The International Organization for Standardization has released 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.
Representatives from more than 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.
Organizations are increasingly moving from paper-based systems to electronic media. Recent revisions to ISO 9001 reflect this change, and ISO 10013 adds guidance to this.
ISO 10013 can be used to support the implementation of other management systems, such as environmental (ISO 14001) or occupational health and safety (ISO 45001).
ISO 10013 no longer prescribes a particular hierarchy but reflects the ability of electronic media to organize itself in a multitude of ways. It’s important to understand 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.”