FOP

INTERNATIO NAL
STANDARD ISO
9001

Fift h edition
2015-09-15

r
Quality management systems -
Requirements
r
System es de ma nagement de la qualite - Exigenc es

I
(

I
[
l
I
I
(

I
l
( - .---==
-
ISO
I J -
-=
 Re fere nce n um ber
ISO 9001 :2015(E)

I
-·
0
tn
-
1,0
0
0

N
0
,.U...l,
,
. m,
- - ---,
 ISO 9001:2015(E)

Contents Page

Fore word................................................................................................................................................. v
Introduction............................................................................................................................................ vi
1 Scope.............................................................................................................................................. 1
2 Norn1ative referen ces............................................................................................................................1
3 Terms and definitions................................................................................................................... 1
4 Context of the organiza tion......................................................................................................... 1
4.1 Und ers ta nd in g the organization and its contex t...................................................................1
4.2 2............................................Un de rsta ndin g the needs and expectations of interes ted par ties 2
4.3 Deter mining the scope of the quality management sys tem...................................................2
4.4 Quality management system and its processes ...........................................................................2..
5 Leadership..................................................................................................................................... 3
5.1 Le aders hi p and cmn1nitn1e nt..................................................................................................3.
5.1.1 Ge nera l..........................................................................................................................3
5.1.2 Customer focus .............................................................................................................3.
5.2 Policy.............................................................................................................................................4
5.2.1 Est ablish ing the quality policy.....................................................................................4
5.2.2 Commun icatin g the quality policy...............................................................................4
5.3 Orga niz atio nal roles, res pons ib iliti es and authorities.......................................................4
6 Planning......................................................................................................................................... 4
6.1 Action s to add ress risks and opportun ities...............................................................................4
6.2 Quality objec tives and planning to achieve them...............................................................5
6.3 Plannin g of changes........................................................................................................... 5
7 Support.......................................................................................................................................... 6
7.1 Resources............................................................................................................................ 6

l 7.1.1
7.1.2
7.1.3
Ge ne ral ..........................................................................................................................6.
People ..........................:.,........................................................................................... 6
In fras tructure.................................................................................................................6
7.1.4 Environment for the operation of processes..........................................................6
7.1.5 Monitoring and meas uring resources....................................................................7
7.1.6 Organizational knowledge ...........................................................................................7.
7.2 Con1petence..................................................................................................................................8
7.3 Aware ness....................................................................................................................................8
7.4 Co n1munication...........................................................................................................................8
7.5 Docun1ented inforn1ation............................................................................................................8
7.5.1 Ge neral ................. ..
..........................................................................................................................8..
7.5.2 Cr ea ting and upda ting .......... ............................................. ...................................................9....
7.5.3 Control of documented information ......................................................................................9..
8 Operat ion................................................................................................................................................9
8.1 Oper ational planning and control...................................................................................... 9
8.2 Requ irements for products and serv ices................................................................................10
8.2.1 Custo 1n e r communi cation.......................................................................................10
8.2.2 Deter mining the requirement s for products and se rvices .....................................1..0.....
8.2.3 Review of the req uirem ents for products and ser vic es....................................10
8.2.4 Changes to requirements for products and se rvi ces..........................................11
8.3 Des ign and deve lopment of products and ser vices ...................................................................1..1....
8.3.1 General................................................................................................................ 11
8.3.2 Des ign and development planning.....................................................................11
8.3.3 Design and dev elopment input s ..........................................................................................1 1
8.3.4 Design and development cont ro ls............................................................................12
8.3.5 Des ign and development outputs..............................................................................1 2
8.3.6 Des ign and development changes.............................................................................12

iii
 ISO 9001:2015(E)

8.4 Control of externally provided processes, products and services...................................... 13

8.4.1 General......................................................................................................................... 13
8.4.2 Typ e and extent of control......................................................................................... 13

8.5
8.4.3 I nfor ma t io n for ex te rna l pro v ide rs.............................................................................. 13
Product io n and service provis io n .................................................................................................. 1. 4
r
8.5.1 Co ntro l of production and se rvice provision.......................................................... 14
8.5.2 Ide n ti ficat ion and tra cea bili ty.......................................................................................... 14
8.5.3 Pro pe r ty be lo nging to customers or external providers.............................................1 5
8.5.4 Pre se rva tio n................................................................................................................... 15
8.5.5 Pos t- delive ry activities.................................................................................................. 15
8.5.6 Control of cha nges .......................................................................................................................1 5
8.6 Re lease of p rod ucts and se rvices................................................................................................. 1. 5
8.7 Con tro l of no n co nfor min g outputs ............................................................................................... 1. 6
9 Perfonnance evaluation............................................................................................................ 16
9.1 Monitoring, meas u reme n t, analysis and evalua tio n........................................................................1 6
9.1.1 Ge11era l.................................................................................................................................. 16
9.1.2 Customer satis fac tion.................................................................................................... 17
9.1.3 Analy s is and eva l uat io n................................................................................................... 17
9.2 I nt e r nal a udit...................................................................................................................................... 17
9.3 Ma nageme n t review ...............................................................................................................................1..8......
9.3.1 General .................................................................................................................................. 1. 8
9.3.2 Ma na ge me nt revie w in p ut s ..............................................................................................1...8.......
9.3.3 Ma na ge me nt revi ew outputs ......................................................................................... 1. 8
10 Improvement.............................................................................................................................. 19
10.1 Ge ne ra l................................................................................................................................................. 19
10.2 Nonconformity and cor rective a ct io n .......................................................................................... 1. 9
10.3 Continual irnp roven1e n t .................................................................................................................... 1. 9
Annex A (in forma tive) Clar ification of new structure, terminology and concepts....................21
Annex B (in for ma tive) Other International Standards on quality management and quality
management systems developed by ISO/TC 176.....................................................................25
Bibliography......................................................................................................................................................28

l
iv l
l
r ISO 9001:2015(E)

I Foreword

r ISO (the I ntern a tiona l Organization for Sta nda rdiza t io n) is a worldw ide federation of national standards
bodies (ISO member bodies). The work of preparing I nte rn a tio nal Standards is norma lly carried out
through IS O techn ical committee s . Each mem ber body interested in a subject for which a technical
committee has bee n es ta blis hed has the r ight to be represented on that committee. International
r organizations, governmental and non-go vern me nta l, in liaison with ISO, also take part in the work.
ISO collaborates closely with the I nte rn a tio na l Electrotechnical Com miss ion (! EC) on all matters of
electrotechnical standa rdiza tio n.
f The pro cedur es used to develop this document and those intended for its further ma i ntena nce are
described in the ISO/ IEC Directives, Part 1. In par ticula r the di ffe r ent approval criter ia neede d for the
different types of ISO do cum ents s hou ld be noted. This document was drafted in accordance with the
editor ial rules of the ISO/IEC Directives, Pa rt 2 (see www.is o.or g/ direct iyes).

Attention is drawn to the possibility tha t some of the elements of this document may be the sub ject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. De ta ils of
I any patent rights ide nti fied during the deve lo pment of the document will be in the Int rod uct io n and/or
on the ISO lis t of patent declarations received (see www.iso.oq /patents).

Any trade name used in this document is information given for the convenience of use rs and does not
constitute an endorseme n t.

For an explanation on the meaning of ISO s peci fic terms and expression s related to conformity
f assess me nt,
as well as information about ISO's adherence to the World Trade Organization (WTO) principles in the
Tech nica l Barriers to Trade (TBT) see the following URL: www .is o.or g/ iso / forew ord.htm l.

The committee responsible for this docume nt is Tech nical Committee ISO/TC 176, Quality management
and quality assurance, Subcommittee SC 2, Quality systems.

I This fifth ed it ion cancels a nd replaces the fourth edition (ISO 9001:2008), which has bee n tech nically
revised, through the adopt ion of a revised clause sequence and the adapta tio n of the revised quality
ma nage me nt principles and of new concepts. It als o cancels and replaces the Technical Corrigendum IS O

9001:2008/Cor.1:2009.
I
[

I
I
I
t
V

[
 ISO 9001:2015(E)

Introduction

0.1 General
f
The adoption of a quality management sys tem is a strategic decision for an organization that can help
to improve its overall performance and provide a sound basis for sustainable development initi ativ es.
The potential benefi ts to an organization of imp le menting a qualit y management system based on this
Interna tion al Standard are:

'
a) the ability to consiste nt ly provide products and services that meet customer and applica ble
s ta tut ory and regulatory requirement s;

b) facilitating opportun ities to enhance cust omer satisfaction;

c) address ing ris ks and opportunities associated with its context and obje ctives;
d) the ability to demonstrate conformity to specified quality management system requirements. This
International Standard can be used by internal and external parties .
It is not the intent of this Internat ional Standard to imply the nee d for:
- uniformity in the s tructure of different qua lity management systems;
- alignment of documentation to the clause structure of this Int ernat io nal Standard;
- the use of the specific terminology of this Inte rnat io na l Standard within the organization.
The quality management system require ments specified in this I nte rnat ional Standard are
com plementary to requirements for products and services.

This I nternational Standard employs the process approach, which in corporate s the Plan-D o-Check-Act
(POCA) cycle and ris k- based thinking.
The process approach enables an organiz at ion to plan its processes and their interactions.
The POCA cycle enab les an organization to ensure that its processes are adequately resourced and
managed, and that opportunities for imp rovement are determined and acted on.
Risk - based thinking enables an organization to determ ine the factors that could cause its processes and
its quality management system to deviate from the planned resul ts, to put in place preventive controls
to min imize negative effects and to make maximum use of opportunit ies as they arise (see Clause A.4).
Consistently meeting requirements and addressing future needs and expectations poses a cha llenge for
organizations in an incre asingly dynam ic and complex environment. To achieve this objective, the
organiza tion might find it necessary to adopt various forms of improvement in addition to correction and
continual improvement, such as breakthrough change, innovation and re-organization.
In th is Internat ional Standard, the following verba l forms are used:
- "shall" indicates a requirement;
- "should" indicates a recommendation;
- "may" indicates a permissi on;
- "can" indicates a possibility or a capability.

