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Irish Standard
I.S. EN ISO 9001:2015
Quality management systems -

Requirements (ISO 9001:2015)
© CEN 2015 No copying without NSAI permission except as permitted by copyright law.
I.S. xxx: Irish Standard – national specification based on the consensus of an expert panel and
subject to public consultation.
S.R. xxx: Standard Recommendation - recommendation based on the consensus of an expert

panel and subject to public consultation.
SWiFT xxx: A rapidly developed recommendatory document based on the consensus of the
participants of an NSAI workshop.
EN ISO 9001:2015 23 September, 2015

EN ISO 9001:2008 15 November, 2008
ICS number:
This document was published 03.120.10
under the authority of the NSAI
and comes into effect on:
23 September, 2015
1 Swift Square, T +353 1 807 3800 T +353 1 857 6730

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W
Údarás um Chaighdeáin Náisiúnta na hÉireann

I.S. EN ISO 9001:2015

EN ISO 9001

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I.S. EN ISO 9001:2015
EN ISO 9001:2015 (E)
Contents Page
European foreword....................................................................................................................................................... 3
2
I.S. EN ISO 9001:2015
EN ISO 9001:2015 (E)
European foreword
This document (EN ISO 9001:2015) has been prepared by Technical Committee ISO/TC 176 "Quality
management and quality assurance".
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by March 2016, and conflicting national standards shall
be withdrawn at the latest by March 2016.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
This document supersedes EN ISO 9001:2008.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 9001:2015 has been approved by CEN as EN ISO 9001:2015 without any modification.
3
I.S. EN ISO 9001:2015
This page is intentionally left BLANK.

I.S. EN ISO 9001:2015
INTERNATIONAL ISO
STANDARD 9001
Fifth edition
2015-09-15
Quality management systems —

Requirements
Systèmes de management de la qualité — Exigences
Reference number
ISO 9001:2015(E)
© ISO 2015
I.S. EN ISO 9001:2015
ISO 9001:2015(E)
COPYRIGHT PROTECTED DOCUMENT

© ISO 2015, Published in Switzerland
''(&) :!%' +)9( 6((!>%+-+8)( '(6-(+%-.+!6!+('(B!+)9( (%-%.8+
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the requester.

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Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
6+.(&)( ++&
www.iso.org
ii © ISO 2015 – All rights reserved

I.S. EN ISO 9001:2015
ISO 9001:2015(E)
Contents Page
Foreword ..........................................................................................................................................................................................................................................v
Introduction................................................................................................................................................................................................................................ vi
1 Scope ................................................................................................................................................................................................................................. 1
2 Normative references ...................................................................................................................................................................................... 1

..................................................................................................................................................................................... 1
4 Context of the organization ....................................................................................................................................................................... 1
4.1 Understanding the organization and its context ....................................................................................................... 1
4.2 Understanding the needs and expectations of interested parties .............................................................. 2
; (%(%&) 6++8)0-'(.-%-&% . ............................................................................. 2
;; ,-'(.-%-&% . -%!( +6 .......................................................................................................... 2
5 Leadership .................................................................................................................................................................................................................. 3
5.1 Leadership and commitment ..................................................................................................................................................... 3
5.1.1 General...................................................................................................................................................................................... 3
5.1.2 Customer focus .................................................................................................................................................................. 3
+'(6. ............................................................................................................................................................................................................... 4
-'( )(%&)0-'(.+'(6.............................................................................................................................. 4
+%(6-(%&)0-'(.+'(6..................................................................................................................... 4
5.3 Organizational roles, responsibilities and authorities.......................................................................................... 4
6 Planning......................................................................................................................................................................................................................... 4
6.1 Actions to address risks and opportunities ................................................................................................................... 4
,-'(.+6(: -%!'-%%(%&+-6)(:)...................................................................................................... 5
6.3 Planning of changes ............................................................................................................................................................................ 5
7 Support ........................................................................................................................................................................................................................... 6
7.1 Resources..................................................................................................................................................................................................... 6
7.1.1 General...................................................................................................................................................................................... 6
7.1.2 People ........................................................................................................................................................................................ 6
7.1.3 Infrastructure ..................................................................................................................................................................... 6
7.1.4 Environment for the operation of processes ........................................................................................... 6
7.1.5 Monitoring and measuring resources ........................................................................................................... 7
7.1.6 Organizational knowledge....................................................................................................................................... 7
7.2 Competence ............................................................................................................................................................................................... 8
7.3 Awareness ................................................................................................................................................................................................... 8
7.4 Communication ...................................................................................................................................................................................... 8
7.5 Documented information............................................................................................................................................................... 8
7.5.1 General...................................................................................................................................................................................... 8
7.5.2 Creating and updating ................................................................................................................................................. 9
7.5.3 Control of documented information ............................................................................................................... 9
8 Operation ..................................................................................................................................................................................................................... 9
8.1 Operational planning and control .......................................................................................................................................... 9
8.2 Requirements for products and services ...................................................................................................................... 10
8.2.1 Customer communication..................................................................................................................................... 10
8.2.2 Determining the requirements for products and services ....................................................... 10
8.2.3 Review of the requirements for products and services .............................................................. 10
8.2.4 Changes to requirements for products and services ..................................................................... 11
8.3 Design and development of products and services .............................................................................................. 11
8.3.1 General................................................................................................................................................................................... 11
8.3.2 Design and development planning................................................................................................................ 11
8.3.3 Design and development inputs ...................................................................................................................... 11
8.3.4 Design and development controls ................................................................................................................. 12
8.3.5 Design and development outputs .................................................................................................................. 12
8.3.6 Design and development changes.................................................................................................................. 12
© ISO 2015 – All rights reserved iii

I.S. EN ISO 9001:2015
ISO 9001:2015(E)
$; +%+'+85%-''.+:(!!+6 >+!6 -%! :(6 ........................................................... 13

8.4.1 General................................................................................................................................................................................... 13
$; .-%!5%+86+%+'.................................................................................................................................... 13
8.4.3 Information for external providers............................................................................................................... 13
8.5 Production and service provision........................................................................................................................................ 14
8.5.1 Control of production and service provision........................................................................................ 14
$ !%((6-(+%-%!-6-('(. ........................................................................................................................... 14
$ +.'+%&(%&+6 + +5%-'+:(! ............................................................ 15
8.5.4 Preservation...................................................................................................................................................................... 15
$ + /!'(:.-6(:(( ............................................................................................................................................ 15
8.5.6 Control of changes ....................................................................................................................................................... 15
8.6 Release of products and services ......................................................................................................................................... 15
8.7 Control of nonconforming outputs ..................................................................................................................................... 16
9 Performance evaluation ............................................................................................................................................................................16
" +%(+(%&>- %>-%-'. ( -%!:-'-(+% ............................................................................................ 16
9.1.1 General................................................................................................................................................................................... 16
9.1.2 Customer satisfaction ............................................................................................................................................... 17
" %-'. ( -%!:-'-(+% .......................................................................................................................................... 17
9.2 Internal audit ......................................................................................................................................................................................... 17
9.3 Management review ........................................................................................................................................................................ 18
9.3.1 General................................................................................................................................................................................... 18
9.3.2 Management review inputs ................................................................................................................................. 18
9.3.3 Management review outputs ............................................................................................................................. 18
10 Improvement .........................................................................................................................................................................................................19
10.1 General ........................................................................................................................................................................................................ 19
+%6+%8+(.-%!6+6(:-6(+% .............................................................................................................................. 19
10.3 Continual improvement ............................................................................................................................................................... 19
Annex A (informative)

............................................21
Annex B (informative) Other International Standards on quality management and quality
management systems developed by ISO/TC 176 .............................................................................................................25
Bibliography ............................................................................................................................................................................................................................. 28
iv © ISO 2015 – All rights reserved

I.S. EN ISO 9001:2015
ISO 9001:2015(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
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electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
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editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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on the ISO list of patent declarations received (see www.iso.org/patents).
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constitute an endorsement.
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as well as information about ISO’s adherence to the World Trade Organization (WTO) principles in the
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The committee responsible for this document is Technical Committee ISO/TC 176, Quality management
and quality assurance, Subcommittee SC 2, Quality systems.
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management principles and of new concepts. It also cancels and replaces the Technical Corrigendum
ISO 9001:2008/Cor.1:2009.
© ISO 2015 – All rights reserved v

I.S. EN ISO 9001:2015
ISO 9001:2015(E)
Introduction
0.1 General
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to improve its overall performance and provide a sound basis for sustainable development initiatives.
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The process approach enables an organization to plan its processes and their interactions.
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managed, and that opportunities for improvement are determined and acted on.
Risk-based thinking enables an organization to determine the factors that could cause its processes and
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and continual improvement, such as breakthrough change, innovation and re-organization.
In this International Standard, the following verbal forms are used:
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vi © ISO 2015 – All rights reserved

I.S. EN ISO 9001:2015
ISO 9001:2015(E)
0.2 Quality management principles

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0.3 Process approach
0.3.1 General
This International Standard promotes the adoption of a process approach when developing,
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overall performance of the organization can be enhanced.
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© ISO 2015 – All rights reserved vii

I.S. EN ISO 9001:2015
ISO 9001:2015(E)
Figure 1 — Schematic representation of the elements of a single process
0.3.2 Plan-Do-Check-Act cycle

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Figure 2 illustrates how Clauses 4 to 106-%&+!(%'-(+%+)6.6'
NOTE Numbers in brackets refer to the clauses in this International Standard.
Figure 2 — Representation of the structure of this International Standard in the PDCA cycle
viii © ISO 2015 – All rights reserved

