Document support 
ISO 15189:2022

The editable ISO 15189 Document support has more than 120 files and SOPs for the medical laboratory quality management system. 

The ISO 15189:2022 standard edition has been completely revised and aligned with ISO/IEC 17025 standard. Among other major changes like the increased emphasis on risk throughout the standard, the latest standard includes the requirements for point of care testing (POCT), which were earlier specified in the ISO 22870 standard.  This kit includes the following ready-to-use templates, which can accelerate the documentation process for ISO 15189 accreditation.

Quality Procedures - Total 34 procedures in word format for various departments.
Exhibits - Total 08 editable exhibits in word format to follow while implementing an effective system.
Standard Operating Procedures - Total 07 SOPs for collection, operation and testing process and used as reference documents.
Blank Formats /Templates - Total 62 editable forms and templates for various departments of medical laboratories to fill up records and learn system requirements.
Job description: It covers sample copy of job descriptions.
ISO 15189 Audit Checklist - More than 500 audit questions to verify the implemented quality management system and add effectiveness in the medical laboratory accreditation.
Sample Risk Assessment and Opportunity Sheet: 01 editable file to cover sample copy-filled risk assessment and opportunity sheet as per the ISO 15189 standard.
ISO 15189:2022 document compliance matrix: The ISO 15189:2022 requirement wise list of documented information reference of this kit is given in compliance matrix for ready reference to user to understand how this system is made.

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