What Documentation is Necessary for ISO 9001 2015?

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ISO 9001:2015 Documentation - What is Really Necessary?

Organizations are beginning to transition their QMS to the 2015 version of ISO 9001 prompting some clients to ask how much documentation is necessary. The answer is your choice as 2015 is very open regarding documentation.

ISO 9001:2015 splits documentation into a category called "maintain documented information" and a second category called "retain documented information."

Maintain Documented Information

refers to procedures, work instructions, forms and other items that were controlled in Clause 4.2.3 of ISO 9001:2008. Therefore, your existing documented procedures, forms and work instructions are probably acceptable and can be used in most cases without changes. However, ISO 9001:2015 adds to the "maintain documented information" requirement. See the attached list for the specific sections regarding maintain document information.

Retain Documented Information

refers to records, and documented performance, either hard copy or electronic. Section 4.2.4 of ISO 9001:2008 that addressed control of records is similar to ISO 9001:2015. See the attached list for the specific sections addressing retain documented information.

Mandatory Procedures

are NOT listed in ISO 9001:2015. Each organization must evaluate what written procedures are necessary for the day to day success of their operation.

An example is Section 4 – Context of the organization could be verbal rather than documented. Also, strategic direction, internal and external issues, and interested parties could be verbal. Only Clause 4.3 Scope needs to be controlled or documented.

If the organization elects verbal clauses, elect wisely. An example - auditors are trained to ask appropriate personnel the organization's Scope - 4.3. Scope is a "maintained document" so the answer should be easy.

If personnel are asked the organization's strategic direction, how many will provide the correct answer since it is not required as a "maintained document?" Auditors will first look for the answer by chatting with the president to determine personnel that would have to be aware of the strategic direction.

In a small company two or three people would be aware of the company's strategic direction. In a larger organization there will be more. If personnel provide nearly the same response, then the organization's strategic direction might be effectively implemented. However, if differing answers are provided this might suggest to the auditor that strategic direction is not fully implemented resulting in a nonconformance.
Procedures – big question from clients pondering the 2015 version - "do we have to throw out all our existing procedures?"

Just to repeat, mandatory procedures are NOT listed in ISO 9001:2015. Each organization must evaluate what written procedures are necessary for the day to day success of their operation.

If procedures help your company stay organized and push your quality management system for results, then keep the existing documents in place adding only the new "documented information" as outlined in ISO 9001:2015. However, if an existing procedure is not being used, the organization might determine the procedure can be eliminated.

Bottom line – ISO 9001 has been updated to meet the needs of business and industry in 2015 and beyond. The 2015 updates can easily be adjusted to fit into an existing quality management system without starting from square one!

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