ISO13485：2016医疗器械管理体系培训课件英文版.pptxVIP

ISO 13485:2016 QUALITY MANAGEMENTSYSTEMS STANDARD ISO 13485 Background Overview4The ISO 13485 standardISO certification What is ISO 13485 ?5ISO 13485 is an International Organization for Standardization (ISO) standard that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. Quality Management SystemWhat is a quality management system (QMS)?A system to establish policy and objectives and to achieve those objectives (ISO)Your organization6 About ISO 134857Designed in particular for medical device manufacturersReleased in 2003; updated in 2016.Is a “stand-alone” Standard, meaning that a company can apply it without the support of any other quality system standard (i.e. the support of ISO 9001).The standard can be used by an organization for the design, development, production, installation and servicing of medical devices as well as for the design, development and provision of related services. About ISO 134858Based on the broader ISO 9001 standard, ISO 13485 was firstimplemented in Europe in 1996.In Europe, ISO 13485 Standard designated as EN ISO 13485:2016 is seen as the de facto standard for the medical device industry.Addresses most or all of the quality system requirements in markets including Europe, Australia, Japan, Canada, South Korea and Brazil, etc.However, certification in Europe, for example, does not mean your ISO 13485 certification is valid in other markets such as Canada or Japan. Many countries impose their own additional QMS requirements on top of those outlined in the standard. You must meet those additional requirements – on top of ISO 13485 – to be certified to sell in those markets. Relation to Other Standards9Closely aligned to other management standards:ISO 9001 (Quality)ISO 14001 (Environmental)ISO 45001 (Occupational Health and Safety)ISO/TR 14969:2004: A Technical Report intended to provide a guidance on the application of ISO 13485:2016.The guid