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This third edition of ISO 13485 cancels and replaces the second edition (ISO 13485:2003) and ISO/TR 14969:2004, which have been technically revised. It also incorporates the Technical Corrigendum ISO 13485:2003/Cor.1:2009. A summary of the changes incorporated into this edition compared with the previous edition is given in Annex A. v
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Quality management for medical devices. ISO 13485, Medical devices –. Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry.
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ISO 13485:redline:2016(E) Introduction 0.1 General This International Standard specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services.
This International Standard specifies requirements for a quality management system that can be used by an organization involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and...
This standard specifies requirements for a quality management system for medical devices and related services that meet customer and regulatory needs. It is available in PDF, ePub and paper formats and can be purchased online.
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The International Standard ISO 13485:2016 defines criteria for a Quality Management System for Medical Device Manufacturing; this ensures that all medical devices meet proper regulatory compliance laws and customer needs. ISO 13485 derived from ISO 9001, a quality management standard that is available to businesses in a wide variety of industries.
INTERNATIONAL ISO This is a preview of ISO 13485:2016. Click here to purchase the full version from the ANSI store. STANDARD 13485. ©ISO 2016. Medical devices — Quality management systems — Requirements for regulatory purposes. Dispositifs médicaux — Systèmes de management de la qualité —.
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Official EN Standards. Single Publications or Company-Wide Subscriptions. Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes.
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