ISO 15189:2022 Documentation Package — Medical Laboratories

The package gives you the complete documentation foundation required by ISO 15189:2022. To pass an accreditation assessment, you also need to implement the procedures in the field: train staff, conduct method verifications per parameter, start IQC/PT, and demonstrate real traceability of examinations. The package saves you the 6 to 12 months of writing work. Operational implementation remains your work (typically 3 to 6 months depending on lab size).

A generic template is written for ISO 9001 or another sector. It doesn't cover medical lab-specific requirements: method verification/validation, uncertainty calculation, IQC/PT, two-tier result validation, point-of-care testing (POCT), CLIA-defined personnel roles, CAP checklist alignment, HIPAA-compliant data management. The QSE Academy package is written specifically for clinical laboratories, with verifiable clause-by-clause mapping (clauses 4 to 8).

The 2022 version brings three major changes: complete restructuring (format aligned with ISO/IEC 17025:2017, technical requirements first in clauses 4 to 7 and management system in clause 8, instead of the old 2012 "management requirements + technical requirements" structure); absorption of the former ISO 22870 (withdrawn at publication) — point-of-care testing is now covered by the normative Annex A and sub-clause 6.7.2 (POCT agreements); reinforcement of risk-based thinking (alignment with ISO 22367) and introduction of a new sub-clause 7.8 Continuity / emergencies. The IAF transition deadline for already-accredited laboratories was end of 2025 / early 2026. The package is fully up to date with the 2022 version.

CLIA (Clinical Laboratory Improvement Amendments of 1988) are US federal regulations under CMS that require every laboratory testing human specimens to hold a valid CLIA certificate. CLIA defines testing complexity (waived, moderate, high) and personnel qualifications (Lab Director, Technical Supervisor, General Supervisor, Testing Personnel). ISO 15189 is the international quality benchmark that goes beyond CLIA's minimum regulatory requirements. CAP, A2LA, and ANAB accreditation programs incorporate both CLIA compliance and ISO 15189 alignment. The package addresses both layers: it provides the QMS infrastructure required for ISO 15189 accreditation while documenting the CLIA-defined roles, personnel competence, and quality system elements that CAP and other accreditors verify.

Plan 4 to 6 weeks to customize the documents: logo, organizational chart, accreditation scope, disciplines covered, analyzers used. Then plan time for operational implementation: method verifications, IQC/PT rollout, staff training, mock assessment — 3 to 6 additional months depending on lab size and starting maturity level.

All documents are delivered in fully editable Microsoft Word (.docx) format. No locked PDFs, no proprietary software dependency. The ISO 15189 ↔ CAP checklist mapping matrices and the uncertainty calculation templates are delivered in Excel format. The graphic charter is neutral, ready to receive your logo and colors.

Yes. The 2022 version of ISO 15189 absorbed ISO 22870 (withdrawn at publication) by placing POCT requirements in two locations: the normative Annex A (governance A.2, quality assurance program A.3, training program A.4) and sub-clause 6.7.2 (service agreements with POCT operators). The package includes: POCT governance procedure, standard agreement between laboratory and clinical user, POCT QA program, POCT operator training and competency assessment program, IQC procedure for POCT devices, POCT proficiency testing participation, register of devices and authorized users. This is currently a particular focus area for accreditation bodies.

Yes. Sub-clause 7.8 — Continuity and emergency preparedness is new in the 2022 version (it didn't exist in 2012). The package includes a business continuity and emergency preparedness plan, a procedure for periodic plan testing, and scenario-specific action plans (power outage, LIS failure, disaster, staff unavailability). The standard requires the plan to be tested periodically and response capability exercised (7.8). Assessors now systematically verify this point during 2012 → 2022 transition assessments.

Yes. The package includes dedicated HIPAA procedures: HIPAA Privacy Rule procedure (Protected Health Information / PHI handling, minimum necessary principle, patient rights), HIPAA Security Rule procedure (administrative, physical, and technical safeguards), breach notification procedure (HHS / OCR notification within 60 days), and 21st Century Cures Act information blocking compliance procedure. These procedures integrate with the LIS control procedure (sub-clause 7.6) and the confidentiality procedure (sub-clause 4.2) of ISO 15189:2022.

The $689 license covers a single laboratory entity, with unlimited internal use (all lab directors, QAMs, technical supervisors, and technologists can use the package). For multi-entity rollout (laboratory groups, multiple distinct labs) or consulting use across multiple clients, contact us for an adapted license.

Yes. In case of an ISO 15189 amendment, CAP checklist revision, CLIA regulation update, or new FDA guidance impacting the package, you receive relevant updates free of charge for 12 months after your purchase.

You're covered by a 30-day money-back guarantee, no conditions. You write us a simple email — no justification required — and the refund is processed within 5 business days.