Conducting and Leading Medical Devices Management Systems Audits

SAI Global
Training overview
Professional Course
2 days

Course description

Conducting and Leading Medical Devices Management Systems Audits

This course is designed for people who need to conduct external audits of medical devices quality management systems or lead audits on behalf of their organization. Typically, professionals who:

  • Need to develop their knowledge and skills to lead internal audits of their organization?s management systems
  • Want to obtain a formal qualification relating to the auditing discipline
  • Are Quality Managers, Engineers, and Consultants
  • Want to become a Certified Lead Auditor through their relevant certifying body such as Exemplar Global
  • Want to lead their organization to ISO 13485 certification
  • May also be useful for those implementing a medical devices quality management system in their organization

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Training content

  • Understand Auditing Principles and Practices as described in ISO 19011
  • How to manage an audit program including the scope, objectives and criteria for the audit, and selecting an appropriate audit team
  • Perform all aspects of a management systems audit in accordance with ISO 19011, from preparation through to conducting follow-up
  • Evaluate evidence collected during the audit and prepare reports of conformity and nonconformity to the audit criteria, including writing a formal audit report
  • Practice effective team leadership and communication skills
  • Throughout the course a series of activities will provide the opportunity for attendees to demonstrate the knowledge they have gained. The course uses a detailed medical devices case study to conduct the practical in-class activities

Costs

Costs may vary by location. Request information to learn more.

About SAI Global

sai global

SAI Global

At SAI Global, we understand the challenges of building stakeholder trust and confidence for companies at all stages of maturity. We work with organizations to help them meet stakeholder expectations for quality, safety, sustainability, integrity and desirability in any market...


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