Hkkjrh; ekud IS/ISO 9001 : 2015

(Reaffirmed 0)
Indian Standard

xq.krk çcaèk i¼fr;k¡ — vis{kk,¡

(pkSFkk iqujh{k.k)

Quality Management
nag Systems —
Requirements
Re
Req
(F
Fourth Revision )

ICS 03.120.10

© BIS 2015

Hkkjrh; ekud C;wjks

BUREAU OF INDIAN STANDARDS
ekud Hkou] 9 cgknqj'kkg T+kiQj ekxZ] ubZ fnYyh&110002
MANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG
NEW DELHI-110002
www.bis.org.in www.standardsbis.in

September 2015 Price Group 11

 IS/ISO 9001 : 2015

Contents Page

National Foreword .................................................................................................................................................................................................................iii

Introduction................................................................................................................................................................................................................................ iv
1 Scope ................................................................................................................................................................................................................................. 1
2 Normative references ...................................................................................................................................................................................... 1
͵ ‡”•ƒ††‡ϐ‹‹–‹‘• ..................................................................................................................................................................................... 1
4 Context of the organization ....................................................................................................................................................................... 1
4.1 Understanding the organization and its context ....................................................................................................... 1
4.2 Understanding the needs and expectations of interested ested parties .............................................................. 2
ͶǤ͵ ‡–‡”‹‹‰–Š‡•…‘’‡‘ˆ–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡ –•›•–– ............................................................................. 2
ͶǤͶ —ƒŽ‹–›ƒƒ‰‡‡–•›•–‡ƒ†‹–•’”‘…‡••‡• ..........................................................................................................
............ 2
5 Leadership ..................................................................................................................................................................................................................
............ 3
5.1 Leadership and commitment .....................................................................................................................................................
............ 3
5.1.1 General......................................................................................................................................................................................
.... ..... . 3
5.1.2 Customer focus ..................................................................................................................................................................
.........
.. 3
ͷǤʹ ‘Ž‹…› ...............................................................................................................................................................................................................
.......... ..... 4
ͷǤʹǤͳ •–ƒ„Ž‹•Š‹‰–Š‡“—ƒŽ‹–›’‘Ž‹…› Ž‹…›.............................................................................................................................
.. .......... 4
ͷǤʹǤʹ ‘—‹…ƒ–‹‰–Š‡“—ƒŽ‹–›’‘Ž‹…› Ž‹–›’ ’‘Ž ....................................................................................................................
.........
...... 4
5.3 Organizational roles, responsibilities bilitie
ilitities aand authorities tho .......................................................................................... 4
6 Planning.........................................................................................................................................................................................................................
............. . .... .......
.... 4
6.1 Actions to address risks and opportunities
d opp
op ties ................................................................................................................... 4
͸Ǥʹ —ƒŽ‹–›‘„Œ‡…–‹˜‡•ƒ†’Žƒ‹‰–‘ƒ…Š‹‡˜‡–Š‡ ƒ‹
ƒ …Š‹‡˜ ...................................................................................................... 5
6.3 Planning of changes ............................................................................................................................................................................
..... .... .... .. 5
7 Support ...........................................................................................................................................................................................................................
.............. .......... 6
7.1 Resources.....................................................................................................................................................................................................
..... ... ........ . 6
7.1.1 General......................................................................................................................................................................................
...... .... ........
... . 6
7.1.2 Peoplee ........................................................................................................................................................................................
............ ........
...... 6
7.1.3 Infrastructure
stru
tru .....................................................................................................................................................................
...........
......... .. .. 6
7.1.4 Environment
iron
ro for
o th
or the operation of processes ........................................................................................... 6
7.1.5 Monitoring
onit
nitoito andnd measuring
m resources ........................................................................................................... 7
7.1.6 Organizational
Orga
Org on nal al knowledge
k ....................................................................................................................................... 7
7.2 Competence tenc
ten nce ...............................................................................................................................................................................................
........
.. . 8
7.3 Awareness enees ...................................................................................................................................................................................................
........ 8
7.4 Communication
mmu on n ......................................................................................................................................................................................
.. 8
7.5 Documented
ocum
cum d in information
inf
nfo ............................................................................................................................................................... 8
7.5.1
7
7.5. General
en nera ...................................................................................................................................................................................... 8
ner
7.5.2
7.
7 5 Creating
Cr eaatin and updating ................................................................................................................................................. 9
reat
7.5.3
7 Control
on of documented information ............................................................................................................... 9
8 Operation ..................................................................................................................................................................................................................... 9
8.1 Operational planning and control .......................................................................................................................................... 9
8.2 Requirements for products and services ...................................................................................................................... 10
8.2.1 Customer communication..................................................................................................................................... 10
8.2.2 Determining the requirements for products and services ....................................................... 10
8.2.3 Review of the requirements for products and services .............................................................. 10
8.2.4 Changes to requirements for products and services ..................................................................... 11
8.3 Design and development of products and services .............................................................................................. 11
8.3.1 General................................................................................................................................................................................... 11
8.3.2 Design and development planning................................................................................................................ 11
8.3.3 Design and development inputs ...................................................................................................................... 11
8.3.4 Design and development controls ................................................................................................................. 12
8.3.5 Design and development outputs .................................................................................................................. 12
8.3.6 Design and development changes.................................................................................................................. 12

i
IS/ISO 9001 : 2015

ͺǤͶ ‘–”‘Ž‘ˆ‡š–‡”ƒŽŽ›’”‘˜‹†‡†’”‘…‡••‡•ǡ’”‘†—…–•ƒ†•‡”˜‹…‡• ........................................................... 13

8.4.1 General................................................................................................................................................................................... 13
ͺǤͶǤʹ ›’‡ƒ†‡š–‡–‘ˆ…‘–”‘Ž.................................................................................................................................... 13
8.4.3 Information for external providers............................................................................................................... 13
8.5 Production and service provision........................................................................................................................................ 14
8.5.1 Control of production and service provision........................................................................................ 14
ͺǤͷǤʹ †‡–‹ϐ‹…ƒ–‹‘ƒ†–”ƒ…‡ƒ„‹Ž‹–› ........................................................................................................................... 14
ͺǤͷǤ͵ ”‘’‡”–›„‡Ž‘‰‹‰–‘…—•–‘‡”•‘”‡š–‡”ƒŽ’”‘˜‹†‡”•............................................................ 15
8.5.4 Preservation...................................................................................................................................................................... 15
ͺǤͷǤͷ ‘•–Ǧ†‡Ž‹˜‡”›ƒ…–‹˜‹–‹‡• ............................................................................................................................................ 15
8.5.6 Control of changes ....................................................................................................................................................... 15
8.6 Release of products and services ......................................................................................................................................... 15
8.7 Control of nonconforming outputs .....................................................................................................................................
............
......... 16
9 Performance evaluation ............................................................................................................................................................................
.... 16
ͻǤͳ ‘‹–‘”‹‰ǡ‡ƒ•—”‡‡–ǡƒƒŽ›•‹•ƒ†‡˜ƒŽ—ƒ–‹‘ ............................................................................................
....... 16
9.1.1 General...................................................................................................................................................................................
........... 16
9.1.2 Customer satisfaction ...............................................................................................................................................
............ 17
ͻǤͳǤ͵ ƒŽ›•‹•ƒ†‡˜ƒŽ—ƒ–‹‘ ..........................................................................................................................................
.... ... 17
9.2 Internal audit .........................................................................................................................................................................................
........
.... 17
9.3 Management review ........................................................................................................................................................................
......... ... 18
9.3.1 General...................................................................................................................................................................................
........... .......... 18
9.3.2 Management review inputs .................................................................................................................................
.... ........
...... 18
9.3.3 Management review outputs uts .............................................................................................................................
.. ... ........ 18
10 Improvement .........................................................................................................................................................................................................
.... .............
.... 19
10.1 General ........................................................................................................................................................................................................
.... ... .........
...... 19
ͳͲǤʹ ‘…‘ˆ‘”‹–›ƒ†…‘””‡…–‹˜‡ƒ…–‹‘ ˜‡ƒ
‡ƒ ‹‘ ..............................................................................................................................
.. .......... 19
10.3 Continual improvement ...............................................................................................................................................................
.. .... .... .. 19
‡™
™ –—”
—”‡
”‡
Annex A (informative)Žƒ”‹ϐ‹…ƒ–‹‘‘ˆ‡™•–”—…–—”‡ǡ–‡”‹‘Ž‘‰›ƒ†…‘…‡’–• ............................................21
nation
on Standards
Annex B (informative) Other International ndaar on quality management and quality
velop
management systems developedope by ISO/TC
SO/T 176 .............................................................................................................25
SO/
Bibliography .............................................................................................................................................................................................................................
......
... ............ ... 28

ii
 IS/ISO 9001 : 2015

—ƒŽ‹–›ƒƒ‰‡‡–‡…–‹‘ƒŽ‘‹––‡‡ǡͲʹ

 

Š‹• †‹ƒ –ƒ†ƒ”† ȋ ‘—”–Š ‡˜‹•‹‘Ȍ ™Š‹…Š ‹• ‹†‡–‹…ƒŽ ™‹–Š  ͻͲͲͳ ǣ ʹͲͳͷ
Ǯ—ƒŽ‹–› ƒƒ‰‡‡– •›•–‡• Ȅ ‡“—‹”‡‡–•ǯ ‹••—‡† „› –Š‡ –‡”ƒ–‹‘ƒŽ
”‰ƒ‹œƒ–‹‘ ˆ‘” –ƒ†ƒ”†‹œƒ–‹‘ ȋȌ ™ƒ• ƒ†‘’–‡† „› –Š‡ —”‡ƒ— ‘ˆ †‹ƒ
–ƒ†ƒ”†• ‘ –Š‡ ”‡…‘‡†ƒ–‹‘ ‘ˆ –Š‡ —ƒŽ‹–› ƒŽ‹–›
‹ ƒƒ‰‡‡– ‡…–‹‘ƒŽ
›••–‡
–‡
‘‹––‡‡ƒ†ƒ’’”‘˜ƒŽ‘ˆ–Š‡ƒƒ‰‡‡–ƒ†›•–‡•‹˜‹•‹‘‘—…‹ŽǤ

† •—
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‡†† ƒ‰
ʹͲͲͲ ƒ† ʹͲͲͺǤ Š‹• •–ƒ†ƒ”† ‹• „‡‹‰ ”‡˜‹•‡† ƒ‰ƒ‹ ˆ‘” ƒ†‘’–‹‘ ‘ˆ  ͻͲͲͳ ǣ
ʹͲͳͷ˜‡”•‹‘Ǥ

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‹‹‹
IS/ISO 9001 : 2015

Introduction
0.1 General
Š‡ƒ†‘’–‹‘‘ˆƒ“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡‹•ƒ•–”ƒ–‡‰‹…†‡…‹•‹‘ˆ‘”ƒ‘”‰ƒ‹œƒ–‹‘–Šƒ–…ƒŠ‡Ž’
to improve its overall performance and provide a sound basis for sustainable development initiatives.
Š‡’‘–‡–‹ƒŽ„‡‡ϐ‹–•–‘ƒ‘”‰ƒ‹œƒ–‹‘‘ˆ‹’Ž‡‡–‹‰ƒ“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡„ƒ•‡†‘–Š‹•
International Standard are:
ƒȌ –Š‡ ƒ„‹Ž‹–› –‘ …‘•‹•–‡–Ž› ’”‘˜‹†‡ ’”‘†—…–• ƒ† •‡”˜‹…‡• –Šƒ– ‡‡– …—•–‘‡” ƒ† ƒ’’Ž‹…ƒ„Ž‡
•–ƒ–—–‘”›ƒ†”‡‰—Žƒ–‘”›”‡“—‹”‡‡–•Ǣ
„Ȍ ˆƒ…‹Ž‹–ƒ–‹‰‘’’‘”–—‹–‹‡•–‘‡Šƒ…‡…—•–‘‡”•ƒ–‹•ˆƒ…–‹‘Ǣ
…Ȍ ƒ††”‡••‹‰”‹••ƒ†‘’’‘”–—‹–‹‡•ƒ••‘…‹ƒ–‡†™‹–Š‹–•…‘–‡š–ƒ†‘„Œ‡…–‹˜‡•Ǣ
–ƒ†
†Ȍ –Š‡ƒ„‹Ž‹–›–‘†‡‘•–”ƒ–‡…‘ˆ‘”‹–›–‘•’‡…‹ϐ‹‡†“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡”‡“—‹”‡‡–•Ǥ
ƒ
ƒƒ‰
Š‹•–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†…ƒ„‡—•‡†„›‹–‡”ƒŽƒ†‡š–‡”ƒŽ’ƒ”–‹‡•Ǥ
š–‡”ƒ
–‡”ƒŽŽ
–‹•‘––Š‡‹–‡–‘ˆ–Š‹•–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†–‘‹’Ž›–Š‡‡‡†ˆ‘”ǣ
Ž›
›–Š‡ ˆ‘”ǣ
Ȅ —‹ˆ‘”‹–›‹–Š‡•–”—…–—”‡‘ˆ†‹ˆˆ‡”‡–“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡•Ǣ
ƒƒƒ‰‡ •›••–‡
Ȅ ƒŽ‹‰‡–‘ˆ†‘…—‡–ƒ–‹‘–‘–Š‡…Žƒ—•‡•–”—…–—”‡‘ˆ–Š‹•–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†Ǣ
—……–—”
—…–—”‡ ‹•
–
Ȅ –Š‡—•‡‘ˆ–Š‡•’‡…‹ϐ‹…–‡”‹‘Ž‘‰›‘ˆ–Š‹•–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†™‹–Š‹–Š‡‘”‰ƒ‹œƒ–‹‘Ǥ
–‡”
‡” Ž–– ƒ
Ž–ƒ
Š‡ “—ƒŽ‹–› ƒƒ‰‡‡– •›•–‡ ”‡“—‹”‡‡–•
”‡‡
‡ •’‡…‹ϐ‹‡†
’‡‡…‹
…‹ϐ ‹ –Š‹• –‡”ƒ–‹‘ƒŽ –ƒ†ƒ”† ƒ”‡
…‘’Ž‡‡–ƒ”›–‘”‡“—‹”‡‡–•ˆ‘”’”‘†—…–•ƒ†•‡”˜‹…‡•Ǥ
—……–•ƒ ˜‹…‡
‹……‡•
Š‹•–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†‡’Ž‘›•–Š‡’”‘…‡••ƒ’’”‘ƒ…Šǡ™Š‹…Š‹…‘”’‘”ƒ–‡•–Š‡ŽƒǦ‘ǦŠ‡…Ǧ…–
–Š‡’
’” ƒ’’”
’”
ȋȌ…›…Ž‡ƒ†”‹•Ǧ„ƒ•‡†–Š‹‹‰Ǥ
‰Ǥ
The process approach enables an organization
org ion to p
plan its processes and their interactions.
Š‡  …›…Ž‡ ‡ƒ„Ž‡• ƒ ‘”‰ƒ‹œƒ–‹‘
”‰ƒƒ‹ –‘
‘ ‡•—”‡
‡ –Šƒ– ‹–• ’”‘…‡••‡• ƒ”‡ ƒ†‡“—ƒ–‡Ž› ”‡•‘—”…‡† ƒ†
managed, and that opportunities
ities for
f improvement
prov are determined and acted on.
Risk-based thinking enables
less an
a organization
zati to determine the factors that could cause its processes and
niizat
‹–•“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡–‘†‡˜‹ƒ–‡ˆ”‘–Š‡’Žƒ‡†”‡•—Ž–•ǡ–‘’—–‹’Žƒ…‡’”‡˜‡–‹˜‡…‘–”‘Ž•
•›•
›
›•–‡ †‡˜‹ƒ
–‘‹‹‹œ‡‡‰ƒ–‹˜‡‡ˆˆ‡…–•ƒ†–‘ƒ‡ƒš‹——•‡‘ˆ‘’’‘”–—‹–‹‡•ƒ•–Š‡›ƒ”‹•‡ȋ•‡‡Clause
‡ˆˆ‡
ˆˆˆ‡…– –‘ A.4).
‘•‹•–‡–Ž› ‡‡–‹‰
‹‰ ”‡“—‹”‡‡–•
‰ ”‡ ‡– ƒ† ƒ††”‡••‹‰ ˆ—–—”‡ ‡‡†• ƒ† ‡š’‡…–ƒ–‹‘• ’‘•‡• ƒ …ŠƒŽŽ‡‰‡
‡
‡–
ˆ‘”‘”‰ƒ‹œƒ–‹‘•‹ƒ‹…”‡ƒ•‹‰Ž›†›ƒ‹…ƒ†…‘’Ž‡š‡˜‹”‘‡–Ǥ‘ƒ…Š‹‡˜‡–Š‹•‘„Œ‡…–‹˜‡ǡ–Š‡
•‹ƒ ‡ƒ•
ƒ•‹
‹
‘”‰ƒ‹œƒ–‹‘‹‰Š–ϐ‹†‹–‡…‡••ƒ”›–‘ƒ†‘’–˜ƒ”‹‘—•ˆ‘”•‘ˆ‹’”‘˜‡‡–‹ƒ††‹–‹‘–‘…‘””‡…–‹‘
ϐ
and continual improvement, such as breakthrough change, innovation and re-organization.
In this International Standard, the following verbal forms are used:
Ȅ Dz•ŠƒŽŽdz‹†‹…ƒ–‡•ƒ”‡“—‹”‡‡–Ǣ
Ȅ Dz•Š‘—Ž†dz‹†‹…ƒ–‡•ƒ”‡…‘‡†ƒ–‹‘Ǣ
Ȅ Dzƒ›dz‹†‹…ƒ–‡•ƒ’‡”‹••‹‘Ǣ
Ȅ Dz…ƒdz‹†‹…ƒ–‡•ƒ’‘••‹„‹Ž‹–›‘”ƒ…ƒ’ƒ„‹Ž‹–›Ǥ
ˆ‘”ƒ–‹‘ƒ”‡†ƒ•Dzdz‹•ˆ‘”‰—‹†ƒ…‡‹—†‡”•–ƒ†‹‰‘”…Žƒ”‹ˆ›‹‰–Š‡ƒ••‘…‹ƒ–‡†”‡“—‹”‡‡–Ǥ

