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ISO 15189: 2012 Medical Laboratories
ISO 15189: 2012 Medical Laboratories is the international standard recognized for medical device regulations around the world.
ISO 15189 Medical laboratories - Particular requirements for quality and competence specifies the quality management system requirements particular to medical laboratories. The standard was developed by the International Organization for Standardizations’ Technical Committee 212 (ISO/TC 212). ISO/TC 212 assigned ISO 15189 to a working group to prepare the standard based on the details of ISO/IEC 17025:1999 General requirements for the competence of testing and calibration laboratories. This working group included provision of advice to users of the laboratory service, the collection of patient samples, the interpretation of test results, acceptable turnaround times, how testing is to be provided in a medical emergency and the lab's role in the education and training of health care staff.
ISO 15189: 2012 Medical Laboratories is the latest version of ISO 15189:2012, published in July 2003. This standard is based on the ISO 9001:2000 process model approach. All requirements of ISO 13485 are specific to organisations providing medical devices, regardless of the type or size of the organisation.
- ISO 15189 Introduction: ISO 15189 is an international standard developed particularly for the medical laboratories. Though it is based upon ISO/IEC 17025:1999 and ISO 9000:2000, it is a standalone standard for medical laboratories with a title particularly referred to "quality and competence”. Under the International Laboratory Accreditation Cooperation (ILAC) Multilateral Mutual Recognition Arrangement(MLA)accreditation of medical laboratories against ISO 15189 and ISO/IEC 17025 are both acceptable.
- Whatever devices you produce, as a medical device manufacturer you have a responsibility to consistently deliver devices that are safe and effective.
- The basic idea of the European Union is freedom of movement of people, products and services. This is realized through harmonization of practices, for example in the field of laboratory medicine, a patient wants to be sure that the result of a test can be trusted and is interpreted in the right way during his stay abroad. The primary aims of both Evidence-based Health Care(EBHC) and quality management of health care services are to improve clinical effectiveness and patients' outcomes.
