Introduction to ISO 15189:2012 Medical Laboratories – Particular Requirements for Quality and Competence
ISO 15189:2012 ‘Medical Laboratories – Particular requirements for quality and competence’ specifies quality system requirements applicable to medical laboratories. These requirements cover arrangements for requisition, patient preparation, identification, collection of samples, transportation, storage, processing and examination of clinical samples, together with subsequent validation, interpretation, reporting and advice, in addition to considerations relating to safety and ethics in medical laboratory work. This interactive and practical foundation course is designed to provide delegates with an understanding of the requirements of ISO 15189: 2012 with specific emphasis to those specified in the Clinical Laboratory Accreditation document ‘Standards for the Medical Laboratory’ Nov 2010
- Quality and Quality Management concepts
- Commonly used quality management system standards
- Overview and requirements of ISO 15189
- Additional requirements of ISO 15189 over CPA (2010)
- Structure of Quality System Documentation
- Sources of information and further development
- Laboratory Quality/Technical Managers
- Laboratory Technicians/Supervisors
- Assessors of Laboratory Management Systems
- Personnel responsible for procurement and evaluation of Laboratory Services
- Users of clinical test services
- Interpret the basic requirements of ISO 15189 and its inter-relationship between ISO 9001/CPA and ISO/IEC 17025 management system standards.
- Identify the key requirements and actions that would be required to meet ISO 15189 requirements over and above those currently specified by CPA.