Recognize The Changes To The Most Recent Iso 15189:2022 Standard

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A universal standard for medical laboratories is ISO 15189. The ISO 15189 standard for Medical laboratories - Requirements for quality and competence, also known as ISO 15189, was initially released in 2003 and has since received four revisions: in 2007, 2012, and most recently in 2022. Accreditation for laboratories supports the development of quality management systems, evaluates their proficiency, and confirms that they are operating by regulatory and statutory requirements. On December 6, 2022, the International Organization for Standardization (ISO) released the fourth edition of ISO 15189:2022.

It has been decided by the International Laboratory Accreditation Cooperation (ILAC) that there will be a three-year transition period; after this time, all providers accredited to ISO 15189:2012 on a global scale must have been evaluated and accredited to ISO 15189:2022. Implementing the requirements of ISO 22870:2016 Point-of-care testing (POCT) - Requirements for quality and competence, as well as a structural restructuring to bring the standard in line with ISO 17000-series standards (the "parent" standards of ISO 15189), ...
... are among the standard's major revisions. Accredited POCT providers will only be evaluated in the future against the requirements of ISO 15189:2022, rendering ISO 22870:2016 obsolete, as the new ISO 15189:2022 standard integrates the requirements of ISO 22870:2016.

The standard's introduction establishes that it is a patient-centered standard. Some requirements mentioned within the ISO 15189 documents are aimed to guarantee that patient risk is core to the character of the laboratory's quality management planning and practices. One of the key differences between this version and the 2012 standard is that it is far less prescriptive, which means there is greater freedom in meeting and demonstrating the requirements outlined in the document. The terminology fulfills ISO guidelines, therefore there are still " shall " and "should" expressions ("shall" indicating a necessary necessity, "should" suggesting a strong recommendation). After "shall" sentences, qualifiers are used more frequently. Clause 6.6.3 exemplifies this, with a " shall " assertion followed by the term "as appropriate" after the sentence as a caveat.

This will necessitate services knowing what is suitable for their local service, and if something is deemed inappropriate, there is scope to argue why this requirement is not met. The second notable difference between ISO 15189:2012 and ISO 22870:2016 is that point-of-care testing (POCT) is now required, implying that ISO 22870:2016 will be phased out. An Annex summarises these standards, and there are references to the POCT requirements throughout the text. Laboratory-supported POCT should be included in the scope of the management system and adhere to the standard's standards. Because of changes in the ISO directives used to inform standard writing, the notes included in the 2012 standard have been changed.

Because "shall" and "should" statements can no longer be contained in notes, they have been relocated into the main text. Since the publication of the 2012 standard, several informative companion standards have been produced and changed. ISO/TS 20914:2019, for example, specifies how to quantify measurement uncertainty and includes a lot of practical examples. As previously stated, the emphasis of the new version is on risk and how risk affects the patient. ISO 22367:2020 is a companion standard that addresses risk management. One of the important themes in this document is how clinical decision-making can be used as a factor in risk evaluations.