Infor mation marked as "NOTE" is for guidance in understanding or clar ifying the associated requirement.

vi l
 ISO 9001:2015(E)

0.2 Quality management principles

l
This I ntern at io nal Standard is based on the quality ma nage me nt pr i ncip les described in IS O 9000. The
descriptions include a statement of each princi ple, a rat io na le of why the principle is important for the
organization, some exa mples of benefits associated with the princi ple an d examples of typical act ions to
improve the organization's performance when applying the principle.

I The quality management princip les are:

- customer focus;

f - leadership;

- engagement of people; -

process approach ; -

improvement;

- evidence-based decision making; -

relations hip management.

I 0.3 Process approach

0.3.1 General
r This Inte rn a tiona l Standard promotes the adopt io n of a proces s approach when developing,
i mp le mentin g and improving the effectiveness of a quality management system, to enhance customer
satisfaction by mee ti ng customer requ i re me nts. Specific requirements cons ide re d essential to the

I adoption of a process approach are included in 4.4.

Understanding and ma nagin g interrelated processes as a system contributes to the organization's

effectiveness and efficiency in achieving its intended results. This approach enables the organiza tion to
l co ntro l the i nte rr e la t ions hip s and interdependencies among the processes of the system, so that the
overall performance of the organization can be enhanced.

I
The pro cess approach involve s the systema tic definition and management of processes, and their
interactions, so as to achieve the intended results in accordance with the quality policy and s tra te gic
direction of the organization. Management of the processes and the system as a whole can be achieved
using the POCA cycle (see 0.3.2) with an overall focus on ris k- based thinking (see 0.3.3) aimed at taking

I adva ntage of opportu niti es and preventing unde si ra ble res ults.
The a p pli ca t io n of the process approach in a quality management system e nables:

I a) understanding and consistency in meeting requ ireme nts ;

b) the co nside ra tion of proc esses in terms of added value;

I c) the achievement of effective pro cess per form ance;

d) impro vement of processes based on evaluation of data and in forma tio n.

l Figure 1 gives a schematic repres entat io n of any pro cess and shows the i nte ra ction of its ele me nts . The
monitoring and mea suring check points, which are necessary for control, are specific to each process and
will vary depend ing on the rela ted ris ks.

I
I
I vii

l
 ISO 9001:2015(E)

r - - - - - - -, I '
I \:r,u llflg p11l111 I I E11d p111111
t I I •

Sour ces of Inpu I nput s Act ivi tie s Out puts Receiver s of Output s I
r
ts
I I I I ' I
I l'IO'II H .ES\1)1{
1·11orn ssr •;
I
: M1\'l"l' U l , I : \l,\'ITI I( I : \ ll HSl' (/1!1:NT
l 1 I
/1'-K ,H J)ll )Vid •, \ : ENFIH,Y I I ENFfll;Y I l •HOCl' S';E\ I
1I N FOHM1\'I IP N. : : INlll l<M,\' IW N, : : 1· 1 11 1'1l' -t 11n 1u , :
:e-.t: Hl lh <'

r
I I I C,f!· 111 lhc· I I (mtc•rn,11 or r,tc·rn.ilI,I
i(i 111,•1n11I o r ''->:l•.·n ,,i
I Ifo n..'s-0 t t· , , I L1l't.:
rn 1 11'1111.ltl' I I !I n 111 ol p11!dth' l 1
: St'l \ ' ic.C, I
:
1: ,IIllllln l lll'
I
t n·l<•\ •.1111
' l l' t1:d 11.tJ !fl''.,
1.1I) :
!.ti l ll(,(Olllt' I!•; fI
I
I
l,H u l h 1•1 rclcv ,m l
l ltlt 4' fl ''ili · d p , H I H·S I n• quh , ·1111"nl\ : I

l
L_ - _J_ _
_ L__ _ _ _ _! t,it• i io 11 j: I I
_. _ _ _ _ _ _ _ _ I
• -- - - - .- - - - - . .J
•
Po,, \hlt t't111111,1, ,11ul
1

rhl·rl, 111111,11 to
mo11i1ur
<1111! ll ll ',1 111 •' pt' I kil lll ,tl lf t'

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

0.3.2 Plan-Do-Check-Act cycle

The POCA cycle can be app lied to all processes and to the quality ma nagem en t s ystem as a whole . Figure
Z illu s trate s how Clauses 4· to 10 can be grouped in relation to the POCA cycle.

.- - - --- - - -- -- -- -- .........
/, / Qualitv Man, 1gl' ll1Cl1t Sy lClll ( 4) '" ·

()rg, 111i;r.a l i1>1t .

and il n 1ntc.x1
.
I
f,:: - l \.
1
(4) i j
,0,, .....""'_ j I
' _ ). \
,Pl ,, I fl i "'"
<:,"'".
I , . sat1s focti n11

i ! /1
1i ·

!
I
,J-,L...i-
r

t
Resul
C,

' -,
m lo
mcr 7,-( \ t he

I ,PrndJ ucL ,11td

d
.,,..-,,.J- / C h eck SCl'V ICl' S
. , ,. ., , . .,,. --,--v
.,, . -, - i j
.
·1

Nee ds a n d '[ /
1•xp(•1·t,1lio n ol _
1clcvatccl
nl \· /.

l
intcrc

p a r ties (4) _ __ "· ........_ ___ ____ ____ __ _ ,..,.,../

NOTE Numbers in brackets re fe r to the clauses in this I ntern at io nal Sta nda rd. l
 ISO 9001:2015(E)
Figure 2 - Represe ntation of the structure of this International Standard in the POCA cycle

viii

l
 ISO 9001:2015(E)

The POCA cycle can be briefly des cr ibed as follows:

Plan: establish the objectives of the system and its processes, and the resources needed to
deliver results in accordance with customers' requirements and the organization's polic ies, and
identify and address ris ks and opportunities;

- Do: implement what was planned;

l - Check: monitor and (where a pplicable) measure processes and the res ulting products and services
agains t polic ie s, o bjecti ves, requirements and planned activities, and report the results;

- Act: take actions to improve performance, as nece ssa ry.

0.3.3 Risk-based thinking

Risk-based thinking (see Clause A.'1-) is essential for achieving an effective quality ma nagement system.
The concept of ris k-based thinking has been implicit in prev io us editions of this International Standard
including, for example, carrying out prevent ive action to eliminate pote nt ia l noncon form i ties, a nalys ing

I any nonconformities that do occur, and taking action to prevent recurrence that is appropriate for the
effects of the nonconformity.

To conform to the requirements of this Inte rn ationa l Standard, an organizat ion needs to plan and
( implement actions to address risks and opportunities . Addressing both risks and opportunit ies
establishes a basis for increa s ing the effectiveness of the quality management system, achiev ing improved
results and preventing negative effects .

I Opportunities can arise as a result of a situation favourable to achieving an i nte nded result, for example,
a set of circumstances that allow the organization to attract customers, develop new product s and services,
reduce waste or improve prod uct ivi ty. Actions to address opportunities can also include conside ra tio n of
( ass ociated risks. Risk is the effect of uncertainty and any such uncertainty can have positive or negative
effects. A pos iti ve deviation arising from a risk can provide an opportunity, but not all pos itive effects of
risk result in opportunitie s.

I 0.4 Relationship with other management system standards

This I nt ern a tio nal Standard applies the framework developed by ISO to improve alignment among it s

I
I n te rn a tiona l Standards for ma nag en, ent sys te ms (see Clause A.1).

This International Standard enables an organization to us e the pro cess approach, coupled with the POCA
cyc le and r is k-based thinking, to align or integrate its quality managem ent system with the req uireme nts

I of other management system s tanda rds.

This I nt e rn a tional Standard rela tes to ISO 9000 and ISO 9004 as follows:

I - ISO 9000 Quality management systems - Fundamentals and vocabulary provides essential
backgro und for the proper understanding and implementation of this International Standard;

ISO 9004 Managing for the sustained success of an organization - A quality management approach
[ provide s guidance for organiza tions that choose to progress beyond the requirements of this
I nt e rn a tiona l Standard.

Annex B provides detai ls of other International Standards on quality management and quality
management systems that have been developed by ISO/TC 176.

This I nt ern a tio nal Standard does not include require ments specific to other management systems, such

I
as those for enviro nmental management, occupational health and safety ma nage me nt, or fina ncia l
management.

Sector-specific qua lity management system standards based on the requirements of this International
[ Standard have been developed for a number of s ecto rs. Some of these standards specify additional quality
management system requirements, while othe rs are limited to provid i ng guidance to the application of

l
this International Standard within the particula r sector.

ix
 ISO 9001:2015(E)

I
 ISO 9001:2015(E)

A matrix showing the correlation between the clauses of this ed it io n of this I nte rn a tional Standard and r
the previou s edition (ISO 9001:2008) can be found on the ISO/T C 176/SC 2 open access web site at:
ww vv.iso.or g/ tcl 76 /sc02/ pub lic.
r

i
r

l
X l
I
 ISO 9001:2015(E)
INTERNATIONAL STANDARD ISO 9001:2015(E)

I
I Quality management systems - Requirements

[ 1 Scope
This I nte rn a tional Standard specifie s requirements for a quality managem ent system when an

r organiza t io n:

a) needs to demonstrate its ability to co nsis te ntly provide products and services that meet customer
and appli ca ble statutory and regulatory require me nts, and
( b) aims to enhance customer satis faction through the effective application of the system, including
processes for improvement of the system and the assurance of conformity to customer and
applica ble s ta t utory and regulatory requirements.

I All the requirements of this International Standard are gene ric and are intended to be applica ble to any
organization, regardless of its type or size, or the products and services it provides.

I NOTE 1 In this International Standard, the terms "product" or "service" only apply to products and services
int ended for, or required by, a customer.

NOTE 2 Statutory and reg ulatory requirements can be express ed as legal requirements.

2 Normative references

I The follow in g documents, in whole or in part, are normatively refe re nced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
refere nces, the latest ed it ion of the refere nced document (including any amend me nts) app lies.

I ISO 9000:2015, Quality management systems- Fundamentals and vocabu/a,y

[ 3 Terms and definitions

For the purp oses of this docum en t, the term s and definitions given in ISO 9000:2015 apply.

