iso 15189 2022 audit

Review the ISO 15189:2022 standard requirements

Assemble the audit team and assign roles

Schedule the audit dates and notify relevant personnel

Prepare the audit plan and objectives

Gather necessary documents (e.g., quality manual, procedures, records)

Here are some additional steps that could be included in the "Preparation for the Audit" section of the ISO 15189:2022 audit checklist

Conduct a pre-audit meeting with the audit team to discuss roles, responsibilities, and expectations

Review previous audit findings and corrective actions to ensure follow-up during the current audit

Identify key personnel to be interviewed and prepare a list of questions or topics for discussion

Develop a checklist of specific areas or processes to be audited based on risk assessment and previous audits

Ensure all team members are trained on the audit process and ISO 15189:2022 requirements

Confirm the availability of necessary resources and equipment for the audit (e.g., meeting rooms, technology)

Communicate logistics and expectations to the auditees regarding the audit process and any required preparations

Establish a method for documenting findings and observations during the audit

Prepare for potential challenges or obstacles that may arise during the audit and develop contingency plans

Verify the laboratory's quality manual for compliance with ISO 15189:2022

Check laboratory procedures and protocols for updates

Review records of internal audits and management reviews

Evaluate the documentation of quality control and assurance processes

Assess training and competency records of staff

Conduct an opening meeting to outline the audit process

Observe laboratory processes and workflows

Interview staff about their roles and responsibilities

Examine equipment calibration and maintenance records

Review sample handling and storage procedures

Check the implementation of quality control measures

Verify compliance with health and safety regulations

Document non-conformities and areas for improvement

Discuss preliminary findings with the laboratory management

Collect evidence and examples for each finding

Assess the effectiveness of corrective actions previously taken

Conduct a closing meeting to present findings

Provide a summary of non-conformities and commendable practices

Discuss the timeline for corrective actions

Obtain feedback from the laboratory about the audit process

Prepare and distribute the final audit report

Monitor the implementation of corrective actions

Schedule follow-up audits if necessary

Review the effectiveness of corrective actions during subsequent audits

Update the audit checklist based on lessons learned

This checklist can be adjusted based on the specific requirements and context of the laboratory being audited.