iv
 IS/ISO 9001 : 2015

0.2 Quality management principles

Š‹•–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†‹•„ƒ•‡†‘–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–’”‹…‹’Ž‡•†‡•…”‹„‡†‹ͻͲͲͲǤŠ‡
†‡•…”‹’–‹‘•‹…Ž—†‡ƒ•–ƒ–‡‡–‘ˆ‡ƒ…Š’”‹…‹’Ž‡ǡƒ”ƒ–‹‘ƒŽ‡‘ˆ™Š›–Š‡’”‹…‹’Ž‡‹•‹’‘”–ƒ–ˆ‘”–Š‡
‘”‰ƒ‹œƒ–‹‘ǡ•‘‡‡šƒ’Ž‡•‘ˆ„‡‡ϐ‹–•ƒ••‘…‹ƒ–‡†™‹–Š–Š‡’”‹…‹’Ž‡ƒ†‡šƒ’Ž‡•‘ˆ–›’‹…ƒŽƒ…–‹‘•
–‘‹’”‘˜‡–Š‡‘”‰ƒ‹œƒ–‹‘ǯ•’‡”ˆ‘”ƒ…‡™Š‡ƒ’’Ž›‹‰–Š‡’”‹…‹’Ž‡Ǥ
Š‡“—ƒŽ‹–›ƒƒ‰‡‡–’”‹…‹’Ž‡•ƒ”‡ǣ
Ȅ …—•–‘‡”ˆ‘…—•Ǣ
Ȅ Ž‡ƒ†‡”•Š‹’Ǣ
Ȅ ‡‰ƒ‰‡‡–‘ˆ’‡‘’Ž‡Ǣ
Ȅ ’”‘…‡••ƒ’’”‘ƒ…ŠǢ
Ȅ ‹’”‘˜‡‡–Ǣ
Ȅ ‡˜‹†‡…‡Ǧ„ƒ•‡††‡…‹•‹‘ƒ‹‰Ǣ
— relationship management.
0.3 Process approach
0.3.1 General
This International Standard promotess thee adoption ion of a process approach when developing,
pttio
ption
‹’Ž‡‡–‹‰ƒ†‹’”‘˜‹‰–Š‡‡ˆˆ‡…–‹˜‡‡••‘ˆƒ“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡ǡ–‘‡Šƒ…‡…—•–‘‡”
‹˜‡
‡‡ “—
“—ƒ
—ƒ
•ƒ–‹•ˆƒ…–‹‘ „› ‡‡–‹‰ …—•–‘‡” ”‡“—‹”‡‡–•Ǥ
‡“—‹”
‡“— –•Ǥ ’‡…‹ϐ‹… ”‡“—‹”‡‡–• …‘•‹†‡”‡† ‡••‡–‹ƒŽ –‘ –Š‡
•Ǥ ’
adoption of a process approach are inclu
included
clud
l in 4.4
4.4.
4
†‡”•–ƒ†‹‰ ƒ† ƒƒ‰‹‰ ‹–‡””‡Žƒ–‡†
‹
–‡””‡‡ ’”‘…‡••‡•
’”‘ ƒ• ƒ •›•–‡ …‘–”‹„—–‡• –‘ –Š‡ ‘”‰ƒ‹œƒ–‹‘ǯ•
‡ˆˆ‡…–‹˜‡‡••ƒ†‡ˆϐ‹…‹‡…›‹ƒ…Š‹‡˜‹‰‹–•‹–‡†‡†”‡•—Ž–•ǤŠ‹•ƒ’’”‘ƒ…Š‡ƒ„Ž‡•–Š‡‘”‰ƒ‹œƒ–‹‘
ƒ…Š‹‡
‹‡ –•‹–
–‘…‘–”‘Ž–Š‡‹–‡””‡Žƒ–‹‘•Š‹’•ƒ†‹–‡”†‡’‡†‡…‹‡•ƒ‘‰–Š‡’”‘…‡••‡•‘ˆ–Š‡•›•–‡ǡ•‘–Šƒ––Š‡
Š‹’•ƒ
• ƒ ”†
”†‡
overall performance of thee org
organization
or gan ion can be enhanced.
n ca
Š‡ ’”‘…‡•• ƒ’’”‘ƒ…Š ‹˜‘Ž˜‡•
˜‘ –Š‡
‡ •›•–‡ƒ–‹…
Š‡ •›•–
•› †‡ϐ‹‹–‹‘ ƒ† ƒƒ‰‡‡– ‘ˆ ’”‘…‡••‡•ǡ ƒ† –Š‡‹”
‹–‡”ƒ…–‹‘•ǡ•‘ƒ•–‘ƒ…Š‹‡˜‡–Š‡‹–‡†‡†”‡•—Ž–•‹ƒ……‘”†ƒ…‡™‹–Š–Š‡“—ƒŽ‹–›’‘Ž‹…›ƒ†•–”ƒ–‡‰‹…
ƒ…Š‹‡
‹‡˜ ‹–‡
‹–
–‡
†‹”‡…–‹‘‘ˆ–Š‡‘”‰ƒ‹œƒ–‹‘Ǥƒƒ‰‡‡–‘ˆ–Š‡’”‘…‡••‡•ƒ†–Š‡•›•–‡ƒ•ƒ™Š‘Ž‡…ƒ„‡ƒ…Š‹‡˜‡†
‹œƒ–
‹œƒ ƒƒ‰‡
ƒ
—•‹‰–Š‡…›…Ž‡ȋ•‡‡ͲǤ͵ǤʹȌ™‹–Šƒ‘˜‡”ƒŽŽˆ‘…—•‘”‹•Ǧ„ƒ•‡†–Š‹‹‰ȋ•‡‡ͲǤ͵Ǥ͵Ȍƒ‹‡†ƒ––ƒ‹‰
‡ȋ
‡ȋ• ʹȌ™
™
™‹
advantage of opportunities
rtu and
d preventing
p undesirable results.
Š‡ƒ’’Ž‹…ƒ–‹‘‘ˆ–Š‡’”‘…‡••ƒ’’”‘ƒ…Š‹ƒ“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡‡ƒ„Ž‡•ǣ
‘ˆ
ˆ– ‘…‡‡••
‘…‡•
ƒȌ —†‡”•–ƒ†‹‰ƒ†…‘•‹•–‡…›‹‡‡–‹‰”‡“—‹”‡‡–•Ǣ
”•–ƒ†
ƒ†
†‹ †
†…‘
‘
„Ȍ –Š‡…‘•‹†‡”ƒ–‹‘‘ˆ’”‘…‡••‡•‹–‡”•‘ˆƒ††‡†˜ƒŽ—‡Ǣ
…Ȍ –Š‡ƒ…Š‹‡˜‡‡–‘ˆ‡ˆˆ‡…–‹˜‡’”‘…‡••’‡”ˆ‘”ƒ…‡Ǣ
d) improvement of processes based on evaluation of data and information.
Figure 1‰‹˜‡•ƒ•…Š‡ƒ–‹…”‡’”‡•‡–ƒ–‹‘‘ˆƒ›’”‘…‡••ƒ†•Š‘™•–Š‡‹–‡”ƒ…–‹‘‘ˆ‹–•‡Ž‡‡–•ǤŠ‡
‘‹–‘”‹‰ƒ†‡ƒ•—”‹‰…Š‡…’‘‹–•ǡ™Š‹…Šƒ”‡‡…‡••ƒ”›ˆ‘”…‘–”‘Žǡƒ”‡•’‡…‹ϐ‹…–‘‡ƒ…Š’”‘…‡••
ƒ†™‹ŽŽ˜ƒ”›†‡’‡†‹‰‘–Š‡”‡Žƒ–‡†”‹••Ǥ

v
IS/ISO 9001 : 2015

Figure 1 — Schematic representation of the elements

elem
leme of a single process

0.3.2 Plan-Do-Check-Act cycle

Š‡  …›…Ž‡ …ƒ „‡ ƒ’’Ž‹‡† –‘ ƒŽŽ ’”‘…‡••‡• ƒ†
† –‘ –Š‡
–Š “—ƒŽ‹–›
Ž‹–› ƒƒ‰‡‡– •›•–‡ ƒ• ƒ ™Š‘Ž‡Ǥ
ƒŽ‹–›
Figure 2 illustrates how Clauses 4 to 10…ƒ„‡‰”‘—’‡†‹”‡Žƒ–‹‘–‘–Š‡…›…Ž‡Ǥ
—’‡†
‡† ‹ ‘

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

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

vi
 IS/ISO 9001 : 2015

Š‡…›…Ž‡…ƒ„‡„”‹‡ϐŽ›†‡•…”‹„‡†ƒ•ˆ‘ŽŽ‘™•ǣ
— Planǣ‡•–ƒ„Ž‹•Š–Š‡‘„Œ‡…–‹˜‡•‘ˆ–Š‡•›•–‡ƒ†‹–•’”‘…‡••‡•ǡƒ†–Š‡”‡•‘—”…‡•‡‡†‡†–‘†‡Ž‹˜‡”
”‡•—Ž–•‹ƒ……‘”†ƒ…‡™‹–Š…—•–‘‡”•ǯ”‡“—‹”‡‡–•ƒ†–Š‡‘”‰ƒ‹œƒ–‹‘ǯ•’‘Ž‹…‹‡•ǡƒ†‹†‡–‹ˆ›
ƒ†ƒ††”‡••”‹••ƒ†‘’’‘”–—‹–‹‡•Ǣ
— Doǣ‹’Ž‡‡–™Šƒ–™ƒ•’Žƒ‡†Ǣ
— Check: monitor and (where applicable) measure processes and the resulting products and services
ƒ‰ƒ‹•–’‘Ž‹…‹‡•ǡ‘„Œ‡…–‹˜‡•ǡ”‡“—‹”‡‡–•ƒ†’Žƒ‡†ƒ…–‹˜‹–‹‡•ǡƒ†”‡’‘”––Š‡”‡•—Ž–•Ǣ
— Actǣ–ƒ‡ƒ…–‹‘•–‘‹’”‘˜‡’‡”ˆ‘”ƒ…‡ǡƒ•‡…‡••ƒ”›Ǥ
0.3.3 Risk-based thinking
Risk-based thinking (see Clause A.4Ȍ‹•‡••‡–‹ƒŽˆ‘”ƒ…Š‹‡˜‹‰ƒ‡ˆˆ‡…–‹˜‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǥ
‰ƒ‡
The concept of risk-based thinking has been implicit in previous
vious editions of this International Standard
‹…Ž—†‹‰ǡˆ‘”‡šƒ’Ž‡ǡ…ƒ””›‹‰‘—–’”‡˜‡–‹˜‡ƒ…–‹‘–‘‡Ž‹‹ƒ–‡’‘–‡–‹ƒŽ‘…‘ˆ‘”‹–‹‡•ǡƒƒŽ›•‹‰
‡Ž‹‹
ƒ›‘…‘ˆ‘”‹–‹‡•–Šƒ–†‘‘……—”ǡƒ†–ƒ‹‰ƒ…–‹‘–‘’”‡˜‡–”‡…—””‡…‡–Šƒ–‹•ƒ’’”‘’”‹ƒ–‡ˆ‘”–Š‡
–‘’”‡
”‡˜
‡ˆˆ‡…–•‘ˆ–Š‡‘…‘ˆ‘”‹–›Ǥ
To conform to the requirements of this International nal Standard, an organization needs to plan and
ation
implement actions to address risks and opportunities.ortuni Addressing both risks and opportunities
Addr
‡•–ƒ„Ž‹•Š‡• ƒ „ƒ•‹• ˆ‘” ‹…”‡ƒ•‹‰ –Š‡ ‡ˆˆ‡…–‹˜‡‡••
˜‡‡• ‘ˆ –Š‡
–‹˜‡ –Š‡
Š‡ “—ƒŽ‹–› ƒƒ‰‡‡– •›•–‡ǡ ƒ…Š‹‡˜‹‰
improved results and preventing negative effects.
ffec
ec
ects.
Opportunities can arise as a result of a situation
sit
itu
t n favourable
fav
fa
favo to achieving an intended result, for
example, a set of circumstances that allow w the
ow th organization
nizaat to attract customers, develop new products
ƒ†•‡”˜‹…‡•ǡ”‡†—…‡™ƒ•–‡‘”‹’”‘˜‡’”‘†—…–‹˜‹–›Ǥ…–‹‘•–‘ƒ††”‡••‘’’‘”–—‹–‹‡•…ƒƒŽ•‘‹…Ž—†‡
˜‡’”‘† ‹˜ ‹–›Ǥ
˜‡’ 
…‘•‹†‡”ƒ–‹‘‘ˆƒ••‘…‹ƒ–‡†”‹••Ǥ‹•‹•–Š‡‡ˆˆ‡…–‘ˆ—…‡”–ƒ‹–›ƒ†ƒ›•—…Š—…‡”–ƒ‹–›…ƒŠƒ˜‡
‹•‹
•‹•
 ˆˆ‡…
‡…––
’‘•‹–‹˜‡‘”‡‰ƒ–‹˜‡‡ˆˆ‡…–•Ǥ’‘•‹–‹˜‡†‡˜‹ƒ–‹‘ƒ”‹•‹‰ˆ”‘ƒ”‹•…ƒ’”‘˜‹†‡ƒ‘’’‘”–—‹–›ǡ„—–‘–
–‹˜
˜‡† ‘ƒ”
all positive effects of risk result in
n opportunities.
opp nit
ities
0.4 Relationship with other
er management
ma ent system standards
ment
Š‹•–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†ƒ’’Ž‹‡•–Š‡ˆ”ƒ‡™‘”†‡˜‡Ž‘’‡†„›–‘‹’”‘˜‡ƒŽ‹‰‡–ƒ‘‰‹–•
”†ƒ’
†ƒ –Š‡
Š‡ ˆ”ƒ
ˆ”
–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†•ˆ‘”ƒƒ‰‡‡–•›•–‡•ȋ•‡‡Clause
ˆ‘”
‘” ‡
‡–
‡ A.1).
This International Standard
and enables
ab les an organization to use the process approach, coupled with the
bles
 …›…Ž‡ ƒ† ”‹•Ǧ„ƒ•‡†
„ƒ• –Š‹‹‰ǡ
Ǧ„ƒ
Ǧ„
„ƒ Š‹
 ‹
‹ –‘ ƒŽ‹‰ ‘” ‹–‡‰”ƒ–‡ ‹–• “—ƒŽ‹–› ƒƒ‰‡‡– •›•–‡ ™‹–Š –Š‡
”‡“—‹”‡‡–•‘ˆ‘–Š‡”ƒƒ‰‡‡–•›•–‡•–ƒ†ƒ”†•Ǥ
–Š‡”
‡”  ‰‡
‡
‡
This International
naal SStandard
nal ard relates to ISO 9000 and ISO 9004 as follows:
d re
— ISO 9000
00
0 0 Quality
Q management
y ma
m an systems — Fundamentals and vocabulary provides essential
„ƒ…‰”‘—†ˆ‘”–Š‡’”‘’‡”—†‡”•–ƒ†‹‰ƒ†‹’Ž‡‡–ƒ–‹‘‘ˆ–Š‹•–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†Ǣ
”‘— Š‡’
’”
— ISO 9004 Managing for the sustained success of an organization — A quality management approach
’”‘˜‹†‡• ‰—‹†ƒ…‡ ˆ‘” ‘”‰ƒ‹œƒ–‹‘• –Šƒ– …Š‘‘•‡ –‘ ’”‘‰”‡•• „‡›‘† –Š‡ ”‡“—‹”‡‡–• ‘ˆ –Š‹•
International Standard.
Annex B ’”‘˜‹†‡• †‡–ƒ‹Ž• ‘ˆ ‘–Š‡” –‡”ƒ–‹‘ƒŽ –ƒ†ƒ”†• ‘ “—ƒŽ‹–› ƒƒ‰‡‡– ƒ† “—ƒŽ‹–›
ƒƒ‰‡‡–•›•–‡•–Šƒ–Šƒ˜‡„‡‡†‡˜‡Ž‘’‡†„›Ȁͳ͹͸Ǥ
Š‹• –‡”ƒ–‹‘ƒŽ –ƒ†ƒ”† †‘‡• ‘– ‹…Ž—†‡ ”‡“—‹”‡‡–• •’‡…‹ϐ‹… –‘ ‘–Š‡” ƒƒ‰‡‡– •›•–‡•ǡ
•—…Š ƒ• –Š‘•‡ ˆ‘” ‡˜‹”‘‡–ƒŽ ƒƒ‰‡‡–ǡ ‘……—’ƒ–‹‘ƒŽ Š‡ƒŽ–Š ƒ† •ƒˆ‡–› ƒƒ‰‡‡–ǡ ‘”
ϐ‹ƒ…‹ƒŽƒƒ‰‡‡–Ǥ
‡…–‘”Ǧ•’‡…‹ϐ‹…“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡•–ƒ†ƒ”†•„ƒ•‡†‘–Š‡”‡“—‹”‡‡–•‘ˆ–Š‹•–‡”ƒ–‹‘ƒŽ
–ƒ†ƒ”† Šƒ˜‡ „‡‡ †‡˜‡Ž‘’‡† ˆ‘” ƒ —„‡” ‘ˆ •‡…–‘”•Ǥ ‘‡ ‘ˆ –Š‡•‡ •–ƒ†ƒ”†• •’‡…‹ˆ› ƒ††‹–‹‘ƒŽ
“—ƒŽ‹–› ƒƒ‰‡‡– •›•–‡ ”‡“—‹”‡‡–•ǡ ™Š‹Ž‡ ‘–Š‡”• ƒ”‡ Ž‹‹–‡† –‘ ’”‘˜‹†‹‰ ‰—‹†ƒ…‡ –‘ –Š‡
application of this International Standard within the particular sector.