I 4 Context of the organization

I
4.1 Understanding the organization and its context
The orga niza tio n shall determine external and int e rn a l iss ues that are relevant to its purpose and its
s tra teg ic direction and that affect it s ab il i ty to achieve the i ntended res ult( s ) of its qua lity management
system.

The organization shall monitor and review information about these external and internal iss ues.

I NOTE 1 Issues can includ e positive and negative factors or cond itions for consideration.
NO TE 2 Understanding the exte rnal context can be facilitated by considering issues ansmg from legal,
techno logical, compe titive, market, cult ural, socia l and econo mic environments, whether i ntern a tio nal, national,
regio nal or local.

NOTE 3 Un ders ta nd ing the internal context can be facilitated by consider ing iss ues related to values, culture,
knowle dge and per forma nce of the organization.

I
I 1
l
 ISO 9001:2015(E)

4.2 Understanding the needs and expectations of interested parties

Due to their effect or potential effect on the organizat io n's a bil ity to co ns is te ntly provide products a nd
s e rv ices t hat mee t custom er a nd applica ble s ta tutory and reg ula to ry require ments, the organization sha ll
d e te r min e:

a) the int e res ted parties that are releva nt to the quality manage men t sys tem;

b) the requ ir e me nts of these interested pa rtie s t ha t are relevant to the quali ty management system.

The orga nization s ha ll monitor and revie w in for ma tion a bou t the se inte res ted par ties and their rele vant
requirements.

f
4.3 De te rmi ning the scope of the quality management system
The orga niza tion shall determine the boundar ie s a nd applicability of the qua lity mana ge me nt sys te m to
es ta blis h it s s cope.

Whe n dete rmining this sc o pe, th e organ iza tion shall consid e r:
a) the exte rnal and in tern al iss ues re ferr ed to in 4.1;

b) the requireme nts of relevant in teres ted pa rties re fe rre d to in 4.2;

c) the products and services of the organiz atio n.

The o rga niza tion s ha ll apply all the requireme n ts of this International Sta nd ard if th ey are applicable
wit hin th e determined scope of it s quality ma nag ement sys tem.

The sco pe of the organiza t io n's quality ma na gement syste m s ha ll b e a vaila ble a nd be mai nta in ed as
doc um ented in forma tion. The scope sha ll state the types of products and services covered, and provide
justification for any require ment of this I nte rna tion al Standard that the orga niza tion de te rm i nes is not
ap plica ble to the scope of its quality management sys tem.

Conformity to this Intern ational Standard may only be cla imed if the requireme nts de te rm ined as not
being applicable do not affect the organiza tio n's ability or res ponsi bility to en sure the conformity of its
products a nd se rv ice s a nd the enh a nce ment of customer sa tis fact io n.

4.4 Quality management system and its processes

4-.4.1 The organ iza tion shall es tabl is h, impl eme nt, mainta i n and cont i nua l ly improv e a quali ty
ma nageme nt sys tem, i ncl uding the processes needed and their in te ract ion s, in accorda nce with the
requir e me nts of this I nt e rnation a l S ta ndard.

The organ iza tion s ha ll de te rmi ne the processes need ed for the quality manageme nt system and their
applica tion throughout the orga niza tio n, and shall:

a) determine the inputs required and the output s expected from these processes;

b) de term ine the seque nce and i nt e ract ion of these processes ;

c) determine and apply t he criter ia and met hod s (including mon it or i ng, meas ure me nts and rela ted
per formanc e indi ca tors) needed to ensure the effecti ve opera tion and cont rol of these pro cess es; l
d) dete rmin e th e resources needed for these processes and ensure the ir ava ila bility;
e) ass ig n the res ponsibi lities and author iti es for these processes;

f) addr ess the ris ks and oppor tunitie s as dete rmin ed in accorda nce with the requir e me nts of 6.1 ;

g) evaluate these pro cesses and impl ement any changes needed to ensure that these pro cesses ac hieve
their int e nded res ults;

2 I
 ISO 9001:2015(E)

h) i mpro ve the processes and the qua lit y ma nagement system.

4.4.2 To the extent necessary, the organiza t io n s ha ll:

a) maintain document ed information to support the ope ra tion of it s processes;

b) re tain documented i nfor ma tion to have confid e nce tha t the processes are bein g car rie d out as
plan ned.

r 5
5.1
Leadership
Le adership and commitment

I 5.1.1 Ge neral

Top ma nageme nt s ha ll demon s tra te le ade rship and com m i tment with respect to the qua lity
l management system by:

a) taking accounta bility for the effec tive ness of the qua lity management system;

bJ ensuring that the quali ty policy a nd quality object ives are establis hed for the quality ma nagem ent
system and are compa tible with the context and strategic direct ion of the organiza tion;

c) ensuring the in tegration of the quality ma nageme nt system req ui re ments into the organizat ion's
bus i ness processes;

cl) promoting the use of the pro cess appro ac h a nd ris k-based think ing;

e) ens uring that the resources nee ded for the quality management system are availa ble;

f) communi ca tin g the i mportan ce of effective qu a lity ma nag eme nt and of conforming to the qua lity

I ma na gement sys tem req uireme nts;

g) ens uri ng that the quality management system achi eves its int e nde d res ul ts;

I h) engaging, directin g and sup port in g persons to cont rib ute to the effectiveness of the q ua lity
management system;

i) promoting im proveme n t;
I j) sup portin g other rele vant ma nagement roles to demons trate their le a de rs hip as it applies to
the ir areas of res ponsib il ity.
( NOTE Reference to "business" in this Internat io nal Sta nda rd can be int er preted broad ly t o mean those activit ies
that are core to the purposes of the organizat ion's exis tence, whether the organiza tio n is public, pr iva te, for profit or
not for profit.

5. 1.Z Customer focus

Top manageme nt shall demons tr a te leade rshi p and commitment with res pect to customer focus by
( ens ur in g tha t:

a) cus tome r and ap plica ble statutory and regu la t ory r eq uirement s are de te rmin ed, und e rs tood and
cons is te ntly met;
l b) the ris ks and opport un ities tha t ca n affect conformit y of products and se r vices and the ability to
e nhan ce cus tome r sa tis faction a re determined and addresse d;

c) the focus on enhancing cus tome r sa tis fact io n is maintained.

I 3

11
 ISO 9001:2015(E)

5.2 Policy I
5.2.1 Establishing the quality policy
r
Top management sha ll establish, implement and main tain a qual i ty poli cy tha t:

a) is appro pr ia te to the purpo se and conte xt of the organization and supports its strategic direction;
b) provides a framework for sett ing qua lity objectives;

c) in clude s a comm itme nt to sa tis fy a pplica ble re quirem ents;

d) i nclud es a co mm it me nt to continual improv ement of the quali ty manageme nt system.

r
5.2.2 Communicating the quality policy

The qua lity policy s ha ll:

a) be available and be maintained as docu me nt ed information;

b) be communica ted, understood and applied within the organization;

c) be availa ble to relevant i nt e res ted parties, as appro pria te .

5.3 Organizational roles, responsibilities and authorities

Top mana geme nt s hall ensure that the responsib ilit ies a nd authorities for relevant roles are assigne d,
communic ated and understood with i n the organ izat io n.

Top management sha ll ass ign the respons i b ili ty and a u thority for:

a) ens urin g that the quali ty ma na ge me nt system conforms to the requir eme n ts of this
I nte rnational Sta nda rd;

b) ens ur i ng that the processes are delivering the ir in te nded outputs;

c) report ing on the performa nce of the qua lity ma nage ment sys te m a nd on opportunities for
improve ment (see 10 .1), in particular to top ma nage ment;
d) ens ur in g the pro motion of cus to me r focus thro ughou t the organiza tio n;

e) ensuring that the integrity of the quality ma nage ment system is maintained when changes to the
qua lity ma nage me nt sys tem are pla nn ed and imp le mented.

6 Planning

6.1 Actions to address risks and opportunities

6.1.1 Whe n plan ning for th e qualit y ma nageme nt sys te m, the or ganization shall consid er the iss ues
referred to in 4.1 and the requ ire me nts referred to in 4.2 and de te rmine the risks and opportuniti es th at
need to be add resse d to:

a) give assurance that the quality managem ent system can achieve its i nte nded res ult (s);
I
b) e nhance desirable effects;

c) prevent, or reduce, undesired effects;

l
d) achieve improvement.
l
4 l
ISO 9001:2015(E)

t
 ISO 9001:2015(E)

6 .1.2 The organization sha l l pla n:

( a) act io ns to address thes e risks and opport unitie s;

b) how to:
1) i n tegra te and implement the action s into its quality ma nagement sys te m process es (see 4.4);
r 2) evalua te the effectiveness of these actions.

Actions taken to ad dr ess ris ks and opportunities sha ll be proportionate to the potential impa ct on the
r conformi ty of products and serv ices.
NOTE 1 Optio ns to address risks can includ e avoiding ris k, tak in g ris k in order to pursue an oppor tunity,
elimina ting the ris k source, chang i ng the likel ihood or conseq uen ces, sharing the ris k, or reta ining risk by informed
decis io n.

NOTE 2 Oppor tun it ies can lead to the ado ption of new practices, launching new products, opening new ma rkets,
add ress ing ne w customers, building partnerships, using new tech nolo gy and other desirable and viable possibiliti es
to add ress the organizat i o n's or its c ustom ers' nee ds.

6.2 Quality objectives and planning to achieve them

6.2.1 The organization s ha ll es ta blis h quality object ives at relevant functions, leve ls a nd processes
nee ded for the qua lity management system.

The quality o bject ives shall:

a) ) be consistent with the quality policy;

b) be meas ura ble;

c) take into account applica ble requirem ents;

I d) be relevant to conform ity of prod ucts and se rvices a nd to enha nceme nt of customer satisfaction;
e) be monitored;

I f) be com munica ted;

g) be upda ted as appropriate.

The organizat ion sha ll main ta i n documented information on the quality objectives.

I
6.2.2 When planning how to ac hieve its qua lity objectives, the organiza tio n s ha ll de term ine:

a) what will be done;

[ b) what resources will be requi red ;

c) who will be res pons i b le;

l
d) w hen it will be comple te d;

e) how the results will be evalua te d.

