Course Outline
Introduction
Overview of ISO 13485
- Purpose and scope of ISO 13485
- Importance of ISO 13485 in the medical device industry
- Key terminologies and definitions
ISO 13485 Structure and Clauses
- Understanding the structure (Annex SL)
- Overview of key clauses: 4 to 8
Quality Management Principles
- Process approach and PDCA (Plan-Do-Check-Act)
- Risk-based thinking in medical devices
- The importance of customer focus and regulatory requirements
Key Requirements of ISO 13485:2016
- Clause-by-clause breakdown (4 to 8)
- Design and development controls
- Risk management throughout the product lifecycle
- Control of documents and records
Implementation and Maintenance of ISO 13485 QMS
- Steps to establish an ISO 13485-compliant QMS
- Training and competency requirements for personnel
- Monitoring and measuring processes
Audit and Certification Process
- Introduction to internal and external audits
- Preparing for certification: what to expect
- Non-conformities and corrective actions
Summary and Next Steps
Requirements
- Basic understanding of quality management concepts
Audience
- Quality managers
- Quality engineers
- Auditors and regulatory compliance staff
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 3200 € + VAT*
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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