I agree that the changes are minor and there is little advantage to creating a new guidance document. I understand that the technical committee is not convinced that there is a need for a guidance document for this new revision (i.e., there is no need for ISO 14969 to be updated). The Standard itself actually begins on page five and ends on page 36. The draft’s first four pages are a forward and table of contents. I read through the 113 pages of the draft and was surprised to see fewer significant changes than I expected. If the comments can be resolved quickly, the technical committee is expected to release the final version of ISO 13485:2015 this fall prior to the release of ISO 9001:2015. The expectation is that there will be very few comments of significance for this second draft. On February 5, 2015, a second draft of ISO 13485 was released to the world for comment. This article summarizes the 113 page draft to 3 pages. But, you need to familiarize yourself with the changes. Big changes expected from ISO 13485: 2015? The short answer is, no.
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