ISO 15189:2022 Medical Laboratories

The ISO 15189:2022 Lead Auditor – Medical Laboratories course prepares professionals to plan, conduct, report, and follow up audits of medical laboratory quality and competence in line with international best practices. Delivered by BGMC and accredited by Exemplar Global, this program develops auditors capable of evaluating technical competence, clinical relevance, and quality governance across medical laboratories.

Why ISO 15189:2022 Lead Auditor?

ISO 15189:2022 Lead Auditor

The program integrates ISO 15189:2022 requirements with professional auditing competence:

1. Understanding ISO 15189:2022 Requirements

Structure and intent of the standard
Patient-centered approach and clinical responsibility
Leadership, impartiality, and confidentiality

2. Technical & Clinical Competence Auditing

Auditing examination methods and validation
Pre-examination, examination, and post-examination processes
Ensuring result accuracy, traceability, and turnaround time

3. Risk-Based Medical Laboratory Auditing

Auditing risk management and quality indicators
Personnel competence, training, and authorization
Equipment, reagents, and sample management

4. Audit Planning & Execution

Audit programs, scope, and criteria
On-site assessments, witnessing, and interviews
Sampling techniques and objective evidence collection

5. Audit Reporting & Corrective Actions

Writing clear technical findings and nonconformities
Evaluating root cause analysis and corrective actions
Follow-up audits and continual improvement

This course is ideal for:

Medical Laboratory Managers and Technical Managers
Quality Managers and Accreditation Coordinators
Internal Auditors and External Assessors
Pathologists, Laboratory Scientists, and Supervisors
Consultants supporting ISO 15189 implementation and accreditation

Clinical or laboratory experience is beneficial but not mandatory.

1. Real-World Medical Laboratory Auditing

BGMC trainers are experienced medical laboratory auditors and assessors who translate ISO 15189 clauses into practical clinical scenarios, technical questioning, and evidence-based evaluation.

2. Flexible Learning Formats

BGMC offers:

Classroom-based training
Live virtual instructor-led sessions
Hybrid and in-house laboratory-focused delivery
LMS-supported learning and exam preparation

3. Alignment with Accreditation Practices

We align ISO 15189 auditing with:

International medical laboratory accreditation expectations
Risk management and patient safety principles
Integration with ISO/IEC 17025 and ISO 9001 where applicable

4. Exam-Focused Coaching

Mock examinations and audit simulations
Guidance aligned with Exemplar Global competency requirements
Clear pathways toward professional auditor certification

Participants completing this course will:

Earn a globally recognized ISO 15189 Lead Auditor credential
Gain confidence auditing clinical and technical laboratory processes
Enhance career prospects in laboratory management, accreditation, and auditing
Develop strong analytical, clinical, and reporting skills
Support laboratories in achieving and maintaining accreditation

Benefits for Organizations

Organizations training teams through BGMC typically achieve:

Stronger internal laboratory audits and quality governance
Improved reliability and clinical relevance of test results
Reduced accreditation nonconpliances and patient risk
Better readiness for accreditation body assessments
Increased confidence among clinicians, patients, and regulators

ISO 15189 Lead Auditors are essential to building safe, competent, and trusted medical laboratories.

Assessment & Certification

Assessment:
- Exemplar Global–aligned written examination
- Continuous evaluation through audit and assessment exercises
Certification Awarded:
- Exemplar Global–accredited ISO 15189:2022 Lead Auditor certificate upon successful completion

BGMC provides full support—from registration to certification readiness.

PHYSICAL CLASSES

Classroom-based learning

QR10,727.18

Online Classes

Live, instructor-led virtual learning

QR8,283.63

Enterprise Solutions

Organization-wide laboratory audit programs

Contact For Price

E-LEARNING

Self-paced learning

QR3,904.79

Not Sure Which Course is Right for You?

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Why Choose BGMC?

Exemplar Global–accredited training provider
Trainers with deep medical laboratory and accreditation expertise
Practical, clinically focused audit methodology
Flexible in-house and laboratory-specific delivery options
Integrated learning via BGMC’s EdTech platforms

At BGMC, ISO 15189 training is positioned as a strategic clinical quality and accreditation assurance capability, not merely a compliance exercise.