I.S. EN ISO 9001:2015
ISO 9001:2015(E)
)6.6'6-%('.! 6(!- 8+''+9 #

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0.3.3 Risk-based thinking
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The concept of risk-based thinking has been implicit in previous editions of this International Standard
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To conform to the requirements of this International Standard, an organization needs to plan and
implement actions to address risks and opportunities. Addressing both risks and opportunities
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improved results and preventing negative effects.
Opportunities can arise as a result of a situation favourable to achieving an intended result, for
example, a set of circumstances that allow the organization to attract customers, develop new products
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all positive effects of risk result in opportunities.
0.4 Relationship with other management system standards
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This International Standard enables an organization to use the process approach, coupled with the
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This International Standard relates to ISO 9000 and ISO 9004 as follows:
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— ISO 9004 Managing for the sustained success of an organization — A quality management approach
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application of this International Standard within the particular sector.
© ISO 2015 – All rights reserved ix

I.S. EN ISO 9001:2015
ISO 9001:2015(E)
A matrix showing the correlation between the clauses of this edition of this International Standard and
the previous edition (ISO 9001:2008) can be found on the ISO/TC 176/SC 2 open access web site at:
www.iso.org/tc176/sc02/public.
x © ISO 2015 – All rights reserved

I.S. EN ISO 9001:2015
INTERNATIONAL STANDARD ISO 9001:2015(E)
Quality management systems — Requirements
1 Scope
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ISO 9000:2015, Quality management systems — Fundamentals and vocabulary

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4 Context of the organization
4.1 Understanding the organization and its context

The organization shall determine external and internal issues that are relevant to its purpose
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The organization shall monitor and review information about these external and internal issues.
NOTE 1 Issues can include positive and negative factors or conditions for consideration.
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technological, competitive, market, cultural, social and economic environments, whether international, national,
regional or local.
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knowledge and performance of the organization.
© ISO 2015 – All rights reserved 1

I.S. EN ISO 9001:2015
ISO 9001:2015(E)
4.2 Understanding the needs and expectations of interested parties

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:(6 )-6 +-%!-'(6-' -+.-%!&'-+.0(% >)+&-%(B-(+%
shall determine:
-2 )(% !-( )--':-%+)0-'(.-%-&% .
2 )0(% +8) (% !-( )--':-%+)0-'(.-%-&% .
The organization shall monitor and review information about these interested parties and their
relevant requirements.
4.3 Determining the scope of the quality management system

)+&-%(B-(+% )-''!(%)+%!-( -%!-'(6-('(.+8)0-'(.-%-&% .
to establish its scope.
When determining this scope, the organization shall consider:
a) the external and internal issues referred to in 4.1
b) the requirements of relevant interested parties referred to in 4.2
c) the products and services of the organization.
)+&-%(B-(+% )-''-'.-'')0(% +8)( %%-(+%-'

-%!-!(8).--'(6-'
9()(%)!(%! 6++8( 0-'(.-%-&% .
) 6+ +8 ) +&-%(B-(+% 0-'(. -%-&% . )-'' -:-('-' -%! -(%-(%! -
!+6%!(%8+-(+%) 6+ )-'' -). +8+!6 -%! :(6 6+:!>-%!+:(!
((6-(+%8+-%.0(%+8)( %%-(+%-'
-%!-!)-)+&-%(B-(+%!(% ( %+
-'(6-'+) 6++8( 0-'(.-%-&% .
+%8+(.+)( %%-(+%-'
-%!-!-.+%'.6'-(!(8)0(% !(%!- %+
(%&-'(6-'!+%+-886)+&-%(B-(+% -('(.+ +% (('(.+% )6+%8+(.+8(
products and services and the enhancement of customer satisfaction.
4.4 Quality management system and its processes
4.4.1 ) +&-%(B-(+% )-'' -'( )> ('%> -(%-(% -%! 6+%(%-''. (+: - 0-'(.
-%-&% . > (%6'!(%& ) +6 %!! -%! )( (%-6(+% > (% -66+!-%6 9() )
requirements of this International Standard.
)+&-%(B-(+% )-''!(%)+6 %!!8+)0-'(.-%-&% . -%!)(

application throughout the organization, and shall:
-2 !(%)(% 0(!-%!)+ 56!8+) +6
2 !(%) 0%6-%!(%-6(+%+8) +6
62 !(%-%!-'.)6((--%!)+! 1(%6'!(%&+%(+(%&>- % -%!'-!
8+-%6(%!(6-+ 2%!!+% )886(:+-(+%-%!6+%+'+8) +6
!2 !(%) +6 %!!8+) +6 -%!% )(-:-('-('(.
2 - (&%) +% (('(( -%!-)+(( 8+) +6
f) address the risks and opportunities as determined in accordance with the requirements of 6.1
&2 :-'-) +6 -%!('%-%.6)-%& %!!+% )-) +6 -6)(:
)((%%!! '
2 © ISO 2015 – All rights reserved

I.S. EN ISO 9001:2015
ISO 9001:2015(E)
)2 (+:)+6 -%!)0-'(.-%-&% .
4.4.2 +)5%%6 -.>)+&-%(B-(+% )-''#
-2 -(%-(%!+6%!(%8+-(+%+ +)+-(+%+8( +6

2 -(% !+6%! (%8+-(+% + )-: 6+%(!%6 )- ) +6 - (%& 6-(! + -
planned.
5 Leadership
5.1 Leadership and commitment
5.1.1 General
+ -%-&% )-'' !+% - '-! )( -%! 6+(% 9() 6 + ) 0-'(.
-%-&% . .#
-2 -C(%&-66+%-('(.8+)886(:% +8)0-'(.-%-&% .
2 % (%&)-)0-'(.+'(6.-%!0-'(.+6(: - -'( )!8+)0-'(.-%-&%
. -%!-6+-('9())6+%5-%! -&(6!(6(+%+8)+&-%(B-(+%
62 % (%&)(%&-(+%+8)0-'(.-%-&% . 0(% (%+)+&-%(B-(+%
(% +6
!2 ++(%&) +8)+6 -+-6)-%!( C/- !)(%C(%&
2 % (%&)-) +6 %!!8+)0-'(.-%-&% . --:-('-'
82 6+%(6-(%&)(+-%6+8886(:0-'(.-%-&%-%!+86+%8+(%&+)0-'(.
-%-&% . 0(%
&2 % (%&)-)0-'(.-%-&% . -6)(: ( (%%!! '
)2 %&-&(%&> !(6(%& -%! +(%& +% + 6+%( + ) 886(:% +8 ) 0-'(.
-%-&% .
(2 ++(%&(+:%
2 +(%&+)':-%-%-&%+' +!+% -)('-! )(- (-'( +)(
-- +8 +% (('(.
8%6 + (% (% )( %%-(+%-'
-%!-! 6-% (%! +-!'. + -% )+
activities that are core to the purposes of the organization’s existence, whether the organization is public, private,
8++(+%+8++(
5.1.2 Customer focus
+ -%-&% )-'' !+% - '-! )( -%! 6+(% 9() 6 + 6 + 8+6 .
ensuring that:
-2 6 +-%!-'(6-' -+.-%!&'-+.0(% -!(%!>%! ++!-%!
6+% ( %'.
2 )( C -%!++%(( )-6-%-8866+%8+(.+8+!6 -%! :(6 -%!)-('(.+
%)-%66 + -( 8-6(+%-!(%!-%!-!! !
c) the focus on enhancing customer satisfaction is maintained.

I.S. EN ISO 9001:2015
ISO 9001:2015(E)
5.2 Policy
5.2.1 Establishing the quality policy
+-%-&% )-'' -'( )>('%-%!-(%-(%-0-'(.+'(6.)-#

-2 ( -+(-+)+ -%!6+%5+8)+&-%(B-(+%-%! + ( -&(6!(6(+%
2 +:(! -8-9+C8+ (%&0-'(.+6(:
62 (%6'! -6+(%+ -( 8.-'(6-'0(%
!2 (%6'! -6+(%+6+%(%-'(+:%+8)0-'(.-%-&% .
5.2.2 Communicating the quality policy
)0-'(.+'(6. )-''#
-2 -:-('-'-%!-(%-(%!- !+6%!(%8+-(+%
2 6+%(6-!>%! ++!-%!-'(!9()(%)+&-%(B-(+%
c) be available to relevant interested parties, as appropriate.

Top management shall ensure that the responsibilities and authorities for relevant roles are assigned,
communicated and understood within the organization.
+-%-&% )-''- (&%) +% (('(.-%!-)+(.8+#
-2 % (%& )- ) 0-'(. -%-&% . 6+%8+ + ) 0(% +8 )(
%%-(+%-'
-%!-!
2 % (%&)-)+6 -!'(:(%&)((%%!!+
62 +(%& +% ) 8+-%6 +8 ) 0-'(. -%-&% . -%! +% ++%(( 8+
improvement (see 10.12>(%-(6'-++-%-&%
!2 % (%&)++(+%+86 +8+6 )+&)+)+&-%(B-(+%
2 % (%&)-)(%&(.+8)0-'(.-%-&% . ( -(%-(%!9)%6)-%& +)
0-'(.-%-&% . -'-%%!-%!('%!
6 Planning
6.1 Actions to address risks and opportunities
6.1.1 )% '-%%(%& 8+ ) 0-'(. -%-&% . > ) +&-%(B-(+% )-'' 6+% (! ) (
referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that
need to be addressed to:
-2 &(:- -%6)-)0-'(.-%-&% . 6-%-6)(:( (%%!! '1 2

2 %)-%6! (-'886
62 :%>+!6>%! (!886
d) achieve improvement.

