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> Tesing institute auditing based on ISO 17025
Tesing institute auditing based on ISO 17025
1. Pre-Audit Preparation
Review the scope of accreditation.
Gather and review previous audit reports.
Ensure all relevant documents are up to date (procedures, manuals, records).
Confirm the audit schedule and notify relevant personnel.
Prepare audit checklists specific to the laboratory’s activities.
2. Management Requirements
Verify the management system is documented and implemented.
Check the organizational structure and responsibilities.
Review management reviews and their outcomes.
Assess communication procedures within the institute.
Evaluate the effectiveness of the quality management system.
3. Technical Requirements
Confirm the adequacy of methods and procedures used.
Review competency of personnel conducting testing.
Check equipment calibration and maintenance records.
Examine sample handling and testing processes.
Assess validation of methods and results.
4. Document Control
Verify the procedure for document control is followed.
Review the format and identification of documents.
Check for proper revision control.
Ensure that obsolete documents are removed from use.
5. Records Management
Examine the retention policies for records.
Ensure records are complete and legible.
Verify the accessibility of records for audit purposes.
6. Non-Conformities and Corrective Actions
Review the process for identifying non-conformities.
Check the records of corrective actions taken.
Assess the effectiveness of corrective actions implemented.
7. Final Audit Report
Prepare a draft report summarizing findings.
Include observations, non-conformities, and recommendations.
Discuss findings with laboratory management.
Issue the final report, ensuring it is distributed to relevant stakeholders.
8. Follow-Up Actions
Schedule follow-up audits for unresolved issues.
Monitor implementation of corrective actions.
Review updates in procedures and processes post-audit.
This checklist should help guide the auditing process for testing institutes according to ISO 17025 standards.
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