[ 6.3 Planning of changes

Whe n the orga niza tio n de ter mine s the nee d for changes to the quality manage me nt sys tem, the cha nges

I sha ll be carried out in a plann e d ma nner (see 4.4).

I 5

I I
 ISO 9001:2015(E)

The organizat ion sha ll c ons id e r:

a) the pu rpos e of the changes and their potential consequences;

b) the integr ity of t he qua lity management system;
c) the availability of reso urces;

d) the allocatio n or real loc ation of res ponsibili ties and au thor i ties.

7 Support f
7.1 Resources

7.1.1 General
The orga niza tio n sha ll de te rm in e and pro vide the resources needed for the es ta blis hme nt,
implementation, mainten ance and continual i mp rove ment of the quality management system.

The or ganiza tion s hall cons ider :

a) the capa bilities of, and constraints on, exis tin g i ntern al r eso ur ces;

b) what needs to be obtained from exte rnal p ro vide rs.

7.1.2 People
The organiza tion s ha ll dete rmin e and pro vid e t he persons necessa ry for the effect ive impl eme n ta tion of its
quality manage men t sys te m and for the o pera tion and co ntro l of its pro cesses .

7.1.3 Infrastructure

The orga niza tion sha ll de term in e, provide and maintain the infr as t ructu re necessary for the opera tion of l
its pro cesses and to achieve conformity of prod ucts a nd se rvices.
NOTE In fras tru ctu re ca n in clud e:

a) buildi ngs and assoc iated utili ties;

b) eq uipment, includin g ha rdw a re and so ftw are;

c) tr a ns po rta tio n resou rces;

cl) informa tion and com m unicat ion tec hnology.

7.1.4 Environment for the operation of processes

The organizat io n sh all de term i ne, provide and maint ain the environment necessary for th e ope ra tio n of
its processes and to achieve conformity of pro ducts and services.

NOTE A suita ble enviro nment ca n be a combina tion of hum an and phys ica l factors, such as:

a) so cial (e.g . non-discr iminato ry, calm, non-con fro ntational);

b) psyc hologica l (e.g. s tress- red ucing, burn ou t pr eventio n, emo tio nally pro tective) ;

c) physical (e.g. te mpera tu re, hea t, humidi ty, light, airflow, hygiene, noise) .

These facto rs ca n differ substa ntia lly depending on the products and services provid e d.
l
6 l
ISO 9001:2015(E)

l
 ISO 9001:2015(E)

7.1.5 Monitoring and measuring resources

f_ 7 . 1.5 .1 General

The organization sha ll determine and provide the res ources needed to ensure valid. and reliable
res ult s when moni to rin g or measuring is use d to verify the conform ity of products and ser vices to
req uir e ments .
r
The organization sha ll en s ure that the resources provided:

r a) are suitable for the specific type of mon it oring and measurement activ it ies being und e rt aken;
b) are ma int ain ed to ens ure their cont i nuing fitne ss for their purpo se.
The organization shall retain appropr iate doc um ented information as evid ence of fitness for pur pose of
the mon it orin g and meas urement resources.

7 . 1.5.2 Measurement traceability

When meas ureme n t traceability is a requi r e ment, or is cons idered by the organization to be an essential
part of providing confidence in the validity of meas ur em e nt res ults, meas ur ing equipment shall be:
a) calib ra ted or verified , or both, at specified int ervals , or prior to use, agains t measure ment s tandard s
traceable to in ternat ional or nation al meas ur eme nt s tandards; when no such s tan dards exis t, t he
bas is used for calibr ation or ver ific ation s hall be retain e d as documen ted information;
b) identified in order to de termi ne their status;

c) safeg uarded from ad jus tmen ts, damage or deterioration that would invalidate the calibr ation
l s ta tus and subsequent me asurem ent resu lts .
The organization sh all dete rm in e if the validi ty of pr evious mea sur eme nt res ults has been adve rse ly
affected whe n meas ur ing equ ipment is found to be unfit for its intended purpose, and sha ll ta ke
appropria te action as ne cessary.

7.1.6 Organizational knowledge

The organiz ation sh all determine the knowledg e nece ssa ry for the operation of it s processes and to achie
ve conformity of products and se rvice s.
( This knowledg e shall be maint ai ned and be made a vail able to the extent nec essary.

When addr ess ing chang i ng nee ds and tr end s, the organization sha ll cons ider it s current knowled ge

( and dete rm i ne how to acquir e or access any necessary addit ion al kn owledge and requir e d upd ates.
NOTE 1 Orga niza t iona l knowled ge is kno wledge specific to the organization; it is genera lly gained by experie nce.
It is informa tion that is used a nd shared to ac hieve the organiza tio n's ob ject ives.

[ NOTE 2 Orga niza tiona l knowledge can be based on:

a) int ern al so ur ces (e.g. intellectual property; know le dge gained from exper ie nce; lesso ns lea rn e d from failure s

l a nd successfu l projec ts; ca ptur ing and shar ing undocum ente d know ledge a nd expe rie nce; the res ult s of
i mprovemen ts in pro cesses, products and se rvices);

b) extern al so urces (e.g . s tand a rds; academia; confere nces; ga therin g know ledg e from customers or extern al

l
p roviders ).

l 7
I
ISO 9001:2015(E)
 ISO 9001:2015(E)

7.2 Competence
The orga niza tio n shall:

a) determine the necessa ry competence of person(s) doing work under its control that affects the
r
per formance and effectiveness of the quality management system;

b) ens ure that these person s are compe te nt on the basis of app ropr iate e duca tion, tra i n i ng, or
exper ience;

c) where applica ble, take actions to acquire the necessa ry compe te nce, and evaluate the effectiveness
of th e actions taken;

d) retain appropria te documented in forma tio n as evide nce of competence.

NOTE Appl ica ble ac tions ca n i nclud e, for exa mp le, the pro vis io n of training to, the men torin g of, or the
reassignment of curr ent ly empl oyed perso ns; or the hirin g or co ntra cting of co mp ete nt perso ns.

7.3 Awareness
The or ga nization shall ensure that persons doin g work und er the org aniza tion' s control are awa re of:
a) the qual ity policy;

b) re le vant qua lity o bjec tives ;

c) their con tribut io n to the effectiveness of the quality mana geme nt system, including the benefit s of
imp roved perfor ma nce;

d) the imp lica t io ns of not conforming with the qua li ty management system requ i re me nts .
7.4 Com munication I
The orga nization s ha ll det er mi ne the internal and exte rn a l commun ica t ions relevant to the qualit y
management system, i ncluding:

a) on what it will comm unica te;

b) when to communicate;

c) with whom to communicate;

d) how to communi cate;

e) who communicat es.

7.5 Documen ted information

7.5.1 General
The organiza tion' s quality management system shall in clud e:
a) docum ented information required by this Inte rnatio nal Standard;
(
b) documented inform atio n determined by the organization as bein g necessa ry for the effectiveness
of the quality management system.

NOTE The exte nt of documented in format io n for a quality ma nageme nt system can differ from one
l
organization to anoth er due to:

- the size of organizatio n and its type of activities, processes, products and services ; I
8 l
I
 ISO 9001:2015(E)

- the comple xity of processes and the ir interactions;

- the competence of persons.

7.5.2 Creating and updating

When creating and updating documented info rma tion, the organization shall ensure appropriate:

a) ide nti fica t ion and description (e.g. a tit le, date, author, or refe re nce num ber);

b) format (e.g. language, software vers ion, graphics) and media (e.g. paper, ele ctro nic);

c) review and approval for suitability and adequa cy.

7.5.3 Control of documented information

7.5.3.1 Documented i nfor ma tion required by the qua lity management system and by this International
Standard shall be controlled to ensure:

a) it is available and suita ble for use, where and when it is needed;

b) it is adequa te ly p ro te cted (e.g. from loss of confide n tia lity, im pro pe r use, or lo ss of in tegr ity).

7.5.3.2 For the co n tro l of docu me nt ed in forma tion, the organization shall address the following
activities, as applicable:

a) dis tr ib ution, access, retrieval and use;

I
b) storage and preservation, including preservation of leg i bil i ty;

c) control of cha nges (e.g. version con tro l);

d) retention and dis pos itio n.

Documented information of exte rnal ongm determined by the organization to be necessary for the planning
and operation of the quality management system sha ll be identified as appropriate, and be co n tr
olle d.

Docu me nte d information retained as evide nce of conformity shall be protected from unintended
alterations.

NOTE Access can imply a decision regard ing the permission to view the documented informati on only, or the
permiss io n and aut hori ty to view and cha nge the docu mented infor matio n.

8 Operation

8.1 Operational planning and control

The organization shall plan, implement and control the processes (see 4.4) needed to mee t the
requirements for the provision of pro ducts and services, and to im pleme nt the actions determined in

l Clause 6. by:

a) de te rmini ng the requirements for the products and se rvices;

b) establishing criteria for:

1) the processes;

I 2) the accep tance of products and services;

c) determining the res ou rces needed to achieve conformity to t he product and service require men ts;

l' 9
I I

ISO 9001:2015(E)
 ISO 9001:2015(E)

d) imple me nting control of the processes in accordance with the criteria;

e) determining, ma i nta inin g and re tain i ng documented information to the extent ne cessa ry:

1) to have confidence that the processes have been carried out as pla nned;
2) to demonstrate the conformity of products and services to their require me nts.
The output of t his pla nning shall be suita ble for the organization's operations. r
The organization shall control planned changes and revie w the cons equence s of unintended changes,
taking action to mitigate any adverse effects, as necessa ry.

The organization shall ensure that outsourced processes are contro lled (see 8.4).

8.2 Requirements for products and services

8.2.1 Customer communication

Communication with customers shall include:

a) providing information relating to products and services;

b) handling enquiries, contracts or orders, including changes;

c) obtaining customer feedback relat i ng to products and services, i nclud i ng customer complaints;
d) handling or controlling customer property;

e) establish ing specific requireme nts for contingency actions, when rele vant.

