The National Standards Authority of Ireland And/or Its All Rights Reserved
The National Standards Authority of Ireland And/or Its All Rights Reserved
The National Standards Authority of Ireland And/or Its All Rights Reserved
05/04/2018
© 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.
SWiFT xxx: A rapidly developed recommendatory document based on the consensus of the
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ICS number:
This document was published 03.120.10
under the authority of the NSAI
and comes into effect on:
23 September, 2015
EN ISO 9001
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Contents Page
European foreword....................................................................................................................................................... 3
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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be withdrawn at the latest by March 2016.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 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,
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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
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I.S. EN ISO 9001:2015
Fifth edition
2015-09-15
Reference number
ISO 9001:2015(E)
© ISO 2015
I.S. EN ISO 9001:2015
ISO 9001:2015(E)
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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
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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
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
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
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committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
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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
Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.
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.
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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International Standard are:
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This International Standard promotes the adoption of a process approach when developing,
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adoption of a process approach are included in 4.4.
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overall performance of the organization can be enhanced.
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advantage of opportunities and preventing undesirable results.
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d) improvement of processes based on evaluation of data and information.
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Figure 2 — Representation of the structure of this International Standard in the PDCA cycle
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:
— ISO 9000 Quality management systems — Fundamentals and vocabulary provides essential
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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.
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.
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1 Scope
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2 Normative references
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ISO 9000:2015, Quality management systems — Fundamentals and vocabulary
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technological, competitive, market, cultural, social and economic environments, whether international, national,
regional or local.
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requirements of this International Standard.
5 Leadership
5.1.1 General
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(% +6
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activities that are core to the purposes of the organization’s existence, whether the organization is public, private,
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ensuring that:
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c) the focus on enhancing customer satisfaction is maintained.
5.2 Policy
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c) be available to relevant interested parties, as appropriate.
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Top management shall ensure that the responsibilities and authorities for relevant roles are assigned,
communicated and understood within the organization.
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6 Planning
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NOTE 2 Opportunities can lead to the adoption of new practices, launching new products, opening new
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possibilities to address the organization’s or its customers’ needs.
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e) how the results will be evaluated.
7 Support
7.1 Resources
7.1.1 General
The organization shall determine and provide the resources needed for the establishment,
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The organization shall consider:
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b) what needs to be obtained from external providers.
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7.1.2 People
7.1.3 Infrastructure
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7.1.5.1 General
The organization shall determine and provide the resources needed to ensure valid and reliable
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requirements.
The organization shall ensure that the resources provided:
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the monitoring and measurement resources.
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When addressing changing needs and trends, the organization shall consider its current knowledge
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external providers).
7.2 Competence
The organization shall:
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8+-%6-%!886(:% +8)0-'(.-%-&% .
b) ensure that these persons are competent on the basis of appropriate education, training, or
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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-
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7.3 Awareness
The organization shall ensure that persons doing work under the organization’s control are aware of:
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2 ':-%0-'(.+6(:
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7.4 Communication
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e) who communicates.
7.5.1 General
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When creating and updating documented information, the organization shall ensure appropriate:
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2 8+-1&'-%&-&> +89-: (+%>&-)(6 2-%!!(-1&->'6+%(62
62 :(9-%!-+:-'8+ (-('(.-%!-!0-6.
7.5.3.2 For the control of documented information, the organization shall address the following
activities, as applicable:
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8 Operation
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.
-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 !
) +&-%(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.
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.
8.3.1 General
stephen.beveridge@roadbridge.co.uk, 05/04/2018, IHS Global Ltd
The organization shall establish, implement and maintain a design and development process that is
appropriate to ensure the subsequent provision of products and services.
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.
) +&-%(B-(+% )-'' !(% ) 0(% %(-' 8+ ) 6((6 . +8 +!6 -%!
services to be designed and developed. The organization shall consider:
-2 8%6(+%-'-%!8+-%60(%
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-(+%
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 +
stephen.beveridge@roadbridge.co.uk, 05/04/2018, IHS Global Ltd
products and services in accordance with requirements. The organization shall retain documented
(%8+-(+%+8) -6(:(( -%!-%.%6 -.-6(+% -( (%&8+):-'-(+%
) +&-%(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.
) +&-%(B-(+% )-'' % ) -!0-6. +8 0(% (+ + )( 6+%(6-(+% + )
external provider.
The organization shall communicate to external providers its requirements for:
-2 )+6 >+!6 -%! :(6 ++:(!!
