Non-Conformance Management: Critical for ISO Compliance

Internal and external audits commonly reveal non-conformances. A single non-conformance isn’t necessarily a bad thing. A pattern of non-conformances, however, is a sign of high-level weaknesses in quality management.

Without good non-conformance management, non-conformances continue and can have serious ramifications for an organization. Most importantly, non-conformance management is critical for ISO compliance.

What is non-conformance?

Non-conformance is the failure of an organization to meet one or more of the ISO requirements and standards.

A non-conformance can happen anywhere in an organization from quality control and production processes to personnel procedures.

What is non-conformance management?

Non-conformance management is the process an organization uses to ensure that issues, mistakes and deviations from specifications and regulations are identified and corrected. Non-conformance management can quickly identify system issues within an organization.

Recording and managing non-conformances is an important element of any quality management system (QMS). It minimizes the impact of quality issues and drives improvements. The benefits of non-conformance management, include:

learning from errors
continuous quality improvement
regulatory compliance
efficient use of resources
reduction in customer complaints
improved QMS effectiveness.

ISO regulations requiring non-conformance management

ISO standards exist primarily to protect consumers. They also help manufacturers integrate quality into their operations and avoid the consequences of poor-quality products. The following are some of the ISO standards that require appropriate non-conformance management.

The ISO 9001:2015 quality management systems standard requires management reviews of product conformity and process performance data (clause 5.6.2). Organizations must ensure that any non-conforming product is identified and controlled to prevent its unintended delivery or use (clause 8.3).

The ISO 13485:2016 standard for medical devices requires organizations to plan and implement the monitoring, measurement, analysis and improvement processes needed to demonstrate product conformity and ensure conformity of the quality management system (clause 8.1).

The ISO 14001:2015 standard requires organizations to react to non-conformities that occur in their environmental management systems and take action to control and correct them (clause 10.2).

Non-conformance with ISO 9001

Non-conformances can be minor or major. An example of a major non-conformance is a poor calibration procedure that results in incorrectly tested products. A minor non-conformance might be a single unauthorized change to a document.

If you know the common causes of non-conformance with ISO 9001:2015, you can take steps to avoid them. Common causes include:

defining interested parties
planning and defining changes to QMS
accuracy with measuring devices
examining, documenting and controlling operations and inspections.

Risks of failing to manage non-conformance

If non-conformance is not managed properly, there may be serious repercussions. Specifically, a non-conforming product that’s not corrected properly could lead to a customer’s injury, even death. More generally, there are numerous risks of failing to manage non-conformance. These include:

loss of – or failure to get – ISO certification
risks to consumers
product recalls
reputational damage
loss of opportunities in international markets
end of contracts with customers requiring ISO certification
financial losses
lawsuits.

isoTracker’s Non-Conformance Management Software

Our non-conformance management software helps your organization comply with standards and drive improvements. It ensures that every non-conformance is properly recorded and addressed. The software:

records non-conformances, easily and consistently
ensures corrective actions are implemented
always has a complete, up-to-date record
uses real-time analytics to drive improvements.

The module can stand alone or integrate with our other quality management software.

isoTracker

isoTracker offers modular, subscription-based quality management software that’s secure, cloud-based and affordable. As well as the non-conformance management software, it includes a document control module, as well as complaints management, audit management, and training modules, with built-in CAPA capabilities.

Digital quality management is one, straightforward way for small to medium manufacturing businesses to start realizing value from Industry 4.0 – and with isoTracker’s QMS, it’s easy and cost-effective to implement.