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SkillCertSkillCert Specialist

ISO 15189 Advanced: Medical Laboratory Quality & Competence

Advanced, patient-safety-focused preparation for medical laboratory competence and accreditation

  • 8 modules
  • 100% online · Recorded lessons
  • English
  • innoryx
Enroll now

100% online with recorded lessons. Start right after you enrol and learn anytime, anywhere, at your own pace.

What you'll learn

  • Interpret ISO 15189:2022 through patient-safety and competence principles
  • Build defensible personnel authorization and resource controls
  • Control pre-examination risks from request through specimen receipt
  • Apply verification, validation, traceability, uncertainty and reference-interval principles
  • Design and interpret IQC and investigate EQA performance
  • Control result review, authorization, critical communication and amendments
  • Strengthen LIS, data integrity, nonconformity, CAPA and risk controls
  • Apply effective POCT governance
  • Conduct risk-based internal audits and management review
  • Prepare objective evidence for accreditation assessment and sustain readiness

About this course

Master advanced ISO 15189:2022 implementation through patient-safety thinking, technical competence, pre-examination control, method verification and validation, metrological traceability, measurement uncertainty, reference intervals, IQC, EQA, post-examination review, critical-result communication, data integrity, POCT governance, CAPA, audits, management review and sustained accreditation readiness.

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Who this is for

  • Medical laboratory scientists
  • Clinical scientists
  • Pathology and diagnostic laboratory professionals
  • Laboratory managers and supervisors
  • Quality managers and coordinators
  • Section heads
  • Internal auditors
  • Accreditation coordinators
  • POCT coordinators
  • Professionals preparing for ISO 15189 accreditation

Prerequisites

Recommended: prior medical or diagnostic laboratory experience and a working understanding of laboratory quality systems. Familiarity with ISO 15189 fundamentals is helpful.

Assessment

Six interactive activities, three advanced quizzes, one integrated branching scenario and a 50-question final assessment. Final assessment pass mark: 70%. SkillCert attempts are unlimited. Certificate is issued only after passing the final assessment.

Certificate

Earn an Innoryx SkillCert certificate in ISO 15189 Advanced: Medical Laboratory Quality & Competence after completing the mandatory learning items and passing the final assessment.

Certificates can be verified online

Career relevance

Advanced preparation for medical laboratory quality, technical leadership, clinical science, section supervision, POCT governance, internal auditing, accreditation coordination and quality-management roles in diagnostic and healthcare laboratories.

Frequently asked questions

Refund eligibility for course fees, books and third-party registrations is explained in our Refund & Cancellation Policy. Please review it before enrolling, including the Highfield and awarding-body terms where applicable.

How enrolment works

Start this course in three steps

  1. 1

    Enrol online

    Choose Enroll now, sign in or create your Innoryx account, and complete secure checkout.

  2. 2

    Learn at your own pace

    Your course appears in your Innoryx Learn account, ready to start on any device.

  3. 3

    Get certified

    Complete the assessment to earn your certificate.

Enroll now
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