Non-conformance in ISO 9001:2015 / What is Non-conformance?

Non-conformance in ISO 9001:2015 / What is Non-conformance?

What is Non-conformance (NC) in ISO 9001?

 - Non-conformance is defined as any instance where your organization fails to conform to the requirements of ISO 9001.

 - ISO 9001 is a standard set by the worldwide organization for standardization, It outlines quality management system requirements to ensure that your products and services meet the expectations and needs of customers, regulators and legislation.

 - Non-conformances can therefore occur on your products, products, or even inside the movements of your employees.

 - Non-conformances are typically found during internal and external audits, as well throughout ordinary inspections.

 - They can be anything from one-off errors that are easily amended to major mistakes that severely impact your conformance to ISO 9001.

What is difference between major and minor non-conformance?

1. Minor NC

 - A minor-conformance refers to an incident that does not observe ISO 9001 requirements, but is a one-off occurrence this is not going to have a serious effect on your QMS and commercial enterprise operations.

 - Minor nonconformities include a missing training record, a single unauthorized document alteration, or one machine past its calibration date.

 - Anything that can easily be fixed by noting the violation is usually considered minor. The less time it takes to fix the issue, the more time can be spent operating efficiently and safely.

2. Major NC

 - Major NC may be both a repeated minor incident or a greater serious single incident that does not agree to ISO 9001 requirements. It might have a excessive impact in your QMS, potentially disrupting whole commercial enterprise operations.

 - These mistakes can result in loss of productivity and decrease in customer satisfaction.

Under ISO 9001, all non-conformances regardless of which category they fall under will need to be dealt with through corrective actions which stop the non-conformance from happening again.

ISO 9001 non-conformance examples

1. A failure to address a drop in quality.

2. A mistake made by personnel.

3. Ineffective risk assessment and management.

4. Material used in organization not defined clearly.

5. Process and procedures not monitoring and measuring properly.

6. product specifications not meeting customer requirements.

7. Failure to document corrective action

8. Missing documents like training records, skill matrix etc.

What are the results of non-conformance?

 - If they are not found and are left undealt with, can potentially have a severe impact on your organization.

 - E.g. not addressing a fall in the quality of your products may result in dissatisfied customers and a tarnished reputation.

 - Repeated personnel actions that do not follow ISO 9001 requirements could also have a detrimental impact on the morale of your organization.

 - Making sure you're complying with the requirements of ISO 9001, and correcting any instances where you do now not comply, is therefore essential.

 - It will ensure that you maintain the satisfaction and trust of your customers, the smooth running of your systems and processes, and the quality of your products and services.

How to deal with non-conformance

 - Once a non-conformance has been identified, either by yourself or an internal or external auditor, it is essential that you act quickly to control and amend the situation.

 - The first step when dealing with a non-conformance is to fill out a Non-Conformance Report (NCR).

 - In that report person responsible for non-conformance, what is  non-conformance and where it is observed, How it will be corrected and prevented from happening in the future etc. details are included.

 - After completing an NCR, you should follow the plan of action you have outlined to correct the non-conformance. It's also an amazing idea to evaluate how effective your corrective movements were at resolving the problem.

 - By taking these actions, you may be better placed to make sure that your corporation is compliant with the necessities of ISO 9001.

Why Conformance to ISO 9001 is important?

 - Successful conformance to ISO 9001 can lead to increased efficiency by reducing the likelihood of errors and saving you time.

 - It can also create better consistency within your processes and systems, and help continuously improve your QMS.

 - These benefits will in turn contribute to happier staff and happier customers.


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