ISO 9001 Nonconformance Risks to Watch For

ISO 9001 Nonconformance Risks to Watch For

Receiving your ISO 9001 certification takes work. Maintaining that certification is an on-going process that may cause stress for some business owners. If you’re concerned about ISO 9001 nonconformance, you’re not the only one.

Receiving a nonconformance notification is something almost all organizations experience, but it’s what they do with that information that is most important. Is it a bad violation? Is there a pattern of nonconformance notifications? As an ISO 9001 certified organization is it critical that you maintain the level of standard necessary to avoids these notifications as much as possible.

You don’t have to wait for official notifications to know if you’re at risk. ISO 9001:2015 standards for Quality Management Systems (QMS) require organizations define and conduct their own internal audits to ensure they are not at risk and discover where they can improve their systems to ensure they don’t cross that line. The internal audit is the last step in the process with the goal to ensure the company’s quality system aligns with internationally recognized standards.

If you discover repeat offenses or a pattern of offenses that is a sign of weakness in a quality management system. Furthermore, it’s a sign that you are failing to discover, measure, communicate, and improve things that matter. First let’s discuss the different between minor and major nonconformance.

A minor nonconformance issue is typically a weakness in the system that has been identified that left untouched could turn into a bigger issue, such as a chance to a document or process that is unauthorized. It only takes a single change to create this nonconformance issue but all should be avoided regardless of it being considered “minor”. 

A major nonconformance issue is as the label implies, a significant failure (not just weaknesses) in the quality management system. Evidence of this failure is often a sign of a threat to an organization’s ability to achieve their quality management goals or protect their customers. Poor product or machine calibration procedures or multiple unauthorized document or process changes are examples of major nonconformance.

Regardless of the level of infraction is it important that your organization responds to the nonconformance discovery with an effective plan to correct the issue in order to avoid failing either the initial certification or suspension of an existing certification.

Here are some of the most common issues with ISO 9001:2015 standards, and how to protect your organization against them.

Most Common Nonconformances:

According to recent reports from American Systems Registrar and American Global Standards, auditors most common discovered issues within the following sections of ISO 9001:2015.

  • Section 4: Failure to identify and define interested parties
  • Section 5: Difficulties with control of records
  • Section 6: Incomplete definition of change management
  • Section 7: Poor documentation of training and records capture
  • Section 9: Incomplete documentation of internal audit systems

Based on these common nonconformances you can see many organizations are found to have ineffective documentation processes and responses for risk. Knowing these common nonconformances can help your organization stay ahead of potential issues and maintain quality management systems that meet the standard requirements.

Keep in mind that finding a nonconformity within your ISO 9001:2015 quality management system isn’t all negative and it’s not uncommon for organizations to find a few. It’s what you do with that information and your ability to address and resolve the potential risk that makes all the difference and keeps you within the standard requirements for certification.

American Global Standards can help you navigate the most common nonconformances, such as ineffective documentation processes and inadequate responses to risk. Discover the benefits of partnering with American Global Standards and stay ahead of potential issues.