The International Organization for Standardization is pleased to announce the release of ISO 10013:2021, Quality management systems – Guidance for documented information. This document replaces ISO/TR 10013:2001.
In addition to updating terminology to align with ISO 9001:2015, this version acknowledges advancements in documentation that have occurred since the prior release, such as improvements in digitization of documented information, the associated security measures that are often necessary to protect such digitized information and the emergence of automation to control the flow of processes.
The output of the 31-month project is reflective of an international effort. Representatives from over 20 countries and organizations actively participated in the development of this updated standard. Moving it from a technical report to a standard guidance resulted in recommendations to organizations to maintain and retain documented information to support the operation of its processes. With applying ISO 10013 confidence that the processes are being carried out as planned increases. Reason for this is that documented information enables the knowledge and experiences of the organization to be preserved and can generate value to support the improvement of products or services.
Organizations have been moving from paper-based systems to electronic media in the last two decades. ISO 9001 has reflected this change and ISO 10013 adds guidance to this. In addition, it can be used to support the implementation of other management systems, e.g. environmental or occupational health and safety. Furthermore, ISO 10013 no longer prescribes a particular hierarchy but reflects the ability of electronic media to organize itself in a multitude of ways. It is important to realize that while a quality manual is not required, it can still be useful, and many sector-specific standards still require “quality manuals and documented procedures”.