1. INTRODUCTION ON ISO 15189:

The standards published by ISO undergo changes periodically, to reflect the best-suited practices over the changing times. ISO series of standards For a business unit to successfully set up an ISO 15189 Point-of-care Testing (POCT) Accreditation management systems or get maximum benefits from an established management system, auditors within the organization have to be trained to assess the system ISO 15189 Point-of-care Testing (POCT) Accreditation requirements. They must also be able to assess their suppliers required management system to support own Quality Initiative.

To increase professionalism, quality auditors also seek formal registration with the IAF-AB (UK & INDIA) one of the prerequisites for such registration requires the quality auditors and practitioners to successfully complete an IAF-AB (UK & INDIA) approved auditor training.

 

1. OBJECTIVE OF THE COURSE ON ISO 15189:

The objective of the course is to illustrate the importance of the Two Days Training Programme role, skills and competency in bearing the ultimate responsibility for the effective performance of the audit team. A practical and intensive course for training quality professionals to External, Internal and manage third and second party audits of an ISO 15189 Point-of-care Testing (POCT) Accreditation Management System.

Course describes how to plan and perform an audit, report findings, conduct opening and closing meetings and establish follow-up action. You will understand by the end of the course how regular auditing by an audit team directed by a competent internal auditor is the foundation of an effective ISO 15189 Point-of-care Testing (POCT) Accreditation Management System. On completion of the course, you will have the necessary skills and the experience to Internal Audit and manage your own audits. The learning process will include a series of tutorials, exercises, culminating in both practical and written examination. Delegates will be supplied with a bound set of comprehensive course notes.

 

1. COURSE CONTENTS ON ISO 15189:

• Introduction to ISO 15189 Point-of-care Testing (POCT) Accreditation Management System
•  Vocabulary & understanding definitions
•  Introduction to ISO 15189 Point-of-care Testing (POCT) Accreditation – Management System Requirements
•  Need for Internal Quality Audits
•    Auditing Techniques
•  Conducting Internal Quality Audits
•     Course Examination with minimum 50% passing marks.

2. Purpose of ISO 15189 POCT Accreditation

The purpose of accrediting POCT under ISO 15189 is to ensure that:

• POCT results are accurate, reliable, and clinically valid

• POCT activities are controlled, supervised, and standardized

• Patient safety and risk management are maintained

• Staff performing POCT are trained and competent

• Results are traceable, documented, and fit for clinical use

Accreditation provides confidence to clinicians, patients, regulators, and accreditation bodies that POCT meets the same quality standards as central laboratory testing.

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3. Scope of POCT under ISO 15189

POCT accreditation may include, but is not limited to:

• Blood glucose testing

• Blood gas and electrolyte analysis

• Cardiac markers

• Coagulation testing (e.g., INR)

• Urinalysis

• Pregnancy testing

• Infectious disease rapid tests

• HbA1c testing

The scope must clearly define test types, locations, instruments, and clinical applications.

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4. Governance and Management Responsibility for POCT

4.1 POCT Governance Structure

ISO 15189 requires that POCT be under the responsibility of the medical laboratory, even when testing is performed outside the laboratory. Key governance requirements include:

• Appointment of a POCT Coordinator

• Defined roles and responsibilities for POCT management

• Clear authority for oversight and decision-making

• Integration of POCT into laboratory management systems

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4.2 POCT Policies and Procedures

Documented procedures must cover:

• Selection and evaluation of POCT devices

• Approval of POCT tests and locations

• Risk assessment and control

• Quality assurance and quality control

• Result reporting and record retention

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5. Personnel Competence and Training

5.1 POCT Operator Competence

ISO 15189 requires that all POCT operators:

• Receive initial training before performing tests

• Demonstrate competence through assessment

• Be authorized to perform specific POCT tests

• Undergo periodic re-assessment and refresher training

Training records and competence evaluations must be documented.

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5.2 Responsibilities of the POCT Coordinator

The POCT Coordinator is responsible for:

• Training and authorization of POCT users

• Monitoring compliance with procedures

• Ensuring quality control and EQA participation

• Liaison between clinical areas and the laboratory

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6. Equipment and Reagents Management

6.1 POCT Equipment Control

ISO 15189 requires that POCT devices be:

• Fit for intended clinical use

• Validated or verified before use

• Maintained and calibrated as required

• Subject to ongoing performance monitoring

Records of installation, maintenance, calibration, and performance checks must be retained.

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6.2 Reagents and Consumables

Reagents used in POCT must be:

• Approved and evaluated before use

• Stored under defined conditions

• Used within expiry dates

• Traceable to lot numbers

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7. Quality Assurance for POCT

7.1 Internal Quality Control (IQC)

POCT must include appropriate internal quality control procedures, including:

• Frequency and acceptance criteria

• Actions for QC failures

• Documentation and review of results

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7.2 External Quality Assessment (EQA)

ISO 15189 requires participation in suitable EQA or proficiency testing schemes where available. If EQA is not available, alternative methods must be defined and justified.

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8. Pre-Examination, Examination, and Post-Examination Processes

8.1 Pre-Examination Processes

Includes:

• Patient identification

• Sample collection and handling

• Patient preparation and consent

• Environmental conditions

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8.2 Examination Processes

Includes:

• Following approved test procedures

• Operator identification and traceability

• Control of environmental conditions

• Managing device limitations and interferences

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8.3 Post-Examination Processes

Includes:

• Result review and authorization

• Reporting and communication of results

• Management of critical values

• Record retention and traceability

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9. Information Management and Connectivity

ISO 15189 requires effective information management, including:

• Secure data transfer from POCT devices

• Integration with Laboratory Information Systems (LIS)

• Data integrity and confidentiality

• Backup and contingency plans

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10. Risk Management and Patient Safety

POCT services must apply risk management principles, including:

• Identification of risks related to testing, users, and devices

• Implementation of control measures

• Incident reporting and investigation

• Corrective and preventive actions

Risk management is central to POCT accreditation.

