4. What documented information is required?
In addition to the documented information required by ISO9001, it is not uncommon for organizations to have other documented information, in particular information that is necessary for the smooth running of the organization. This information is left to the discretion of each organization, but as long as it is necessary, it is an integral part of the QMS and must be managed. And the quality system, in response to the requirements of chapter 7.5, makes it possible to manage this documentation (see
[FIC 0393]
).
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What documented information is required?