Internal audits and management review (clauses 8.8 and 8.9)
Internal audits check the management system against the standard and the laboratory's own procedures; management review checks whether the system is still suitable, adequate and effective.
Clause 8.8 requires internal audits at planned intervals to determine whether the management system conforms to the laboratory's own requirements and to the standard, and is effectively implemented and maintained. Clause 8.9 requires management to review the system at planned intervals.
Management-review inputs the standard lists
- Changes in internal and external issues.
- Fulfilment of objectives; suitability of policies and procedures.
- Status of actions from previous reviews.
- Outcomes of internal audits, corrective actions, external assessments.
- Customer feedback and complaints.
- Results of interlaboratory comparisons and proficiency testing.
- Effectiveness of improvements; adequacy of resources; risk identification; quality assurance results.
Outputs are decisions on effectiveness, improvements, resources and any need for change. A review without recorded decisions is not a review.
Frequently asked questions
- Can the quality manager audit their own area?
- The standard requires impartiality of auditors where resources permit; auditing one's own work is avoided and, where unavoidable, the limitation is recorded.
References
- [1]ISO/IEC 17025:2017 — General requirements for the competence of testing and calibration laboratories
General technical guidance written against the cited sources. It is not regulatory or legal advice and does not replace the applicable standard, guideline or a qualified reviewer's judgement.
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