Overview
ISO 15189 specifies the requirements for quality and competence particular to medical laboratories, covering the examination of materials derived from the human body for the purpose of diagnosis, patient management, and the prevention and treatment of disease. Its purpose is to ensure that medical laboratories deliver accurate, reliable, and clinically relevant results while safeguarding patient safety and the interests of patients and clinicians. The standard applies to medical laboratories of all types and sizes, including hospital, clinical, and point-of-care settings, and it addresses the full testing process across the pre-examination, examination, and post-examination phases. It combines management-system requirements, comparable in intent to those of ISO 9001, with technical competence requirements similar in spirit to ISO/IEC 17025 but tailored to the clinical context. Impartiality and ethical conduct are emphasized, alongside the protection of patient information and confidentiality. Competence requirements address the qualification, training, and assessment of laboratory personnel, method validation and verification, measurement traceability, quality control, participation in proficiency testing and interlaboratory comparisons, and the assurance of examination validity. The standard also covers resources, equipment, reagents and consumables, laboratory information management, risk management, and the handling of complaints and nonconforming work, with a strong focus on patient-centred outcomes. ISO 15189 is closely related to the ISO/IEC 17000 series of conformity-assessment standards, drawing on concepts from ISO/IEC 17025 while functioning as the recognized benchmark for medical laboratory accreditation. Accreditation bodies operating under ISO/IEC 17011, often within the ILAC arrangement, accredit medical laboratories against ISO 15189. The main benefits include improved diagnostic reliability, enhanced patient safety, national and international recognition of results, and support for healthcare quality and regulatory requirements. Accreditation to ISO 15189 confirms that a medical laboratory is both technically competent and effectively managed for clinical care.
Included: 81 ready-to-use, fully editable documents (manual, procedures, forms, records, checklists, guidance and training material).
License: single-organization license; delivered electronically as a ZIP archive.
From purchase to audit-ready
Buy & download instantly
Pay securely by card. Your ZIP download link appears immediately on the confirmation page and in your email.
Edit & brand as your own
Open the native Word & Excel files, add your logo and details, and adapt everything to your organisation.
Implement & get audit-ready
Roll out the manuals, procedures, forms and checklists to build a working, certification-ready system.
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?
Because these are digital products delivered instantly, all sales are final once downloaded. If you have any issue with your files, contact us and we'll make it right. See our Refund Policy for full details.