Without documented information, experiences and knowledge can fade away. This is as true today when preserved on digital storage devices capable of holding up to 18 terabytes as it was in the days of using cuneiform tablets to record transactions of livestock or quipu cords that counted with clusters of knots. ISO 9001 quality management systems require documented information, a topic that is expanded in new international standard ISO 10013:2021 – Quality Management Systems – Guidance For Documented Information.
About ISO 9001 for Quality Management Systems
Today, quality remains one of the top attributes for ensuring a business’s success. As such, ISO 9001 is the most popular standard in the world. There are over 1 million certifications issued to the quality management systems standard worldwide.
ISO 9001:2015 details the requirements for a quality management system. Adopting this system is a strategic decision that can realize numerous benefits. An effective quality management system can help an organization improve its overall performance, achieve its objectives, keep up with the needs of its customers, meet necessary regulatory and statutory requirements, and even open the possibility for new business opportunities.
You can learn more about ISO 9001 in our post ISO 9001:2015 Quality Management Systems Standard.
Documented Information in ISO 9001
Proper planning is crucial to meet quality management goals. ISO 9001 quality management systems must consider an organization’s context, the expectations of interested parties, and the strategic direction of the organization. An organization also needs to to plan what documented information it needs to maintain and retain.
Through Clause 7.5, “Documented Information,” of ISO 9001:2015, an organization is required to maintain and retain documented information to support the operation of its processes. This information can grant confidence that processes carry out as planned, and, in preserving an organization’s knowledge, it may help generate value to fuel improved products or services.
About ISO 10013:2021 for Documented Information
ISO 10013:2021 provides practitioners of quality management with guidance for the development and maintenance of documented information.
The information outlined in ISO 10013:2021 helps support the use of documented information tailored to the specific needs of an organization by outlining the structure, content, and scope of documented information, the documented information to be maintained (e.g. organizational charts, work instructions, and checklists), documented information to be retained, and creating, updating, and controlling documented information.
ISO 10013:2021 is the first edition of the international standard for documented information, and it revises a technical report, ISO/TR 10013:2001. This past edition suggested a hierarchy of documentation (e.g. quality manual) for documenting the quality management system, which no longer is used but left open for the user. Another change to this standard was aligning it with the new structure and requirements of ISO 9001:2015.
While ISO 10013:2021 supports a quality management system, it can also be used with other management systems.
ISO 10013:2021 – Quality Management Systems – Guidance For Documented Information is available on the ANSI Webstore. For anyone needing to make use of it and related quality management standards (such as ISO 10005:2018 – Quality Management – Guidelines for Quality Plans and ISO 10015:2019 – Quality Management – Guidance for Competence Management and People Management), it is available as part of the following standards packages:
ISO 19011 / ISO 10005 / ISO 10015 / ISO 10013 – Quality Management Systems Package