Course Outline
Introduction
ISO 13485 Overview
- Purpose and scope of ISO 13485
- Relevance of ISO 13485 within the medical device industry
- Essential terms and definitions
ISO 13485 Framework and Clauses
- Interpreting the structure (Annex SL)
- Summary of primary clauses: 4 through 8
Quality Management Principles
- Process approach and the PDCA (Plan-Do-Check-Act) cycle
- Risk-based thinking applied to medical devices
- Emphasis on customer focus and regulatory obligations
Core Mandates of ISO 13485:2016
- Detailed review of clauses (4 to 8)
- Design and development controls
- Risk management across the product lifecycle
- Management of documents and records
Implementation and Sustainment of ISO 13485 QMS
- Procedure for establishing an ISO 13485-compliant QMS
- Personnel training and competency standards
- Process monitoring and measurement
Auditing and Certification Procedures
- Basics of internal and external audits
- Certification preparation: key expectations
- Handling non-conformities and corrective actions
Conclusion and Future Actions
Requirements
- Familiarity with core quality management concepts
Target Audience
- Quality managers
- Quality engineers
- Auditors and regulatory compliance personnel
Testimonials (5)
Theory followed by practical examples and exercices. Job well done!
Vincenzo Delle Donne - Department of National Defence
Course - ISO 37301 Compliance Management System
the expertise & knowledge of the trainer
Erica DeRosa DeRosa - Aecon Group INc.
Course - ISO 37001 Anti-Bribery Management System
With both my 2022 ISO 9001 audit prep-related training & the recently completed ISO 9001 audit prep refresher course; Dereck has helped me significantly with regards to gaining a new & practical perspective of the ISO 9001:2015 clauses & sections & how they apply to our business. Dereck has also helped me with both training courses --- to improve my ISO-related communications both with our company's employees and the external ISO Auditors .
Dana Foster - Corrigan Oil Company
Course - ISO 9001 Foundation
The quizzes to reinforce the reading and the ability to ask questions at any time
Jonathan
Course - ISO 9001 Lead Auditor
Speed of response and communication