ISO 13485 Foundation Training Course
The ISO 13485 Fundamentals course is an introductory training programme that equips participants with a solid grasp of ISO 13485, the international standard for quality management systems (QMS) tailored specifically for the medical device sector.
This instructor-led, live session (available online or on-site) targets quality assurance beginners, regulatory compliance officers, medical device engineers, and any professionals engaged in medical device manufacturing who seek a foundational understanding of ISO 13485. The goal is to enable them to implement and sustain a compliant quality management system while ensuring their organisations meet regulatory obligations.
Upon completion of this training, participants will be able to:
- Comprehend the structure, purpose, and requirements of ISO 13485:2016.
- Acquire knowledge of quality management principles unique to medical devices.
- Gain insight into the critical processes and documentation necessary for compliance.
- Understand the procedures for implementing and maintaining an ISO 13485 quality management system (QMS).
Course Format
- Interactive lectures and discussions.
- Ample exercises and practical practice.
- Hands-on implementation within a live laboratory environment.
Customisation Options
- To arrange customised training for this course, please contact us to make the necessary 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
- Basic understanding of quality management concepts
Target Audience
- Quality managers
- Quality engineers
- Auditors and regulatory compliance staff
Need help picking the right course?
southafrica@nobleprog.co.za or +27 (0)10 005 5793
ISO 13485 Foundation Training Course - Enquiry
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 .
Dana Foster - Corrigan Oil Company
Course - ISO 9001 Foundation
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