ISO 13485:2016 Medical Devices Lead Auditor Course - North America

Learn how to lead an audit to the ISO 13485 Medical Devices standard.

Duration: 4 Days | Cost: $2195 USD | CEUs: 3.6




This course provides 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. It meets the training requirements for the Exemplar Global (TPECS) Auditor Certification Program, Competency Units MD, AU and TL.

Upcoming Classes

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SAI Global is an Exemplar Global certified TPECS provider. This course meets the knowledge examination requirements of the Medical Device (MD) certification scheme. Attendees who successfully demonstrate competence during this course will receive a Certificate of Attainment for the following knowledge competency units:

Exemplar Global - MD - Medical Device Management Systems

Exemplar Global - AU - Management systems auditing

Exemplar Global - TL - Leading management systems audit teams
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
Studying the current published version of ISO 13485 prior to attending this course is recommended
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