Tiêu chuẩn iso ts 22163 2017

The proc d r s used t o develo this document an those int en ed for it furthe maint enanc ar desc ibed in the ISO/IEC Dir ctives, Part 1.. In this Int ernational Stan ard, the folowing v

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Rail way applications — Quality

Ap lications fe ro iaire s — S stème de ma a ement de la q alité —

Exigence s liée s a système de ma a ement de l’activité à de stination

des org nisme s fe roviaire s: ISO 9 01:2 15 et exigence s p rtic ulière s

co c rn nt le s a plications da s le sec teur fe roviaire

Refer ence n mb r

ISO/TS 2 163:2 17(E)

Fir t edition

2 17-0

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COPYRIGHT PROTECTED DOCUMENT

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F r ewor d vi

0 Introduction vii

1 Sc ope 1

1.1 S o e — Sup lemental 1

2 Nor mati ve referenc es 2

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3.2 A bbr eviations 7

4 Co te x t of the or ganization 8

4.1 Un e s an ing the or ganization an it context 8

4.2 Un e s an ing the ne ds an ex pe tations of inter es ed p rties 8

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5 Le der ship 11

5.1 Leade ship an commitment 1

5.1.1 General 1

5.1.2 Cus ome focus 1

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5.3 Or ganizational r oles, r esp nsibi ties an authorities 1

5.3.1 Or ganizational r oles, r esp nsibi tiesand authorities — Sup lemental 1

5.3.2 Resp nsibi ties and authorities of pr oc s owne s

1 6 Planning 14

6.1 A ctions to ad r es risks an o p rtu ities 14

6.1.3 A ctionsto ad r es risks an o p rtu ities — Sup lemental

14 ?????? ? ????? ????????? ??? 1

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6.3 Plan ing of chang es 1

6.4 Busines plan ing 1

7 Sup or t 17

7.1 Resour ces 1

7.1.1 General 1

7.1.2 Peo le 1

7.1.3 Infrastructur e 1

7.1.4 E vir onment for the o eration of pr oc s es 1

7.1.5 Monitoring an measuring r esour ces 1

7.1.6 Or ganizational k owledg e 2

7.2 Competenc 2

7.2.1 C mpetenc — Sup lemental 2

7.3 Awar enes 2

7.3.1 Awar enes — Sup lemental 2

7.4 Commu ication 2

7.5 Documented information 2

7.5.1 General 2

7.5.2 Cr eating an updating 2

7.5.3 C ntr ol of documented information 24

8 Operatio 25

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8.1 Oper ational plan ing an contr ol 2

8.1.1 Plan ing for the out our cing or tr anse of pr oc s es 2

8.1.2 Tende manag ement 2

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8.1.5 Chang e manag ement 3

8.2 Req ir ement for prod ct and se vic s 3

8.2.1 Cus ome commu ication 3

8.2.2 Dete mining the r eq ir ement r elated to pr od ct an se vic s 3

8.2.3 Review of r eq ir ements r elated to pr od cts and se vic s 34

8.2.4 Chang es to r eq ir ements for pr od ct an se vic s 34

8.2.5 Req ir ements for pr od cts an se vic s — Sup lemental 34

8.3 Desig n an develo ment of pr od ct an se vic s 3

8.3.1 General 3

8.3.2 Desig n an develo ment plan ing 3

8.3.3 Desig n an develo ment input 3

8.3.4 Desig n an develo ment contr ols 3

8.3.5 Desig n an develo ment outputs 40

8.3.6 Desig n an develo ment chang es 41

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8.4.1 General 41

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8.4.3 Information for ex te nal pr ovide s 46

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8.5 Pr od ction and se vic pr ovision 48

8.5.1 C ntrol of prod ction and se vic pr ovision 48

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8.5.4 Pr ese v tion 5

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8.5.6 C ntrol of chang es 54

