Take the ISO 9001 course exam and get the ISO 14001 or ISO 13485 course exam for free
LIMITED-TIME OFFER – VALID UNTIL SEPTEMBER 30, 2021

Expert Advice Community

Guest

Transition of ISO 9001 and ISO 13485

  Quote
Guest
Guest user Created:   May 11, 2017 Last commented:   May 11, 2017

Transition of ISO 9001 and ISO 13485

Hello,
0 0

Assign topic to the user

ISO 9001 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 9001 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Strahinja Stojanovic May 11, 2017
I want to know if there is no production of medical machine after successfully ISO 13485 and ISO 9001:2008 what will be the consequences in future surveillance audits, as ISO 9001:2015 is update from 2008 so it is necessary to implement ISO 9001:2015 in surveillance audit?

If you want to maintain your ISO 9001 certificate, you will need to make transition to the new version of the standard until September 2018. This can be done during surveillance audits or re-certification audits. In my opinion, it is better to conduct it during re-certification audit since the cost of the surveillance audit is smaller than the re-certification and getting certified against new version of ISO 9001 is practically a certification audit and will be charged appropriately. The same rule applies to ISO 13485 as well.

Since ISO 13485:2016 is developed according to ISO 9001:2008, you won't have too much problems making the transition because all elements of ISO 9001:2008 will remain in the new version. When making transition to ISO 9001:2015 you will basically only need to add new requirements (context of the organization, risks and opportunities, etc) and leave all the old elements (quality manual, preventive actions, etc) because they are still required by ISO 13485:2016.

For more information, see: How to make the transition from ISO 9001:2008 revision to the 2015 revision https://advisera.com/9001academy/blog/2015/10/06/how-to-make-the-transition-from-iso-90012008-revision-to-the-2015-revision/
Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

May 11, 2017

May 11, 2017

Suggested Topics