ISO 9001 Non-conformance justification

Normally, auditors audit processes or departments, let us call it the physical audit scope. While auditing a process or a department they have to consider the audit criteria, and the audit criteria can be all clauses of the standard and internal procedures applicable within the scope of the audit.

Let me imagine you are auditing process “Prevent breakdown time” or the Maintenance Department. Now, go to ISO 9001:2015 clause 4.4.1 c) – methods and criteria have to be determined. Then, go to ISO 9001:2015 clause 4.4.2 – organizations are free to design the required documented information structure, they have to comply with the mandatory documents and records of standard, but they can go beyond. Once included in the system’s design those documents and records have to be controlled according to ISO 9001:2015 clause 7.5.1 b).

In the case of documentation being lacking or incomplete, as long as it is considered part of the QMS, you should raise a nonconformity. However, I think it is not about 7.5.1 b). Think, what is the problem with those records? Bad design? (clause 7.5.2). Lack of control? (clause 7.5.3). People not knowing how to fill a record? (clause 7.2). Not clear who has to fill the record? (clause 5.3)

You can find more information about documentation below:

• New approach to document and record control in ISO 9001:2015 - https://advisera.com/9001academy/blog/2015/06/30/new-approach-to-document-and-record-control-in-iso-90012015/
• Some tips to make Document Control more useful for your QMS - https://advisera.com/9001academy/blog/2014/05/20/tips-make-document-control-useful-qms/
• Free online training ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
• Book - Managing ISO Documentation: A Plain English Guide - https://advisera.com/books/managing-iso-documentation-plain-english-guide/