I.S. EN ISO 9001:2015
ISO 9001:2015(E)
6.1.2 The organization shall plan:
-2 -6(+% +-!! ) ( C -%!++%((

b) how to:
2 (%&--%!('%)-6(+% (%+( 0-'(.-%-&% . +6 1 4.42
2) evaluate the effectiveness of these actions.
Actions taken to address risks and opportunities shall be proportionate to the potential impact on the
6+%8+(.+8+!6 -%! :(6
(+% + -!! ( C 6-% (%6'! -:+(!(%& ( C> -C(%& ( C (% +! + -% ++%(.>
'((%-(%& ) ( C +6> 6)-%&(%& ) '(C'()++! + 6+% 0%6 > )-(%& ) ( C> + -(%(%& ( C .
informed decision.
NOTE 2 Opportunities can lead to the adoption of new practices, launching new products, opening new
-C >-!! (%&%96 + >('!(%&-% )( > (%&%96)%+'+&.-%!+)! (-'-%!:(-'
possibilities to address the organization’s or its customers’ needs.
6.2 Quality objectives and planning to achieve them
6.2.1 ) +&-%(B-(+% )-'' -'( ) 0-'(. +6(: - ':-% 8%6(+% > ':' -%! +6
%!!8+)0-'(.-%-&% .
)0-'(.+6(: )-''#
-2 6+% ( %9())0-'(.+'(6.
2 - -'
62 -C(%+-66+%-'(6-'0(%
!2 ':-%+6+%8+(.+8+!6 -%! :(6 -%!+%)-%6%+86 + -( 8-6(+%
2 +%(+!
82 6+%(6-!
g) be updated as appropriate.
)+&-%(B-(+% )-''-(%-(%!+6%!(%8+-(+%+%)0-'(.+6(:
6.2.2 )%'-%%(%&)+9+-6)(:( 0-'(.+6(: >)+&-%(B-(+% )-''!(%#
-2 9)-9(''!+%
2 9)- +6 9(''0(!
62 9)+9('' +% ('
!2 9)%(9(''6+'!
e) how the results will be evaluated.
6.3 Planning of changes

)%)+&-%(B-(+%!(% )%!8+6)-%& +)0-'(.-%-&% . >)6)-%&
shall be carried out in a planned manner (see 4.4).

I.S. EN ISO 9001:2015
ISO 9001:2015(E)
The organization shall consider:

-2 )+ +8)6)-%& -%!)(+%(-'6+% 0%6
2 )(%&(.+8)0-'(.-%-&% .
62 )-:-('-('(.+8 +6
d) the allocation or reallocation of responsibilities and authorities.
7 Support
7.1 Resources
7.1.1 General
The organization shall determine and provide the resources needed for the establishment,
('%-(+%>-(%%-%6-%!6+%(%-'(+:%+8)0-'(.-%-&% .
The organization shall consider:
-2 )6--('(( +8>-%!6+% -(% +%>5( (%&(%%-' +6
b) what needs to be obtained from external providers.
7.1.2 People
)+&-%(B-(+% )-''!(%-%!+:(!) +% %6 -.8+)886(:('%-(+%

+8( 0-'(.-%-&% . -%!8+)+-(+%-%!6+%+'+8( +6
7.1.3 Infrastructure
)+&-%(B-(+% )-''!(%>+:(!-%!-(%-(%)(%8- 6%6 -.8+)+-(+%

+8( +6 -%!+-6)(:6+%8+(.+8+!6 -%! :(6
NOTE Infrastructure can include:
-2('!(%& -%!- +6(-!('((
20(%>(%6'!(%&)-!9--%! +89-
62-% +-(+% +6
!2(%8+-(+%-%!6+%(6-(+%6)%+'+&.
7.1.4 Environment for the operation of processes
)+&-%(B-(+% )-''!(%>+:(!-%!-(%-(%)%:(+%%%6 -.8+)+-(+%

+8( +6 -%!+-6)(:6+%8+(.+8+!6 -%! :(6
(-'%:(+%%6-%-6+(%-(+%+8)-%-%!). (6-'8-6+ > 6)- #
-2 +6(-'1&%+%/!( 6((%-+.>6-'>%+%/6+%8+%-(+%-'2
2 .6)+'+&(6-'1& /!6(%&>%+:%(+%>+(+%-''.+6(:2
62). (6-'1&->)->)(!(.>'(&)>-('+9>).&(%>%+( 2
) 8-6+ 6-%!(88 -%(-''.!%!(%&+%)+!6 -%! :(6 +:(!!

I.S. EN ISO 9001:2015
ISO 9001:2015(E)
7.1.5 Monitoring and measuring resources
7.1.5.1 General
The organization shall determine and provide the resources needed to ensure valid and reliable
' 9)% +%(+(%& + - (%& ( ! + :(8. ) 6+%8+(. +8 +!6 -%! :(6 +
requirements.
The organization shall ensure that the resources provided:
-2 - (-'8+) 6((6.+8+%(+(%&-%!- %-6(:(( (%&%!-C%
2 --(%-(%!+% )(6+%(%(%&(% 8+)(+
)+&-%(B-(+% )-''-(%-+(-!+6%!(%8+-(+%- :(!%6+8(% 8++ +8
the monitoring and measurement resources.
7.1.5.2 Measurement traceability
)%- %-6-('(.( -0(%>+( 6+% (!!.)+&-%(B-(+%+-% %(-'

-+8+:(!(%&6+%(!%6(%):-'(!(.+8- % ' >- (%&0(% )-''#
-2 6-'(-!+:((!>++)>- 6((!(%:-' >+(++ >-&-(% - % -%!-!
-6-'+(%%-(+%-'+%-(+%-'- % -%!-! 9)%%+ 6) -%!-! 5( >)
- ( !8+6-'(-(+%+:((6-(+% )-''-(%!- !+6%!(%8+-(+%
2 (!%((!(%+!+!(%)( -

62 -8&-!! 8+ -! % > !--& + !(+-(+% )- 9+'! (%:-'(!- ) 6-'(-(+%
status and subsequent measurement results.
)+&-%(B-(+% )-''!(%(8):-'(!(.+8:(+ - % ' )- %-!: '.
-886! 9)% - (%& 0(% ( 8+%! + %( 8+ ( (%%!! + > -%! )-'' -C
-+(--6(+%- %6 -.
7.1.6 Organizational knowledge
) +&-%(B-(+% )-'' !(% ) C%+9'!& %6 -. 8+ ) +-(+% +8 ( +6 -%! +
-6)(:6+%8+(.+8+!6 -%! :(6
)( C%+9'!& )-''-(%-(%!-%!-!-:-('-'+)5%%6 -.
When addressing changing needs and trends, the organization shall consider its current knowledge
-%!!(%)+9+-60(+-66 -%.%6 -.-!!((+%-'C%+9'!&-%!0(!!-
&-%(B-(+%-' C%+9'!& ( C%+9'!& 6((6 + ) +&-%(B-(+% ( ( &%-''. &-(%! .
5(%6( (%8+-(+%)-( !-%! )-!+-6)(:)+&-%(B-(+% +6(:
NOTE 2 Organizational knowledge can be based on:
-2 (%%-' +6 1& (%''6-' +. C%+9'!& &-(%! 8+ 5(%6 ' +% '-%! 8+
8-(' -%! 66 8'+6 6-(%&-%! )-(%&%!+6%!C%+9'!&-%!5(%6) ' +8
(+:% (%+6 >+!6 -%! :(6 2
2 5%-' +6 1& -%!-! -6-!(- 6+%8%6 &-)(%& C%+9'!& 8+ 6 + +
external providers).

I.S. EN ISO 9001:2015
ISO 9001:2015(E)
7.2 Competence
The organization shall:
-2 !(% ) %6 -. 6+%6 +8 +%1 2 !+(%& 9+C %! ( 6+%+' )- -886 )
8+-%6-%!886(:% +8)0-'(.-%-&% .
b) ensure that these persons are competent on the basis of appropriate education, training, or
5(%6
62 9)-'(6-'>-C-6(+% +-60()%6 -.6+%6>-%!:-'-)886(:%
+8)-6(+% -C%
d) retain appropriate documented information as evidence of competence.
NOTE Applicable actions can include, for example, the provision of training to, the mentoring of, or the re-
- (&%%+86%'.'+.! +% +))((%&+6+%-6(%&+86+% +%
7.3 Awareness
The organization shall ensure that persons doing work under the organization’s control are aware of:
-2 )0-'(.+'(6.
2 ':-%0-'(.+6(:
62 )(6+%((+%+)886(:% +8)0-'(.-%-&% . >(%6'!(%&)%( +8

(+:!8+-%6
!2 )('(6-(+% +8%+6+%8+(%&9())0-'(.-%-&% . 0(%
7.4 Communication
) +&-%(B-(+% )-'' !(% ) (%%-' -%! 5%-' 6+%(6-(+% ':-% + ) 0-'(.
-%-&% . >(%6'!(%&#
-2 +%9)-(9(''6+%(6-
2 9)%+6+%(6-
62 9()9)++6+%(6-
!2 )+9+6+%(6-
e) who communicates.
7.5 Documented information
7.5.1 General
)+&-%(B-(+% 0-'(.-%-&% . )-''(%6'!#

-2 !+6%!(%8+-(+%0(!.)( %%-(+%-'
-%!-!
2 !+6%!(%8+-(+%!(%!.)+&-%(B-(+%- (%&%6 -.8+)886(:%
+8)0-'(.-%-&% .
) 5% +8 !+6%! (%8+-(+% 8+ - 0-'(. -%-&% . 6-% !(88 8+ +%
organization to another due to:
) (B+8+&-%(B-(+%-%!( .+8-6(:(( >+6 >+!6 -%! :(6

I.S. EN ISO 9001:2015
ISO 9001:2015(E)
)6+'5(.+8+6 -%!)((%-6(+%
— the competence of persons.
7.5.2 Creating and updating
When creating and updating documented information, the organization shall ensure appropriate:
-2 (!%((6-(+%-%!! 6((+%1&-('>!->-)+>+8%6%2
2 8+-1&'-%&-&> +89-: (+%>&-)(6 2-%!!(-1&->'6+%(62
62 :(9-%!-+:-'8+ (-('(.-%!-!0-6.
7.5.3 Control of documented information
7.5.3.1 +6%!(%8+-(+%0(!.)0-'(.-%-&% . -%!.)( %%-(+%-'

Standard shall be controlled to ensure:
-2 (( -:-('-'-%! (-'8+ >9)-%!9)%(( %!!

