ISO 15189:2022 Lead Auditor Training
ISO 15189:2022 Lead Implementer Training
ISO 15189:2022 Medical Laboratories – Lead Auditor Training Course
Audit, evaluate, and improve medical laboratory quality and competence in line with ISO 15189:2022 – and qualify as an ABIS‑accredited Lead Auditor for medical laboratory management systems.
Duration
- 5 days of intensive lead auditor training (≈ 35–40 hours)
- Self‑paced learning option available (flexible completion timeline)
Format
- Live virtual sessions (evening IST timings for working professionals)
- Classroom / in‑person workshops (on request)
- Self‑paced theory – learn ISO 15189:2022 and audit concepts via digital materials and recorded sessions, then join a scheduled live audit‑practice and exam batch
Prerequisites
- Basic understanding of medical laboratory operations, quality management or ISO standards
- Prior exposure to internal audits or accreditation (e.g. NABL) is helpful but not mandatory
Certification
- ABIS‑accredited ISO 15189:2022 Lead Auditor Certificate for Medical Laboratory Management Systems
- Certificates digitally verifiable on ABIS and Pacific Certifications’ verification portals, helping laboratories, employers and accreditation bodies to confirm authenticity quickly
Exam
- Online, proctored, 2‑hour exam
- Scenario‑based and multiple‑choice questions covering ISO 15189:2022 requirements, medical laboratory processes and audit principles
- For self‑paced learners, the exam can be scheduled on any available date after completing self‑study
- Exam voucher typically valid for up to 6 months from enrolment
Price
- Early‑bird, group, corporate and self‑paced options available
- Contact us for detailed fees
About the Training
The ISO 15189 Lead Auditor course by Pacific Certifications (ABIS‑accredited) equips you to plan, conduct, report and follow up on audits of medical laboratories against ISO 15189:2022.
You will learn how to interpret ISO 15189 requirements from an auditor’s perspective, assess both management and technical competence, and write clear, evidence‑based audit findings and reports using real‑life examples, audit workshops and a full audit simulation.
Who Should Attend
This course is ideal for:
- Medical laboratory directors, quality managers and section heads
- Technical managers, QA/QC personnel and NABL/NABH coordinators
- Internal auditors and members of medical laboratory audit teams
- Consultants supporting ISO 15189 implementation and accreditation projects
- Professionals aiming to work with accreditation or certification bodies as medical laboratory auditors
- Anyone responsible for evaluating or improving a laboratory quality management system based on ISO 15189:2022
ISO 15189:2022 Lead Auditor – Course Outline
Day 1 – ISO 15189:2022 Foundations & Laboratory Context
- Introduction to ISO 15189 – scope, purpose and key changes from earlier editions
- Structure of the standard (management and technical requirements)
- Understanding medical laboratory processes, patients, clinicians and other interested parties
- Laboratory context, risk‑based thinking and patient safety focus
- Overview of accreditation (e.g. NABL/other bodies) and the role of a Lead Auditor in medical laboratory audits
Day 2 – Audit Principles, Planning & Documentation Review
- Audit principles, auditor competence and ethical behaviour
- Types of audits (internal, external, accreditation) and audit programme planning
- Defining audit scope, criteria and objectives for medical laboratories
- Developing risk‑based audit plans, checklists and sampling strategies
- Reviewing laboratory documentation: quality manual (if used), policies, SOPs, equipment records, method validation/verification, quality control and EQA/PT records
Day 3 – Conducting the Medical Laboratory Audit
- Opening meetings: confirming scope, areas, test disciplines and logistics
- Effective communication with laboratory management, pathologists, technologists and support staff
- Collecting and verifying audit evidence via interviews, document review, observation and witnessing of test activities where appropriate
- Auditing key processes: pre‑examination (sample collection, identification, transport), examination (testing, validation, verification), post‑examination (reporting, interpretation, release of results)
- Auditing support processes: equipment, reagents and consumables, environmental conditions, IT/LIS, safety, risk management and point‑of‑care testing (POCT)
- Maintaining objective audit trails and records for multi‑discipline laboratories
Day 4 – Findings, Reporting & Follow‑up
- Analysing evidence and determining conformity / nonconformity
- Classifying findings (major/minor nonconformities, observations, opportunities for improvement) in the laboratory context
- Writing clear nonconformity statements, linked to ISO 15189 clauses and objective evidence (records, observations, interviews)
- Preparing concise, factual audit reports that support management and technical leadership decisions
- Conducting closing meetings and explaining findings, risks and timelines
- Corrective actions, root cause analysis, follow‑up audits and ongoing surveillance in accredited laboratories
Day 5 – Certification Audit Simulation & Exam Preparation
- Full ISO 15189:2022 medical laboratory audit case study with role‑play (auditor and auditee)
