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Healthcare & PharmaceuticalAGS-11-014

DHA-28 Clinical Laboratory Services QMS Templates

DHA-28 Clinical Laboratory Services QMS Templates

A laboratory result is only as defensible as the specimen, the control chart and the register standing behind it.

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See all 59 documents included

Written and reviewed by practising specialists. Who writes this

Built and reviewed with our methodology. Read it

Read the guide: Clinical Laboratory Accreditation in Dubai: A Practical Guide to DHA-28

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59 ready-to-use documents 59 Word · plus the AGS license

By document type

Total 59
CategoryFiles
Manuals2
Policies1
Procedures & SOPs14
Forms & Records15
Checklists & Audit Tools6
Registers, Logs & Matrices14
Training & Awareness3
Guides & Work Instructions4

Key documents

ReferenceDocumentFormat
AGS-QM-01Quality Manual Word
AGS-SOP-05Specimen Collection, Handling and Transport Word
AGS-SOP-06Method Validation and Verification Word
AGS-SOP-08Internal Quality Control and External Quality Assessment Word
AGS-FRM-04Critical Value Notification Form Word
AGS-REC-07EQA Register Word

Overview

Standard reference DHA-28 defines how licensed clinical laboratories must operate within the Emirate of Dubai, United Arab Emirates, and applies to diagnostic services in public and private facilities alike. Its emphasis falls where a result is won or lost: specimen collection, labelling, transport and handling; staff qualification and demonstrated competency; participation in external quality assessment and proficiency testing; method validation and verification; internal quality control; identification and timely reporting of critical values; and the governance and integrity of the Laboratory Information System.

This set is organised the way a laboratory works, from pre-analytical through analytical to post-analytical. Standard operating procedures cover specimen collection, handling and transport, method validation and verification, internal quality control and external quality assessment, result verification and reporting, equipment calibration, laboratory safety and biohazard management, referral laboratories, risk management, personnel competency, internal audit, CAPA, management review and complaints. Behind them runs a deep register layer tracking specimen accession, critical values, validations, EQA rounds, nonconformities, incidents, equipment, referrals, risk and complaints. Quick-reference guidance covers Westgard rules, primary specimen collection, waste segregation and SOP writing, and every file is editable to your test menu, escalation pathways and nomenclature.

What this system covers

  • Pre-analytical control: requisition, primary specimen collection, labelling, transport, accession and rejection
  • Method validation and verification, with a record and register behind each assay in use
  • Internal quality control and external quality assessment, with Westgard rule interpretation and EQA review
  • Result verification, reporting and critical value notification, logged as it happens
  • Equipment calibration, preventive maintenance and temperature monitoring
  • Laboratory safety, biohazard management and waste segregation
  • Referral and outsourced testing, tracked against a register of referral laboratories
  • Personnel competency and training, internal audit, nonconformity, CAPA and management review

Who it's for

Laboratory managers, quality officers and technical supervisors running clinical laboratory services in Dubai, usually facing a licensing application, an inspection cycle or a renewal judged on records. They leave with an auditable line from each DHA-28 clause to the procedure and register that evidences it, and record retention they can defend.

Everything you get

Every toolkit gives you a full set of working documents for your standard, ready to edit and use.

Editable Word and Excel

Native Microsoft files. Add your logo and adapt every document to how you work.

Instant download

Your full toolkit arrives as a ZIP the moment payment clears.

Your whole company

Any of your staff, at any of your own sites. No per-seat fees.

Written by specialists

Sector specialists author each toolkit. A principal reviewer with more than twenty years reviews it.

Yours to keep

One payment, perpetual licence for your organisation. No subscriptions, no renewals.

Fix or refund

If a document is wrong, missing or not as described, tell us within 14 days. We fix it or refund you.

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, for 12 months. Fixes and revisions to this toolkit are free for 12 months from your order. Email us with your order number to get them.

What is your refund policy?

If a document is wrong, missing or not as described, tell us within 14 days of your order. We fix it or refund you. If you have not downloaded yet, we can cancel the order and refund you in full. We don't refund a change of mind after download. See the Refund policy.

Cannot find your standard?

Tell us which scheme you work to. We will point you to the right toolkit.

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