ISO 13485 Foundation Training Course
The ISO 13485 Foundation course offers an entry-level training experience, equipping participants with the core knowledge of ISO 13485, the global standard for Quality Management Systems (QMS) tailored specifically for the medical device sector.
This instructor-led live session, available both online and in-person, targets quality assurance professionals at the beginner stage, regulatory compliance specialists, medical device engineers, and any individuals engaged in medical device manufacturing who seek a solid grounding in ISO 13485. This foundation enables them to effectively implement and uphold a compliant QMS, thereby ensuring their organizations meet regulatory standards.
Upon completing this training, participants will be capable of:
- Comprehending the framework, objectives, and mandates of ISO 13485:2016.
- Grasping the quality management principles uniquely applicable to medical devices.
- Gaining valuable insights into the essential processes and documentation necessary for compliance.
- Understanding the procedures for implementing and sustaining an ISO 13485 Quality Management System (QMS).
Course Structure
- Engaging lectures and group discussions.
- Abundant practical exercises and hands-on practice.
- Real-world implementation within a simulated lab environment.
Customization Choices
- For inquiries regarding tailored training for this course, please reach out to us to make arrangements.
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
- Foundational knowledge of quality management concepts
Target Audience
- Quality managers
- Quality engineers
- Auditors and regulatory compliance personnel
Open Training Courses require 5+ participants.
ISO 13485 Foundation Training Course - Booking
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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
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
Speed of response and communication
Bader Bin rubayan - Lean Business Services
Course - ISO/IEC 27001 Lead Implementer
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