8.2.2 Determining the requirements for products and services

When determining the requ ire me nts for the prod ucts and services to be offered to cus tome rs, the
organizatio n sha ll ensure that:

a) the requirements for the products and service s are defined, includ i ng:

1) any applicable statutory and regula tory requirements;

2) those cons idered necessary by the organization;

b) the organiza t io n 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 The organization shall ens ure that i t has the a bility to meet the requirements for products and
services to be offered to customers. The organization shall conduct a revie w before committ ing to sup ply
products and services to a customer, to include:

a) requirements specified by the customer, includ ing the req uireme nts for delivery and pos t-
delive ry activ ities;

b) requirements not stated by the customer, but necessary for the speci fie d or intended use, when
known;

c) requirements specified by the organization;

d) statutory and regulatory requirements applica ble to the products and services;
e) contract or order requirements differing from those previously expressed .

10
 ISO 9001:2015(E)

T he organization sha ll ensure that contract or order requireme nts differing from those previou s ly de fin ed
are reso lved.

The cus tome r's requir e ments sha ll be confirmed by the organization before acceptance, when the
customer does not pro vide a documented stateme nt of their requirem ents .

NOTE In so me situations, such as internet sales, a formal r eview is impra c tical for each order. Instead, the

r rev iew ca n cove r relev ant product informatio n, such as cat alogu es.

8 .2.3. 2 The organiza tion s ha ll retain docu ment ed in forma tion, as applicable:
a) on the r es ul ts of the review ;

b) on any new requirements for the p rodu cts and services.

8.2.4 Changes to requirements for products and services

The organiza tion sha ll e ns ur e that releva nt documented information is ame nded, a nd that rel evant
perso ns are mad e aware of the chang ed requireme nt s, when the requireme nts for products and services
are c hanged.

8.3 Design and development of products and services

8.3.1 Gener al

Th e organization shall es ta blis h, implement and main ta in a des ign and developmen t process that is
a ppro pria te to ensur e the s ubse quent provision of products and se rvices.

8 .3. 2 Design and development planning

In determining the s tages a nd cont rols for de s ign and development, the organiza tion shall cons ide r:

a) the na ture, du ra tio n and complexity of the design and development a ctiv ities ;
b) the required process stages, i nclud ing applica ble design and development reviews ;

r c) the required design and deve lopme nt verifica tio n a nd valid at io n activities;

d) the responsib ili t ies and aut hor iti es involved in the des ign and development process;

e) the i nte rn al a nd exte rn al resource needs for the des ig n and dev elop ment of p ro d uc ts and services;
f) the need to cont ro l i nterfaces betw een pers ons involved in the design and dev elo pme nt process;

l g) the need for involvement of customers and use rs in the des ign and development process;

h) the requirements for subseq ue nt provision of products and se rvices;

i) the level of cont ro l ex pect ed for the design a nd development process by cus tom ers and other
rele vant in teres ted pa rt ies;

j) t he docum ented in form ation nee ded to demon strate that design and develop ment require
ment s have been met.

8.3.3 Design and development inputs

The organization shall dete rmine the requirements essential for the specific types of produc ts and
s e1-vices to be designed and deve lo pe d. The orga nizat io n shall consider:

a) functional and performance requireme nts;

I 11

I
 ISO 9001:2015(E)

b) in forma tio n derived from previous similar design and development activities;

c) statutory and regulatory requirements;

d) standards or codes of practice that the organization has committed to implement;

e) potential consequences of failure due to the nature of the produc ts and services.
Inputs sha ll be adequate for design and development purpo s es, complete and unambiguous.

Conflicting design and development inputs shal l be resolved.

The organization shall re tai n documented in format ion on design and development inputs. l
8.3.4 Design and development controls
The organization shall apply cont ro ls to the design and development process to ensure that:
a) the results to be achieved are defined;

b) reviews are conducted to evaluate the ability of the results of design and development to meet
requirements;

c) verifica t io n activities are conducted to ens ure that the design and deve lopme nt out puts meet the
input requirements;

cl) validation act ivities are conducted to ensure that the resulting products and s erv ices meet the
requ ire ments for the specified ap plic a tion or intended use;

e) any necessary actions are taken on problems de ter mined duri ng the reviews, or verifica tion and
val ida tion act ivi ties;

f) documented i nforma tion of thes e act ivities is re ta ined.

NOTE Design and developm e nt reviews, verification and valida tion have dis tin c t purposes. They can be
conducted separately or in any combination, as is suitab le for the products and services of the organ izatio n.

8.3.5 Design and development outputs

The orga nizat io n s ha ll ensure that design and development outputs:

a) meet the inpu t requirements;

b) are adequate for the subseq ue nt processes for the pro vis io n of pro du cts and se rvi ces ;

c) include or reference monitoring and meas uring requirements, as appropriate, and accepta nce crite r ia;

cl) s pecify the character is t ics of the products and services that are essenti al for their in te nded purpose
and their safe and proper provision .

The organization shall retain document ed information on design and development outputs.

8.3.6 Des ign and develo pment changes

The organization shall id entify, review and control changes made during, or subs eq uent to, th e design and
development of products and services, to the extent necessary to ensure that there is no adverse impact
on conform ity to requirements.

The organization shall retain documented information on:

l
a) design and development changes;
b) the results of reviews;

12
 ISO 9001:2015(E)

c) the a uthor iza t io n of the changes;

cl) the actions taken to prevent adverse impacts.
r
8.4 Control of externally provided processes , products and services

8.4.1 General
The organization sha ll e nsure that externally provided processes, products and services conform to
require me nts .

The organization sha ll de term i ne the controls to be applie d to exte rna lly pro vided processes, products
and services when:

a) products and services from external providers are intended for incorporation into the organization's
own products and services;

b) products and se rvices are provided direct ly to the custorner(s) by external providers on behalf of
the orga niza tion;

c) a process, or part of a process, is provided by an external provider as a result of a decision by the

organizat io n.

The organization shal l determine and apply cr i te r ia for the evalu a tion, selection, monitoring of
performance, and re-eva l uat io n of exte rnal providers, based on the ir a b ili ty to provide processes or
product s and services in accordance with req uireme nts. The organization sha ll reta i n do cume nte d
informa tion of these activit ies and any necessa ry actions arising from the evalua tions.

8.4.2 Type and extent of control

The organiz ation shall ensure that externally provided processes, products and services do not
adversely affect the organiza tion's ability to consis tent ly deliver conforming products and services to
its customers.

The organization sha ll:

a) ensure that externally pro vided processes remain within the control of its quality management
system;

b) define both the contro ls that it inte nds to apply to an external provid er and those it intends to apply
to the res ultin g output;
c) take into cons idera tion:

I 1) the pote ntia l impact of the exte rn a lly provided pro cess es, pro ducts and serv ices on the
organization's ability to consistently meet customer and applicable statutory and regulatory
requirements;

l 2) the effectiveness of the co nt ro ls a pplied by the exte rnal provider;

d) determine the verification, or other activit ies, nece ssa ry to ensure that the externally provided

l 8.4.3
processes, products and se rvices mee t requi re ments.

Information for external providers

I The orga niza tio n s ha ll ens ure the adequacy of requir e me nts prio r to their communication to the external
provider.

I The organization shall comm un ica te to external providers its req uir eme nts for:
a) the pro cesses, products and se rvices to be provided;

l 13

I
 ISO 9001:2015(E)

b) the approv al of:

1) products and services;

2) methods, processes and equi pme nt; f

3) the release of products and services;

c) compete nc e, in cludin g any required qualification of persons;

d) the external providers' interactions with the organization;

e) contro l and monitoring of the external providers' performance to be applied by the orga niza tion; I
f) verification or validation act ivities that the organization, or its customer, i ntend s to perform at the
exte rnal prov ide rs' premises.

8.5 Production and service provision

8.5.1 Control of production and service provision

The organization sha ll implement production and service provis ion under controlled conditions.
Cont ro lled conditions shall include, as applicable: (
a) the availability of documented information tha t defines:

1) the characteristics of the products to be produced, the se rvices to be provided, or the activ it ies
to be performed;

2) the results to be achieved;

b) the ava ilab ility and use of s uita ble monitoring and measuring resources;

c) the imp le me nta tio n of monitoring and measurement activities at appropriate stages to verify
that crit er ia for control of processes or outputs, and acceptance crite ria for products and
services,
have been met;

cl) the use of suita ble infras t ructu re and e nviro nment for the operation of processes;

e) the appointment of competent persons, including any required qualification;

f) the valid a tio n, and periodic revalidation, of the ability to achie ve planned results of the processes
for production and serv ice pro vis ion, whe re the resulting output cannot be verified by su bseq ue nt
monitoring or measurement;
g) the implemen tation of actions to prevent human error;

h) the implementation of release, delivery and post-delivery activities.

8.5.2 Identification and traceability

j
The organiza t io n shall use suitab le means to identify outputs when it is necessary to ensure the
conformity of products and services.

The organization sha ll identify the s tatus of outputs with respect to monitoring and mea sure me nt
requ ire ments throughout production and service provis ion .
The organization sha ll cont rol the unique identification of the outputs when tracea bili ty is a
I
requirement, and shall retain the documented information necessary to enable tracea bility.
l
14 I
 ISO 9001:2015(E)

8 .5.3 Property belonging to customers or external providers

The orga niz a tion shall exercise care wi t h property belonging to cus tome rs or external providers while it

r is under the organization' s control or being used by the orga niza tio n.
The organization shall iden tify, verify, protect and safeguard cus tome rs' or external provide rs' property
provided for us e or inco rpora tio n into the products and se rvice s .

When the property of a customer or external provider is lost, damaged or otherwise found to be
uns uit a ble for use, the organization shall report this to the customer or external provider and retain

i
documented information on what has occur red .

NOTE A cus tome r's or external provider's property can includ e ma ter ials, co mponents, tools and equip ment,
premises, intellectual property and personal data.

8.5.4 Preservation

The organiza tio n sha ll preserve the outputs during production and se rvice provision, to the extent
necessary to ensure conform i ty to requirements.

NOTE Preservation can include identi fica tio n , handling, contam i nation control, packagi ng, storage,
transmission or tra ns portat ion, a nd protection.

