ISO - ISO 13485 — Medical devices
WEBISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification …
ISO 13485:2016 Medical devices — Quality management systems ...
WEBAbstract. ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including ...
ISO 13485 - Wikipedia
WEBISO 13485. ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.
What is ISO 13485? Detailed Explanation of the Standard
WEBEN 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.
ISO 13485:2016(en), Medical devices ? Quality management ...
WEBThis 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.
ISO 13485 for Medical Devices QMS [Complete Guide]
WEBTo align with ISO 13485:2016, contents of the QMS should address the specific, applicable requirements of the standard, as well as the specific, applicable regulatory requirements based on markets where you plan to manufacture and market medical devices. One concept formally introduced in the 2016 standard is the notion of a risk-based QMS.
ISO 13485 - Quality Management System - BSI
WEBISO 13485 is a stand-alone QMS standard, based on ISO 9001:2008, which has been superseded by ISO 9001:2015. While ISO 13485 is based on the ISO 9001 process model concepts of ‘Plan, Do, Check, Act’, it is designed for medical devices QMS and therefore can’t be replaced by ISO 9001. Relevant for designers, manufacturers, and distributors ...
WEBISO 13485 has an additional set of requirements specific to the medical device industry, and it discards some of the requirements of the new ISO 9001. Therefore, compliance with ISO 13485 does not imply compliance with ISO 9001, and any organization that aims to be compliant with both standards has to implement all applicable requirements of ...
WEBDec 15, 2014 · The primary international version is ISO 13485:2003. The variant EN ISO 13485:2012 is the latest European harmonized version of ISO 13485; it replaces the prior harmonized version, EN ISO 13485:2003, which is now considered to be obsolete. EN ISO 13485:2012 is applicable only to manufacturers placing devices on the market in Europe.
WEBISO/TC 210, Quality management and corresponding general aspects for medical devices. This secondthird edition ISO 13485 cancels and replaces the of second edition first (ISO 13485:19962003) and ISO/TR 14969:2004, which hashave …