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ISO 13485 Internal Auditor

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Guest user Created:   Sep 19, 2022 Last commented:   Sep 20, 2022

ISO 13485 Internal Auditor

As I work through the course material it is becoming increasingly clear that as a small company like mine-my ability to act as an internal auditor may not be feasible as I cannot audit the processes I am involved in.  I am also Purchaser and QMS Manager.
It would not be possible for another member of my team to audit purchasing processes as they are not qualified.  We received a finding on a past audit as our Internal Audit was deemed unqualified.
Please advise how other small companies navigate this situation.

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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 Sep 20, 2022

One solution is that all of you are educated for internal auditors and audit each other. Another solution is to hire an external company that will provide the internal audit for you. It can be a consultant company that knows the ISO 13485 (you need proof of that), or a person who is an auditor for other notify bodies and with whom you will have a contract that he/she is your internal auditor.   

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Sep 19, 2022

Sep 20, 2022