Under the GAHAR Handbook for Clinical Laboratories Accreditation Standards, Edition 2025, a single unmet GAHAR Safety Requirement blocks accreditation outright. Not "partially met" — blocked. Specimen identification, critical results, hand hygiene, fire safety, equipment and utilities management: nine requirements, nine chances to fail before a surveyor reads a single SOP. For laboratory quality officers building documentation from scratch, that is a daunting starting line.
Why the paperwork problem is really a system problem
Most laboratories don't lack documents — they lack a system. A biosafety policy written in 2019, an equipment SOP borrowed from a sister lab, forms that no procedure mentions. GAHAR surveyors trace the thread from policy to procedure to record, and every broken thread is a finding. The fix is not more templates; it's one coherent architecture where every document knows its place.
A complete laboratory QMS, built for GAHAR 2025
The AGS Clinical Laboratory Quality Management System is a 65-document system written specifically for the GAHAR 2025 edition. All nine GAHAR Safety Requirements (GSR.01–GSR.09) are implemented and individually mapped to their SOPs, and the Compliance Matrix links every requirement to a document and an evidence source — so you always know what a surveyor will ask for next.
What you get:
- 1 Laboratory Quality Manual — the apex document for the whole system
- 4 policies: Quality; Biosafety & Biosecurity; Confidentiality & Information Security; Ethics & Conflict of Interest
- 22 SOPs and 19 ready-to-use forms, one controlled file each
- 12 audit checklists, including a gap-assessment and survey-readiness checklist
- 1 Master Records Register plus 3 guidance documents (Compliance Matrix, Roadmap, Scoring Guide)
- 3 training documents, including a GAHAR 2025 laboratory awareness course
Close the gaps before GAHAR finds them
Score your laboratory with the survey-readiness checklist, close every GSR gap first, and follow the implementation roadmap month by month. The system arrives as an instant digital download of fully editable Microsoft Word files — rebrand it, adapt it and put it to work the same day. Download the AGS Clinical Laboratory QMS — GAHAR 2025 Edition — from AGS.
Product: GAHAR-Clinical-Laboratory-Management-System-2025 — available as an instant-download, fully editable package from AGS (SKU AGS-02-001).