8.5.5 Post-de livery activities

The organization shal l meet requir emen ts for post-delivery activit ies assoc iate d with the produ cts and
se rvices.

In determining the extent of post-de live ry activities that are required, the organization shall consider:
a) s tatutory and regulatory requirements;

[
b) the potential undesired consequences associa ted with its products and services;
c) the nature, use and intended lifetime of i ts produ cts and se rvi ces;
d) customer require me nts;

e) customer feedback.

NOTE Post-delivery activities can include actions under warranty provis ions, co ntractua l obligations such <1s
maintenance se rvices, a nd suppleme ntary services such as recycling or final disposal.

8.5.6 Control of changes

The organization shall rev iew and control changes for production or service pro vis ion, to the extent
necessary to ensure continuing conformity with requirements.

l The organization sha ll retain docu me nted information describing the result s of the re view of changes, the
person(s) authorizing the change, and any necessary actions arising from the review.

l 8.6
The
Release of products and services
organiza
and service reqtio n shall
uire imple
me nts haveme nt met.
been pla nned arrangements, at appropriate stages, to verify that the product

I The release of prnducts and services to the customer sha ll not proceed until the pla nned arrangements
have been sa tisfactori ly comp leted, un less otherwise approved by a relevan t authority and, as applicable,

[
by the customer.

l 15

[
ISO 9001:2015(E)

The organization shall retain do cumente d infor ma tion on the release of products and services. The
documented informa tion shall include:

a) evidence of conformity with the acceptance crite ria;

b) tra cea bility to the per so n(s) aut horizin g the release.

8.7 Con trol of nonconforming outputs

8.7.1 The organization shall ensure that outputs that do not conform to their re quire me nts are
identified and controlled to prevent their unintended use or delivery. J

The organization shall take appropri a te action based on the nature of the non conformity a nd its effect on
the confor mity of pro ducts and se rvices. T his s ha ll als o a pp ly to nonconforming produ cts and services
detected afte r delivery of products, during or afte r the pr ovis io n of se rvices.

The or ga niza t ion shall deal wi t h noncon forming output s in one or more of the following ways:

a) corre ction;

b) segrega tion, containmen t, retu rn or s us pe nsion of provision of pro du cts and se rvices ;
c) in formin g the customer;

d) obtain ing aut horizatio n for acceptance under concess io n.

Conformity to the requirements sha ll b e verified when nonconforming outputs are corrected.

8.7.2 The organization shall retain docume nted i nform at io n tha t:

a) describes the nonco nform ity;

b) d es cribes the a ctio ns taken;

c) describes any concessions obtained;

d) identifies the author ity deciding the action in respect of the non conform il-y.

9 Performance evaluation

9.1 Monito l"ing, measurement, analysis and evaluation

9.1.1 General
The organization shall de ter mi ne:
a) what nee ds to be mon itor e d and measured;

b) the methods for monitoring, measurement, analysis and evalua tion needed to ensure vali d res ul ts;

c ) when the monitoring and meas uring shall be performed;

d) when the results from mon itor ing and meas ureme nt shall be analysed and evaluated.

The organization shall eva lua te the pe rformance and the effectiveness of the quality ma nagement sys tem .

The orga niza tion sha ll re tain a ppro priate documented information as evidenc e of the res ults.

16 I
 l
ISO 9001:2015(E)
 9.1.2 Customer sa tisfaction
The organization shall monitor customers' perceptions of the degree to which their needs and
expectations have been fulfilled. The organization shall determine the methods for obtaining,
monitoring and reviewing this in formation.
NOTE Examples of mo nitor i ng customer perceptions can include customer surveys, customer feedback on
delivered products and serv ic es, meetings wit h customers, mar ket -s ha re a na lys is, com pliments, warranty claims
and dealer reports.

i 9.1.3 Analysis and evaluation

The organization shall analyse and evalu ate appropriate data and in form at io n arising from monitoring
and measurement.
The results of analy sis shall be used to evaluate:
a) conformity of products and services;
b) the degree of customer sat is facti on;
c) the performance and effectiveness of the quality management system;
d) if plann i ng has been implemented effe ctive ly;
e) the e ffe ctiveness of actio ns taken to address risks and opportunities;
t) the performance of external providers;
g) the need for improveme nts to the quality management sys tem.
I NOTE Methods to analyse data can include statis tical techniques.

l 9.2 Inte rnal audit

9.2 .1 The organization shall conduct internal aud its at planned interva ls to provide information on

l
whether the quality management system:

a) conforms to:
1) the organization's own requirement s for its quality management system;
2) the requirements of this International Standa rd;

I b) is effect ive ly implemented and maintained.

9.2.2 The organization shall:

I a) plan, establis h, imp le ment and maintain an audit programme(s) including the frequency, methods,
res ponsibilities, plann ing requirements and reporting, which shall take into consideration the
importance of the processes concerned, changes affecting the organization, and the resu lts of
previous audits;

b) define the audit criter ia and scope for each aud it;
c) se le ct auditor s and conduct audits to ensure objectivity and th e impartiality of the audit process;
d) ens ur e that the results of the audits are reported to relevant management;

I e) take appropriate correction and corrective actions without undue delay;

l 17
l
ISO 9001:2015(E)
ISO 9001:2015(E)

f) re tai n documented in forma tio n as evid e nce of the impl e me nta tio n of the audit programme and the
aud it results.

NOTE See ISO 19011 for guidance.

f
9.3 Management review

9.3.1 General

Top ma nageme nt shall review the organizat io n's quality manageme nt system, at planned int ervals, to
ensure it s co ntinu ing suitability, adequacy, effect iveness and alig nme nt with the strategic direction of the
organiza tion.

9.3.2 Management review inputs

The ma nage me nt re view shall be pla nned and carr ied out taking into consideration:

a) the status of actions from previou s ma nage me nt rev iew s ;

b) change s in external and i nt ern a l iss ues that are rele vant to the qua li ty ma na gemen t system;
c) information on the performance and effectiveness of the qua lity management system, including
trends in: I
1) customer satisfaction and feed bac k from releva nt interested parties;

2) the extent to which quality objectives have been met; I

3) process performa nce and conform ity of products and se rvices ;

4) noncon formitie s and co rr ect i ve ac tio ns;

l
5) monitoring and measurement results;

6) audit results;

7) the performance of exte rn a l p ro vid e rs ;

d) t he adequacy of resources;
e) the e ffec tive ness of act ions take n to addr ess risks and oppor tun i t ies (see hl );

f) opportunit ies for improv eme nt.

9 .3.3 Management review outputs

The outp uts of the manage ment review shall include decisio ns and actions related to:

a) opport unitie s for improvement;

b) any need for changes to the quality management system;

c) resource needs.
The organ iza tion shall retai n docume nted in format ion as evidence of the res ult s of management revie w s.
I

18 l
 ISO 9001:2015(£)

r 10 Improvement

f 10.1 General
The organization shall determine and select oppor tunities for improvement and implement any
necessary actio ns to me et customer require ment s and e nhance customer sa tis faction .
These shall include:

a) improving products and services to meet requirements as well as to ad dre ss future needs and
expectations;

b) correcting, preventing or reducing unde s ired effects ;

c) improving the performance and effectiveness of the qu ali ty ma na gement sys tem.

NOTE Exa mp les of i mprovem ent can include correct ion, correct ive action, conti nual imp rove ment,
breakthrough change, innovation and re-organization.

10.2 Nonconformity and corrective action

10.2.1 When a nonconformity occurs, including any ar is ing from complaints, the organization shall:
a) react to the nonconformity and , as app licab le:
1) take action to control and correct it;

2) deal wit h the consequences;

[ b) evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not
recur or occur elsew her e, by:

1) reviewing and ana lys ing the nonconformity;

2) determining the causes of the nonconfom1ity;

( 3) determining if s im il a r nonconformities exis t, or could potentially occur;

c) imp le ment a ny action needed;

d) review the effectiveness of any corrective action taken;

e) update risks and opportun it ie s determined dur i ng planning, if neces sa ry;

( fJ make changes to the quality management system, if necessa ry.

Corrective actions shall be appropriate to the effec ts of the nonconformities encountered.

l 10.2.2 The organiza t io n sha ll retain documented information as evidence of:

a) the nature of the no nconformit ies and any s ubse que nt actions taken;

[ b) the results of any correct i ve action.

10.3 Continual improvement

l The organization sha ll continually im prove the suita bili ty, adequacy and effectiveness of the quality
management system.

I
I 19
l
 ISO 9001:2015(£)
ISO 9001:2015(E)

The organization shall cons ider the results of analysis and evaluation, and the outputs from
management review, to determine if there are need s or opportunitie s that shall be addressed as part of
continual improvement.
f

l
20 l
l
 ISO 9001:2015(E)

Annex A
(in formative )

Clarification of new structure, terminology and concepts

i A.1 Structure and terminology

The clause structure (i.e. clause se qu ence) a nd some of the te rm i nology of this e d iti o n of this
I ntern a tio nal Standard, in compa riso n wit h the p rev io us editio n (ISO 9 001 :2 008 ), have been cha nged to
improve alignmen t wit h other manageme nt sys te ms s ta nda rds.

There is no req uire me nt in this In te rn a t iona l Sta nda rd for its s t ru ct ure a nd ter mino logy to be applied to the
docume nt ed in forma tion of an orga niza tion' s quality management sys tem.

The structure of clauses is i nte nded to pro vide a cohe rent p rese nta tion of requi re ments, rather tha n a
mode l for docu me nt i ng an or ganiza bon' s policies, obj ect ives a nd pro cesses . The structur e and cont ent
of docu mented in forma tion rela te d to a quality manage ment sys te m can ofte n be more relev a nt to its
users if it re la tes to both the processes operate d by th e or ganiza tio n and in forma tio n ma inta in ed for
other pur poses.

The re is 110 r eq uire ment for the te rm s use d by a n organiza tion to be replaced by the term s used in this
I nte rnationa l Standa rd to specify quali ty manage ment s ys te m requir eme nts. Or ga niza ti ons can choose
to use terms which suit their ope ra tions (e.g. using "rec ord s", "docum entation " or "pro to cols" ra ther tha n

I "documen ted in forma tio n"; or "supplier", "par tner" or "vendor" rather tha n "external p ro vider"). Table A.l
s hows the ma jor differ ences in termi nology be tw ee n this edit ion of this I nte rna tion al Standa rd and t he
prev io us edit io n.

