ISO 15189 Point-Of-Care Testing (POCT) Accreditation

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 15189 Point-Of-Care Testing (POCT) Accreditation

 

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 15189 Point-Of-Care Testing (POCT) Accreditation or get maximum benefits from an established management system, auditors within the organization have to be trained to assess the system against ISO 15189 Point-Of-Care Testing (POCT) Accreditation 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 15189 Point-Of-Care Testing (POCT) Accreditation 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 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 15189 Point-Of-Care Testing (POCT) Accreditation Vocabulary & understanding definitions
•  Introduction to ISO 15189 Point-Of-Care Testing (POCT) Accreditation Need for Internal Quality Audits
•    Auditing Techniques
•  Conducting Internal Quality Audits
•     Course Examination with minimum 70% passing marks.

 

Day 1: Introduction to ISO 15189 and Quality Management Systems

• Session 1: Overview of ISO 15189
  • Purpose and scope of ISO 15189
  • Importance of accreditation in medical laboratories
  • Differences between ISO 15189 and other ISO standards
• Session 2: Fundamentals of Quality Management Systems (QMS)
  • Key principles of QMS
  • Quality policies and objectives
  • Roles and responsibilities in a QMS
• Session 3: Document Control and Records Management
  • Importance of documentation
  • Procedures for document control
  • Record-keeping requirements
• Workshop:
  • Group activity on developing a quality policy for a POCT laboratory

Day 2: ISO 15189 Requirements for Point-of-Care Testing

• Session 1: Management Requirements
  • Organizational structure and governance
  • Management review and improvement processes
  • Resource management, including staff competence and training
• Session 2: Technical Requirements
  • Pre-analytical, analytical, and post-analytical phases
  • Quality control and assurance in POCT
  • Equipment calibration and maintenance
• Session 3: Risk Management and Patient Safety
  • Identifying and assessing risks in POCT
  • Implementing risk management strategies
  • Patient safety and ethical considerations
• Workshop:
  • Case study analysis of POCT implementation and quality challenges

Day 3: Audit Principles and Techniques

• Session 1: Audit Principles and Types of Audits
  • Overview of auditing principles
  • Different types of audits: internal, external, and compliance audits
• Session 2: Planning and Conducting an Audit
  • Audit planning and preparation
  • Developing audit checklists and plans
  • Communication skills for auditors
• Session 3: Evidence Collection and Evaluation
  • Techniques for effective evidence collection
  • Evaluating compliance with ISO 15189 requirements
  • Identifying non-conformities and areas for improvement
• Workshop:
  • Role-play exercise on conducting an audit interview

Day 4: Reporting and Follow-Up

• Session 1: Reporting Audit Findings
  • Structure of an audit report
  • Best practices for reporting non-conformities
  • Recommendations for corrective actions
• Session 2: Follow-Up Procedures
  • Importance of follow-up in the audit process
  • Monitoring corrective actions and improvements
  • Maintaining communication with relevant stakeholders
• Session 3: Continuous Improvement and Quality Culture
  • Tools for continuous improvement in POCT
  • Promoting a culture of quality and compliance
  • Leadership’s role in sustaining quality
• Workshop:
  • Group discussion on strategies for fostering a quality culture in a POCT environment

Day 5: Practical Application and Examination

• Session 1: Case Studies and Best Practices
  • Review of successful POCT accreditation case studies
  • Lessons learned and best practices in auditing POCT laboratories
• Session 2: Mock Audits
  • Conducting mock audits in small groups
  • Role-playing different audit scenarios
• Session 3: Examination and Certification
  • Written examination on course content
  • Feedback session and discussion
  • Certification of completion for participants

Additional Notes:

• Materials Provided:
  • Course handbook
  • ISO 15189 standard copies
  • Access to online resources and forums
• Assessment:
  • Continuous assessment through participation in workshops and discussions
  • Final examination to evaluate understanding of course content

Target Audience:

• Auditors, laboratory managers, quality assurance personnel, and anyone involved in POCT accreditation processes.

 

For detail of contents refer our website at www.UKJAS.in

 

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) 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 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 15189 Point-Of-Care Testing (POCT) Accreditation [Timings: 10.00 am to 6.00 pm]

 

FEES:

 

1. 5 Days Lead Auditor Training  program of ISO 15189 Point-Of-Care Testing (POCT) Accreditation and any other program is Rs 25000+18%GST Payment should be made by Cheque / DD in favor of “UKJAS Accreditation Pvt.Ltd, Mumbai