vii
IS/ISO 9001 : 2015

A matrix showing the correlation between the clauses of this edition of this International Standard and
the previous edition (ISO 9001:2008) can be found on the ISO/TC 176/SC 2 open access web site at:
www.iso.org/tc176/sc02/public.

viii
 IS/ISO 9001 : 2015

IndianStandard

Ȅ
(FourthRevision)

1 Scope
Š‹• –‡”ƒ–‹‘ƒŽ –ƒ†ƒ”† •’‡…‹ϐ‹‡• ”‡“—‹”‡‡–• ˆ‘” ƒ “—ƒŽ‹–› ƒƒ‰‡‡– •›•–‡ ™Š‡ ƒ
organization:
ƒȌ ‡‡†•–‘†‡‘•–”ƒ–‡‹–•ƒ„‹Ž‹–›–‘…‘•‹•–‡–Ž›’”‘˜‹†‡’”‘†—…–•ƒ†•‡”˜‹…‡•–Šƒ–‡‡–…—•–‘‡”
’”‘
‘†—…
ƒ†ƒ’’Ž‹…ƒ„Ž‡•–ƒ–—–‘”›ƒ†”‡‰—Žƒ–‘”›”‡“—‹”‡‡–•ǡƒ††
„Ȍ ƒ‹•–‘‡Šƒ…‡…—•–‘‡”•ƒ–‹•ˆƒ…–‹‘–Š”‘—‰Š–Š‡‡ˆˆ‡…–‹˜‡ƒ’’Ž‹…ƒ–‹‘‘ˆ–Š‡•›•–‡ǡ‹…Ž—†‹‰
‡ˆˆ‡…–
’”‘…‡••‡• ˆ‘” ‹’”‘˜‡‡– ‘ˆ –Š‡ •›•–‡ ƒ† –Š‡
‡ ƒ••—”ƒ…‡
ƒƒ• ‘ˆ …‘ˆ‘”‹–› –‘ …—•–‘‡” ƒ†
ƒ’’Ž‹…ƒ„Ž‡•–ƒ–—–‘”›ƒ†”‡‰—Žƒ–‘”›”‡“—‹”‡‡–•Ǥ•Ǥ
ŽŽ–Š‡”‡“—‹”‡‡–•‘ˆ–Š‹•–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†ƒ”‡‰‡‡”‹…ƒ†ƒ”‡‹–‡†‡†–‘„‡ƒ’’Ž‹…ƒ„Ž‡–‘ƒ›
†ƒƒ”‡
ƒ”
‘”‰ƒ‹œƒ–‹‘ǡ”‡‰ƒ”†Ž‡••‘ˆ‹–•–›’‡‘”•‹œ‡ǡ‘”–Š‡’”‘†—…–•ƒ†•‡”˜‹…‡•‹–’”‘˜‹†‡•Ǥ
‡’”
’”‘† ƒ†•
ͳ –Š‹•–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†ǡ–Š‡–‡”•Dz’”‘†—…–dz‘”Dz•‡”˜‹…‡dz‘Ž›ƒ’’Ž›–‘’”‘†—…–•ƒ†•‡”˜‹…‡•
”•Dz’
Dz – ‘
‘” Dz
‘”
‹–‡†‡†ˆ‘”ǡ‘””‡“—‹”‡†„›ǡƒ…—•–‘‡”Ǥ

ʹ ‡
‡–• „‡‡‡š’”
š’
’”
–ƒ–—–‘”›ƒ†”‡‰—Žƒ–‘”›”‡“—‹”‡‡–•…ƒ„‡‡š’”‡••‡†ƒ•Ž‡‰ƒŽ”‡“—‹”‡‡–•Ǥ

2 Normative references
Š‡ ˆ‘ŽŽ‘™‹‰ †‘…—‡–•ǡ ‹ ™Š‘Ž‡
Š‘ ‘
Š‘Ž‡ ‘” ‹ ’
’ƒ”–ǡ
ƒ”–ǡ ƒ”‡ ‘”ƒ–‹˜‡Ž› ”‡ˆ‡”‡…‡† ‹ –Š‹• †‘…—‡– ƒ† ƒ”‡
‹†‹•’‡•ƒ„Ž‡ ˆ‘” ‹–• ƒ’’Ž‹…ƒ–‹‘Ǥ ‘” †ƒ–‡†
‹‘Ǥ ‘
‡† ””‡ˆ‡”‡…‡•ǡ ‘Ž› –Š‡ ‡†‹–‹‘ …‹–‡† ƒ’’Ž‹‡•Ǥ ‘” —†ƒ–‡†
”‡ˆ‡”‡…‡•ǡ–Š‡Žƒ–‡•–‡†‹–‹‘‘ˆ–Š‡”‡ˆ‡”‡…‡††‘…—‡–ȋ‹…Ž—†‹‰ƒ›ƒ‡†‡–•Ȍƒ’’Ž‹‡•Ǥ
‘ˆ–Š
–Š‡ ”‡… †
…‡
ISO 9000:2015, Quality management
nag
nage systems
ystem — Fundamentals and vocabulary
system

͵ ‡”•ƒ††‡ϐ‹‹–‹‘•
ϐ‹ ‹
ϐ‹‹
‘”–Š‡’—”’‘•‡•‘ˆ–Š‹•†‘…—‡–ǡ–Š‡–‡”•ƒ††‡ϐ‹‹–‹‘•‰‹˜‡‹ͻͲͲͲǣʹͲͳͷƒ’’Ž›Ǥ
‘ˆ–Š
–Š‹•
Š —‡
‡–
‡

4 Context
xt off the
t organization
organ
rga
ga

4.1 Understanding
rs g the
t organization and its context
The organization shall determine external and internal issues that are relevant to its purpose
ƒ† ‹–• •–”ƒ–‡‰‹… †‹”‡…–‹‘ ƒ† –Šƒ– ƒˆˆ‡…– ‹–• ƒ„‹Ž‹–› –‘ ƒ…Š‹‡˜‡ –Š‡ ‹–‡†‡† ”‡•—Ž–ȋ•Ȍ ‘ˆ ‹–• “—ƒŽ‹–›
ƒƒ‰‡‡–•›•–‡Ǥ
The organization shall monitor and review information about these external and internal issues.
NOTE 1 Issues can include positive and negative factors or conditions for consideration.

ʹ †‡”•–ƒ†‹‰ –Š‡ ‡š–‡”ƒŽ …‘–‡š– …ƒ „‡ ˆƒ…‹Ž‹–ƒ–‡† „› …‘•‹†‡”‹‰ ‹••—‡• ƒ”‹•‹‰ ˆ”‘ Ž‡‰ƒŽǡ
technological, competitive, market, cultural, social and economic environments, whether international, national,
regional or local.

͵ †‡”•–ƒ†‹‰–Š‡‹–‡”ƒŽ…‘–‡š–…ƒ„‡ˆƒ…‹Ž‹–ƒ–‡†„›…‘•‹†‡”‹‰‹••—‡•”‡Žƒ–‡†–‘˜ƒŽ—‡•ǡ…—Ž–—”‡ǡ
knowledge and performance of the organization.

1
IS/ISO 9001 : 2015

4.2 Understanding the needs and expectations of interested parties

—‡–‘–Š‡‹”‡ˆˆ‡…–‘”’‘–‡–‹ƒŽ‡ˆˆ‡…–‘–Š‡‘”‰ƒ‹œƒ–‹‘ǯ•ƒ„‹Ž‹–›–‘…‘•‹•–‡–Ž›’”‘˜‹†‡’”‘†—…–•ƒ†
•‡”˜‹…‡•–Šƒ–‡‡–…—•–‘‡”ƒ†ƒ’’Ž‹…ƒ„Ž‡•–ƒ–—–‘”›ƒ†”‡‰—Žƒ–‘”›”‡“—‹”‡‡–•ǡ–Š‡‘”‰ƒ‹œƒ–‹‘
shall determine:
ƒȌ –Š‡‹–‡”‡•–‡†’ƒ”–‹‡•–Šƒ–ƒ”‡”‡Ž‡˜ƒ––‘–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǣ
„Ȍ –Š‡”‡“—‹”‡‡–•‘ˆ–Š‡•‡‹–‡”‡•–‡†’ƒ”–‹‡•–Šƒ–ƒ”‡”‡Ž‡˜ƒ––‘–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǥ
The organization shall monitor and review information about these interested parties and their
relevant requirements.

4.3 Determining the scope of the quality management system

te
em
Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ†‡–‡”‹‡–Š‡„‘—†ƒ”‹‡•ƒ†ƒ’’Ž‹…ƒ„‹Ž‹–›‘ˆ–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡
›‘ˆ–
to establish its scope.
When determining this scope, the organization shall consider:
r::
a) the external and internal issues referred to in 4.1Ǣ
b) the requirements of relevant interested parties referred
erre to in 4.2Ǣ
c) the products and services of the organization.
Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽƒ’’Ž›ƒŽŽ–Š‡”‡“—‹”‡‡–•‘ˆ–Š‹•–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†‹ˆ–Š‡›ƒ”‡ƒ’’Ž‹…ƒ„Ž‡
–•‘ˆ
ˆ– 
–‡”
–‡”
‡”ƒ
™‹–Š‹–Š‡†‡–‡”‹‡†•…‘’‡‘ˆ‹–•“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǥ
ƒ‰‡
‰‡ ›•–‡
–‡
Š‡ •…‘’‡ ‘ˆ –Š‡ ‘”‰ƒ‹œƒ–‹‘ǯ• “—ƒŽ‹–› ƒƒ‰‡‡–
ƒƒ‰‡
ƒ‰
ƒ •›•–‡
•› –‡ •ŠƒŽŽ „‡ ƒ˜ƒ‹Žƒ„Ž‡ ƒ† „‡ ƒ‹–ƒ‹‡† ƒ•
›•–‡
†‘…—‡–‡†‹ˆ‘”ƒ–‹‘ǤŠ‡•…‘’‡•ŠƒŽŽ•–ƒ–‡–Š‡–›’‡•‘ˆ’”‘†—…–•ƒ†•‡”˜‹…‡•…‘˜‡”‡†ǡƒ†’”‘˜‹†‡
•––ƒ–‡ ’‡•
‡•• ‘
Œ—•–‹ϐ‹…ƒ–‹‘ˆ‘”ƒ›”‡“—‹”‡‡–‘ˆ–Š‹•–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†–Šƒ––Š‡‘”‰ƒ‹œƒ–‹‘†‡–‡”‹‡•‹•‘–
•–‡”” ƒŽ–
–
ƒ’’Ž‹…ƒ„Ž‡–‘–Š‡•…‘’‡‘ˆ‹–•“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǥ
ƒƒ‰‰‡ •›•––‡
‘ˆ‘”‹–›–‘–Š‹•–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†ƒ›‘Ž›„‡…Žƒ‹‡†‹ˆ–Š‡”‡“—‹”‡‡–•†‡–‡”‹‡†ƒ•‘–
–ƒ
ƒ†ƒ” › ‘Ž
›‘
„‡‹‰ƒ’’Ž‹…ƒ„Ž‡†‘‘–ƒˆˆ‡…––Š‡‘”‰ƒ‹œƒ–‹‘ǯ•ƒ„‹Ž‹–›‘””‡•’‘•‹„‹Ž‹–›–‘‡•—”‡–Š‡…‘ˆ‘”‹–›‘ˆ‹–•
‘”‰ƒ
‘”‰ ‹‘ǯ•ƒ
‘ ƒ„
products and services and the enhancement
nha customer satisfaction.
ntt of cu

4.4 Quality management

ntt system
ssy and
nd its processes

4.4.1 Š‡ ‘”‰ƒ‹œƒ–‹‘‘ •ŠƒŽŽ

•
•Š ‡•–ƒ„Ž‹•Šǡ
•–
•–ƒ„Ž‹ ‹’Ž‡‡–ǡ ƒ‹–ƒ‹ ƒ† …‘–‹—ƒŽŽ› ‹’”‘˜‡ ƒ “—ƒŽ‹–›
ƒƒ‰‡‡– •›•–‡ǡ ‹‹…Ž—†‹‰
‹…Ž
…Ž— –Š‡
–Š‡
–Š
Š‡ ’’”‘…‡••‡• ‡‡†‡† ƒ† –Š‡‹” ‹–‡”ƒ…–‹‘•ǡ ‹ ƒ……‘”†ƒ…‡ ™‹–Š –Š‡
requirements of this International
is Inte
ter onall SStandard.
nal

Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ†‡–‡”‹‡–Š‡’”‘…‡••‡•‡‡†‡†ˆ‘”–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡ƒ†–Š‡‹”
•ŠƒŽ ”‹‹
application throughout the organization, and shall:
ƒȌ †‡–‡”‹‡–Š‡‹’—–•”‡“—‹”‡†ƒ†–Š‡‘—–’—–•‡š’‡…–‡†ˆ”‘–Š‡•‡’”‘…‡••‡•Ǣ
„Ȍ †‡–‡”‹‡–Š‡•‡“—‡…‡ƒ†‹–‡”ƒ…–‹‘‘ˆ–Š‡•‡’”‘…‡••‡•Ǣ
…Ȍ †‡–‡”‹‡ƒ†ƒ’’Ž›–Š‡…”‹–‡”‹ƒƒ†‡–Š‘†•ȋ‹…Ž—†‹‰‘‹–‘”‹‰ǡ‡ƒ•—”‡‡–•ƒ†”‡Žƒ–‡†
’‡”ˆ‘”ƒ…‡‹†‹…ƒ–‘”•Ȍ‡‡†‡†–‘‡•—”‡–Š‡‡ˆˆ‡…–‹˜‡‘’‡”ƒ–‹‘ƒ†…‘–”‘Ž‘ˆ–Š‡•‡’”‘…‡••‡•Ǣ
†Ȍ †‡–‡”‹‡–Š‡”‡•‘—”…‡•‡‡†‡†ˆ‘”–Š‡•‡’”‘…‡••‡•ƒ†‡•—”‡–Š‡‹”ƒ˜ƒ‹Žƒ„‹Ž‹–›Ǣ
‡Ȍ ƒ••‹‰–Š‡”‡•’‘•‹„‹Ž‹–‹‡•ƒ†ƒ—–Š‘”‹–‹‡•ˆ‘”–Š‡•‡’”‘…‡••‡•Ǣ
f) address the risks and opportunities as determined in accordance with the requirements of 6.1Ǣ
‰Ȍ ‡˜ƒŽ—ƒ–‡–Š‡•‡’”‘…‡••‡•ƒ†‹’Ž‡‡–ƒ›…Šƒ‰‡•‡‡†‡†–‘‡•—”‡–Šƒ––Š‡•‡’”‘…‡••‡•ƒ…Š‹‡˜‡
–Š‡‹”‹–‡†‡†”‡•—Ž–•Ǣ
2
 IS/ISO 9001 : 2015

ŠȌ ‹’”‘˜‡–Š‡’”‘…‡••‡•ƒ†–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǥ

4.4.2 ‘–Š‡‡š–‡–‡…‡••ƒ”›ǡ–Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽǣ

ƒȌ ƒ‹–ƒ‹†‘…—‡–‡†‹ˆ‘”ƒ–‹‘–‘•—’’‘”––Š‡‘’‡”ƒ–‹‘‘ˆ‹–•’”‘…‡••‡•Ǣ
„Ȍ ”‡–ƒ‹ †‘…—‡–‡† ‹ˆ‘”ƒ–‹‘ –‘ Šƒ˜‡ …‘ϐ‹†‡…‡ –Šƒ– –Š‡ ’”‘…‡••‡• ƒ”‡ „‡‹‰ …ƒ””‹‡† ‘—– ƒ•
planned.

5 Leadership

5.1 Leadership and commitment

5.1.1 General

‘’ ƒƒ‰‡‡– •ŠƒŽŽ †‡‘•–”ƒ–‡ Ž‡ƒ†‡”•Š‹’ ƒ†

† …‘‹–‡–
…‘ ™‹–Š ”‡•’‡…– –‘ –Š‡ “—ƒŽ‹–›
ƒƒ‰‡‡–•›•–‡„›ǣ
ƒȌ –ƒ‹‰ƒ……‘—–ƒ„‹Ž‹–›ˆ‘”–Š‡‡ˆˆ‡…–‹˜‡‡••‘ˆ–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǣ
Š‡‡“—ƒ
“
„Ȍ ‡•—”‹‰–Šƒ––Š‡“—ƒŽ‹–›’‘Ž‹…›ƒ†“—ƒŽ‹–›‘„Œ‡…–‹˜‡•ƒ”‡‡•–ƒ„Ž‹•Š‡†ˆ‘”–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–
›
›‘„Œ‡ ƒ”‡‡
•›•–‡ƒ†ƒ”‡…‘’ƒ–‹„Ž‡™‹–Š–Š‡…‘–‡š–ƒ†•–”ƒ–‡‰‹…†‹”‡…–‹‘‘ˆ–Š‡‘”‰ƒ‹œƒ–‹‘Ǣ
‡š–ƒ
ƒ† ‡‰‹…
‡‰‹…
…Ȍ ‡•—”‹‰–Š‡‹–‡‰”ƒ–‹‘‘ˆ–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡”‡“—‹”‡‡–•‹–‘–Š‡‘”‰ƒ‹œƒ–‹‘ǯ•
›ƒ
› ƒ ‡–
–•
„—•‹‡••’”‘…‡••‡•Ǣ
†Ȍ ’”‘‘–‹‰–Š‡—•‡‘ˆ–Š‡’”‘…‡••ƒ’’”‘ƒ…Šƒ†”‹•Ǧ„ƒ•‡†–Š‹‹‰Ǣ
ƒ’’”‘
ƒ’ ƒ†”‹‹
‡Ȍ ‡•—”‹‰–Šƒ––Š‡”‡•‘—”…‡•‡‡†‡†ˆ‘”–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡ƒ”‡ƒ˜ƒ‹Žƒ„Ž‡Ǣ
‡‡‡†‡† ‡“—
“—
—ƒ
ˆȌ …‘—‹…ƒ–‹‰–Š‡‹’‘”–ƒ…‡‘ˆ‡ˆˆ‡…–‹˜‡“—ƒŽ‹–›ƒƒ‰‡‡–ƒ†‘ˆ…‘ˆ‘”‹‰–‘–Š‡“—ƒŽ‹–›
–ƒ…‡
…‡ ‡…–‹˜
‹˜‡
ƒƒ‰‡‡–•›•–‡”‡“—‹”‡‡–•Ǣ
—‹”‡
”‡
‰Ȍ ‡•—”‹‰–Šƒ––Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡ƒ…Š‹‡˜‡•‹–•‹–‡†‡†”‡•—Ž–•Ǣ
‹–›
–› ‰‡‡
‡–
–
ŠȌ ‡‰ƒ‰‹‰ǡ †‹”‡…–‹‰ ƒ†
† •—’’‘”–‹‰
‰ ƒƒ ”–‹‰ ’‡”•‘• –‘ …‘–”‹„—–‡ –‘ –Š‡ ‡ˆˆ‡…–‹˜‡‡•• ‘ˆ –Š‡ “—ƒŽ‹–›
’‘”–
ƒƒ‰‡‡–•›•–‡Ǣ
–‡
‹Ȍ ’”‘‘–‹‰‹’”‘˜‡‡–Ǣ
’”‘
”‘˜‡
‘˜
ŒȌ •—’’‘”–‹‰‘–Š‡””‡Ž‡˜ƒ–ƒƒ‰‡‡–”‘Ž‡•–‘†‡‘•–”ƒ–‡–Š‡‹”Ž‡ƒ†‡”•Š‹’ƒ•‹–ƒ’’Ž‹‡•–‘–Š‡‹”
‘–Š‡ ˜ƒ–
ƒ–
ƒ”‡ƒ•‘ˆ”‡•’‘•‹„‹Ž‹–›Ǥ
‡•’
•’
•’‘ Ž‹–›Ǥ
›Ǥ
 ‡
‡ˆ‡”‡…‡
‡”‡
” –‘
‘ Dz„—
Dz„—•‹‡••dz
„—
—•‹ ‹ –Š‹• –‡”ƒ–‹‘ƒŽ –ƒ†ƒ”† …ƒ „‡ ‹–‡”’”‡–‡† „”‘ƒ†Ž› –‘ ‡ƒ –Š‘•‡
activities thatt are
a core too the
th purposes of the organization’s existence, whether the organization is public, private,
ˆ‘”’”‘ϐ‹–‘”‘–ˆ‘”’”‘ϐ‹–Ǥ

5.1.2 Customer focus

‘’ ƒƒ‰‡‡– •ŠƒŽŽ †‡‘•–”ƒ–‡ Ž‡ƒ†‡”•Š‹’ ƒ† …‘‹–‡– ™‹–Š ”‡•’‡…– –‘ …—•–‘‡” ˆ‘…—• „›
ensuring that:
ƒȌ …—•–‘‡”ƒ†ƒ’’Ž‹…ƒ„Ž‡•–ƒ–—–‘”›ƒ†”‡‰—Žƒ–‘”›”‡“—‹”‡‡–•ƒ”‡†‡–‡”‹‡†ǡ—†‡”•–‘‘†ƒ†
…‘•‹•–‡–Ž›‡–Ǣ
„Ȍ –Š‡”‹••ƒ†‘’’‘”–—‹–‹‡•–Šƒ–…ƒƒˆˆ‡…–…‘ˆ‘”‹–›‘ˆ’”‘†—…–•ƒ†•‡”˜‹…‡•ƒ†–Š‡ƒ„‹Ž‹–›–‘
‡Šƒ…‡…—•–‘‡”•ƒ–‹•ˆƒ…–‹‘ƒ”‡†‡–‡”‹‡†ƒ†ƒ††”‡••‡†Ǣ
c) the focus on enhancing customer satisfaction is maintained.

3
IS/ISO 9001 : 2015

5.2 Policy

5.2.1 Establishing the quality policy

‘’ƒƒ‰‡‡–•ŠƒŽŽ‡•–ƒ„Ž‹•Šǡ‹’Ž‡‡–ƒ†ƒ‹–ƒ‹ƒ“—ƒŽ‹–›’‘Ž‹…›–Šƒ–ǣ
ƒȌ ‹•ƒ’’”‘’”‹ƒ–‡–‘–Š‡’—”’‘•‡ƒ†…‘–‡š–‘ˆ–Š‡‘”‰ƒ‹œƒ–‹‘ƒ†•—’’‘”–•‹–••–”ƒ–‡‰‹…†‹”‡…–‹‘Ǣ
„Ȍ ’”‘˜‹†‡•ƒˆ”ƒ‡™‘”ˆ‘”•‡––‹‰“—ƒŽ‹–›‘„Œ‡…–‹˜‡•Ǣ
…Ȍ ‹…Ž—†‡•ƒ…‘‹–‡––‘•ƒ–‹•ˆ›ƒ’’Ž‹…ƒ„Ž‡”‡“—‹”‡‡–•Ǣ
†Ȍ ‹…Ž—†‡•ƒ…‘‹–‡––‘…‘–‹—ƒŽ‹’”‘˜‡‡–‘ˆ–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǥ
ƒƒ

5.2.2 Communicating the quality policy

Š‡“—ƒŽ‹–›’‘Ž‹…›•ŠƒŽŽǣ
ƒȌ „‡ƒ˜ƒ‹Žƒ„Ž‡ƒ†„‡ƒ‹–ƒ‹‡†ƒ•†‘…—‡–‡†‹ˆ‘”ƒ–‹‘Ǣ
‹‘
‘Ǣ
„Ȍ „‡…‘—‹…ƒ–‡†ǡ—†‡”•–‘‘†ƒ†ƒ’’Ž‹‡†™‹–Š‹–Š‡‘”‰ƒ‹œƒ–‹‘Ǣ
‡‘
‘”‰ƒ
‘”‰
c) be available to relevant interested parties, as appropriate.
opria

ͷǤ͵ ”‰ƒ‹œƒ–‹‘ƒŽ”‘Ž‡•ǡ”‡•’‘•‹„‹Ž‹–‹‡•ƒ†ƒ—–Š‘”‹–‹‡•
ƒ†
† ƒ—
ƒ –‹‡•
Top management shall ensure that the responsibilities
sibi
ibilitie and
d authorities
aau
ut
uth for relevant roles are assigned,
communicated and understood within the organization.
ganiza
ga
‘’ƒƒ‰‡‡–•ŠƒŽŽƒ••‹‰–Š‡”‡•’‘•‹„‹Ž‹–›ƒ†ƒ—–Š‘”‹–›ˆ‘”ǣ
„‹Ž‹–›
–› —–Š
–Š‘
ƒȌ ‡•—”‹‰ –Šƒ– –Š‡ “—ƒŽ‹–› ƒƒ‰‡‡–
ƒ‰
ƒ‰‡ •›•–‡
•›•
›•–‡ …‘ˆ‘”• –‘ –Š‡ ”‡“—‹”‡‡–• ‘ˆ –Š‹•
–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†Ǣ
„Ȍ ‡•—”‹‰–Šƒ––Š‡’”‘…‡••‡•ƒ”‡†‡Ž‹˜‡”‹‰–Š‡‹”‹–‡†‡†‘—–’—–•Ǣ
”‡†
†‡Ž‹ ‰––Š‡
…Ȍ ”‡’‘”–‹‰ ‘ –Š‡ ’‡”ˆ‘”ƒ…‡
ƒ… ‘ˆ –Š‡ “—ƒŽ‹–› ƒƒ‰‡‡– •›•–‡ ƒ† ‘ ‘’’‘”–—‹–‹‡• ˆ‘”
Š‡‡ “—ƒ
“—
improvement (see 10.1Ȍǡ‹’ƒ”–‹…—Žƒ”–‘–‘’ƒƒ‰‡‡–Ǣ
‹’ƒ”
ƒ”– ”–‘
–‘
‘–
†Ȍ ‡•—”‹‰–Š‡’”‘‘–‹‘‘ˆ…—•–‘‡”ˆ‘…—•–Š”‘—‰Š‘—––Š‡‘”‰ƒ‹œƒ–‹‘Ǣ
‘
‘ˆ
‘ˆˆ … ‡”ˆ
‡” ˆ
‡Ȍ ‡•—”‹‰–Šƒ––Š‡‹–‡‰”‹–›‘ˆ–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡‹•ƒ‹–ƒ‹‡†™Š‡…Šƒ‰‡•–‘–Š‡
–‡‰
‡‰” ˆ –Š‡“
–Š
“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡ƒ”‡’Žƒ‡†ƒ†‹’Ž‡‡–‡†Ǥ
‡–
–– • ƒ”‡
ƒ ’
ƒ”‡

6 Planning

6.1 Actions to address risks and opportunities

6.1.1 Š‡ ’Žƒ‹‰ ˆ‘” –Š‡ “—ƒŽ‹–› ƒƒ‰‡‡– •›•–‡ǡ –Š‡ ‘”‰ƒ‹œƒ–‹‘ •ŠƒŽŽ …‘•‹†‡” –Š‡ ‹••—‡•
referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that
need to be addressed to:

ƒȌ ‰‹˜‡ƒ••—”ƒ…‡–Šƒ––Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡…ƒƒ…Š‹‡˜‡‹–•‹–‡†‡†”‡•—Ž–ȋ•ȌǢ
„Ȍ ‡Šƒ…‡†‡•‹”ƒ„Ž‡‡ˆˆ‡…–•Ǣ
…Ȍ ’”‡˜‡–ǡ‘””‡†—…‡ǡ—†‡•‹”‡†‡ˆˆ‡…–•Ǣ
d) achieve improvement.

