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ISO 13485:2016

What is ISO 13485:2016?

ISO 13485:2016 Medical Devices Quality Management Systems Requirements.. It comprises 67 controls organised across 5 domains, published by ISO/IEC, and applies in International.

How ISO 13485:2016 maps to other frameworks

All 67 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 5 domains ISO 13485:2016 groups its controls into

Product realization - ISO 13485:2016
Clause 0 - ISO 13485:2016
Management responsibility - ISO 13485:2016
Quality management system - ISO 13485:2016
Resource management - ISO 13485:2016

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 controls

ISO 10005:2005

16 shared controls

ISO 9001:2015

12 shared controls

ISO/IEC 23894:2023

11 shared controls

ISO 31000:2018

11 shared controls

ISO/IEC 38500:2024

11 shared controls

ISO 50001:2018 - Energy Management Systems

10 shared controls

AS9100D - Aerospace Quality Management System

5 shared controls

Implementation guides for frameworks that overlap ISO 13485:2016

ISO 9001 Quality Managementcovers ISO 9001:2015 →

Where ISO 13485:2016 overlaps with the standards you already hold

ISO 13485:2016 vs ISO 19011:2018View comparison →ISO 13485:2016 vs ISO 10005:2005View comparison →ISO 13485:2016 vs ISO 9001:2015View comparison →ISO 13485:2016 vs ISO/IEC 23894:2023View comparison →ISO 13485:2016 vs ISO 31000:2018View comparison →ISO 13485:2016 vs ISO/IEC 38500:2024View comparison →

Analysis of ISO 13485:2016

FDA 21 CFR Part 820 Quality Management System Integration with ISO 13485:2016: Complete Medical Device Compliance HarmonizationMedical device manufacturers must navigate both FDA QSR requirements and international ISO 13485 standards for global market access. This comprehensive mapping framework demonstrates how to harmonize FDA 21 CFR Part 820 quality management controls with ISO 13485:2016 requirements while maintaining operational efficiency.

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.

ISO 13485 Implementation and Compliance Mastery Course$199 USDISO 13485 Comprehensive Implementation Checklist Training$199 USDISO 13485 Comprehensive Implementation and Audit Preparation Course$199 USDThe Quality Engineer's Course on Building ISO 13485 Evidence When Audits Loom$199 USD

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

ISO 13485:2016 for Healthcare→ISO 13485:2016 for Financial Services→ISO 13485:2016 for Technology→ISO 13485:2016 for Government→ISO 13485:2016 for Manufacturing→ISO 13485:2016 for Energy→ISO 13485:2016 for Retail→ISO 13485:2016 for Education→

What ISO 13485:2016 means for your job

ISO 13485:2016 for CISOs→ISO 13485:2016 for Compliance Officers→ISO 13485:2016 for Risk Managers→ISO 13485:2016 for IT Directors→ISO 13485:2016 for DPOs→ISO 13485:2016 for Auditors→

Questions people ask about ISO 13485:2016

What is ISO 13485:2016?
ISO 13485:2016 Medical Devices Quality Management Systems Requirements..
How many controls does ISO 13485:2016 have?
ISO 13485:2016 contains 67 controls organized across 5 domains.
Where does ISO 13485:2016 apply?
ISO 13485:2016 is applicable in International. Organizations operating in or serving customers in this jurisdiction should evaluate its requirements.
What frameworks does ISO 13485:2016 map to?
ISO 13485:2016 has control-to-control mappings with 106 other compliance frameworks in our database. Use our compliance platform to explore these mappings interactively.
How do I get started with ISO 13485:2016 compliance?
Start by understanding the framework's key controls and domains. Our compliance platform provides AI-powered gap analysis and mapping tools to help you assess your current posture and build a remediation plan.

Query ISO 13485:2016 programmatically

ISO 13485:2016, its 67 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?

Answer 25 questions and get a professional readiness report with gap analysis, maturity scores, and prioritised action items. Results in 5 minutes.

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Written and maintained by Gerard Blokdyk, The Art of Service.Last updated .