easily to your national language ISO/CD2 9004 translates easily to your national language ISO/CD2 9001 gives clear guidance on when an organization may exclude non-applicable requirements The requirements of ISO/CD2 9001 are auditable If you disagree, please provide a separate listing of the specific requirements you feel are not auditable.
Strongly Agree
Agree
Disagree
Strongly disagree
1.9 1.10 1.11
ISO/CD2 9004 can be used for self assessment ISO/CD2 9001 and ISO/CD2 9004 describe a quality management system that is compatible with your environmental management system (note : "compatible" means “that can coexist without conflicting”) ISO/CD2 9001 and ISO/CD2 9004 facilitate integration of the quality management system with your environmental management system (note : "integration" means "combination of two or more systems into one")
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Please note that the questions in sections 2 and 3 are based on the quality management principles as described in ISO/TC176/SC2/N376. 2 Questions relating to ISO/CD2 9004
2.1 ISO/CD2 9004 focuses your organization on interested parties. Please only tick the items where the text of the draft standard needs to be significantly improved. 2.1.1 The meaning of the term "interested parties" (e.g. customers, suppliers, employees, owners, competitors, Society). 2.1.2 Emphasizing the achievement of benefits for all interested parties 2.1.3 Management of relationships with interested parties 2.1.4 Establishing long term and mutually beneficial relationships with key suppliers. 2.1.5 Sharing information and future plans with key suppliers 2.2 ISO/CD2 9004 guides your organization to effectively address leadership Please only tick the items where the text of the draft standard needs to be significantly improved. 2.2.1 Establishment of the vision of the organization's future 2.2.2 Leading by example 2.2.3 Understanding external conditions and changes 2.2.4 Responding to external conditions and changes 2.3 ISO/CD2 9004 promotes involvement of all relevant personnel. Please only tick the items where the text of the draft standard needs to be significantly improved. 2.3.1 Facilitates creativity. 2.3.2 Allows for innovation. 2.3.3 Provides for people to derive satisfaction from work 2.3.4 Enables individual contributions. 2.3.5 Recognizes contributions. 2.4 ISO/CD2 9004 encourages decisions based on analyzed facts. Please only tick the items where the text of the draft standard needs to be significantly improved. 2.4.1 Understanding the value of appropriate tools and techniques for data collection and analysis 2.4.2 The decisions made and the actions taken are based on the results of analysis. 2.5 ISO/CD2 9004 promotes continual improvement Please only tick the items where the text of the draft standard needs to be significantly improved. 2.5.1 Evaluation of customer satisfaction. 2.5.2 Assessment against quality awards criteria. 2.5.3 Review of improvement processes.
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Questions relating to ISO/CD2 9001
3.1 ISO/CD2 9001 focuses your organization on its customers. Please only tick the items where the text of the draft standard needs to be significantly improved. 3.1.1 Identification of customer needs. 3.1.2 Understanding of customer needs. 3.1.3 Communication of customer needs throughout the organization. 3.1.4 Management of relationships with customer 3.2 ISO/CD2 9001 identifies requirements to demonstrate leadership Please only tick the items where the text of the draft standard needs to be significantly improved. 3.2.1 Setting objectives at all relevant levels of the organization 3.2.2 Leading by example 3.2.3 Understanding to external conditions and changes 3.2.4 Responding to external conditions and changes 3.2.5 Promoting open and honest communication. 3.3 ISO/CD2 9001 promotes involvement of all relevant personnel. Please only tick the items where the text of the draft standard needs to be significantly improved. 3.3.1 Facilitates creativity. 3.3.2 Allows for innovation. 3.3.3 Provides for people to derive satisfaction from work 3.3.4 Enables individual contributions. 3.3.4 Recognizes contributions. 3.4 ISO/CD2 9001 promotes mutually beneficial relationships with suppliers. Please only tick the items where the text of the draft standard needs to be significantly improved. 3.4.1 Establishing long term and mutually beneficial relationship with key suppliers. 3.4.2 Establishing effective lines of communication. 3.4.3 Initiating joint development and improvement of relevant products and processes. 3.4.4 Establishing a clear understanding of the mutual benefits. 3.4.5 Sharing information and future plans. 3.4.6 Recognizing supplier improvements and achievements. 3.5 ISO/CD2 9001 encourages process approach Please only tick the items where the text of the draft standard needs to be significantly improved. 3.5.1 Identification of possible hazards 3.5.2 Assessment of risks and consequences.
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3.6 ISO/CD2 9001 encourages system approach to management Please only tick the items where the text of the draft standard needs to be significantly improved. 3.6.1 Controlling interrelations among the processes. 3.6.2 Establish the flow of information within the system 3.7 ISO/CD2 9001 encourages decisions based on analyzed facts. Please only tick the items where the text of the draft standard needs to be significantly improved. 3.7.1 Understanding the value of appropriate tools and techniques for data collection and analysis. 3.8 ISO/CD2 9001 identifies minimum requirements to achieve continual improvement in your organization Please only tick the items where the text of the draft standard needs to be significantly improved. 3.8.1 Use of appropriate quality improvement tools 3.8.2 Evaluation of customer satisfaction. 3.8.3 Review of improvement processes.
Thank you for taking the time to complete the questionnaire.
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