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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.
EN ISO 13485 is a parallel standard that is issued in the European Union for the purpose of creating a QMS in the medical device industry for use in the European Union. The requirements of these two standards are identical, and the entirety of the ISO 13485:2016 standard is included in the EN ISO 13485:2016 document.
EN ISO 13485 is the medical device industry's quality management system (QMS) harmonized standard; written to specify requirements for an organization to design and implement a quality management system to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
ISO 13485 helps an organization design a quality man-agement system that establishes and maintains the effectiveness of its processes. It reflects a strong com-mitment to continual improvement and gives custom - ers confidence in its ability to bring safe and effective products to market. ISO 13485, Medical devices – 1
Published in Switzerland. All organizations face challenges when developing or updating their qual-ity management system (QMS) and it is hoped that this handbook will be used to provide additional insight and understanding of the requirements in ISO 13485 1), Medical devices — Quality management systems — Requirements for regulatory purposes.
Sep 25, 2017 · ISO 13485:2016 – Medical devices – A practical guide has been authored by technical experts of ISO/TC 210. The handbook is intended to guide organizations in the development, implementation and maintenance of their quality management system in accordance with ISO 13485. Organizations active in the medical device sector, such as ...
A free brochure with tips for getting started with ISO 13485, requirements for quality management systems related to medical devices.
