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About

ISO 15189:2022 for Industry and CRO Laboratories provides a comprehensive framework for demonstrating medical laboratory quality, technical competence, reliable examination processes, and effective risk management. It provides practical guidance on personnel competence, equipment, examination procedures, traceability, quality indicators, reporting, and continual improvement.
This ISO 15189:2022 for Industry and CRO Laboratories Training Course & Certification provides essential knowledge on quality management requirements, laboratory processes, internal audits, external quality assessment, reference intervals, method verification and validation, result reporting, nonconformity management, corrective actions, and accreditation readiness. Upon successful completion, learners receive a certification demonstrating their understanding of ISO 15189:2022 requirements and laboratory quality and competence practices.

Who Should Enrol?

  • Laboratory Managers, Directors, and Technical Personnel
  • Quality Assurance and Quality Management Professionals
  • Clinical Research and Laboratory Operations Teams
  • Regulatory Affairs and Compliance Professionals
  • Pharmaceutical, Biotechnology, and CRO Laboratory Personnel
  • Internal Auditors and Accreditation Professionals
  • Method Development, Validation, and Analytical Scientists
  • Professionals responsible for laboratory quality, competence, and accreditation readiness
📢 Every purchase also includes our FREE companion ISO 15189:2022 for Industry and CRO Laboratories eBook, designed to help you apply principles in real-world clinical trial practices.

What you will learn

Understand the principles and requirements of ISO 15189:2022 for medical laboratories, including quality management, technical competence, risk management, and patient-focused laboratory practices.

Learn the roles and responsibilities of laboratory personnel, management, and technical staff in maintaining competence, impartiality, traceability, and reliable examination processes.

Develop knowledge of examination processes, equipment, reference intervals, quality indicators, internal audits, external quality assessment, reporting, and result management.

Gain understanding of accreditation readiness, nonconformity management, corrective actions, and continuous improvement for industry and CRO laboratories.

Course Syllabus

  1. Why an accredited 17025 laboratory still has work to do
  2. Who this course is for
  3. What you will be able to do
  4. The eight modules
  5. How the course is built
  6. The running case study
  7. Five things to unlearn before Module 1
  8. Ground rules, copyright and points to verify

  1. The 2022 edition: what it is, what it withdrew, and what the A11 amendment actually does
  2. Accreditation and certification as different attestations, and why the difference is commercial
  3. ISO/IEC 17025:2017 as a normative reference of ISO 15189
  4. The restructure onto the 17025 high-level structure
  5. The three-way delta: re-skin, adjacent, or no analogue at all
  6. Where the popular claims about this standard are wrong
  7. What ISO 15189 does not do, and what it cannot be used to prove
  8. Knowledge checks, exercises and case study
  9. Module recap

  1. Requirements regarding patients, in a laboratory that never meets one
  2. The laboratory director: competence, responsibilities and what may be delegated
  3. Advisory activities, and where 17025 partially covers them
  4. Biological reference intervals and clinical decision limits
  5. Reporting of results, and the critical-result duty that is genuinely orphan
  6. Adverse incident reporting for equipment and reagents
  7. Quality indicators, which have no analogue at all
  8. Deciding honestly what is and is not applicable to your laboratory
  9. Knowledge checks, exercises and case study

  1. What clause 6.2 requires, and what it deliberately leaves to you
  2. Competence, authorisation to perform, and authorisation to release
  3. Why the accreditation body will not tell you what a good scheme looks like
  4. External quality assessment performance is not competence, and the warning is published
  5. Designing a scheme an assessor will accept
  6. The CLIA six elements and their frequency rules, for a laboratory that also holds CAP
  7. Running one programme against a prescriptive model and a self-defined one
  8. Continuing education, records, and the evidence that survives an assessment
  9. Knowledge checks, exercises and case study

