Internal audit schedule
I am working on a new internal audit schedule, now I was advised to start a 3 year cycle, auditing the most important processes first.
Nice, for me all processes feel important. There certainly is an kind of standard perception on the importance of processes / ISO13485 paragraphs.
Are you able to help out and guide me in this one?
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
I agree with you that all processes feel important. However, according to requirement 4.1.2, it is necessary to apply a risk-based approach to control the appropriate process. So risk approach can be your guideline to decide the priority of your processes for internal audits. First of all, manufacturing is the most important process. Then is purchasing because you need to be sure that the purchase of raw material and packaging is under control. If you have a sterile medical device, the sterilization process is definitively an important process.
For more information on this topic, please see the following articles:
- Five main steps in the ISO 13485:2016 internal audit https://advisera.com/13485academy/knowledgebase/five-main-steps-in-the-iso-134852016-internal-audit/
- How to create a checklist for an ISO 13485 internal audit for your QMS https://advisera.com/13485academy/knowledgebase/how-to-create-a-checklist-for-an-iso-13485-internal-audit-for-your-qms/
- Five Main Steps in ISO 9001 Internal Audit https://advisera.com/9001academy/knowledgebase/five-main-steps-in-iso-9001-internal-audit/
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Dec 09, 2020