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ISO 9001 Standard

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This book, published by the World Health Organization in 2021, provides a comprehensive guide on implementing quality management systems (QMS) within national regulatory authorities. It aims to assist these authorities in ensuring the safety, quality, and efficacy of medical products by implementing standardized practices based on ISO 9001 requirements. The book discusses various components of QMS, such as leadership, document management, and performance evaluation, providing practical examples from different countries. Its primary audience includes national regulatory authorities and professionals in quality assurance, aiming to promote consistency and mutual trust in regulatory practices globally.

ISO 9001 Standard. --- Quality assurance. --- ISO 9001 Standard --- Quality assurance

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A clear and comprehensive guide to quickly set up a cost-effective Quality Management System Revised and expanded, the new edition of this easy-to-understand guide provides practical information on how to set up a cost-effective ISO 9001:2000 compliant Quality Management System. With comprehensive coverage of the meaning, history and requirements of the current ISO 9000 standard, the book explains how businesses can easily and efficiently satisfy customer requirements for quality control and quality assurance. Four years into the current version of ISO 9001, the

ISO 9001 Standard. --- Quality control.

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ISO 9001 Standard --- Quality control --- Standards

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Implementing ISO 9001:2015 is a comprehensive guide to making the necessary transition to the new standard. The changes can also be used to stimulate transformation in organisations and their wider environments, coordinating processes to achieve both customer satisfaction and reduced operating costs.

ISO 9001 Standard. --- Quality assurance. --- Quality control --- Standards.