Table A.1 - Ma jor di fferences in termino logy between ISO 9 0 0 1: 2008 and ISO 9 0 01 :2 0 1 5
.. '· ,.
I
ISO 9 00 1 :2 008 ISO 9 00 1:2 0 15
.
Prod ucts ' Produ cts and services
e';.,- ,.
Exclusions '\:., . No t used
, .... , .a:-L
-
.' (See Cli:!use A.5 for clar ifica tion of a ppl ica b ility )
Ma nage me nt representa tive Not use d

I (Simila r r es pon s ibi lities a nd aut hor iti es

are ass igned
but no requir emen t for a s ingle m anageme n t

l Doc um e nta tion, qua lity ma nual, docume nt e d pro- Doc um ented information
ced ures, rec or ds
Work enviro nm ent Envi ro nment for the operation of process es

l Mo nito ri ng and meas ur ing eq uip me nt

Purc hased pro duct
Mo nit o rin g and meas ur ing res our ces
Exte rnally pro vid e d pro ducts a nd serv ices
Supp lie r Ex ternal provide r

l A.2 Products and services

l ISO 9 001: 2008 used the term "pro du ct" to in clud e a ll output ca tegor ies. This edition of this In te rn a tion al
Sta ndard uses "produ cts a nd ser vices ". "P rodu cts and se rvices" include all output cat egori es (hardware, services
, sof twa r e a n d processed ma teria ls ).
l 21
 ISO 9001:2015(E)

The specific inclusion of "services" is int ended to highlight the differences betw ee n products and services
in the applica tion of some req uirement s. The cha racte ris tic of services is that at least part of the output is
realized at the interface with the custo me r. This mean s, for examp le, that conformity to requirements
cannot necessarily be confirmed before service delive ry. r
In most cases, products and services are used together. Most outputs that organizations pro vide to
customers, or are supplied to them by exte rnal providers, include both products and services. For
example, a ta ngib le 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

Sub cla use 4.2 specifies requirements for the organization to determine the interes ted parties that
are relevant to the quality management system and the requirements of those interested parties.
How ever , 4 . 2 does not imply extension of qualily management system requ ire me nts beyond the scope (
of this Intern atio nal Standard. As stated in the scope, this International Standard is applica ble whe re
an organization needs to demonstrate its ability to co ns is te nt ly provide products and services that
meet customer and app lica ble statutory and regulatory requirements, and aims to enhance customer
sat is factio n.

There is no requirement in this Internatio nal Standard for the organization to conside r interested parties
where it has decided that those parties are not relevant to its quality management system. It is for the
organization to decide if a particular requirement of a relevant interested party is relevant to its quality
management system.

A.4 Risk-based thinking

The concept of risk-based think in g has been imp licit in prev iou s editions of this International Standard,
e.g. through req uir e ment s for planning, review and improvement. This I nt e rn a tional Sta nda rd
s peci fies requirements for the organization to under s ta nd its context (see 4.1) and determine risks as
a basis for planning (see 6.1). This repr esents the application of risk-based thinking to planning and
implementing qua lity management system processes (see 4.4) and will assist in determining the extent
of documented information.
One of the key purposes of a quality management system is to act as a preventive tool. Consequently, this
International Standard does not have a separate clause or subclause on preventive action. The concept of
preventive action is expressed through the use of ris k-based think ing in formulating quality management
system requireme nts.

The risk-based thinking applied in this Int e rn a t io nal Standard has ena ble d some reduction in prescriptive
requ ir e me nts and their replacement by performa nce - based requirements. There is greater flexibility than
in ISO 9001:2008 in the requirements for processes, documented infor ma tion and organizational
responsibi Ii ties.

Although 6.1 specifies that the organization shall pla n actions to address ris ks, there is no requirement
for formal me thods for risk management or a documented risk management process. Organizations can
decide whether or not to develop a more extens ive risk management methodology than is requir ed by
this Int e rna tio nal Standard, e.g. through the ap plication of other guidance or standa rds.

Not all the processes of a quality management system represent the same level of risk in terms of the
organization's ability to meet its objectives, and the effects of uncertainty are not the same for all
organizations. Under the requirements of .6.,1, the organization is responsible for its application of
riskbased thinking and the actions it takes to address risk, including whether or not to retain docum ented
in forma tion as evidence of its determination ofr isks .

22 l
 I
ISO 9001:2015(E)
 A.5 Applicability
This I nte rn a tional Standard does not refe r to "excl usio ns" in relation to the applica b ility of its
requirements to the organization's quality management system. However, an organization can review
the applicability of requirements due to the size or complexity of the orga niza tion , the management
mode l it adopts, the range of the organization's activities and the nature of the risks and opportunities
it encoun ter s.

The requirements for ap plica bility are addressed in :Li, which defines conditions under which an
organiza tio n can decide that a requirement cannot be applied to any of the processes within the scope of
its qu a lity management system. The organization can only decide that a requirement is not appl ica b le if
it s decision will not result in fail ure to achieve conform ity of products and serv ices.

A.6 Documented information

As part of the alignment wi t h other management system s tanda rds, a common clause on "documented
information" has been adopted without significant change or addition (see 7.5). Where appropriate, text
elsewhere in this In te rna tional Standard has been aligned w it h i ts req uire me nts. Conse quen tly,
"documented in form ation" is used for all document requirements.

Where ISO 9001:2008 used specific terminology such as "docume nt" or "documented procedures", "qua lity
ma nua l" or "quality pla n", this edit io n of this Int ern ational Standard defines requirement s to "maint ain
documented in forma tion".

Whe re ISO 9001:2008 used the term "records" to denote documents needed to provide evidence
of co nform ity with requir e me nts, this is now expressed as a requirement to "retain documented
information". The organiza tio n is responsible for determining what documented information needs to
be retain ed, the period of time for which it is to be retained and the media to be used for its retention.
A requirement to "mai nta in" documented inform a tion does not exclude th e possib ili ty that the
organization might also need to "retain" that same documented information for a particul a r purpose, e.g. to

( re tai n previous versions ofit.

Where this International Standard refers to ''in forma tio n" rather than "documented information" (e.g. in
.1,1: "Th e organization shall monitor and review the in format io n about these external a nd i ntern al issues"),
there is no requirement that this information is to be documented. In such situations, the organization can
decide whether or not it is necessary or appropr ia te to maintain documented information.

I A. 7 Organizational Imowl edge

In 7.1.6, this Int e rn a tiona l Standard addr esses the need to determine and manage the knowledge
maintained by the organization, to ensure the operation of its processes and that it can achieve
confo rmi ty of products and se rvices.

Requirements regarding organizational knowledge were introduced for the purpose of:
a) safeguarding the organization from loss of knowledge, e.g.
- through staff turnover;

( - failur e to capture and sha re information;

b) encouraging the organization to acqu ir e knowledge, e.g.

- learning from experience;
- mentoring;

l - benchmarking.

l 23

[
 ISO 9001:2015(E)
ISO 9001:2015(E)

A.8 Control of externally provided processes , products and services

All forms of exte rnally provided processes, products and services are addressed in M, e.g. whether
thro ugh:

a) purchasing from a supp lier;

b) a n a rra ngement with an associate company;

c) outsourcing processes to an external provider.

Out sourcing always has the essential characte ris tic of a service, since it will have at lea s t one ac tivi ty
necessarily perfor med at the interface between the provider and the orga nization.

The controls required for external provision can vary widely depend i ng on the nature of the processes,
products and services. The organization can apply ris k-based thinking to determine the type and extent
of contro ls appropriate to partic ula r external provide r s and externally provided processes, products
and services.

24 l
I
 ISO 9001:2015(E)

AnnexB
(informative)

Other International Standards on quality management and quality

management systems developed by ISO/ TC 17 6

The International Standa rds described in this annex have been deve lo ped by ISO/ TC 176 to provide
supporting in form a tion for organizat ions that apply this I n te rnational Standard, and to provid e
guidance for organiza tions that choose to progress beyond its requirements. Guida nce or r equ irement s
conta ined in the documents listed in this annex do not add to, or modify, the requirements of this
International Sta nda rd.

Ta bl e B:I shows the relationship betwee n these standards and the relevant clauses of this
I nte rn a tio nal Standard.
This annex does not include reference to the sector-s pecific quality management system standards

[ developed by ISO/TC 176.

This International Standa rd is one of the three core standa rd s developed by ISO/TC 176.

ISO 9000 Quality managem ent systems - Fundamentals and vocabulary provides an essential
background for the proper und e rs tandi ng and imp le menta tion of this Int ern a tion a l Sta nda rd .
The quality manage ment principles are described in de tail in ISO 9000 and have been taken into
conside ra tion during the development of this Int erna tional Standard. These princ iple s are not
requirements in the mselves, but they form the foundation of the require me nts spec ified by this
International Standa rd. ISO 9000 also defines the terms, definitions and concepts used in this
International Standard.
( IS O 9001 (this I nt ern a tion al Standard) specifies requirements aimed primarily at giving confidence in
the pro duct s and services provided by an organization and thereby enhancing customer satisfact ion.
Its proper implementation can also be expected to bring other organiza tio nal benefits, such as
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
provides guidance for organiza tion s that choose to progress beyond the requirements of this
I nte rn a tiona l Standard, to add ress a broader range of topics that can lead to i mprov eme nt of the
orga niza tio n's overall performance. ISO 9 00 4 includ es guidance on a se lf -assess me nt methodo lo gy
for an organization to be able to evalu a te the le vel of ma tur it y of its quality management system.
The In terna tio nal Standards outlined below can provide assistance to organizations when they are
establis hing or seeking to improve their qua lity management systems, their processes or their activities.