2 (( -!0-'.+6!1&8+'+ +86+%(!%(-'(.>(+ >+'+ +8(%&(.2
7.5.3.2 For the control of documented information, the organization shall address the following
activities, as applicable:
-2 !( ((+%>-66 >(:-'-%!

2 +-&-%! :-(+%>(%6'!(%& :-(+%+8'&(('(.
62 6+%+'+86)-%& 1&: (+%6+%+'2
d) retention and disposition.
+6%!(%8+-(+%+85%-'+(&(%!(%!.)+&-%(B-(+%+%6 -.8+)
'-%%(%& -%! +-(+% +8 ) 0-'(. -%-&% . )-'' (!%((! - -+(-> -%!
be controlled.
+6%! (%8+-(+% -(%! - :(!%6 +8 6+%8+(. )-'' +6! 8+ %(%%!!
alterations.
66 6-%('.-!6( (+%&-!(%&)( (+%+:(9)!+6%!(%8+-(+%+%'.>+
)( (+%-%!-)+(.+:(9-%!6)-%&)!+6%!(%8+-(+%
8 Operation
8.1 Operational planning and control

The organization shall plan, implement and control the processes (see 4.4) needed to meet the
requirements for the provision of products and services, and to implement the actions determined in
Clause 6>.#
-2 !(%(%&)0(% 8+)+!6 -%! :(6
b) establishing criteria for:
2 )+6
2 )-66-%6+8+!6 -%! :(6
62 !(%(%&) +6 %!!+-6)(:6+%8+(.+)+!6-%! :(60(%

I.S. EN ISO 9001:2015
ISO 9001:2015(E)
!2 ('%(%&6+%+'+8)+6 (%-66+!-%69())6((-

2 !(%(%&>-(%-(%(%&-%!-(%(%&!+6%!(%8+-(+%+)5%%6 -.#
2 +)-:6+%(!%6)-)+6 )-:%6-(!+- '-%%!
2 +!+% -)6+%8+(.+8+!6 -%! :(6 +)(0(%
The output of this planning shall be suitable for the organization’s operations.
The organization shall control planned changes and review the consequences of unintended changes,
-C(%&-6(+%+((&--%.-!: 886 >- %6 -.
The organization shall ensure that outsourced processes are controlled (see 8.4).
8.2 Requirements for products and services
8.2.1 Customer communication
Communication with customers shall include:

-2 +:(!(%&(%8+-(+%'-(%&++!6 -%! :(6
2 )-%!'(%&%0(( >6+%-6 ++! >(%6'!(%&6)-%&
62 +-(%(%&6 +8!-6C'-(%&++!6 -%! :(6 >(%6'!(%&6 +6+'-(%
!2 )-%!'(%&+6+%+''(%&6 ++.

2 -'( )(%& 6((60(% 8+6+%(%&%6.-6(+% >9)%':-%
8.2.2 Determining the requirements for products and services
When determining the requirements for the products and services to be offered to customers, the
organization shall ensure that:
-2 )0(% 8+)+!6 -%! :(6 -!(%!>(%6'!(%&#
2 -%.-'(6-' -+.-%!&'-+.0(%
2 )+ 6+% (!!%6 -..)+&-%(B-(+%
b) the organization can meet the claims for the products and services it offers.
8.2.3 Review of the requirements for products and services
8.2.3.1 )+&-%(B-(+% )-''% )-()- )-('(.+)0(% 8++!6 -%!

:(6 ++88!+6 + )+&-%(B-(+% )-''6+%!6-:(98+6+((%&+ '.
products and services to a customer, to include:
-2 0(% 6((! . ) 6 +> (%6'!(%& ) 0(% 8+ !'(:. -%! + /
!'(:.-6(:((
2 0(% %+ -! . ) 6 +> %6 -. 8+ ) 6((! + (%%!! > 9)%
C%+9%
62 0(% 6((!.)+&-%(B-(+%
!2 -+.-%!&'-+.0(% -'(6-'+)+!6 -%! :(6
2 6+%-6++!0(% !(88(%&8+)+ :(+ '.5 !

I.S. EN ISO 9001:2015
ISO 9001:2015(E)
) +&-%(B-(+% )-'' % )- 6+%-6 + +! 0(% !(88(%& 8+ )+ :(+ '.
!(%!- +':!
) 6 + 0(% )-'' 6+%(! . ) +&-%(B-(+% 8+ -66-%6> 9)% )
customer does not provide a documented statement of their requirements.
NOTE In some situations, such as internet sales, a formal review is impractical for each order. Instead, the
review can cover relevant product information, such as catalogues.
8.2.3.2 The organization shall retain documented information, as applicable:
-2 +%) ' +8):(9

2 +%-%.%90(% 8+)+!6 -%! :(6
8.2.4 Changes to requirements for products and services
The organization shall ensure that relevant documented information is amended, and that relevant
persons are made aware of the changed requirements, when the requirements for products and
services are changed.
8.3 Design and development of products and services
8.3.1 General
The organization shall establish, implement and maintain a design and development process that is
appropriate to ensure the subsequent provision of products and services.
8.3.2 Design and development planning
In determining the stages and controls for design and development, the organization shall consider:
-2 )%->!-(+%-%!6+'5(.+8)! (&%-%!!:'+%-6(:((
2 )0(!+6 -& >(%6'!(%&-'(6-'! (&%-%!!:'+%:(9
62 )0(!! (&%-%!!:'+%:((6-(+%-%!:-'(!-(+%-6(:((
!2 ) +% (('(( -%!-)+(( (%:+':!(%)! (&%-%!!:'+%+6
2 )(%%-'-%!5%-' +6%! 8+)! (&%-%!!:'+%+8+!6 -%! :(6
82 )%!+6+%+'(%8-6 9% +% (%:+':!(%)! (&%-%!!:'+%+6
&2 )%!8+(%:+':%+86 + -%! (%)! (&%-%!!:'+%+6
)2 )0(% 8+ 0%+:( (+%+8+!6 -%! :(6
(2 ) ':' +8 6+%+' 56! 8+ ) ! (&% -%! !:'+% +6 . 6 + -%! +)
':-%(% !-(
2 ) !+6%! (%8+-(+% %!! + !+% - )- ! (&% -%! !:'+% 0(%
have been met.
8.3.3 Design and development inputs
) +&-%(B-(+% )-'' !(% ) 0(% %(-' 8+ ) 6((6 . +8 +!6 -%!
services to be designed and developed. The organization shall consider:
-2 8%6(+%-'-%!8+-%60(%

I.S. EN ISO 9001:2015
ISO 9001:2015(E)
2 (%8+-(+%!(:!8+:(+ (('-! (&%-%!!:'+%-6(:((

62 -+.-%!&'-+.0(%
!2 -%!-! +6+! +8-6(6)-)+&-%(B-(+%)- 6+(!+('%
e) potential consequences of failure due to the nature of the products and services.
Inputs shall be adequate for design and development purposes, complete and unambiguous.
+%'(6(%&! (&%-%!!:'+%(% )-'' +':!
The organization shall retain documented information on design and development inputs.
8.3.4 Design and development controls
)+&-%(B-(+% )-''-'.6+%+' +)! (&%-%!!:'+%+6 +% )-#

-2 ) ' +-6)(:!-!(%!
2 :(9 - 6+%!6! + :-'- ) -('(. +8 ) ' +8 ! (&% -%! !:'+% +
0(%
62 :((6-(+%-6(:(( -6+%!6!+% )-)! (&%-%!!:'+%+ )
(%0(%
d) validation activities are conducted to ensure that the resulting products and services meet the
0(% 8+) 6((!-'(6-(+%+(%%!!
2 -%.%6 -.-6(+% --C%+%+' !(%!!(%&):(9 >+:((6-(+%-%!
:-'(!-(+%-6(:((
f) documented information of these activities is retained.
(&% -%! !:'+% :(9 > :((6-(+% -%! :-'(!-(+% )-: !( (%6 + ). 6-%
6+%!6! --'.+(%-%.6+(%-(+%>- ( (-'8+)+!6 -%! :(6 +8)+&-%(B-(+%
8.3.5 Design and development outputs
The organization shall ensure that design and development outputs:

-2 )(%0(%
2 --!0-8+) 0%+6 8+)+:( (+%+8+!6 -%! :(6
62 (%6'!+8%6+%(+(%&-%!- (%&0(% >- -+(->-%!-66-%66((-
!2 6(8.)6)--6( (6 +8)+!6 -%! :(6 )-- %(-'8+)((%%!!+
and their safe and proper provision.
The organization shall retain documented information on design and development outputs.
8.3.6 Design and development changes
)+&-%(B-(+% )-''(!%(8.>:(9-%!6+%+'6)-%& -!!(%&>+ 0%+>)! (&%

-%!!:'+%+8+!6 -%! :(6 >+)5%%6 -.+% )-)( %+-!:
(-6+%6+%8+(.+0(%
The organization shall retain documented information on:
-2 ! (&%-%!!:'+%6)-%&
2 ) ' +8:(9

