ISO 13485 Foundation Training Course
The ISO 13485 Foundation course is an entry-level training program that offers participants essential knowledge of ISO 13485, the international standard for quality management systems (QMS) tailored specifically for the medical device sector.
This instructor-led, live training (available online or onsite) targets beginner-level quality assurance specialists, regulatory compliance personnel, medical device engineers, and any professionals engaged in medical device manufacturing who seek a solid foundational grasp of ISO 13485. The goal is to enable them to implement and sustain a compliant quality management system and ensure regulatory adherence within their organizations.
Upon completing this training, participants will be capable of:
- Comprehending the structure, purpose, and requirements of ISO 13485:2016.
- Gaining knowledge of quality management principles unique to medical devices.
- Acquiring insights into the critical processes and documentation necessary for compliance.
- Understanding the procedures for implementing and maintaining an ISO 13485 quality management system (QMS).
Course Format
- Interactive lectures and discussions.
- Extensive exercises and practical application.
- Practical implementation within a live-lab setting.
Customization Options
- For information regarding customized training for this course, please reach out to us to arrange.
Course Outline
Introduction
Overview of ISO 13485
- Purpose and scope of ISO 13485
- Significance of ISO 13485 in the medical device industry
- Key terminologies and definitions
Structure and Clauses of ISO 13485
- 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
- Importance of customer focus and regulatory requirements
Key Requirements of ISO 13485:2016
- Clause-by-clause breakdown (4 to 8)
- Controls for design and development
- 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
- Fundamental understanding of quality management concepts
Audience
- Quality managers
- Quality engineers
- Auditors and regulatory compliance staff
Open Training Courses require 5+ participants.
ISO 13485 Foundation Training Course - Booking
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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
Bader Bin rubayan - Lean Business Services
Course - ISO/IEC 27001 Lead Implementer
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