ISO 15189 2022 Medical laboratories — Requirements for quality and competence - Quality manager & Internal auditor course
Instructor
QGLOBAL ACADEMY
795
Students
enrolled
- Description
- Curriculum
ISO 15189 2022 standard specifies requirements for quality and competence in medical laboratories. ISO 15189 standards can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies. ISO 15189 standard aims to promote the welfare of patients and satisfaction of laboratory users through confidence in the quality and competence of medical laboratories. ISO 15189 standard contains requirements for the medical laboratory to plan and implement actions to address risks and opportunities for improvement. Benefits of implementing a laboratory quality management system includes but not limited to – increasing the effectiveness of the management system, decreasing probability of invalid results, and reducing potential harm to patients, laboratory personnel, the public and the environment. ISO 15189 2022 internal auditor and quality manager course will help you learn how to initiate an audit, prepare and conduct audit activities, compile and distribute audit reports and complete follow-up activities. On successful completion of this course, you will be able to optimize your auditing skills with the internationally recognized ISO 15189 2022 standard and boost your audit capabilities. Also gain confidence in planning and performing an effective audit, as well as reporting and taking corrective action where necessary. ISO 15189 2022 internal auditor training course develops the necessary skills to assess and report on the conformance and implementation of processes based on ISO 15189 2022.
Who Should Attend?
- Anyone involved in the planning, implementing, maintaining, supervising or auditing of an ISO 15189 2022 laboratory quality management system
- Those who like to handle the role of an ISO 15189 2022 internal auditor in a laboratory
- Personnel who wish to pursue career as an ISO 15189 2022 internal auditor
- Expert advisors in laboratory quality management
- Lab owners, managers and directors
- Quality managers and technical managers in the laboratory
Key Benefits
- Gain the skills to plan, conduct, report and follow up audits in accordance with ISO 19011
- Learn skills to lead an internal audit team
- Identify the aims and benefits of an ISO 15189 2022 audit
- Interpret ISO 15189 2022 requirements for audit application
- Grasp the application of risk-based thinking, leadership and process management
- Acknowledge the correlation between ISO 15189 2022 and other standards and regulatory frameworks
- Learn the latest techniques in ISO 15189 2022 internal auditing
- Fill gaps in your professional knowledge
Learning & Evaluation Method
This is a live and interactive course. Once you purchase the course, our team will contact you to plan the training. No matter where you are located, we schedule the classes based on your convenience and time zone. You can plan to attend the training in sessions of 4 or 8 hr duration, based on how much time you can spend in a day.
Certification
There are increasing numbers of organizations, who prefer candidates those who have completed management system trainings from a recognized institution. Certification demonstrates your commitment to superior professionalism, upholding industry standards, and continued learning. These merits can help boost your professional credibility and prestige within your own network, in your organisation, with your current clients, and when pursuing new business opportunities. After the successful completion of the course and final exam, you will be awarded with a certificate of completion issued by QGlobal. Your credentials will be made available in the global online directory and can be verified by anyone searching with the certificate number. Without doubt we can say that our training courses are well recognized and sought after by organizations across various geographies.
Sample Certificate
Buy for group Are you planning to buy this course for a group? We have the best prices for you! Select ‘Buy for Group’ option and add to the cart. You will get a discount of 60 – 75% for a group of up to 10 participants. To make a group purchase, create your group name and add individual emails of up to 10 participants. Each participant will get the access to the course materials, exam and the certificate. We will arrange one live-online session for the entire group.
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Buy for group Are you planning to buy this course for a group? We have the best prices for you! Select ‘Buy for Group’ option and add to the cart. You will get a discount of 60 – 75% for a group of up to 10 participants. To make a group purchase, create your group name and add individual emails of up to 10 participants. Each participant will get the access to the course materials, exam and the certificate. We will arrange one live-online session for the entire group.
Total: 222 Courses View all
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$190
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$240
$190
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$290
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$240
$190
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$240
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$190
[/vc_column][/vc_row]
$240
$190
All industries
[/vc_column][/vc_row]
$240
$190
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Course Description Welcome to QGlobal Academy! The API Specification Q2, 3rd edition lead implementer training is an advanced, practical program de...
