Context
Isolating the unreviewed sections of the quality manual's 3-page Audit SOPs list before the next internal audit meant finding the gap directly rather than waiting for the audit to surface it.
Quality Assurance • Internal Audit
Internal Audit Scope Expansion
Duration: 12 months • Role: Quality Assurance Specialist
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.
Clause-by-Clause Checklist Review
Objective Evidence Collection
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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