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The ISO 9000 family is a set of international standards for quality management systems.It was developed in March 1987 by International Organization for Standardization.The goal of it is to help organizations ensure that they meet customer and other stakeholder needs within the statutory and regulatory requirements related to a product or service. [1]
The ISO 9002 and 9003 standards were integrated into one single certifiable standard: ISO 9001:2000. After December 2003, organizations holding ISO 9002 or 9003 standards had to complete a transition to the new standard. ISO released a minor revision, ISO 9001:2008 on 14 October 2008. It contains no new requirements.
The ISO 9001 standard requires organizations seeking compliance or certification to define the processes which form the QMS and the sequence and interaction of these processes. Butterworth-Heinemann and other publishers have offered several books which provide step-by-step guides to those seeking the quality certifications of their products.
Verification is intended to check that a product, service, or system meets a set of design specifications. [6] [7] In the development phase, verification procedures involve performing special tests to model or simulate a portion, or the entirety, of a product, service, or system, then performing a review or analysis of the modeling results.
TickIT also includes a guide. This provides guidance in understanding and applying ISO 9001 in the IT industry. It gives a background to the TickIT scheme, including its origins and objectives. Furthermore, it provides detailed information on how to implement a Quality System and the expected structure and content relevant to software activities.
ISO/IEC 14143-6:2012 Part 6: Guide for use of ISO/IEC 14143 series and related International Standards; ISO 14145 Roller ball pens and refills ISO 14145-2:1998 Part 2: Documentary use (DOC) ISO 14155:2011 Clinical investigation of medical devices for human subjects – Good clinical practice
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