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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.
Design History File (DHF) The sub-clause 4.2.3 of ISO 13485 :2016 requires a manufacturer of medical device to establish a Technical file , similar to a device master record. The EU medical device regulation requires a manufacturer of a medical device to maintain a Technical documentation .
ISO 9000:2005 provides information on the fundamentals and vocabulary used in quality management systems. ISO 9004:2009 provides guidance on a quality management approach for the sustained success of an organization. Neither of these standards can be used for certification purposes as they provide guidance, not requirements.
Thus, Windows 11 is the first consumer version of Windows not to support 32-bit processors (although Windows Server 2008 R2 is the first version of Windows Server to not support them). [152] [153] The minimum RAM and storage requirements were also increased; Windows 11 now requires at least 4 GB of RAM and 64 GB of storage. [154]
Linearized PDF files (also called "optimized" or "web optimized" PDF files) are constructed in a manner that enables them to be read in a Web browser plugin without waiting for the entire file to download, since all objects required for the first page to display are optimally organized at the start of the file. [26]
Historically, most classes of technical documentation lacked universal conformity for format, content and structure. Standards are being developed to redress this through bodies such as the International Organization for Standardization(ISO), which has published standards relating to rules for preparation of user guides, manuals, product specifications, etc. for technical product documentation.
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