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Medical Product Dossier Evaluation and Registration
Good Manufacturing Practices and Inspections
Clinical Trials, Pharmacovigilance and Medicines Safety
Quality Control Laboratories
Quality Management Systems
Information Management Systems
Policy, Legislation and Regulation
Description
To achieve sustained success, top management should adopt a quality management approach. The organization's quality management system should be based on the principles described in Annex B. These principles describe concepts that are the foundation of an effective quality management system. To achieve sustained success, top management should apply these principles to the organization's quality management system. The organization should develop the organization's quality management system to ensure ⎯ the efficient use of resources, decision making based on factual evidence, and ⎯ focus on customer satisfaction, as well as on the needs and expectations of other relevant interested parties.
Abstract
This International Standard provides guidance to organizations to support the achievement of sustained success by a quality management approach. It is applicable to any organization, regardless of size, type and activity. This International Standard is not intended for certification, regulatory or contractual use.
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