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Stage 2 audit requirements

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Guest user Created:   Feb 22, 2019 Last commented:   Feb 22, 2019

Stage 2 audit requirements

We have a Stage 2 audit scheduled for March. The scope of our certification is the control of manufacture as we are intending to outsource all manufacturing. We don't yet have the manufacturers onboard and are arranging Quality Agreements with them now.
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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
Verlene Law Feb 22, 2019
What do they need at a minimum for Stage 2? Will they need to see evidence of control of the manufacture, and how do we provide that if we aren't that far along yet?

Answer:

In a Stage 2 audit, you need to present documented evidence to the auditor to prove that your company’s QMS is in compliance with ISO 13485 .This will include records, agreements such as Quality Agreement also termed as technical agreement signed between the product owner and the manufacturers engaged to control the quality of the product which can include specifications of the product, batch release details, responsibilities and role of parties involved. and practices.

They definitely would need to see the evidence of control of manufacture. What I can suggest would be if you could present some form of writt en commercial agreement to each manufacturer that can also present the requirements and specifications of the product, that might help you and also try to get the draft quality agreement.

For more information, please feel free to look at the following material:

Checklist of ISO 13485 implementation and certification steps:

https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/

First-, Second- & Third-Party Audits for medical device manufacturers & suppliers
https://advisera.com/13485academy/knowledgebase/first-second-third-party-audits-for-medical-device-manufacturers-suppliers/
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Feb 22, 2019

Feb 22, 2019