Quality Systems Standards Questionnaire (Draft)

INTERNATIONAL ORGANIZATION FOR STANDARDIZATION

ISO/TC 210/WG 1, APPLICATION OF QUALITY SYSTEMS TO

MEDICAL DEVICES

As part of the ISO/TC210, Working Group 1 obligation to manage the continuing applicability and relevance of the standards and guidelines it has developed, we are providing this questionnaire to quality systems professionals. The purpose of this questionnaire is to determine the need for modification or updating of the ISO 13485:2003 requirements standard and the ISO/TR 14969:2004 guidance document.

The questionnaire is being sent to quality system professionals in government, industry, and the standards communities. This has been circulated to a comprehensive list of recipients, however, ISO/TC 210 member bodies and other recipients are welcome to forward this list questionnaire to any government agencies, competent authorities, registrars, notified bodies, accreditation bodies, standards groups, industrial organizations or consultants that are appropriate.

The questionnaire is designed to be thought-provoking, without forcing you to spend more than 10 – 20 minutes to complete.

Thank you in advance for your responses; rest assured they will be given serious consideration.

When completed, please send your responses to Rene Whitehead at either of the following:

e-mail address:

or via surface mail to:AAMI

Attn.: Rene Whitehead

1110 N. Glebe Road

Arlington, VA 22201

USA

Or via fax to:+1 (703) 276-0793

Attn.: Rene Whitehead

Name:______

Affiliation:______

Questions

1. The requirements in ISO 13485:2003 play the following role in the contents of my organization’s quality management system (QMS):

  • The sole basis for my QMS’s content ( )
  • Used in conjunction with regulatory requirements (e.g., the FDA Quality System regulation) ( )
  • Not a significant source of requirements ( )
  • Question is not applicable ( )

2. To what extent do you use the content of ISO/TR 14969:2004 to clarify or improve your implementation of ISO 13485:2003 requirements:

  • Never ( )
  • Infrequently ( )
  • Usually ( )
  • Always ( )
  • Question not applicable ( )

3. If the answer to number 2 is either “Never”, “Infrequently”, or “Question not applicable” please provide a short description of why this is so:

4.Do you believe that ISO 13485:2003 represents current QMS practice for your organization:

  • Yes ( )
  • No ( )

5.If your answer to question number 4 was “No”, please provide a short description of the areas where it does not reflect current practice and the reasons for the shortfall:

6.Do you believe that ISO13485:2003 effectively addresses the QMS requirements for current products/services provided by medical device organizations and technologies incorporated into products/services by those organizations?

  • Yes ( )
  • No ( )

7.If your answer to question 6 was “No”, please provide a short description of the areas where it does not reflect current practice and the reasons for the shortfall:

8.Would it be useful for ISO 13485:2003 or a new ISO standard to contain additional requirements or guidance related to:

  1. Management responsibility:yes ( )no ( )
  2. Design and development controls:yes ( )no ( )
  3. Risk management:yes ( )no ( )
  4. Purchasing controls:yes ( )no ( )
  5. Process validation:yes ( )no ( )
  6. Software validation:yes ( )no ( )
  7. Handling of non-conformities:yes ( )no ( )
  8. Corrective action:yes ( )no ( )
  9. Preventive action:yes ( )no ( )
  10. Other process areas:yes ( )no ( )

9.Please provide a brief explanation of any “yes” answers to question 8:

10.Would it be useful for ISO/TR 14969:2004 to contain additional guidance related to:

  1. Management responsibility:yes ( )no ( )
  2. Design and development controls:yes ( )no ( )
  3. Purchasing controls:yes ( )no ( )
  4. Risk management:yes ( )no ( )
  5. Process validation:yes ( )no ( )
  6. Software validation:yes ( )no ( )
  7. Handling of non-conformities:yes ( )no ( )
  8. Corrective action:yes ( )no ( )
  9. Preventive action:yes ( )no ( )
  10. Other process areas:yes ( )no ( )

11.Please provide a brief explanation of any “yes” answers to question 10:

12.Are there any modifications to ISO13485:2003 or ISO TR 14969:2004 that would improve their effectiveness for regulatory purposes?

13.Please provide any other comments you may have:

ISO 13485 Questionnaire 2007Page 1 of 1