QMS 9001 Non-Conformance Procedure Template

What Is Non-Conformance?

Non-conformance is a term often used in manufacturing and quality control. It refers to any deviation from the accepted standards or specifications. When products, processes, or services do not meet the required specifications, they are considered non-conforming. This can be caused by errors made during production, inadequate processes, or incorrect raw materials. Non-conformances can often lead to defects in the final product and impact customer satisfaction and business profitability. In order to maintain quality standards and prevent costly defects, it is important for manufacturers to have comprehensive non-conformance management processes in place.

Non-Conformance Management Process

A non-conformance management process specifies the actions that should be taken when a deviation from the required standards is identified. It is typically implemented as part of a quality management system and includes four main steps:

• Identification: The first step is to identify the non-conformity. This can be done through regular inspections, customer feedback, or testing. 

• Analysis: Once the issue has been identified, it must be analyzed to determine the root cause. This will help identify any corrective actions that need to be taken to prevent the problem from occurring again in the future.

• Correction and Corrective Action: The third step is to take corrective action to fix the non-conformance. This may involve reworking the defective product, changing the production process, or updating the quality control procedures. 

• Closure: The final step is to close out the non-conformance report and document any actions that were taken. This ensures that the issue is properly addressed and prevents it from happening again in the future.

Why Is Conformance To ISO 9001 Important?

ISO 9001 is a quality management system standard that specifies requirements for a quality management system. Organizations around the world use it to improve the performance of their businesses by ensuring that products and services meet customer requirements and expectations. Compliance with ISO 9001 helps organizations demonstrate that they are meeting customer requirements and delivering on their promises, improving customer satisfaction and loyalty. Additionally, compliance with ISO 9001 can also help organizations reduce costs, improve efficiency, and become more agile.

ISO 9001 requirements are generic and can be applied to any organization, regardless of its size, type, or business model. 

The standard is designed to be used by organizations of all types and sizes, including manufacturers, service providers, retailers, government agencies, and non-profit organizations.

The 2015 revision of ISO 9001 is organized around seven quality management principles: customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making, and relationship management.

• Customer focus:
  An organization needs to understand the needs and expectations of its customers and strive to exceed them. This requires an organization-wide commitment to meeting or exceeding customer requirements.

• Leadership:
  Leaders set the direction for an organization and create an environment that allows people to do their best work. Leaders also provide the resources needed to achieve organizational objectives and ensure that processes are in place to continuously improve performance.

• Engagement of people:
  The engagement of people principle in ISO 9001 is about ensuring that everyone who needs to be involved in the quality management system (QMS) is engaged and their input is sought. The objective is to ensure that everyone understands their role and responsibility within the QMS, and that they have the necessary resources and authority to carry out their work effectively. Ultimately, this allows for a more responsive and effective QMS.
  It should be noted that the engagement of people principle goes beyond employee involvement, which is a specific requirement for ISO 9001: 2015.The engagement of people principle applies to all individuals who interact with the QMS in any way, including customers, suppliers, contractors, and other stakeholders.

• Process Approach:
  Process approach principle in QMS 9001 requires organizations to use processes when planning and controlling their operations. The idea behind it is that by breaking down the tasks needed to achieve an objective into a set of identifiable, repeatable processes, an organization can better manage and improve those processes. This helps ensure that quality is consistently maintained and improved over time. Furthermore, adherence to process approach principle can help organizations become more efficient and effective, while also driving overall improvement in quality.

• Improvement:
  An organization must be able to demonstrate improvement in order to continually meet the requirements of QMS 9001. The requirements state that management must "establish, implement, maintain and continually improve the quality management system." This can be done through planned and systematic action, taking corrective and preventive action when necessary. Management must also ensure that resources are available to support continual improvement.

• Evidence-based decision making:
  Evidence-based decision making is a quality management system (QMS) principle that requires factual evidence to support decisions. This principle helps ensure that decisions are based on the best available information and that risks are minimized. Factual evidence can be gathered from a variety of sources, including data, experience, research studies, and expert opinions. The key is to use the right information to make informed decisions that improve quality and meet customer requirements. 

• Relationship Management:
  The Relationship Management Principle in QMS 9001 states that an organization must establish, document, and implement a procedure for managing relationships with interested parties. The objective of this principle is to ensure that the organization interactions with interested are coordinated and aligned with organizational objectives. In order to achieve this, an organization must define: 
  

1. Who the interested parties are.
2. The communication methods to be used.
3. How information will be shared between the organization and the interested party.
4. What actions the organization will take to satisfy the interests of the parties involved.
5. How the organization will monitor and review the effectiveness of its interactions with interested parties.

Benefits of Non-Conformance

• Non-conformance can help to identify and correct problems before they result in larger issues.
• Non-conformance can help to improve quality by revealing areas that need improvement.
• Non-conformance can help to ensure that products and services meet customer requirements and specifications.
• Non-conformance can help to reduce the number of rejects and defects.
• Non-conformance can help to improve productivity by reducing the need for rework and scrap.
• Non-conformance can help to improve safety by identifying potential hazards.
• Non-conformance can help to reduce costs by preventing costly mistakes and correcting them before they happen.