Medical Laboratory Quality Management System - HCAC 2nd Edition (2021)
Medical Laboratory Quality Management System - HCAC 2nd Edition (2021)
Nine compliant elements out of ten still count as Partially Met, not nearly Met, so the audit tools work at that level.
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Written and reviewed by practising specialists. Who writes this
Built and reviewed with our methodology. Read it
By document type
| Category | Files |
|---|---|
| Manuals | 2 |
| Policies | 8 |
| Procedures & SOPs | 33 |
| Plans & Programmes | 2 |
| Forms & Records | 11 |
| Checklists & Audit Tools | 15 |
| Registers, Logs & Matrices | 13 |
| Training & Awareness | 4 |
| Guides & Work Instructions | 2 |
Key documents
| Reference | Document | Format |
|---|---|---|
| AGS-LQM-001 | Medical Laboratory Quality Manual | Word |
| AGS-LP-21 | Method Validation and Verification | Word |
| AGS-LP-24 | Internal Quality Control | Word |
| AGS-LP-17 | Result Reporting, Authorisation and Corrected Reports | Word |
| AGS-LF-05 | Internal Quality Control Run Record | Word |
| AGS-LGD-01 | HCAC Compliance Matrix - 85 Standards Mapped to AGS Documents | Word |
- Need the complete document list? Request it — same day
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Overview
Medical laboratory assessments are settled element by element rather than standard by standard. This system is written to that method and to the standards behind it: the HCAC Medical Laboratory Accreditation Standards, Second Edition (2021), issued by Jordan's Health Care Accreditation Council on the WHO Laboratory Quality Stepwise Implementation approach. All 85 standards are addressed across the seven assessed groups — governance and leadership; human resources; laboratory operations, meaning workflow, equipment, quality control and reagents; client rights; environmental health and safety; information management; and quality improvement.
The Quality Manual carries the total testing process map and the group compliance map. Checklists respond Yes, No or Not Applicable at element level, with the Met, Partially Met and Not Met thresholds set out. Twenty-nine standards are new in the Second Edition, the priority gaps for a laboratory accredited under the first, and the Implementation Roadmap starts from a baseline gap analysis. Competence is scored too, hence an annual training plan, a role-based competency matrix and an awareness course.
What this system covers
- Pre-analytical control begins at order entry and follows the specimen through collection, off-site phlebotomy, labelling against client identity, receipt or rejection, and tracking.
- Analytical quality rests on internal quality control and out-of-control investigation, method validation and verification, proficiency testing, and the calibration, daily function checks and reagent and culture media control behind them.
- Post-analytical reporting sets who may authorise a result, how critical and telephoned values are communicated, and how a corrected report is investigated.
- Safety, client rights and improvement take in biosafety, chemical handling, safe phlebotomy, confidentiality, complaints, indicators, risk and internal audit.
- People and information cover credential verification, competency authorisation and governance of the laboratory information system.
Who it's for
Private, hospital and public health laboratories in Jordan, and laboratories elsewhere that have taken up HCAC's ISQua-accredited framework. Two situations bring it in: an assessment date under the Second Edition, and a bench still on a first-edition system with additional standards to answer. Directors own the outcome, quality and safety officers do the work, and the laboratory ends up auditable at the level the assessor uses.
Everything you get
Every toolkit gives you a full set of working documents for your standard, ready to edit and use.
Native Microsoft files. Add your logo and adapt every document to how you work.
Your full toolkit arrives as a ZIP the moment payment clears.
One purchase covers everyone in your organisation. No per-seat fees.
Built by people who run real audits, so the content matches what assessors check.
One payment, perpetual licence for your organisation. No subscriptions, no renewals.
Full refund if your files are faulty, incomplete or not as described and we can't put it right
Frequently asked questions
What exactly do I receive?
A downloadable ZIP containing the full set of ready-to-use documents for this toolkit — manuals, procedures, forms, records, checklists, guidance and training material, all in editable Word and Excel format. The exact document count is shown at the top of this page.
Are the documents really editable?
Yes. Every file is native Microsoft Word or Excel — no locked PDFs. Add your logo, change wording, and tailor the content to your organisation. The toolkit is yours to keep and reuse.
Does this certify my organisation?
No. These are documentation toolkits aligned to the relevant standard to help you prepare. Certification itself is issued by an accredited certification body after their audit. Our toolkits give you a strong, audit-ready starting point.
How is it delivered?
Instantly and digitally. There's no physical shipment — you download the files right after payment and receive a backup link by email.
Do I get updates?
Yes. If we revise this toolkit, you're entitled to the updated version at no extra cost — just contact us with your order details.
What is your refund policy?
These are digital products, so once a toolkit has been downloaded we cannot take it back. If you have not downloaded yet, contact us and we will cancel the order and refund you in full. We also refund in full if the files are damaged, incomplete, or not what the product page described.
Cannot find your standard?
Tell us which scheme you work to. We will point you to the right toolkit.
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