!. 0121345 674281- 49 6:;;<9911 =34>9 %9481 1he new sLandard: AdopLs hlgh-level sLrucLure and Lermlnology of Annex SL, a unlfled guldellne used for Lhe developmenL of all new lSC sLandards Pas been redrafLed Lo lncrease clarlLy and accesslblllLy, reduclng room for lnLerpreLaLlon lnLroduces Lwo new clauses relaLlng Lo Lhe conLexL of Lhe organlzaLlon, whlch requlre Lhe organlzaLlon Lo deLermlne Lhe lssues and requlremenLs LhaL can lmpacL on Lhe plannlng of Lhe quallLy managemenL sysLem and can be used as an lnpuL lnLo Lhe developmenL of Lhe quallLy managemenL sysLem. 1hese clauses can be found ln secLlons 4.1 and 4.2. Makes Lhe adopLlon of a process approach ln Lhe lmplemenLaLlon of a quallLy managemenL sysLem more expllclL, by lncludlng clause 4.4.2, whlch speclfles Lhe requlremenLs for Lhe adopLlon of a process approach 8eplaces Lhe Lerm 'producLs' by 'goods and servlces', ln order Lo remove Lhe exlsLlng blas Lowards organlzaLlons deallng wlLh physlcal producLs. As a resulL, Lhe new sLandard wlll be appllcable for organlzaLlons of any klnd. uoes noL conLaln a clause wlLh speclflc requlremenLs for prevenLlve acLlon. lSC moLlvaLes Lhls declslon by argulng LhaL prevenLlon ls Lhe Lask of Lhe quallLy managemenL sysLem ln lLs enLlreLy, as opposed Lo a speclflc subsecLlon of lL.
lSC 9001:2013 * of " uCS-uL ClS 2013-06-24
*. %93?@9?345 @74281-
A:91: 1he new clauses ln SecLlon 4 requlre Lhe organlzaLlon Lo deLermlne Lhe lssues and requlremenLs LhaL can lmpacL on Lhe plannlng of Lhe quallLy managemenL sysLem and can be used as an lnpuL lnLo Lhe developmenL of Lhe quallLy sysLem. *((+
*(!/ (. $293:B?@9<:2 C (. $293:B?@9<:2 !. %@:D1 C !. %@:D1 *. A:3;49<,1 31>1312@1- C *. A:3;49<,1 31>1312@1- E. F13;- 42B B1><2<9<:2- C E. F13;- 42B B1><2<9<:2-
". G?45<9H I42481;129 %H-91; ! ". 6:291J9 :> 971 :3842<K49<:2 4.1. Ceneral requlremenLs 4.1. undersLandlng Lhe organlzaLlon and lLs conLexL 4.2. uocumenLaLlon requlremenLs ! See secLlon 7.3
4.2. undersLandlng Lhe needs and expecLaLlons of lnLeresLed parLles
4.3. ueLermlnlng Lhe scope of Lhe quallLy managemenL sysLem 4.4. CuallLy ManagemenL SysLem 8ed LexL: LexL Laken from Annex SL 8lack LexL: LexL Laken from exlsLlng lSC 9001:2008 and developed by WC 24 lSC 9001:2013 E of " uCS-uL ClS 2013-06-24
/. I42481;129 31-D:2-<L<5<9H ! /. M14B13-7<D 3.1. ManagemenL commlLmenL 3.1. Leadershlp and commlLmenL 3.2. CusLomer focus 3.2. CuallLy ollcy 3.3. CuallLy pollcy 3.3. CrganlzaLlonal roles, responslblllLles and auLhorlLles 3.4. lannlng N. O5422<28 6.1. AcLlons Lo address rlsks and opporLunlLles 6.2. CuallLy ob[ecLlves and plannlng Lo achleve Lhem 6.3. lannlng of changes 3.3. 8esponslblllLy, auLhorlLy and communlcaLlon ! See secLlon 3.3. for sLaff responslblllLy, and 7.4. for communlcaLlon 3.6. ManagemenL revlew ! See secLlon 9.3. for managemenL revlew
N. P1-:?3@1 I42481;129 ! Q. %?DD:39 6.1. rovlslon of resources 7.1. 8esources 6.2. Puman resources 7.2. CompeLence 7.3. Awareness 7.4. CommunlcaLlon 6.3. lnfrasLrucLure ! See secLlon 7.1 for lnfrasLrucLure 6.4. Worklng LnvlronmenL ! See secLlon 7.1. for workplace crlLerla lSC 9001:2013 " of " uCS-uL ClS 2013-06-24
Q. O3:B?@9 3145<K49<:2 ! +. &D1349<:2 7.1. lannlng of producL reallzaLlon 8.1. CperaLlonal plannlng and conLrol 7.2. CusLomer-relaLed processes 8.2. ueLermlnaLlon of markeL needs and lnLeracLlons wlLh cusLomers 7.3. ueslgn and developmenL 8.3. CperaLlonal plannlng process 7.4. urchaslng 8.4. ConLrol of exLernal provlslon of goods and servlces 7.3. roducLlon and servlce provlslon 8.3. uevelopmenL of goods and servlces 7.6. ConLrol of monlLorlng and measurlng equlpmenL 8.6. roducLlon of goods and provlslon of servlces 8.7. 8elease of goods and servlces 8.8. nonconformlng goods and servlces
+. I14-?31;129R 4245H-<- 42B <;D3:,1;129 '. O13>:3;42@1 1,45?49<:2 8.1. Ceneral 9.1. MonlLorlng, measuremenL, analysls and evaluaLlon 8.2. MonlLorlng and measuremenL 9.2. lnLernal audlL 9.3. ManagemenL revlew 8.3. ConLrol of nonconformlng producL ! See 8.8 8.4. Analysls of daLa ! See 9.1 8.3. lmprovemenL !(. $;D3:,1;129 10.1. nonconformlLy and correcLlve acLlon 10.2. lmprovemenL