COMPLIANCE ADVISORY
ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence Readiness Advisory
A strategy call with someone who has spent 25 years building compliance systems used by 100,000+ professionals in 160+ countries – not a generalist who read the standard last week.
Why work with Ivanka on ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence
ISO 15189:2022 (4th edition) specifies requirements for quality and competence in medical (clinical) laboratories. It covers examination processes (pre-examination, examination, post-examination), quality management systems, and resource requirements specific to medical laboratories. Applicable to clinical chemistry, haematology, microbiology, pathology, immunology, and other medical laboratory disciplines. Accreditation to ISO 15189 is increasingly required by healthcare regulators and insurers. The 2022 revision introduces risk-based thinking and aligns with ISO/IEC 17025:2017 structure.
Most consultants approach ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence as a checkbox exercise. Ivanka approaches it as a strategic lever. With 25 years of building The Art of Service – a compliance platform now covering 692 frameworks and 819,000+ cross-framework mappings – she doesn't just understand the standard. She understands how it connects to everything else your organisation is already doing.
This matters because ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence doesn't exist in isolation. Ivanka will map your current compliance posture against the 64 controls across 5 domains, identify gaps, and show you where existing controls from other frameworks you may already follow can be leveraged – saving months of redundant work.
Relevant credentials
- Deep experience implementing ISO management systems across 160+ countries
- Experience guiding healthcare organisations through complex regulatory compliance landscapes
- MIT Entrepreneurial Masters graduate – rigorous analytical approach to enterprise challenges
- EXIN Expert Panel member – helping shape global certification standards
THE STRATEGY CALL
What you get in 30 minutes
Ivanka reviews your ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence readiness scores and identifies the critical gaps that carry the highest risk. No generic advice – specific to your domains and controls.
A clear, prioritised plan for addressing gaps across 5 domains. She maps what you can leverage from existing compliance work and what requires new investment.
ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence maps to 243 other frameworks. Ivanka shows you where a single control implementation can satisfy multiple regulatory requirements at once.
Domains covered in ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence
This is for you if
- You need to achieve ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence compliance but don’t know where to start or how to prioritise
- You’ve been told you’re “compliant” but suspect gaps exist that haven’t been properly assessed
- You manage compliance for healthcare organisations and need expert guidance, not generic templates
- You want to leverage existing compliance efforts across multiple frameworks rather than starting from scratch
- You need a strategic plan your leadership team and board will actually understand and support
Start with a free assessment. Then let's talk strategy.
Take the free ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence readiness diagnostic. In 5 minutes you'll have a clear picture of where your gaps are. Then book the strategy call and Ivanka will show you exactly how to close them.
Free · No login required · Results in 5 minutes
Or go directly to the $149 Report + Strategy Call