TS16949 Records Requirement
2
RECORD REQUIREMENTS: SECTION DESCRIPTION 4.2.1 General Reference to records required by the standard 4.2.3 Control of documents For records are controlled according to 4.2.4 4.2.3.1 Engineering specifications Records of date on which engineering specifications are implemented in production (includes updation dates of documents) 4.2.4 Control of records Records are established and maintained to provide evidence of conformity 4.2.4.1 Records retention The control of records shall satisfy regulatory and customer requirements 5.6.1 Management Review – General Management Review records 5.6.1 .1 Quality Management system Performance 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 6.2.2 Competence, Awareness, and Training Education, training, skills, and experience 7.1 Planning a product realization Evidence is recorded that the realization processes and resulting product meet requirements 7.2.2 Review of requirements related to the product Results of the review and actions are rising from the review 7.3.2 Design and development inputs Inputs relating to product requirements 7.3.4 Design and development review Results of the reviews and any necessary actions 7.3.5 Design and development verification Results of the verification and any necessary actions 7.3.6 Design and development of validation Records of the results of validation and any necessary actions 7.3.7 Control of design and development changes Results of the review of changes in any necessary actions 7.4.1 Purchasing process Results of supplier evaluations and any necessary actions are rising from the
Transcript of TS16949 Records Requirement
RECORD REQUIREMENTS:
SECTION DESCRIPTION4.2.1 General Reference to records required by the standard
4.2.3 Control of documents For records are controlled according to 4.2.4
4.2.3.1 Engineering specifications Records of date on which engineering specifications are implemented in production (includes updation dates of documents)
4.2.4 Control of records Records are established and maintained to provide evidence of conformity
4.2.4.1 Records retention The control of records shall satisfy regulatory and customer requirements
5.6.1 Management Review – General Management Review records
5.6.1 .1 Quality Management system Performance
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
6.2.2 Competence, Awareness, and Training Education, training, skills, and experience
7.1 Planning a product realization Evidence is recorded that the realization processes and resulting product meet requirements
7.2.2 Review of requirements related to the product
Results of the review and actions are rising from the review
7.3.2 Design and development inputs Inputs relating to product requirements
7.3.4 Design and development review Results of the reviews and any necessary actions
7.3.5 Design and development verification Results of the verification and any necessary actions
7.3.6 Design and development of validation Records of the results of validation and any necessary actions
7.3.7 Control of design and development changes
Results of the review of changes in any necessary actions
7.4.1 Purchasing process Results of supplier evaluations and any necessary actions are rising from the valuation
7.5.2 Validation of processes for production and service provision
Requirements for records as applicable
7.5.3 Identification and traceability Where traceability is a requirement, the unique identification of the product
7.5.4 Customer property Records of customer property that has lost, damaged, or unsuitable for use
7.6 Control of monitoring and measuring devices
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
8.2.2 Internal audit (QMS, Manufacturing process audit , product audit)
Records of audit results Implied records for reporting verification follow
up activities and results8.2.3.1 Monitoring and measurement of manufacturing processes
Records of effective dates of process changes
8.2.4 Monitoring and measurement of product Records indicates the person(s) authorizing the release of the product
8.3 Control of non-conforming product The nature of nonconformities and any subsequent actions taken, including concessions obtained
8.5.2 Corrective action Records for corrective action results taken
8.5.2.4 Rejected product test / analysis Records of rejected product analysis
8.5.3 Preventive action Records for preventive action results taken
