ISO 15189 Medical Laboratories, NABL Consultancy, NABL Accreditation
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 Organisation for Standardisations's 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.
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. Evidence-based laboratory medicine (EBLM) is an essential tool in the assessment of effectiveness, as high quality systematic clinical research is necessary for investigating the impact of any intervention on clinical outcome.
Implementing ISO 15189 as part of laboratory quality initiatives provides both laboratory and business benefits such as:
- Improved national and global reputation and image of the laboratory.
- Continually improving data quality and laboratory effectiveness.
- Having a basis for most other quality systems related to laboratories, such as Good Laboratory Practices.
- Mutual Recognition Agreement (MRA) amongst various countries test report is acceptable without repetition of analysis.
- Customer satisfaction is achieved through introduction of Quality Management System which is a part of ISO 15189.
- All test equipment will be calibrated and traceable to National Standards so that accuracy of results will be ascertained & maintained.
- Laboratory will be participating in Inter laboratory Comparison program so that quality level of the lab with respect to other accredited lab can be determined.
- Quality control checks will be carried out periodically by which system is always maintained.
While the standard is based on ISO/IEC 17025 and ISO 9001, it is a unique document that takes into consideration the specific requirements of the medical environment and the importance of the medical laboratory to patient care.
GQS carries rich experience in training, implementing, consulting hospitals, pathological laboratories for NABH, ISO 15189 Accreditation.
Interested in having your medical laboratory accredited / certified for ISO 15189, NABL Accreditation drop an email to This e-mail address is being protected from spambots. You need JavaScript enabled to view it or call +919845313910 NABL Consultant, NABL Consultancy, NABL Documentation, ISO 15189 Accreditation, ISO 15189 Consultancy, ISO 15189 Certification, NABL Certification, NABL Training, ISO 15189 Accreditation, ISO 15189 Certification, ISO 15189 Training please drop an email to This e-mail address is being protected from spambots. You need JavaScript enabled to view it
services in Bangalore, Chennai, Hyderabad and other locations in Karnataka, Tamil Nadu, Kerala and Andra Pradesh.
Approved by NABET, NRBPT Quality Council of India.