  1. Risk management in the 2022 edition, and the three places it lives
  2. The related risk standard, and the edition that changed in 2026
  3. Clause 8 against ISO/IEC 17025 clause 8: near identity, and the exceptions
  4. The route through a recognised quality management system standard
  5. Awareness, and what it adds
  6. Quality indicators: designing them, and what an assessor asks
  7. Risk-prioritised internal audit planning
  8. Nonconforming work, corrective action and management review
  9. Knowledge checks, exercises and case study

  1. Verification and validation, and where the boundary actually falls
  2. When a laboratory-developed test crosses into validation
  3. Measurement uncertainty: what is required, and what to do when it is hard
  4. Metrological traceability, and the analyte with no reference measurement procedure
  5. Ensuring the validity of results: internal quality control and external assessment
  6. The novel analyte with no scheme, and the alternative assessment route
  7. Documenting an examination procedure so that it survives an assessment
  8. Where the in-house device rules do and do not reach a CRO laboratory
  9. Knowledge checks, exercises and case study

  1. Service agreements, and identifying the user when the requester is a sponsor
  2. Pre-examination: the sample collected to a protocol you did not write
  3. Pre-analytical variables as a validity issue, not a housekeeping one
  4. Post-examination handling, retention and disposal
  5. Reporting, and what a sponsor-facing report has to carry
  6. Referral laboratories and consultants across a site network
  7. Point-of-care testing: the normative annex and the service agreement duty
  8. Complaints, and the multi-site and legal-entity question
  9. Knowledge checks, exercises and case study

  1. Applying: pre-assessment, initial assessment and what an assessment day looks like
  2. Findings and their categories, and the response timescales that differ by assessment type
  3. The duty to tell the accreditation body before you change anything, and where it comes from
  4. What needs a formal extension, what needs notifying, and what is judged case by case
  5. Bioinformatics pipelines, equipment moves and like-for-like replacements
  6. Flexible scope: what it permits, and why a new applicant cannot start with it
  7. External quality assessment obligations, and the alternative when no scheme exists
  8. The findings the accreditation body reported as trending at the 2022 transition
  9. Knowledge checks, exercises and case study

  1. What the regulator says governs the analysis of clinical trial samples
  2. The status of good clinical laboratory practice guidance
  3. What changed in UK law in April 2026, and what it means for laboratory oversight
  4. Sponsor oversight of laboratories as a named sponsor function
  5. What an inspection of a laboratory looks at, and how it differs from an assessment
  6. The documented value of accreditation, stated without overclaiming
  7. Computerised systems, audit trails, and the gap the standard leaves
  8. When a laboratory problem becomes a reportable serious breach
  9. Knowledge checks, exercises and case study

  1. The delta, restated: what re-skins, what is adjacent, what is new
  2. The six errors that cost laboratories the most time
  3. A ninety-day plan from decision to application
  4. Twenty-five templates and how to use them
  5. Course completion

  1. 📘 Bonus: ISO 15189:2022 for Industry and CRO Laboratories eBook (Free with purchase)

Course Benefits

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eBook

Access the course content in eBook format, which can be downloaded and read on your device.

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CPD Points

Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.

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Certification

Receive a personal certificate to show your subject knowledge on course completion.

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Affordable

You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.

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Flexibility

The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.

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Keep Up to Date

You will stay up to date with any changes to ISO 15189:2022 and its A11 amendment, ISO/IEC 17025:2017, ISO 17511, ISO/IEC 17043, UK accreditation body policy, CLIA and CAP requirements, and the UK Good Clinical Practice framework following ICH E6(R3), as our training courses are constantly monitored, reviewed and updated.

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Learn from Industry Experts

The course content has been developed by laboratory quality and clinical research compliance specialists working from the standards themselves, published accreditation body policy and the regulator's own stated position, so that learners can plan, evidence and defend an ISO 15189 application in a commercial laboratory that also works to Good Clinical Practice.


Our Certified Customers

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NHS
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