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ISO9001-Records_Requirement_List

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ISO9001-Records_Requirement_List Powered By Docstoc
					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
4.2.4 Control of records                       Records are established and maintained to provide
                                               evidence of conformity
5.6.1 Management Review – General              Management Review records
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    Results of the review and actions are rising from the
product                                        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        Results of the review of changes in any necessary actions
changes
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   Requirements for records as applicable
and service provision
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             Where no standards exist, bases used for
devices                                                calibration is recorded
                                                    Records of the results of calibration and
                                                       verification are maintained
8.2.2 Internal audit                                Records of audit results
                                                    Implied records for reporting verification follow
                                                       up activities and results
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
8.5.3 Preventive action                        Records for preventive action results taken

				
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Description: business document