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ISO 13485:2016 internal audit checklist

Practising auditors wrote these 334 audit questions, covering the full standard. Each item names the objective evidence to request, the nonconformities most often raised against it, and what to sample. It is free to read, with no sign-up required.

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Includes all 334 items, formatted for a clipboard.

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334 items32 hours estimated, end to end 27 sectionsISO 13485:2016 · updated 2026-06-22

What each item gives you

This is what an auditor needs at each item. You already hold the standard itself.

The question

Phrases it the way you would ask it in the room.

Objective evidence

Names the specific artefacts that satisfy the item, and how to tell a real one from a placeholder.

Common nonconformities

Lists the findings most often raised here, in the words they get written up in.

Auditor tips

Shows where the item usually goes wrong, and what a mature answer sounds like against a rehearsed one.

What to sample

Explains how many to take, how to choose them, and what to cross-reference them against.

Follow-up questions

Gives the second and third questions to ask when the first answer is too smooth.

All 334 items across 5 clauses

This checklist runs to 334 items, so each top-level clause has its own page rather than one document you have to scroll. Items are there in full, with its objective evidence, common nonconformities and auditor tips — nothing is held back for the PDF.

Clause 4 Quality management system 64 items · 3 sections Clause 5 Management responsibility 43 items · 6 sections Clause 6 Resource management 28 items · 5 sections Clause 7 Product realization 134 items · 7 sections Clause 8 Measurement, analysis and improvement 65 items · 6 sections

Each item shows its evidence, common nonconformities and auditor tips. The PDF above holds the same content, all 334 items, formatted for a clipboard.

Frequently Asked Questions

What is ISO 13485?

ISO 13485:2016 is the international standard for quality management systems in the medical device industry. It specifies requirements for a QMS where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

How many clauses does ISO 13485 have?

ISO 13485:2016 has 8 main sections (Clauses 1-8), with Clauses 4 through 8 containing the auditable requirements. Clause 4 covers the QMS, Clause 5 covers management responsibility, Clause 6 covers resource management, Clause 7 covers product realization, and Clause 8 covers measurement, analysis, and improvement.

What is the difference between ISO 13485 and ISO 9001?

ISO 13485 is specific to medical devices and includes requirements for risk management, regulatory compliance, design controls, process validation, and traceability that are not in ISO 9001. ISO 9001 focuses on continual improvement while ISO 13485 emphasizes maintaining the effectiveness of the QMS. ISO 13485 also requires documented procedures in more areas than ISO 9001.

How often should ISO 13485 internal audits be conducted?

ISO 13485 requires internal audits at planned intervals, typically annually. The audit program should consider the status and importance of processes and areas, as well as results of previous audits. High-risk areas or areas with previous findings may need more frequent auditing. Most organizations audit all clauses at least once per year.

Checklists for the other standards

ISO 9001:2015gap analysis · 251 items AS9100Daerospace · audit FDA QMSR21 CFR 820 transition EU MDR2017/745 compliance
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