ISO 15189:2022 Documentation Consultancy

ISO 15189:2022The ISO/IEC 15189:2022 is a standard for the accreditation of medical and clinical laboratories. In December 2022, the latest fourth edition of the ISO 15189 standard was released with various revisions. Complete revisions 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 revisions like the increased emphasis on risk throughout the standard. To achieve ISO 15189 certification, medical laboratories must have to implement a quality management system and prepare documents that conform to the requirements of ISO 15189:2022 standard. We offer online ISO 15189:2022 documentation consultancy, in which we collect required information from the clients via e-mail and other digital mediums, and prepare documents accordingly by using our documentation toolkit.

ISO 15189 Documentation - Manual, Procedures, Checklist offers ISO 15189:2022 Documentation Toolkit for the accreditation of medical laboratories to must meet the most recent standard requirements, which is a set of ready-to-use templates designed as per the latest version of standard requirements. This readymade ISO 15189 documentation kit consists of following ISO 15189 documents:

  • ISO 15189:2022 Manual (01 editable file)
  • ISO 15189 Procedures (34 procedures)
  • Sample Exhibits (08 exhibits)
  • Standard Operating Procedures (07 SOPs)
  • Blank Formats /Templates (62 forms)
  • Job description
  • ISO 15189 Audit Checklist (more than 500 questions)
  • Sample Risk Assessment and Opportunity Sheet (01 editable file)
  • ISO 15189:2022 document compliance matrix (01 editable file)

The Ready-to-use ISO 15189:2022 documents for medical laboratories cover sample copy of 15189 manual, ISO 15189 procedures, standard operating procedures, blank and filled formats, as well as ready-to-use ISO 15189 audit checklists, etc., drafted and endorsed to ensure effective accreditation. All the medical lab accreditation ISO 15189 documents are written in plain English and provided in editable word format, which saves time and cost in the process of ISO 15189 documentation, and hence, certification.

Recommended List of Medical Accreditation Documentation Toolkits

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D135 ISO 15189 Documentation Kit for Medical Laboratories download $649
D126 ISO 13485 Documents for Medical Devices - Quality Management System download $399