Medical devices quality · Internal auditor
ISO 13485 Internal auditor
Teaches you to plan, carry out, report and follow up internal (first-party) audits of your own organisation’s management system. Usually two days, assessed by continuous assessment and a short test.
1 About this qualification
This is a internal auditor 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 |
|---|---|---|---|---|
| Internal Auditor ISO 13485:2016 Training CourseClassroom; Live online | BSI | Not stated | 2 days | Course pagechecked 3 October 2026 |
| ISO 13485:2016 Internal Auditor | LRQA | Not stated | 2 days (classroom); two sessions (virtual) | Course pagechecked 3 October 2026 |
| NQA ISO 13485 Internal Auditor TrainingVirtual – tutor led | NQA | Not stated | 2 days | Course pagechecked 3 October 2026 |
| ISO 13485 Internal Auditor Training Course | Bywater | Not stated | 2 days | Course pagechecked 3 October 2026 |
| ISO 13485:2016 Internal Auditor Course — CQI|IRCA ref PT264 | Batalas | CQI and IRCA certified | 2 days | 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 | Approx. 14 hours (two days); DNV lists 16 hours | Continuous assessment plus a short test — for example, Batalas describes a short multiple-choice test on the final day |
| Provider-branded courses | 1–2 days | Often continuous assessment; some issue a CPD certificate |
PECB does not run a separate internal auditor course — its auditor route is the five-day Lead Auditor course.
4 How to prepare
- Internal auditor: a 2-week study planTen short sessions to get ready for a two-day internal auditor course and your first internal audits.
- 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 Foundation / requirements 5 courses
- ISO 13485 Lead auditor 3 courses
- ISO 13485 Implementer / lead implementer 3 courses