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ISO 15189

Medical laboratories: Quality and competence requirements for medical laboratories, focused on patient safety.

ISO 15189 accreditation gives doctors and patients confidence in medical lab results, covering the full sample cycle from request to report. We help the lab build a practical, patient-focused management system and prepare its team for assessment.

Who it is for

  • Hospital and health-centre laboratories
  • Private medical laboratories
  • Public health and reference laboratories

Requirement areas

  1. 1General: impartiality, confidentiality, patient requirements
  2. 2Structural and governance requirements
  3. 3Resources: personnel, facilities, equipment, reagents
  4. 4Process: pre-examination, examination, post-examination
  5. 5Management system and risk management

Readiness service

  1. 1

    Gap analysis

    We assess your current state against the standard and deliver a gap report and action plan.

  2. 2

    Documentation

    We build the quality manual, procedures and forms with you, fitted to your work.

  3. 3

    Team training

    Awareness, implementation, internal auditor and specialist technical courses.

  4. 4

    Implementation & records

    We follow the system in operation and the records that prove it works.

  5. 5

    Internal audit & management review

    A full internal audit and a documented management review before you apply.

  6. 6

    Mock assessment

    A visit that simulates the accreditation body’s assessment to catch findings early.

  7. 7

    Support & closing findings

    We support you during the assessment and help close findings until the accreditation decision.

Learning path

ISO 15189

Courses ordered from awareness to specialist.

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How ready are you for accreditation?

Answer short questions and instantly get your readiness score and main gaps in each area.

Test your readiness