Iso 13485:2003
#Iso 13485:2003 update
ISO 9001:2008 is the most recent update of the widely recognized ISO 9001 standard. This standard defines requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer specifications and regulatory requirements. The ISO 13485:2003 standard is specifically designed to certify medical device manufacturers and their key suppliers. ISO 13485, 3rd Edition, MaMedical devices - Quality management systems - Requirements for regulatory purposes This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
The achievement of these ISO certifications will communicate the significant progress we have made toward that goal. Findings Unlike ISO 9001:2000, ISO 13485:2003 stresses the safety and efcacy of medical devices that are being produced. Originally registered: Effective Date: Expiry date. We are committed to providing our customers with world-class printing and contract kitting and fulfillment services to the medical device and life sciences industries. and operates a Quality Management System which complies with the requirements of ISO 13485:2003 for the following scope: For and on behalf of BSI: VP Regulatory Affairs, BSI Group America, Inc.
The Allied Group received dual certification under the International Organization for Standardization (ISO) quality systems standards, for ISO 13485:2003 and ISO 9001:2008. Allied receives ISO 13485:2003 and ISO 9001:2008 Certification