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> ISO 17025 Audit
ISO 17025 Audit
1. Pre-Audit Preparation
Review the ISO 17025 standard requirements
Gather relevant documentation (quality manual, SOPs, etc.)
Identify team members involved in the audit
Schedule audit dates and notify relevant personnel
Prepare audit plan and objectives
2. Opening Meeting
Introduce the audit team and participants
Discuss the audit objectives and scope
Review the audit schedule
Address any questions or concerns from the laboratory staff
3. Document Review
Verify the quality manual and policies
Check procedures for compliance with ISO 17025
Review records of previous audits and corrective actions
Assess calibration and maintenance records for equipment
4. On-Site Audit
Observe laboratory practices and procedures
Interview staff regarding their roles and responsibilities
Evaluate the implementation of SOPs and work instructions
Inspect laboratory facilities and equipment
Check for proper handling of samples and data
5. Non-Conformance Identification
Document any non-conformities or areas of concern
Classify findings as major or minor non-conformities
Discuss findings with the laboratory staff during the audit
6. Closing Meeting
Present audit findings to laboratory management
Discuss identified non-conformities and their implications
Outline next steps and timeline for corrective actions
Collect feedback from laboratory staff on the audit process
7. Post-Audit Activities
Prepare the audit report summarizing findings
Distribute the audit report to relevant stakeholders
Follow up on corrective actions and their implementation
Schedule the next audit or review date
8. Continuous Improvement
Review audit outcomes for trends and areas for improvement
Update the quality management system based on audit findings
Conduct training sessions based on identified needs from the audit
Plan for continuous monitoring and evaluation of processes
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