Preparing for a MDQMS certification audit
What this domain tests
This domain tests readiness for a third-party ISO 13485 certification audit. The exam expects you to distinguish certification from regulatory approval, prepare evidence, manage stage 1 and stage 2 audits, and respond to findings.
Core rules and concepts
- Certification is a conformity assessment against ISO 13485 and the defined scope. It is not a product approval or a substitute for regulatory clearance.
- Select a competent certification body and agree the scope, sites, devices, and exclusions. The audit scope must match the QMS scope.
- Complete at least one full internal audit and a management review before stage 2. Correct significant gaps first.
- Stage 1 reviews documentation and readiness; stage 2 tests implementation and effectiveness through interviews, records, and site observation.
- Nonconformities are classified by the certification body. Major findings usually require correction and corrective action before certification; minor findings may be closed through an accepted plan.
- After certification, surveillance audits and recertification maintain the certificate. Changes to scope or significant processes must be communicated.
Worked example
At stage 1, an auditor finds the quality manual does not justify the clause 7.3 exclusion and the internal audit skipped clause 8. The organization should correct the manual, verify the regulatory basis for the exclusion, extend the internal audit, and retain evidence before stage 2. Arguing that the auditor is too strict is not a corrective action.
Traps that cost marks
Treating the certification audit as a document review only; hiding known nonconformities; having no management review evidence; letting the certificate scope exceed the audited scope; and failing to act on surveillance findings.