$240
$190
Special
All industries
[/vc_column][/vc_row]
$240
$190
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$240
$190
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Awareness training on ISO 15189 2022 standards
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1
ISO 15189 Training 1/6 - IntroductionIn this video, we provide a comprehensive introduction to ISO 15189:2022, the international standard for medical laboratories. This training on ISO 15189 is designed to help you understand the fundamentals of quality management and technical competence required to ensure accurate and reliable laboratory results. ISO 15189 plays a critical role in improving patient safety, laboratory efficiency, and global credibility, making it essential for laboratories seeking international accreditation.
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2Introduction to ISO 15189 2022 standards
- Introduction to ISO 15189 2012 standards
- Process approach
- Risk based thinking
- PDCA
- Medical laboratory accreditation
- Benefits of medical laboratory accreditation
- International Laboratory Accreditation Corporation (ILAC)
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3PDCA Approach
Learn the powerful PDCA Cycle (Plan-Do-Check-Act), a proven method for continuous improvement, problem-solving, and process optimization used in ISO standards and business management systems. This course from QGLOBAL ACADEMY explains the PDCA cycle in a simple and practical way with real-world examples.
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4ISO 15189 Training 2/6 - Clause 4
In this video, we provide a comprehensive explanation of Clause 4 – General Requirements of ISO 15189:2022, focusing on the foundational elements required for medical laboratories to establish a reliable and compliant Quality Management System (QMS). ISO 15189 Clause 4 is critical as it addresses impartiality, confidentiality, and structural requirements, ensuring that laboratory activities are conducted with integrity, independence, and trust.
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5ISO 15189 2022 General requirements
Clause 4.1 Impartiality
Clause 4.2 Confidentiality
Clause 4.2.1 Management of information
Clause 4.2.2 Release of information
Clause 4.2.3 Personnel responsibility
Clause 4.3 Requirements regarding patients
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6ISO 15189 Training 3/6 - Clause 5
In this video, we provide a detailed explanation of Clause 5 – Structural Requirements of ISO 15189:2022, focusing on how medical laboratories should establish a clear organizational framework to ensure effective quality management and operational control. ISO 15189 Clause 5 ensures that laboratories define roles, responsibilities, authorities, and organizational structure, enabling consistent delivery of reliable and accurate test results.
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7ISO 15189 2022 Structural and governance requirements
Clause 5.1 Legal entity
Clause 5.2 Laboratory director
Clause 5.2.1 Laboratory director competence
Clause 5.2.2 Laboratory director responsibilities
Clause 5.2.3 Delegation of duties
Clause 5.3 Laboratory activities
Clause 5.3.1 General
Clause 5.3.2 Conformance with requirements
Clause 5.3.3 Advisory activities
Clause 5.4 Structure and authority
Clause 5.4.1 General
Clause 5.4.2 Quality management
Clause 5.5 Objectives and policies
Clause 5.6 Risk management
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8ISO 15189 Training 4/6 - Clause 6
In this video, we provide a detailed explanation of Clause 6 – Resource Requirements of ISO 15189:2022, focusing on how medical laboratories manage personnel, equipment, facilities, and external services to ensure quality and competence. ISO 15189 Clause 6 is essential for ensuring that laboratories have the right resources, competent staff, and controlled environments to deliver accurate and reliable test results.
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9ISO 15189 2022 Resource requirements
Clause 6.1 General
Clause 6.2 Personnel
Clause 6.2.1 General
Clause 6.2.2 Competence requirements
Clause 6.2.3 Authorization
Clause 6.2.4 Continuing education and professional development
Clause 6.2.5 Personnel records
Clause 6.3 Facilities and environmental conditions
Clause 6.3.1 General
Clause 6.3.2 Facility controls
Clause 6.3.3 Storage facilities
Clause 6.3.4 Personnel facilities
Clause 6.3.5 Sample collection facilities
Clause 6.4 Equipment
Clause 6.4.1 General
Clause 6.4.2 Equipment requirements
Clause 6.4.3 Equipment acceptance procedure
Clause 6.4.4 Equipment instructions for use
Clause 6.4.5 Equipment maintenance and repair
Clause 6.4.6 Equipment adverse incident reporting
Clause 6.4.7 Equipment records
Clause 6.5 Equipment calibration and metrological traceability
Clause 6.5.1 General
Clause 6.5.2 Equipment calibration
Clause 6.5.3 Metrological traceability of measurement results
Clause 6.6 Reagents and consumables
Clause 6.6.1 General
Clause 6.6.2 Reagents and consumables — Receipt and storage
Clause 6.6.3 Reagents and consumables — Acceptance testing
Clause 6.6.4 Reagents and consumables — Inventory management
Clause 6.6.5 Reagents and consumables — Instructions for use
Clause 6.6.6 Reagents and consumables — Adverse incident reporting
Clause 6.6.7 Reagents and consumables — Records
Clause 6.7 Service agreements....
