Complianceonline, Online Web Event
2010-03-31
This ISO 13485:2003 Webinar will discuss the differences of ISO13485:2003 and ISO 9001:2008 and FDA requirements. Which SOP’s are necessary to implement an ISO 13485:2003 Quality Management System and use of harmonized standards. Why Should You Attend: The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001. If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity with ISO 13485:2003 reflect exclusion of design and development controls and the processes required by ISO 13485:2003, applicable to the medical devices, but not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system. Learning Objectives: - The history of ISO 13485:2003.
- The content of the standard and how it differs to ISO 9001:2008 and Food and Drug Administration requirements.
- What exclusions are permitted and how Subcontractors should be handled.
- Which SOP’s are necessary to implement an ISO 13485:2003 Quality Management System.
- What certification and Notified Bodies will look for at an audit.
Areas Covered in the Seminar: - Introduction.
- History of the standard.
- Detailed Content.
- Which SOP’s are necessary to implement an ISO 13485:2003 compliant Quality Management System.
- Differences with ISO 9001:2008.
- Differences with Food and Drug Administration Part 820 requirements.
- The use of Harmonised Standards .
- What Notified Bodies and Certification Bodies look for.
- Questions & Answers.
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