INTRODUCTION ON ISO/IEC 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/IEC 15189 Accreditation For Pathology Laboratory Technical Services management systems or get maximum benefits from an established management system, auditors within the organization have to be trained to assess the system ISO/IEC 15189 Accreditation For Pathology Laboratory Technical Services 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.

OBJECTIVE OF THE COURSE ON ISO/IEC 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/IEC 15189 Accreditation For Pathology Laboratory Technical Services 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/IEC 15189 Accreditation For Pathology Laboratory Technical Services 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 OF ISO/IEC 15189:

• Introduction to ISO/IEC 15189 Accreditation For Pathology Laboratory Technical Services Management System
•  Vocabulary & understanding definitions
•  Introduction to ISO 44001:2017 Collaborative Business Relationship Management Systems Technical Services- Management System Requirements
•  Need for Internal Quality Audits
•    Auditing Techniques
•  Conducting Internal Quality Audits
•     Course Examination with minimum 50% passing marks.

Day 1: Introduction to ISO/IEC 15189 and Laboratory Quality Management

Session 1: Overview of ISO/IEC 15189 Standard

• Introduction to ISO/IEC 15189 Accreditation
  • Purpose and objectives of the ISO/IEC 15189 standard
  • Importance of accreditation in pathology and clinical labs
  • Key terminology and definitions
• Structure of ISO/IEC 15189
  • Requirements for quality management and technical competence
  • Overview of quality management system (QMS) elements in labs

Session 2: Quality Management System (QMS) Requirements

• Developing a Laboratory Quality Management System
  • Key components of a QMS for pathology labs
  • Document control, records management, and traceability
• Quality Policies and Objectives
  • Establishing quality policies and objectives for continuous improvement
  • Understanding roles, responsibilities, and resources needed for QMS

Session 3: Technical Requirements of ISO/IEC 15189

• Technical Competence in Pathology Labs
  • Personnel qualifications and training requirements
  • Equipment selection, validation, calibration, and maintenance
• Pre-examination, Examination, and Post-examination Processes
  • Ensuring accuracy and reliability at all stages of sample handling
  • Quality control processes and proficiency testing in pathology labs

Session 4: Risk Management and Patient Safety

• Identifying and Managing Risks in Laboratory Processes
  • Types of risks in pathology lab operations
  • Implementing risk assessments and mitigation strategies
• Patient Safety and Laboratory Accuracy
  • Ensuring patient confidentiality and integrity in test results
  • Safeguards and procedures to prevent errors in the laboratory

Group Activity:

• Participants will engage in a workshop to identify key areas for improvement in their own lab’s QMS, discussing potential challenges and strategies for enhancement.

Day 2: Practical Implementation, Auditing, and Continuous Improvement

Session 5: Quality Control and Assurance in Pathology Laboratories

• Internal Quality Control (IQC) and External Quality Assurance (EQA)
  • Developing and implementing IQC and EQA programs
  • Proficiency testing and inter-laboratory comparisons
• Performance Monitoring and Measurement
  • Key performance indicators for pathology lab services
  • Tools and metrics for continuous monitoring and improvement

Session 6: Internal Audits and ISO/IEC 15189 Compliance

• Conducting Effective Internal Audits
  • Audit planning, execution, and documentation
  • Identifying and addressing non-conformities within the QMS
• Corrective and Preventive Actions (CAPA)
  • Root cause analysis for non-conformities
  • Implementing CAPA to drive improvements in the QMS

Session 7: Document Control and Record Management

• Document Management Essentials
  • Creating, managing, and reviewing controlled documents
  • Best practices for record-keeping and traceability in laboratories
• Data Integrity and Information Management
  • Ensuring data integrity and accuracy throughout laboratory processes
  • Security and confidentiality of laboratory records and patient data

Session 8: Achieving and Maintaining ISO/IEC 15189 Accreditation

• Preparation for Accreditation Assessment
  • Steps to prepare for an external accreditation assessment
  • Review of common findings and pitfalls during accreditation audits
• Maintaining Compliance Post-Accreditation
  • Continuous improvement practices for sustaining accreditation
  • Regular reviews, updates, and staff training for ongoing compliance

Group Activity:

• Teams will work on developing a mock audit checklist for ISO/IEC 15189 compliance and simulate a mock audit with discussions on audit findings and CAPA planning.

Closing Session:

• Q&A Session
  • Addressing participant queries and specific challenges
• Feedback and Evaluation
  • Collecting feedback on the training programme
• Continuing Education Resources
  • Recommendations for ongoing learning and support materials

Learning Outcomes:

By the end of this training, participants will be able to:

• Understand the ISO/IEC 15189 requirements for quality and technical competence in pathology labs.
• Develop, implement, and manage a quality management system tailored to pathology lab services.
• Conduct internal audits and effectively manage CAPA processes to ensure continuous compliance.
• Prepare for external accreditation assessments and maintain compliance with ISO/IEC 15189 standards.

Delivery Method:

• Classroom Training: Interactive lectures, case studies, group discussions, and practical activities.
• Distance Learning: Recorded lectures, virtual discussions, case-based learning, and assessment quizzes.

Materials Provided:

• Training manual with ISO/IEC 15189 guidelines and supplementary materials
• Access to online resources and templates for laboratory QMS
• Certificate of completion

This course content provides a structured approach for participants to gain a comprehensive understanding of ISO/IEC 15189 and practical insights into achieving and maintaining accreditation for pathology laboratory services.

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 44001:2017 Collaborative Business Relationship Management Systems Technical Services.

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 44001:2017 Collaborative Business Relationship Management Systems Technical Services.

4)   Management Representatives responsible for effective implementation and execution of ISO 44001:2017 Collaborative Business Relationship Management Systems Technical Services.

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/IEC 15189 Accreditation For Pathology Laboratory Technical Services [Timings: 10.00 am to 6.00 pm]

FEES:

1. 2 Days Training program of ISO ISO/IEC 15189 Accreditation For Pathology Laboratory Technical Services is Rs 10500+18%GST

Payment should be made by Cheque / DD in Favor of “IAF-AB, Mumbai”