6 Common Causes of Nonconformance with ISO 9001:2015

6 Common Causes of Nonconformance with ISO 9001:2015
November 10, 2020 isowebseousr
iso 9001

If you’re aware of the common causes of nonconformance with ISO 9001:2015, you can help your organization take steps to avoid them.

A nonconformance is the nonfulfillment of a specified requirement. Here are the six nonconformances most commonly uncovered in audits.

Common nonconformances by clause

These nonconformances are commonly experienced by organizations as they transition to ISO 9001:2015. We break them down by clause.

Clause 4

It’s a new requirement to identify and define interested parties. Many clients are failing to do this.

Also, many organizations are failing to meet the new requirement of monitoring and measuring processes.

Clause 6

In ISO 9001:2015, organizations are required to plan and define actions when changes are being made to the quality management system (QMS). Auditors find that this isn’t effectively implemented.

ISO 9001:2015 requires a risk evaluation throughout an entire organization. Risk is often not properly evaluated in parts of an organization’s business, such as warehousing and external/internal issues.

Clause 7

It’s mandatory to have accuracy with measuring devices. Some organizations aren’t using the appropriate tool/measuring device for a measurement taken, so the result is inaccurate.

A new requirement for ISO 9001:2015 is the need for an organization to improve its knowledge. It’s essential that this knowledge/training/education is captured, but auditors frequently find that it’s not. An example of this is training records that aren’t retained.

Clause 8

This section focuses on the control of operations, which should be carefully examined when an organization is preparing for an audit. Often, auditors find that first piece inspections aren’t effective and not documented.

Receiving inspections are also cited as ineffective. The process for approving and disqualifying vendors that aren’t up to code is often not defined. Also, many organizations aren’t clearly defining materials involved in their processes or manufacturing.

Clause 9

The language may have changed from 2008 to 2015 but the requirements for internal audits remain the same. Many internal audit systems are ineffective, and organizations don’t meet the requirements for clause 9.

Common shortcomings include the lack of addressing the mitigation of risk or actions taken regarding the performance of the QMS.

Clause 10

This clause addresses nonconforming materials and corrective action. It’s virtually the same as 2008, but 2015 adds customer complaints language.

Customer complaints are often recorded, but organizations don’t define or document a corrective action, so they fail to meet the 2015 standard.

Minor versus major nonconformances

Identifying the severity of nonconformances allows third-party auditors to decide whether to recommend the QMS for initial certification, continued certification or recertification.

So, what’s the difference? Primarily, the difference is based on how the non-conformance impacts the QMS or product.

Minor nonconformance

A minor nonconformance is a failure to conform to an ISO 9001:2015 requirement that is a single observed lapse or isolated incident. A minor nonconformance is unlikely to result in a failure of the QMS.

Examples of minor nonconformance include a single unauthorized change to a document, a missing training record or an instrument that’s incorrectly calibrated.

Major nonconformance

A major nonconformance is a total breakdown of the QMS or one of its processes, evidence of a significant failure in the QMS or the failure to address a key ISO 9001 requirement. A major nonconformance could threaten an organization’s ability to assure controlled processes, achieve its goals or protect its customers.

Examples of major nonconformances include a pattern of unauthorized document changes, critical purchases made from unapproved suppliers or untested products being shipped.

Impact of ISO 9001 nonconformance

The average number of minor nonconformances revealed during an audit is four to six. The discovery of a nonconformance with ISO 9001:2015 is not necessarily negative.

It’s an opportunity for your organization to make improvements that lead to corrective actions. Discovering minor issues during an internal audit or management review can prevent long-term significant problems and barriers to ISO 9001:2015 certification.

If an auditor finds one or more major nonconformances, certification would not be recommended. So, it’s worth investing time and energy to avoid both minor and major nonconformances.

isoTracker

It’s easier to comply when you know the common causes of nonconformance with ISO 9001:2015.

At isoTracker, we offer modular, cloud-based quality management software, including nonconformance management software. Our nonconformance management software is specifically designed to ensure ISO 9001 compliance and that every nonconformance is properly recorded and addressed.

It helps businesses comply with standards and drive improvements. The module can standalone or integrate with our other quality management software.

Contact us to find out more or to discuss your company’s nonconformance management needs. Alternatively, go ahead and sign up for a free 60-day trial of isoTracker’s quality management software.

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