4
 IS/ISO 9001 : 2015

6.1.2 The organization shall plan:

ƒȌ ƒ…–‹‘•–‘ƒ††”‡••–Š‡•‡”‹••ƒ†‘’’‘”–—‹–‹‡•Ǣ
b) how to:
ͳȌ ‹–‡‰”ƒ–‡ƒ†‹’Ž‡‡––Š‡ƒ…–‹‘•‹–‘‹–•“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡’”‘…‡••‡•ȋ•‡‡4.4ȌǢ
2) evaluate the effectiveness of these actions.
Actions taken to address risks and opportunities shall be proportionate to the potential impact on the
…‘ˆ‘”‹–›‘ˆ’”‘†—…–•ƒ†•‡”˜‹…‡•Ǥ
ͳ ’–‹‘• –‘ ƒ††”‡•• ”‹•• …ƒ ‹…Ž—†‡ ƒ˜‘‹†‹‰ ”‹•ǡ –ƒ‹‰
‰
‰ ”‹•
”‹ ‹ ‘”†‡” –‘ ’—”•—‡ ƒ ‘’’‘”–—‹–›ǡ
‡…
…‡•ǡ
…‡•ǡ •Šƒ”‹‰ –Š‡ ”‹•ǡ ‘” ”‡–ƒ‹‹‰ ”‹• „›
‡Ž‹‹ƒ–‹‰ –Š‡ ”‹• •‘—”…‡ǡ …Šƒ‰‹‰ –Š‡ Ž‹‡Ž‹Š‘‘† ‘” …‘•‡“—‡…‡•ǡ
informed decision.

NOTE 2 pract ice launching new products, opening new

Opportunities can lead to the adoption of new practices,
—•‹
•‹‰
ƒ”‡–•ǡƒ††”‡••‹‰‡™…—•–‘‡”•ǡ„—‹Ž†‹‰’ƒ”–‡”•Š‹’•ǡ—•‹‰‡™–‡…Š‘Ž‘‰›ƒ†‘–Š‡”†‡•‹”ƒ„Ž‡ƒ†˜‹ƒ„Ž‡
possibilities to address the organization’s or its customers’ n
needs
needs.

6.2 Quality objectives and planning to achieve

hieve them

6.2.1 Š‡ ‘”‰ƒ‹œƒ–‹‘ •ŠƒŽŽ ‡•–ƒ„Ž‹•Š “—ƒŽ‹–›

Ž‹–› ‘„Œ‡…–‹˜‡•
‘„Œ • ƒ–
ƒ– ”‡Ž‡˜ƒ– ˆ—…–‹‘•ǡ Ž‡˜‡Ž• ƒ† ’”‘…‡••‡•
‡‡†‡†ˆ‘”–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǥ

Š‡“—ƒŽ‹–›‘„Œ‡…–‹˜‡••ŠƒŽŽǣ
ƒȌ „‡…‘•‹•–‡–™‹–Š–Š‡“—ƒŽ‹–›’‘Ž‹…›Ǣ
‘Ž‹…›Ǣ
Ž‹…›
„Ȍ „‡‡ƒ•—”ƒ„Ž‡Ǣ
…Ȍ –ƒ‡‹–‘ƒ……‘—–ƒ’’Ž‹…ƒ„Ž‡”‡“—‹”‡‡–•Ǣ
Ž‡”‡“
‡“— ‡–•Ǣ
•Ǣ
†Ȍ „‡”‡Ž‡˜ƒ––‘…‘ˆ‘”‹–›‘ˆ’”‘†—…–•ƒ†•‡”˜‹…‡•ƒ†–‘‡Šƒ…‡‡–‘ˆ…—•–‘‡”•ƒ–‹•ˆƒ…–‹‘Ǣ
‹–›
–›‘ˆ’
› …–•ƒ
–•
• ƒ
‡Ȍ „‡‘‹–‘”‡†Ǣ
ˆȌ „‡…‘—‹…ƒ–‡†Ǣ
†Ǣ
g) be updated as appropriate.
p
ppr e
e.
Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽƒ‹–ƒ‹†‘…—‡–‡†‹ˆ‘”ƒ–‹‘‘–Š‡“—ƒŽ‹–›‘„Œ‡…–‹˜‡•Ǥ
•Šƒ
Š –ƒ
–ƒ‹

6.2.2 Š‡’Žƒ‹‰Š‘™–‘ƒ…Š‹‡˜‡‹–•“—ƒŽ‹–›‘„Œ‡…–‹˜‡•ǡ–Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ†‡–‡”‹‡ǣ
‡
’
’Žƒ ‰Š‘™
Š‘™
Š‘

ƒȌ ™Šƒ–™‹ŽŽ„‡†‘‡Ǣ
ŽŽ
„Ȍ ™Šƒ–”‡•‘—”…‡•™‹ŽŽ„‡”‡“—‹”‡†Ǣ
…Ȍ ™Š‘™‹ŽŽ„‡”‡•’‘•‹„Ž‡Ǣ
†Ȍ ™Š‡‹–™‹ŽŽ„‡…‘’Ž‡–‡†Ǣ
e) how the results will be evaluated.

6.3 Planning of changes

Š‡–Š‡‘”‰ƒ‹œƒ–‹‘†‡–‡”‹‡•–Š‡‡‡†ˆ‘”…Šƒ‰‡•–‘–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡ǡ–Š‡…Šƒ‰‡•
shall be carried out in a planned manner (see 4.4).

5
IS/ISO 9001 : 2015

The organization shall consider:

ƒȌ –Š‡’—”’‘•‡‘ˆ–Š‡…Šƒ‰‡•ƒ†–Š‡‹”’‘–‡–‹ƒŽ…‘•‡“—‡…‡•Ǣ
„Ȍ –Š‡‹–‡‰”‹–›‘ˆ–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǣ
…Ȍ –Š‡ƒ˜ƒ‹Žƒ„‹Ž‹–›‘ˆ”‡•‘—”…‡•Ǣ
d) the allocation or reallocation of responsibilities and authorities.

7 Support

7.1 Resources

7.1.1 General

The organization shall determine and provide the resources rces needed for the establishment,
ource
‹’Ž‡‡–ƒ–‹‘ǡƒ‹–‡ƒ…‡ƒ†…‘–‹—ƒŽ‹’”‘˜‡‡–‘ˆ–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǥ
–Š‡
–Š‡“—
The organization shall consider:
ƒȌ –Š‡…ƒ’ƒ„‹Ž‹–‹‡•‘ˆǡƒ†…‘•–”ƒ‹–•‘ǡ‡š‹•–‹‰‹–‡”ƒŽ”‡•‘—”…‡•Ǣ
–‡””ƒŽ ”…‡
…‡•Ǣ
b) what needs to be obtained from external providers.
iders
derrs

7.1.2 People

Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ†‡–‡”‹‡ƒ†’”‘˜‹†‡–Š‡’‡”•‘•‡…‡••ƒ”›ˆ‘”–Š‡‡ˆˆ‡…–‹˜‡‹’Ž‡‡–ƒ–‹‘
†‡–Š‡
†‡ •‘‘•
• 
‘ˆ‹–•“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡ƒ†ˆ‘”–Š‡‘’‡”ƒ–‹‘ƒ†…‘–”‘Ž‘ˆ‹–•’”‘…‡••‡•Ǥ
Š‡‘’
‘’ ‘ƒ
ƒƒ


7.1.3 Infrastructure

Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ†‡–‡”‹‡ǡ’”‘˜‹†‡ƒ†ƒ‹–ƒ‹–Š‡‹ˆ”ƒ•–”—…–—”‡‡…‡••ƒ”›ˆ‘”–Š‡‘’‡”ƒ–‹‘
’”‘
’””‘˜‹† ƒ
ƒ‹
‘ˆ‹–•’”‘…‡••‡•ƒ†–‘ƒ…Š‹‡˜‡…‘ˆ‘”‹–›‘ˆ’”‘†—…–•ƒ†•‡”˜‹…‡•Ǥ
ˆ‘”
ˆ‘ ‘ˆ’”‘†
’”‘†—
NOTE Infrastructure can include:
lude
de:

ƒȌ„—‹Ž†‹‰•ƒ†ƒ••‘…‹ƒ–‡†—–‹Ž‹–‹‡•Ǣ
—–‹Ž‹–
–‹ŽŽ‹–‹‡
‹–‹

„Ȍ‡“—‹’‡–ǡ‹…Ž—†‹‰Šƒ”†™ƒ”‡ƒ†•‘ˆ–™ƒ”‡Ǣ
ƒ”†
”†™ †•‘ˆ

…Ȍ–”ƒ•’‘”–ƒ–‹‘”‡•‘—”…‡•Ǣ
‘—””…
”…‡

†Ȍ‹ˆ‘”ƒ–‹‘ƒ†…‘—‹…ƒ–‹‘–‡…Š‘Ž‘‰›Ǥ
†…‘
‘ ƒ–– ‹‘
‘
 –‡

7.1.4 Environment for the operation of processes

Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ†‡–‡”‹‡ǡ’”‘˜‹†‡ƒ†ƒ‹–ƒ‹–Š‡‡˜‹”‘‡–‡…‡••ƒ”›ˆ‘”–Š‡‘’‡”ƒ–‹‘
‘ˆ‹–•’”‘…‡••‡•ƒ†–‘ƒ…Š‹‡˜‡…‘ˆ‘”‹–›‘ˆ’”‘†—…–•ƒ†•‡”˜‹…‡•Ǥ
 •—‹–ƒ„Ž‡‡˜‹”‘‡–…ƒ„‡ƒ…‘„‹ƒ–‹‘‘ˆŠ—ƒƒ†’Š›•‹…ƒŽˆƒ…–‘”•ǡ•—…Šƒ•ǣ

ƒȌ•‘…‹ƒŽȋ‡Ǥ‰Ǥ‘Ǧ†‹•…”‹‹ƒ–‘”›ǡ…ƒŽǡ‘Ǧ…‘ˆ”‘–ƒ–‹‘ƒŽȌǢ

„Ȍ’•›…Š‘Ž‘‰‹…ƒŽȋ‡Ǥ‰Ǥ•–”‡••Ǧ”‡†—…‹‰ǡ„—”‘—–’”‡˜‡–‹‘ǡ‡‘–‹‘ƒŽŽ›’”‘–‡…–‹˜‡ȌǢ

…Ȍ’Š›•‹…ƒŽȋ‡Ǥ‰Ǥ–‡’‡”ƒ–—”‡ǡŠ‡ƒ–ǡŠ—‹†‹–›ǡŽ‹‰Š–ǡƒ‹”ϐŽ‘™ǡŠ›‰‹‡‡ǡ‘‹•‡ȌǤ

Š‡•‡ˆƒ…–‘”•…ƒ†‹ˆˆ‡”•—„•–ƒ–‹ƒŽŽ›†‡’‡†‹‰‘–Š‡’”‘†—…–•ƒ†•‡”˜‹…‡•’”‘˜‹†‡†Ǥ

6
 IS/ISO 9001 : 2015

7.1.5 Monitoring and measuring resources

7.1.5.1 General

The organization shall determine and provide the resources needed to ensure valid and reliable
”‡•—Ž–• ™Š‡ ‘‹–‘”‹‰ ‘” ‡ƒ•—”‹‰ ‹• —•‡† –‘ ˜‡”‹ˆ› –Š‡ …‘ˆ‘”‹–› ‘ˆ ’”‘†—…–• ƒ† •‡”˜‹…‡• –‘
requirements.
The organization shall ensure that the resources provided:
ƒȌ ƒ”‡•—‹–ƒ„Ž‡ˆ‘”–Š‡•’‡…‹ϐ‹…–›’‡‘ˆ‘‹–‘”‹‰ƒ†‡ƒ•—”‡‡–ƒ…–‹˜‹–‹‡•„‡‹‰—†‡”–ƒ‡Ǣ
„Ȍ ƒ”‡ƒ‹–ƒ‹‡†–‘‡•—”‡–Š‡‹”…‘–‹—‹‰ϐ‹–‡••ˆ‘”–Š‡‹”’—”’‘•‡Ǥ
’—”’
—”
Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ”‡–ƒ‹ƒ’’”‘’”‹ƒ–‡†‘…—‡–‡†‹ˆ‘”ƒ–‹‘ƒ•‡˜‹†‡…‡‘ˆϐ‹–‡••ˆ‘”’—”’‘•‡‘ˆ
ƒ–‹‘
‘
the monitoring and measurement resources.

7.1.5.2 Measurement traceability

Š‡‡ƒ•—”‡‡––”ƒ…‡ƒ„‹Ž‹–›‹•ƒ”‡“—‹”‡‡–ǡ‘”‹•…‘•‹†‡”‡†„›–Š‡‘”‰ƒ‹œƒ–‹‘–‘„‡ƒ‡••‡–‹ƒŽ
”‹•…‘
‹•…‘
’ƒ”–‘ˆ’”‘˜‹†‹‰…‘ϐ‹†‡…‡‹–Š‡˜ƒŽ‹†‹–›‘ˆ‡ƒ•—”‡‡–”‡•—Ž–•ǡ‡ƒ•—”‹‰‡“—‹’‡–•ŠƒŽŽ„‡ǣ
ƒ•—
—”‡
ƒȌ …ƒŽ‹„”ƒ–‡†‘”˜‡”‹ϐ‹‡†ǡ‘”„‘–Šǡƒ–•’‡…‹ϐ‹‡†‹–‡”˜ƒŽ•ǡ‘”’”‹‘”–‘—•‡ǡƒ‰ƒ‹•–‡ƒ•—”‡‡–•–ƒ†ƒ”†•
–
–‡”˜ ”’”
’
’”‹‘”
–”ƒ…‡ƒ„Ž‡–‘‹–‡”ƒ–‹‘ƒŽ‘”ƒ–‹‘ƒŽ‡ƒ•—”‡‡–•–ƒ†ƒ”†•Ǣ™Š‡‘•—…Š•–ƒ†ƒ”†•‡š‹•–ǡ–Š‡
‡ƒ•—” •–ƒ
–ƒ
„ƒ•‹•—•‡†ˆ‘”…ƒŽ‹„”ƒ–‹‘‘”˜‡”‹ϐ‹…ƒ–‹‘•ŠƒŽŽ„‡”‡–ƒ‹‡†ƒ•†‘…—‡–‡†‹ˆ‘”ƒ–‹‘Ǣ
•Š Ž
•Šƒ ƒ‹‡
„Ȍ ‹†‡–‹ϐ‹‡†‹‘”†‡”–‘†‡–‡”‹‡–Š‡‹”•–ƒ–—•Ǣ
‹”•
”•–ƒ–
…Ȍ •ƒˆ‡‰—ƒ”†‡† ˆ”‘ ƒ†Œ—•–‡–•ǡ †ƒ
†ƒƒ‰‡ ‘”
†ƒƒ †‡–‡”‹‘”ƒ–‹‘ –Šƒ– ™‘—Ž† ‹˜ƒŽ‹†ƒ–‡ –Š‡ …ƒŽ‹„”ƒ–‹‘
” †‡
†‡–‡
status and subsequent measurement
emen nt results.
lts.
s
Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ†‡–‡”‹‡‹ˆ–Š‡˜ƒŽ‹†‹–›‘ˆ’”‡˜‹‘—•‡ƒ•—”‡‡–”‡•—Ž–•Šƒ•„‡‡ƒ†˜‡”•‡Ž›
‡
‡‹ˆ– Ž‹†
‹†‹–›
ƒˆˆ‡…–‡† ™Š‡ ‡ƒ•—”‹‰ ‡“—‹’‡–
—‹’‡ ‹• ˆ‘—
“— ˆ‘—† –‘ „‡ —ϐ‹– ˆ‘” ‹–• ‹–‡†‡† ’—”’‘•‡ǡ ƒ† •ŠƒŽŽ –ƒ‡
ˆ‘
ˆ‘—
ƒ’’”‘’”‹ƒ–‡ƒ…–‹‘ƒ•‡…‡••ƒ”›Ǥ
ƒ”›Ǥ

