ISO 13485:2003 (Medical Device Standard)

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Course Description

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 13485 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 Note: The above syllabus may change during the training course to provide more detail in aspects, which have been ascertained to be of greater value to the trainee. 

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