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ISO 19011 ACCREDITATION FOR COMPETENT PERSON REGISTRATION TECHNICAL SERVICES

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2 DAYS TRAINING PROGRAMME

CLASSROOM & DISTANCE LEARNING COURSE

ISO 19011 ACCREDITATION FOR COMPETENT PERSON REGISTRATION TECHNICAL SERVICES

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

IAF-AB organizing Two Days Training Programme Classroom & online Training course for ISO 19011 Accreditation For Competent Person registration Technical Services series management system.

    1.INTRODUCTION ON ISO 19011

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 19011 Accreditation For Competent Person registration 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 19011 Accreditation For Competent Person registration 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.

  2.OBJECTIVE OF THE COURSE ON ISO 19011

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 19011 Accreditation For Competent Person registration 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 19011 Accreditation For Competent Person registration 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.

 3. COURSE CONTENTS:

  • Introduction to ISO 19011 Accreditation For Competent Person registration Technical Services Management System
  •  Vocabulary & understanding definitions
  •  Introduction to ISO 19011 Accreditation For Competent Person registration 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 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.

write course content 2 DAYS TRAINING PROGRAMME CLASSROOM & DISTANCE LEARNING COURSE ISO 19011 ACCREDITATION FOR COMPETENT PERSON REGISTRATION TECHNICAL SERVICES

Here’s a detailed course content outline for a 2-Day Training Programme on ISO 19011 Accreditation for Competent Person Registration Technical Services. This course is suitable for both classroom and distance learning formats.

Course Title:

ISO 19011 Accreditation for Competent Person Registration Technical Services Training

Duration:

2 Days

Target Audience:

  • Quality managers and auditors
  • Personnel involved in the registration and accreditation of competent persons
  • Professionals in technical services and compliance
  • Regulatory and assessment bodies

Day 1: Introduction to ISO 19011 and Competent Person Registration

Session 1: Overview of ISO 19011

  • Introduction to ISO 19011
    • Purpose and importance in management systems auditing
    • Historical context and development of the standard
  • Key principles of auditing and the role of ISO 19011 in accreditation

Session 2: Understanding Competent Person Registration

  • Definition and scope of competent person registration
  • Importance of competency in technical services and its impact on quality
  • Overview of the types of competent persons and relevant sectors

Session 3: Requirements for Competent Person Registration under ISO 19011

  • Accreditation requirements specific to competent person registration
  • Documentation and record-keeping needs for compliance
  • Role of quality management systems (QMS) in registration processes

Session 4: Implementing Quality Management in Competent Person Registration

  • Key elements of QMS relevant to competent person registration
  • Establishing standard operating procedures (SOPs) for registration
  • Risk management strategies in competent person registration processes

Group Activity:

  • Participants will engage in a group exercise to analyze a case study of a competent person registration body, identifying gaps and areas for improvement related to ISO 19011 standards.

Day 2: Practical Applications and Continuous Improvement

Session 5: Competence and Training for Auditors

  • Training requirements for personnel involved in audits and registration processes
  • Assessing and ensuring the competence of auditors and registrars
  • Continuous professional development in audit practices

Session 6: Conducting Audits for Competent Person Registration

  • Best practices for conducting audits under ISO 19011
  • Techniques for effective auditing and assessment
  • Quality control and assurance measures in auditing

Session 7: Case Studies of Successful ISO 19011 Accreditation

  • Real-world examples of organizations that have successfully implemented ISO 19011 for competent person registration
  • Discussion of challenges faced and solutions implemented
  • Strategies for maintaining accreditation and ensuring continuous improvement

Session 8: Future Trends in Competent Person Registration and Accreditation

  • Emerging trends and technologies in auditing and registration
  • The evolving landscape of regulations and standards affecting competent person registration
  • Preparing for future changes in ISO 19011 and its application in technical services

Group Activity:

  • Teams will develop a mock audit plan for a competent person registration body, outlining key steps and considerations for compliance with ISO 19011.

Closing Session:

  • Q&A session to address participant queries and concerns
  • Discussion on the importance of ongoing education and training in ISO 19011 compliance
  • Feedback collection from participants on the training programme

Learning Outcomes:

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

  • Understand the principles and requirements of ISO 19011 in the context of competent person registration.
  • Implement a quality management system tailored for registration processes.
  • Conduct effective audits and assessments to ensure compliance with ISO standards.
  • Recognize future trends and innovations that may impact competent person registration and auditing practices.

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 is designed to equip participants with the knowledge and skills necessary to enhance the quality and integrity of competent person registration through ISO 19011 accreditation practices.

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

   4. WHO SHOULD ATTEND:

1)   All employees whose work responsibility directly affects ISO 19011 Accreditation For Competent Person registration 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 19011 Accreditation For Competent Person registration Technical Services.

4)   Management Representatives responsible for effective implementation and execution of ISO 19011 Accreditation For Competent Person registration 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.

     2. COURSE DETAILS:

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

      3. DURATION:

Two days Training program for ISO 19011 Accreditation For Competent Person registration Technical Services [Timings: 10.00 am to 6.00 pm]

FEES:

  1. 2 Days Training program of ISO 19011 Accreditation For Competent Person registration Technical Services is Rs 10500+18%GST

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

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