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| | 9 | a register of the monitoring and measuring equipment (that includes: the equipment type, unique identification, location, and the calibration or verification method, frequency, and acceptance criteria). | 7.1.5.2 | | | 9 | a register of the monitoring and measuring equipment (that includes: the equipment type, unique identification, location, and the calibration or verification method, frequency, and acceptance criteria). | 7.1.5.2 | |
| | 10 | The organization shall "determine" and "maintain" //**documented information**// "to the extent necessary:" \\ 1. to have confidence that the processes have been carried out as planned; \\ 2. to demonstrate the conformity of products and services to their requirements; \\ **[SUBJECTIVE requirement - to be determined by the ORGANIZATION (as per 7.5.1b)... NOT the auditor.]** | 8.1.e | | | 10 | The organization shall "determine" and "maintain" //**documented information**// "to the extent necessary:" \\ 1. to have confidence that the processes have been carried out as planned; \\ 2. to demonstrate the conformity of products and services to their requirements; \\ **[SUBJECTIVE requirement - to be determined by the ORGANIZATION (as per 7.5.1b)... NOT the auditor.]** | 8.1.e | |
| | 11 | Controlled conditions shall include, as applicable: \\ a. the availability of //**documented information**// that defines: \\ 1. the characteristics of the products to be produced, the services to be provided, or the activities to be performed; \\ 2. the results to be achieved; \\ **[This documented information //may// be provided by the customer]** | 8.5.1.a | | | 11 | Controlled conditions shall include, as applicable: \\ a. the availability of //**documented information**// that defines: \\ 1. the characteristics of the products to be produced, the services to be provided, or the activities to be performed; \\ 2. the results to be achieved; \\ **[This documented information //may// be provided by the customer (e.g., Drawings)]** | 8.5.1.a | |
| | 12 | c. the implementation of monitoring and measurement activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for products and services, have been met; \\ 1. ensuring that //**documented information**// for monitoring and measurement activity for product acceptance includes: \\ - criteria for acceptance and rejection; \\ - where in the sequence verification operations are to be performed; \\ - measurement results to be retained (at a minimum an indication of acceptance or rejection); \\ - any specific monitoring and measurement equipment required and instructions associated with their use; | 8.5.1.c1 | | | 12 | c. the implementation of monitoring and measurement activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for products and services, have been met; \\ 1. ensuring that //**documented information**// for monitoring and measurement activity for product acceptance includes: \\ - criteria for acceptance and rejection; \\ - where in the sequence verification operations are to be performed; \\ - measurement results to be retained (at a minimum an indication of acceptance or rejection); \\ - any specific monitoring and measurement equipment required and instructions associated with their use; | 8.5.1.c1 | |
| | 13 | The organization’s nonconformity control process shall be maintained as //**documented information**// including the provisions for: \\ − defining the responsibility and authority for the review and disposition of nonconforming outputs and the process for approving persons making these decisions; \\ − taking actions necessary to contain the effect of the nonconformity on other processes, products, or services; \\ − timely reporting of nonconformities affecting delivered products and services to the customer and to relevant interested parties; \\ − defining corrective actions for nonconforming products and services detected after delivery, as appropriate to their impacts (see 10.2). | 8.7.1 | | | 13 | The organization’s nonconformity control process shall be maintained as //**documented information**// including the provisions for: \\ − defining the responsibility and authority for the review and disposition of nonconforming outputs and the process for approving persons making these decisions; \\ − taking actions necessary to contain the effect of the nonconformity on other processes, products, or services; \\ − timely reporting of nonconformities affecting delivered products and services to the customer and to relevant interested parties; \\ − defining corrective actions for nonconforming products and services detected after delivery, as appropriate to their impacts (see 10.2). | 8.7.1 | |
