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Marc Hunkered Down for the Duration Staff member. Sep 2, Thank you for pointing this out. Hi there, Is this handbook available anywhere? Marcelo Inactive Registered Visitor Oct 12, It's still being drafted. Jeffers Starting to get Involved Mar 22, Hello Marcelo, It has been a few months since this post was mentioned. My best friend google was not able to uncover any new results for the ISO Handbook. Does anyone have an idea when this will be published? Are any drafts available? Thanks in advance.
Marcelo Inactive Registered Visitor Mar 22, It's still in development, the last step was an internal ballot which was positive to send to the ISO TMB for publication. It is planned to be published this first semester. The drafts are only internal to the working group. Jul 5, Marcelo Antunes said:.
Marcelo Inactive Registered Visitor Jul 5, Do you have an idea where we can track this? Sanne Jul 20, Does anybody know, what is the current status of the handbook? Is there any timeline? Jul 20, You must log in or register to reply here.
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ISO 14969 (Now Obsolete) --> ISO 13485 handbook
The requirements and process approach are relevant to any regulated organization that designs and develops, produces, installs or services medical devices or provides related services. Your Alert Profile lists the documents that will be monitored. If the document is revised or amended, you will be notified by email. You may delete a document from your Alert Profile at any time. This standard is also available to be included in Standards Subscriptions. Standards Subscriptions from ANSI provides a money-saving, multi-user solution for accessing standards.
Would you like to tell us about a lower price? If you are a seller for this product, would you like to suggest updates through seller support? This Technical Report provides guidance for the application of the requirements for quality management systems contained in ISO It does not add to, or otherwise change, the requirements of ISO
PD CEN ISO/TR 14969:2005