What Is the ISO 15189 Accreditation?

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:

• Strives to create a system that is failure-resistant, catching mistakes before it becomes a serious issue.
• Aims to achieve accurate results in one try by reducing the number of errors.
• Identifies opportunities for continuous improvement in labs.
• Empowers lab staff by involving them in critical problem-solving and implementation of solutions.

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.

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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.

What are the Benefits of an ISO 15189 Accreditation?

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:

• Risk reduction: The accreditation helps labs working with sensitive information/data, complicated equipment, and other critical matters related to people’s health, structure their operations around best practices. It helps accredited laboratories identify any potential risks and design a plan to reduce or resolve them.
• Improved team morale: The accreditation standard works to reduce mistakes, optimize workflows, and mitigate time-wasting. This can help lab staff feel more motivated and supported with appropriate resources and streamlined workflows.
• Globally recognized: Organizations with accreditation certificates are recognized globally for the quality standards of their laboratory services and products. Certificates and test reports are accepted by over 80 countries that contribute to medical health worldwide.
• Cost-savings: The ISO 15189 laboratory accreditation program will ensure that the results produced by labs are technically valid and accurate, reducing both time and money spent on retesting.

The Accreditation Process

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:

• Management Requirements: Regular management reviews and internal audits to ensure labs’ adherence to the QMS. Moreover, it focuses on document control, advisory services, continual improvement, and risk management.
• Technical Requirements: Examination of personnel qualifications and competence, equipment, reagents and supplies, laboratory testing processes, quality assurance of test results, quality control, environmental conditions, laboratory information management, and more.

Besides the independent assessment, medical labs must follow a general series of steps. These steps are summarized below:

Application

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.

Document Review

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.

Accreditation Assessment

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.

Corrective Action and/or Follow-up Visit

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.

Accreditation Decision

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.

Surveillance and Reassessment

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.

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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.

If your lab needs reliable, high-performing equipment, consider leasing with Excedr. Our custom lease program helps labs procure high-quality analytical, clinical, biotech, and all other general lab equipment.