Steps for Implementing ISO 15189

The following five-stage approach supports establishment and implementation of a medical laboratory management system. The original article referred to ISO 15189:2012; current projects should be planned against ISO 15189:2022 and the selected accreditation body’s requirements.

ISO 15189:2022

1. Preparation

• Establish a project team.
• Assign technical and quality management responsibilities within the laboratory.
• Train personnel in medical laboratory quality management and competence requirements under ISO 15189.
• Provide training on measurement uncertainty evaluation where applicable.
• Assess the laboratory’s current arrangements.
• Prepare an implementation plan.

2. Develop the laboratory management system

• Train the project team and key personnel in developing documentation.
• Identify necessary documentation based on the initial assessment and ISO 15189 requirements.
• Develop and issue appropriate system documentation: a manual where useful, procedures, methods, work instructions and forms.

3. Implementation

• Communicate the documentation and train relevant personnel in its use.
• Monitor implementation to check that documented procedures and work instructions are followed.
• Develop records demonstrating establishment, implementation, maintenance and continual improvement of the laboratory management system.

4. Evaluate and improve the system

• Train laboratory internal auditors.
• Conduct audits to identify conformity and improvement needs.
• Correct problems and improve the system based on internal audit findings and recommendations.

5. Accreditation assessment

• Prepare the accreditation application for BoA’s VILAS Med programme or another selected accreditation body.
• Review readiness and complete the preparations for the formal assessment.
• Coordinate the assessment with the accreditation body; accreditation and its scope are decided independently by that body.