ISO 13485 Internal Audit Checklist

A working checklist for internal audits of a medical device quality management system against ISO 13485:2016. It follows the five requirement clauses of the standard — 4 to 8 — so every finding you raise can be traced back to a requirement, and it spends most of its time where medical device audits do: product realization, feedback, complaints and corrective action.

What is inside

ISO 13485 Internal Audit Checklist — 120 checks in 12 sections across clauses 4 to 8, each written as a statement you can find evidence for, with Yes / No / N/A boxes, space for the evidence you saw and a score table at the end.

The document as a designed, print-ready PDF and as an editable Word file.

Who it is for

Quality and regulatory affairs managers, management representatives, internal auditors and consultants working for medical device manufacturers, and for suppliers, distributors and service providers in the medical device supply chain who run a QMS to ISO 13485.

How to use it

Audit by process and by device. Pick a device type or family, open its medical device file, and follow it through design, purchasing, production, release and post-market feedback, using the checklist to make sure no requirement is missed on the way. Mark a section N/A only where your quality manual justifies the exclusion or non-application — for example design and development, sterile devices, installation or servicing. For every No, write a nonconformity that states the requirement, the evidence and why it does not conform, then agree a root cause, an owner and a date.

ISO 13485 is written to be used together with regulatory requirements, and the phrase applicable regulatory requirements appears throughout it. Those requirements depend on the markets you serve and on your role in the supply chain. This checklist covers the standard only: identify the regulations of each market you place devices on, and add their requirements to your audit criteria. Check also which edition of the standard applies to you.