Improve your experience. We are very sorry but this website does not support Internet Explorer. We recommend using a different browser that is supported such as Google Chrome or Mozilla Firefox.

ISO 13485 Lead Auditor

ISO 13485 Lead Auditor training enables you to develop the necessary expertise to perform a Medical Devices Quality Management System (MDQMS) audit by applying widely recognized audit principles, procedures, and techniques.

Description

 

During this training course, you will acquire the knowledge and skills to plan and carry out internal and external audits in compliance with ISO 19011 and ISO/IEC 17021-1 certification process.

Based on practical exercises, you will be able to master audit techniques and become competent to manage an audit program, audit team, communication with customers, and conflict resolution.

After acquiring the necessary expertise to perform this audit, you can sit for the exam and apply for a “PECB Certified ISO 13485 Lead Auditor” credential. By holding a PECB Lead Auditor Certificate, you will demonstrate that you have the capabilities and competencies to audit organizations based on best practices.

About This Course

 

Learning Objectives

 

  • Understand the operations of a Medical Devices Quality Management System based on ISO 13485
  • Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks
  • Understand an auditor’s role to: plan, lead and follow-up on a management system audit in accordance with ISO 19011
  • Learn how to lead an audit and audit team
  • Learn how to interpret the requirements of ISO 13485 in the context of a MDQMS audit
  • Acquire the competencies of an auditor to: plan an audit, lead an audit, draft reports, and follow-up on an audit in compliance with ISO 19011

 

Course Agenda

 

  • Day 1: Introduction to Medical Devices Quality Management Systems (MDQMS) and ISO 13485
  • Day 2: Audit principles, preparation and launching of an audit
  • Day 3: On-site audit activities 
  • Day 4Closing the audit

 

Assessment

 

The “PECB Certified ISO 13485 Lead Auditor” exam fully meets the requirements of the PECB Examination and Certification Programme (ECP). The exam covers the following competency domains: 

  • Domain 1: Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)
  • Domain 2: Medical Devices Quality Management System (MDQMS)
  • Domain 3: Fundamental audit concepts and principles
  • Domain 4: Preparation of an ISO 13485 audit
  • Domain 5: Conducting an ISO 13485 audit
  • Domain 6: Closing an ISO 13485 audit
  • Domain 7: Managing an ISO 13485 audit program 

For specific information about exam type, languages available, and other details, please visit the List of PECB Exams and the Examination Rules and Policies.

Prerequisites

 

A fundamental understanding of ISO 13485 and comprehensive knowledge of audit principles.

What's Included?

 

  • Certification fees are included on the exam price
  • Training material containing over 450 pages of information and practical examples will be distributed
  • An attestation of course completion worth 31 CPD (Continuing Professional Development) credits will be issued to the participants who have attended the training course.
  • In case of exam failure, you can retake the exam within 12 months for free

Who Should Attend?

 

  • Auditors seeking to perform and lead Medical Devices Quality Management System (MDQMS) certification audits 
  • Managers or consultants seeking to master a Medical Devices Quality Management System audit process
  • Individuals responsible for maintaining conformance with Medical Devices Quality Management System requirements
  • Technical experts seeking to prepare for a Medical Devices Quality Management System audit
  • Expert advisors in Medical Devices Quality Management

Similar courses

ISO 9001Foundation

PECB's Official ISO 9001 Foundation Training Course

More Information
ISO 9001 Lead Implementer

PECB's Official ISO 9001 Lead Implementer Training Course

More Information
ISO 9001 Lead Auditor

PECB's Official ISO 9001 Lead Auditor Training Course

More Information
ISO 13485 Quality Management Foundation

ISO 13485 determines the requirements for the medical devices industry. This standard was established to be used by companies during the life cycle of medical devices, from the production to post-production, including decommission and disposal.

More Information
ISO 13485 Lead Implementer

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.

More Information

Press enter to see more results