ISO 13485 Auditor Qualifications

The ability to identify opportunities for improvement is an important skill for an internal or lead auditor. It could involve a reduction in incidents, improved processes or increases in performance.

That's why we've developed auditor qualifications for ISO 13485 – medical devices quality management systems - to give you the skills and knowledge you need to be an auditor practitioner, and by teaching you techniques in process improvement to become an auditor professional.

Why take your ISO 13485 Auditor Qualification with BSI?

BSI delivers over 50,000 auditor training courses a year
BSI's own auditors deliver over 200,000 auditor assessment days a year

Once you've achieved your professional qualification, you can apply to become certified – a 3-year rolling programme to validate the practical application of your learning and your continuing professional development within your industry.

Benefits and training modules of each auditor qualification level

ISO 13485 Internal Auditor Qualification

Internal Auditor Practitioner

A practitioner can successfully carry out a conformity audit to a specific standard. The qualification is proof that learning has been assessed.

Internal Auditor Practitioner training modules include:
- ISO 13485 requirements
- ISO 13485 internal auditor
Each course ends with an examination.

Internal Auditor Professional

The professional qualification goes beyond conformity. It develops the ability to audit improvement initiatives.

Internal Auditor Professional training modules include:
- ISO 13485 requirements
- ISO 13485 internal auditor
- Process improvement introduction
- Process improvement auditor
Each course ends with an examination.

Internal Auditor Certified Professional

Having your professional auditor qualification certified means you can prove you’ve applied what you’ve learned in the workplace, evidence to demonstrate your proven experience of conducting audits.

Becoming an Internal Auditor Certified Professional
- Completed Internal Auditor Professional training modules
- Practical application

Benefit and training modules of each auditor qualification level

ISO 13485 Lead Auditor Qualifications

Lead Auditor Practitioner

A practitioner can successfully carry out a conformity audit to a specific standard. The qualification is proof that learning has been assessed.

Lead Auditor Practitioner training modules include:
- ISO 13485 requirements
- ISO 13485 lead auditor
Each course ends with an examination.

Lead Auditor Professional

The professional qualification goes beyond conformity. It develops the ability to audit improvement initiatives.

Lead Auditor Professional training modules include:
- ISO 13485 requirements
- ISO 13485 lead auditor
- Process improvement introduction
- Process improvement auditor
Each course ends with an examination.

Lead Auditor Certified Professional

Having your professional auditor qualification certified means you can prove you’ve applied what you’ve learned in the workplace, evidence to demonstrate your proven experience of conducting audits.

Becoming a Lead Auditor Certified Professional
- Completed Lead Auditor Professional training modules
- Practical application

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