- Leading an audit team in a multi‑discipline lab: role allocation, time management, coordination and sampling of sections (e.g. biochemistry, microbiology, haematology, histopathology)
- Typical challenges in ISO 15189 audits (traceability, uncertainty of measurement, verification/validation, EQA/PT performance, personnel competence, IT/LIS controls) and how to address them
- Revision of key ISO 15189:2022 requirements and audit domains for the Lead Auditor exam
- Mock test, practice questions and exam tips
Assessment & ABIS‑Accredited Certification
- Continuous evaluation through quizzes, practical exercises, group work and audit role‑plays during the course
- Final online ISO 15189 Lead Auditor exam (2 hours), covering medical laboratory quality and competence requirements, audit principles, planning, conducting, reporting and managing an audit programme
- Participants who meet the competency and exam requirements receive the ABIS‑accredited ISO 15189 Lead Auditor certificate for Medical Laboratory Management Systems
- Certificates are digitally verifiable, supporting trust and recognition by employers, laboratories, regulators and accreditation bodies
Key Outcomes
By the end of the ISO 15189:2022 Lead Auditor course, participants will be able to:
- Explain the purpose, structure and key concepts of ISO 15189, including its focus on quality, competence and patient safety in medical laboratories
- Plan medical laboratory audits, including scope, objectives, criteria, audit schedules and audit team assignments across multiple disciplines
- Conduct process‑based audits of medical laboratories, gather objective evidence and evaluate the effectiveness and competence of laboratory processes and staff
- Evaluate critical aspects such as pre‑examination, examination and post‑examination processes, equipment management, method validation, quality control and EQA/PT participation
- Write clear, well‑structured nonconformity reports and audit reports that support accreditation readiness and continual improvement
- Lead audit teams and manage the full audit cycle, including follow‑up and surveillance audits in an ISO 15189‑accredited environment
Why Choose Pacific Certifications for ISO 15189:2022 Lead Auditor?
- ABIS‑Accredited: Training and certificates backed by ABIS, aligned with international expectations for medical laboratory Lead Auditors
- Healthcare‑focused & Practical: Real medical laboratory scenarios, case studies and audit simulations across disciplines, not just generic theory
- Expert Trainers: Delivered by professionals with hands‑on experience in ISO 15189 audits, accreditation assessments and laboratory quality management
- Ready‑to‑use Tools: Sample audit plans, discipline‑wise checklists, interview guides and report templates tailored for medical laboratories
- Post‑Course Support: Limited‑period email support and access to an alumni community for Q&A, peer learning and networking
Ready to advance your medical laboratory career and become an ABIS‑accredited ISO 15189 Lead Auditor?
Enroll now or contact us at trainings@pacificcert.com to join an upcoming ISO 15189:2022 Lead Auditor public batch.
ISO 15189:2022 – Medical Laboratory Management System
Lead Implementer Training
Design, implement, and continually improve a medical laboratory management system aligned with ISO 15189:2022 – and qualify as an ABIS‑accredited Lead Implementer recognised by laboratories, hospitals and accreditation bodies.
Duration
- 3–4 days of guided implementation training (live/classroom option)
- Self‑paced option available with flexible completion timeline
Format
- Live virtual sessions (e.g. IST 6:00 PM–10:30 PM)
- Classroom / in‑person workshops (on request)
- Self‑paced learning – study using Pacific Certifications’ digital materials and recordings, then join a live implementation / Q&A / exam‑prep session
Prerequisites
- Basic understanding of medical laboratory operations, quality management or ISO standards
- Prior exposure to internal audits, NABL/other accreditation, or lab QA is helpful but not mandatory
Certification
- ABIS‑accredited ISO 15189:2022 Lead Implementer Certificate
- Certificates digitally verifiable on ABIS and Pacific Certifications’ verification portals, enabling quick authenticity checks and strong credibility with employers, laboratories and accreditation bodies
Exam
- Online, open‑book, 2‑hour exam
- Scenario‑based and multiple‑choice questions covering ISO 15189:2022 requirements, risk‑based laboratory management and implementation practices
- For self‑paced learners, the exam can be booked on any available date after completing self‑study
- Exam voucher valid for up to 6 months from enrollment
Price
- Early‑bird, group, corporate and self‑paced options available
- Contact us for detailed fees
About the Training
The ISO 15189:2022 Lead Implementer course by Pacific Certifications equips you to plan, build and maintain a medical laboratory management system that meets ISO 15189:2022 requirements for quality and competence.
You will learn how to translate the standard into practical laboratory processes, documentation and controls across pre‑examination, examination and post‑examination phases, using real‑life examples, implementation workshops and step‑by‑step guidance toward accreditation readiness.
