ISO 15189:2022 – Medical laboratories — Requirements for quality and competence
This document specifies requirements for quality and competence in medical laboratories.
This document is applicable to medical laboratories in developing their management systems and assessing their competence. It is also applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies.
This document is also applicable to point-of-care testing (POCT).
NOTE : International, national, or regional regulations or requirements can also apply to specific topics covered in this document.
This document was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems, in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/TC 140, In vitro diagnostic medical devices, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
The main changes are as follows:
- Alignment with ISO/IEC 17025:2017 resulted in the management requirements now appearing at the end of the document;
- Requirements for point-of-care testing (POCT), previously in ISO 22870, have been incorporated;
- Increased emphasis on risk management.
The objective of this document is to promote the welfare of patients and satisfaction of laboratory users through confidence in the quality and competence of medical laboratories.
This document contains requirements for the medical laboratory to plan and implement actions to address risks and opportunities for improvement. Benefits of this approach include: increasing the effectiveness of the management system, decreasing probability of invalid results, and reducing potential harm to patients, laboratory personnel, the public and the environment.
The requirements for risk management are aligned with the principles of ISO 22367.
The requirements for laboratory safety are aligned with the principles of ISO 15190.
The requirements for sample collection and transport are aligned with ISO 20658.1
This document contains the requirements for point-of-care testing (POCT) and supersedes ISO 22870, which will be withdrawn upon publication of this document.
The format of this document is based on ISO/IEC 17025:2017.
The medical laboratory is essential to patient care; activities are provided within an ethical and governance framework, that recognizes the obligations of healthcare providers to the patient. These activities are undertaken in a timely manner to meet the needs of all patients and the personnel responsible for the care of those patients. Activities include arrangements for examination requests, patient preparation, patient identification, collection of samples, transportation, processing of patient samples, selection of examinations that are fit for intended use, examination of samples, sample storage, as well as subsequent interpretation, result reporting and advice to laboratory users. This may also include the provision of results to the patient, arrangements for urgent testing and the notification of critical results.
While this document is intended for use throughout the currently recognized medical laboratory disciplines, it can effectively be applied to other healthcare services, such as diagnostic imaging, respiratory therapy, physiological sciences, blood banks and transfusion services.
The use of this document facilitates cooperation between medical laboratories and other healthcare services, assists in the exchange of information, and in the harmonization of methods and procedures.
The comparability of patient examination results between medical laboratories, regardless of city or country, is facilitated when medical laboratories conform to this document.
When a laboratory seeks accreditation, it should select an accreditation body which operates in accordance with ISO/IEC 17011, and which takes into account the particular requirements of medical laboratories.
Transition Timeline Announcement
ILAC Announcement – 8th
ISO 15189:2022 Medical Laboratories – Requirements for quality and competence has now been published.
Further a resolution was endorsed at the ILAC General Assembly to allow a 3-year implementation period from the date of publication of this revised standard (ie now December 2025) as shown below:
ILAC Resolution GA 26.08
As the revised version of ISO 15189 is scheduled for publication in 2022 or early 2023, the General Assembly endorses the recommendation of the AIC that a transition period of 3 years from the date of publication be adopted.
Noting that the requirements for Point of Care Testing (POCT) contained in ISO 22870:2016 have been incorporated into the revised ISO 15189, ISO 22870:2016 in conjunction with ISO15189:2012 will still be recognised as a Level 4 standard for POCT for the duration of the transition period.
At the end of the transition period, accreditation of a medical laboratory to ISO 15189:2012 and accreditation of POCT to ISO 22870:2016 in conjunction with ISO15189:2012 will not be recognised under the ILAC Arrangement.
The implementation of this transition period for ISO 15189:2022 by the signatories to the ILAC MRA for the accreditation of medical laboratories will be monitored by the ILAC AMC to ensure the deadline is achieved. The process used by the AMC to monitor this implementation of the revised standard will be similar to that used during the implementation of ISO/IEC 17025:2017
Posted on 08th December 2022
Transition Timeline Announcement of NABL
NABL has released transition announcement for Accredited Medical Testing Labs in the country