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Complaint Handling in ISO 13485

ISO 13485 & EU MDR
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Guest user Created:   Oct 21, 2018 Last commented:   Oct 21, 2018

Complaint Handling in ISO 13485

ISO 13485 & EU MDR
Hi, looking at your page regarding complaint handling for ISO13485:2016 but the article didn't state what section it was in? In 2003 it was part of 8.5.1 but there is no talk of complaints in 8.5.1 in the 2016 standard.
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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.
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Verlene Law Oct 21, 2018

Answer:

In the 2016 Standard, Complaint handling falls under Clause 8.2.2.

For further information regarding other changes in the Standard, please refer to :

ISO 13485:2016 vs. ISO 13485:2003 matrix
https://info.advisera.com/13485academy/free-download/iso-13485-2016-vs-iso-13485-2003-matrix

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Oct 21, 2018

Oct 21, 2018

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