| Provide on-the-job training (which shall include customer requirements training)
Includes contract or agency personnel
Includes new or modified responsibilities
Informed about the consequences of nonconformity to customer requirements.
| Document processes for identifying training needs
Awareness, is a new requirement which would typically include:
Quality policy, quality objectives, personnel contribution to the QMS, benefits of improved performance, and implications of not conforming with QMS requirements.
Focus on satisfaction of customer requirements
Qualified for specific assigned tasks
| Organizational assessments or second party are allowed when approved by customer
Calibration requirements are increased to accreditation
the laboratory shall be accredited to ISO/IEC 17025 or national equivalent and include the relevant inspection, test, or calibration service in the scope of the accreditation (certificate); the certificate of calibration or test report shall include the mark of a national accreditation body; or
there shall be evidence that the external laboratory is acceptable to the customer.
Calibration services may be performed by the equipment manufacturer when a qualified laboratory is not available
Use of calibration services, other than by qualified (or customer accepted) laboratories, may be subject to government regulatory confirmation, if required.
| Revisions following engineering changes
Out-of-specification readings as received for calibration/verification;
Assessment of the risk of the intended use of the product caused by the out-of-specification condition;
M&TE with “AS-Found: calibration data out of tolerance – records of evaluation of previous measurement results
Notification to the customer if suspect product or material has been shipped;
statements of conformity to specification after calibration/verification;
verification that the software version used for product and process control is as specified;
records of the calibration and maintenance activities for all gauging (including employee-owned equipment, customer-owned equipment, or on-site supplier-owned equipment);
production-related software verification used for product and process control
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- S019 - Section 22.214.171.124: Plant, facility, and equipment planning
- S018 - Section 126.96.36.199: Quality objectives and planning to achieve them – supplemental
- S017 - Section 188.8.131.52: Contingency Plans