ISO 15189:2022 Accreditation Documentation Service
Complete, audit-ready documentation packages for medical laboratory accreditation. Tailored to your lab. Delivered fast. Trusted by labs across 40+ countries.
What is ISO 15189:2022 and why does it matter?
ISO 15189:2022 is the international standard for competence and Quality of medical laboratories. It defines requirements for quality management systems, technical competence, and patient-focused care.
Accreditation under this standard signals clinical excellence, improves patient safety, and is increasingly required for laboratory operations in regulated markets worldwide.
- Mandatory in many countries for hospital and private lab licensing
- Required by international tender and contract frameworks
- Reduces liability and audit non-conformances
- Demonstrates commitment to patient safety and quality outcomes
- 2022 revision includes new requirements for impartiality and Confidentiality risk-based thinking
End-to-end documentation services
Every deliverable is written to clause level — ready for assessor review on day one.
Full Documentation Package
Complete quality manual, all mandatory procedures, forms, and records — pre-mapped to every ISO 15189:2022 clause. Fully editable in Word/Excel.
Gap Analysis Report
We review your current documentation against the 2022 requirements and deliver a prioritised action plan with clause-by-clause findings.
SOP & Policy Writing
Custom standard operating procedures and policies written to match your lab's scope, test menu, and existing workflows.
Quality Manual Only
A professionally structured quality manual aligned to Clauses 4–8 of ISO 15189:2022, tailored to your laboratory's name and scope.
Forms and Register
Ready-to-use controlled forms and registers covering all ISO 15189:2022 recordkeeping requirements — fully editable and pre-referenced to clause level.
Free — see exactly which documents your lab needs for accreditation.
From order to accreditation-ready in four steps
Intake Form
Complete a short online questionnaire about your lab's scope, test menu, and structure.
Expert Assignment
We assign a dedicated ISO 15189 specialist with relevant clinical laboratory background.
Document Drafting
Your complete documentation package is written, structured, and cross-referenced to the standard.
Review & Deliver
You review the drafts, we refine, and you receive fully formatted final files within the agreed timeline.
Every document your assessor will ask for
The full package includes 20+ controlled documents, all editable and pre-referenced to ISO 15189:2022.
ISO 15189:2022 Internal Audit Checklist
Tick each requirement your lab currently meets. Use this to identify gaps before your formal assessment.
One complete package for your lab
One-time payment. No subscriptions. No hidden fees. Everything you need to achieve ISO 15189:2022 accreditation.
- Quality Manual (all clauses)
- 15+ Mandatory SOPs
- 20+ Forms, checklists & templates
- Gap analysis report
- Risk management documents
- Competency assessment framework
- Pre/post-examination procedures
- Equipment & calibration records
- Internal audit procedure & forms
- Management review template
- Unlimited revisions
- 90 days email support
Labs that passed their first time
The documentation package was exactly what our assessor expected. We passed our SANAS accreditation with zero major non-conformances. Outstanding quality.
We'd been struggling with our own documentation for months. This team delivered a complete, clause-referenced package in 8 days. Genuinely impressive work.
As a newly established private lab, we needed professional documents fast. The team understood our scope perfectly and delivered well beyond what we paid for.
Meet Our Expertise
Our consultants bring decades of hands-on laboratory accreditation experience across four continents — guiding labs from gap analysis through to successful assessor review.
Frequently asked questions
Ready to get accredited?
Let's start today.
Take the first step toward ISO 15189:2022 accreditation. Our experts will guide your lab through every clause, document, and assessor requirement — from intake to approval.
