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ISO 13485:2016 Medical Devices Lead Auditor
- To provide an in-depth review of the requirements of the ISO 13485:2016 standard and how they are applied in the context of an audit
- To provide participants with the necessary knowledge and skills to lead audit teams in auditing medical devices management systems in accordance with the guidelines outlined in ISO 19011
- To meet the training requirements for the Exemplar Global (TPECS) Auditor Certification Program, Competency Units MD, AU and TL
Who should attend?
- Individuals who want to obtain a formal qualification in the application of Medical Devices to add to their auditing experience
- Individuals leading their companies to ISO 13485 certification
- Individuals who want to lead internal audits or become Third-Party Auditors
- Business Managers, Quality Managers, Engineers, Compliance Officers, and Consultants
- Individuals who want to become a Certified Medical Device Quality Management Systems Auditor through their relevant certifying body such as Exemplar Global
- May also be useful for those implementing a medical devices quality management system in their organization
- Understand the intent and requirements of the ISO 13485:2016 Standard in the context of a quality management system audit
- Understand the relationship between the applicable regulatory requirements and ISO 13485
- Explain the concepts of the process approach, Plan-Do-Check-Act, process-based activities and associated inputs, outputs, controls, and resources
- Understand how to evaluate the effectiveness of an entire quality management system, including process, customer focus and improvement to meet regulatory requirements
- Evaluate, using risk-based thinking, the effectiveness of an entire quality management system as applied to medical devices
- 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
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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