Clause 6.7.1 Agreements with laboratory users
Clause 6.7.2 Agreements with POCT operators
Clause 6.8 Externally provided products and services
Clause 6.8.1 General
Clause 6.8.2 Referral laboratories and consultants
Clause 6.8.3 Review and approval of externally provided products and services
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10ISO 15189 Training 5/6 - Clause 7
This course provides a comprehensive understanding of Clause 7 – Process Requirements of ISO 15189:2022, focusing on the core laboratory processes that directly impact the accuracy and reliability of test results. ISO 15189 Clause 7 is one of the most critical sections of the standard, covering the entire laboratory workflow, from sample collection to reporting of results. It ensures that all processes are controlled, validated, and consistently performed to maintain high-quality outcomes.
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11ISO 15189 2022 Process requirements
Clause 7.1 General
Clause 7.2 Pre-examination processes
Clause 7.2.1 General
Clause 7.2.2 Laboratory information for patients and users
Clause 7.2.3 Requests for providing laboratory examinations
Clause 7.2.4 Primary sample collection and handling
Clause 7.2.5 Sample transportation
Clause 7.2.6 Sample receipt
Clause 7.2.7 Pre-examination handling, preparation, and storage
Clause 7.3 Examination processes
Clause 7.3.1 General
Clause 7.3.2 Verification of examination methods
Clause 7.3.3 Validation of examination methods
Clause 7.3.4 Evaluation of measurement uncertainty (MU)
Clause 7.3.5 Biological reference intervals and clinical decision limits
Clause 7.3.6 Documentation of examination procedures
Clause 7.3.7 Ensuring the validity of examination results
Clause 7.4 Post-examination processes
Clause 7.4.1 Result reporting
Clause 7.4.2 Post-examination handling of samples
Clause 7.5 Nonconforming work
Clause 7.6 Control of data and information management
Clause 7.6.1 General
Clause 7.6.2 Authorities and responsibilities for information management
Clause 7.6.3 Information systems management
Clause 7.6.4 Downtime plans
Clause 7.6.5 Off site management
Clause 7.7 Complaints
Clause 7.7.1 Process
Clause 7.7.2 Receipt of complaint
Clause 7.7.3 Resolution of complaint
Clause 7.8 Continuity and emergency preparedness planning
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12Biomedical waste management
Learn the complete process of Biomedical Waste Management in healthcare and laboratory settings. This course provides a clear and practical understanding of how biomedical waste should be handled safely—from generation to final disposal—while ensuring compliance with regulations. In this training, key topics such as waste categories, segregation, collection, storage, transportation, treatment, disposal methods, occupational safety, risks and controls, documentation, and compliance are explained with real-world examples. The course also covers Do’s and Don’ts, proper use of PPE, and essential safety practices to prevent infection and environmental contamination.
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13ISO 15189 Training 6/6 - Clause 8
This course provides a comprehensive understanding of ISO 15189 Clause 8 – Management System Requirements of ISO 15189:2022, focusing on how medical laboratories establish, implement, and maintain an effective Medical Laboratory Quality Management System (QMS). ISO 15189 Clause 8 ensures that laboratories operate in a systematic, controlled, and continuously improving manner, supporting consistent delivery of accurate and reliable test results.
