Skip to content
LISORA

ISO 15189:2022 · Medical Laboratories

ISO 15189 Accreditation Medical Laboratories

ISO 15189 specifies requirements for quality and competence in medical laboratories. It covers the entire testing process — pre-analytical, analytical and post-analytical — to ensure valid, reliable patient results. The 2022 revision integrates point-of-care testing (POCT) and strengthens risk-based, patient-centered care.

Request a ConsultationGet a Quote
Laboratory scientist handling blood sample tubes
Standard
ISO 15189:2022
Typical timeline
30–90 days
Outcome
Accreditation
Delivery
Remote & on-site, worldwide

In general

Assurance for patients, payers and clinicians

Accreditation drives gains in quality, customer satisfaction and financial performance at a time when laboratory budgets are under pressure. It reduces risk, encourages shared best practice and stimulates innovation.

For payers and healthcare providers it provides assurance that services are safe, reliable and good value; for patients it gives confidence that results are competent and safe.

How it works

Your path to ISO 15189 accreditation

  1. 01Service agreementThe engagement begins with a signed agreement and a dedicated project team.
  2. 02Gap analysisWe assess your current practices against ISO 15189:2022 and prepare a detailed action plan.
  3. 03Documentation and implementationWe develop procedures and records, train your team and embed the system into daily operations.
  4. 04Internal auditA comprehensive internal audit confirms readiness and resolves any nonconformities.
  5. 05Accreditation assessmentThe accreditation body assesses your laboratory and grants accreditation.

How we can help

ISO 15189 service packages

  • A01DocumentationISO 15189:2022 documentation — ready-made templates or fully customized to how your organization actually works.
  • B02Implementation & consultationHands-on ISO 15189:2022 implementation, training and expert consultation until the system runs on its own.
  • C03Internal audit & gap analysisA full internal audit against ISO 15189:2022 with a gap report and corrective-action plan before the external audit.
  • D04Certification auditWe arrange the assessment with a recognized accreditation body and support you through Stage 1 and Stage 2.
  • E05Full packageEverything above end-to-end — documents, implementation plan, training, internal audit and your final ISO 15189:2022 certificate.

FAQ

ISO 15189 frequently asked questions

01Is ISO 15189 a certification or an accreditation?

Accreditation. Medical laboratories are assessed by a national accreditation body (an ILAC signatory), which confirms both the quality system and technical competence for specific examinations.

02What changed in ISO 15189:2022?

The 2022 edition aligns with ISO/IEC 17025:2017, adds point-of-care testing requirements previously in ISO 22870, and places greater emphasis on risk management and patient welfare.

Free consultation

Request a ISO 15189 consultation.

Share a few details and one of our lead auditors will respond within 24 hours with recommended next steps and a fixed-price proposal.

We respond within one business day. Your information is kept strictly confidential.

Related services

ISO 17025

Testing & Calibration Laboratories

Demonstrate laboratory competence, impartiality and reliable results.

ISO 13485

Medical Devices Quality Management System

The quality management foundation for FDA, EU MDR and MDSAP compliance.

ISO 9001

Quality Management System

The internationally recognized standard for quality management systems.