The organization shall implement production and service provision under controlled conditions.
Controlled conditions shall include, as applicable:
-2 )-:-('-('(.+8!+6%!(%8+-(+%)-!(% #
stephen.beveridge@roadbridge.co.uk, 05/04/2018, IHS Global Ltd
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-('(.
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.
) +&-%(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'(%&+(%-'!( + -'
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
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(%&)'-
8.7.1 The organization shall ensure that outputs that do not conform to their requirements are
(!%((!-%!6+%+''!+:%)(%(%%!! +!'(:.
9 Performance evaluation
'* +
$
9.1.1 General
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.
82 )8+-%6+85%-'+:(!
&2 )%!8+(+:% +)0-'(.-%-&% .
)+! +-%-'. !--6-%(%6'! -( (6-'6)%(0
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(:'.('%!-%!-(%-(%!
f) retain documented information as evidence of the implementation of the audit programme and the
audit results.
NOTE See ISO 19011 for guidance.
9.3.1 General
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+':-%(% !-(
stephen.beveridge@roadbridge.co.uk, 05/04/2018, IHS Global Ltd
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.
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.
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.
) +&-%(B-(+% )-'' 6+% (! ) ' +8 -%-'. ( -%! :-'-(+%> -%! ) + 8+
management review, to determine if there are needs or opportunities that shall be addressed as part of
continual improvement.
stephen.beveridge@roadbridge.co.uk, 05/04/2018, IHS Global Ltd
Annex A
(informative)
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
) 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.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
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+-(+%
,!
#
$
$
'' 8+ +8 5%-''. +:(!! +6 > +!6 -%! :(6 - -!! ! (% 8.4, e.g. whether
through:
-2 6)- (%&8+- '(
2 -%--%&%9()-%- +6(-6+-%.
c) outsourcing processes to an external provider.
+6(%&-'9-. )- ) %(-'6)--6( (6+8- :(6> (%6(9('')-:-'- +%-6(:(.
%6 -('.8+!-)(%8-69%)+:(!-%!)+&-%(B-(+%
)6+%+' 0(!8+5%-'+:( (+%6-%:-.9(!'.!%!(%&+%)%-+8)+6 >
+!6 -%! :(6 )+&-%(B-(+%6-%-'.( C/- !)(%C(%&+!(%).-%!5%
+86+%+' -+(-+-(6'-5%-'+:(! -%!5%-''.+:(!!+6 >+!6
and services.
stephen.beveridge@roadbridge.co.uk, 05/04/2018, IHS Global Ltd
Annex B
(informative)
) %%-(+%-'
-%!-! ! 6(! (% )( -%%5 )-: % !:'+! .
< + +:(!
+(%& (%8+-(+% 8+ +&-%(B-(+% )- -'. )( %%-(+%-'
-%!-!> -%! + +:(!
&(!-%68++&-%(B-(+% )-6)++ ++& .+%!( 0(% @(!-%6+0(%
6+%-(%! (% ) !+6% '( ! (% )( -%%5 !+ %+ -!! +> + +!(8.> ) 0(% +8 )(
International Standard.
Table B.1 shows the relationship between these standards and the relevant clauses of this
International Standard.
)( -%%5 !+ %+ (%6'! 8%6 + ) 6+/ 6((6 0-'(. -%-&% . -%!-!
!:'+!.
<
)( %%-(+%-'
-%!-!( +%+8))6+ -%!-! !:'+!.
<
— ISO 9000 Quality management systems — Fundamentals and vocabulary provides an essential
stephen.beveridge@roadbridge.co.uk, 05/04/2018, IHS Global Ltd
background for the proper understanding and implementation of this International Standard.
)0-'(.-%-&%(%6(' -! 6(!(%!-('(%
"-%!)-:%-C%(%+
consideration during the development of this International Standard. These principles are not
0(% (% ) ': > ). 8+ ) 8+%!-(+% +8 ) 0(% 6((! . )(
%%-(+%-'
-%!-!
" -' + !(% ) > !(%((+% -%! 6+%6 ! (% )(
International Standard.
— 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
";(%6'! &(!-%6+%- '8/- %)+!+'+&.
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+
— 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
stephen.beveridge@roadbridge.co.uk, 05/04/2018, IHS Global Ltd
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
stephen.beveridge@roadbridge.co.uk, 05/04/2018, IHS Global Ltd
[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)
&;<=*%=*=
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