TS16949 Records Requirement

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 sp specifications

Records of date on on hich en engineering sp specifications ar are implemented in production !includes updation dates of documents" Records are established and maintained to pro#ide e#idence of conformity $he control of records shall satisfy regulatory and customer requirements 'anagement Re Re#ie re records

4.2.4 Control of records 4.2.4.1 Records retention %.&.1 'a 'anagement Re Re#ie ( General %.&.1 .1 )uality 'anagement system *erformance

&.2.2 &.2.2 Compet Competence ence,, -ar -arenes eness, s, and $raini $raining ng 0.1 *lanning a product realiation

'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 Educat Education ion,, trai trainin ning, g, sills sills,, and and e/peri e/perience ence

0.2.2 Re#ie of requirements related to the  product 0.3.2 e esign an and de de#elopment in inputs

E#idence is recorded that the realiation processes and resulting product meet requirements Results of the re#ie and actions are rising from the re#ie nputs re relating to to pr product re requirements

0.3.4 3.4 e esign and de de#el #elopment re re#ie

Result ults of of th the re re#ie #ies an and an any ne necessary ac actions

0.3.% 0.3.% esi esign gn and and de#el de#elop opme ment nt #er #erif ific icat atio ion n

Resu Result ltss of of the the #er #erif ific icat atio ion n and and any any nec neces essa sary ry acti action onss

0.3.& 0.3.& esi esign gn and and de#elop de#elopmen mentt of of #ali #alidat dation ion

Record Recordss of the result resultss of of #ali #alidat dation ion and any necess necessary ary actions Results of the re#ie of changes in any necessary actions

0.3.0 Control of design and de#elopment changes 0.4.1 *urchasing process 0.%.2 alidation of processes for production and ser#ice pro#ision 0.%.3 d dentification an and tr traceability 0.%.4 Customer property 0.& Control of monitoring and measuring de#ices

6.2.2 nternal audit !)'7, 'anufacturing  process audit , product audit"

Results of supplier e#aluations and any necessary actions are rising from the #aluation Requirements for records as applicable 5here tr traceability is is a requirement, th the un unique identification of the product Records of customer property that has lost, damaged, or unsuitable for use 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 Records of audit results •

mplied records for reporting #erification follo up acti#ities and results Records of effecti#e dates of process changes •

6.2.3.1 'onitoring and measurement of manufacturing processes 6.2.4 'onitoring and measurement of product

6.%.2 Correcti#e action

Records indicates the person!s" authoriing the release of the product $he nature of nonconformities and any subsequent actions taen, including concessions obtained 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

6.3 Control of non8conforming product