I.S. EN ISO 9001:2015
ISO 9001:2015(E)
62 )-)+(B-(+%+8)6)-%&
d) the actions taken to prevent adverse impacts.
!"
#
$
$
8.4.1 General
) +&-%(B-(+% )-'' % )- 5%-''. +:(!! +6 > +!6 -%! :(6 6+%8+ +
requirements.
)+&-%(B-(+% )-''!(%)6+%+' +-'(!+5%-''.+:(!!+6 >+!6
and services when:
a) products and services from external providers are intended for incorporation into the organization’s
+9%+!6 -%! :(6
2 +!6 -%! :(6 -+:(!!!(6'.+)6 +1 2.5%-'+:(! +%)-'8+8
)+&-%(B-(+%
62 -+6 >+-+8-+6 >( +:(!!.-%5%-'+:(!- - '+8-!6( (+%.)
organization.
) +&-%(B-(+% )-'' !(% -%! -'. 6((- 8+ ) :-'-(+%> '6(+%> +%(+(%& +8
8+-%6> -%! /:-'-(+% +8 5%-' +:(! > - ! +% )( -('(. + +:(! +6 +
products and services in accordance with requirements. The organization shall retain documented
(%8+-(+%+8) -6(:(( -%!-%.%6 -.-6(+% -( (%&8+):-'-(+%
8.4.2 Type and extent of control
) +&-%(B-(+% )-'' % )- 5%-''. +:(!! +6 > +!6 -%! :(6 !+ %+
-!: '.-886)+&-%(B-(+% -('(.+6+% ( %'.!'(:6+%8+(%&+!6 -%! :(6 +
its customers.
The organization shall:
-2 % )- 5%-''. +:(!! +6 -(% 9()(% ) 6+%+' +8 ( 0-'(. -%-&%
.
2 !(%+))6+%+' )-((%%! +-'.+-%5%-'+:(!-%!)+ ((%%! +-'.
+) '(%&+
c) take into consideration:
2 ) +%(-' (-6 +8 ) 5%-''. +:(!! +6 > +!6 -%! :(6 +% )
+&-%(B-(+% -('(.+6+% ( %'.6 +-%!-'(6-' -+.-%!&'-+.
0(%
2 )886(:% +8)6+%+' -'(!.)5%-'+:(!
!2 !(% ) :((6-(+%> + +) -6(:(( > %6 -. + % )- ) 5%-''. +:(!!
processes, products and services meet requirements.
8.4.3 Information for external providers
) +&-%(B-(+% )-'' % ) -!0-6. +8 0(% (+ + )( 6+%(6-(+% + )
external provider.
The organization shall communicate to external providers its requirements for:
-2 )+6 >+!6 -%! :(6 ++:(!!

I.S. EN ISO 9001:2015
ISO 9001:2015(E)
b) the approval of:

2 +!6 -%! :(6
2 )+! >+6 -%!0(%
2 )'- +8+!6 -%! :(6
62 6+%6>(%6'!(%&-%.0(!0-'((6-(+%+8 +%
!2 )5%-'+:(! (%-6(+% 9())+&-%(B-(+%
2 6+%+'-%!+%(+(%&+8)5%-'+:(! 8+-%6+-'(!.)+&-%(B-(+%
82 :((6-(+%+:-'(!-(+%-6(:(( )-)+&-%(B-(+%>+( 6 +>(%%! +8+-)
external providers’ premises.
8.5 Production and service provision
8.5.1 Control of production and service provision
The organization shall implement production and service provision under controlled conditions.
Controlled conditions shall include, as applicable:
-2 )-:-('-('(.+8!+6%!(%8+-(+%)-!(% #
1) the characteristics of the products to be produced, the services to be provided, or the activities
+8+!
2 ) ' +-6)(:!
2 )-:-('-('(.-%! +8 (-'+%(+(%&-%!- (%& +6
62 )('%-(+%+8+%(+(%&-%!- %-6(:(( --+(- -& +:(8.)-
criteria for control of processes or outputs, and acceptance criteria for products and services,
)-:%
!2 ) +8 (-'(%8- 6-%!%:(+%%8+)+-(+%+8+6
2 )-+(%%+86+% +% >(%6'!(%&-%.0(!0-'((6-(+%
82 ):-'(!-(+%>-%!(+!(6:-'(!-(+%>+8)-('(.+-6)(:'-%%! ' +8)+6
8++!6(+%-%! :(6+:( (+%>9)) '(%&+6-%%+:((!. 0%
+%(+(%&+- %
&2 )('%-(+%+8-6(+% +:%)-%+
)2 )('%-(+%+8'- >!'(:.-%!+ /!'(:.-6(:((
!% &

) +&-%(B-(+% )-'' (-' -% + (!%(8. + 9)% ( ( %6 -. + % )
6+%8+(.+8+!6 -%! :(6
) +&-%(B-(+% )-'' (!%(8. ) - +8 + 9() 6 + +%(+(%& -%! - %
requirements throughout production and service provision.
) +&-%(B-(+% )-'' 6+%+' ) %(0 (!%((6-(+% +8 ) + 9)% -6-('(. ( -
0(%>-%! )-''-(%)!+6%!(%8+-(+%%6 -.+%-'-6-('(.

I.S. EN ISO 9001:2015
ISO 9001:2015(E)
8.5.3 Property belonging to customers or external providers
)+&-%(B-(+% )-''56( 6-9()+.'+%&(%&+6 + +5%-'+:(! 9)('

(( %!)+&-%(B-(+% 6+%+'+(%& !.)+&-%(B-(+%
)+&-%(B-(+% )-''(!%(8.>:(8.>+6-%! -8&-!6 + +5%-'+:(! +.
provided for use or incorporation into the products and services.
)% ) +. +8 - 6 + + 5%-' +:(! ( '+ > !--&! + +)9( 8+%! +
unsuitable for use, the organization shall report this to the customer or external provider and retain
documented information on what has occurred.
6 + +5%-'+:(! +.6-%(%6'!-(-' >6++%% >++' -%!0(%>
( >(%''6-'+.-%! +%-'!--
8.5.4 Preservation
The organization shall preserve the outputs during production and service provision, to the extent
%6 -.+% 6+%8+(.+0(%
:-(+% 6-% (%6'! (!%((6-(+%> )-%!'(%&> 6+%-(%-(+% 6+%+'> -6C-&(%&> +-&>
transmission or transportation, and protection.
8.5.5 Post-delivery activities

) +&-%(B-(+% )-'' 0(% 8+ + /!'(:. -6(:(( - +6(-! 9() ) +!6
and services.
%!(%(%&)5%+8+ /!'(:.-6(:(( )--0(!>)+&-%(B-(+% )-''6+% (!#
-2 -+.-%!&'-+.0(%
2 )+%(-'%! (!6+% 0%6 - +6(-!9()( +!6 -%! :(6
62 )%-> -%!(%%!!'(8(+8( +!6 -%! :(6
!2 6 +0(%
e) customer feedback.
+ /!'(:.-6(:(( 6-%(%6'!-6(+% %!9--%.+:( (+% >6+%-6-'+'(&-(+% 6)
- -(%%-%6 :(6 >-%! '%-. :(6 6)- 6.6'(%&+(%-'!( + -'
8.5.6 Control of changes
The organization shall review and control changes for production or service provision, to the extent
%6 -.+% 6+%(%(%&6+%8+(.9()0(%
The organization shall retain documented information describing the results of the review of changes,
) +%1 2-)+(B(%&)6)-%&>-%!-%.%6 -.-6(+% -( (%&8+):(9
8.6 Release of products and services

) +&-%(B-(+% )-'' ('% '-%%! --%&% > - -+(- -& > + :(8. )- )
product and service requirements have been met.
The release of products and services to the customer shall not proceed until the planned arrangements
)-: % -( 8-6+('. 6+'!> %' +)9( -+:! . - ':-% -)+(. -%!> -
-'(6-'>.)6 +

I.S. EN ISO 9001:2015
ISO 9001:2015(E)
The organization shall retain documented information on the release of products and services. The
documented information shall include:
-2 :(!%6+86+%8+(.9())-66-%66((-
2 -6-('(.+) +%1 2-)+(B(%&)'-
8.7 Control of nonconforming outputs
8.7.1 The organization shall ensure that outputs that do not conform to their requirements are
(!%((!-%!6+%+''!+:%)(%(%%!! +!'(:.
)+&-%(B-(+% )-''-C-+(--6(+%- !+%)%-+8)%+%6+%8+(.-%!( 886

+% ) 6+%8+(. +8 +!6 -%! :(6 )( )-'' -' + -'. + %+%6+%8+(%& +!6 -%!
:(6 !6!-8!'(:.+8+!6 >!(%&+-8)+:( (+%+8 :(6
)+&-%(B-(+% )-''!-'9()%+%6+%8+(%&+ (%+%+++8)8+''+9(%&9-. #
-2 6+6(+%
2 &&-(+%>6+%-(%%>%+ % (+%+8+:( (+%+8+!6 -%! :(6
62 (%8+(%&)6 +
d) obtaining authorization for acceptance under concession.
+%8+(.+)0(% )-'':((!9)%%+%6+%8+(%&+ -6+6!
8.7.2 The organization shall retain documented information that:
-2 ! 6( )%+%6+%8+(.

2 ! 6( )-6(+% -C%
62 ! 6( -%.6+%6 (+% +-(%!
!2 (!%(( )-)+(.!6(!(%&)-6(+%(% 6+8)%+%6+%8+(.
9 Performance evaluation
'* +

$
9.1.1 General
The organization shall determine:

-2 9)-%! ++%(+!-%!- !
2 ))+! 8++%(+(%&>- %>-%-'. ( -%!:-'-(+%%!!+% :-'(! '
62 9)%)+%(+(%&-%!- (%& )-''8+!
!2 9)%) ' 8++%(+(%&-%!- % )-''-%-'. !-%!:-'-!
)+&-%(B-(+% )-'':-'-)8+-%6-%!)886(:% +8)0-'(.-%-&% .
The organization shall retain appropriate documented information as evidence of the results.

