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ISO 9001:2015 Documented Information

What are the new requirements for Documentation in the ISO 9001:2015 standard?

The ISO 9001:2015 standard has removed the distinction between documents and records. Both are now called documented information. As per ISO’s definition, the term documented information refers to information that must be controlled and maintained. Therefore, it expects that you also maintain and control the medium as well as the information.

This Documented Information is used as evidence of conformance.

ISO Annex SL ISO standards integration has many tools to help you integrate ISO Standards in their existing format, which will be simplified with Annex SL.

Will a Quality Manual be required?

Signup for free iso9001 information buttonA Quality Manual is not required. The DIS ISO 9001:2015 standard does not specify a Quality Manual.

Is the Quality Manual now unimportant?

Do not scrap the Quality Manual. The 2015 standard requires you maintain documented information that supports the operation of your organization’s processes which, is most likely covered in your quality manual. In addition, the following documented information is still required and may be referenced in your quality manual:

  • Quality Policy
  • Quality Objectives
  • QMS Scope

Since the new ISO 9001:2015 standard no longer mandates a Quality Manual, a condensed version serves as an introduction (or a table of contents) for the QMS and as such, see our ISO 9001:2015 QMS page for required documentation.

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