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 5 Days Lead Auditor 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 5 Days Lead Auditor 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 70% passing marks.

 

Day 1: Introduction to ISO/IEC 15189 and Auditing Principles

• Session 1: Overview of ISO/IEC 15189
  • Purpose and importance of ISO/IEC 15189 in pathology laboratories
  • Key concepts of quality management systems in medical laboratories
  • Scope and application of ISO/IEC 15189
• Session 2: Structure of ISO/IEC 15189
  • Understanding the clauses and sub-clauses of the standard
  • Specific requirements related to management and technical operations
  • Documentation requirements and record-keeping practices
• Session 3: Auditing Principles and the Role of the Auditor
  • Overview of the fundamental principles of auditing (integrity, objectivity, confidentiality, competence)
  • Types of audits relevant to ISO/IEC 15189
  • The role and responsibilities of the lead auditor in a pathology laboratory
• Workshop:
  • Group discussion on the significance of quality in pathology services

Day 2: ISO/IEC 15189 Requirements and Implementation

• Session 1: Quality Management System Requirements
  • Developing a quality management system tailored for pathology laboratories
  • Key processes and policies for effective quality management
  • Importance of customer focus in laboratory services
• Session 2: Pre-Examination, Examination, and Post-Examination Processes
  • Overview of pre-examination processes (specimen collection, handling, and transportation)
  • Examination processes (testing methods, equipment calibration, and validation)
  • Post-examination processes (reporting, communication, and records management)
• Session 3: Competence and Training of Personnel
  • Importance of competency assessment and ongoing training
  • Strategies for evaluating staff performance and training needs
  • Ensuring compliance with training and competency requirements in laboratories
• Workshop:
  • Case studies on competency assessment in pathology laboratories

Day 3: Audit Planning and Conducting the Audit

• Session 1: Audit Planning for Pathology Laboratories
  • Steps to develop an audit plan in accordance with ISO/IEC 15189
  • Defining audit scope, objectives, and criteria
  • Developing checklists and tools for auditing laboratory practices
• Session 2: Conducting the Audit
  • Detailed steps in the audit process (opening meeting, evidence collection, closing meeting)
  • Techniques for interviews and observations in laboratory settings
  • Collecting and evaluating evidence against ISO/IEC 15189 requirements
• Session 3: Identifying and Documenting Non-Conformities
  • Understanding non-conformities and their significance in laboratories
  • Procedures for documenting and reporting findings effectively
  • Strategies for addressing non-conformities in laboratory processes
• Workshop:
  • Role-play exercises to practice conducting audits in laboratory scenarios

Day 4: Reporting, Follow-Up, and Continuous Improvement

• Session 1: Audit Reporting
  • Components of an effective audit report
  • Communicating findings and recommendations to management and staff
  • Importance of clear and actionable reporting in pathology laboratories
• Session 2: Follow-Up Procedures
  • Procedures for monitoring corrective actions and improvements
  • Evaluating the effectiveness of corrective actions taken
  • Importance of follow-up audits in maintaining compliance
• Session 3: Continuous Improvement in Pathology Laboratories
  • Strategies for fostering a culture of continuous improvement
  • Tools for identifying opportunities for improvement in laboratory practices
  • Integrating audit findings into the continuous improvement process
• Workshop:
  • Group activity to develop a continuous improvement plan based on hypothetical audit findings

Day 5: Practical Application and Certification

• Session 1: Best Practices and Case Studies
  • Review of successful implementations of ISO/IEC 15189 in various pathology laboratories
  • Discussion on challenges faced in achieving and maintaining accreditation
• Session 2: Mock Audits
  • Conducting mock audits in small groups using prepared laboratory scenarios
  • Peer feedback and discussion on audit findings and improvement suggestions
• Session 3: Examination and Certification
  • Written examination to assess understanding of course content
  • Feedback session to discuss exam results and clarify doubts
  • Issuance of certificates for successful participants

Additional Notes:

• Materials Provided:
  • Course handbook and reference materials
  • Copies of ISO/IEC 15189 standard
  • Access to online resources, templates, and discussion forums
• Assessment:
  • Continuous assessment through participation in workshops and group activities
  • Final examination to evaluate understanding of course content

Target Audience:

• Laboratory managers, quality managers, technical staff, and individuals involved in the accreditation of pathology laboratories.

 

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:

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

 

FEES:

 

1. 5 Days Lead Auditor Training program of ISO/IEC 15189 ACCREN FOR PATHOLOGY LABORATORY TECHNICADITATIOL SERVICES and any other program is Rs 25000+18%GST  Payment should be made by Cheque / DD in favor of “UKJAS Accreditation Pvt Ltd, Mumbai