Perform an audit using ISO 17025 guidelines
I am a quality manager and i have to perform an internal audit using the guidelines of iso17025:2017. Do you have any guidelines and tips to excel in this audit?
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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 following will provide more information:
- ISO 17025 document template: Internal Audit Procedure at https://advisera.com/17025academy/documentation/internal-audit-procedure/
- 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/
- Clause-by-clause explanation of ISO 17025:2017 at https://info.advisera.com/17025academy/free-download/clause-by-clause-explanation-of-iso-17025/
- How to perform an internal audit using ISO 19011 at https://info.advisera.com/free-download/how-to-perform-an-internal-audit-using-iso-19011
- Book - ISO internal audit: A plain English guide at https://advisera.com/books/iso-internal-audit-plain-english-guide/
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Oct 23, 2020