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1Stop Solutions
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Quality System - ISO 13485
Quality System - ISO 13485. ISO 13485 is an ISO standard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices. This standard supersedes earlier documents such as EN 46001 and EN 46002 (both 1997), the ISO 13485 published in 1996 and ISO 13488 (also 1996). Controls in the work environment to ensure product safety. Focus on risk management activities and design transfer activities during product development. Http:/ prax...
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Quality Management - ISO/TS 16949
Quality Management - ISO/TS 16949. Is developed by International Automotive Task Force (IATF). First published in March 1999 and revised in 2002 and there are now over 25,000 certificates were issued. Is an ISO Technical Specification, which aligns existing US, German, French, Japanese, and Italian automotive quality system standards. Is a more process-based approach that requires stricter controls on each individual manufacturing process. In addition, it also specifies development of a quality managemen...
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Quality System - ISO 17025
Quality System - ISO 17025. ISO/IEC 17025 is the main standard used by testing and calibration laboratories, which originally known as ISO/IEC Guide 25, ISO/IEC 17025. The official title of this standard is: BS EN ISO/IEC 17025:2005 - General requirements for the competence of testing and calibration laboratories. It was produced by Technical Committee ISO/CASCO in collaboration with Technical Committee CEN/CLC/TC 1. There are two main sections in ISO/IEC 17025 standard -. Management requirements are pri...
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Quality Management - ISO 17799 / ISO 27002
Quality Management - ISO 17799 / ISO 27002. ISO/IEC 27002 part of a growing family of ISO/IEC ISMS standards, the 'ISO/IEC 27000 series' is an information security standard published by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) as ISO/IEC 17799:2005 and subsequently renumbered ISO/IEC 27002:2005 in July 2007, bringing it into line with the other ISO/IEC 27000-series standards. The preservation of confidentiality (ensuring that informa...
