ISO 13485 Foundation

• Basic understanding of quality management concepts

Audience

• Quality managers
• Quality engineers
• Auditors and regulatory compliance staff

ISO 13485 Foundation is an introductory-level training course that provides participants with fundamental knowledge of ISO 13485, the international standard for quality management systems (QMS) specifically designed for the medical device industry.

This instructor-led, live training (online or onsite) is aimed at beginner-level quality assurance professionals, regulatory compliance staff, medical device engineers, and any professionals involved in medical device manufacturing who wish to gain a foundational understanding of ISO 13485 to implement and maintain a compliant quality management system and ensure regulatory compliance in their organizations.

By the end of this training, participants will be able to:

• Understand the structure, purpose, and requirements of ISO 13485:2016.
• Learn about the quality management principles specific to medical devices.
• Gain insights into key processes and documentation required for compliance.
• Understand the steps to implement and maintain an ISO 13485 quality management system (QMS).

Format of the Course

• Interactive lecture and discussion.
• Lots of exercises and practice.
• Hands-on implementation in a live-lab environment.

Course Customization Options

• To request a customized training for this course, please contact us to arrange.

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