ISO 13485 Auditor Certification: Medical Devices Quality Management System
Auditor certification for ISO 13485:2016 Medical Devices Quality Management System at five grades, from Associate Auditor to Principal Auditor, awarded on a rubric-based assessment of a verified auditor course, verified audit experience, a work sample and, for the higher grades, a structured interview, with an independent decision.
The ISO 13485:2016 Medical Devices Quality Management System scheme certifies auditors who audit against ISO 13485:2016. It is one of ten QA Assessor schemes. Certification is granted at one of five grades on a structured assessment of your evidence against a published rubric: the auditor course you have completed and had verified, the audits you have logged and had verified, a work sample of your own audit work (Auditor and above) and a structured interview (Lead Auditor and Principal Auditor; a sample of Auditor applications). Auditor, Lead Auditor and Principal Auditor also need four years of verified work experience, two of them in the discipline of the scheme. An assessor who did not train you scores the evidence; a different person makes the decision.
Who this scheme is for
Internal auditors, supplier auditors, consultants and certification body auditors who audit MDQMS arrangements: regulatory requirements, design and development files, traceability and controls for sterile devices. Every audit you log for this scheme must have been against ISO 13485, with ISO 19011 as the auditing method.
The five grades
For people who have completed an auditor course and want formal recognition before they have built up audit experience.
- Completed a Foundation, Internal Auditor or Lead Auditor course for the scheme, verified from your training record (QA Assessor, an Approved Training Provider or any provider we can confirm)
- No audit experience needed
For people who audit parts of their own organisation's management system, or a supplier's, usually alongside another job.
- Completed an Internal Auditor or Lead Auditor course for the scheme, verified from your training record (QA Assessor, an Approved Training Provider or any provider we can confirm)
- 5 audits in the last 5 years, each of at least 3 hours, 2 audit days in total
For people who carry out full management system audits, as a team member or on their own, internally, for customers or for certification bodies.
- Completed a Lead Auditor course for the scheme, verified from your training record (QA Assessor, an Approved Training Provider or any provider we can confirm)
- At least 4 years of verified work experience, 2 of them in the discipline of the scheme
- 4 audits in the last 5 years, 20 audit days in total, 15 on site or in live remote sessions
- A work sample: a redacted audit plan, checklist or report you produced for one of the audits counted, scored against the published rubric
- A structured interview for a sample of applications
For experienced auditors who plan and lead audit teams through full management system audits.
- Completed a Lead Auditor course for the scheme, verified from your training record (QA Assessor, an Approved Training Provider or any provider we can confirm)
- At least 4 years of verified work experience, 2 of them in the discipline of the scheme
- 4 audits in the last 5 years, 20 audit days in total, 15 on site or in live remote sessions
- 3 full audits as team leader, 15 days, 10 on site
- A work sample: a redacted audit plan, checklist or report you produced for one of the audits counted, scored against the published rubric
- A structured interview (online, about 45 minutes, recorded with your consent after a live identity check)
For senior audit professionals with a long auditing history who now work mainly in training, consultancy or management and may no longer audit regularly.
- Completed a Lead Auditor course for the scheme, verified from your training record (QA Assessor, an Approved Training Provider or any provider we can confirm)
- At least 4 years of verified work experience, 2 of them in the discipline of the scheme
- 4 audits in the last 15 years, 20 audit days in total, 15 on site or in live remote sessions
- 3 full audits as team leader, 15 days, 10 on site
- 10 or more years of auditing history
- A work sample: a redacted audit plan, checklist or report you produced for one of the audits counted, scored against the published rubric
- A structured interview (online, about 45 minutes, recorded with your consent after a live identity check)
Every grade also requires a verified identity, the declaration, the Code of Conduct and the annual fee; the certification period is three years, with CPD (at least 3 complete CPD records, each verified by QA Assessor, in every full calendar year of the three-year certification period; they are checked at recertification). Your evidence is scored against a published rubric by an assessor who did not train you, and the decision is made by a different person. Full rules: the Applicant Handbook.
How to get certified on this scheme
- Train. Complete a ISO 13485 auditor course at the level the grade needs: Foundation or above for Associate Auditor, Internal Auditor or Lead Auditor for Internal Auditor, Lead Auditor for Auditor, Lead Auditor and Principal Auditor. A QA Assessor course is added to your Training and Qualifications when you complete it; a course from an Approved Training Provider or any other provider counts once we confirm it. See the ISO 13485 courses.
- Log your records. Record your work experience (Auditor and above) and every ISO 13485 audit in your Audit Log with dates, role, days, on-site days and a person who can confirm it, and attach evidence. For Auditor and above, attach a redacted audit plan, checklist or report you produced to one of these audits and flag it as your work sample. QA Assessor verifies each record, normally within five working days of the evidence.
- Apply. Choose this scheme and the grade you meet. Your verified records are checked against the grade requirements before you submit, so there are no surprises. Accept the declaration; nothing is paid yet. Once QA Assessor has confirmed your eligibility you pay the scheme application fee (US $16, once per scheme and not again if already paid for this scheme) and the first annual fee together, in one payment, and assessment begins when it is received.
- Prerequisite review, assessment and decision. The prerequisites are confirmed and your records frozen; an assessor who did not train you scores your records, work sample and, where the grade requires it, a structured interview against the published rubric; a Certification Manager who did not assess you makes the decision, normally within 15 working days of the prerequisite review, not counting time waiting for you.
- Listed. Approved auditors are entered on the public Auditor Register with a Register ID, a certificate number, a certificate and a digital card that anyone can verify by QR code or link, and may use the title “QA Assessor Certified [grade], ISO 13485”.
Keeping your certification
Registration is renewed each year by paying the annual fee for your grade. Recertification is due every three years and confirms that you have completed at least three verified CPD records in each full calendar year and kept auditing. You can regrade at any time as your experience grows.
Apply on this scheme How certification works
QA Assessor certification processes are self-declared as aligned with ISO/IEC 17024:2026. QA Assessor is not accredited and makes no claim of accreditation.