ISO 15189: 2022 A Primer for the Practicing Pathologist and Laboratory Professional

By Gaurav Sharma, Neeraj Jain, Rohit Gulati, and Rakesh Sharma - April 03, 2023


The International Organization for Standardization (ISO) is a federation of national standards bodies that develop and publish standards for various industries and technologies. These standards aim to ensure the quality and safety of products, services, and processes responding to the need for scalability in the retrieving industrial sector post-World War II.

Medical laboratories play a crucial role in providing accurate and reliable test results for the diagnosis and management of patients. In response to the growing demand for quality and competence, the ISO published the first edition of ISO 15189: Medical Laboratories — Particular Requirements for Quality and Competence in 2003. It was developed with the collaboration of the extensive experience and efforts of the Technical Committee ISO/TC 212 and the European Committee for Standardization (CEN) Technical Committee CEN/TC 140 in accordance with the Vienna Agreement. The evolution of ISO 15189 to its current form involved amalgamating principal elements from multiple other ISO standards (ISO 17025, ISO 9001, ISO 22367, and ISO 22870) to meet the unique needs of medical laboratories. The standard covers various aspects of laboratory operations, including governance, personnel, infrastructure, processes, and management systems, to ensure that medical laboratories provide accurate and reliable test results that meet the needs of patients and healthcare providers.

Since its inception in the early 2000s, ISO 15189 has been widely adopted in clinical laboratories worldwide. Many countries have made it a national accreditation requirement, and many laboratories seek accreditation to ISO 15189 to demonstrate their commitment to quality and competence. Additionally, many healthcare organizations prefer or require laboratories accredited to ISO 15189 standard. Since its first publication, ISO 15189 has undergone periodic revisions to keep pace with medical laboratory science changes and align with related standards. The most recent revision of the standard was published in late 2022, making significant updates to align with the newest version of ISO/IEC 17025:2017. Herein, we describe the structure of global accreditation programs, the ISO 15189 standard, and its 2022 updates.

ISO 15189 accreditation and accreditation agencies

Accreditation in ISO 15189 refers to the formal recognition of a medical laboratory’s competence to perform specific tests, as demonstrated by their conformance with the requirements of the ISO 15189 standard. To attain ISO 15189 accreditation, medical laboratories must undergo a rigorous assessment process by an accredited certification body. Across the globe, there are numerous ISO 15189 accreditation agencies, each of which plays a critical role in ensuring the quality and competence of medical laboratories. Such accrediting agencies include April 2023 | critical values 21 the College of American Pathologists in the United States, the Swiss Accreditation Service in Switzerland, and the National Accreditation Board for Testing and Calibration Laboratories in India. Other countries also have accreditation bodies and programs recognized locally or internationally. These agencies and programs serve as the foundation for laboratory performance and implementation of ISO 15189.

ILAC, or the International Laboratory Accreditation Cooperation, is an international organization for accreditation bodies that assess conformity in accordance with the ISO/ IEC 17011 standard and include medical testing laboratories using ISO 15189. Its goal is to ensure that accreditation by conformity assessing bodies is performed to an internationally recognized level of quality. ILAC lays a crucial framework for mutual recognition of accreditation bodies, fostering international cooperation and collaboration, and promoting the global use of accredited services. And by doing so, ILAC helps build confidence in test results and laboratory accreditations supporting international service provision by removing technical barriers.

Education and training around ISO 15189 is an investment in professional development and can help build the skills needed to work effectively in medical laboratories and support quality patient care. In addition to books, articles, and online resources, many accreditation agencies and programs offer workshops, seminars, and training courses that provide in-depth knowledge of the standard and how it is applied in medical laboratories. Additionally, an internal auditor certification in ISO 15189 formally recognizes the expertise and understanding of the standard.

Overview of ISO 15189 structure and requirements

To access the ISO 15189 standard, individuals or organizations can visit the official ISO website. Search for the standard “ISO 15189: Medical Laboratories—Particular Requirements for Quality and Competence,” and the standard can be purchased as a physical copy or as a digital download in PDF format.

The ISO 15189:2022 document is organized into eight sections, with the first three providing an overview of the standard’s scope, normative references, and terms and definitions. Section 4 (General Requirements) covers impartiality, confidentiality, patient rights, safety, and well-being. Section 5 (Structural and Governance Requirements) outlines the legal accountability and responsibilities of the laboratory director and management structure for ensuring quality management. This section also covers objectives, policies, and test interpretation to meet end-user needs, with a strong emphasis on an efficient risk management system for detecting and addressing potential patient harm and improvement opportunities.