Who Should Attend
This course is ideal for:
- Medical laboratory directors, quality managers and section heads
- Technical managers, QA/QC personnel and NABL/NABH coordinators
- Pathologists, senior technologists and lab supervisors involved in quality and accreditation
- Consultants supporting ISO 15189 implementation and accreditation projects
- Internal auditors transitioning into implementation roles
- Anyone responsible for establishing, upgrading or maintaining an ISO 15189:2022‑based laboratory management system
ISO 15189:2022 Lead Implementer – Course Outline
Day 1 – ISO 15189:2022 Overview, Context & Project Initiation
- Introduction to ISO 15189:2022 and key changes from earlier versions
- Structure of the standard: management and technical requirements and their links to patient care
- Understanding lab context: patients, clinicians, regulators, accreditation bodies and other interested parties
- Defining the scope of the laboratory management system (disciplines, locations, services)
- Building the business case for ISO 15189:2022 and securing leadership commitment
- Planning the implementation project: roles, responsibilities, timelines and milestones
Day 2 – Risk‑Based Laboratory Management, Processes & Documentation
- Process approach in medical laboratories: pre‑examination, examination and post‑examination workflows
- Risk‑based thinking in the lab: identifying and managing risks to patients, staff, results and services
- Mapping laboratory processes, interfaces and responsibilities across disciplines
- Documentation requirements: policies, SOPs, work instructions, forms and records (including electronic systems)
- Managing documented information: creation, approval, version control, retention and accessibility
- Designing practical templates and registers (equipment, reagents, EQA/PT, quality indicators, nonconformities)
Day 3 – Implementing Management & Technical Requirements
- Governance, leadership responsibility and quality culture in the laboratory
- Personnel competence: job descriptions, qualifications, training, authorization and ongoing competency assessment
- Infrastructure and environmental conditions (premises, equipment, IT/LIS, safety and biosafety)
- Pre‑examination processes: request forms, patient identification, sample collection, transport, reception and acceptance/rejection criteria
- Examination processes: selection/verification/validation of methods, quality control, traceability, uncertainty of measurement where applicable
- Post‑examination processes: review and authorization of results, reporting, critical values, turnaround times and communication with clinicians
- Handling nonconforming work, complaints, errors and incidents, and implementing corrective actions
Day 4 – Performance Evaluation, Improvement & Accreditation Readiness
- Monitoring and measuring lab performance: quality indicators, internal QC, EQA/PT and trend analysis
- Internal audit programme: planning, performing and following up audits from an implementer’s viewpoint
- Management review: inputs, outputs and action tracking for continual improvement
- Risk management and continual improvement: root cause analysis, corrective and preventive actions
- Preparing for accreditation: understanding the accreditation process, gap assessment, documentation review and on‑site assessment expectations
- Managing transitions to ISO 15189:2022 within the allowed transition period and sustaining compliance
- Exam preparation, sample questions and course review
Assessment & Certification
- Continuous evaluation through quizzes, case studies, implementation exercises and discussions
- Final online exam (2 hours, open‑book), focused on ISO 15189:2022 requirements and implementation practices in medical laboratories
- Participants who meet competency and exam requirements receive the ABIS‑accredited ISO 15189:2022 Lead Implementer certificate
- Certificates are digitally verifiable, supporting recognition by employers, laboratories, regulators and accreditation bodies
Key Outcomes
By the end of the ISO 15189:2022 Lead Implementer course, participants will be able to:
- Explain the purpose, structure and key concepts of ISO 15189:2022, including its focus on quality, competence and patient safety
- Plan an ISO 15189 implementation project, including scope, objectives, stakeholders, responsibilities and resources
- Map and control pre‑examination, examination and post‑examination processes to meet standard requirements and minimise risks
- Develop and manage documentation, including policies, SOPs, work instructions, records and quality indicators
- Implement controls for personnel competence, equipment, reagents, IT/LIS, EQA/PT, nonconforming work and incident management
- Monitor and improve the laboratory management system using quality indicators, internal audits and management reviews
- Prepare the laboratory for accreditation and maintain ongoing compliance with ISO 15189:2022
Why Choose Pacific Certifications for ISO 15189:2022 Lead Implementer?
- ABIS‑Accredited: Training and certificates backed by ABIS and aligned with international expectations for medical laboratory implementers
- Laboratory‑focused & Practical: Real medical laboratory scenarios, discipline‑wise examples and implementation workshops, not just generic QMS theory
- Expert Trainers: Delivered by professionals with hands‑on ISO 15189 implementation, audit and accreditation experience
- Ready‑to‑use Templates: Sample SOPs, forms, registers and implementation checklists tailored to medical laboratories
- Post‑Course Support: Limited‑period email support and access to an alumni community for questions, sharing experiences and networking
Enroll now or contact us at trainings@pacificcert.com to join an upcoming ISO 15189:2022 Lead Implementer batch.