I.S. EN ISO 9001:2015
ISO 9001:2015(E)
9.1.2 Customer satisfaction
The organization shall monitor customers’ perceptions of the degree to which their needs and
56-(+% )-: % 8'(''! ) +&-%(B-(+% )-'' !(% ) )+! 8+ +-(%(%&>
monitoring and reviewing this information.
5-' +8 +%(+(%& 6 + 6(+% 6-% (%6'! 6 + :. > 6 + 8!-6C
+% !'(:! +!6 -%! :(6 > (%& 9() 6 + > -C/ )- -%-'. ( > 6+'(% > 9--%.
claims and dealer reports.
9.1.3 Analysis and evaluation
)+&-%(B-(+% )-''-%-'. -%!:-'--+(-!---%!(%8+-(+%-( (%&8++%(+(%&

and measurement.
) ' +8-%-'. ( )-'' !+:-'-#
-2 6+%8+(.+8+!6 -%! :(6
2 )!&+86 + -( 8-6(+%
62 )8+-%6-%!886(:% +8)0-'(.-%-&% .
!2 (8'-%%(%&)- %('%!886(:'.
2 )886(:% +8-6(+% -C%+-!! ( C -%!++%((
82 )8+-%6+85%-'+:(!
&2 )%!8+(+:% +)0-'(.-%-&% .
)+! +-%-'. !--6-%(%6'! -( (6-'6)%(0
9.2 Internal audit
9.2.1 The organization shall conduct internal audits at planned intervals to provide information on
9)))0-'(.-%-&% . #
a) conforms to:
2 )+&-%(B-(+% +9%0(% 8+( 0-'(.-%-&% .
2 )0(% +8)( %%-(+%-'
-%!-!
2 ( 886(:'.('%!-%!-(%-(%!
9.2.2 The organization shall:
-2 '-%> -'( )>('%-%!-(%-(%-%-!(+&-1 2(%6'!(%&)80%6.>)+! >

responsibilities, planning requirements and reporting, which shall take into consideration the
importance of the processes concerned, changes affecting the organization, and the results of
:(+ -!(
2 !(%)-!(6((--%! 6+8+-6)-!(
62 '6-!(+ -%!6+%!6-!( +% +6(:(.-%!)(-(-'(.+8)-!(+6
!2 % )-) ' +8)-!( -+!+':-%-%-&%
2 -C-+(-6+6(+%-%!6+6(:-6(+% 9()+%!!'-.

I.S. EN ISO 9001:2015
ISO 9001:2015(E)
f) retain documented information as evidence of the implementation of the audit programme and the
audit results.
NOTE See ISO 19011 for guidance.
9.3 Management review
9.3.1 General
+-%-&% )-'':(9)+&-%(B-(+% 0-'(.-%-&% . >-'-%%!(%:-' >+

% ( 6+%(%(%& (-('(.>-!0-6.>886(:% -%!-'(&%%9()) -&(6!(6(+%+8
the organization.
9.3.2 Management review inputs
The management review shall be planned and carried out taking into consideration:
-2 ) - +8-6(+% 8+:(+ -%-&%:(9
2 6)-%& (%5%-'-%!(%%-'( )--':-%+)0-'(.-%-&% .
62 (%8+-(+% +% ) 8+-%6 -%! 886(:% +8 ) 0-'(. -%-&% . > (%6'!(%&
trends in:
2 6 + -( 8-6(+%-%!8!-6C8+':-%(% !-(
2 )5%+9)(6)0-'(.+6(: )-:%

2 +6 8+-%6-%!6+%8+(.+8+!6 -%! :(6
;2 %+%6+%8+(( -%!6+6(:-6(+%
2 +%(+(%&-%!- % '
2 -!( '
2 )8+-%6+85%-'+:(!
!2 )-!0-6.+8 +6
e) the effectiveness of actions taken to address risks and opportunities (see 6.12
f) opportunities for improvement.
9.3.3 Management review outputs
The outputs of the management review shall include decisions and actions related to:
-2 ++%(( 8+(+:%
2 -%.%!8+6)-%& +)0-'(.-%-&% .
c) resource needs.
The organization shall retain documented information as evidence of the results of management reviews.

I.S. EN ISO 9001:2015
ISO 9001:2015(E)
10 Improvement
10.1 General
) +&-%(B-(+% )-'' !(% -%! '6 ++%(( 8+ (+:% -%! ('% -%.
%6 -.-6(+% +6 +0(% -%!%)-%66 + -( 8-6(+%
These shall include:
a) improving products and services to meet requirements as well as to address future needs and
56-(+%
2 6+6(%&>:%(%&+!6(%&%! (!886
62 (+:(%&)8+-%6-%!886(:% +8)0-'(.-%-&% .
NOTE Examples of improvement can include correction, corrective action, continual improvement,
breakthrough change, innovation and re-organization.
10.2 Nonconformity and corrective action
10.2.1 )%-%+%6+%8+(.+66 >(%6'!(%&-%.-( (%&8+6+'-(% >)+&-%(B-(+% )-''#
-2 -6+)%+%6+%8+(.-%!>- -'(6-'#

2 -C-6(+%+6+%+'-%!6+6(
2 !-'9())6+% 0%6
2 :-'-)%!8+-6(+%+'((%-)6- 1 2+8)%+%6+%8+(.>(%+!)-(!+ %+
6++66' 9)>.#
2 :(9(%&-%!-%-'. (%&)%+%6+%8+(.
2 !(%(%&)6- +8)%+%6+%8+(.
2 !(%(%&(8 (('-%+%6+%8+(( 5( >+6+'!+%(-''.+66
62 ('%-%.-6(+%%!!
!2 :(9)886(:% +8-%.6+6(:-6(+%-C%
2 !-( C -%!++%(( !(%!!(%&'-%%(%&>(8%6 -.
82 -C6)-%& +)0-'(.-%-&% . >(8%6 -.
Corrective actions shall be appropriate to the effects of the nonconformities encountered.
10.2.2 The organization shall retain documented information as evidence of:
-2 )%-+8)%+%6+%8+(( -%!-%. 0%-6(+% -C%

2 ) ' +8-%.6+6(:-6(+%
10.3 Continual improvement

) +&-%(B-(+% )-'' 6+%(%-''. (+: ) (-('(.> -!0-6. -%! 886(:% +8 ) 0-'(.
-%-&% .

I.S. EN ISO 9001:2015
ISO 9001:2015(E)
) +&-%(B-(+% )-'' 6+% (! ) ' +8 -%-'. ( -%! :-'-(+%> -%! ) + 8+
management review, to determine if there are needs or opportunities that shall be addressed as part of
continual improvement.

I.S. EN ISO 9001:2015
ISO 9001:2015(E)
Annex A
(informative)

A.1 Structure and terminology

) 6'- 6 1( 6'- 0%62 -%! + +8 ) (%+'+&. +8 )( !((+% +8 )(
International Standard, in comparison with the previous edition (ISO 9001:2008), have been changed
+(+:-'(&%%9()+)-%-&% . -%!-!
)( %+0(%(%)( %%-(+%-'
-%!-!8+( 6-%!(%+'+&.+-'(!
+)!+6%!(%8+-(+%+8-%+&-%(B-(+% 0-'(.-%-&% .
The structure of clauses is intended to provide a coherent presentation of requirements, rather than a
+!'8+!+6%(%&-%+&-%(B-(+% +'(6( >+6(: -%!+6 ) 6-%!6+%%
+8!+6%!(%8+-(+%'-!+-0-'(.-%-&% . 6-%+8%+':-%+(
(8('- ++))+6 +-!.)+&-%(B-(+%-%!(%8+-(+%-(%-(%!8+
other purposes.
)( %+0(%8+) !.-%+&-%(B-(+%+'-6!.) !(%)(

%%-(+%-'
-%!-!+ 6(8.0-'(.-%-&% . 0(% &-%(B-(+% 6-%6)++
to use terms which suit their operations (e.g. using “records”, “documentation” or “protocols” rather
)-%!+6%!(%8+-(+%+ '(>-%+:%!+-))-%5%-'+:(!2
Table A.1 )+9 ) -+ !(88%6 (% (%+'+&. 9% )( !((+% +8 )( %%-(+%-'
Standard and the previous edition.
Table A.1 — Major differences in terminology between ISO 9001:2008 and ISO 9001:2015
ISO 9001:2008 ISO 9001:2015
Products Products and services
Exclusions Not used
(See Clause A.58+6'-((6-(+%+8-'(6-('(.2
Management representative Not used
(Similar responsibilities and authorities are assigned
but no requirement for a single management repre-
sentative)
+6%-(+%>0-'(.-%-'>!+6%!+- Documented information
cedures, records
Work environment Environment for the operation of processes
Monitoring and measuring equipment Monitoring and measuring resources
Purchased product 5%-''.+:(!!+!6 -%! :(6
Supplier External provider
A.2 Products and services

ISO 9001:2008 used the term “product” to include all output categories. This edition of this International
Standard uses “products and services”. “Products and services” include all output categories (hardware,
services, software and processed materials).

