The QMS also needs to include the size of the organization and type of activities, complexity of processes and interactions, and the competence of persons.Īdditionally, there are requirements for creating and updating documented information, which include identification, appropriate format, and review & approval of documented information. The QMS needs to include documented information required by the ISO 9001 standard and documented information determined necessary for the effectiveness of the QMS. The requirements for documented information are captured in section 7.5 of the draft standard, and include many of the same requirements already in place for documentation and records. Notes to this definition indicate that documented information can refer to the Quality Management System (QMS) and its processes, documentation, and records. ISO 9001:2015 defines documented information as meaningful data that is required to be controlled and maintained by the organization and the medium on which it is contained. Here is a bit more about what is meant by documented information. Can we get rid of our documented procedures? What about documents or records – are there no more requirements for that? While it appears from all advanced drafts of the new 2015 version of ISO 9001 that the specific requirements for documented procedures and records have been removed, there is a new requirement for documented information, which is intended to incorporate both the documents and the records. There is a lot of talk going around about how documented information is changing in the new version of ISO 9001.
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