What is Documented Information?
Documented information refers to the requirements from ISO 9001:2026, ISO 14001, and ISO 27001 that are placed on the documentation of a quality management system or an information security management system (ISMS). It is about ensuring that fundamental documents – such as work instructions, descriptions of business processes, or safety instructions – are stored in clearly designated documents, protected against accidental changes and/or deletion, and are retrievable at all times.
Objective of Documented Information
The ISO 9001 requirements for documented information are fundamentally very logical. What good is the best work instruction if anyone can change it? What is the point of a safety instruction that no one can find when needed? And what would you say if you were using an older product from a manufacturer and, in the event of a quality defect, received the answer: “The product is older; we no longer have any documentation for it.” The principles of document information described in ISO 9001 are intended to prevent such situations. In doing so, they support one of the most important goals companies pursue with the establishment of quality management systems: to guarantee high reliability to customers and thus continuously increase customer orientation.
What are the requirements for documented information in ISO 9001, ISO 14001, and ISO 27001?
First, ISO 9001, ISO 14001, and ISO 27001 demand fundamental things: documentation must be available in an appropriate form (i.e., no orally transmitted work instructions), it must be clearly identified and named, and it must be made available to all employees for whom this information is relevant.
However, the requirements for documented information go even further: to ensure it is always clear who created which documents and who approved them, the ISO standards require that approval processes are defined and approvals are documented. This prevents situations where one might say: “No idea where this instruction came from. It was just suddenly there.”
Fundamental documents must also be protected against loss, use in the wrong context, or accidental changes. Again, this can be explained with examples. How thrilled would you be if, in your company, it was said: “I thought the safety instructions applied to a different machine. That’s how the accident happened.” Or: “Didn’t we have completely different work instructions yesterday?” “No idea, someone must have changed them by mistake.” Further requirements for documented information include comprehensive documentation of who changed what and when, as well as an archiving function for older documents.
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