8.6 Internal Systems Audits (ISO 19011)
While LPAs check the floor execution, Internal Audits verify the management system against the ISO standard.
- Independence: Auditors cannot audit their own department. Engineering audits Purchasing; Purchasing audits HR. This ensures objectivity.
- Evidence-Based: Findings must be supported by Objective Evidence (samples, records, observations). "I think" is not a valid audit finding.
- The Audit Schedule: Audits must be scheduled based on risk. Critical areas (SMT Reflow, IQC) are audited more frequently than low-risk areas (Training Records).
Final Checklist
Audit Component | Requirement | Standard |
Schedule | Risk-Based Frequency | Annual Coverage Minimum |
Auditor | Independent of Area | Certified Internal Auditor |
Reporting | Objective Evidence | Non-Conformance Reports (NCR) |
Closure | CAPA Verification | Follow-up Audit |
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