INTRODUCTION

Medical device regulatory requirements are becoming more stringent throughout every step of a medical device life cycle, including service and delivery. Increasingly, organizations in the industry are expected to demonstrate their quality management processes are compliant and ensure best practice in everything they do.

This internationally accepted ISO 13485 2016 standard sets out the requirements for a quality management system specific to the medical devices industry. Its implementation in a quality management system is mandatory for an organisation involved is one or more phases of a medical device life cycle either as a manufacturer, supplier or external organisation providing products which has to consistently meet customer and applicable regulatory requirements.

COURSE OBJECTIVES

Participants will be introduced to the concepts required to understand, implement and maintain an ISO 13485 2016 medical device quality management system (QMS).  Participants will also be imparted with the knowledge on the utilisation of mandatory requirements within an ISO 13485 2016 compliant QMS for the one or more stages of a medical device life-cycle.

• Introduction on the background of this standard currently in its third edition.
• An understanding of what is termed and defined as a medical device.
• Guided understanding of the of the ISO 13485 2016 clauses and its application.

COURSE OUTLINES

• An overview of the ISO 13485 2016
• Clause 1: Scope
• Clause 2: Normative References
• Clause 3: Terms and Definitions
• Clause 4: Quality Management System
• Clause 5: Management Responsibility
• Clause 6: Resource Management
• Clause 7: Product Realization
• Clause 8: Measurement, Analysis and Improvement

COURSE BENEFITS

At the end of the session, participants will;

• Gain an understanding of the intent of the various clauses.
• Be aware of the application of the clauses in its implementation.
• Be knowledgeable on the maintenance of the QMS effectiveness to reflect current ‘state of the art’.
• Fulfil the prerequisite competence prior to participating in an ISO13485 2016 Internal Audit training.

TARGET AUDIENCE

This programme is designed for ALL functions and levels of an organization who need to gain understanding of the requirements in the standard, especially organizations that has embarked on the journey and plan to be certified with ISO 13485.

This programme is particularly useful to those managing the quality management system, process owners and internal auditors.