I.S. EN ISO 9001:2015
ISO 9001:2015(E)
) 6((6 (%6' (+% +8 :(6 ( (%%!! + )(&)'(&) ) !(88%6 9% +!6 -%!
services in the application of some requirements. The characteristic of services is that at least part of
)+( -'(B!-)(%8-69())6 +)( -% >8+5-'>)-6+%8+(.+
0(% 6-%%+%6 -('.6+%(!8+ :(6!'(:.
In most cases, products and services are used together. Most outputs that organizations provide to
6 + > + - '(! + ) . 5%-' +:(! > (%6'! +) +!6 -%! :(6 ?+
example, a tangible or intangible product can have some associated service or a service can have some
associated tangible or intangible product.
A.3 Understanding the needs and expectations of interested parties

Subclause 4.2 6(( 0(% 8+ ) +&-%(B-(+% + !(% ) (% ! -( )-
- ':-% + ) 0-'(. -%-&% . -%! ) 0(% +8 )+ (% ! -(
However, 4.2!+ %+('.5% (+%+80-'(.-%-&% . 0(% .+%!) 6+
of this International Standard. As stated in the scope, this International Standard is applicable where
-% +&-%(B-(+% %! + !+% - ( -('(. + 6+% ( %'. +:(! +!6 -%! :(6 )-
6 +-%!-'(6-' -+.-%!&'-+.0(% >-%!-( +%)-%66 +
satisfaction.
There is no requirement in this International Standard for the organization to consider interested
-( 9)()- !6(!!)-)+ -( -%+':-%+( 0-'(.-%-&% . (
8+)+&-%(B-(+%+!6(!(8--(6'-0(%+8-':-%(% !-.( ':-%+(
0-'(.-%-&% .
A.4 Risk-based thinking

The concept of risk-based thinking has been implicit in previous editions of this International Standard,
e.g. through requirements for planning, review and improvement. This International Standard
6(( 0(% 8+)+&-%(B-(+%+%! -%!( 6+%51 4.1) and determine risks as
a basis for planning (see 6.1). This represents the application of risk-based thinking to planning and
('%(%&0-'(.-%-&% . +6 1 4.4) and will assist in determining the extent
of documented information.
%+8)C.+ +8-0-'(.-%-&% . ( +-6- -:%(:++'+% 0%'.>
this International Standard does not have a separate clause or subclause on preventive action. The
6+%6+8:%(:-6(+%( 5 !)+&)) +8( C/- !)(%C(%&(%8+'-(%&0-'(.
-%-&% . 0(%
The risk-based thinking applied in this International Standard has enabled some reduction in
6((:0(% -%!)('-6%.8+-%6/- !0(% )( &-
'5(('(. )-% (%
"#$ (% ) 0(% 8+ +6 > !+6%! (%8+-(+% -%!
organizational responsibilities.
Although 6.1 6(( )-)+&-%(B-(+% )-'''-%-6(+% +-!! ( C >)( %+0(%
for formal methods for risk management or a documented risk management process. Organizations can
!6(!9))+%++!:'+-+5% (:( C-%-&%)+!+'+&.)-%( 0(!.
this International Standard, e.g. through the application of other guidance or standards.
+-'')+6 +8-0-'(.-%-&% . %) -':'+8( C(% +8)
+&-%(B-(+% -('(. + ( +6(: > -%! ) 886 +8 %6-(%. - %+ ) - 8+ -''
organizations. Under the requirements of 6.1, the organization is responsible for its application of risk-
based thinking and the actions it takes to address risk, including whether or not to retain documented
information as evidence of its determination of risks.

I.S. EN ISO 9001:2015
ISO 9001:2015(E)
A.5 Applicability
)( %%-(+%-'
-%!-! !+ %+ 8 + 56' (+% (% '-(+% + ) -'(6-('(. +8 (
0(% +)+&-%(B-(+% 0-'(.-%-&% . +9:>-%+&-%(B-(+%6-%:(9
) -'(6-('(. +8 0(% ! + ) (B + 6+'5(. +8 ) +&-%(B-(+%> ) -%-&%
model it adopts, the range of the organization’s activities and the nature of the risks and opportunities
it encounters.
) 0(% 8+ -'(6-('(. - -!! ! (% 4.3> 9)(6) !(% 6+%!((+% %! 9)(6) -%
+&-%(B-(+%6-%!6(!)--0(%6-%%+-'(!+-%.+8)+6 9()(%) 6+
+8( 0-'(.-%-&% . )+&-%(B-(+%6-%+%'.!6(!)--0(%( %+-'(6-'
(8( !6( (+%9(''%+ '(%8-('+-6)(:6+%8+(.+8+!6 -%! :(6
A.6 Documented information

-+8)-'(&%%9()+)-%-&% . -%!-! >-6++%6'- +%!+6%!
(%8+-(+% )- % -!+! 9()+ (&%((6-% 6)-%& + -!!((+% 1 7.5). Where appropriate,
5 ' 9) (% )( %%-(+%-'
-%!-! )- % -'(&%! 9() ( 0(% +% 0%'.>
“documented information” is used for all document requirements.
)
"#$ ! 6((6 (%+'+&. 6) - !+6% + !+6%! +6! >
0-'(.-%-'+0-'(.'-%>)( !((+%+8)( %%-(+%-'
-%!-!!(% 0(% +
“maintain documented information”.
Where ISO 9001:2008 used the term “records” to denote documents needed to provide evidence
+8 6+%8+(. 9() 0(% > )( ( %+9 5 ! - - 0(% + -(% !+6%!
information”. The organization is responsible for determining what documented information needs to
be retained, the period of time for which it is to be retained and the media to be used for its retention.
0(% + -(%-(% !+6%! (%8+-(+% !+ %+ 56'! ) + (('(. )- )
organization might also need to “retain” that same documented information for a particular purpose,
e.g. to retain previous versions of it.
Where this International Standard refers to “information” rather than “documented information” (e.g. in
4.1: “The organization shall monitor and review the information about these external and internal issues”),
there is no requirement that this information is to be documented. In such situations, the organization
6-%!6(!9))+%+(( %6 -.+-+(-+-(%-(%!+6%!(%8+-(+%
A.7 Organizational knowledge

In 7.1.6, this International Standard addresses the need to determine and manage the knowledge
-(%-(%! . ) +&-%(B-(+%> + % ) +-(+% +8 ( +6 -%! )- ( 6-% -6)(:
6+%8+(.+8+!6 -%! :(6
Requirements regarding organizational knowledge were introduced for the purpose of:
a) safeguarding the organization from loss of knowledge, e.g.
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b) encouraging the organization to acquire knowledge, e.g.
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— benchmarking.

I.S. EN ISO 9001:2015
ISO 9001:2015(E)
,!
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c) outsourcing processes to an external provider.
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+!6 -%! :(6 )+&-%(B-(+%6-%-'.( C/- !)(%C(%&+!(%).-%!5%
+86+%+' -+(-+-(6'-5%-'+:(! -%!5%-''.+:(!!+6 >+!6
and services.

I.S. EN ISO 9001:2015
ISO 9001:2015(E)
Annex B
(informative)
Other International Standards on quality management and quality

management systems developed by ISO/TC 176
) %%-(+%-'
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< + +:(!
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6+%-(%! (% ) !+6% '( ! (% )( -%%5 !+ %+ -!! +> + +!(8.> ) 0(% +8 )(
Table B.1 shows the relationship between these standards and the relevant clauses of this
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)( %%-(+%-'
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— ISO 9000 Quality management systems — Fundamentals and vocabulary provides an essential
background for the proper understanding and implementation of this International Standard.
)0-'(.-%-&%(%6(' -! 6(!(%!-('(%
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consideration during the development of this International Standard. These principles are not
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— ISO 90011)( %%-(+%-'
-%!-!2 6(( 0(% -(!(-('.-&(:(%&6+%(!%6(%
)+!6 -%! :(6 +:(!!.-%+&-%(B-(+%-%!).%)-%6(%&6 + -( 8-6(+%
+ ('%-(+% 6-% -' + 56! + (%& +) +&-%(B-(+%-' %( > 6) -
improved internal communication, better understanding and control of the organization’s processes.
— ISO 9004 Managing for the sustained success of an organization — A quality management approach
+:(! &(!-%6 8+ +&-%(B-(+% )- 6)++ + +& .+%! ) 0(% +8 )(
International Standard, to address a broader range of topics that can lead to improvement of the
+&-%(B-(+% +:-''8+-%6
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8+-%+&-%(B-(+%+-'+:-'-)':'+8-(.+8( 0-'(.-%-&% .
) %%-(+%-'
-%!-! +'(%! '+9 6-% +:(! - ( -%6 + +&-%(B-(+% 9)% ). -
-'( )(%&+ C(%&+(+:)(0-'(.-%-&% . >)(+6 +)(-6(:((
— ISO 10001 Quality management — Customer satisfaction — Guidelines for codes of conduct for
organizations provides guidance to an organization in determining that its customer satisfaction
+:( (+% 6 +%! -%!56-(+% 6-%%)-%66 +6+%(!%6(%-%
+&-%(B-(+%-%!(+:6 +%! -%!(%&+89)-+568+-%+&-%(B-(+%>).
reducing the likelihood of misunderstandings and complaints.
— ISO 10002 Quality management — Customer satisfaction — Guidelines for complaints handling
in organizations +:(! &(!-%6 +% ) +6 +8 )-%!'(%& 6+'-(% . 6+&%(B(%& -%!
-!! (%& ) %! -%! 56-(+% +8 6+'-(%-% -%! +':(%& -%. 6+'-(% 6(:!

