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

This 3 day course is designed to provide participants with the knowledge and skills required to perform an internal audit of a quality management system based on ISO 13485.

Duration: 3 Days | Cost: $1395 USD | CEUs: 2.4




This course will provide a hands-on approach to planning, conducting and reporting on internal audits in accordance with ISO 19011 and meets the training requirements for Exemplar Global (TPECS) Auditor Certification for Quality Auditors.

SAI Global is an Exemplar Global certified TPECS provider. This course meets the knowledge examination requirements of the Medical Devices Quality Management Systems (MD) certification scheme. Learn the necessary skills and activities required to successfully perform effective internal audits of your organization's quality management system against ISO 13485:2016 Medical Devices. This highly participative course is presented by SAI Global's instructors, each of whom have decades of experience in the medical devices industry and extensive experience conducting and leading audits in FDA regulated industries. This course is based on quality management systems ISO 9001 and ISO 13485.

Upcoming Classes

Start DateEnd DateLocation 
No classes scheduled
 
At the end of the course, participants will have obtained a sound appreciation of:

Explain the purpose of a Quality Management System

Explain the purpose of the ISO 9000 Standards

Explain the audit process plan, conduct, report and follow-up in accordance with ISO 19011

Undertake an audit of a Quality Management System against the requirements of the ISO 13485 Standard
Module 1: Quality Management Systems

Module 2: Audit Fundamentals

Module 3: ISO 13485:2016 Standard

Module 4: Managing an Audit Program

Module 5: Audit Planning and Preparation

Module 6: Conducting Audit Activities

Module 7: Preparing and Distributing the Audit Report

Module 8: Completing the Audit and Conducting Follow-up
Quality coordinators/QMS management representatives

Quality professionals

Any personnel who will act as internal auditors
Before starting this course, it would be an advantage for participants to understand some of the quality management principles and concepts:

The process approach used in quality management

The Model of a Process Based Quality Management System

The Plan, Do, Check, Act (PDCA) cycle

The relationship between quality management and customer satisfaction

Commonly used quality management terms and definitions and the 7 Quality Principles as given in ISO 9000
SAI Global is an Exemplar Global certified TPECS provider. This course meets the knowledge examination requirements of the Medical Devices Quality Management Systems (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 Devices Quality Management Systems

Exemplar Global - AU - Management systems auditing

Please note: Additional experience/qualification requirements must be met to achieve certification as an auditor. These are provided through Exemplar Global. Additional information can be found at exemplarglobal.org.