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11. Internal Audits and Management Review

ISO 15189 requires:

• Regular internal audits covering POCT activities

• Review of POCT performance in management review

• Evaluation of quality indicators and trends

• Continuous improvement actions

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12. Accreditation Assessment Process

Accreditation bodies assess POCT under ISO 15189 through:

• Document review

• On-site assessment of POCT locations

• Witnessing POCT activities

• Review of records, training, and quality control

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13. Benefits of ISO 15189 POCT Accreditation

ISO 15189 POCT accreditation provides:

• Improved patient safety and clinical confidence

• Standardized POCT practices across locations

• Reduced errors and variability

• Regulatory and stakeholder confidence

• Integration of POCT into laboratory quality systems

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14. Conclusion

ISO 15189 accreditation for POCT ensures that rapid diagnostic testing performed at the point of care meets the same rigorous quality and competence standards as centralized laboratory testing. Through strong governance, competent personnel, controlled processes, and robust quality assurance, POCT accreditation supports safe, reliable, and effective patient care.

Accredited POCT services demonstrate a commitment to excellence, patient safety, and continual improvement within modern healthcare systems.

 

Day 1: Introduction to ISO 15189 and Point-of-Care Testing

Session 1: Overview of ISO 15189

• Introduction to ISO 15189
  • Purpose and significance in medical laboratories
  • Historical context and development of the standard
• Key principles of quality management in laboratory settings

Session 2: Understanding Point-of-Care Testing (POCT)

• Definition and scope of POCT
• Benefits and challenges of POCT in healthcare delivery
• Overview of common POCT devices and technologies

Session 3: Requirements for POCT Accreditation under ISO 15189

• Overview of accreditation requirements specific to POCT
• Documentation and record-keeping needs for compliance
• Role of quality management systems (QMS) in POCT

Session 4: Implementing Quality Management in POCT

• Key elements of QMS in laboratory services
• Establishing standard operating procedures (SOPs) for POCT
• Risk management strategies in POCT implementation

Group Activity:

• Participants will analyze a case study of a healthcare facility implementing POCT and identify key areas for improvement related to ISO 15189 standards.

Day 2: Practical Applications and Continuous Improvement

Session 5: Competence and Training in POCT

• Training requirements for personnel involved in POCT
• Assessing and ensuring the competence of staff
• Continuous professional development in laboratory services

Session 6: Conducting and Managing POCT

• Best practices for performing point-of-care tests
• Quality control and assurance measures in POCT
• Data management and reporting in POCT settings

Session 7: Case Studies of Successful ISO 15189 Accreditation in POCT

• Real-world examples of laboratories that have successfully achieved ISO 15189 accreditation for their POCT services
• Discussion of challenges faced and solutions implemented
• Strategies for maintaining accreditation and continuous quality improvement

Session 8: Future Trends in POCT and Accreditation

• Emerging technologies and innovations in point-of-care testing
• The evolving landscape of laboratory accreditation and regulations
• Preparing for future changes in ISO 15189 standards and practices

Group Activity:

• Teams will develop a mock implementation plan for a new POCT service, including considerations for accreditation under ISO 15189.

Closing Session:

• Q&A session to clarify participant queries
• Discussion on the importance of ongoing education and training in maintaining ISO 15189 accreditation
• Feedback collection from participants regarding the training programme

Learning Outcomes:

Upon completion of this training programme, participants will be able to:

• Understand the principles and requirements of ISO 15189 in the context of point-of-care testing.
• Implement a quality management system tailored for POCT.
• Conduct and manage POCT effectively while ensuring compliance with ISO standards.
• Recognize future trends and innovations that may impact POCT and laboratory accreditation.

Delivery Method:

• Classroom Training: Interactive lectures, group discussions, case studies, and hands-on activities.
• Distance Learning: Recorded lectures, online discussions, virtual group activities, and assessment quizzes.

Materials Provided:

• Course handbook and supplementary materials
• Access to online resources and additional reading materials
• Certificates of completion

This structured content aims to equip participants with the knowledge and skills necessary to enhance the quality of point-of-care testing through effective ISO 15189 accreditation practices.

 

For detail of contents refer our website at   https://iaf-ab.org/

 

1. WHO SHOULD ATTEND:

1)   All employees whose work responsibility directly affects ISO 15189 Point-of-care Testing (POCT) Accreditation.

2)   Those individuals willing to take up external auditing as a future profession by becoming an independent auditor.

3)   Those who intend to enroll themselves to IAF-AB (UK & INDIA) Registration Schemes of ISO 15189 Point-of-care Testing (POCT) Accreditation.

4)   Management Representatives responsible for effective implementation and execution of ISO 15189 Point-of-care Testing (POCT) Accreditation.

 

1. FACILITIES:

All facility for delegates covering lecture hall, tea and lunch will be arranged by Client or if you are attending the course at IAF-AB office. IAF-AB institute will arrange the above facility.

 

1. COURSE DETAILS:

Detail program of every days training course will be sent / given on the first day to the delegates on registration.

 

1. DURATION:

Two days Training program for ISO 15189 Point-of-care Testing (POCT) Accreditation [Timings: 10.00 am to 6.00 pm]

 

FEES:

1. 2 Days Training program of ISO 15189 Point-of-care Testing (POCT) Accreditation is Rs 10500+18%GST Payment should be made by Cheque / DD in favour of “IAF-AB, Mumbai”