Omnex is an Exemplar Global Certified TPECS provider for Exemplar Global-MD and Exemplar Global-AU Competency Units. This seminar fully covers the ISO 13485:2016 requirements. Other topics include audit systems, the auditing process and audit instruments; the documentation process, conducting an audit, writing the audit report, and taking corrective action. Auditing case studies will be used to develop the required auditing skills based on ISO 19011.
This class also covers the comparable 21 CFR 820 content for additional guidance for organizations in the Medical Device sector.
Attendees who successfully pass the exams during this course will achieve a Certificate
of Attainment for the following competency units:
- Exemplar Global-MD
- Exemplar Global-AU
Who Should Attend
This seminar is designed for Management Representatives, ISO 13485:2016 Implementation Teams, Internal Auditors and others who would like learn the widely-used international auditing process for management systems based on ISO 19011.
Recommended Training and/or Experience
An understanding of the ISO 13485:2016 requirements and a minimum 6 months of work experience in applying or auditing quality management systems is recommended. The first 1.5 days of this class are offered separately for those new to auditing or quality management.
Each participant will receive a seminar manual and a breakout workbook that includes
auditing case studies.
- Understand the application of Quality Management Principles in the context of ISO
- Relate the quality management system to the organization’s medical devices, and
provision of related services.
- Understand the application of the principles, procedures and techniques of management systems auditing.
- Understand the conduct of an effective audit in the context of the auditee’s organizational
- Understand the application of the regulations, and other considerations that are
relevant to the management system, and the conduct of the audit.
- Practice personal attributes necessary for the effective and efficient conduct of
a management system audit.
- Introduction and Welcome
- Chapter 1 – Introduction to ISO 13485
- Chapter 2 – The ISO 13485 Standard Explained
- MD Written Exercise 1 (individual
- Chapter 3 – Overview of ISO 13485:2016 Requirements
- MD Written Exercises 2a, 2b (Audit Scenarios)
- Overview of ISO 13485:2016 Requirements (cont’d)
- Breakout Exercise 2c (Audit Scenarios)
- MD Written Exercise (individual)
- Introduction to Management System Audit Trails
- AU Breakout Exercise 1: Scope and Objectives
- Management of Audit Programs
- Management System Audit Planning and Preparation
- AU Breakout Exercise 2: Documentation Review
- AU Breakout Exercise 3: Audit Plan
- Performing the Audit
- AU Breakout Exercise 4: Conducting the Audit
- Writing Nonconformity Statements
- AU Breakout Exercise 5: Writing Nonconformities
- Closing Meeting
- Completing the Audit Report
- Corrective Action and Closeout
- AU Written Exercise (individual)