audit checklist based on iso 15189: 2022

1. General Requirements

Confirm the laboratory's compliance with applicable legal and regulatory requirements.

Verify the laboratory's scope of accreditation.

Review the laboratory's quality management system documentation.

Here are some additional steps that could be included in the "General Requirements" section of the audit checklist based on ISO 15189:2022

Assess the laboratory's organizational structure and responsibilities

Evaluate the qualifications and competence of laboratory personnel

Review the laboratory's policies for ensuring impartiality and confidentiality

Confirm the availability and adequacy of facilities and environmental conditions

Verify the maintenance and calibration status of laboratory equipment

Check for the implementation of safety measures and risk assessments

Review the laboratory's procedures for handling and storage of samples

Assess the laboratory's communication processes with clients and stakeholders

Verify the laboratory's adherence to ethical standards and practices

Evaluate the laboratory's training and continuing education programs for staff

Check for the establishment and maintenance of a complaint handling process

Review the laboratory's procedures for managing and reporting nonconformities

Assess the laboratory's engagement with external quality assessment programs

Confirm the laboratory's procedures for managing changes to the quality management system

2. Management Requirements

Evaluate the effectiveness of the quality management system.

Assess the management's commitment to quality.

Verify that there are defined roles and responsibilities for management and staff.

Review the laboratory's quality objectives and targets.

3. Technical Requirements

Confirm that the laboratory has appropriate resources and facilities.

Assess the competency of personnel performing laboratory activities.

Review the procedures for sample collection, handling, and storage.

Evaluate the calibration and maintenance of equipment.

Verify the validation of test methods and procedures.

Assess the quality control measures in place.

4. Pre-examination Procedures

Review the procedures for patient identification and sample collection.

Evaluate the documentation related to pre-analytical processes.

Confirm that there are procedures for handling and transporting samples.

5. Examination Procedures

Assess the implementation of standard operating procedures for testing.

Verify the accuracy and reliability of test results.

Review the procedures for reporting results and handling discrepancies.

6. Post-examination Procedures

Check the procedures for the interpretation of test results.

Evaluate the communication of results to relevant stakeholders.

Review the laboratory’s protocol for managing complaints and feedback.

7. Continuous Improvement

Verify the processes for internal audits and management reviews.

Assess the implementation of corrective and preventive actions.

Review the laboratory's training and competency assessment programs.

8. Document Control

Confirm that there is a system for managing documents and records.

Evaluate the procedures for reviewing and updating documents.

Check the accessibility of relevant documents to staff.

9. Risk Management

Review the laboratory's risk management processes.

Assess the identification and mitigation of potential risks to quality.

This checklist provides a structured approach to auditing a laboratory's compliance with ISO 15189:2022 standards.