ISO 15189:2022 Documents | Editable Manual, Procedures, Forms, Checklist

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The standard ISO 15189:2022 is developed for use by medical laboratories in developing their quality management systems and assessing their own competence. The ISO 15189 standard’s fourth edition was published in December 2022. The ISO 15189:2022 standard edition has been totally revised and is now in accordance with the ISO/IEC 17025 standard. The current standard incorporates the standards for point of care testing (POCT), which were previously established in the ISO 22870 standard, among other notable modifications such as the increased emphasis on risk throughout the standard. ISO 15189 certification can be also used for confirming or recognizing the competence of medical laboratories by laboratory customers (patients / corporate customers/ hospitals etc.), regulating authorities, and accreditation bodies.

The editable ISO 15189:2022 Documentation which includes quality manual, procedures, SOPs, forms, audit checklists, etc., is a primary requirement for conforming to the competence of medical laboratories. The documentation kit designed by Global Manager Group contains ready-to-use sample documents like ISO 15189 manual, procedures, standard operating procedures, formats, forms, Job description, Sample Risk Assessment & Opportunity Sheet and templates as well as more than 500 questions in the audit checklist, etc., which cover all documented information required for ISO 15189:2022 accreditation. The overall aim of this documentation kit for medical laboratories is to give confidence to the laboratory customers (patients / corporate customers/ hospitals etc.), regulating authorities, and accreditation bodies that are associated with the medical laboratory as well as for iso 15189 consultant. The key advantage of the ISO 15189 certification documents kit is its user compatibility. It is a globally used documentation tool available with easy editing features and compatible with clause-wise requirements. All the documents covered in more than 120 MS Word files are editable and written in simple English. The users can update sample document templates as per their organization’s working system and create their own documents for their company in just a couple of man-days.