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14ISO 15189 2022 Management system requirements
Clause 8.1 General requirements
Clause 8.1.1 General
Clause 8.1.2 Fulfilment of management system requirements
Clause 8.1.3 Management system awareness
Clause 8.2 Management system documentation
Clause 8.2.1 General
Clause 8.2.2 Competence and quality
Clause 8.2.3 Evidence of commitment
Clause 8.2.4 Documentation
Clause 8.2.5 Personnel access
Clause 8.3 Control of management system documents
Clause 8.3.1 General
Clause 8.3.2 Control of documents
Clause 8.4 Control of records
Clause 8.4.1 Creation of records
Clause 8.4.2 Amendment of records
Clause 8.4.3 Retention of records
Clause 8.5 Actions to address risks and opportunities for improvement
Clause 8.5.1 Identification of risks and opportunities for improvement
Clause 8.5.2 Acting on risks and opportunities for improvement
Clause 8.6 Improvement
Clause 8.6.1 Continual improvement
Clause 8.6.2 Laboratory patients, user, and personnel feedback
Clause 8.7 Nonconformities and corrective actions
Clause 8.7.1 Actions when nonconformity occurs
Clause 8.7.2 Corrective action effectiveness
Clause 8.7.3 Records of nonconformities and corrective actions
Clause 8.8 Evaluations
Clause 8.8.1 General
Clause 8.8.2 Quality indicators
Clause 8.8.3 Internal audits
Clause 8.9 Management reviews
Clause 8.9.1 General
Clause 8.9.2 Review input
Clause 8.9.3 Review output
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15Control of documents & records
Learn the fundamentals of Document Control and how to effectively manage documents and records in line with ISO standards. This video covers document control, document control ISO 9001, ISO document control, document management system, and records management, including ISO 9001 document control, control of documents and records, document control training, and document control explained, along with key aspects such as document control procedure, document lifecycle management, version control documents, document revision control, document approval process, and document identification ISO, as well as document retention policy, record retention and disposal, ISO document control, QMS document control, and quality management system documents, further highlighting document control audit, document control best practices, document controller training, document distribution control, document storage and protection, document review and update, and document control process, while supporting compliance documentation, audit documentation, ISO training, and quality training from QGLOBAL ACADEMY.
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16ISO 15189 2022 - Implementation guidance for medical laboratories
Scope
Normative references
Terms and definitions
General requirements
Structural and governance requirements
Resource requirements
Process requirements
Management system requirements
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17Laboratory safety
- Laboratory safety
- Recognition of hazards
- Assess risks
- Minimize Risks
- Prepare for emergencies
- Safe laboratory practices
- Immunization
- Laboratory safety guidelines
- Action plan
Implementation training on ISO 15189 2022 standards
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18LI 01 Building the team
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19LI 02 Conducting gap analysis
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20LI 03 Preparing implementation plan
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21LI 04 Creating awareness
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22LI 05 Training
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23LI 06 Procuring documents
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24LI 07 Creating management system manual
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25LI 08 Creating policies and procedures
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26LI 09 Creating forms and templates
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27LI 10 Planning for certification
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28LI 11 Implementation methodology
- Building the culture
- Plan-Do-Check-Act
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29LI 12 Role of leadership in implementing the management system
- Leadership concepts
- Role of leaders in implementing the management system
- 12 Characteristics of team leaders and managers
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30LI 13 Employee motivation and involvement
- Employee wants
- Achieving a motivated workforce
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31LI 14 Obstacles in implementing the management system
- Inability to manage the change
- No planned review of the system
- Inadequate planning
- Not aligning the goals and matrices
- Poor commitment from top management
- Differences between departments and individuals
- Lack of awareness and not providing continuous training
- Poor documentation
- Inadequate monitoring, measuring and analysis of data and results
- Not paying attention to internal and external customers
- Failure to continually improve
- Failure to motivate and empower employees
Internal auditor training on ISO 15189 2022 standards
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32ISO 19011 Introduction
This lesson introduces ISO 19011, the international guideline for auditing management systems. It explains the purpose, scope and importance of audits.
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33Introduction to ISO 19011 Guidelines for auditing management systems
- Scope
- Normative references
- Terms and definitions
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34ISO 19011 Terms & definitions
This lesson introduces the key terminology used in ISO 19011 for auditing management systems. It explains essential concepts such as audit, audit criteria, audit evidence, findings, and audit results, along with roles like auditor, auditee, and audit team. The lesson also covers terms related to audit planning and execution, including audit programme, scope, and plan, as well as newer concepts like remote auditing methods. Understanding these definitions ensures clear communication, consistent interpretation, and effective implementation of auditing practices.
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35ISO 19011 Principles of auditing
This lesson explains the fundamental principles of auditing defined in ISO 19011:2026, which ensure audits are credible, objective, and reliable. It covers key principles such as integrity, fair presentation, due professional care, confidentiality, independence, and evidence-based approach, along with the risk-based approach to auditing. Learners understand how these principles guide auditor behavior, decision-making, and audit outcomes, forming the foundation for conducting effective and trustworthy management system audits.
