ISO 10013:2021 pdf download – Quality management systems — Guidance for documented information.
3? Terms? and? definitions For the purposes of this document, the terms and definitions given in ISO 9000:2015 and the following apply. ISO and IEC maintain terminological databases for use in standardization at the following addresses: — ISO Online browsing platform: available at https:// www .iso .org/ obp — IEC Electropedia: available at http:// www .electropedia .org/ 3.1 work instruction detailed description of how to perform tasks EXAMPLE Detailed written descriptions, flow charts, templates, models, technical notes incorporated into drawings, specifications, equipment instruction manuals, pictures, audios and videos, checklists or combinations thereof. Note 1 to entry: Work instructions can be documented. Note 2 to entry: Work instructions describe any materials, equipment and documented information to be used. When relevant, work instructions include acceptance criteria. 3.2 form documented information to be maintained and used to record data required by the quality management system Note 1 to entry: A form becomes documented information to be retained (i.e. a record) when data are entered.
4 Documented information 4.1 General 4.1.1 Structure Documented information can be structured and created in many ways based on the needs of the organization and other factors such as leadership, intended results of the management system, context (including statutory and regulatory requirements) and interested parties. The structure of the documented information used in the quality management system can be described in a hierarchy. This structure facilitates the distribution, maintenance and understanding of the documented information. Electronic systems provide additional choices for structuring documented information. Annex A illustrates examples of documented information structures. Smaller organizations may choose a simplified documented information structure to meet their needs. The type and extent of the documented information needed for the quality management system should be based on an analysis of processes and can differ from one organization to another due to, for example: a) the size of the organization and type of activities; b) the complexity of processes and their interactions; c) the maturity of the quality management system; d) risks and opportunities; e) the competence of persons; f) statutory and regulatory requirements; g) customer and other interested party requirements; h) the need for evidence of results achieved; i) the need to support accessibility and retrievability remotely.