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How to use the ISO 13485:2016 Internal Audit Toolkit

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Guest user Created:   Feb 05, 2021 Last commented:   Feb 08, 2021

How to use the ISO 13485:2016 Internal Audit Toolkit

I am looking for templates to use for conducting internal ISO 13485:2016 audits, such as Audit plan or Working documents (checklists, agenda, report). These templates appear to be designed for an audit of an entire company, how could I use them to audit one department at a time?

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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

You can always customize any document and use it for just one department. In the audit plan, you will then state that the audit criterion is only one requirement that applies specifically to that department. For example, if you only want to audit the sterilization department, then you will specify requirement 7.5.5 Particular requirements for sterile medical devices and 7.5.7 Particular requirements for validation of the process for sterilization and sterile barrier systems as the audit criteria. If you want to audit only Installation Processes, then your auditing criteria will be requirement 7.5.3 Installation activities. 

If you look at the audit checklist, you can apply the same principle here, so that you fulfill the audit results only in those requirements in which you performed the audit.

How these documents look like in our ISO 13485:2016 Documentation toolkit you can see on the following link:

The following articles can be useful:

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Feb 05, 2021

Feb 08, 2021