Section 6 (Resource Requirements) addresses the resources required for laboratory operations, including personnel, infrastructure, and equipment. It covers human resource management, including recruitment, training, and professional development, as well as technical aspects such as laboratory facilities, equipment maintenance, calibration and metrological traceability, and service agreements and referral services. The 2022 document also incorporates point-of-care testing.

Section 7 (Process Requirements) includes risk mitigation during the pretest, examination, and posttest phases, as well as the measurement of uncertainty. Section 8 (Management Systems) comprehensively covers management system requirements, including responsibilities, policies and objectives, risk management, audits, corrective actions, continuous improvement, and regular management system reviews. This section has been rearranged compared to the previous edition to align with ISO/IEC 17025:2017. Finally, the annexures section provides additional information to assist with implementing the standard, including point-of-care testing requirements and correlation with prior ISO standards.

2022 changes in the ISO 15189 standard

The evolution of ISO 15189 is a continuous process to ensure it stays current and meets the demands of the laboratory industry. ISO 15189 began in 2003 with the publication of the first edition. Then, as part of the ISO standard review protocol, the first five-year review was carried out in 2008, resulting in the second edition. In 2012, the third edition was published. The next five-year review took place in 2017, resulting in the fourth edition’s publication in 2022.

The 2022 update to ISO 15189 was necessary due to several factors. Firstly, significant changes had occurred since the last edition was published in 2012. Laboratories were concerned about the definitions of terms, including the distinction between a laboratory, an examination method, and an examination procedure, as well as terms such as metrological traceability, measurement uncertainty, validation, and verification. Additionally, other standards referenced in ISO 15189, including ISO/IEC 17025:2017 and ISO 9001:2015, had been revised. Further, feedback from users of ISO 15189:2012 indicated room for improvement. As a result, the revision was approved on a 48-month timeline.

The updated edition of ISO 15189:2022 brings significant changes deemed critical to the laboratory community. Firstly, the new edition was designed in conjunction with ISO/IEC 17025:2017 to prioritize technical requirements and mention management requirements at the end of the document. This revised standard merged, separated, or emphasized some requirements. The new edition also includes POCT testing requirements for the first time in an ISO standard for medical laboratories. Although, there is a different standard, ISO 22870:2016, specifically for POCT, which is now withdrawn.

Additionally, the new edition greatly emphasizes risk management and assessment (ISO 22367) and patient safety, rights, and requirements (ISO 15190) in medical laboratories. The ISO 15189 standard now emphasizes risk management, reflecting the importance of this concept as outlined in ISO 9001:2015, Quality Management Systems—Requirements. The revised standard establishes “risk-based thinking” as a core aspect of the management system, which both prevents harm in dayto- day operations and addresses nonconformities in the future. The updated standard also provides a more comprehensive examination of measurement uncertainty and traceability. Measurement uncertainty pertains to the range of values within which a measurement’s true value is likely to lie. Traceability ensures consistency in test results over time. Finally, the new edition has added a few more terms and definitions and is aligned with ISO 22367, ISO 15190, and ISO 20658.

Conclusion and summary

ISO 15189 is a globally recognized standard that sets the requirements for quality and competence in medical laboratories. It was derived from the general standard ISO 17025, which focuses on the competence of testing and calibration laboratories but provides more specific requirements for medical laboratories. The standard is widely adopted and recognized by numerous accreditation agencies and programs worldwide.

Many medical laboratories seek accreditation to ISO 15189 to demonstrate their commitment to quality and competence and to assure their customers, regulators, and patients that they meet specific standards. Individuals can obtain education and training around ISO 15189 through various means, including workshops, training courses, books, articles, and online resources. They can also earn an internal auditor certification by completing an accredited training program and passing a certification exam.

ISO 15189:2022 is an eight-section document that outlines the requirements for impartiality, patient rights, safety, and well-being in the laboratory. It covers the legal responsibilities of the laboratory director, the resources required for laboratory operations, and the management system requirements, including risk management and audits. The standard also includes point-of-care testing requirements for the first time and is aligned with other relevant ISO standards.

The recent update to ISO 15189 was driven by changes in definitions of terms, revision of referenced standards, and feedback from users indicating room for improvement. The updated edition of ISO 15189:2022 was designed in line with other ISO standards, prioritizes technical requirements, and places greater emphasis on risk management, patient safety, and rights. Obtaining education and training in ISO 15189 is an investment in professional development and helps individuals work effectively in medical laboratories to support quality patient care.