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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.

2 Information and Documents required

Participants will need to have access to the following information and documents:

3 Impact Assessment Process

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 3.2 - 3.5.

Please submit a brief report of the results of your assessment.

3.2 Particular Impact

Please answer each of the following questions for each of clauses 5 to 8 of ISO/CD2 9001:2000.

  1. Are there any new requirements?
  2. What is needed to comply with the new requirements?
  3. Will the new standard require you to perform additional activities (functions/tasks)?
  4. Will the new standard require you to change the methods of carrying out existing tasks?
  5. Will the new standard require you to expand existing activities?
  6. Will the new standard require you to reduce existing activities?
  7. For items a) - f) above, what benefits or disadvantages do you expect from the changes?
  8. Are new documents required? If so, estimate how many.

3.3 General (overall) Impact

Estimate what additional resources may be needed to make the changes detailed in ISO/CD2 9001:2000:

  1. capital investment (e.g. hardware, software)
  2. time to fully implement the changes required by the new standard, e.g.:

    3. - less than 3 months

    - 3 to 6 months

    - 6 to 12 months

    - more than 12 months.

  3. external expertise,
  4. training,
  5. additional personnel
  6. top management commitment
  7. 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.

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.

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?

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.

 

 

 

 

5 Submission of results

Please return the report of your impact assessment and your completed validation questionnaire to your member body no later than:

20 June 1999

 

 

Thank you for your support of the ISO 9000 standards and for your participation in this validation programme.
 

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: 20 June 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

Software

Hardware

Processed material

(tick applicable box(es))

¨

¨

¨

¨

 
   

1

General questions related to the Committee Drafts
(ISO/CD2 9001 and ISO/CD2 9004)

Strongly Agree

Agree

Disagree

Strongly disagree

1.1

The purpose of ISO/CD2 9001 is clear.

¨

¨

¨

¨

1.2

The purpose of ISO/CD2 9004 is clear.

¨

¨

¨

¨

1.3

ISO/CD2 9001 can be used without ISO/CD2 9004.

¨

¨

¨

¨

1.4

ISO/CD2 9004 is easy to understand

¨

¨

¨

¨

1.5

ISO/CD2 9001 translates easily to your national language

¨

¨

¨

¨

1.6

ISO/CD2 9004 translates easily to your national language

¨

¨

¨

¨

1.7

ISO/CD2 9001 gives clear guidance on when an organization may exclude non-applicable requirements

¨

¨

¨

¨

1.8

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.

¨

¨

¨

¨

1.9

ISO/CD2 9004 can be used for self assessment

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¨

¨

¨

1.10

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")

¨

¨

¨

¨

1.11

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")

¨

¨

¨

¨

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.

¨

 

3

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.

¨

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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