8.5.7 Pr od ction schedulng 54

8.6 Release of pr od ct an se vic s 5

8.6.1 Release of pr od ct an se vic s — Supplemental 5

8.7 Contr ol of nonconforming output 5

8.7.3 C ntrol of nonconforming outputs — Sup lemental 5

8.8 R A MS / L C 5

8.9 Firs article inspe tion 5

8.1 Obsolesc nc manag ement 5

8.1 In o ation manag ement 5

9 P erformanc e evaluatio 59

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9.1.1 General 5

9.1.2 Cus ome satis action 6

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9.2 Inte nal au it 6

9.2.3 Inte nal au it — Sup lemental 6

9.3 Manag ement r eview 6

9.3.1 General 6

9.3.2 Manag ement r eview input 64

9.3.3 Manag ement r eview outputs 6

9.4 Pr oc s r eviews 6

10 Improvement 66

1 1 General 6

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1 3 Contin al impr ovement 6

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Biblog raph y 69

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For eword

ISO (he Int ernational Org nization for Stan ardization) is a worldwide fede ation of national s an ards

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committ ee has be n es a lshed has the right t o be r pr sent ed on that committ ee Int ernational

org nizations, g overnmental an non-g ove nmental, in laison with ISO, also take p rt in the work

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ele trot ech ical s an ardization

The proc d r s used t o develo this document an those int en ed for it furthe maint enanc ar

desc ibed in the ISO/IEC Dir ctives, Part 1 In p rticular the dife ent a pro al c it eria ne ded for the

World Trade Org nization (WTO) principles in the Te hnical Bar ie s t o Trade (TBT) se the folowing

URL: www iso org iso / for word html

inclu ing the t ext out ide the b x es

Whenever this document r fe s t o clause n mbe s, it is t o be un e st ood that al the r q ir ment

un e this clauseinclu ing sub-clauses ar t o be conside ed

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manag ed, an that o p rtunitiesfor impro ement ar det ermined an act ed on.

Risk-b sed thinking ena les an org nization t o det ermine the fact ors that could cause it proc s es

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Clause A.4 )

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an contin al impro ement, such asbr akthrough chang e, in o ation an r -org nization

In this Int ernational Stan ard, the folowing verb l forms ar used:

0.2 Qualty manag ement principles

ISO 9 01:201 , Qualty manag ement sy stems — Requirements

0.2 Qual ty manag ement principles

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Figure 1 — Schematic representatio of the elements of a single proces

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0.3.2 Plan-Do-Check-A ct cycle

ISO 900 :20 5, Qualty manag ement sy stems — Requirements

0.3.2 Plan-Do-Check-A ct cycle

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???-ur 2i lus rat es how Cla uses 4 t o 1 ???????????????????? ???????? ?????????? ???????

NOTE Numbe s in bracket r fe t o the clausesin this Int ernational Standard

Figure 2— Representation of the structure of this Internatio al Standard in the PDCA cycle

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0.3.3 Risk-based thinking

To conform t o the r q ir ment of this Int ernational Standard, an org nization ne ds t o plan an

implement actions t o ad r s risks an o p rtunities Ad r s ing b th risks and o portu ities

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impro ed r sult an pr venting neg tive efe t

Op ortunities can arise as a r sult of a situation fa oura le t o achieving an int en ed r sult, for

ex mple, a set of cir ums anc s that alow the org nization t o at ract cust ome s, develo new

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0.4 Relatio ship with othe manag ement sy stem standards

This Int ernational Stan ard r lat es t o ISO 9 00 an ISO 9 04 as folow s:

— ISO 9 00 Qu lt y ma a ement sys tems — Fu damental s a d v c ab lar y pro ides es ential

t o the a plcation of this Int ernational Stan ard within the p rticular se t or

A matrix showing the cor elation betwe n the cla uses of this edition of this Int ernational Stan ard

an the pr vious edition (ISO 9 0 :2 0 ) can be fou d on the ISO/TC 176 /SC 2 o en ac es web sit e

at : www.iso.org t c 17 6 /sc0 / ublc

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Railway applications — Quality manag ement system

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ISO an IECmaintain t erminolo ical data ases for use in s andardization at the folowing ad r s es:

— IEC Ele tro edia:a ai a le at ht p:/ www ele tro edia org

— ISO Onlne brow sing platorm: a aia le at ht p:/ www iso org o p

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3.1.1

appl catio sof ware

comput er pro ram that pe formsa set of functions t o sup ort the ex ecution of a proc s

