Documents and information of the QMS must be controlled. This is a key element of a QMS. The main idea is to provide control over the documented information necessary for the operation of the QMS. In order to achieve this high-importance quality objective, the ISO 9001:2015 Standard expects a method. The new term “documented information” brings an improved and a closer reality perspective of documents and records into the ISO 9001:2015 Standard requirements.
Documented information refers to the information necessary for the planning and operation of the QMS coming from any source and the medium on which it is contained. For the first time, the standard does not separate between procedures, documentations, and records and refers to all as documented information. The very strict definition refers to information used by the QMS or produced by it that
- Was defined by the organization as necessary for the planning and the operation of the QMS—the definition includes the media on which the information is stored and maintained. Information can be in any format and media and from any source.
- Is required to be maintained and controlled by the organization.
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