International Organization for Standardization (ISO) 15189 is an international standard for medical laboratories that is closely based on ISO/IEC 17025 and ISO 9001. The accreditation assists labs in developing quality management systems (QMS), assessing their competence/performance, and ensuring their operations meet industry and legal standards for patient safety. It assesses risks on the basis of probability, severity, and impact on patient care. Additionally, ISO 15189:
The ISO 15189 standard for medical laboratories was first published in 2003. It was later revised in 2007 and 2012 with an added section on laboratory information management systems (LIMS).
It is the current standard for competency and regulatory standards in medical and clinical laboratories.
While not mandatory, it is recommended that any healthcare and medical lab that wants to produce clinically relevant results and meet the highest ethical standards become ISO 15189 accredited. The accreditation ensures that labs or organizations are fully up-to-date with all the complex legal requirements; it also shows customers and key stakeholders your commitment to best practices.
This article will cover the benefits of the ISO 15189 accreditation program and the required steps an organization must take to become ISO 15189 accredited.
Please note that the information provided in this blog is for informational purposes only. We do not offer certification or accreditation services. If you are interested in obtaining certification or accreditation, we recommend contacting the relevant program directly.
The ISO 15189 accreditation ensures the highest quality of patient care and lessens the risk of any non-compliance in labs. It not only ensures the end patient’s safety but also improves laboratories’ competence in performing tests, system management, and delivering results.
Some other benefits of ISO 15189-accredited laboratories are:
ISO 15189 accreditation is a multistep process that involves an independent assessment of the medical laboratory by the College of American Pathologists (CAP) leaders. The ISO 15189 assessment is composed of two major components:
Besides the independent assessment, medical labs must follow a general series of steps. These steps are summarized below:
The laboratory completes the online application for accreditation and submits it to CAP. CAP then assigns a dedicated lead assessor who will direct the medical lab through all the steps of the accreditation process to earn the certificate.
The lead accessor reviews the submitted documents to learn about quality management systems (QMS), any major issues associated with documentation, and the lab’s preparedness for the accreditation assessment. Based on the review, the assessor will sometimes recommend some supplemental CAP online courses.
Before the on-site assessment, the labs are recommended to perform at least one internal audit of its QMS against the ISO 15189 standard.
The assessment team performs a detailed on-site assessment of the QMS and technical competency. This step helps labs identify any gaps between the lab system and accreditation requirements.
After the assessment, the assessing team creates a report on the level of conformance, listing specific non-conformities, the lab’s strengths and vulnerabilities, and any opportunities for improvement.
The labs then perform a root cause analysis (RCA) for all non-conformities and submit a corrective response to CAP.
The assessing team reviews and evaluates the RCA for each non-conformity and makes a recommendation to the CAP 15189 Accreditation Committee.
The committee is composed of pathologists and quality experts who review the assessors’ report, documentation, and corrective action reports. The committee will then grant or deny accreditation to the lab.
The accreditation bodies perform a review of the laboratory’s QMS focusing on ISO 15189 Section 4, Management Requirements, and Section 5, Technical Requirements. Moreover, the corrective actions from the previous report will be reviewed by the committee.
*It must be noted that labs seeking ISO 15189 accreditation must first be CLIA-approved. This is because the ISO 15189 accreditation alone does not meet the US Clinical Laboratory Improvement Amendments (CLIA) requirements.
ISO 15189 helps medical labs improve the quality of their processes, refine their quality management systems, and ensure accurate delivery of test results.
However, obtaining the ISO 15189 accreditation can be much more difficult without high-quality equipment and technology. In fact, the lack thereof may possibly impede your lab in more ways than one.
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