Context
The audit covering ISO 13485 clauses 4, 5, and 8 surfaced sections of the quality manual and SOP list that had never been through a formal review. Closing those out before the next audit meant finding them internally first.
Internal Audit • Quality Assurance
Internal Audit Scope Expansion
Duration: 18 months • Role: Internal Auditor
Auditing sections 4, 5, and 8 of the internal audit program showed that isolating unreviewed sections of a quality plan or SOP list before an audit prevents surprises during the audit itself. It's cheaper to find the gap yourself first.
Primary Risks Identified
- An unaudited section or site carrying an undetected nonconformance into an external MDSAP or notified body audit
Testing Approach
Applied a clause-by-clause internal audit checklist against ISO 13485:2016, collected objective evidence for each section, and logged findings/observations through the internal audit SOP.
ISO 13485 Checklist
Objective Evidence Collection
Internal Audit SOP
Outcome
Identified and closed out the previously unreviewed sections, bringing the quality manual/SOP list fully current ahead of the next internal audit.
Key Lessons
Isolating unreviewed sections of a quality plan or SOP list before an audit prevents surprises during the audit itself. It's cheaper to find the gap yourself first.
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