ISO/IEC 15189 ACCREN FOR PATHOLOGY LABORATORY TECHNICADITATIOL SERVICES

Description

As is widely known, UKJAS Accreditation Pvt.  Ltd  conducting various technical courses inviting interested personnel/technocrats for enhancing & fine-tuning of the skill.

 

UKJAS Accreditation Pvt. Ltd organizing 4 Days Advance Training Programe Classroom & online Training course for ISO/IEC 15189 ACCREN FOR PATHOLOGY LABORATORY TECHNICADITATIOL SERVICES

 

1. ISO INTRODUCTION

 

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 and   ISO/IEC 15189 ACCREN FOR PATHOLOGY LABORATORY TECHNICADITATIOL SERVICES or get maximum benefits from an established management system, auditors within the organization have to be trained to assess the system against ISO/IEC 15189 ACCREN FOR PATHOLOGY LABORATORY TECHNICADITATIOL SERVICES. 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) one of the prerequisites for such registration requires the quality auditors and practitioners to successfully complete an IAF-AB (UK) approved auditor training.

 

1. OBJECTIVE OF THE COURSE:

The objective of the course is to illustrate the importance of the 4 Days Advance Training Programe 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 a ISO/IEC 15189 ACCREN FOR PATHOLOGY LABORATORY TECHNICADITATIOL SERVICES.

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 ACCREN FOR PATHOLOGY LABORATORY TECHNICADITATIOL SERVICES 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:

• Introduction to ISO/IEC 15189 ACCREN FOR PATHOLOGY LABORATORY TECHNICADITATIOL SERVICES  Vocabulary & understanding definitions
•  Introduction to ISO/IEC 15189 ACCREN FOR PATHOLOGY LABORATORY TECHNICADITATIOL SERVICES
•  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 Quality Management Systems in Laboratories

Session 1: Overview of ISO/IEC 15189

• Introduction to ISO/IEC 15189
  • Purpose and scope of the standard.
  • Key concepts and terminology in medical laboratory accreditation.

Session 2: Importance of Accreditation

• Benefits of ISO/IEC 15189 Accreditation
  • Enhancing laboratory performance and reliability.
  • Improving patient safety and care quality.
  • Compliance with regulatory requirements.

Session 3: Quality Management System (QMS) Principles

• Key Elements of a QMS
  • Quality policy, objectives, and planning.
  • Document control and records management.
  • Internal audits and management reviews.

Session 4: Laboratory Organization and Management

• Structure and Governance of Medical Laboratories
  • Roles and responsibilities of laboratory personnel.
  • Organizational charts and reporting structures.

Group Activity:

• Participants will analyze their current laboratory management structures and discuss potential improvements for compliance with ISO/IEC 15189.

Day 2: Implementing ISO/IEC 15189 Standards in Pathology Laboratories

Session 5: Personnel Competence and Training

• Staff Qualifications and Training
  • Defining competence and its assessment.
  • Continuous education and training programs.

Session 6: Equipment Management

• Managing Laboratory Equipment
  • Calibration, maintenance, and validation of equipment.
  • Record-keeping and traceability.

Session 7: Pre-Analytical, Analytical, and Post-Analytical Processes

• Understanding the Laboratory Workflow
  • Sample collection, handling, and processing.
  • Testing methodologies and result reporting.
  • Quality control and assurance processes.

Session 8: Risk Management in Laboratories

• Identifying and Mitigating Risks
  • Risk assessment strategies and tools.
  • Developing risk management plans specific to laboratory operations.

Group Activity:

• Participants will develop a risk assessment plan for their laboratory processes, identifying potential hazards and mitigation strategies.

Day 3: Quality Assurance and Continuous Improvement in Pathology Laboratories

Session 9: Quality Control and Quality Assurance

• Implementing QC and QA Programs
  • Importance of quality control measures.
  • Monitoring and evaluating laboratory performance metrics.

Session 10: External Quality Assessment (EQA)

• Participating in EQA Schemes
  • Overview of EQA and its role in laboratory accreditation.
  • Selecting appropriate EQA programs for pathology laboratories.

Session 11: Managing Nonconformities and Corrective Actions

• Addressing Nonconformities
  • Identifying nonconformities in laboratory operations.
  • Developing corrective and preventive action plans (CAPA).

Session 12: Internal Audits and Management Reviews

• Conducting Effective Audits
  • Planning and executing internal audits.
  • Reviewing audit findings and implementing improvements.

Group Activity:

• Participants will role-play as auditors to conduct a mock internal audit of a pathology laboratory, focusing on identifying nonconformities and suggesting corrective actions.

Day 4: Preparing for ISO/IEC 15189 Accreditation and Future Trends

Session 13: Preparing for Accreditation

• Steps to Achieve ISO/IEC 15189 Accreditation
  • Documentation requirements and preparation.
  • Key considerations during the accreditation application process.

Session 14: Accreditation Audit Process

• Understanding the Audit Process
  • What to expect during the accreditation audit.
  • Strategies for effectively managing the audit.

Session 15: Continuous Quality Improvement in Pathology Laboratories

• Future Trends and Innovations
  • Embracing new technologies in laboratory practice.
  • Developing a culture of continuous improvement.

Session 16: Course Review and Action Planning

• Recap of Key Learnings
  • Summary of the major topics covered in the training.
• Personal Action Plans
  • Participants will create action plans for implementing ISO/IEC 15189 standards in their laboratories.

Session 17: Certification of Completion

• Issuing Certificates
  • Participants receive certificates of completion for the training program.
• Networking Opportunities
  • Facilitating networking among participants for future collaboration.

Learning Outcomes:

By the end of this training, participants will:

• Understand the requirements and principles of ISO/IEC 15189.
• Be equipped to implement and maintain a quality management system in pathology laboratories.
• Develop skills in conducting internal audits and managing quality assurance processes.
• Prepare for the accreditation process and effectively address challenges.

Delivery Method:

• Classroom Training: Interactive lectures, discussions, group activities, and case studies.
• Distance Learning: Online lectures, downloadable materials, quizzes, and discussion forums.

Materials Provided:

• Course manual covering ISO/IEC 15189 requirements, implementation strategies, and best practices.
• Templates for document control, risk management, and audit planning.
• Certificate of completion for participants.

This training program aims to provide participants with the advanced knowledge and practical skills needed to achieve and maintain ISO/IEC 15189 accreditation, ensuring high standards of quality and safety in pathology laboratory services.

 

For detail of contents refer our website at www.ukjas.com

 

1. WHO SHOULD ATTEND:

1)   All employees whose work responsibility directly affects ISO/IEC 15189 ACCREN FOR PATHOLOGY LABORATORY TECHNICADITATIOL 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) Registration Schemes of ISO/IEC 15189 ACCREN FOR PATHOLOGY LABORATORY TECHNICADITATIOL SERVICES

4)   Management Representatives responsible for effective implementation and execution of ISO/IEC 15189 ACCREN FOR PATHOLOGY LABORATORY TECHNICADITATIOL 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 UKJAS Offices. UKJAS 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:

Four days Advance Training program for ISO/IEC 15189 ACCREN FOR PATHOLOGY LABORATORY TECHNICADITATIOL SERVICES [Timings: 10.00 am to 6.00 pm]

 

FEES:

 

1. 4 Days Advance Training program of ISO/IEC 15189 ACCREN FOR PATHOLOGY LABORATORY TECHNICADITATIOL SERVICES and any other program is Rs 18000+18%GST Payment should be made by Cheque / DD in favor of “UKJAS Accreditation Pvt Ltd, Mumbai