ISO 15189:2022 for Auditors - Africa Laboratory Management Academy

About Course

This intensive 4-week online course delivers the complete ISO 15189:2022 standard verbatim — every clause, requirement, note, and definition presented exactly as it appears in the official document, the sole source of truth for the program.

Structured into 12 lessons across four progressive weeks, the course covers Scope & Terms, General & Governance, Resource Requirements, Process Requirements, Management System, and normative POCT requirements (Annex A). Weekly quizzes reinforce learning, while hands-on assignments build practical skills that culminate in a professional Laboratory Accreditation Readiness Portfolio (including a full self-inspection checklist and mock audit materials).

Perfect for laboratory directors, quality managers, technical staff, and accreditation teams, this course equips you to prepare any medical laboratory for successful ISO 15189:2022 accreditation and to perform competent internal or external audits.

• Self-paced • 100% based on the official standard • Capstone-focused for real-world implementation.

Course Content

Week 1: Foundations – Scope, Terms, General & Structural/Governance Requirements (Clauses 1–5)
Understanding the purpose, definitions, impartiality, confidentiality, patient focus, legal entity, director responsibilities, and risk management.

Lesson 1.1: Scope, Normative References, Terms and Definitions (Clauses 1–3)
Auditor’s Corner: Impartiality (Clause 4.1)
Lesson 1.2: General Requirements – Impartiality, Confidentiality, Patients (Clause 4)
Auditor’s Corner: Confidentiality (Clause 4.2)
Lesson 1.3: Structural and Governance Requirements (Clause 5)
Auditor’s Corner: Structural & Governance Requirements (Clause 5)
Foundational Clauses Assessment
Week 1 Assignment: Full gap analysis against Clauses 1–5

Week 2: Resource Requirements (Clause 6)
Personnel competence, facilities, equipment, calibration, reagents, service agreements, and external providers.

Week 3: Process Requirements (Clause 7)
End-to-end laboratory workflow – pre-examination, examination, post-examination, nonconforming work, data management, complaints, and continuity planning.

Week 4: Management System Requirements, POCT, Comparisons & Accreditation Readiness
Documented management system, continual improvement, audits, reviews, POCT specifics, comparisons, and full accreditation preparation.

Supplemental Case Studies
These are optional case studies but attempting them will greatly increase your understanding of point of care auditing, instrument validations and referrals.

Capstone Project

Student Ratings & Reviews

No Review Yet

About Course

What Will You Learn?

Course Content

Week 1: Foundations – Scope, Terms, General & Structural/Governance Requirements (Clauses 1–5) Understanding the purpose, definitions, impartiality, confidentiality, patient focus, legal entity, director responsibilities, and risk management.

Lesson 1.1: Scope, Normative References, Terms and Definitions (Clauses 1–3)

Auditor’s Corner: Impartiality (Clause 4.1)

Lesson 1.2: General Requirements – Impartiality, Confidentiality, Patients (Clause 4)

Auditor’s Corner: Confidentiality (Clause 4.2)

Lesson 1.3: Structural and Governance Requirements (Clause 5)

Auditor’s Corner: Structural & Governance Requirements (Clause 5)

Foundational Clauses Assessment

Week 1 Assignment: Full gap analysis against Clauses 1–5

Week 2: Resource Requirements (Clause 6) Personnel competence, facilities, equipment, calibration, reagents, service agreements, and external providers.

Lesson 2.1: Personnel (6.1–6.2)

Auditor’s Corner: Personnel & Competence (Clause 6.1–6.2)

Lesson 2.2: Facilities and Environmental Conditions (6.3)

Auditor’s Corner: Facilities & Environmental Conditions (Clause 6.3)

Lesson 2.3: Equipment (6.4)

Lesson 2.4: Equipment Calibration & Metrological Traceability, Reagents/Consumables, Service Agreements, Externally Provided Products (6.5–6.8)

Auditor’s Corner: Equipment, Reagents, and Consumables (Clause 6.4–6.6)

Resource Requirements Assessment

Week 2 Assignment: Personnel, Facilities, Equipment, Procedure, and Reagent SOP

Week 3: Process Requirements (Clause 7) End-to-end laboratory workflow – pre-examination, examination, post-examination, nonconforming work, data management, complaints, and continuity planning.

Lesson 3.1: Pre-Examination Processes (7.1–7.2)

Auditor’s Corner: Pre-analytical Processes (Clause 7.1–7.2)

Lesson 3.2: Examination Processes (7.3)

Auditor’s Corner: Analytical Processes (Clause 7.3)

Lesson 3.3: Post-Examination Processes, Nonconforming Work, Data Management, Complaints, Continuity (7.4–7.8)

Auditor’s Corner: Post-analytical & Reporting (Clause 7.4–7.5)

Auditor’s Corner: Nonconforming Work (Clause 7.6)

Process Requirements Assessment

Week 3 Assignment: End-to-end process map, three sample SOPs, and 5 quality indicators

Week 4: Management System Requirements, POCT, Comparisons & Accreditation Readiness Documented management system, continual improvement, audits, reviews, POCT specifics, comparisons, and full accreditation preparation.

Lesson 4.1: Management System Requirements (8.1–8.9)

Auditor’s Corner: Control of Documents and Records (Clause 8.2–8.4)

Lesson 4.2: Annex A (Normative) – Additional Requirements for POCT + Annexes B & C (Informative)

Auditor’s Corner: Actions to Address Risks and Opportunities (Clause 8.5)

Lesson 4.3: Accreditation Readiness – Putting It All Together

Auditor’s Corner: Internal Audits and Corrective Actions (Clause 8.7–8.8)

Auditor’s Corner: Management Review (Clause 8.9)

Management Requirements Assessment

Week 4 Assignment: Complete Self-Inspection Checklist

Supplemental Case Studies These are optional case studies but attempting them will greatly increase your understanding of point of care auditing, instrument validations and referrals.

Auditor’s Corner: Point of Care

Auditor’s Corner: Automated Validation (Clause 7.3.3)

Auditor’s Corner: The “Referral” Mirage (Clause 6.8)