internal controls

What ISO 9001 Clause is Used Writing Audit Findings For Not Following Procedures?

One of the most typical internal audit findings (nonconformities) is discovering that workers are not following procedures or work instruction. Surprisingly, while ISO 9001 requires you to establish procedures as needed, there is no ISO clause that requires anybody to follow such plans! What ISO 9001 clause is used writing audit findings for not following procedures?

Which ISO 9001 Clause Do You Use for the Audit Finding for Not Following Procedures?

The standard does not directly address this issue. The old standard (ISO 9001:2008) had better language and used “implement actions necessary” under clause 4.1.f but that is obsolete now. As a result, auditors frequently struggle with how to write an audit finding or nonconformity (NC), even though all such NCs must be based on a provision in the applicable ISO standard.

If you discover that employees are not following the defined procedures, work instructions, process maps, or the “plan” for the work in your process audit, then first I would suggest

ISO 9001 clause 4.4.1.g

“Evaluate the processes and implement any changes needed to ensure that the processes achieve the intended results.”

This is in the “plan” part of PDCA related to ISO 9001 and means you have identified a gap between what the company requires and what the company is doing. I would cite the “planning” documentation as a reference or the criteria that is not being met by the results.

Second, you can use ISO 9001 clause 8.1.e.1

“The organization shall plan, implement and control the processes needed to meet the requirements for the provision of products and services…by: (e) determining, maintaining and retaining documented information to the extent necessary (1) to have confidence that the processes have been carried out as planned.”

This mean you have identified a gap in confidence while conducting your ISO 9001:2015 Internal Audit. Employees are not executing the process as planned in the documentation. It isn’t ideal, but it comes close because the requirement requires you to plan the processes with (“documented information”), and also requires you to “implement” the documented information.

ISO 9001 Clause Used for an Audit Finding for Not Following Procedures

The next time you conduct an ISO internal audit (also applies to AS or IATF) and you come across a process where workers are not following procedures, you can use clause 4.4.1.g or 8.1.e.1 depending on where you need to put the emphasis. This is an ISO 9001 Frequently Asked Question within ISO internal Audits.

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