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PQB D 16 S

ISO/TS 16 949 readiness

D 16
ISO/TS 16 949 readiness
Goal 1 Quality approach 1.1 Back round 1.! Scope ! "rinciples and steps # "rocess approach #.1 De$initions #.! "rocess #.!.1 %ana e&ent process #.!.! 'eali(ation process #.!.# Support process #.# "rocess &appin #.4 "rocess approach 4 Quality &ana e&ent syste& )Q%S* re+uire&ents 4.1 General re+uire&ents 4.! Docu&entation , %ana e&ent responsi-ility ,.1 .o&&it&ents ,.! %ana e&ent re/ie0 6 'esource &ana e&ent 1 "roduct reali(ation 1.1 "lannin 1.! .usto&er 1.# Desi n and de/elop&ent 1.4 "urchasin 1., "roduction 1.6 %onitorin and &easurin 2 %easure&ent3 analysis and i&pro/e&ent 2.1 General 2.! Internal audit 2.# 4oncon$or&in product 2.4 5nalysis o$ data 2., I&pro/e&ent 2.,.1 .ontinual i&pro/e&ent 2.,.! .orrecti/e action 2.,.# "re/enti/e action 5nne6es Goal o$ the &odule: Readiness for implementation, certification, maintenance and improvement of your quality management system for automotive production (ISO/TS 16 ! " so as to #e a#le to: increase t$e satisfaction of sta%e$olders improve economic and financial results demonstrate conformity to customer automotive, statutory and regulatory requirements

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ISO/TS 16 949 readiness

PQB D 16 S

1 Quality approach 1.1 Back round T$e quality management systems (&'S" ISO ((( standards $ave appeared in:

1 )*: ISO ((( first edition: ISO ((1+ ISO ((,+ ISO ((-+ ISO ((! 1 !: ISO ((( first revision: ISO ((1+ ISO ((,+ ISO ((-+ ISO ((! . more understanda#le, customer focus #etter defined, preventive actions added ,(((: ISO ((( second : ISO (((+ ISO ((1+ ISO ((! . simplified structure () clauses", priority to process approac$ and customer satisfaction ,((): t$ird revision (fourt$ edition of ISO ((1": clarification of t$e requirements (no ne/ requirement", #etter alignment /it$ ISO 1! ((1

T$e ISO standards (more t$an 10 6((" are used in countless fields and are recogni1ed all over t$e /orld2 ISO is t$e international organi1ation for standardi1ation and /as created in 1 !*2 T$e ISO ((( family of standards contains t$ree core #oo%lets: ISO 9777 )!77,*8 Quality &ana e&ent syste&s 9 :unda&entals and /oca-ulary ISO 9771 )!772*8 Quality &ana e&ent syste&s 9 'e+uire&ents ISO 9774 )!779*8 %ana in $or the sustained success o$ an or ani(ation 9 5 +uality &ana e&ent approach

3 specialised la#oratory standard: ISO 11 7!, )!77,*8 General re+uire&ents $or the co&petence o$ testin cali-ration la-oratories and

3ll t$ese standards and many more can #e ordered on t$e ISO site2 T$e automotive standards $ave appeared in t$e 1 7aimler, 4al;o<": (s (34S& 5 6I3T, 473 5 89' : 49 :

1 !: =3&6 (>S3 : Renalt"+ &S ((( (?$rysler : 6ord : @'" 1 ): &S ((( t$ird version 1 : ISO/TS 16 ! first version ,((,: ISO/TS 16 ! second version ,(( : ISO/TS 16 ! t$ird version

T$e role of t$e I3T6 (International 3utomotive Tas% 6orce" /as essential to replace t$e eAisting standards in different countries /it$ a single tec$nical specification: ISO/TS 16 9498 Quality &ana e&ent syste&s. "articular re+uire&ents $or the application o$ ISO 97718 !772 $or auto&oti/e production and rele/ant ser/ice part or ani(ations T$is allo/s a single certification recogni1ed /orld/ide for any organi1ation lin%ed to automotive production2 T$e requirements of ISO/TS 16 ! and t$e specific requirements of customers are t$e #asis of any quality management system for automotive manufacturers2

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PQB D 16 S

ISO/TS 16 949 readiness

T$e tec$nical specification ISO/TS 16 ! fully resumes t$e ) clauses of ISO ((1: ,(() (#oAed teAt" and adds t$e specific requirements for t$e automotive industry ()1 su#clauses, ! notes and one normative anneA"2 Some of t$ese requirements: #usiness plan special c$aracteristics 3dvanced >roduct &uality >lanning (3>&>" analysis of potential ris%s (6ailure 'ode and =ffects 3nalysis, 6'=3" control plan la#oratory control product acceptance process (>roduction >art 3pproval >rocess, >>3>" measurement systems analysis ('S3" statistical process control (S>?" 6or more information on t$ese core tools you can consult t$e follo/ing manuals: >roduction >art 3pproval >rocess (>>3>", ,((6, 3I3@ 3nalysis tec$niques for system relia#ility2 >rocedure for failure mode and effects analysis (6'=3", ,((6, I=? >otential 6ailure 'ode and =ffects 3nalysis (6'=3", ,((), 3I3@ 3dvanced >roduct &uality >lanning (3>&>", ,((), 3I3@ 'easurement Systems 3nalysis ('S3" B ,(1(, 3I3@ Statistical >rocess ?ontrol (S>?" B ,((0, 3I3@ =ffective >ro#lem Solving @uideline B ?ontinious &uality Improvement (?&I B1(" B ,((6, 3I3@ ISO/TS 16 ! :,(( @uidance 'anual B ?ontinious &uality Improvement (?&I B16" B ,(( , 3I3@

T$e standards of t$e series ISO 17 771 to ISO 17 719 are guidelines for quality management systems and /ill $elp you find many ans/ers (cf2 ISO ((!:,(( , 8i#liograp$y"2 1.! Scope T$e ISO/TS 16 ! tec$nical specification is applied to any organi1ation (/it$out limitations a#out si1e" manufacturing automotive products in t$e scope of design, development, production and relevant service2 Some requirements of clause *2- can #e eAcluded /$en t$e responsi#ility of product design and development is outsourced2 T$is is possi#le /$en t$ese eAclusions:

do not affect in any case product conformity lin%ed to: o customer requirements o applica#le regulation requirements do not release t$e organi1ation of its responsi#ilities are Custified in t$e quality manual do not concern design manufacturing processes

! "rinciples and steps Quality is anythin that can -e i&pro/ed. %asaaki I&ai &uality approac$ is a state of mind /$ic$ starts /it$ top management as a priority strategic decision and eAtends to all employees2 Top management defines t$e quality policy /$ic$
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