ISO 13485:2003 Medical Devices training course, to be delivered in Limerick as one - day public programme gives participants a broad understanding of the quality management system requirements outlined in the medical devices standard ISO 13485. 

ISO 13485 is a quality system standard that is exclusive to the design, manufacturing and servicing of medical devices. Manufacturers may become certified to the standard by having an independent assessment of their quality system, by an ISO registrar or Notified Body.

Upon completion of this course, participants will have gained an understanding and knowledge of:

• Format of the new ISO 13485:2003 standard
• Major changes from the previous revision of the standard
• Differences between ISO 9001:2000 and ISO 13485:2003
• CE Marking implications
• How to carry out an audit against ISO 1348

The ISO 13485 training can be also delivered as customized in-company programme at clients facilities nationwide in Ireland, including Dublin, Cork, Limerick & Galway.

Pre-requirements

This course is designed for Quality Engineers, Quality Managers, Documentation Management, Regulatory Affairs and any other personnel in medical device manufacturing industry who must adhere to the ISO 13485:2003 standard.

Participants Study:

• Intro to ISO 13485:2003
• Relationship to ISO9000
• New Revision: ISO 13485:2003
• Process Approach
• Terms & Definitions
• Quality Management System
• Requirements
• Group Assignments
• Group Internal Audit

Course Contents:

Introduction to ISO 13485:2003

• Structure of the standard
• Contents and purpose of each section
• New Revision: ISO 13485:2003
• Major changes from the previous revision
• Correspondence to and differences between ISO 9001:2000
• CE marking implications

Overview of the standard

• Process approach
• Quality management system
• Requirements
• Resource management
• Product realization
• Measurement, Analysis and improvement

Audit Exercise using the standard

• Attendees will break into groups and carry out an audit of a specific area of the facility.
• This will require prior preparation within the facility.
• Afterwards the groups will convene to share experience.
• Responding to an Audit