ISO 13485:2016 Internal Auditor
This course is certified by Exemplar Global.
This course is intended to help you to understand ISO 13485:2016 and to conduct internal audits. Through examples, exercises, and a final exam, you will be familiar how this standard applies to the life-cycle of a medical device. The course covers the entire standard ISO13485:2016, and participants will learn about audit techniques, including behavior as well as questions and approaches for different clauses and requirements. Explanations of the necessary audit tasks and appropriate treatment of the nonconformities are an integral part of the training.
- Learning to plan, conduct, and report the audit in accordance with the ISO 13485:2016 standard
- How to prepare audit reports
- The roles and responsibilities of an internal auditor an internal auditor in keeping medical devices safe
This course is designed for every employee who can perform internal audits under the scope of ISO 13485:2016, including medical device manufacturers and vendor personnel who will be involved in the launch of management systems or updating of the current management system, quality management officers (QMOs), product managers, consultants in the medical device industry.
ISO 13485:2016 Management System Implementation
- Risk Management: Identify hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of these controls.
- Risk Management Process: Risk Analysis, Risk Evaluation, Risk Control, Production and Post-Production Information.
- Risk Analysis & Preliminary Hazard Analysis
- Risk Control
- Validation/Packaging Validation
- Production
- Device History Record
Auditing Concepts and Principles
- Roles and responsibility of Auditors
- Planning an internal audit part 1
- Audit plan and Checklists
- Initiating the audit
- Collecting objective/audit evidence
- Effective interviewing techniques
- Identifying and recording nonconformities
- Conducting the closing meeting
- Preparing and distributing the audit report
- Corrective and preventive actions
- Follow up scheduling
- Monitoring corrective actions
- Conducting an audit
- Reporting audit results
- Corrective actions and follow-ups
- Examination
At TÜV SÜD Academy we agree with Dr. Eamonn Hoxey, Chair of ISO technical committee ISO/TC 210, Quality management and corresponding general aspects for medical devices, the patient comes first.
ISO 13485:2016 is the management system that governs medical devices, the management system upon which compliance with regulatory and customer compliance can be built. It embodies an agreed upon, repeatable way of managing production, validation, quality, and risk management.
At the heart of ISO 13485:2016 is a comprehensive risk management process meant to be implemented in all medical device-related quality management processes within an organization, including processes that occur after the medical devices are placed on the market.
This two-day course, conducted by our experienced TÜV SÜD Academy instructors, will introduce students to the requirements of ISO 13485:2016 and will explain in detail how to integrate the requirements into quality management systems. Students will be equipped with the knowledge and skills needed to plan and conduct effective internal audits.
This online course is designed to illustrate how organizations can benefit from becoming skilled in integrating this standard into their processes. By learning how to audit your processes, you signal to your customers that you take quality and customer needs seriously.
TÜV SÜD has achieved Exemplar Global Accreditation as a Recognized Training Provider. This accreditation confirms our commitment to providing the highest quality services and demonstrates our expertise in our industry.
As a professional, it's important to have recognition for your skills and knowledge. Exemplar Global Accreditation provides this recognition, giving you a competitive edge in the marketplace. With over 30 years of experience building certification programs, Exemplar Global is the leading authority in accreditation for the conformity community.
As a student of an Exemplar Global Recognized Training Provider (RTP) course, you are eligible to receive:
- Access to Exemplar LINK
- 12-months of exclusive benefits including:
- One self-coaching assessment
- Extended learning content
- Complimentary access to online events, online magazine, newsletters, and low-cost professional liability insurance
- Access to an exclusive LinkedIn Community
- The chance to look into alternatives for employment and career advancement
- A TÜV SÜD / Exemplar Global Graduate Certificate
At TÜV SÜD, we believe in maximizing your career and providing you with the tools you need to succeed. Our Exemplar Global Accreditation is a testament to our commitment to excellence and our commitment to helping you succeed.
Learn more about TÜV SÜD's Exemplar Global Accreditation today
- Instructor-led in a virtual classroom
- Course delivered by one of TÜV SÜD's leading industry experts
- Small class sizes enhance trainer-delegate relationship
- Receive globally recognised TÜV SÜD certificate upon completion
Learners must obtain a copyof the ISO standard to be referenced during the course. The standard may bepurchased through the American National Standards Institute (ANSI) (www.ansi.org) and/or American Society for Quality (ASQ) (www.asq.org).
We can also offer this training as in-house training courses onsite in your company