Quality Management Excellence: QMS 9001 Non-Conformance Procedure Template

What is non-conformity?

The term non-conformance can be used to describe a variety of issues in manufacturing, quality control and other areas. Any deviation from accepted standards or specifications is considered non-conforming. Non-conformity is the term used to describe products, services, and processes that do not conform to specifications. It can be due to errors in production, improper processes or incorrect raw material. 

Non-conformances often result in defects and can impact the customer's satisfaction and profitability. To maintain quality standards and avoid costly defects, manufacturers must have comprehensive nonconformance management systems in place.

QMS Non-Conformance Procedure

The non-conformance process specifies what actions should be taken if a deviation is detected from the standards. It is usually implemented as part a quality system, and includes four steps:

QMS 9001 Process for Non-Conformance Management

Identification: The first thing to do is identify the nonconformity. Regular inspections, feedback from customers, or testing can all be used to identify the non-conformity.

Analysis: After identifying the problem, it is important to analyze it in order to identify the root cause. This will allow you to identify the corrective measures that are needed to avoid the problem occurring again.

Correction and Corrective Measures: The third stage is to correct the non-conformance. It may be necessary to rework the defective product or change the production process.

Closure: The last step is to close the report of non-conformance and document all actions taken. It is important to ensure that the problem has been properly addressed in order to prevent it from occurring again.

Why is ISO 9001 compliance important?

ISO 9001 specifies the requirements of a management system for quality. It is used by organizations around the globe to improve their business performance, ensuring products and services are in line with customer expectations and requirements. ISO 9001 compliance helps organizations prove that they meet customer expectations and deliver on their promises. This improves customer satisfaction and loyalty. Compliance with ISO 9001 also helps organizations to reduce costs, increase efficiency and become more agile.

ISO 9001 is a generic standard that can be used by any type of organization regardless of size or business model.

The standard can be used by all organizations, regardless of their size, such as manufacturers, service providers and retailers, as well government agencies and non-profit organisations.

The 2015 revision to ISO 9001 is organized according to seven quality management principles, including customer focus, leadership and engagement of people, the process approach, improvement of evidence-based decisions, relationship management, and process approach.

Principles of QMS 9001 Non-Conformance Procedural

Customer focus:

It is important for an organization to be aware of the expectations and needs of its clients and to strive to meet or exceed these. It is important that the entire organization commits to meeting and exceeding customer expectations.

Leadership:

Leaders create an environment where people can do their best work. Leaders provide resources to meet organizational goals and make sure that processes exist to continually improve performance.

Engagement of people:

ISO 9001's engagement of people principle aims to ensure that all those who need to be involved with the quality management system are engaged and their input sought. It is important that all employees understand their roles and responsibilities within the QMS and have the resources and authority they need to do their jobs effectively. This allows for a QMS that is more effective and responsive.

The engagement of people principles goes beyond employee participation, which is a requirement of ISO 9001:2015. It applies to everyone who interacts with the QMS, whether it be customers, suppliers or contractors.

Process Approach:

The QMS 9001 Process Approach Principle requires that organizations use processes to plan and control their operations. It is based on the idea that an organization can improve its processes by dividing tasks into identifiable and repeatable processes. It helps to ensure that the quality is maintained and continuously improved. In addition, adhering to the process approach principle will help an organization become more effective and efficient, as well as driving overall improvements in quality.

Improvement:

To meet the QMS 9001 requirements, an organization must continually demonstrate improvement. According to the requirements, management must "establish a quality management system, implement it, maintain it and continuously improve its performance." You can achieve this by taking planned and systematic actions, and corrective and prevention action when needed. The management must ensure that there are resources available to support continuous improvement.

Evidence-based decision-making:

Evidence-based decisions are a principle of the quality management system. This requires that factual evidence be used to support any decision. This principle ensures that decisions are made based on best information available and risks are minimised. Factual evidence can come from many sources, such as data, experience and research studies. Expert opinions are also a good source. It is important to use accurate information to make decisions that will improve quality and satisfy customer needs.

Relationship Management (Relationship Management):

According to the Relationship Management Principle of QMS 9001, an organization is required to establish, document and implement a process for managing relationships. This principle aims to ensure that interactions between the organization and interested parties are aligned and coordinated with organizational goals. To achieve this, an organizationmust define:

Who are the interested parties?

Communication methods that will be used

What information will the organization share with the interested parties?

What steps will the organization take to satisfy all parties?

How the organization will evaluate and monitor the effectiveness of their interactions with interested parties.