ISO 15189 2022 Documentation Kit in Editable Format Is Now Available at

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The has recently introduced the ISO 15189:2022 Documentation Kit for medical laboratory’s quality management system for implementation and accreditation. The ready-to-use documentation toolkit can be used as a ready-reference tool to complete the ISO 15189 documentation process to achieve ISO 15189 accreditation.

The ISO 15189 standard’s most recent fourth edition was published in December 2022. Complete changes were made to the ISO 15189:2022 standard version to bring it into compliance with the ISO/IEC 17025 standard. The most recent standard incorporates the requirements for point of care testing (POCT), which were previously established in the ISO 22870 standard, among other significant changes like the increased emphasis on risk throughout the standard. Also, under the supervision of an expert consultant, has devoted the past few months to designing and developing the documentation.

The readymade documentation kit will help medical laboratories in developing a documented quality management system and assessing their competence by ISO 15189 requirements and finally achieve ISO 15189 accreditation from a recognized accreditation body anywhere in the world. The ISO 15189 documentation kit also includes an ISO 15189 quality manual, procedures, SOPs, exhibits, Blank Formats /Templates, Job description, ISO 15189 audit checklist, Sample risk assessment & opportunity Sheet, and ISO 15189:2022 document compliance matrix. Users can easily amend and change the templates as per their working system and create quality documents quickly. The ISO 15189 documents save much time and cost in document preparation for accreditation. It gives 100% value for money to customers.

ISO 15189 Procedures and formats provided in this documentation kit can help in fine-tuning the processes and establish better control over the quality management system of medical laboratories. Documents are useful in training staff on QMS requirements, as well as assessing their competence. This kit takes care of all the sections and sub-sections of ISO 15189:2022, which gives better confidence and improves the system. To know more about the editable ISO 15189:2022 documentation kit, visit here:

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