ISO 13485:2016 Internal Auditor
Building on knowledge acquired through previous training in the requirements of ISO 13485:2016, this course delivers the practical knowledge required to conduct internal audits of an ISO 13485:2016 Quality Management System.
A review of ISO 13485:2016 to ensure thorough and common understanding of the new requirements is followed by information on how to conduct audits in accordance with the ISO 9000 series of standards:
- ISO 19011:2018 – “Guidelines for Auditing Management Systems”, and
- “Guidance on the Concept and Use of the Process Approach for Management Systems”.
Through a balance of formal presentations, case studies, simulation of audit activities and group activities, participants will learn the necessary elements to perform a quality audit.
Who Should Take It
Individuals with responsibility for management, operation, implementation or maintenance of an ISO 13485:2016 QMS. This includes, but is not limited to:
- Those responsible for implementing (or transitioning) their organization’s QMS to meet the ISO 13485:2016 requirements.
- Senior Management
- ISO Coordinators, Quality Managers & Management Representatives
- Members of the Quality Team and/or Internal Audit Team
- ISO 13485 Auditors, Quality Professionals and Consultants
- Become familiar with the standard’s requirements (review of each section and its requirements).
- Appreciate the roles and responsibilities of the Auditor.
- Understand the basic skills and principles of auditing.
- Apply the concepts and guidelines detailed in ISO 19011:2018 when performing an audit.
- Learn the different methods of gathering evidence.
- Practice all phases of an internal audit (using checklists, recording evidence, writing reports, etc.).
- Develop the communication skills, leadership skills and attitudes required to perform internal audits.
Attendees should already be familiar with the ISO 13485:2016 standard and its requirements for medical device quality management systems. “Understanding & Implementing ISO 13485:2016” or equivalent training is strongly recommended as a prerequisite.
Public Course Dates
On-site group training is delivered at your place of business and can be customized to meet your specific requirements. Contact The Business Resource Centre to schedule your next on-site group training event.
Please call 1-888-535-1401 or fill out the form below to request a quote.
Public training is available for this course. Locations and dates can be found using the form below. Please fill out and submit the form to register for this course.
Online training is available for this course. Please fill out and submit the form to register for this course.