This one-day workshop will help you understand the requirements of and how to successfully implement ISO 13485:2003. The instructors will provide an explanation of the process-based concepts of the new ISO 13485:2003 - Medical Devices Quality Management Systems requirements for regulator purposes.
Understand the relationships to the ISO 9001:2000 standard and the U.S. Quality System Regulation 21 CFR 820 Compare ISO 13485:2003 to ISO 13485:1996, 21CFR820 and ISO 9001 Understand the implications of changes to ISO 13485 and how they will affect your company Discover regulators' approach to the ISO 13485:2003 requirements Discuss the process approach and how it affects your implementation process.
Topics Covered Include:
Objectives of the standard, concept and rationale of the changes Understanding the Standard (Clauses 4 - 8) ISO 13485:2003 vs. ISO 9001 vs. 21CFR820 Implementation, transition and planning Quality system structure, documentation and process mapping.
Contacts
An IES representative is available to answer your questions. Visit our Regional Map to find a representative in your area.
