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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