How to Make Internal Audits Work for You, Not Against You

QMS & Auditing
Written By Adam Isaacs Rae

The rush to complete the audit schedule is an all too familiar occurrence.

So is completing the same audits year on year.

Clause 8.2.4 of ISO 13485 specifies the following: An audit program shall be planned, taking into consideration the status and importance of the processes and area to be audited, as well as the results of previous audits.

Here is a small guide I've put together to hopefully help in making audits work for you, not the other way around.

I’ve been dead nice and generated such a document that organisations can use to justify their rationale, you can find it here - I can’t attach word documents here yet, so I’ll put it on my LinkedIn and my website - https://www.theotherconsultants.com/productsandservices/p/iso-13485-audit-schedule-rationale-document

Adam Isaacs Rae
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