Update to ISO13485 / 14969 - Request for assistance from ISO/TC210 Working Group

R

Roland Cooke

Received from ISO/TC210, I thought this was a good place to highlight it!

ISO/TC210 said:
Ladies and Gentlemen,

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 the attached 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 (see attached list), 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 and rest assured they will be given serious consideration.

DEADLINE: 5 June 2007

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

e-mail address: [email protected]

or via surface mail to:

AAMI
Attn.: Rene Whitehead
1110 N. Glebe Road
Arlington, VA 22201
USA
 

Attachments

  • List of ISO13485 update questionnaire recipients 04 2007.doc
    53.5 KB · Views: 419
  • ISO 13485 and 14969 Questionnaire 04 2007.doc
    66.5 KB · Views: 495
G

Gert Sorensen

I for one am going to have a look at it. Thanks for posting :)
 
R

Roland Cooke

>The questionnaire that was sent previously said “DRAFT” in the header and this has been removed in the attached questionnaire. The content of the questionnaire has not changed.

Best regards,
Hillary Woehrle<
 
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