7.1.6 Organizational knowledge

kno e

Š‡ ‘”‰ƒ‹œƒ–‹‘ •ŠƒŽŽ

ƒŽŽ †‡–‡”‹‡
ŽŽ † – ‡‡ –Š‡
–Š ‘™Ž‡†‰‡ ‡…‡••ƒ”› ˆ‘” –Š‡ ‘’‡”ƒ–‹‘ ‘ˆ ‹–• ’”‘…‡••‡• ƒ† –‘
ƒ…Š‹‡˜‡…‘ˆ‘”‹–›‘ˆ’”‘†—…–•ƒ†•‡”˜‹…‡•Ǥ
‘ˆ
‘ˆ’
ˆ ’”
’”‘ •ƒ
ƒ††
Š‹•‘™Ž‡†‰‡•ŠƒŽŽ„‡ƒ‹–ƒ‹‡†ƒ†„‡ƒ†‡ƒ˜ƒ‹Žƒ„Ž‡–‘–Š‡‡š–‡–‡…‡••ƒ”›Ǥ
•ŠƒŽ
ŠƒŽŽ ‹–ƒ‹
When addressingn changing
sin
ing ging needs and trends, the organization shall consider its current knowledge
nging
ƒ††‡–‡”‹‡Š‘™–‘ƒ…“—‹”‡‘”ƒ……‡••ƒ›‡…‡••ƒ”›ƒ††‹–‹‘ƒŽ‘™Ž‡†‰‡ƒ†”‡“—‹”‡†—’†ƒ–‡•Ǥ
‹
‡Š
‡ Š‘ ƒ…“—
…“
“—‹
ͳ ”‰ƒ‹œƒ–‹‘ƒŽŽ ‘™Ž‡†‰‡ ‹• ‘™Ž‡†‰‡ •’‡…‹ϐ‹… –‘ –Š‡ ‘”‰ƒ‹œƒ–‹‘Ǣ ‹– ‹• ‰‡‡”ƒŽŽ› ‰ƒ‹‡† „›
‡š’‡”‹‡…‡Ǥ–‹•‹ˆ‘”ƒ–‹‘–Šƒ–‹•—•‡†ƒ†•Šƒ”‡†–‘ƒ…Š‹‡˜‡–Š‡‘”‰ƒ‹œƒ–‹‘ǯ•‘„Œ‡…–‹˜‡•Ǥ

NOTE 2 Organizational knowledge can be based on:

ƒȌ   ‹–‡”ƒŽ •‘—”…‡• ȋ‡Ǥ‰Ǥ ‹–‡ŽŽ‡…–—ƒŽ ’”‘’‡”–›Ǣ ‘™Ž‡†‰‡ ‰ƒ‹‡† ˆ”‘ ‡š’‡”‹‡…‡Ǣ Ž‡••‘• Ž‡ƒ”‡† ˆ”‘
ˆƒ‹Ž—”‡•ƒ†•—……‡••ˆ—Ž’”‘Œ‡…–•Ǣ…ƒ’–—”‹‰ƒ†•Šƒ”‹‰—†‘…—‡–‡†‘™Ž‡†‰‡ƒ†‡š’‡”‹‡…‡Ǣ–Š‡”‡•—Ž–•‘ˆ
‹’”‘˜‡‡–•‹’”‘…‡••‡•ǡ’”‘†—…–•ƒ†•‡”˜‹…‡•ȌǢ

„Ȍ   ‡š–‡”ƒŽ •‘—”…‡• ȋ‡Ǥ‰Ǥ •–ƒ†ƒ”†•Ǣ ƒ…ƒ†‡‹ƒǢ …‘ˆ‡”‡…‡•Ǣ ‰ƒ–Š‡”‹‰ ‘™Ž‡†‰‡ ˆ”‘ …—•–‘‡”• ‘”
external providers).

7
IS/ISO 9001 : 2015

7.2 Competence
The organization shall:
ƒȌ †‡–‡”‹‡ –Š‡ ‡…‡••ƒ”› …‘’‡–‡…‡ ‘ˆ ’‡”•‘ȋ•Ȍ †‘‹‰ ™‘” —†‡” ‹–• …‘–”‘Ž –Šƒ– ƒˆˆ‡…–• –Š‡
’‡”ˆ‘”ƒ…‡ƒ†‡ˆˆ‡…–‹˜‡‡••‘ˆ–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǣ
b) ensure that these persons are competent on the basis of appropriate education, training, or
‡š’‡”‹‡…‡Ǣ
…Ȍ ™Š‡”‡ƒ’’Ž‹…ƒ„Ž‡ǡ–ƒ‡ƒ…–‹‘•–‘ƒ…“—‹”‡–Š‡‡…‡••ƒ”›…‘’‡–‡…‡ǡƒ†‡˜ƒŽ—ƒ–‡–Š‡‡ˆˆ‡…–‹˜‡‡••
‘ˆ–Š‡ƒ…–‹‘•–ƒ‡Ǣ
d) retain appropriate documented information as evidence of competence.
tenc
tence
NOTE Applicable actions can include, for example, the provision of training
rainin to, the mentoring of, or the re-
ˆ…‘
ƒ••‹‰‡–‘ˆ…—””‡–Ž›‡’Ž‘›‡†’‡”•‘•Ǣ‘”–Š‡Š‹”‹‰‘”…‘–”ƒ…–‹‰‘ˆ…‘’‡–‡–’‡”•‘•Ǥ

7.3 Awareness
The organization shall ensure that persons doing work under
nd
der th
the organization’s control are aware of:
ƒȌ –Š‡“—ƒŽ‹–›’‘Ž‹…›Ǣ
„Ȍ ”‡Ž‡˜ƒ–“—ƒŽ‹–›‘„Œ‡…–‹˜‡•Ǣ
‡“—ƒŽ
ƒŽ‹
ƒŽ‹– ƒƒ‰‡
ƒƒ
…Ȍ –Š‡‹”…‘–”‹„—–‹‘–‘–Š‡‡ˆˆ‡…–‹˜‡‡••‘ˆ–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡ǡ‹…Ž—†‹‰–Š‡„‡‡ϐ‹–•‘ˆ
‹’”‘˜‡†’‡”ˆ‘”ƒ…‡Ǣ
–Š‡
–Š‡“ ›
ƒ
ƒ
†Ȍ –Š‡‹’Ž‹…ƒ–‹‘•‘ˆ‘–…‘ˆ‘”‹‰™‹–Š–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡”‡“—‹”‡‡–•Ǥ

7.4 Communication
Š‡ ‘”‰ƒ‹œƒ–‹‘ •ŠƒŽŽ †‡–‡”‹‡ –Š‡ ‹
‹–‡”ƒŽ ƒ†
ƒ† ‡š–‡”ƒŽ …‘—‹…ƒ–‹‘• ”‡Ž‡˜ƒ– –‘ –Š‡ “—ƒŽ‹–›
ƒƒ‰‡‡–•›•–‡ǡ‹…Ž—†‹‰ǣ
ƒȌ ‘™Šƒ–‹–™‹ŽŽ…‘—‹…ƒ–‡Ǣ
‡ǢǢ
„Ȍ ™Š‡–‘…‘—‹…ƒ–‡Ǣ
—‹…
‹…ƒ
‹…
…Ȍ ™‹–Š™Š‘–‘…‘—‹…ƒ–‡Ǣ
ƒ–‡
ƒ–‡Ǣ
–‡Ǣ
†Ȍ Š‘™–‘…‘—‹…ƒ–‡Ǣ
e) who communicates.
caattes

7.5 Documented information

7.5.1 General

Š‡‘”‰ƒ‹œƒ–‹‘ǯ•“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡•ŠƒŽŽ‹…Ž—†‡ǣ
ƒȌ †‘…—‡–‡†‹ˆ‘”ƒ–‹‘”‡“—‹”‡†„›–Š‹•–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†Ǣ
„Ȍ †‘…—‡–‡†‹ˆ‘”ƒ–‹‘†‡–‡”‹‡†„›–Š‡‘”‰ƒ‹œƒ–‹‘ƒ•„‡‹‰‡…‡••ƒ”›ˆ‘”–Š‡‡ˆˆ‡…–‹˜‡‡••
‘ˆ–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǥ
 Š‡ ‡š–‡– ‘ˆ †‘…—‡–‡† ‹ˆ‘”ƒ–‹‘ ˆ‘” ƒ “—ƒŽ‹–› ƒƒ‰‡‡– •›•–‡ …ƒ †‹ˆˆ‡” ˆ”‘ ‘‡
organization to another due to:

Ȅ–Š‡•‹œ‡‘ˆ‘”‰ƒ‹œƒ–‹‘ƒ†‹–•–›’‡‘ˆƒ…–‹˜‹–‹‡•ǡ’”‘…‡••‡•ǡ’”‘†—…–•ƒ†•‡”˜‹…‡•Ǣ

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 IS/ISO 9001 : 2015

Ȅ–Š‡…‘’Ž‡š‹–›‘ˆ’”‘…‡••‡•ƒ†–Š‡‹”‹–‡”ƒ…–‹‘•Ǣ

— the competence of persons.

7.5.2 Creating and updating

When creating and updating documented information, the organization shall ensure appropriate:
ƒȌ ‹†‡–‹ϐ‹…ƒ–‹‘ƒ††‡•…”‹’–‹‘ȋ‡Ǥ‰Ǥƒ–‹–Ž‡ǡ†ƒ–‡ǡƒ—–Š‘”ǡ‘””‡ˆ‡”‡…‡—„‡”ȌǢ
„Ȍ ˆ‘”ƒ–ȋ‡Ǥ‰ǤŽƒ‰—ƒ‰‡ǡ•‘ˆ–™ƒ”‡˜‡”•‹‘ǡ‰”ƒ’Š‹…•Ȍƒ†‡†‹ƒȋ‡Ǥ‰Ǥ’ƒ’‡”ǡ‡Ž‡…–”‘‹…ȌǢ
…Ȍ ”‡˜‹‡™ƒ†ƒ’’”‘˜ƒŽˆ‘”•—‹–ƒ„‹Ž‹–›ƒ†ƒ†‡“—ƒ…›Ǥ

7.5.3 Control of documented information

7.5.3.1 ‘…—‡–‡†‹ˆ‘”ƒ–‹‘”‡“—‹”‡†„›–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡ƒ†„›–Š‹•–‡”ƒ–‹‘ƒŽ

›ƒ
Standard shall be controlled to ensure:

ƒȌ ‹–‹•ƒ˜ƒ‹Žƒ„Ž‡ƒ†•—‹–ƒ„Ž‡ˆ‘”—•‡ǡ™Š‡”‡ƒ†™Š‡‹–‹•‡‡†‡†Ǣ
Š‡ ‹–
Š‡‹–
„Ȍ ‹–‹•ƒ†‡“—ƒ–‡Ž›’”‘–‡…–‡†ȋ‡Ǥ‰Ǥˆ”‘Ž‘••‘ˆ…‘ϐ‹†‡–‹ƒŽ‹–›ǡ‹’”‘’‡”—•‡ǡ‘”Ž‘••‘ˆ‹–‡‰”‹–›ȌǤ
…‘ϐ‹
ϐ‹†‡ –›ǡ‹

7.5.3.2 For the control of documented information,

nfo
nfor
form he organization shall address the following
the
activities, as applicable:

ƒȌ †‹•–”‹„—–‹‘ǡƒ……‡••ǡ”‡–”‹‡˜ƒŽƒ†—•‡Ǣ
•‡Ǣ
„Ȍ •–‘”ƒ‰‡ƒ†’”‡•‡”˜ƒ–‹‘ǡ‹…Ž—†‹‰’”‡•‡”˜ƒ–‹‘‘ˆŽ‡‰‹„‹Ž‹–›Ǣ
†‹
‹‰’”
‰ ˜ƒ–
ƒ–‹‘
‘
…Ȍ …‘–”‘Ž‘ˆ…Šƒ‰‡•ȋ‡Ǥ‰Ǥ˜‡”•‹‘…‘–”‘ŽȌǢ
‘…‘
‘
d) retention and disposition.
n.
‘…—‡–‡†‹ˆ‘”ƒ–‹‘‘ˆ‡š–‡”ƒŽ‘”‹‰‹†‡–‡”‹‡†„›–Š‡‘”‰ƒ‹œƒ–‹‘–‘„‡‡…‡••ƒ”›ˆ‘”–Š‡
‘ˆ‡š–
‘ˆ ƒŽ‘”‹
‘”‹‰
”‹‰
’Žƒ‹‰ ƒ† ‘’‡”ƒ–‹‘ ‘ˆ –Š‡
–Š “—ƒŽ‹–›
–› ƒƒ‰‡‡–
Ž‹–›  •›•–‡ •ŠƒŽŽ „‡ ‹†‡–‹ϐ‹‡† ƒ• ƒ’’”‘’”‹ƒ–‡ǡ ƒ†
be controlled.
‘…—‡–‡† ‹ˆ‘”ƒ–‹‘
–‹‘ ”‡–ƒ‹‡†
ƒ–‹‘ † ƒƒ• ‡˜‹†‡…‡ ‘ˆ …‘ˆ‘”‹–› •ŠƒŽŽ „‡ ’”‘–‡…–‡† ˆ”‘ —‹–‡†‡†
‡†
alterations.
 ……‡••…ƒ‹’Ž›ƒ†‡…‹•‹‘”‡‰ƒ”†‹‰–Š‡’‡”‹••‹‘–‘˜‹‡™–Š‡†‘…—‡–‡†‹ˆ‘”ƒ–‹‘‘Ž›ǡ‘”
•……ƒ ƒ†‡
†‡…
ƒ
ƒ†ƒ
† ‘” –›
–›–‘
–‘
–Š‡’‡”‹••‹‘ƒ†ƒ—–Š‘”‹–›–‘˜‹‡™ƒ†…Šƒ‰‡–Š‡†‘…—‡–‡†‹ˆ‘”ƒ–‹‘Ǥ

8 Operation
atio

8.1 Operational planning and control

The organization shall plan, implement and control the processes (see 4.4) needed to meet the
requirements for the provision of products and services, and to implement the actions determined in
Clause 6ǡ„›ǣ
ƒȌ †‡–‡”‹‹‰–Š‡”‡“—‹”‡‡–•ˆ‘”–Š‡’”‘†—…–•ƒ†•‡”˜‹…‡•Ǣ
b) establishing criteria for:
ͳȌ –Š‡’”‘…‡••‡•Ǣ
ʹȌ –Š‡ƒ……‡’–ƒ…‡‘ˆ’”‘†—…–•ƒ†•‡”˜‹…‡•Ǣ
…Ȍ †‡–‡”‹‹‰–Š‡”‡•‘—”…‡•‡‡†‡†–‘ƒ…Š‹‡˜‡…‘ˆ‘”‹–›–‘–Š‡’”‘†—…–ƒ†•‡”˜‹…‡”‡“—‹”‡‡–•Ǣ
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IS/ISO 9001 : 2015

†Ȍ ‹’Ž‡‡–‹‰…‘–”‘Ž‘ˆ–Š‡’”‘…‡••‡•‹ƒ……‘”†ƒ…‡™‹–Š–Š‡…”‹–‡”‹ƒǢ
‡Ȍ †‡–‡”‹‹‰ǡƒ‹–ƒ‹‹‰ƒ†”‡–ƒ‹‹‰†‘…—‡–‡†‹ˆ‘”ƒ–‹‘–‘–Š‡‡š–‡–‡…‡••ƒ”›ǣ
ͳȌ –‘Šƒ˜‡…‘ϐ‹†‡…‡–Šƒ––Š‡’”‘…‡••‡•Šƒ˜‡„‡‡…ƒ””‹‡†‘—–ƒ•’Žƒ‡†Ǣ
ʹȌ –‘†‡‘•–”ƒ–‡–Š‡…‘ˆ‘”‹–›‘ˆ’”‘†—…–•ƒ†•‡”˜‹…‡•–‘–Š‡‹””‡“—‹”‡‡–•Ǥ
The output of this planning shall be suitable for the organization’s operations.
The organization shall control planned changes and review the consequences of unintended changes,
–ƒ‹‰ƒ…–‹‘–‘‹–‹‰ƒ–‡ƒ›ƒ†˜‡”•‡‡ˆˆ‡…–•ǡƒ•‡…‡••ƒ”›Ǥ
The organization shall ensure that outsourced processes are controlled
d (see
(se 8.4).

