ISO 13485:2016 Internal Assessor Workshop
Course Description
Three-day (24-hour course) designed to provide participants with auditing skills to ISO 13485:2016. Highly interactive session limited to 18 attendees. Session is based on the guidelines provided by ISO 19011:2018 (Guideline standard for internal auditing).
Audience
Quality professionals, supervisors/managers, engineers, senior technicians. Attendees will utilize both analytical and communication skills.
What the Attendees Walk Away With:
- Comprehensive ISO 13485:2016 Workbook
- ISO 13485:2016 Internal Auditor Certificate (after completing the course and passing the exam).
Course Outline:
Overview of ISO 13485 and Quality Management Medical System Standards
- Class objectives
- History of Quality Management Standards (Medical Standards focus)
- Quality Management System Terms and Vocabulary
Understanding ISO 13485:2016
- Risk based approach and Process Orientation
- Philosophy and Principles with ISO 13485
- History of the ISO 13485 Standard
- Documentation pyramid
- Good documentation practices
Interpreting ISO 13485:2016
- Element Analysis Exercise
- Element by Element Review including
- Element key points and intent
- What to look for during an audit
- Who is audited
- Role plays of audit scenarios
Audit Process
- Audit Preparation Activities, Including:
- Documentation Review
- Reviewing Previous Audit History
- Creation of Element Application Matrix
- Creating the Audit Checklist
- Audit Performance Activities, Including:
- Providing Introductions
- Framing Questions
- Recording Objective Evidence
- Forward and Backward Audits
- Audit Report Writing Activities, Including:
- Creating the Audit Report
- Presenting Findings
- Follow-up Activities
Auditor Skills
- Audit Responsibilities
- Role of Lead Auditor
- Being a participative auditor
- Remote audits (methodologies and applicability)
- Communication Skills and Conflict Resolution
- Do’s and Don’ts During the Audit
- Audit Interaction Role Plays
Presentation of Final Exam