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> audit checklist accortding to ISO15189:2022
audit checklist accortding to ISO15189:2022
1. General Requirements
Verify the laboratory's compliance with applicable regulations and standards.
Ensure the laboratory has a defined scope of accreditation.
Confirm the laboratory's quality management system is documented and implemented.
2. Management Requirements
Review the laboratory's quality policy and objectives.
Assess the effectiveness of the quality management system.
Evaluate the management review process and its documentation.
Check for effective communication and information dissemination within the laboratory.
3. Technical Requirements
Confirm that laboratory personnel are qualified and competent.
Review the training records of laboratory staff.
Ensure that equipment is properly maintained and calibrated.
Evaluate the laboratory's procedures for sample handling and storage.
Check the validity and reliability of test methods used in the laboratory.
Review the laboratory's process for validation of results.
4. Pre-examination Processes
Assess the procedures for specimen collection, transportation, and handling.
Confirm that there are protocols for identifying and managing pre-examination variables.
Evaluate the laboratory's methods for maintaining the integrity of specimens.
5. Examination Processes
Review the documentation for examination procedures.
Ensure that the laboratory uses appropriate and validated methods for testing.
Check for the implementation of quality control measures during testing.
Confirm the systems in place for reporting and recording results.
6. Post-examination Processes
Assess the laboratory's procedures for result interpretation and reporting.
Verify that there are protocols for handling and investigating discrepancies.
Review the processes for archiving records and documentation.
7. Continuous Improvement
Evaluate the laboratory's commitment to continuous improvement.
Review the processes for monitoring performance indicators.
Assess the effectiveness of corrective and preventive actions taken.
8. External Assessments
Confirm participation in proficiency testing programs.
Review the outcomes of external audits and assessments.
Check the laboratory's response and follow-up actions to external findings.
This checklist can be tailored to fit specific laboratory needs while ensuring compliance with ISO 15189:2022 standards.
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