8.2 Requirements for products and services

8.2.1 Customer communication

Communication with customers shall include:

ƒȌ ’”‘˜‹†‹‰‹ˆ‘”ƒ–‹‘”‡Žƒ–‹‰–‘’”‘†—…–•ƒ†•‡”˜‹…‡•Ǣ
˜‹…
‹…‡•Ǣ
„Ȍ Šƒ†Ž‹‰‡“—‹”‹‡•ǡ…‘–”ƒ…–•‘”‘”†‡”•ǡ‹…Ž—†‹‰…Šƒ‰‡•Ǣ
‰…Šƒƒ
†—…
—…–•ƒ
…–• ”˜‹……‡
…Ȍ ‘„–ƒ‹‹‰…—•–‘‡”ˆ‡‡†„ƒ…”‡Žƒ–‹‰–‘’”‘†—…–•ƒ†•‡”˜‹…‡•ǡ‹…Ž—†‹‰…—•–‘‡”…‘’Žƒ‹–•Ǣ
†Ȍ Šƒ†Ž‹‰‘”…‘–”‘ŽŽ‹‰…—•–‘‡”’”‘’‡”–›Ǣ
‡Ȍ ‡•–ƒ„Ž‹•Š‹‰•’‡…‹ϐ‹…”‡“—‹”‡‡–•ˆ‘”…‘–‹‰‡…›ƒ…–‹‘•ǡ™Š‡”‡Ž‡˜ƒ–Ǥ
‘–
‘–‹‰ ›ƒƒ…–‹
…–‹‘

8.2.2 Determining the requirements

tss for products
p cts and
a services

When determining the requirements for the prod

nts fo products
ro and services to be offered to customers, the
organization shall ensure that:
ƒȌ –Š‡”‡“—‹”‡‡–•ˆ‘”–Š‡’”‘†—…–•ƒ†•‡”˜‹…‡•ƒ”‡†‡ϐ‹‡†ǡ‹…Ž—†‹‰ǣ
‘†— †••‡”˜
‡”˜‹…
ͳȌ ƒ›ƒ’’Ž‹…ƒ„Ž‡•–ƒ–—–‘”›ƒ†”‡‰—Žƒ–‘”›”‡“—‹”‡‡–•Ǣ
–‘”›
‘” ‡‰‰ —Žƒ–
—Žƒ
ʹȌ –Š‘•‡…‘•‹†‡”‡†‡…‡••ƒ”›„›–Š‡‘”‰ƒ‹œƒ–‹‘Ǣ
‡…
‡…
‡…‡ ›„›
„›–Š
›–
b) the organization can
an meet thee cla
n me claims
i for the products and services it offers.

8.2.3 Review of the

e requirements
r re
em en for products and services
me

8.2.3.1 Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ‡•—”‡–Šƒ–‹–Šƒ•–Š‡ƒ„‹Ž‹–›–‘‡‡––Š‡”‡“—‹”‡‡–•ˆ‘”’”‘†—…–•ƒ†
•‡”˜‹…‡•–‘„‡‘ˆˆ‡”‡†–‘…—•–‘‡”•ǤŠ‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ…‘†—…–ƒ”‡˜‹‡™„‡ˆ‘”‡…‘‹––‹‰–‘•—’’Ž›
products and services to a customer, to include:

ƒȌ ”‡“—‹”‡‡–• •’‡…‹ϐ‹‡† „› –Š‡ …—•–‘‡”ǡ ‹…Ž—†‹‰ –Š‡ ”‡“—‹”‡‡–• ˆ‘” †‡Ž‹˜‡”› ƒ† ’‘•–Ǧ
†‡Ž‹˜‡”›ƒ…–‹˜‹–‹‡•Ǣ
„Ȍ ”‡“—‹”‡‡–• ‘– •–ƒ–‡† „› –Š‡ …—•–‘‡”ǡ „—– ‡…‡••ƒ”› ˆ‘” –Š‡ •’‡…‹ϐ‹‡† ‘” ‹–‡†‡† —•‡ǡ ™Š‡
‘™Ǣ
…Ȍ ”‡“—‹”‡‡–••’‡…‹ϐ‹‡†„›–Š‡‘”‰ƒ‹œƒ–‹‘Ǣ
†Ȍ •–ƒ–—–‘”›ƒ†”‡‰—Žƒ–‘”›”‡“—‹”‡‡–•ƒ’’Ž‹…ƒ„Ž‡–‘–Š‡’”‘†—…–•ƒ†•‡”˜‹…‡•Ǣ
‡Ȍ …‘–”ƒ…–‘”‘”†‡””‡“—‹”‡‡–•†‹ˆˆ‡”‹‰ˆ”‘–Š‘•‡’”‡˜‹‘—•Ž›‡š’”‡••‡†Ǥ

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 IS/ISO 9001 : 2015

Š‡ ‘”‰ƒ‹œƒ–‹‘ •ŠƒŽŽ ‡•—”‡ –Šƒ– …‘–”ƒ…– ‘” ‘”†‡” ”‡“—‹”‡‡–• †‹ˆˆ‡”‹‰ ˆ”‘ –Š‘•‡ ’”‡˜‹‘—•Ž›
†‡ϐ‹‡†ƒ”‡”‡•‘Ž˜‡†Ǥ
Š‡ …—•–‘‡”ǯ• ”‡“—‹”‡‡–• •ŠƒŽŽ „‡ …‘ϐ‹”‡† „› –Š‡ ‘”‰ƒ‹œƒ–‹‘ „‡ˆ‘”‡ ƒ……‡’–ƒ…‡ǡ ™Š‡ –Š‡
customer does not provide a documented statement of their requirements.
NOTE In some situations, such as internet sales, a formal review is impractical for each order. Instead, the
review can cover relevant product information, such as catalogues.

8.2.3.2 The organization shall retain documented information, as applicable:

ƒȌ ‘–Š‡”‡•—Ž–•‘ˆ–Š‡”‡˜‹‡™Ǣ
„Ȍ ‘ƒ›‡™”‡“—‹”‡‡–•ˆ‘”–Š‡’”‘†—…–•ƒ†•‡”˜‹…‡•Ǥ

8.2.4 Changes to requirements for products and services

ces

The organization shall ensure that relevant documented

d information
nted in is amended, and that relevant
persons are made aware of the changed requirements,
ent when the requirements for products and
ents,
services are changed.

8.3 Design and development of productss and

d services
ices

8.3.1 General

The organization shall establish, implement

me and
ment a maintain
main
mai nta a design and development process that is
aint
appropriate to ensure the subsequent pr
provision
vis off prod
products
pro
ro and services.

8.3.2 Design and developmentt p

planning
plann

In determining the stages and controls

tro for desi
contr design
sig and development, the organization shall consider:
ƒȌ –Š‡ƒ–—”‡ǡ†—”ƒ–‹‘ƒ†…‘’Ž‡š‹–›‘ˆ–Š‡†‡•‹‰ƒ††‡˜‡Ž‘’‡–ƒ…–‹˜‹–‹‡•Ǣ
†…
†…‘’ ›‘ˆ
‘ˆ –Š
„Ȍ –Š‡”‡“—‹”‡†’”‘…‡•••–ƒ‰‡•ǡ‹…Ž—†‹‰ƒ’’Ž‹…ƒ„Ž‡†‡•‹‰ƒ††‡˜‡Ž‘’‡–”‡˜‹‡™•Ǣ
•–ƒƒ‰‡ Ž—†‹‰
—†‹
…Ȍ –Š‡”‡“—‹”‡††‡•‹‰ƒ††‡˜‡Ž‘’‡–˜‡”‹ϐ‹…ƒ–‹‘ƒ†˜ƒŽ‹†ƒ–‹‘ƒ…–‹˜‹–‹‡•Ǣ
‰ƒ Ž‘’
‘’
†Ȍ –Š‡”‡•’‘•‹„‹Ž‹–‹‡•ƒ†ƒ—–Š‘”‹–‹‡•‹˜‘Ž˜‡†‹–Š‡†‡•‹‰ƒ††‡˜‡Ž‘’‡–’”‘…‡••Ǣ
–‹‡
–‹‡• — Š‘
—–Š‘
‘”
‡Ȍ –Š‡‹–‡”ƒŽƒ†‡š–‡”ƒŽ”‡•‘—”…‡‡‡†•ˆ‘”–Š‡†‡•‹‰ƒ††‡˜‡Ž‘’‡–‘ˆ’”‘†—…–•ƒ†•‡”˜‹…‡•Ǣ
ƒ†
† ƒŽ
ƒŽ ”‡
ˆȌ –Š‡‡‡†–‘…‘–”‘Ž‹–‡”ˆƒ…‡•„‡–™‡‡’‡”•‘•‹˜‘Ž˜‡†‹–Š‡†‡•‹‰ƒ††‡˜‡Ž‘’‡–’”‘…‡••Ǣ
†–
†–‘… Ž‹
‹‹–‡
–‡”
–
‰Ȍ –Š‡‡‡†ˆ‘”‹˜‘Ž˜‡‡–‘ˆ…—•–‘‡”•ƒ†—•‡”•‹–Š‡†‡•‹‰ƒ††‡˜‡Ž‘’‡–’”‘…‡••Ǣ
‡†ˆ‘ Ž˜‡
ŠȌ –Š‡”‡“—‹”‡‡–•ˆ‘”•—„•‡“—‡–’”‘˜‹•‹‘‘ˆ’”‘†—…–•ƒ†•‡”˜‹…‡•Ǣ
‹Ȍ –Š‡ Ž‡˜‡Ž ‘ˆ …‘–”‘Ž ‡š’‡…–‡† ˆ‘” –Š‡ †‡•‹‰ ƒ† †‡˜‡Ž‘’‡– ’”‘…‡•• „› …—•–‘‡”• ƒ† ‘–Š‡”
”‡Ž‡˜ƒ–‹–‡”‡•–‡†’ƒ”–‹‡•Ǣ
ŒȌ –Š‡ †‘…—‡–‡† ‹ˆ‘”ƒ–‹‘ ‡‡†‡† –‘ †‡‘•–”ƒ–‡ –Šƒ– †‡•‹‰ ƒ† †‡˜‡Ž‘’‡– ”‡“—‹”‡‡–•
have been met.

8.3.3 Design and development inputs

Š‡ ‘”‰ƒ‹œƒ–‹‘ •ŠƒŽŽ †‡–‡”‹‡ –Š‡ ”‡“—‹”‡‡–• ‡••‡–‹ƒŽ ˆ‘” –Š‡ •’‡…‹ϐ‹… –›’‡• ‘ˆ ’”‘†—…–• ƒ†
services to be designed and developed. The organization shall consider:
ƒȌ ˆ—…–‹‘ƒŽƒ†’‡”ˆ‘”ƒ…‡”‡“—‹”‡‡–•Ǣ

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„Ȍ ‹ˆ‘”ƒ–‹‘†‡”‹˜‡†ˆ”‘’”‡˜‹‘—••‹‹Žƒ”†‡•‹‰ƒ††‡˜‡Ž‘’‡–ƒ…–‹˜‹–‹‡•Ǣ
…Ȍ •–ƒ–—–‘”›ƒ†”‡‰—Žƒ–‘”›”‡“—‹”‡‡–•Ǣ
†Ȍ •–ƒ†ƒ”†•‘”…‘†‡•‘ˆ’”ƒ…–‹…‡–Šƒ––Š‡‘”‰ƒ‹œƒ–‹‘Šƒ•…‘‹––‡†–‘‹’Ž‡‡–Ǣ
e) potential consequences of failure due to the nature of the products and services.
Inputs shall be adequate for design and development purposes, complete and unambiguous.
‘ϐŽ‹…–‹‰†‡•‹‰ƒ††‡˜‡Ž‘’‡–‹’—–••ŠƒŽŽ„‡”‡•‘Ž˜‡†Ǥ
The organization shall retain documented information on design and development inputs.

8.3.4 Design and development controls

Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽƒ’’Ž›…‘–”‘Ž•–‘–Š‡†‡•‹‰ƒ††‡˜‡Ž‘’‡–’”‘…‡••–‘‡•—”‡–Šƒ–ǣ
–’”‘
ƒȌ –Š‡”‡•—Ž–•–‘„‡ƒ…Š‹‡˜‡†ƒ”‡†‡ϐ‹‡†Ǣ
„Ȍ ”‡˜‹‡™• ƒ”‡ …‘†—…–‡† –‘ ‡˜ƒŽ—ƒ–‡ –Š‡ ƒ„‹Ž‹–› ‘ˆ –Š‡ ”‡•—Ž–•
”‡•—Ž– ‘ˆ †‡•‹‰ ƒ† †‡˜‡Ž‘’‡– –‘ ‡‡–
”‡•—Ž
”‡“—‹”‡‡–•Ǣ
…Ȍ ˜‡”‹ϐ‹…ƒ–‹‘ƒ…–‹˜‹–‹‡•ƒ”‡…‘†—…–‡†–‘‡•—”‡–Šƒ––Š‡†‡•‹‰ƒ††‡˜‡Ž‘’‡–‘—–’—–•‡‡––Š‡
ƒ–––Š‡ ‰ƒ
ƒ
‹’—–”‡“—‹”‡‡–•Ǣ
d) validation activities are conducted to ensuree th
tha thee resulting
that resu
suul products and services meet the
”‡“—‹”‡‡–•ˆ‘”–Š‡•’‡…‹ϐ‹‡†ƒ’’Ž‹…ƒ–‹‘‘”‹–‡†‡†—•‡Ǣ
‘”
”‹–‡ —•‡Ǣ
—•
—•‡‡Ǣ
‡Ȍ ƒ›‡…‡••ƒ”›ƒ…–‹‘•ƒ”‡–ƒ‡‘’”‘„Ž‡•†‡–‡”‹‡††—”‹‰–Š‡”‡˜‹‡™•ǡ‘”˜‡”‹ϐ‹…ƒ–‹‘ƒ†
‘„Ž‡•
„Ž‡ ‡”‹‡
”
˜ƒŽ‹†ƒ–‹‘ƒ…–‹˜‹–‹‡•Ǣ
f) documented information of these activities
ctiviti is re
act retained.
etain
 ‡•‹‰ ƒ† †‡˜‡Ž‘’‡– ”‡˜‹‡™•ǡ
‡˜‹‡™•
™• ˜‡”‹ϐ‹…ƒ–‹‘
…ƒ–‹‘
ƒ– ƒ† ˜ƒŽ‹†ƒ–‹‘ Šƒ˜‡ †‹•–‹…– ’—”’‘•‡•Ǥ Š‡› …ƒ „‡
‹ƒ–
ƒ–‹‘ ••—
—‹–ƒ
—‹–ƒ
…‘†—…–‡†•‡’ƒ”ƒ–‡Ž›‘”‹ƒ›…‘„‹ƒ–‹‘ǡƒ•‹••—‹–ƒ„Ž‡ˆ‘”–Š‡’”‘†—…–•ƒ†•‡”˜‹…‡•‘ˆ–Š‡‘”‰ƒ‹œƒ–‹‘Ǥ

8.3.5 Design and development

men
nt outputs
nt o s

The organization shall ensuree th

that design
g aand
ign n development outputs:
ƒȌ ‡‡––Š‡‹’—–”‡“—‹”‡‡–•Ǣ
”‡
„Ȍ ƒ”‡ƒ†‡“—ƒ–‡ˆ‘”–Š‡•—„•‡“—‡–’”‘…‡••‡•ˆ‘”–Š‡’”‘˜‹•‹‘‘ˆ’”‘†—…–•ƒ†•‡”˜‹…‡•Ǣ
Š‡••— “—‡
—‡
‡– ’
…Ȍ ‹…Ž—†‡‘””‡ˆ‡”‡…‡‘‹–‘”‹‰ƒ†‡ƒ•—”‹‰”‡“—‹”‡‡–•ǡƒ•ƒ’’”‘’”‹ƒ–‡ǡƒ†ƒ……‡’–ƒ…‡…”‹–‡”‹ƒǢ
‡”‡…
‡… ‹–‘
‘”‹
‹‰
†Ȍ •’‡…‹ˆ›–Š‡…Šƒ”ƒ…–‡”‹•–‹…•‘ˆ–Š‡’”‘†—…–•ƒ†•‡”˜‹…‡•–Šƒ–ƒ”‡‡••‡–‹ƒŽˆ‘”–Š‡‹”‹–‡†‡†’—”’‘•‡
and their safe and proper provision.
The organization shall retain documented information on design and development outputs.

