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Information meeting about ISO 15189:2022 is arranged this spring

During the next three years, the updated standard ISO 15189:2022 will be introduced. The standard concerns accredited medical laboratories. Swedac will arrange an information meeting in English to guide concerned laboratories in the implementation.

Information meeting about ISO 15189:2022 is arranged this spring

It is during May that Swedac arrange the information meeting about the update in ISO 15189:2022.
– Everyone who is a contact person at a medical laboratory with an accreditation will receive an invitation. If more people from the same laboratory would like to take part, that’s also fine, says Helene I Johansson, lead assessor at Swedac.

Lead assessors from Swedac will be responsible for the information meetings.
– The focus is on how the implementation of the updated standard should be done. We will not look at individual paragraphs, the information will be given on an overall level, says Helene I Johansson. The updated standard was published in December 2022 and is available at your national standardization body.

The meeting will take part the 22 May, at 10-12, UTC +2.
An invitation will be sent to all contact persons at accredited medical laboratories.
The meeting is free of charge.

Is your organisation at the start of an accreditation process and wants to get more information about the new version of  ISO 15189:2022?
You can also register for one of the events. The information meetings are aimed at existing customers familiar with accreditation, but new customers can also use much of the information.

From 1 January 2024, Swedac will start to perform assessments according to ISO 15189:2022.

Background to the changes

During the next three years, the updated standard SS-EN ISO 15189:2022 will be introduced. The standard concerns accredited medical laboratories.

The background to the change

ISO 15189:2022 Medical laboratories – Requirements for quality and competence was published on 6 December 2022. The International Laboratory Accreditation Cooperation (ILAC) has set a transition period of three years, which means that all medical laboratories with an existing accreditation to ISO 15189:2012 must have been assessed and found to comply with the requirements of ISO 15189:2022 in full within the end of the transition period. For that reason, Swedac will start to perform surveillance assessments to ISO 15189:2022 from 1 January 2024. If you have your upcoming assessment planned for 2024 and beyond, the new version of the standard will apply. For new applications for accreditation, the new version will be applied from 1 October 2023.  You can apply for accreditation before 1 October and indicate in the application that you would like to be assessed according to the new version. If you apply for accreditation and want your assessment before 1 October 2023, the assessment will be done according to ISO 15189:2012.

The news in SS-EN ISO 15189:2022 in brief

ISO 15189:2022 now has a structure similar to standards within the ISO 17000 series. ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories is now a normative reference. Nomenclature and definitions are according to ISO/IEC 17000:2020 Conformity assessment – ​​Vocabulary and general principles. The standard is also harmonized with several other standards; ISO 22367 Medical laboratories – Application of risk management to medical laboratories, ISO 15190 Medical laboratories – Requirements for safety and ISO 20658: Medical laboratories – Requirements for collection and transport of samples.

The main differences between the old and new versions are, as previously informed, a greater focus on clinical risk and risk assessments with the patient in focus, and that the requirements of the standard intended for patient-related activities (ISO 22870:2016) now is integrated in ISO 15189:2022 and therefore will be withdrawn. In general, the standard is more coherent and less normative. Regarding impartiality and independence, there are increased requirements compared previous version.