ISO 15189 Medical laboratories — Requirements for quality and competence is an international standard that specifies the quality management system requirements particular to laboratories. The revised version was published in the year 2012 which cancels and replaces the older version which was released on 2007.
The standard was developed by ISO’s technical committee- ISO/TC 212. They assigned working group ISO 15189 to prepare the standard based on the details of ISO/IEC 17025:1999 (General requirements for the competence of testing and Calibration laboratories)
The standard establishes a stringent set of quality management requirements specifically for laboratories at every level of the health care system. Some of the standard’s objectives for lab operations include ensuring the quality and traceability of patients’ information, maintaining the safety and integrity of lab materials, monitoring the facility’s environmental conditions, and supporting public health decision-making.
This International Standard ISO 15189 is the gold standard for certifying medical laboratories as it covers both management and technical requirements needed for assessing the competence of the personnel.
Hence the ISO 15189 certification is an assurance that the laboratory has been assessed against internationally recognized standard which aims to improve the existence of a quality system, technical competence, and that the personnel is actually capable to generate technically valid results and suitable information for the intended use of each test.
Adapting to the certification of ISO 15189:2012 assist the medical laboratories in developing their quality management system and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by regulating authorities, laboratory customers and accreditation bodies.
This certification differs from the ISO 17025 –laboratory Accreditation, and ISO 15189 Certification is more preferred as this gives more importance to the patient well being. It also addresses pre-analytical and post-analytical activities, where as ISO 17025 only addresses the general requirements for testing laboratories.
IAS is one of the most well-known ISO Certification Bodies in Hong kong who provides the service of ISO certification Audits in Asia for various International standards. Apart from certification we also delivers ISO Lead Auditor Training , ISO Internal Auditor Training, and ISO Awareness/Foundation Training in Asia. All these certification and Training services by IAS for the country is managed from its office in Asia India,Indonesia,Malaysia,Singapore,Philippines,Bangladesh,srilanka,Vietnam,Bhutan,Bangladesh,Thailand.
To know more about ISO 15189 – Medical Laboratory Requirement and its certification, click here.
Process to obtain an ISO Certification
Stage 1Audit : Readiness Audit
Stage 2 Audit : Verifying the effectiveness of the System