What is Documented Information | Lean Quality Management System Training Videos | ISO 9001
This video discusses what is documented information. We will talk about the last two requirements of clause 4.4: documented information and evidence of process performance. Element 4.4.2 a) requires maintaining documented information to support the operation of its processes. Requirements to establish and maintain such information are present in numerous standard clauses. When you create your documentation structure, start from the standard requirements – those clauses required to be documented, for example:
4.3, the scope of the QMS,
5.2.2, the quality policy,
6.2.1, quality objectives, and others.
Yet, in addition to this list, you should also consider documenting processes critical to the business, such as Complex technological processes, high-risk activities, practices related to compliance with regulators, and others.
Surprisingly the standard sometimes is confusing about what is documented information. For example, it does not require documentation of some critical processes, such as
Element 4, Context of the organization
Element 5.3, Organizational roles, responsibilities, and authorities,
Element 6.1, Actions to address risks and opportunities, and many others
I do not know how ISO 9001 technical committee justified that these elements DO NOT need to be documented, but, as I can see it, these processes are significant enough to be documented. This concludes our discussion of what is documented information in clause 4.4.
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