On December 6, 2022, the International Organization for Standardization (ISO) released the fourth revision of ISO 15189:2022. ISO 15189 is implemented by medical laboratories to build management systems and evaluate their competence. It is also relevant for laboratory users, regulatory agencies, and accreditation bodies to certify or recognize the competence of medical laboratories. The standard was revised to include a greater emphasis on the patient, including enhanced standards for point-of-care testing (POCT). POCT requirements were originally described in ISO 22870:2016, which has now been integrated as an appendix in ISO 15189’s 4th edition. The revised standard is less restrictive, with a greater emphasis on risk management, putting patient care rightly at the forefront of the criteria.
The management requirements are now included towards the conclusion of the publication as a result of additional revisions made to the standard to bring it into compliance with ISO/IEC 17025:2017. The ILAC Resolution GA 26.08, which was released by the International Laboratory Accreditation Cooperation, stipulates a transition time of three years starting from the date of publication. To keep their current certification and provide testing laboratories enough time to adjust to the new regulations. Individuals find the changes in quality management changes, equipment updates, new terms & definitions in ISO 15189:2022, and management system documentation changes.
ISO 15189:2022 Requirements for Quality and Competence aim to improve patient welfare and laboratory users’ satisfaction by fostering trust in the caliber and expertise of medical laboratories. After 10 years, technical updates to ISO 15189 have been made. The ISO 15189 Standard for Quality and Competence in Medical Laboratories ISO 15189:2022 specifies requirements for quality and competence in medical laboratories. This standard contains requirements for the medical laboratory to plan and implement actions to address risks and opportunities for improvement. Besides applying to medical laboratories developing their management systems and assessing their competence, ISO 15189 is also applicable to users, regulatory authorities, and accreditation bodies confirming or recognizing the competence of medical laboratories by the laboratory.
The benefits of the standard’s approach include: Increasing the effectiveness of the management system Decreasing the probability of invalid results Reducing potential harm to patients, laboratory personnel, the public, and the environment. The main changes of the ISO 15189:2022 standard are alignment with ISO/IEC 17025:2017- General Requirements for The Competence of Testing and Calibration Laboratories resulted in the management requirements now appearing at the end of the document Requirements in ISO 22870:2016 for point-of-care testing (POCT) have been incorporated and is a new inclusion in the standard’s scope Increased emphasis on risk management.
General requirements for management system documentation are categorized in the new ISO 15189 specification under the following categories like ISO 15189:2022 documents, personnel access, proof of commitment, competence, and quality. It also goes into considerably more detail about document control, with subsections on record generation, record amendment, and record retention. The earlier ISO 15189 specification is more comprehensive and uses a list/bullet point structure in its management parts rather than segmenting sections with sub-sections. The management system documentation may, but is not needed to, be included in a quality manual, according to a substantial revision to ISO 15189:2022; nevertheless, ISO 15189:2012 specified that the laboratory should produce and maintain a quality manual.
Meanwhile, documentationconsultancy.com began developing editable ISO 15189:2022 Documents that adhere to all of the most recent standards criteria. The easy and quick implementation/revision of the ISO 15189:2022 standard can be supported by the ready-to-use ISO 15189:2022 documents. So, stay tuned for more details, about the ISO 15189:2022 documents.
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