What is ISO 15189:2012?

ISO 15189 Medical laboratories — Particular requirements for quality and competence include 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.

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.

Benefits of ISO 15189 accreditation :

v Improved national and global reputation and image of the laboratory.

v Continually improving data quality and laboratory effectiveness.

v Having a basis for most other quality systems related to laboratories, such as Good Laboratory Practices.

v Mutual Recognition Agreement (MRA) amongst various countries test report is acceptable without repetition of analysis.

v Customer satisfaction is achieved through introduction of Quality Management System which is a part of ISO 15189.

v All test equipment will be calibrated and be traceable to National Standards so that accuracy of results will be ascertained & maintained.

v Laboratory will be participating in Inter laboratory Comparison program so that quality level of the lab with respect to other accredited labs can be determined.

v Quality control checks will be carried out periodically by which system is always maintained.

v National and international recognition

v Assurance to clients of good laboratory practice

v Meets purchaser or regulatory specifications

v Decision makers can rely on test results

v Improves staff motivation and esteem

v Ensure better support in the event of legal challenge

v Saves money by getting it right the first time

What do we offer for ISO 15189 accreditation?

v With a team of highly competent consultant and technical experts, you are sure to kick start your ISO 15189 accreditation journey with us in full confidence.

v We provide you the following services for your ISO 15189 accreditation project :-

v Awareness training

v Gap analysis of your existing system

v Process mapping and process definition

v Documentation including manuals, procedures, work instructions, test instructions, check lists, formats etc.

v Assistance in proficiency testing, inter laboratory comparison and measurement of uncertainty

v Assistance in documentation implementation

v Internal auditor training and conduct of internal audit

v Pre assessment audit and pre certification audit.

v Assistance during the entire phase of accreditation audit

v Post certification assistance in system maintenance.