ISO 15189 Medical Laboratories — Particular requirements for quality and competence is a ‘variant’ standard derived from ISO/IEC 17025 with specific focus on clinical laboratories. The standard covers an ‘end-to-end’ approach to the application of quality assurance methodologies in a clinical environment. This range from definition of services offered through to collection of patient samples, sample transport, storage, transportation and test and includes the reporting, interpretation and delivery of test results. The standard also focuses on management responsibilities as well as supporting processes such as facilities, calibration, method validation, training etc.
Within the healthcare sector as in most other areas of industry and commerce, the need for organisations to operate formal Quality Management Systems is fast becoming a Commissioner, Service User, and/or Regulatory Authority prerequisite.
Some of the other common healthcare standards currently in place include external certifications such as ISO 22870, ISO 17043, ISO 13485, MHRA, HTA, Imaging Services Accreditation Scheme-ISAS many others.
ISO 15189:2012 can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies. ISO 15189 is very robust and heavy with precise requirements.
ISO 15189 quality standards provide an effective quality management and technical competence framework that enables medical laboratories to meet international standards for patient care and laboratory responsibility. The ISO 15189 quality standards, when carefully planned to meet laboratory requirements, can also improve laboratory services, products and business processes.
Medical laboratories can also benefit from the automation of business processes and controls that help obtain or continually maintain ISO 15189 quality standards.
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