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ISO 13485 Training

Lead Implementer

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ISO 13485 Medical Devices Quality Management System Training Course

ISO 13485 Lead Implementer

Designed to develop expertise to support an organization in establishing and maintaining a Medical Devices Quality Management System (MDQMS).

5 Days

LENGTH

31
CE/PDU
CREDITS

REGISTER

Master the implementation and management of Medical Devices Quality Management System (MDQMS) based on ISO 13485

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Why should you attend?
ISO 13485 Lead Implementer training enables you to develop the necessary expertise to support an organization in establishing, implementing, managing and maintaining a Medical Devices Quality Management System (MDQMS) based on ISO 13485. During this training course, you will also gain a thorough understanding of the best practices of Medical Devices Quality Management Systems and be able to improve an organization`s overall performance by consistently providing safe and qualitative medical devices.

After mastering all the necessary concepts of Medical Devices Quality Management Systems, you can sit for the exam and apply for a "PECB Certified ISO 13485 Lead Implementer" credential. By holding a PECB Lead Implementer Certificate, you will be able to demonstrate that you have the practical knowledge and professional capabilities to implement ISO 13485 in an organization.

Who Should Attend?

  • Managers or consultants involved in Medical Devices Quality Management
  • Expert advisors seeking to master the implementation of a Medical Devices Quality Management System
  • Individuals responsible for maintaining conformance with MDQMS requirements
  • MDQMS team members

COURSE AGENDA

DURATION: 5 DAYS

DAY 1

Introduction to ISO 13485 and initiation of a MDQMS

  • Course objectives and structure
  • Standard and regulatory framework
  • Medical Devices Quality Management System (MDQMS)
  • Fundamental principles of quality and medical devices
  • Initiating the MDQMS implementation

DAY 2

Plan the implementation of a MDQMS

  • Understanding the organization and clarifying the quality objectives
  • Analysis of the existing management system
  • Leadership and approval of the MDQMS project
  • MDQMS scope
  • Quality Policy
  • Definition of the organizational structure

DAY 3

Implementation of a MDQMS

  • Definition of the document management process
  • Design of controls and drafting procedures
  • Communication plan
  • Training and awareness plan
  • Product Realization
  • Operations Management

DAY 4

MDQMS monitoring, measurement, continuous improvement and preparation for a certification audit

  • Monitoring, measurement, analysis and evaluation
  • Internal audit
  • Management review
  • Treatment of problems and non-conformities
  • Improvement
  • Preparing for the certification audit
  • Competence and evaluation of implementers
  • Closing the training

DAY 5

Certification Exam

Learning Objectives

  • Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks
  • Master the concepts, approaches, methods and techniques used for the implementation and effective management of a MDQMS
  • Learn how to interpret the ISO 13485 requirements in the specific context of an organization
  • Learn how to support an organization to effectively plan, implement, manage, monitor and maintain a MDQMS
  • Acquire the expertise to advise an organization in implementing Medical Devices Quality Management System best practices

EXAMINATION

The "PECB Certified ISO 13485 Lead Implementer" exam fully meets the requirements of the PECB Examination and Certification Program (ECP). The exam covers the following competency domains:

1

Domain 1: Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

2

Domain 2: Medical Devices Quality Management System (MDQMS)

3

Domain 3: Planning a MDQMS implementation based on ISO 13485

4

Domain 4: Implementing a MDQMS based on ISO 13485

5

Domain 5: Performance evaluation, monitoring and measurement of a MDQMS based on ISO 13485

6

Domain 6: Continual improvement of a MDQMS based on ISO 13485

7

Domain 7: Preparing for a MDQMS certification audit

CERTIFICATION

Upon the successful completion of the exam, you can apply for the credentials shown on the table below. You will receive a certificate once you comply with all the requirements related to the selected credential.


Credential

PECB Certified ISO 13485 Provisional Implementer

PECB Certified ISO 13485 Implementer

PECB Certified ISO 13485 Lead Implementer

PECB Certified ISO 13485 Senior Lead Implementer

PECB Certified ISO 13485 Master


Exam

PECB Certified ISO 13485 Lead Implementer exam or equivalent

PECB Certified ISO 13485 Lead Implementer exam or equivalent

PECB Certified ISO 13485 Lead Implementer exam or equivalent

PECB Certified ISO 13485 Lead Implementer exam or equivalent

ISO 13485 Lead Implementer + ISO 13485 Lead Auditor (4 additional foundation exams)

Professional
Experience

None


Two years: One year of work experience in Medical Devices Quality Management

Five years: Two years of work experience in Medical Devices Quality Management

Ten years: Seven years of work experience in Medical Devices Quality Management

Fifteen years: Ten years of work experience in Medical Devices Quality Management

SOMS Project
Experience

None


Project activities: a total of 200 hours

Project activities: a total of 300 hours

Project activities: a total of 1,000 hours

Audit activities: 700 hours
Project activities: 700 hours

Other
Requirements

Signing the PECB
code of ethics

Signing the PECB
code of ethics

Signing the PECB
code of ethics

Signing the PECB
code of ethics

Signing the PECB
code of ethics

Note: PECB Certified Individuals who do possess the Lead Implementer and Lead Auditor Credentials are qualified for the respective PECB Master Credential, given they have taken 4 additional Foundation Exams which are related to this scheme. For more detailed information about the Foundation Exams and the overall Master Requirements, please go to the following link: https://pecb.com/en/master-credentials.

GENERAL INFORMATION

  • Certification fees are included in the exam price.
  • Training material containing over 450 pages of information and practical examples will be distributed.
  • A participation certificate of 31 CPD (Continuing Professional Development) credits will be issued.
  • In case of exam failure, you can retake the exam within 12 months for free.

Training Calendar

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SOUTH AFRICA COURSES

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ISO 13485
Lead Implementer

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