The problem with box-ticking audits
Internal audit is required by ISO/IEC 17025 clause 8.8, yet in many laboratories it never goes beyond ticking a checklist. Real issues then surface for the first time during the accreditation visit.
- Auditors auditing their own work, weakening impartiality
- Only management system documents reviewed, technical records left out
- Vague findings and corrective actions that are never followed up
Audit scope
Management system
Document control, risks and opportunities, nonconformities and corrective action, complaints, management review.
Technical requirements
Method validation, uncertainty, calibration and traceability, environmental conditions, QC and PT records.
Vertical audits
Selected reports traced back from issue to sample receipt.
Witnessing
Observing analysts perform tests and checking consistency with the method and records.
Our audit process
- Programme and plan: a risk-based annual programme and a plan for each audit.
- Preparation: document review and checklists tailored to your laboratory.
- On-site audit: opening meeting, record review, interviews, vertical audits and witnessing.
- Grading findings: nonconformities and observations clearly linked to the relevant clause.
- Report and closing: closing meeting and written audit report.
- Corrective action follow-up: root cause analysis and verification of effectiveness.
Audits follow ISO/IEC 17025 and the ISO 19011 guidelines for auditing management systems. For accreditation audit preparation we also run mock assessments in the accreditation body's format.
Train your own auditors
Our hands-on internal auditor training prepares your staff to audit using your laboratory's real records.
Deliverables
- Annual internal audit programme and audit plan
- Checklists tailored to your laboratory
- Clause-referenced findings report
- Corrective action tracker and close-out verification
- Summary input for management review