Medical devices quality · MD-QMS
ISO 13485:2016
Quality management system requirements for organisations involved in the life cycle of medical devices, written to support regulatory compliance. Unlike most standards here, it does not use the Harmonized Structure.
1 What it covers
ISO 13485 specifies QMS requirements for organisations that design, produce, install, service or supply medical devices (and related services). Its focus is on meeting regulatory requirements and on safety and performance of devices, so it places more emphasis on documentation, risk management through product realisation, validation, traceability, complaint handling and reporting to regulators than ISO 9001 does.
It keeps the older clause structure based on ISO 9001:2008 rather than the Harmonized Structure, so clause numbers do not line up with ISO 9001.
2 Who uses it
Medical device manufacturers, their component and service suppliers, distributors and contract sterilisers, and the regulatory and quality professionals who support them.
3 Structure and key clauses
4 Quality management system
- General requirements, documentation requirements (including the medical device file)
5 Management responsibility
6 Resource management
7 Product realization
- Planning, customer-related processes, design and development, purchasing, production and service provision (including validation and traceability)
8 Measurement, analysis and improvement
- Feedback, complaint handling, reporting to regulatory authorities, internal audit, control of nonconforming product, corrective and preventive action
4 Key facts for courses and exams
- Current edition: ISO 13485:2016 (confirmed on review).
- Clauses 4–8 follow the pre-2012 structure; there is no clause 9 or 10.
- Preventive action is still a named requirement (clause 8.5.3).
5 ISO 13485 qualifications
| Qualification | UK courses listed |
|---|---|
| ISO 13485 Foundation / requirements | 5 |
| ISO 13485 Internal auditor | 5 |
| ISO 13485 Lead auditor | 3 |
| ISO 13485 Implementer / lead implementer | 3 |
S Sources
Facts on this page last checked 3 October 2026.
- iso.org, ISO 13485:2016 page — https://www.iso.org/standard/59752.html