ISO 9001:2015 Clause 10.2

What is ISO 9001:2015 Clause 10.2?

This clause of ISO 9001:2015 addresses the processes an organization should have in place to identify and manage nonconformities (instances where products, services, or processes do not meet specified requirements) and to implement corrective actions.

Key points are outlined in Clause 10.2 include:

Nonconformity Identification:

• Establish a process for identifying and documenting nonconformities.
• Ensure that employees are aware of how to report nonconformities.

Evaluation and Decision on Nonconformity:

• Evaluate the significance of nonconformities, considering factors such as the impact on products, services, and customer satisfaction.
• Determine the need for corrective action based on this evaluation.

Correction vs. Corrective Action:

• Differentiate between correction (immediate action to eliminate a detected nonconformity) and corrective action (action to eliminate the root cause of a nonconformity to prevent its recurrence).

Root Cause Analysis:

• Conduct a thorough analysis to identify the root causes of nonconformities.
• Implement corrective actions addressing these root causes to prevent the recurrence of similar issues.

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Monitoring Corrective Actions:

• Monitor the effectiveness of corrective actions implemented.
• Verify that corrective actions have addressed the identified root causes.

Documentation:

• Document information related to the nature of the nonconformity, the actions taken, and the results of corrective actions.

Review by Management:

• Include nonconformities and corrective actions in the management review process.
• This clause ensures that organizations have a systematic approach to dealing with nonconformities, taking corrective actions, and preventing the recurrence of similar issues in the future. It aligns with the broader objective of continual improvement within the ISO 9001:2015 standard.

Other ISO 9001:2015 Clauses:

Clause 10

Clause 10.1

Clause 10.3

How do you comply with Clause 10.2?

Compliance with Clause 10.2 of ISO 9001:2015, titled “Nonconformity and corrective action,” involves establishing and maintaining effective processes for identifying, addressing, and preventing nonconformities within your organization’s quality management system (QMS). Here are steps you can take to comply with Clause 10.2:

Establish Nonconformity Identification Procedures:

• Develop procedures to identify and document nonconformities. This may involve regular inspections, audits, and monitoring processes.

Employee Awareness and Training:

• Ensure that employees are aware of how to identify and report nonconformities.
• Provide training on recognizing and documenting nonconformities.

Nonconformity Evaluation:

• Establish a process for evaluating the significance of nonconformities. Consider the impact on products, services, and customer satisfaction.
• Determine the need for corrective action based on the evaluation.

Correction and Corrective Action Differentiation:

• Clearly define and communicate the difference between correction (immediate action to eliminate a detected nonconformity) and corrective action (action to address the root cause and prevent recurrence).

Root Cause Analysis:

• Conduct thorough root cause analysis for identified non-conformities.
• Use appropriate tools and methodologies to determine the underlying causes.

Corrective Action Planning:

• Develop a corrective action plan that outlines the steps to be taken to address the root cause.
• Assign responsibilities and establish timelines for corrective actions.

Implementation of Corrective Actions:

• Implement corrective actions according to the established plan.
• Verify that the corrective actions effectively address the root cause.

Monitoring and Measurement:

• Monitor and measure the effectiveness of corrective actions.
• Use performance indicators to assess whether similar nonconformities are recurring.

Documentation and Records:

• Document information related to the nonconformity, the corrective action taken, and the results of the corrective action.
• Maintain records to demonstrate compliance with Clause 10.2.

Management Review:

• Include nonconformities and corrective actions in the organization’s management review process.
• Use the information gathered to drive continuous improvement initiatives.

Communication:

• Communicate nonconformities and corrective actions within the organization.
• Ensure that relevant stakeholders are informed of the actions taken.

By following these steps, you can establish a systematic and effective approach to complying with Clause 10.2 of ISO 9001:2015. This helps maintain the integrity of the quality management system, preventing the recurrence of nonconformities, and contributing to the overall improvement of organizational processes. Regular monitoring, review, and communication are essential elements of ensuring ongoing compliance and effectiveness.

What is the History of Clause 10.2?

ISO 9001:2015 is the latest version of the ISO 9001 standard, and Clause 10.2, titled “Nonconformity and corrective action,” addresses processes related to handling nonconformities and implementing corrective actions. The historical evolution of this clause can be traced through the previous versions of the standard:

ISO 9001:1987:

The initial version of ISO 9001 did not have a dedicated clause specifically addressing nonconformities and corrective actions.

ISO 9001:1994:

The 1994 version introduced the concept of preventive action as part of Clause 4.14. Preventive action aimed to address potential issues before they resulted in nonconformities. While it wasn’t a specific clause for handling nonconformities, preventive action was a step toward proactive quality management.

ISO 9001:2000:

The year 2000 revision brought a significant change by restructuring the standard and introducing a dedicated clause for “Control of nonconforming product” (Clause 8.3). This was a specific section addressing the identification, documentation, and control of nonconformities in products.

ISO 9001:2008:

The 2008 version continued to have a specific clause for “Control of nonconforming product” (Clause 8.3), emphasizing the need for organizations to have processes to ensure that nonconforming products were identified and controlled.

ISO 9001:2015:

The current version, ISO 9001:2015, further evolved the approach by merging the concepts of corrective action and preventive action into a unified clause. Clause 10.2, titled “Nonconformity and corrective action,” addresses the broader spectrum of nonconformities and emphasizes the importance of understanding and addressing their root causes.

The history of Clause 10.2 reflects a progression in the ISO 9001 standard’s approach to managing nonconformities and driving continual improvement. The shift from preventive action to a comprehensive approach that includes corrective action aligns with the standard’s emphasis on risk-based thinking and a more integrated quality management system.

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