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IAF MD 9, ISO 13485 and ISO 9001

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Guest user Created:   Sep 16, 2017 Last commented:   Sep 16, 2017

IAF MD 9, ISO 13485 and ISO 9001

Is the 13485 will get a MD9 jointed with the 9001 or do they remain 2 separate entities (for example companies wanting to have both 9001 & 13485) in relation to term of audit duration? With the new standard 13485:2016, it's trying to be more inclusive and englobe the product from design to production, selling and post market. Do distributors of medical device have to comply to the new standard (if previously 9001)? Or is it just a nice to have and can keep distributing under a 9001?
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Strahinja Stojanovic Sep 16, 2017

Answer:

There are no any restrictions on implementing ISO 13485, IAF MD 9 and ISO 9001 at the same time and integrating them into one single management system. Having integrated management system that covers several standards will decrease number of audit days compared to certifying these standards separately.

New ISO 13485 has more specific requirements regarding the design, production, sales and post delivery activities and, in my opinion it is better that the previous one. The standard is applicable to the distributors, and in some countries ISO 13485 i s a legal requirement for both manufacturers and distributes of medical devices, so if your country o customers requires it, you should implement it.

ISO 13485 is basically ISO 9001 adopted to medical device industry and I think it provides more value to medical device industry than the universal ISO 9001.

For more information, see: ISO 9001 vs. ISO 13485 https://advisera.com/9001academy/blog/2015/01/21/iso-9001-vs-iso-13485/
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Sep 16, 2017

Sep 16, 2017