Medical devices quality · Lead auditor
ISO 13485 Lead auditor
The full auditor course: how to plan, lead and report first-, second- and third-party audits of a complete management system. Usually 4–5 days (about 40 hours) with continuous assessment and an exam. The qualification most auditor job adverts ask for.
1 About this qualification
This is a lead 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 |
|---|---|---|---|---|
| ISO 13485:2016 Lead Auditor Training CourseClassroom; Live online | BSI | Not stated | 4 days | Course pagechecked 3 October 2026 |
| ISO 13485 Lead Auditor Training Course | Bywater | CQI and IRCA certified | 5 days | Course pagechecked 3 October 2026 |
| ISO 13485:2016 Lead Auditor Course — CQI|IRCA ref PR369 | Batalas | CQI and IRCA certified | 5 days | Course pagechecked 3 October 2026 |
Certified by: CQI and IRCA certified (2) · Not stated (1). What the schemes mean.
3 How it is assessed
| Scheme | Typical length | Assessment |
|---|---|---|
| CQI and IRCA | Approx. 40 hours — usually 5 days (some providers run 4 longer classroom days) | Continuous assessment plus an exam. CQI and IRCA’s course table describes a 2-hour written examination; some providers now use an online multiple-choice exam after the course (Batalas: 1 hour 45 minutes, within 30 days) |
| PECB | 5 days, exam on day 5 | PECB exam — the ISO/IEC 27001 Lead Auditor handbook describes 80 multiple-choice questions, open book, 70% pass mark |
| IBITGQ (GRC Solutions, ISO 27001 only) | 5 days | CIS LA exam; qualification valid for three years |
| Provider-certified (e.g. BSI for some standards) | 4–5 days | Written exam and skills assessment, as stated by the provider |
4 How to prepare
- Lead auditor: a 4-week study planFour weeks of evening study (about 5 hours a week) before a five-day lead auditor course — what to read, what to practise and how to arrive…
- 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 Internal auditor 5 courses
- ISO 13485 Implementer / lead implementer 3 courses