System Guides

ISO 9001 Clause 8.7 - QMS Control of Nonconforming Process Outputs, Products, and Services

Clause 8.7 of the ISO 9001 standard addresses the control of nonconforming process outputs, products, and services within the Quality Management System (QMS). This clause focuses on identifying and managing instances where process outputs or products do not meet specified requirements.

1. Identification of Nonconformities

Step 1: Detection

Implement mechanisms to detect and identify instances of nonconformities in process outputs, products, or services. This can be achieved through inspections, tests, audits, or customer feedback.

Step 2: Documentation

Document the criteria for identifying and classifying nonconformities, including the nature and severity of the nonconformity.

2. Evaluation and Decision

Step 1: Evaluation

Assess the nonconformity to determine its impact on product or service quality, customer requirements, and safety.

Step 2: Decision-Making

Determine the appropriate action to take based on the evaluation. This may involve rework, repair, scrapping, or other corrective actions.

3. Documentation and Record-Keeping

Step 1: Record Nonconformities

Document details of the identified nonconformity, including its nature, location, severity, and any corrective actions taken.

Step 2: Maintain Records

Maintain records of all nonconformities and their resolution processes.

4. Corrective and Preventive Actions

Step 1: Corrective Actions

Implement corrective actions to address the root cause of the nonconformity and prevent its recurrence.

Step 2: Preventive Actions

Implement preventive actions to eliminate the potential for similar nonconformities in the future.

5. Review and Approval

Step 1: Review

Review the effectiveness of corrective and preventive actions to ensure that they adequately address the nonconformity.

Step 2: Approval

Ensure that relevant stakeholders review and approve the proposed corrective and preventive actions.

6. Communication

Step 1: Communication

Notify relevant departments, teams, and individuals about the identified nonconformity, its impact, and the actions being taken.

Step 2: Preventive Measures

Communicate preventive actions to relevant parties to prevent the recurrence of similar nonconformities.

7. Continuous Improvement

Step 1: Analysis

Analyze data related to nonconformities to identify trends and patterns that can guide process improvements.

Step 2: Improvement Initiatives

Use insights gained from nonconformities to drive continuous improvement initiatives in processes, products, and services.

8. Benefits of Nonconformity Control

• Quality Improvement: Effective control of nonconformities leads to improved product and service quality.
• Customer Satisfaction: Preventing nonconformities enhances customer satisfaction and trust.
• Risk Mitigation: Addressing nonconformities reduces the risk of delivering defective products or services.
• Regulatory Compliance: Control of nonconformities helps organizations meet regulatory and legal requirements.
• Learning and Improvement: Analyzing nonconformities provides valuable insights for process enhancement.

9. Conclusion

Clause 8.7 of ISO 9001 emphasizes the importance of effectively controlling nonconforming process outputs, products, and services. By implementing systematic processes for identifying, evaluating, and addressing nonconformities, organizations can ensure that their products and services consistently meet customer requirements and adhere to established quality standards. Through corrective and preventive actions, continuous improvement can be achieved, resulting in enhanced product and service quality, customer satisfaction, and overall organizational performance.