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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.

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

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

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