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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.
ISO 9001:2015 Quality management systems — Requirements is a document of approximately 30 pages available from the national standards organization in each country. Only ISO 9001 is directly audited against for third-party assessment purposes. Contents of ISO 9001:2015 are as follows: Section 1: Scope; Section 2: Normative references
PDF is a standard for encoding documents in an "as printed" form that is portable between systems. However, the suitability of a PDF file for archival preservation depends on options chosen when the PDF is created: most notably, whether to embed the necessary fonts for rendering the document; whether to use encryption; and whether to preserve additional information from the original document ...
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.
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 24517-1:2008 is an ISO Standard published in 2008.. Document management—Engineering document format using PDF—Part 1: Use of PDF 1.6 (PDF/E-1) This standard defines a format (PDF/E) for the creation of documents used in geospatial, construction and manufacturing workflows [1] and is based on the PDF Reference version 1.6 from Adobe Systems.
An open file format is a file format for storing digital data, defined by a published specification usually maintained by a standards organization, and which can be used and implemented by anyone. For example, an open format can be implemented by both proprietary and free and open source software , using the typical software licenses used by each.
The binary transport format for an ODA-conformant file is called Open Document Interchange Format (ODIF) and is based on the Standard Generalized Markup Language and Abstract Syntax Notation One (ASN.1). One of the features of this standard could be stored or interchanged in one of three formats: Formatted, Formatted Processable, or Processable.