audit checklist based on iso 15189: 2022

Pre-audit Preparation

Review ISO 15189: 2022 standard requirements

Identify audit scope and objectives

Assign audit team members

Conduct a gap analysis to identify areas of non-compliance

Review previous audit findings and corrective actions taken

Schedule a pre-audit meeting with key personnel to discuss audit expectations and roles

Prepare audit checklists and documentation templates

Conduct a mock audit to simulate the actual audit process and identify any areas needing improvement

Ensure all necessary documentation and records are organized and readily accessible for the audit team

Documentation Review

Verify documentation compliance with ISO 15189: 2022

Check for documented procedures and policies

Ensure documentation is regularly updated

Review documentation for evidence of management commitment to quality

Confirm that all personnel have access to and are trained on the documented procedures

Assess the organization's document control process for effectiveness

Verify that all required records are being maintained and retained as per ISO 15189 requirements

Check for evidence of review and approval of all documented procedures by designated personnel

Laboratory Facilities

Inspect laboratory facilities for compliance with ISO 15189: 2022

Check for cleanliness and organization

Verify equipment calibration and maintenance records

Quality Management System

Review quality management system procedures

Ensure quality control measures are in place

Verify corrective and preventive action processes

Personnel Competency

Review personnel training and competency records

Verify qualifications and certifications

Check for ongoing training and professional development

Testing Procedures

Review testing procedures for adherence to ISO 15189: 2022

Verify sample handling and processing protocols

Check for accuracy and reliability of test results

Internal Audits

Review internal audit reports and findings

Verify corrective actions taken from previous audits

Ensure effectiveness of internal audit program

External Proficiency Testing

Verify participation in external proficiency testing programs

Review proficiency testing results and corrective actions

Ensure compliance with proficiency testing requirements

Customer Feedback

Review customer feedback and complaints

Verify customer satisfaction surveys

Ensure customer feedback is addressed and resolved

Post-audit Review

Compile audit findings and observations

Develop audit report with recommendations

Communicate audit results to laboratory management