ISO 9001:2015 Clause 8.7.2

What is ISO 9001:2015 Clause 8.7.2

Clause 8.7.2 of ISO 9001:2015 is titled “Control of Nonconforming Outputs.” This clause addresses the process by which organizations must deal with products or services that do not conform to specified requirements.

Key points outlined in Clause 8.7.2 include:

Identification:

Nonconforming outputs must be identified to prevent their unintended use or delivery.

Evaluation:

The organization needs to determine the significance of the nonconformity and its potential impact on the quality management system (QMS) and customer satisfaction.

Correction:

Actions must be taken to correct the nonconformity, which may include taking immediate action to mitigate any negative effects.

Review:

The organization should review the nonconformity to determine the root cause and take steps to prevent its recurrence.

Authorization:

The organization must have a process for authorizing the release of nonconforming products or services under specific conditions, which could include customer approval or rework.

Recording:

Records of nonconformities and actions taken should be maintained to demonstrate compliance with the requirements of the QMS and to provide evidence for audits. Overall, Clause 8.7.2 ensures that organizations have effective processes in place to manage nonconforming outputs, minimize their impact, and prevent their recurrence to maintain product and service quality.

Other ISO 9001:2015 Clauses:

How do companies comply with clause 8.7.2?

Companies can comply with Clause 8.7.2 of ISO 9001:2015 by implementing specific procedures and processes within their quality management system (QMS). Here’s how they typically achieve compliance:

Establishment of Procedures:

Companies should establish documented procedures for identifying, evaluating, and controlling nonconforming outputs. These procedures should be clear, well-defined, and easily accessible to relevant personnel.

Training and Awareness:

Ensure that employees are trained and aware of the procedures for identifying and handling nonconformities. This includes training on how to recognize nonconforming outputs, the importance of reporting them, and the steps to take for correction and control.

Nonconformity Identification:

Implement robust processes for identifying nonconforming outputs at various stages of production or service delivery. This may involve inspection, testing, customer feedback, or internal audits.

Evaluation of Nonconformities:

Develop criteria for evaluating the significance of nonconformities, considering factors such as the impact on product quality, customer requirements, safety, and regulatory compliance.

Correction and Corrective Action:

Take immediate action to correct nonconformities to prevent their unintended use or delivery. Additionally, establish procedures for investigating the root cause of nonconformities and implementing corrective actions to address underlying issues and prevent recurrence.

Authorization for Release:

Define criteria for authorizing the release of nonconforming products or services under controlled conditions. This may involve obtaining customer approval, implementing rework or repair procedures, or documenting deviations from standard processes.

Record Keeping:

Maintain accurate records of all nonconformities, actions taken for correction and corrective actions implemented, and any authorizations for the release of nonconforming products or services. These records provide evidence of compliance with ISO 9001 requirements and support continuous improvement efforts.

Monitoring and Review:

Regularly monitor and review the effectiveness of the processes for controlling nonconformities. This includes evaluating the frequency and nature of nonconformities, the timeliness and adequacy of corrective actions, and opportunities for preventive action to minimize future occurrences. By implementing these measures, companies can effectively comply with Clause 8.7.2 of ISO 9001:2015 and demonstrate their commitment to maintaining product and service quality while continuously improving their quality management system.

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