is being presented by Susan Soderholm, Quality Manager & Certified Quality Auditor, Amcor Rigid Plastics and airs on Tuesday, June 29th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
Regulatory agencies are 'upping the ante' with regards to implied and written compliance. As they currently exist, the ICH guidance documents may or may not be issued. Our global marketplace makes it critical to understand the linkages between FDA, ISO and ICH requirements to have a quality system that meets all requirements in the broad customer base – in particular, 21CFR211/820, ISO 13485, ISO 9001 and ICH Q8, Q9, Q10 and IPEC 2006 requirements, similarities and differences.
Preparation for a successful audit, product approval and a compliant Quality Management System is key to compliance and ultimately, product and site approval. In this audio conference, our speaker draws on extensive experience in hosting regulatory agency and customer audits, as she shares practical experience and established best practice approaches.
Showing posts with label ISO 9001. Show all posts
Showing posts with label ISO 9001. Show all posts
Friday, May 28, 2010
Friday, August 21, 2009
Implementing a Quality Management System: ISO 13485
ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices that consistently meet customer and regulatory requirements. One of the main objectives of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. It includes many of the elements of ISO 9001 but excludes some aspects not appropriate as regulatory requirements. ISO 13485:2003 is applicable to all medical device manufacturers, regardless of the type or size of the organization.
If regulatory requirements permit exclusions of design and development controls, or if “product realization” (Clause 7) is not applicable, these can be excluded from the quality management system. However, organizations claiming conformity with ISO 13485:2003 must reflect these exclusions. The processes required by ISO 13485:2003, which are applicable to the medical device(s) but are outsourced, must be accounted for in the organization's quality management system. ISO 13485:2003 is used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer and regulatory requirements.
This conference looks at the requirements of ISO 13485:2003 and some practical aspects of setting up a quality system for medical device manufacturers.
Implementing a Quality Management System: ISO 13485 is being presented by Salma Michor, CEO & Principal Consultant, with Michor Consulting EU and airs on Thursday, October 15, 2009. For more details or to register, please visit our site at www.fxconferences.com
If regulatory requirements permit exclusions of design and development controls, or if “product realization” (Clause 7) is not applicable, these can be excluded from the quality management system. However, organizations claiming conformity with ISO 13485:2003 must reflect these exclusions. The processes required by ISO 13485:2003, which are applicable to the medical device(s) but are outsourced, must be accounted for in the organization's quality management system. ISO 13485:2003 is used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer and regulatory requirements.
This conference looks at the requirements of ISO 13485:2003 and some practical aspects of setting up a quality system for medical device manufacturers.
Implementing a Quality Management System: ISO 13485 is being presented by Salma Michor, CEO & Principal Consultant, with Michor Consulting EU and airs on Thursday, October 15, 2009. For more details or to register, please visit our site at www.fxconferences.com
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