The objective of this standard 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this document contains the requirements for point-of-care testing (POCT) and supersedes ISO 22870, which will be withdrawn upon publication of this document.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.
NAABNorth America Accreditation Body