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combination of al t echnical and manag ement actions int en ed t o r tain an it em in, or r st or it t o a

s at e in w hich it can pe form as r q ir d

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pro uct equipment

eq ipment used for prod ction

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qualty as urance metho s

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e ror pr vention rathe than det ection

E AMP E In design an development

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4 Contex t of the or ganization

4.1 Under tanding the or ganization and its contex t

4.1 Under tanding the org nizatio and its context

The org nization shal det ermine ext ernal an int ernal is ues that ar r lev nt t o it purp se

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The org nization shal monit or and r view information a out these ext ernal an int ernal is ues

NOT 1 Is ues can inclu e positive an ne ative fact or or con itions for consideration

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tech olo ical, competitive, market, cultural, social an economic en ironments, whether international,

national, re ionalor local

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culture, k owledg an performance of the org nization

4.2 Under tanding the needs and e x pectations of interested parties

ISO 9001:201 , Qualty manag ement sy stems — Requirements

4.2 Under tanding the ne ds and ex ectatio s of interested parties

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4.3 Determining the sc ope of the qual ty manag ement system

4.3 Determining the s o e of the q al ty manag ement sy stem

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t o es a lsh it sco e

When det ermining this sco e, the org nization shal conside :

a) the ext ernal an int ernal is ues r fe r d t o in 4.1?

b) the r q ir ment of r lev nt int er st ed p rties r fe r d t o in 4.2?

c) the prod ct an se vic s of the org nization

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4.4 Qual ty manag ement system and its proc es es

4.4 Qualty manag ement sy stem and its proces es

4.4.3 Qualty manag ement system and its pr oc es es — Supplemental

When this document r q ir s a document ed proc s , the proc s documentation shal co e as a

minimum the r q ir ment desc ibed in 4.4.1 a) t o 4.4.1 e)

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The org nization shal :

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b) commu icat e proc s es ( e 7.4???? ?????? ????????? ????? ????? ???????????? ? ???

c) train peo le on proc s es an ensur u de s anding ( e 7.2.1 f? ?

d) ensur proc s es ar a pled an peo le ad e e t o proc s es ( e 9.2??

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of this document

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5 Leadership

5.1 Le der hip and c ommitment

5.1.1 General

5.1 Le der hip an commitment

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5.2 Pol cy

5.2.1 Establ shing the q alty polcy

5.2.2 C mmunicating the qual ty polcy

5.2.2 C mmunicating the qualty polcy

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c) be a aia let o r lev nt int er st ed parties, as a pro riat e

5.2.3 Qualty polcy — Su plemental

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5.3 Or ganizational roles, responsibi ities and author ities

5.3 Org nizatio al roles, respo sibiities and auth rities

To manag ement hal ensur that he r sp nsibi ties an authorities for r lev nt rolesar as igned,

communicat ed and un e st ood within the org nization

5.3.1 Or ganizatio al r oles, respo sibiities and authorities — Supplemental

The t op manag ement shal:

a) a point proc s owne s ( e 4.4.1????

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c) emp we r pr sentatives in epen ent, from the proc s ex ecution, t o st op the proc s or prod ct

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The org nization shal r tain r lat ed document ed information

5.3.2 Resp nsibi ities and authorities of pr oc es owner s

Proc s owne shal be r sp nsible for the proc s complanc t o r q ir ment lst ed in 4.4 ex cept

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6 Planning

6.1 Actions to addr es risks and oppor tunities

6 Planning

6.1 A ctions to addres risks and op ortunities

6.1.1 ????????? ??? ?????????? ?????????? ????????? ?????????? ? ?????????????????????? ??????? ????

r efe red to in 4.1 an the r eq ir ements refe r ed to in 4.2 an dete mine the risks an o portu ities

that ne d to be addr es ed to:

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d) achieveimpro ement

6.1.2 The or ganization shal plan:

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b) how t o:

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2) ev luat e the efe tivenes of these actions

A ctions taken t o ad r s risks an o p rtu ities shal be pro ortionat e t o the p t ential imp ct on

via le pos ibilities to ad res the org nization or its cust omer ’ ne ds

6.1.3 Actio s to addres risks and o por tu ities — Supplemental

The org nization shal es a l sh, implement an maintain a document ed risk manag ement proc s

This proc s shal conside :

a) ther q ir ment desc ibed in 6.1.1 an 6.1.2???

