ISO 15189:2022 · Medical Laboratories · Evidence & Implementation Kit
Prove the quality and competence behind every result, and pass your ISO 15189 accreditation.
Every ISO 15189 requirement handed to you as an adopt-ready control, with the medical-laboratory specifics, the exact evidence an assessor examines, and the finding they most often raise.
Accreditation-ready in a weekend, not a quarter.
Here is the honest situation. ISO 15189 accreditation is what tells health systems, regulators and clinicians that your laboratory's results can be trusted. The hard part is producing it: personnel competence, equipment calibration and metrological traceability, method validation and quality control, and control of the pre-examination, examination and post-examination processes, all evidenced the way an assessor examines. The 2022 restructure adds work. A consultant charges heavily and takes months.
This Kit removes the build. It is the complete ISO 15189:2022 requirement set and evidence guide that you personalize in a weekend.
What you get, the moment you buy
36
Requirements as adopt-ready controls. Every requirement across the general, structural and governance, resource, process and management system clauses. Personalize and you are done.
36
Evidence-they-examine checklists. For each requirement, exactly what an assessor examines, plus the finding they most often raise, and the medical-laboratory specifics that catch labs out.
1
15189 Control Matrix, pre-built. Every requirement in a working spreadsheet, ready to record your implementation, status and evidence location.
1
Gap & Readiness Assessment. Score each requirement and the workbook tells you your accreditation readiness as a single percentage, and exactly what to fix next.
Built for medical laboratories to the ISO 15189:2022 structure, with personnel competence, metrological traceability, quality control and point-of-care testing called out. Editable Word and Excel files.
Quality and competence, with the patient first
ISO 15189 assesses both your management system and the technical competence to produce reliable results. This Kit builds both, framed around risk to patients and the reliability of results across the total testing process, which is exactly what an assessor tests.
What one control looks like
This is clause 7.3, Examination processes, the technical heart of the standard. All 36 are built to this depth.
7.3 Examination processes PROCESS REQUIREMENTS
Adopt this requirement
[Laboratory] selects and uses examination methods validated for their intended use to assure clinical accuracy, defines performance specifications relating to intended use, verifies methods before introduction and validates laboratory-developed or modified methods, and retains verification and validation records. It evaluates and maintains measurement uncertainty where relevant, documents procedures available at the workbench, and defines and communicates biological reference intervals and clinical decision limits.
Evidence an assessor examines
- Method verification and validation records with performance specifications
- Measurement uncertainty evaluations and periodic review
- Controlled examination procedures available at the point of use
- Basis and review records for biological reference intervals and decision limits
Common finding they raise: A modified or laboratory-developed method is placed into service with verification only, without validation appropriate to the change.
Why this is not another template pack
- The evidence is the point. Generic quality templates ignore the laboratory. This tells you exactly what an assessor examines and the finding they raise, for every requirement, including the technical competence.
- Written for medical labs. Personnel competence, metrological traceability, method validation, quality control and the total testing process are built in, not bolted on.
- Built on a mapped compliance corpus, not one person's opinion, from a graph of thousands of controls across standards.
- It compounds. ISO 15189 aligns with ISO/IEC 17025 and ISO 9001, so your laboratory and quality systems share the same backbone.
Who buys this
Medical and clinical laboratories seeking or maintaining accreditation, laboratory directors and quality managers who own the system, and consultants preparing labs for assessment. Whether it is a first accreditation or a reassessment against the 2022 edition, you save weeks and walk in with the competence and evidence ready.
By the end of the weekend you will have
✓ A requirement for every ISO 15189 clause
✓ A completed 15189 control matrix
✓ The evidence an assessor examines
✓ Your competence and traceability records anchored
✓ A readiness percentage and a fix list
✓ The common findings closed before assessment
Common questions
Is it really editable? Yes. Word and Excel files you own and adapt. No portal, no subscription.
Does this accredit me? Accreditation is granted by an accreditation body. The Kit gets you ready: the requirements, the matrix, and the exact evidence they examine, across every clause.
Is it the 2022 edition? Yes. It follows the ISO 15189:2022 structure, aligned to ISO/IEC 17025, including point-of-care testing.
Does it cover technical competence? Yes. Personnel competence, equipment traceability, method validation and quality control are built in alongside the management system.
What if it is not for me? A 30-day money-back guarantee.
Do not let the quality system delay your accreditation.
A consultant is a heavy fee and months. The Kit is instant, and it is guaranteed.
Add it to your cart and be accreditation-ready this weekend.
Instant digital download · 30-day money-back guarantee · The Art of Service Pty Ltd, GPO Box 2673, Brisbane QLD 4001 · support@theartofservice.com
