Clinical Laboratory Quality Management System - GAHAR 2025 Edition
Clinical Laboratory Quality Management System - GAHAR 2025 Edition
A laboratory survey follows the specimen, and so does this documentation.
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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 | 1 |
| Policies | 4 |
| Procedures & SOPs | 22 |
| Forms & Records | 11 |
| Checklists & Audit Tools | 12 |
| Registers, Logs & Matrices | 9 |
| Training & Awareness | 4 |
| Guides & Work Instructions | 2 |
Key documents
| Reference | Document | Format |
|---|---|---|
| AGS-LQM-001 | Laboratory Quality Manual | Word |
| AGS-LP-03 | Specimen Identification & Collection | Word |
| AGS-LP-06 | Internal Quality Control | Word |
| AGS-LP-08 | Result Review, Release & Reporting | Word |
| AGS-LF-07 | Method Verification/Validation Record | Word |
| AGS-LGD-01 | GAHAR 2025 Compliance Matrix | Word |
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Overview
Built for the GAHAR Handbook for Clinical Laboratories Accreditation Standards, Edition 2025, issued by Egypt's General Authority for Healthcare Accreditation and Regulation, this is a quality management system for private and hospital-based clinical laboratories. It runs the length of the testing pathway and carries the supporting systems GAHAR assesses alongside it: biosafety and biosecurity, information security, ethics, equipment, utilities and environmental safety.
The technical weight sits where laboratory accreditation is decided: method selection, verification and validation; internal quality control with a defined violation and corrective action route; external quality assessment and method comparison where no EQA scheme exists for an analyte. Result review and release, turnaround time and STAT testing, critical result communication and amended reporting are separately controlled, each with the log that proves it happened. The nine GAHAR Safety Requirements, GSR.01 to GSR.09, are treated individually, from specimen identification and critical results through to fire safety and equipment management, because one unmet safety requirement stops an accreditation decision on its own. A compliance matrix links each 2025 requirement to a document and an evidence source.
What this system covers
- Pre-examination process — test requesting, patient preparation and identification, collection, transport, reception and rejection
- Examination integrity — reagent control, method selection, verification and validation, new-lot and shipment checks
- Quality control and external assessment — internal QC, violation and corrective action, EQA and method comparison
- Reporting and critical results — result review and release, turnaround time, STAT testing, critical result notification
- Biosafety and infection prevention — hand hygiene, sterilisation and autoclave load release, hazardous materials
- Facility, equipment and utilities — calibration, environmental safety rounds, utilities and emergency preparedness
- Client rights and information governance — informed consent, confidentiality, complaints and satisfaction
Who it's for
For laboratory directors, quality officers, biosafety officers and accreditation coordinators in private and hospital-based clinical laboratories in Egypt. It is bought when a GAHAR survey date is fixed and daily practice turns out to be largely undocumented, and it leaves the laboratory able to score itself against the 2025 decision rules and to show, for each requirement, an owner, a procedure and a record.
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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