IMLABM 01

Background

ISO 15189 specifies the quality and competence requirements applicable to medical biology laboratories. ISO 15189 can be used by medical laboratories that develop their quality management systems and evaluate their own competence. Laboratory customers, regulatory authorities and accreditation bodies may also use it.

Educational objective

• Understand and identify the requirements of ISO 15189;
• Identify the provisions to implement to implement the quality approach according to ISO 15189.

Who is concerned

Anyone wishing to understand and know how to implement ISO 15189: Doctors or pharmacists biologists, quality managers, technicians, consultants, auditors

Content

Have reading keys of ISO 15189

• Principles of quality management and process;
• Reference documents for SEMAC accreditation
• Structure of ISO 15189.

Interpret the requirements of ISO 15189

• The fields of application;
• The vocabulary ;
• Chapter 4 and management requirements (responsibility, contracts, outsourced examinations, registrations, evaluations and audits ...);
• Chapter 5 and the technical requirements (pre-analytical, analytical, post-analytical process, material vigilance, dissemination of results, information management ...).

Define the strategy of the process approach for LBMs From the definition of the quality policy to the determination of the laboratory processes Quality planning

Identify, plan and monitor the processes of the quality management system Activity identification, management and process analysis Graphical Representation: Process Mapping

Promote the improvement of the process system put in place Continuous improvement Development of action plans Process monitoring and management review Risk analysis Implementation of a simple technique of process analysis Case study