Vendor Agreement In relation to ISO 13485:2016
We have a query regarding vendor agreement In ISO 13485:2016, Is it mandatory to have such agreements with vendors. We have internal control measures such as vendor evaluation, rating of vendors for each and every transaction for materials procured, etc.
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
It is mandatory to have a written quality agreement with the company that provides outsourced process (as stated in requirement 4.1.5 from ISO 13485:2016). In that quality agreement control measures of your company over the outsourced process must be described. Control measures must be proportionate to the risk involved and the ability of the external party to meet the requirements of ISO 13485:2016.
For more details about the Purchasing process please read the article at the following link:
How can ISO 13485 clause 7.4, Purchasing, enhance procurement? https://advisera.com/13485academy/blog/2018/04/18/how-can-iso-13485-clause-7-4-purchasing-enhance-procurement/
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Feb 21, 2020