To succeed with effective internal audits, the purpose and ISO 17025 requirements of clause 8.8 (internal auditing) must be clearly understood and met. A good understanding of the ISO 17025:2017 standard is needed as the audit criteria will be ISO 17025 and the laboratory’s own requirements. Refer to the white paper Clause-by-clause explanation of ISO 17025:2017. Internal auditing in an ISO 17025 laboratory involves auditing both management and technical activities. Plan the technical and management audits separately. Select Technical auditors who have a good technical working knowledge of the particular technical activity they are auditing. Base your approach on the general guidelines of the ISO 19011 standard, Guidelines For Auditing Management Systems. Techniques / tools that will assist include checklists, document reviews, questioning and listening during interviews, and witnessing of activities. Follow these steps as a guideline:
Seek objective evidence against the audit criteria.
Document observations, recording audit findings, documents and records supplied during the audit, including version.
Justify confirmation of findings as compliant or noncompliant against the audit criteria.
Discuss the noncompliant findings with the auditees and raise nonconformances (NC) using the process agreed to, either within the audit report or on a NC form.
The Five Internal Audit Procedure appendices Internal Audit Program, Internal Audit Checklist, Audit Nonconformity Report, Internal Audit Process Checklist and Internal Audit Report available separately from the procedure link above; or included in the toolkit at https://advisera.com/17025academy/iso-17025-documentation-toolkit/