ISO 15189:2022 Medical Laboratory Quality System
ISO 15189:2022 Medical Laboratory Quality System
Take a medical laboratory from sample receipt to released result under ISO 15189:2022, with the technical evidence an assessor expects to see.
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Read the guide: ISO 15189:2022: what the standard requires of medical laboratories
By document type
| Category | Files |
|---|---|
| Manuals | 2 |
| Procedures & SOPs | 25 |
| Forms & Records | 31 |
| Checklists & Audit Tools | 12 |
| Registers, Logs & Matrices | 1 |
| Training & Awareness | 3 |
| Guides & Work Instructions | 5 |
Key documents
| Reference | Document | Format |
|---|---|---|
| AGS-QM-01 | Quality Manual | Word |
| AGS-SOP-11 | Pre-examination Sample Collection, Transport and Receipt | Word |
| AGS-SOP-12 | Examination Method Selection, Verification and Validation | Word |
| AGS-SOP-14 | Ensuring the Validity of Results — IQC and EQA | Word |
| AGS-FRM-20 | Method Verification/Validation Report | Word |
| AGS-FRM-11 | Equipment Register | Word |
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Overview
ISO 15189:2022 specifies the requirements for quality and competence particular to medical laboratories: the examination of materials derived from the human body for diagnosis, patient management, and the prevention and treatment of disease. It applies to hospital, clinical and point-of-care settings alike, and follows the testing process through its pre-examination, examination and post-examination phases. Management-system requirements comparable in intent to ISO 9001 sit alongside technical competence requirements in the spirit of ISO/IEC 17025 but written for the clinical setting, where impartiality, patient rights and the confidentiality of patient information are first-order obligations.
The documentation follows the same pathway. Procedures cover sample collection, transport and receipt; method selection, verification and validation; measurement uncertainty and biological reference intervals; internal quality control and external quality assessment; equipment, calibration and metrological traceability; referral laboratories; and point-of-care testing carried out away from the main bench. Guidance explains Westgard rules, laboratory risk management and what changed on the move from ISO 15189:2012. An internal audit checklist and an accreditation readiness gap analysis rehearse the assessment an accreditation body operating under ISO/IEC 17011, typically within the ILAC arrangement, will carry out.
What this system covers
- Pre-examination — service agreements, review of requests, collection, transport, receipt and sample acceptance
- Examination — method selection, verification and validation, measurement uncertainty, biological reference intervals
- Validity of results — internal quality control, Westgard rules, external quality assessment, interlaboratory comparison
- Post-examination — result review, authorised release, reporting and record retention
- Equipment, reagents and consumables — calibration, metrological traceability and environmental monitoring
- Point-of-care testing — site assessment, operator authorisation and supervision outside the laboratory
- Personnel competence — training, authorisation and reassessment of examination staff
- Impartiality, patient rights, confidentiality, risk management, nonconforming work and complaints
Who it's for
Hospital quality directors, laboratory managers and quality officers, usually working to a fixed date: a first accreditation assessment, a surveillance visit, or the transition of an existing system from the 2012 edition. The result is a laboratory whose controls are written down, whose competence and quality-control records are retrievable, and whose staff can show an assessor how a released result was produced.
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.
Any of your staff, at any of your own sites. No per-seat fees.
Sector specialists author each toolkit. A principal reviewer with more than twenty years reviews it.
One payment, perpetual licence for your organisation. No subscriptions, no renewals.
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.
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