ISO 9001 Certification (Part 4): Oh No! We Have a Non-Conformity!

Now that we’ve covered the cost of ISO certification, what the audit process entails and how to choose a conformity assessment body (CAB) let’s dive into non-conformities! It is important to know what they are, how they can be reported and what to do post non-conformity.
At some point in the ISO 9001 certification process, the CAB auditor may observe and report a situation they deem to be a non-conformity. If this happens, it shouldn’t be viewed by anyone as a failure. Because it isn’t.
ISO 9000, the vocabulary document for ISO 9001, defines a non-conformity (3.6.9) as “non-fulfillment of a requirement.” If we consider that regulatory requirements may be related to customers, this simply means one of these has not been met.
A non-conformity might indicate that an ISO 9001 “shall” statement hasn’t been fulfilled, such as a program of internal audits not being implemented or a contractual arrangement with a customer wasn’t satisfied. A non-conformity might also indicate that a quality management process is not effective. For example, there are recurring product defects after corrective action has been taken.
Non-conformities reported during an ISO 9001 certification audit should never be a surprise. The CAB auditor should clearly point out what they observe at the time the non-conformity is detected. This allows the representatives of the organization to understand what the auditor is observing and to discuss the facts in case of potential misunderstanding.
At some point during the audit, the CAB auditor will provide a documented non-conformity statement as part of their overall audit report. A well-constructed non-conformity statement should include:
  • Audit Criteria – by reference to a document and the stated requirement(s)
  • Audit Evidence – the situation observed as non-conforming and its location
The above should be communicated in the non-conformity report as statements of fact, like the examples below:
               “ISO 9001:2015, Clause 7 requires that the organization shall…”
“The organization’s procedure QOP-76.01 states that all operators are trained, and their training record is signed off by a line supervisor before operating process equipment.
In the driveshaft assembly cell, an operator (employee #123) was observed using a hydraulic press to assemble a hub bearing and no record of their training was available.”
Typically, non-conformity statements are prepared and delivered toward the end of an audit as a record of the facts found. There should rarely be a non-conformity that has not been previously identified and discussed. A non-conformity should never be reported after the audit is completed.
What should an organization do in response to an audit non-conformity? Easy! If it is accurate and factual, the organization is usually required to submit a response to the CAB indicating what action is being taken to rectify the observed non-conformity. This may include a root-cause analysis, but there are cases where the situation only needs correction. The nature of the non-conformity and the specific type of audit when the non-conformity was discovered will often dictate the timeframe for a response and any actions taken thereafter by the CAB and their auditor. This can range from submitting documentation (evidence) to an on-site re-audit of actions taken.
Periodically, and for many reasons attributed to both parties, what’s reported isn’t always a factual account of a non-conformity. What then? After an audit, a critical review might indicate the auditor misunderstood or misjudged a situation. What to do if the organization subsequently discovers the reported issue wasn’t what it seemed? Accredited conformity assessment bodies are required to have a process in place for appealing findings that their client organizations do not agree with. The use of this appeals process is encouraged since it allows for cool heads and calm minds to review the significance and accuracy outside of the anxiety of the moment.
Non-conformities, which are discovered during an ISO 9001 certification audit, rarely lead to the suspension and eventual de-certification of an organization. Even when a “major” non-conformity is reported, there are usually other related issues occurring that lead to the suspension of an ISO certificate. Commonly, the organization about to lose its certification is in financial trouble, the quality management system has become ineffective at satisfying internal and external needs, and the inexorable slide into insolvency has started.
It is beneficial to look at a non-conformity to learn and improve your processes. Remember, the auditor is there to help you keep your ISO certification, not to rip it from your hands.
There are two primary benefits associated with being ISO certified: a competitive advantage and the discipline necessary for future growth. Many companies expect their suppliers to have some form of ISO certification. Without certification, suppliers are unlikely to even be considered. The Center’s experts can assist manufacturers in integrating their QMS/EMS objectives into their strategic and business plans. Take the first steps in the certification process by scheduling your free assessment today!
MEET OUR EXPERT: Andy Nichols, Program Manager
Nichols_A.jpgTo The Center’s clients, Andy Nichols, CQP FCQI, brings 40 years of expertise in a wide variety of roles and industries, with a particular focus on quality management systems in manufacturing organizations. Prior to joining the Michigan Manufacturing Technology Center, he was the East Coast Regional Sales Manager for NQA, a “Top 5” Global Certification Body, responsible for significant sales growth in a highly competitive marketplace. He has authored three books, “Exploding the Myths Surrounding ISO 9000 – A Practical Implementation Guide” (published by ITG in April 2013) and “A Guide to Effective Internal Management Systems Audits" (published May 2014) and “Implementing ISO 9001:2015 – A practical guide to busting myths surrounding quality management systems” (published October 2022).

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