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Is vendor agreement mandatory for ISO 13485?

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Guest user Created:   May 11, 2019 Last commented:   May 13, 2019

Is vendor agreement mandatory for ISO 13485?

Regarding vendor agreements in ISO 13485 2016
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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 May 11, 2019
Does ISO 13485 : 2016 , makes Mandatory for doing agreements with vendors
Is it a must to do agreements with vendors.

Answer:

Yes, it is mandatory to have an agreement with the vendor in order to ensure that the purchased product or services conform to the requirements.

For more information, please read article:

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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Verlene Law May 13, 2019
We received another question:

>Purchase order mailed to supplier prior to purchase, can Purchase order be considered as an agreement. We are into manufacturing of class 1 medical devices , hence Purchase order can be considered as an agreement of ISO 13485 clause 7.4.2. As Some suppliers are unwilling for sign agreements

Answer:

If the purchase order contains the purchasing information of the products or services that you are sourcing from the supplier, it is valid. However, there should also be some email communication between your company and the supplier to ensure that the supplier will notify you of any changes made to the purchased product or service which could have an impact on the quality and performance of the medical device that you are dealing with.
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