ISO 9001:2015 Clause 8.7.1 is a subsection of Clause 8.7, "Control of nonconforming outputs," which provides further specifics on how organizations should deal with nonconforming products or services. This clause does not exist as a standalone section; instead, the requirements for controlling nonconforming outputs are outlined within Clause 8.7 without further subdivisions in the standard. Therefore, when referring to the control of nonconforming outputs within ISO 9001:2015, one directly addresses the overall expectations set forth in Clause 8.7.
In addressing nonconforming outputs, ISO 9001:2015 emphasizes the importance of:
- Identification: Recognizing and documenting any outputs that do not meet the requirements.
- Control: Taking appropriate actions to prevent the unintended use or delivery of nonconforming outputs. This might include correction, segregation, or even scrapping of the product.
- Correction: Actions to make the nonconforming output meet requirements or to take suitable actions that mitigate the potential impact.
- Evaluation: Deciding on the acceptability of the nonconforming outputs, including any concessions obtained from the customer.
- Notification: Informing relevant internal parties and, where necessary, the customer or external parties about the nonconformity.
- Mitigation: Taking actions to address any consequences of the nonconformity, including preventing its recurrence.
Organizations are required to document information that describes the nonconformity, actions taken, any concessions obtained, and the identification of the authority deciding the action regarding the nonconformity. This ensures that there is traceability and accountability in how nonconformities are managed and resolved.
The comprehensive approach in Clause 8.7 ensures that organizations have a robust process for managing and mitigating the impact of nonconforming outputs, thereby safeguarding product and service quality, and ultimately, customer satisfaction.