ISO 13485:2016
What is ISO 13485:2016?
ISO 13485:2016 Medical Devices Quality Management Systems Requirements.. It comprises 83 controls organised across 6 domains, published by ISO/IEC, and applies in International.
How ISO 13485:2016 maps to other frameworks
All 83 controls, each one mapped to the equivalent requirement in other standards, with the evidence that carries across and the mappings that were judged and rejected shown alongside. No account needed to look.
See the control mappings →The 6 domains ISO 13485:2016 groups its controls into
Frameworks that share controls with ISO 13485:2016
Each of these has at least one control mapped to a control in ISO 13485:2016. The number is how many ISO 13485:2016 controls are shared, counted from the mapping graph.
ISO 19011:2018
20 shared controlsISO 10005:2005
16 shared controlsISO 9001
12 shared controlsISO/IEC 23894:2023
11 shared controlsISO 31000:2018
11 shared controlsISO/IEC 38500:2024
11 shared controlsISO 50001:2018 - Energy Management Systems
10 shared controlsAS9100D - Aerospace Quality Management System
5 shared controlsImplementation guides for frameworks that overlap ISO 13485:2016
Where ISO 13485:2016 overlaps with the standards you already hold
Analysis of ISO 13485:2016
Where to get trained on ISO 13485:2016
4 courses in the catalogue cover ISO 13485:2016 directly. Each is self-paced, includes the downloadable toolkit and the implementation playbook, and carries a certificate of completion.
Training more than one person? Ten seats of any course is $1,490 on a single licence, against $199 a seat bought one at a time.
What ISO 13485:2016 means in your sector
What ISO 13485:2016 means for your job
Questions people ask about ISO 13485:2016
What is ISO 13485:2016?
How many controls does ISO 13485:2016 have?
Where does ISO 13485:2016 apply?
What frameworks does ISO 13485:2016 map to?
How do I get started with ISO 13485:2016 compliance?
Query ISO 13485:2016 programmatically
ISO 13485:2016, its 83 controls and every mapping into other standards are available over a REST endpoint and an MCP server, so an agent can read them directly. The free tier is 10 calls a day and needs no signup.
ISO 13485:2016 API reference and MCP config →How ready are you for ISO 13485:2016?
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