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Healthcare & PharmaceuticalAGS-11-003

CBAHI Clinical Labs & Blood Banks QMS Templates

CBAHI Clinical Labs & Blood Banks QMS Templates

A laboratory and transfusion quality system organised the way CBAHI assesses one, by quality system essential and across the full testing continuum.

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See all 31 documents included

Written and reviewed by practising specialists. Who writes this

Built and reviewed with our methodology. Read it

Read the guide: CBAHI Standards for Clinical Laboratories & Blood Banks: An Accreditation Overview

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31 ready-to-use documents 31 Word · plus the AGS license

By document type

Total 31
CategoryFiles
Manuals2
Policies1
Procedures & SOPs12
Forms & Records9
Checklists & Audit Tools4
Registers, Logs & Matrices1
Training & Awareness1
Guides & Work Instructions1

Key documents

ReferenceDocumentFormat
AGS-QM-001Quality Manual Word
AGS-SOP-007Process Management Workflow Word
AGS-SOP-006Equipment Management Word
AGS-SOP-009Information Management (LIS) Word
AGS-FRM-008Internal Quality Control Log Word
AGS-FRM-005Specimen Rejection Log Word

Overview

Issued by the Saudi Central Board for Accreditation of Healthcare Institutions, the national accreditation authority of the Kingdom of Saudi Arabia, the CBAHI Clinical Laboratories and Blood Banks standards, 2016 Edition, govern diagnostic laboratory and transfusion services inside licensed healthcare facilities. The architecture mirrors the quality system essentials laboratory assessment rests on: organisation and management, customer focus and complaints, facilities and safety, personnel and competency, purchasing and inventory control, equipment, process management and workflow, document and record control, information management through the LIS, nonconforming events and CAPA, internal audit, and continual improvement. Each essential is answered in turn, and the internal audit checklist works to the same headings.

The pre-analytical phase is covered by specimen collection guidance and documented specimen rejection; the analytical phase by internal quality control logging, external quality assessment and equipment calibration and planned maintenance; the post-analytical phase by result reporting and critical value communication. Transfusion medicine brings its own demands, from donor selection and screening through component preparation and compatibility testing to haemovigilance, alongside laboratory biosafety and waste handling.

What this system covers

  • Every quality system essential, from organisation and management to continual improvement
  • Pre-analytical control: specimen collection, identification, transport and recorded specimen rejection
  • Analytical quality: internal quality control logging, external quality assessment and method performance
  • Post-analytical control: result reporting, critical value communication and record retention
  • Equipment calibration and maintenance, with reagent and consumable purchasing and inventory control
  • Transfusion services: donor selection and screening, component preparation, compatibility testing and haemovigilance
  • Laboratory biosafety, waste handling and daily safety and environment rounds
  • Nonconforming events, CAPA, competency assessment, internal audit and CBAHI accreditation readiness

Who it's for

Laboratory directors, blood bank supervisors and quality officers in Saudi hospital and standalone laboratories facing a CBAHI survey, a scope extension into transfusion, or an audit that has exposed gaps between bench practice and written procedure. The result is a quality system that reads in the order it will be assessed in, with control, calibration, rejection and CAPA records already positioned as evidence.

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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