[ IS O 10001 Quality management - Customer sati:,faction - Guidelines for codes of conduct for
organizations prov ides guid a nce to an organization in determining that its customer satis factio n
pro visio ns meet customer needs and expectat ions . Its use can enha nce customer con fide nce in an
organization and impro ve customer und ers ta nding of what to expect from an organ iza tion, thereby
l reducing the likelihood of misunderstandings and complaints.
ISO 10002 Quality management - Custom er satisfaction - Guidelines for complaints handling

l in organizations provid es guida nce on the process of handling complaints by recogn izin g and
a ddres sing the ne e ds a nd expectations of comp la ina nts and resolvin g any complaints received.
IS O 1 000 2 provides an open, effective and easy-to-use compla ints proce ss, includ i ng training of

l
peo ple. It als o provides guidanc e for s mall bus ine sses.
IS O 1 000 3 Quality management - Customer satisfaction - Guidelines for dispute resolution external
to organizati ons provides guidance for effective and e fficient exte rnal dispute resolution for
[
25
I
 ISO 9001:2015(E)
ISO 9001:2015(E)

product-related complai nts. Dis pute reso lution gives an avenue of redress whe n organiza tio ns do not
remedy a complai nt internally. Most com plai nts can be resolved successf ully wit hin the organization,
I
with out adve rsa ria l pro ce dures.

- ISO 10004 Quality managem ent - Customer satisfaction - Guidelines for monitoring and measuring
provides guide lines for act io ns to enhance customer satisfactio n and to de te rmin e o p portun ities
for im proveme nt of produ cts, processes and attribut es tha t ar e valued by customer s. Such action s
can
s t ren gthen customer loya lty a nd help retain custo mers .

ISO 10005 Quality manag ement systems - Gui delines for quality plans pro vid es gu idance on
es ta blis hin g and using qu ality p lans as a means of rela ting req uir ements of th e pro cess ,
produ ct, pro ject or contract, to work methods and practice s t hat s upport produ ct realization.
Benefits of es tablis hing a quality plan are in creased confid ence t ha t requirements will be met, tha
t processes are in control and the motivation tha t this ca n give to those invo lved.

- ISO 10006 Qua lity management systems - Guidelines for quality management in projects is applicable
to p ro je c ts from the s ma ll to la rge, from simpl e to comp lex, from an i ndi vid ual project to bei ng
part of a port folio of pro jects. ISO 1 00 06 is to be use d by person nel ma na ging pro jects and who
need to e ns ure th a t th eir organiza tion is applying the practi ces contained in the ISO quality
manage me nt sys te m s tanda rds.

- ISO 10007 Quality management systems - Guidelines/or configuratio n management is to assist

organiza tion s applying configura t io n ma na gement for the techn ica l and ad minis tra tive
direction over the li fe cycle of a pro duc t. Con figura tio n management can be used to meet the
product
iden tificatio n and traceability requireme nts s peci fie d in this I nte rnational Standard.

ISO 10008 Quality management - Customer satisfaction - Guide lines / or business-t o-consumer
electronic commerce tran sactions giv es guida nce on how organizat io ns can imple ment an e ffect ive
and efficient busin ess-to-co nsume r elec tronic commerce transac tio n (8 2C ECT) sys te m, and
thereby provid e a bas is for co ns um ers to have in creas ed confid ence in 82C ECTs, e nh a nce the ability
of orga nizat ions to sa tis fy consumers and help reduce comp lai nts and dis putes.
ISO 10012 Measurement management systems - Requ irements for measurement processes and
measuring equi pment provides guidance for the management of meas ureme nt processes and
met rolog ica l confirmation of meas ur i ng equ i pment use d to s up por t and demons tra te co mpli a nce
with me tro log ical requirements. ISO 10012 provid es qua lity management crit er ia for a meas u reme nt
management sys tem to ensure me tr ological req uir eme nts are met.

- ISO/ TR 10 013 Guidelines/or quality management system documentation provides guideli nes for
the develo pment and main te na nce of the do cu me nta tio n necessa ry for a qua li ty ma nage ment
sys te m. ISO/ TR 10013 can be used to docume nt management systems other than those of the
IS O q ua lity mana gement system sta nda rds, e.g. enviro nment al management systems and safe ty
ma nagement sys te ms.

- IS O 1 0014 Quali ty management - Guidelines for realizing financial and economic bene fits is a ddressed
to top manage ment. It provide s guidelin es for rea lizing financial and economi c bene fit s throug h the
a pplic a tion of quality manage ment princip les. It facil itates app lica tion of ma nageme nt pr in ciples
a nd se lect ion of methods and tools th a t ena ble t he sus ta ina ble s uccess ofan organizat ion.

ISO 10015 Quality managem ent - Guidelines for training pro vides guidelines to assist organiz at io ns
in addr ess ing iss ues rel a ted to training. ISO 10 01 5 ca n be applied whenever guidance is required
to inter pret re ferences to "educa tion" and "tra ini ng" wi t hin the ISO qua lity management system
s tanda rds. Any reference to "training" includ es all types of educ a tion and trainin g.

- ISO/ TR 10017 Guidance on stat istical techniques for IS O 9001:2000 expla ins s ta tis tica l tech
niq ues which follow from the varia bility that can be observed in the behaviour a nd res ults of pro
cesses ,
even und er conditions of appare nt s tabi lity. Sta tis tical te c hniques a llow be tter use of ava ila ble data
to assist in decis ion making, and thereby help to continu ally imp rove the qua lity of products and
processes to achieve cus tome r sa tisfactio n.
26 I
I
 ISO 9001:2015(E)

r ISO 10018 Quality management - Guidelines on people involvement and competence provides
guideline s which influence people involvement and competenc e. A quality management
system depends on the involvement of competent people and the way that they are introduced
r and integrated into the organization. It is critical to determine, develop and evaluate the
knowledge, sk ills, behaviour and work environme nt required.

I - ISO 10019 Guidelines for the selection of quality management system consultants and use of their services
provides guidance for the selecti on of quality management system consultants and the use of their
se rvices. It gives guidance on the process for evaluating the competence of a quality management
sys tem consult ant and provides confiden ce that the organiza tion's ne e ds and expectations for the
cons ult ant's service s will be met.

ISO 1 9 011 Guidelines for auditing manag ement systems provides guidance on the management of an
aud it p rogramm e, on the planning and conductin g of an audit of a management system, as well as
on the comp etence and evaluation ofan auditor and an audit team. ISO 19011 is i ntend ed to apply to
auditor s, organizations implementing management systems, and organizations needing to conduct
audit s of man agement sys tems.

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 9 000 All All All All - All All All
ISO 900 4 All All All All All All All
ISO 10001 - 8.2.2, 9.1.2
I ISO 10002 .
·,
,
v·
8.5.1
8. 2.1. 9.1.2 10.2.1
ISO 100 03 9.1.2
(
, ::!:

ISO 10004 ' 9.1.2,.2.,1,_3_

ISO 10 005 .5.J. 6.1 , .6.,,2, All All .2.J. 1 0.2

( ISO 10006
ISO 10 00 7
All All
'
All All All
8.5.2
All All

ISO 10 008 All All...... '.,' All All All All All
( ISO 10012 7.1.S
ISO/ TR 10013 7.5
ISO 10014 All
l
All All All All All All
ISO 10 015 7.2
ISO/TR 1 0017 6.1 7.1.5 9.1
ISO 10018 All All All All All All All
( ISO 10019 M
ISO 1 9 011 2..2
l NOTE "All" indica tes that all the sub clau se s in the specific cla use of this Intern ation al Standard are relate d to the other
Int ern a tiona l Sta nd ar d.

I
(
I 27
 ISO 9001 :20 1 5 (
E)

Bibliography I
l
[1] ISO 9004, Managing for the sustained successof an organization -A quality management approach
[2]
ISO10001, Quality management - Customer satisfaction - Guidelines for codes of conduct for
[3]
organizations r
ISO 10002, Quality management- Customer sa,ti\ faction - Guidelin es for com plaints handling in
organizations
[4]
ISO1 0003, Quality management- Customer satisfaction - Guidelines for dispute resolution
exte rnal to organizations
[S]
ISO10004, Quality man agement - Customer sati faction - Gui delines for monitoring and measuring
[6]
ISO 10005, Qua lity manag ement ystems - Guidelines for quality plans
[7]
ISO10 006, Qua lity managem ent syste ms - Guidelines for quality manageme nt in projects
[8]
ISO 1 0007, Qua lity management systems - Guidelines for config uration manag ement
[9]
ISO 10008, Quality manag ement - Custo mer satisfact ion - Guidelines for business-to-consumer
electronic commerce transactions

[10] ISO 10012, Measurement management systems - Requirements for measurement processes and
measuring equipment
[11] ISO/ TR 1 0013, Guidelines for quality manageme nt system dow mentation
[12] ISO 1 0014, Quality management - Guidelines for realizing financial and economic benefits

[13] ISO 10015, Quality management- Guidelines for training

[14] ISO/ TR 1 0017, Guidance on stat istical techniques for ISO 9001:2000
[15] ISO 10 018, Quality management - Guidelines on people involvement and competence
[16] ISO 1 0019, 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 310 00, Risk management - Prin ciples and guidelines

[20] ISO 375 00, Guidance on outsourcing

[21] IS O/ IEC 90003, Softw are eng ineer ing - Guidelines for the a pp lica tion of IS O 9001: 2008 to
computer software

[22] IEC 6 0300 -1, Dependability managem ent - Part 1: Gui dance for manag ement and application
[23] IEC 611 6 0, Design review
[24] Quality managem ent pri ncipl es, IS01l
[25] Selection and use of th e ISO 900 0 fam ily of s ta nda rds, IS01l
[26] ISO9001 for Small Bus ine ss es - What to do, IS01)

1) Ava ila ble fr o m website: htt p:/ / www.iso.o rg.

28
 ISO 9 00 1 :2 0 1 5
(E)

f [2 7 ] Integra ted use of ma nage ment sys tem s tand a rds, IS01l

[28] ww w.is o .or g/ tcl 76 / sc02 / p11blic

r [ 2 9 ] www.iso.or g/ tel 76 /1SO9001 Aud it i n Pra cti ces Group

(
l

I
I
(

(
{
I
[
I
[
l
l
[

l
 29

l
 I
ISO 9 00 1 :2 0 1 5
ISO 9001:2015(E) (E) f

I
I

l
ICS 0 3.120.10 I
Price based on 29 pages

l
(