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In ad ition, this proc s should:

out our ing r q ir ment desc ibed in 8.1.1 shal be a pled

6.2 Q ual ty objecti ves and planning to achieve them

6.2 Qual ty o jectives and planning to achieve them

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chang esshal be car ied out in a plan ed man e ( e 4.4).

The org nization shal conside :

This busines plan ing should conside :

i chang e of ext ernal tr n s an int er st ed p rties ne ds (e.g e onomic p lcies, environmental

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i i an a pro riat e communication of plan ing output

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The org nization shal es a l sh, implement an maintain a document ed proc s for bu g et planning,

a pro al an control ing

This proc s shal conside :

a) the r sour es ne ded for peo le an infras ructur as a minimum for ex ecution of proc s es ( e

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7.1.4 Environment for the o eratio of pr oc es es

7.1.4 En iro ment for the o eratio of proces es

7.1.5 Mo itoring and me suring reso r es

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7.1.5.2 Me surement trac eabiity

7.1.5.2 Me surement trace biity

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7.1.6 Or ganizatio al knowledg e

7.1.6 Org nizational know ledg e

7.1.6.1 Or ganizatio al knowledg e — Su plemental

R eg rding org nizational know ledg e, the org nization shal :

a) manag e r turn of ex e ienc inclu ing:

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????????

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NOT R eturn of e perience can b derived from an not limited t o non-conformities, RAM / L C data,

cust omer complaints, int ernal au its, e t ernal provider au its, b nchmarks

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d) r tain a pro riat e document ed information as evidenc of compet enc

NOT Ap lica le actions can inclu e,for e ample, the provision of training to, the ment oring of, or the

The org nization shal r tain document ed information r lat ed t o compet enc manag ement activities

This proc s should:

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7.5 Documented information

— the compet ence of per ons

7.5.2 Creating and up ating

7.5.2 Cre ting and updating

When c eating an updating document ed information, the org nization shal ensur a pro riat e:

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7.5.3 C ntrol of documented informatio

7.5.3 Co trol of documented informatio

7.5.3.3 Co trol of documented infor mation — Supplemental

The org nization shal es a l sh, implement an maintain a document ed proc s for the control of

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8 Operation

8.1 Operational planning and control

8 Operatio

8.1 Operational planning and co trol

The org nization shal plan, implement an control the proc s es ( e 4.4) ne ded t o me t the

r q ir ment for the pro ision of prod ct an se vic s, an t o implement he actions det ermined in

The output of thisplanning shal be suita le for the org nization o e ations

The org nization shal control planned chang es an r view the conseq enc s of u int en ed chang es,

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The org nization shal ensur that out our ed proc s es ar control ed ( e 8.4)

8.1.1 Planning for the outso r cing or transfe of proc es es

The org nization shal es a lsh, implement an maintain a document ed proc s for the plan ing of the

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8.1.2 Tende manag ement

The org nization shal es a lsh, implement an maintain a document ed proc s t o manag e t ende s

This proc s shal inclu e:

a) r q ir ment manag ement ( e 8.2???

r g rding r q ir ment manag ement

8.1.3 Project manag ement

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??????? ????? ??????????????????????? ???????????? ?????? ???????????????? ???????????????? ?????????????

????????????????????? ????????????????????????? ?? ???? ????? ?????????? ??????? ?????????????????????????????????????

???????? ????????????????????? ????????????????????????????????????????????????????????? ????????????????? ?????

This proc s shal inclu e:

a) r q ir ment manag ement se 8.2??

Tiêu đề	Railway Applications — Quality Management System — Business Management System Requirements For Rail Organizations
Trường học	ISO
Chuyên ngành	Quality Management System
Thể loại	technical specification
Năm xuất bản	2017
Thành phố	Vernier

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Số trang	85
Dung lượng	3,28 MB