Have You Aware That ISO 15189: 2022 Standard Has Been Revised, And What Changes Have Been Made?

Have You Aware That ISO 15189: 2022 Standard Has Been Revised, And What Changes Have Been Made?
4 min read

The 4th edition of the ISO 15189:2022 Medical Laboratories - Criteria for quality and competence standard is ultimately amended on December 6, 2022. To assist medical professionals in adopting the new specifications into their service. The significant differences are a re-alignment of the clause structuring to bring it broadly in line with the most recent version of ISO/IEC 17025: 2017 and the incorporation of the Point-Of-Care Testing (POCT) standard ISO 22870, which is currently a 'stand-alone' add-on standard used in conjunction with the current version of ISO 15189. A team of professionals worked on the standard modifications for four years.

We are all aware that medical laboratories are an important part of patient care. To begin, they must work within an ethical and governance framework that respects healthcare practitioners' responsibility to their patients. Furthermore, all actions should be completed as soon as possible to fulfill the demands of the patients and the people in charge of their care. The standard covers medical laboratory operations such as examination request arrangements, patient preparation, patient identification, sample collection, transportation, clinical sample processing, examination of samples, examination of samples, and sample storage.

Laboratories are also in charge of interpreting, reporting, and advising users. This might entail giving patients findings, doing urgent tests, and notifying them of vital results. When necessary, the standard advises that medical labs give guidance on patient situations. The following are some of the significant modifications that will be found in the revised standard to make the laboratory more precise and efficient.

  • This has been developed by ISO/IEC 17025: 2017 (General Requirements for Testing and Calibration Laboratory Competence), with the result management requirements listed after the publication. Priority is given to technical needs. In this revised standard, several criteria have been merged/separated/explained/emphasized more.
  • POCT testing standards have been included for the first time in an ISO standard for medical laboratories. For the needs of point-of-care testing, there is a distinct standard ISO 22870:2016. This standard will likewise become outdated after December 2025. The Joint Commission International (JCI) hospital standard contains POCT criteria that are exclusively controlled by Laboratory Management.
  • Although risk management standards were included in ISO 1589:2012 at the time of the revision, there is now a greater emphasis on risk management and assessment in medical labs.
  • The importance of patient rights, safety, and regulations that adhere to the Joint Commission International Standard (JCI) for hospitals is increased.
  • Although the previous ISO 15189:2012 standard mandated the existence of a quality manual, the updated ISO 15189:2022 standard permits but does not mandate the inclusion of a quality manual in the management system documents.

Here, a few new terms and definitions have also been introduced in the revised ISO 15189:2022 standard is mentioned below.

  • Bias/measurement Bias
  • Clinical decision Limit Examination
  • Commutability of a reference material /commutability
  • Complaint
  • Consultant
  • Examination procedure
  • External quality assessment
  • Impartiality
  • In Vitro Medical device (IVD)
  • Laboratory user
  • Management system
  • Measurement accuracy/ Accuracy of Measurement/Accuracy
  • Measurement Uncertainty (MU)
  • Patient trueness/ Measurement Trueness
  • Management system Documentation

To adopt the ISO 15189:2022 standard, companies, senior management teams, professionals, consultants, auditors, and individuals begin attending ISO 15189:2022 training courses to comprehend the standard as well as its requirements and easily adopt the new standard. It might also be a fantastic chance for medical laboratories that desire to get ISO 15189:2022 accreditation with all-efficient requirements and make the laboratory more well-organized. So, what are you waiting for? Begin by getting training on the most recent ISO 15189:2022 standard requirements and implementing them in your business/laboratories.


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