What is ISO 15189:2012 –Medical Laboratory Accreditation?

ISO 15189 Certification – Medical Laboratories — Particular necessities for quality and capability incorporate the quality management system prerequisites specific to medical laboratories.This standard is used for accreditation of clinical lab competence. It enables labs to establish proficient operational procedures, meet client expectations and improve service.

This standard makes a significant template for evaluating the technical ability of medical labs and management of their service and staff. This  Standard  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.

Why ISO 15189:2012 accreditation is important?


Competence in any field is crucial, but it’s even more pertinent in the medical sphere where the patient’s system is compromised by disease or injury. ISO 15189 is a mark of confidence awarded to medical laboratories – an accreditation that proves you are dedicated to delivering a proficient and quality service across all aspects of your operation.


Becoming ISO 15189 accredited will verify three key components of a laboratory: your integrity, impartiality and capabilities.


What are the benefits of ISO 15189:2012 accreditation?
  • Improved national and global reputation and image of the laboratory.
  • Continually improving data quality and laboratory effectiveness.
  • Mutual Recognition Agreement (MRA) amongst various countries test report is acceptable without repetition of analysis.
  • Customer assurance on test results and reports and hence satisfaction
  • Decision makers can rely on test results
  • All test equipment are calibrated and be traceable to National Standards
  • Quality control checks will be carried out periodically by which system is always maintained.
  • Measurement of Uncertainty values and Error-values are explicitly calculated, defined within the results and reports
  • Saves money by getting it right the first time 

Who need ISO 15189:2012?

Medical Laboratory testing is incredibly important in the delivery of information-based healthcare outcomes – this is incredibly important in a world where decisions need to be driven by facts, science and data. Any medical laboratory that wants to deliver clinically relevant results that meet the highest ethical standards should become ISO 15189 accredited..

Is ISO 15189:2012 accreditation mandatory?

ISO 15189 accreditation is not mandatory in every jurisdiction, but it’s worth checking your local regulations. Nevertheless, the importance of laboratory accreditation should never be overlooked, especially when you are dealing with public health.


As part of your accreditation process, you will get your organisation up-to-date with all the complex legal requirements that a medical laboratory must adhere to. With the ISO’s culture of continuous improvement, any changes to law or regulation will be implemented as part of your ongoing commitment to best practice

What is the validity ISO 15189:2012 accreditation?

A yearly surveillance audit will be conducted followed by the next 2 years of certificate validity.

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