ISO 9001:2015 Clause 8.7.1

What is ISO 9001:2015 Clause 8.7.1

Clause 8.7.1 of ISO 9001:2015 is titled “Control of Nonconforming Outputs.” This clause outlines requirements for organizations to establish processes to identify, control, and take appropriate actions regarding nonconforming products or services.

Key points outlined in Clause 8.7.1 include:

Identification of Nonconformities:

Organizations must have processes in place to identify products, services, or processes that do not meet specified requirements.

Documentation and Recording:

Nonconformities must be documented, including the nature of the nonconformity and any actions taken.

Evaluation and Decision Making:

Organizations must determine the significance of nonconformities and decide on appropriate actions, which may include segregation, quarantine, rework, repair, or other actions to mitigate the impact of nonconformities.

Authorization for Nonconforming Outputs:

There should be defined criteria for authorizing the use, release, or acceptance of nonconforming products or services.

Review and Approval:

Nonconforming outputs and the actions taken to address them should be reviewed and approved by relevant personnel.

Recording and Reporting:

Organizations must maintain records of nonconforming products or services, as well as any actions taken, and report relevant information to appropriate stakeholders as necessary.

Continual Improvement:

Organizations should analyze data related to nonconformities to identify trends, root causes, and opportunities for improvement in their processes.

Overall, this clause emphasizes the importance of promptly identifying and addressing nonconformities to prevent their recurrence, ensure customer satisfaction, and continually improve the effectiveness of the quality management system.

Other ISO 9001:2015 Clauses:

How do companies comply with clause 8.7.1?

Compliance with Clause 8.7.1 of ISO 9001:2015, which focuses on the control of nonconforming outputs, involves implementing systematic processes to identify, evaluate, and address instances where products, services, or processes do not meet specified requirements. Here are the steps a company can take to comply with this clause:

Establish Procedures:

Develop documented procedures that define how nonconformities will be identified, documented, evaluated, and addressed within the organization. These procedures should be clear, accessible, and communicated to relevant personnel.

Nonconformity Identification:

Implement processes to systematically identify nonconformities, whether they are detected during production, inspection, testing, customer feedback, or other stages of the product/service lifecycle.

Documentation and Recording:

Ensure that nonconformities are documented promptly and accurately, including details such as the nature of the nonconformity, its location, the product or service affected, and any other relevant information.

Evaluation and Decision Making:

Establish criteria for evaluating the significance of nonconformities and determining appropriate actions. This may include segregating nonconforming items, initiating rework or repair, seeking customer approval, or taking other corrective or preventive actions as necessary.

Authorization for Use or Release:

Define criteria and procedures for authorizing the use, release, or acceptance of nonconforming products or services based on factors such as risk, customer requirements, regulatory compliance, and the organization’s quality objectives.

Review and Approval:

Ensure that decisions regarding nonconformities and the actions taken to address them are reviewed and approved by competent personnel, including those responsible for quality assurance, production, and relevant management roles.

Recording and Reporting:

Maintain accurate records of nonconforming outputs, actions taken, and their outcomes. Report relevant information to stakeholders as required, such as customers, regulatory authorities, or internal management, to facilitate transparency and accountability.

Analysis and Improvement:

Regularly analyze data related to nonconformities to identify trends, root causes, and opportunities for improvement. Use this information to implement corrective and preventive actions aimed at reducing the occurrence of nonconformities and enhancing the effectiveness of the quality management system.

By following these steps and integrating robust nonconformity control processes into their quality management system, companies can effectively comply with Clause 8.7.1 of ISO 9001:2015 and demonstrate their commitment to delivering products and services that meet customer requirements and regulatory standards.

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