The purpose of this field guide is to assist organizations, step by step, in implementing a quality management system (QMS) in conformance with ISO 9001:2008, whether from scratch or by transitioning from ISO 9001:2000. It examines each sub-clause of Sections 4–8 of ISO 9001:2008, which contain the requirements, and gives a list of the documentation/documents required, internal audit questions, a summary of management’s responsibilities, and a flowchart of the steps that need to be undertaken to satisfy the requirements.
View?This new and expanded second edition maintains the organizational approach of the first and includes the requirements and guidance contained in the Quality System Regulation (QSReg), the ISO 13485:2003 standard, the ISO/TR 14969:2004 guidance document, and, as appropriate, a number of the FDA and Global Harmonization Task Force (GHTF) guidance documents.
ViewThis second edition has been updated and revised to reflect the most recent Six Sigma techniques, and to match the ASQ Certified Six Sigma Black Belt Body of Knowledge (BOK).
ViewThe quality inspector is the person perhaps most closely involved with day-to-day activities intended to ensure products and services meet customer expectations. The quality inspector is required to understand and apply a variety of tools and techniques as described in the ASQ Certified Quality Inspector (CQI) Body of Knowledge (BoK).
ViewThis new handbook was developed to assist those preparing for the Certified Quality Process Analyst certification.
ViewIf a business expects to be a player in their market segment, their product(s) must have the quality expected by their customers. This can only be accomplished with test equipment that produces repeatable, accurate, and traceable measurements and/or outputs. Without a quality calibration system in place, this cannot and will not happen.
ViewThis reference manual is designed to help those interested in passing the ASQ’s certification exam for Six Sigma Green Belts, those who may need to train future green belts, and others who want a handy reference to the appropriate materials needed to conduct successful green belt projects.
ViewManagement of quality continues to play a significant role in organizations as they struggle to deal with ever increasing complexities and challenges in our fast-paced world.
ViewPerfect for anyone charged with implementing a quality audit program or those performing the audit, this book is an ideal reference on the established techniques of quality auditing.
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