Course Outline
Introduction
ISO 13485 Overview
- The objective and scope of ISO 13485
- The significance of ISO 13485 within the medical device industry
- Essential terminology and definitions
ISO 13485 Architecture and Clauses
- Comprehending the structure (Annex SL)
- Summary of principal clauses: 4 through 8
Quality Management Principles
- The process approach and the PDCA (Plan-Do-Check-Act) cycle
- Application of risk-based thinking to medical devices
- The critical role of customer focus and regulatory obligations
Core Requirements of ISO 13485:2016
- Detailed analysis of clauses 4 through 8
- Controls for design and development
- Risk management across the product lifecycle
- Management of documents and records
Implementing and Maintaining an ISO 13485 QMS
- Procedure for establishing an ISO 13485-compliant QMS
- Staff training and competency standards
- Process monitoring and measurement
Audit and Certification Procedures
- Overview of internal and external auditing
- Preparation for certification: key expectations
- Addressing non-conformities and implementing corrective actions
Conclusion and Future Directions
Requirements
- Familiarity with fundamental quality management concepts
Target Audience
- Quality Managers
- Quality Engineers
- Auditors and Regulatory Compliance Personnel
Custom Corporate Training
Training solutions designed exclusively for businesses.
- Customized Content: We adapt the syllabus and practical exercises to the real goals and needs of your project.
- Flexible Schedule: Dates and times adapted to your team's agenda.
- Format: Online (live), In-company (at your offices), or Hybrid.
Price per private group, online live training, starting from 2600 € + VAT*
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Testimonials (4)
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
I enjoyed the quizzes, and Driton's style of teaching.
Chloe - SEEC MM Ltd.,
Course - ISO 9001 Lead Implementer
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 .