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36ISO 19011 Principles of auditing
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37ISO 19011 Managing audit programme
This lesson introduces how to establish, implement, monitor, and improve an audit programme in accordance with ISO 19011.
It explains the need to align the programme with organizational objectives, risks, and priorities, and covers key aspects such as defining scope, assigning responsibilities, allocating resources, and scheduling audits. The lesson also highlights the importance of monitoring performance, evaluating effectiveness, and driving continual improvement, ensuring the audit programme remains efficient, risk-based, and value-adding.
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38ISO 19011 Managing an audit program
- Establishing audit programme objectives
- Determining and evaluating audit programme risks and opportunities
- Establishing the audit programme
- Roles and responsibilities of the individual(s) managing the audit programme
- Competence of individual(s) managing audit programme
- Establishing extent of audit programme
- Determining audit programme resources
- Implementing audit programme
- Defining the objectives, scope and criteria for an individual audit
- Selecting and determining audit methods
- Selecting audit team members
- Assigning responsibility for an individual audit to the audit team leader
- Managing audit programme results
- Managing and maintaining audit programme records
- Monitoring audit programme
- Reviewing and improving audit programme
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39ISO 19011 Conducting audit
This lesson explains the process of planning and carrying out an audit in line with ISO 19011 standard. It covers key stages such as initiating the audit, preparing audit plans, conducting audit activities, collecting and verifying evidence, and communicating findings. The lesson also emphasizes effective interaction with the auditee, use of appropriate audit methods (including remote auditing), and maintaining objectivity throughout the audit. Learners gain an understanding of how to ensure audits are systematic, evidence-based, and result-oriented.
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40ISO 19011 Conducting an audit
- Initiating audit
- Establishing contact with auditee
- Determining feasibility of audit
- Preparing audit activities
- Performing review of documented information
- Audit planning
- Assigning work to audit team
- Preparing documented information for audit
- Conducting audit activities
- Assigning roles and responsibilities of guides and observers
- Conducting opening meeting
- Communicating during audit
- Audit information availability and access
- Reviewing documented information while conducting audit
- Collecting and verifying information
- Generating audit findings
- Determining audit conclusions
- Conducting closing meeting
- Preparing and distributing audit report
- Preparing audit report
- Distributing audit report
- Completing audit
- Conducting audit follow-up
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41ISO 19011 Auditor competence
This lesson explains the competence requirements for auditors as defined in ISO 19011. It covers the necessary knowledge, skills, and personal attributes required to perform effective audits, including understanding of management system standards, audit principles, and industry-specific processes. The lesson also addresses evaluation of auditor competence, ongoing development, and maintaining proficiency, ensuring auditors can conduct audits that are credible, consistent, and value-adding.
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42ISO 19011 Auditor Competence
- Determining auditor competence
- Personal behavior
- Knowledge and skills
- Achieving auditor competence
- Achieving audit team leader competence
- Establishing auditor evaluation criteria
- Selecting appropriate auditor evaluation method
- Conducting auditor evaluation
- Maintaining and improving auditor competence
Evaluation - ISO 15189 2022 internal auditor course
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43ISO 19011 Auditor training practice questions
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44Best laboratory practices in medical laboratories
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45Quality control in medical laboratory
• Exam duration is 45 minutes
• All questions carry 1 mark each
• Select only the most appropriate answer
• Minimum pass mark is 50%
• You have 3 attempts to pass the exam
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46Measurement uncertainty
• Exam duration is 45 minutes
• All questions carry 1 mark each
• Select only the most appropriate answer
• Minimum pass mark is 50%
• You have 3 attempts to pass the exam
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47Ensuring validity of test results
• Exam duration is 60 minutes
• All questions carry 1 mark each
• Select only the most appropriate answer
• Minimum pass mark is 50%
• You have 3 attempts to pass the exam
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48Practice Questions - ISO 15189 auditor trainingExam duration is 150 minutesAll questions carry 1 mark eachSelect only the most appropriate answerMinimum pass mark is 50%
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49ISO 15189 2022 Course activities
Course details
Duration
32 hr
Lectures
44
Quizzes
5
Level
Beginner
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