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Information on Certificates such as CoC / CoA or 3.1 certifications

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Guest user Created:   Jan 21, 2022 Last commented:   Jan 22, 2022

Information on Certificates such as CoC / CoA or 3.1 certifications

I am looking for more information on supplier documentation, specifically Certificates such as CoC / CoA or 3.1 certifications I woud like to know if there is a link to the ISO 13485 requiring suppliers to send us these types of certificates.. basically following DIN EN 10204
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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
Kristina Zvonar Brkić Jan 22, 2022

It is up to the manufacturer to define which data from the suppliers are necessary. In requirement ISO 13485:2016, 7.4.2 Purchasing information is stated that product specification is one of the elements of purchasing information. So, you as a manufacturer define do you need a Certificate of analysis, Certificate of material, or similar.   

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Jan 21, 2022

Jan 22, 2022