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?
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?
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
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.