Delivering practical, end-to-end support to help medical laboratories build robust Quality Management Systems (QMS), train their teams, and achieve ISO 15189:2022 accreditation with confidence.
Outcome: Trained staff, standardized practices, complete training records and competency evidence you can show during assessments.
Hands-on help to prepare for accreditation bodies.
Outcome: A working QMS, complete objective evidence, and a lab team that is audit-ready.
1. Discover – Readiness review and gap assessment
2. Build – Co-create your QMS and train your team
3. Implement – Pilot workflows, collect records & objective evidence
4. Assure – Internal audits, management review & mock assessments
5. Submit – Pre-assessment support and accreditation preparation
We tailor the pace to your lab’s size, test menu, and resources.
What is ISO 15189 and why does it matter?
ISO 15189:2022 sets competence and quality requirements for medical laboratories. Accreditation builds trust with clinicians, patients, regulators, and partners by proving your lab’s results are reliable and traceable.
Do you help with accreditation bodies?
Yes. We align your QMS to ISO 15189:2022 and prepare you for accreditation bodies pre-assessment and assessments with mock audits and evidence packaging.
Can you work with our existing documents?
Absolutely. We enhance what you have, close gaps, and provide any missing SOPs, logs, and templates.
Do you offer post-accreditation support?
Yes—surveillance audit prep, refresher trainings, and continual improvement reviews.
How do we start?
Book a readiness call. We’ll scope your tests, equipment, and records, then share a clear proposal with deliverables and timeline.
Practical, standards-aligned workshops on internal audits, method verification, and measurement uncertainty—complete with templates and competency records.