ISO 15189 Management System
ISO 15189 Management 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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Written by practising auditors with 20+ years in the field.
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-14 | Ensuring the Validity of Results — IQC and EQA | Word |
| AGS-SOP-12 | Examination Method Selection, Verification and Validation | Word |
| AGS-SOP-11 | Pre-examination Sample Collection, Transport and Receipt | Word |
| AGS-SOP-25 | Point-of-Care Testing (POCT) | Word |
| AGS-CHK-01 | ISO 15189 2022 Internal Audit Checklist | 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.
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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