Medical devices quality · Foundation / requirements
ISO 13485 Foundation / requirements
An introduction to a standard: what it requires, the vocabulary and how the clauses fit together. Usually one or two days, with a short test or none. The usual first step, and often a recommended prerequisite for auditor courses.
1 About this qualification
This is a foundation / requirements course applied to ISO 13485, the standard for medical devices quality.
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.
2 UK courses
Course names, certification, duration and delivery as stated by each provider. We do not list prices — they change often; see the provider’s page.
| Course (as named by the provider) | Provider | Certified by | Duration | Link |
|---|---|---|---|---|
| Introduction to ISO 13485:2016 Medical Devices Training CourseLive online; On-demand eLearning | BSI | Not stated | 1 day | Course pagechecked 3 October 2026 |
| Introduction to ISO 13485:2016 | LRQA | Not stated | 1 day | Course pagechecked 3 October 2026 |
| Introduction to ISO 13485 for Medical Devices | Bywater | Not stated | 1 day | Course pagechecked 3 October 2026 |
| MD-QMS ISO 13485:2016 Foundation Course — CQI|IRCA ref FD132 | Batalas | CQI and IRCA certified | See provider | Course pagechecked 3 October 2026 |
| ISO 13485 Awareness – Online TrainingOnline | Amtivo (British Assessment Bureau) | Not stated | 1 day | Course pagechecked 3 October 2026 |
Certified by: Not stated (4) · CQI and IRCA certified (1). What the schemes mean.
3 How it is assessed
| Scheme | Typical length | Assessment |
|---|---|---|
| CQI and IRCA | Auditing foundation approx. 7 hours; quality foundation courses approx. 8–16 hours | Short assessment at the end (format varies by provider) |
| PECB | 2 days (e.g. ISO/IEC 27001 Foundation, ISO 9001 Foundation) | Exam; leads to a “Certificate Holder” credential |
| IBITGQ (GRC Solutions) | 1 day (ISO 27001 Foundation) | 60-minute online exam |
| Provider-branded courses | 1 day classroom/live online, or a few hours of eLearning | Often none, or a short quiz |
4 How to prepare
- Foundation: getting started with a standard in 2 weeksHow to get the most from a foundation or requirements course when a standard is completely new to you.
- ISO 13485: structure and key clausesThe clauses to know before day one.
Practice questions
- Harmonized Structure (clauses 4–10) 9 questions
- Audit findings and nonconformities 8 questions
- Certification schemes and auditor registration 9 questions
5 Other ISO 13485 qualifications
- ISO 13485 Internal auditor 5 courses
- ISO 13485 Lead auditor 3 courses
- ISO 13485 Implementer / lead implementer 3 courses