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Stage 1 audit

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Guest user Created:   Feb 04, 2021 Last commented:   Feb 08, 2021

Stage 1 audit

What can a company expect from Stage 1 - 13485:2016 Auditor?

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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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Kristina Zvonar Brkić Feb 08, 2021

Stage 1 is usually called „Documentation audit“ because auditors what will check are all documentation requirements from the standard fulfilled. SO, you need to prepare all documents from the requirements that are applicable for your company and within the scope. If some of the major documents are missing, it is not possible to access the next step, the initial audit or so-called Stage 2 audit.

For more information regarding the certification process, please see the following articles:

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