Here is the rule that surprises laboratories preparing for the HCAC Medical Laboratory Accreditation Standards, Second Edition (2021): each standard is scored on its measurable elements, and anything from 60% to 99% is Partially Met. Nine elements out of ten is not nearly Met — there is no credit for close. With 85 standards across seven groups, winning means auditing element by element, and that takes documentation built for exactly that level of granularity.
What the Second Edition expects
Built on the WHO Laboratory Quality Stepwise Implementation framework, the standard spans governance, human resources, laboratory operations (workflow, equipment, quality control, reagents), environmental health and safety, client rights, quality improvement and information management. The Second Edition added 29 new standards — the priority gaps for any laboratory previously accredited under the First Edition. Assessment methods are documents, interview and observation, so the paper must match the bench.
A 90-document QMS aligned to all 85 standards
The AGS Medical Laboratory Quality Management System organises the whole build around the total testing process. Its checklists are written for HCAC's Yes/No/NA element scoring, its Compliance Matrix maps every group to documents and evidence, and its roadmap takes you from baseline gap analysis to assessment day in ordered steps.
What you receive:
- 1 Medical Laboratory Quality Manual — total testing process, compliance map and 24 balanced KPIs
- 8 policies covering all seven groups, from governance to LIS
- 36 SOPs and 24 ready-to-use forms, one controlled file each
- 14 audit checklists built for element-level Yes/No/NA scoring
- 1 Master Records Register plus 3 guidance documents (Matrix, Roadmap, Scoring Guide)
- 3 training documents, including a staff awareness course
Audit by element, pass by design
Don't discover the scoring rules on assessment day. Download the AGS Medical Laboratory QMS — HCAC 2nd Edition — as an instant digital package of fully editable Microsoft Word documents, run your element-level baseline this week, and close the gaps in order. Available now from AGS.
Product: HCAC-Medical-Laboratory-Management-System-2nd-Edition — available as an instant-download, fully editable package from AGS (SKU AGS-02-009).