ISO 13485:2016 Internal Auditor Exemplar Global Recognized (3-Day)
Learn how to interpret the 13485 Standard and apply it to your own organization. This course prepares you to perform effective audits of Medical Device Quality Management Systems. This training is taught in conjunction with Omnex, who is an Exemplar Global Certified provider.
This 3-day course has been developed to satisfy the Exemplar Global MD, AU and TL Examination Profiles and, as such, all 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.
This seminar fully covers the ISO 13485:2016 requirements. Auditing topics from ISO 19011 such as the auditing process and methodologies, e. g. planning and conducting an audit, writing nonconformity statements, preparing an audit summary and report, and verifying corrective actions are also covered with a focus on ISO 45001:2018. Auditing case studies to develop skills for identifying nonconformities will be used.
Within the 3-Day ISO 13485 Internal Auditor training, you'll learn to:
- Quality management principles
- Standards and guidelines
- Interpretation of the latest revision ISO 9001 and ISO 13485
- FDA 21 CFR 820
- Introduction to quality audit
- Managing the audit process
- Audit scheduling and preparation
- Performing and Reporting the audit
- Corrective action and follow-up
- Professionals from FDA regulated industries
- Quality professionals
- ISO Managers/Management Reps
- Internal Auditors
- Process owners
- Systems professionals
- Improvement Specialists
- Buyers in FDA regulated industries
- Leaders/managers/professionals in the Medical Device industry
An understanding of the ISO 13485:2016 requirements and a minimum 12 months of work experience in applying or auditing quality management systems is recommended. The first 1.5 and 3 days of this class are offered separately for those new to auditing or quality management.
- Introduction to ISO 13485
- The ISO 13485 Standard Explained
- MD Written Exercise 1
- Overview of ISO 13485:2016 Requirements
- MD Written Exercises 2a, 2b (Audit Scenarios)
- Overview of ISO 13485:2016 Requirements (cont’d)
- MD Written Exercise 2c (Audit Scenarios)
- MD Written Exercise 3c
- Introduction to Management System Audit Trails
- Management of Audit Programs
- Management System Audit Planning and Preparation
- Breakout Exercise 1: Writing an Objective and Scope Statement
- Breakout Exercise 2: Documentation Review
- Breakout Exercise 3: Creating an Audit Plan
- Performing the Audit
- Breakout Exercise 4: Performing an Audit
- Writing Nonconformity Statements
- Breakout Exercise 5: Writing Nonconformity Statements
- Closing Meeting
- Completing the Audit Report Corrective Action and Closeout
- Management Systems Auditing Exam