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 hich engineering specifications are
implemented in production !includes updation dates of
documents"
4.2.4 Control of records Records are established and maintained to pro#ide
e#idence of conformity
4.2.4.1 Records retention $he control of records shall satisfy regulatory and
customer requirements
%.&.1 'anagement Re#ie ( General 'anagement Re#ie records
%.&.1 .1 )uality 'anagement system
*erformance
'onitoring of quality ob+ecti#es and reporting and
e#aluation of cost of poor quality. Records to sho at a
minimum , e#idence of achie#ement of quality ob+ecti#es
and customer satisfaction
&.2.2 Competence, -areness, and $raining Education, training, s.ills, and e/perience
0.1 *lanning a product reali1ation E#idence is recorded that the reali1ation processes and
resulting product meet requirements
0.2.2 Re#ie of requirements related to the
product
Results of the re#ie and actions are rising from the
re#ie
0.3.2 2esign and de#elopment inputs 3nputs relating to product requirements
0.3.4 2esign and de#elopment re#ie Results of the re#ies and any necessary actions
0.3.% 2esign and de#elopment #erification Results of the #erification and any necessary actions
0.3.& 2esign and de#elopment of #alidation Records of the results of #alidation and any necessary
actions
0.3.0 Control of design and de#elopment
changes
Results of the re#ie of changes in any necessary actions
0.4.1 *urchasing process Results of supplier e#aluations and any necessary actions
are rising from the #aluation
0.%.2 4alidation of processes for production
and ser#ice pro#ision
Requirements for records as applicable
0.%.3 3dentification and traceability 5here traceability is a requirement, the unique
identification of the product
0.%.4 Customer property Records of customer property that has lost, damaged, or
unsuitable for use
0.& Control of monitoring and measuring
de#ices
5here no standards e/ist, bases used for
calibration is recorded
Records of the results of calibration and
#erification are maintained
Records of #alidity of pre#ious measuring results
hen equipment is found not to conform to
requirements
6.2.2 3nternal audit !)'7, 'anufacturing
process audit , product audit"
Records of audit results
3mplied records for reporting #erification follo
up acti#ities and results
6.2.3.1 'onitoring and measurement of
manufacturing processes
Records of effecti#e dates of process changes
6.2.4 'onitoring and measurement of product Records indicates the person!s" authori1ing the release of
the product
6.3 Control of non8conforming product $he nature of nonconformities and any subsequent actions
ta.en, including concessions obtained
6.%.2 Correcti#e action Records for correcti#e action results ta.en
6.%.2.4 Re+ected product test 9 analysis Records of re+ected product analysis
6.%.3 *re#enti#e action Records for pre#enti#e action results ta.en