RECORD REQUIREMENTS:

SECTION
4.2.1 General 4.2.3.1 Engineering specifications 4.2.4 Control of records 4.2.4.1 Records retention 5.6.1 Management Review General 5.6.1 .1 Quality Management system Performance 6.2.2 Competence, Awareness, and Training 7.1 Planning a product realization 7.2.2 Review of requirements related to the product 7.3.2 Design and development inputs 7.3.4 Design and development review 7.3.5 Design and development verification 7.3.6 Design and development of validation 7.3.7 Control of design and development changes 7.4.1 Purchasing process 7.5.2 Validation of processes for production and service provision 7.5.3 Identification and traceability 7.5.4 Customer property 7.6 Control of monitoring and measuring devices

DESCRIPTION
Reference to records required by the standard Records of date on which engineering specifications are implemented in production (includes updation dates of documents) Records are established and maintained to provide evidence of conformity The control of records shall satisfy regulatory and customer requirements Management Review records Monitoring of quality objectives and reporting and evaluation of cost of poor quality. Records to show at a minimum , evidence of achievement of quality objectives and customer satisfaction Education, training, skills, and experience Evidence is recorded that the realization processes and resulting product meet requirements Results of the review and actions are rising from the review Inputs relating to product requirements Results of the reviews and any necessary actions Results of the verification and any necessary actions Records of the results of validation and any necessary actions Results of the review of changes in any necessary actions Results of supplier evaluations and any necessary actions are rising from the valuation Requirements for records as applicable Where traceability is a requirement, the unique identification of the product Records of customer property that has lost, damaged, or unsuitable for use Where no standards exist, bases used for calibration is recorded Records of the results of calibration and verification are maintained Records of validity of previous measuring results when equipment is found not to conform to requirements Records of audit results

8.2.2 Internal audit (QMS, Manufacturing process audit , product audit)

8.2.3.1 Monitoring and measurement of manufacturing processes 8.2.4 Monitoring and measurement of product 8.3 Control of non-conforming product 8.5.2 Corrective action 8.5.2.4 Rejected product test / analysis 8.5.3 Preventive action

Implied records for reporting verification follow up activities and results Records of effective dates of process changes Records indicates the person(s) authorizing the release of the product The nature of nonconformities and any subsequent actions taken, including concessions obtained Records for corrective action results taken Records of rejected product analysis Records for preventive action results taken