Course Outline
Introduction
Overview of ISO 13485
- Stated objectives and applicable scope of ISO 13485
- Significance of ISO 13485 within the medical device sector
- Essential terminology and defined concepts
Architectural Framework and Clauses of ISO 13485
- Interpretation of the Harmonized Structure (Annex SL)
- Summary of core requirements: Clauses 4 through 8
Core Quality Management Principles
- Process approach and the Plan-Do-Check-Act (PDCA) cycle
- Application of risk-based thinking in medical device contexts
- Emphasis on customer orientation and adherence to regulatory mandates
Principal Requirements of ISO 13485:2016
- Detailed examination of clauses (4 to 8)
- Controls for design and development activities
- Risk management integrated across the product lifecycle
- Administration of documentation and record-keeping
Deployment and Sustainment of the ISO 13485 QMS
- Methodology for establishing an ISO 13485-conformant Quality Management System
- Personnel training and competency assurance requirements
- Process surveillance and performance measurement
Audit and Certification Procedures
- Fundamentals of internal and external audit activities
- Certification preparation and procedural expectations
- Identification of non-conformities and execution of corrective actions
Conclusion and Recommended Follow-up Actions
Requirements
- Familiarity with fundamental quality management concepts
Target Audience
- Quality Management Directors
- Quality Engineers
- Auditors and Regulatory Compliance Specialists
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