+:(! -% +%> 886(: -%! - ./+/ 6+'-(% +6 > (%6'!(%& -(%(%& +8
people. It also provides guidance for small businesses.
— ISO 10003 Quality management — Customer satisfaction — Guidelines for dispute resolution external
to organizations +:(! &(!-%6 8+ 886(: -%! 8(6(% 5%-' !( +'(+% 8+

I.S. EN ISO 9001:2015
ISO 9001:2015(E)
product-related complaints. Dispute resolution gives an avenue of redress when organizations

!+ %+ !. - 6+'-(% (%%-''. + 6+'-(% 6-% +':! 66 8''. 9()(% )
organization, without adversarial procedures.
— ISO 10004 Quality management — Customer satisfaction — Guidelines for monitoring and measuring
provides guidelines for actions to enhance customer satisfaction and to determine opportunities for
(+:%+8+!6 >+6 -%!-( )--:-'!.6 +
6)-6(+% 6-%
%&)%6 +'+.-'.-%!)'-(%6 +
— ISO 10005 Quality management systems — Guidelines for quality plans provides guidance on
-'( )(%&-%! (%&0-'(.'-% - --% +8'-(%&0(% +8)+6 >+!6>
+6 + 6+%-6> + 9+C )+! -%! -6(6 )- + +!6 -'(B-(+% A%( +8
-'( )(%&-0-'(.'-%-(%6- !6+%(!%6)-0(% 9(''>)-+6
are in control and the motivation that this can give to those involved.
— ISO 10006 Quality management systems — Guidelines for quality management in projects is applicable
++6 8+) -''+'-&>8+ ('+6+'5>8+-%(%!(:(!-'+6+(%&-
+8-+8+'(++8+6
( + !. +%%'-%-&(%&+6 -%!9)+%!+
% )-)(+&-%(B-(+%( -'.(%&)-6(6 6+%-(%!(%)
0-'(.-%-&%
. -%!-!
— ISO 10007

is to assist
+&-%(B-(+% -'.(%&6+%(&-(+%-%-&%8+)6)%(6-'-%!-!(%( -(:!(6(+%
+: ) '(8 6.6' +8 - +!6 +%(&-(+% -%-&% 6-% ! + ) +!6
(!%((6-(+%-%!-6-('(.0(% 6((!(%)( %%-(+%-'
-%!-!
— ISO 10008 Quality management — Customer satisfaction — Guidelines for business-to-consumer

electronic commerce transactions gives guidance on how organizations can implement an effective
-%! 8(6(% (% /+/6+% '6+%(6 6+6 -% -6(+% 1A 2 . > -%!
).+:(!-- ( 8+6+% +)-:(%6- !6+%(!%6(%A >%)-%6)-('(.
+8+&-%(B-(+% + -( 8.6+% -%!)'!66+'-(% -%!!(
— ISO 10012 Measurement management systems — Requirements for measurement processes and
measuring equipment provides guidance for the management of measurement processes and
+'+&(6-'6+%(-(+%+8- (%&0(% !+ +-%!!+% -6+'(-%6
9()+'+&(6-'0(%
+:(! 0-'(.-%-&%6((-8+-- %
-%-&% . +% +'+&(6-'0(% -
— ISO/TR 10013 Guidelines for quality management system documentation provides guidelines for
) !:'+% -%! -(%%-%6 +8 ) !+6%-(+% %6 -. 8+ - 0-'(. -%-&%
. ISO/TR 6-% ! + !+6% -%-&% . +) )-% )+ +8 )

0-'(.-%-&% . -%!-! >&%:(+%%-'-%-&% . -%! -8.
-%-&% .
— ISO 10014

is addressed
++-%-&%+:(! &(!'(% 8+-'(B(%&(%-%6(-'-%!6+%+(6%( )+&))
-'(6-(+% +8 0-'(. -%-&% (%6(' 8-6('(- -'(6-(+% +8 -%-&% (%6('
and selection of methods and tools that enable the sustainable success of an organization.
— ISO 10015 Quality management — Guidelines for training provides guidelines to assist organizations
in addressing issues related to training. ISO 10015 can be applied whenever guidance is required
+ (% 8%6 + !6-(+% -%! -(%(%& 9()(% )
0-'(. -%-&% .
-%!-! %.8%6+-(%(%&(%6'! -''. +8!6-(+%-%!-(%(%&
— ISO/TR 10017 Guidance on statistical techniques for ISO 9001:2000 explains statistical techniques
9)(6)8+''+98+):-(-('(.)-6-%+ :!(%))-:(+-%! ' +8+6 >
:%%!6+%!((+% +8--% -('(.
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+- ( (%!6( (+%-C(%&>-%!).)'+6+%(%-''.(+:)0-'(.+8+!6 -%!
processes to achieve customer satisfaction.

I.S. EN ISO 9001:2015
ISO 9001:2015(E)
— ISO 10018 Quality management — Guidelines on people involvement and competence provides
&(!'(% 9)(6) (%'%6 +' (%:+':% -%! 6+%6 0-'(. -%-&% .
!%! +% ) (%:+':% +8 6+% +' -%! ) 9-. )- ). - (%+!6! -%!
integrated into the organization. It is critical to determine, develop and evaluate the knowledge,
skills, behaviour and work environment required.
— ISO 10019 Guidelines for the selection of quality management system consultants and use of their services
+:(! &(!-%68+) '6(+%+80-'(.-%-&% . 6+% '-% -%!) +8)(
:(6 &(: &(!-%6+%)+6 8+:-'-(%&)6+%6+8-0-'(.-%-&%
. 6+% '-%-%!+:(! 6+%(!%6)-)+&-%(B-(+% %! -%!56-(+% 8+)
consultant’s services will be met.
— ISO 19011 Guidelines for auditing management systems provides guidance on the management of an
-!(+&->+%)'-%%(%&-%!6+%!6(%&+8-%-!(+8--%-&% . >- 9''-
+%)6+%6-%!:-'-(+%+8-%-!(+-%!-%-!(-
"( (%%!!+-'.+
-!(+ >+&-%(B-(+% ('%(%&-%-&% . >-%!+&-%(B-(+% %!(%&+6+%!6
-!( +8-%-&% .
Table B.1 — Relationship between other International Standards on quality management and
quality management systems and the clauses of this International Standard
Other Interna- Clause in this International Standard
tional Standard
4 5 6 7 8 9 10
ISO 9000 All All All All All All All

ISO 10001 8.2.2, 8.5.1 9.1.2
ISO 10002 8.2.1, 9.1.2 10.2.1
ISO 10003 9.1.2
ISO 10004 9.1.2, 9.1.3
ISO 10005 5.3 6.1, 6.2 All All 9.1 10.2
ISO 10007 8.5.2
ISO 10012 7.1.5
ISO/TR 10013 7.5
ISO 10015 7.2
ISO/TR 10017 6.1 7.1.5 9.1
ISO 10019 8.4
ISO 19011 9.2
''(%!(6- )--'') 6'- (%) 6((66'- +8)( %%-(+%-'
-%!-!-'-!+)+)

I.S. EN ISO 9001:2015
ISO 9001:2015(E)
Bibliography
[1] ISO 9004, Managing for the sustained success of an organization — A quality management approach
[2] ISO 10001, Quality management — Customer satisfaction — Guidelines for codes of conduct for
organizations
[3] ISO 10002, Quality management — Customer satisfaction — Guidelines for complaints handling in
organizations
[4] ISO 10003, Quality management — Customer satisfaction — Guidelines for dispute resolution
external to organizations
[5] ISO 10004, Quality management — Customer satisfaction — Guidelines for monitoring and measuring
[6] ISO 10005, Quality management systems — Guidelines for quality plans
[7] ISO 10006, Quality management systems — Guidelines for quality management in projects
[8] ISO 10007,

[9] ISO 10008, Quality management — Customer satisfaction — Guidelines for business-to-consumer
electronic commerce transactions
[10] ISO 10012, Measurement management systems — Requirements for measurement processes and
measuring equipment
[11] ISO/TR 10013, Guidelines for quality management system documentation
[12] ISO 10014,

[13] ISO 10015, Quality management — Guidelines for training
[14] ISO/TR 10017, Guidance on statistical techniques for ISO 9001:2000
[15] ISO 10018, Quality management — Guidelines on people involvement and competence
[16] ISO 10019, Guidelines for the selection of quality management system consultants and use of
their services
[17] ISO 14001, Environmental management systems — Requirements with guidance for use
[18] ISO 19011, Guidelines for auditing management systems
[19] ISO 31000, Risk management — Principles and guidelines
[20] ISO 37500, Guidance on outsourcing
[21] ISO/IEC 90003, Software engineering — Guidelines for the application of ISO 9001:2008 to
computer software
[22] IEC 60300-1, Dependability management — Part 1: Guidance for management and application
[23] IEC 61160, Design review
¡;¢ ,-'(.-%-&%(%6(' >
1)
¡¢
'6(+%-%! +8)
"8-('.+8 -%!-! >
1)
[26] ISO 9001 for Small Businesses — What to do, ISO1)
1) Available from website: http://www.iso.org.

I.S. EN ISO 9001:2015
ISO 9001:2015(E)
¡¢ %&-! +8-%-&% . -%!-! >

1)
[28] www.iso.org/tc176/sc02/public
[29] www.iso.org/tc176/ISO9001AuditingPracticesGroup

I.S. EN ISO 9001:2015
ISO 9001:2015(E)
&;<=*%=*=
Price based on 29 pages
© ISO 2015 – All rights reserved

I.S. EN ISO 9001:2015
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EN ISO 9001:2015 23 September, 2015

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0.2 Quality management principles

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Figure 1 — Schematic representation of the elements of a single process

0.3.2 Plan-Do-Check-Act cycle

NOTE Numbers in brackets refer to the clauses in this International Standard.

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Quality management systems — Requirements

4 Context of the organization

4.1 Understanding the organization and its context

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4.2 Understanding the needs and expectations of interested parties

4.3 Determining the scope of the quality management system

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5.2.1 Establishing the quality policy

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