8.3.6 Design and development changes

Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ‹†‡–‹ˆ›ǡ”‡˜‹‡™ƒ†…‘–”‘Ž…Šƒ‰‡•ƒ†‡†—”‹‰ǡ‘”•—„•‡“—‡––‘ǡ–Š‡†‡•‹‰
ƒ††‡˜‡Ž‘’‡–‘ˆ’”‘†—…–•ƒ†•‡”˜‹…‡•ǡ–‘–Š‡‡š–‡–‡…‡••ƒ”›–‘‡•—”‡–Šƒ––Š‡”‡‹•‘ƒ†˜‡”•‡
‹’ƒ…–‘…‘ˆ‘”‹–›–‘”‡“—‹”‡‡–•Ǥ
The organization shall retain documented information on:
ƒȌ †‡•‹‰ƒ††‡˜‡Ž‘’‡–…Šƒ‰‡•Ǣ
„Ȍ –Š‡”‡•—Ž–•‘ˆ”‡˜‹‡™•Ǣ
12
 IS/ISO 9001 : 2015

…Ȍ –Š‡ƒ—–Š‘”‹œƒ–‹‘‘ˆ–Š‡…Šƒ‰‡•Ǣ
d) the actions taken to prevent adverse impacts.

ͺǤͶ ‘–”‘Ž‘ˆ‡š–‡”ƒŽŽ›’”‘˜‹†‡†’”‘…‡••‡•ǡ’”‘†—…–•ƒ†•‡”˜‹…‡•

8.4.1 General

Š‡ ‘”‰ƒ‹œƒ–‹‘ •ŠƒŽŽ ‡•—”‡ –Šƒ– ‡š–‡”ƒŽŽ› ’”‘˜‹†‡† ’”‘…‡••‡•ǡ ’”‘†—…–• ƒ† •‡”˜‹…‡• …‘ˆ‘” –‘
requirements.
Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ†‡–‡”‹‡–Š‡…‘–”‘Ž•–‘„‡ƒ’’Ž‹‡†–‘‡š–‡”ƒŽŽ›’”‘˜‹†‡†’”‘…‡••‡•ǡ’”‘†—…–•
and services when:
a) products and services from external providers are intended for incorporation into the organization’s
ed fo
‘™’”‘†—…–•ƒ†•‡”˜‹…‡•Ǣ
„Ȍ ’”‘†—…–•ƒ†•‡”˜‹…‡•ƒ”‡’”‘˜‹†‡††‹”‡…–Ž›–‘–Š‡…—•–‘‡”ȋ•Ȍ„›‡š–‡”ƒŽ’”‘˜‹†‡”•‘„‡ŠƒŽˆ‘ˆ
‡…—•–
—•–‘
–Š‡‘”‰ƒ‹œƒ–‹‘Ǣ
…Ȍ ƒ’”‘…‡••ǡ‘”’ƒ”–‘ˆƒ’”‘…‡••ǡ‹•’”‘˜‹†‡†„›ƒ‡š–‡”ƒŽ’”‘˜‹†‡”ƒ•ƒ”‡•—Ž–‘ˆƒ†‡…‹•‹‘„›–Š‡
›ƒ
‡
organization.
Š‡ ‘”‰ƒ‹œƒ–‹‘ •ŠƒŽŽ †‡–‡”‹‡ ƒ† ƒ’’Ž› › …”‹–‡”‹ƒ
’Ž› …” ˆ‘”
‘” –Š‡ ‡˜ƒŽ—ƒ–‹‘ǡ •‡Ž‡…–‹‘ǡ ‘‹–‘”‹‰ ‘ˆ
ˆ‘”
’‡”ˆ‘”ƒ…‡ǡ ƒ† ”‡Ǧ‡˜ƒŽ—ƒ–‹‘ ‘ˆ ‡š–‡”ƒŽ ’”‘˜‹†‡”•ǡ
ƒŽŽ ’”‘
’” „ƒ•‡†
ǡ „ƒ•
ƒ ‘ –Š‡‹” ƒ„‹Ž‹–› –‘ ’”‘˜‹†‡ ’”‘…‡••‡• ‘”
products and services in accordance with ith rerequirements.
req
eq ements
me The organization shall retain documented
‹ˆ‘”ƒ–‹‘‘ˆ–Š‡•‡ƒ…–‹˜‹–‹‡•ƒ†ƒ›‡…‡••ƒ”›ƒ…–‹‘•ƒ”‹•‹‰ˆ”‘–Š‡‡˜ƒŽ—ƒ–‹‘•Ǥ
‡…‡
…‡• …–‹‘
–‹‘
‘

8.4.2 Type and extent of controll

Š‡ ‘”‰ƒ‹œƒ–‹‘ •ŠƒŽŽ ‡•—”‡ –Šƒ–

– ‡š–‡”ƒŽŽ›
ƒŽŽ› ’”‘˜‹†‡† ’”‘…‡••‡•ǡ ’”‘†—…–• ƒ† •‡”˜‹…‡• †‘ ‘–
ƒ†˜‡”•‡Ž›ƒˆˆ‡…––Š‡‘”‰ƒ‹œƒ–‹‘ǯ•ƒ„‹Ž‹–›–‘…‘•‹•–‡–Ž›†‡Ž‹˜‡”…‘ˆ‘”‹‰’”‘†—…–•ƒ†•‡”˜‹…‡•–‘
‹‘ǯ•ƒ ›–‘
–‘…‘
its customers.
The organization shall:
ƒȌ ‡•—”‡ –Šƒ– ‡š–‡”ƒŽŽ›
ŽŽ› ’”‘˜‹†‡†
ƒŽŽ› ’ ‡† ’”‘…‡••‡•
†‡† ’ ”‡ƒ‹ ™‹–Š‹ –Š‡ …‘–”‘Ž ‘ˆ ‹–• “—ƒŽ‹–› ƒƒ‰‡‡–
•›•–‡Ǣ
„Ȍ †‡ϐ‹‡„‘–Š–Š‡…‘–”‘Ž•–Šƒ–‹–‹–‡†•–‘ƒ’’Ž›–‘ƒ‡š–‡”ƒŽ’”‘˜‹†‡”ƒ†–Š‘•‡‹–‹–‡†•–‘ƒ’’Ž›
‡…‘
…‘ –Šƒ
Šƒ–
ƒ– ‹
–‘–Š‡”‡•—Ž–‹‰‘—–’—–Ǣ
–‹‰
‰‘ –Ǣ
c) take into
o consideration:
con
ons ation:
tio
on
ͳȌ –Š‡
Š‡ ’‘–‡–‹ƒŽ
’‘ Ž ‹’ƒ…–
‹
 ‘ˆ –Š‡ ‡š–‡”ƒŽŽ› ’”‘˜‹†‡† ’”‘…‡••‡•ǡ ’”‘†—…–• ƒ† •‡”˜‹…‡• ‘ –Š‡
‘”‰ƒ‹œƒ–‹‘ǯ•ƒ„‹Ž‹–›–‘…‘•‹•–‡–Ž›‡‡–…—•–‘‡”ƒ†ƒ’’Ž‹…ƒ„Ž‡•–ƒ–—–‘”›ƒ†”‡‰—Žƒ–‘”›
”‡“—‹”‡‡–•Ǣ
ʹȌ –Š‡‡ˆˆ‡…–‹˜‡‡••‘ˆ–Š‡…‘–”‘Ž•ƒ’’Ž‹‡†„›–Š‡‡š–‡”ƒŽ’”‘˜‹†‡”Ǣ
†Ȍ †‡–‡”‹‡ –Š‡ ˜‡”‹ϐ‹…ƒ–‹‘ǡ ‘” ‘–Š‡” ƒ…–‹˜‹–‹‡•ǡ ‡…‡••ƒ”› –‘ ‡•—”‡ –Šƒ– –Š‡ ‡š–‡”ƒŽŽ› ’”‘˜‹†‡†
processes, products and services meet requirements.

8.4.3 Information for external providers

Š‡ ‘”‰ƒ‹œƒ–‹‘ •ŠƒŽŽ ‡•—”‡ –Š‡ ƒ†‡“—ƒ…› ‘ˆ ”‡“—‹”‡‡–• ’”‹‘” –‘ –Š‡‹” …‘—‹…ƒ–‹‘ –‘ –Š‡
external provider.
The organization shall communicate to external providers its requirements for:
ƒȌ –Š‡’”‘…‡••‡•ǡ’”‘†—…–•ƒ†•‡”˜‹…‡•–‘„‡’”‘˜‹†‡†Ǣ
13
IS/ISO 9001 : 2015

b) the approval of:

ͳȌ ’”‘†—…–•ƒ†•‡”˜‹…‡•Ǣ
ʹȌ ‡–Š‘†•ǡ’”‘…‡••‡•ƒ†‡“—‹’‡–Ǣ
͵Ȍ –Š‡”‡Ž‡ƒ•‡‘ˆ’”‘†—…–•ƒ†•‡”˜‹…‡•Ǣ
…Ȍ …‘’‡–‡…‡ǡ‹…Ž—†‹‰ƒ›”‡“—‹”‡†“—ƒŽ‹ϐ‹…ƒ–‹‘‘ˆ’‡”•‘•Ǣ
†Ȍ –Š‡‡š–‡”ƒŽ’”‘˜‹†‡”•ǯ‹–‡”ƒ…–‹‘•™‹–Š–Š‡‘”‰ƒ‹œƒ–‹‘Ǣ
‡Ȍ …‘–”‘Žƒ†‘‹–‘”‹‰‘ˆ–Š‡‡š–‡”ƒŽ’”‘˜‹†‡”•ǯ’‡”ˆ‘”ƒ…‡–‘„‡ƒ’’Ž‹‡†„›–Š‡‘”‰ƒ‹œƒ–‹‘Ǣ
ˆȌ ˜‡”‹ϐ‹…ƒ–‹‘‘”˜ƒŽ‹†ƒ–‹‘ƒ…–‹˜‹–‹‡•–Šƒ––Š‡‘”‰ƒ‹œƒ–‹‘ǡ‘”‹–•…—•–‘‡”ǡ‹–‡†•–‘’‡”ˆ‘”ƒ––Š‡
—••–‘
•–‘
external providers’ premises.

8.5 Production and service provision

8.5.1 Control of production and service provision

The organization shall implement production and service provision und

cee pro under controlled conditions.
Controlled conditions shall include, as applicable:
ƒȌ –Š‡ƒ˜ƒ‹Žƒ„‹Ž‹–›‘ˆ†‘…—‡–‡†‹ˆ‘”ƒ–‹‘–Šƒ–†‡ϐ‹‡•ǣ
Šƒƒ–†‡
1) the characteristics of the products to bee pr
produced, the
pro he services to be provided, or the activities
th
–‘„‡’‡”ˆ‘”‡†Ǣ
ʹȌ –Š‡”‡•—Ž–•–‘„‡ƒ…Š‹‡˜‡†Ǣ
„Ȍ –Š‡ƒ˜ƒ‹Žƒ„‹Ž‹–›ƒ†—•‡‘ˆ•—‹–ƒ„Ž‡‘‹–‘”‹‰ƒ†‡ƒ•—”‹‰”‡•‘—”…‡•Ǣ
‡‘
‘‹ ‰ƒ†
†
…Ȍ –Š‡‹’Ž‡‡–ƒ–‹‘‘ˆ‘‹–‘”‹‰ƒ†‡ƒ•—”‡‡–ƒ…–‹˜‹–‹‡•ƒ–ƒ’’”‘’”‹ƒ–‡•–ƒ‰‡•–‘˜‡”‹ˆ›–Šƒ–
”‹
‹‰ƒ ƒ•—
—”‡
criteria for control of processes
sses
se oor outputs,
ts and acceptance criteria for products and services,
utputs
puts,
Šƒ˜‡„‡‡‡–Ǣ
†Ȍ –Š‡—•‡‘ˆ•—‹–ƒ„Ž‡‹ˆ”ƒ•–”—…–—”‡ƒ†‡˜‹”‘‡–ˆ‘”–Š‡‘’‡”ƒ–‹‘‘ˆ’”‘…‡••‡•Ǣ
•–”—
—…–— †‡
‡Ȍ –Š‡ƒ’’‘‹–‡–‘ˆ…‘’‡–‡–’‡”•‘•ǡ‹…Ž—†‹‰ƒ›”‡“—‹”‡†“—ƒŽ‹ϐ‹…ƒ–‹‘Ǣ
’
’‡ ‡””•‘
•‘
ˆȌ –Š‡˜ƒŽ‹†ƒ–‹‘ǡƒ†’‡”‹‘†‹…”‡˜ƒŽ‹†ƒ–‹‘ǡ‘ˆ–Š‡ƒ„‹Ž‹–›–‘ƒ…Š‹‡˜‡’Žƒ‡†”‡•—Ž–•‘ˆ–Š‡’”‘…‡••‡•
’ ‹
’‡”‹ ‡˜ƒ
˜ƒŽ‹
ˆ‘”’”‘†—…–‹‘ƒ†•‡”˜‹…‡’”‘˜‹•‹‘ǡ™Š‡”‡–Š‡”‡•—Ž–‹‰‘—–’—–…ƒ‘–„‡˜‡”‹ϐ‹‡†„›•—„•‡“—‡–
†
†•
†•‡ ‡’”‘
’ ˜‹
’”‘˜
‘‹–‘”‹‰‘”‡ƒ•—”‡‡–Ǣ
‡
‡ƒ• ‡–Ǣ
–
–Ǣ
‰Ȍ –Š‡‹’Ž‡‡–ƒ–‹‘‘ˆƒ…–‹‘•–‘’”‡˜‡–Š—ƒ‡””‘”Ǣ
ƒ–‹ –‹‘
ŠȌ –Š‡‹’Ž‡‡–ƒ–‹‘‘ˆ”‡Ž‡ƒ•‡ǡ†‡Ž‹˜‡”›ƒ†’‘•–Ǧ†‡Ž‹˜‡”›ƒ…–‹˜‹–‹‡•Ǥ

ͺǤͷǤʹ †‡–‹ϐ‹…ƒ–‹‘ƒ†–”ƒ…‡ƒ„‹Ž‹–›

Š‡ ‘”‰ƒ‹œƒ–‹‘ •ŠƒŽŽ —•‡ •—‹–ƒ„Ž‡ ‡ƒ• –‘ ‹†‡–‹ˆ› ‘—–’—–• ™Š‡ ‹– ‹• ‡…‡••ƒ”› –‘ ‡•—”‡ –Š‡
…‘ˆ‘”‹–›‘ˆ’”‘†—…–•ƒ†•‡”˜‹…‡•Ǥ
Š‡ ‘”‰ƒ‹œƒ–‹‘ •ŠƒŽŽ ‹†‡–‹ˆ› –Š‡ •–ƒ–—• ‘ˆ ‘—–’—–• ™‹–Š ”‡•’‡…– –‘ ‘‹–‘”‹‰ ƒ† ‡ƒ•—”‡‡–
requirements throughout production and service provision.
Š‡ ‘”‰ƒ‹œƒ–‹‘ •ŠƒŽŽ …‘–”‘Ž –Š‡ —‹“—‡ ‹†‡–‹ϐ‹…ƒ–‹‘ ‘ˆ –Š‡ ‘—–’—–• ™Š‡ –”ƒ…‡ƒ„‹Ž‹–› ‹• ƒ
”‡“—‹”‡‡–ǡƒ†•ŠƒŽŽ”‡–ƒ‹–Š‡†‘…—‡–‡†‹ˆ‘”ƒ–‹‘‡…‡••ƒ”›–‘‡ƒ„Ž‡–”ƒ…‡ƒ„‹Ž‹–›Ǥ

14
 IS/ISO 9001 : 2015

8.5.3 Property belonging to customers or external providers

Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ‡š‡”…‹•‡…ƒ”‡™‹–Š’”‘’‡”–›„‡Ž‘‰‹‰–‘…—•–‘‡”•‘”‡š–‡”ƒŽ’”‘˜‹†‡”•™Š‹Ž‡
‹–‹•—†‡”–Š‡‘”‰ƒ‹œƒ–‹‘ǯ•…‘–”‘Ž‘”„‡‹‰—•‡†„›–Š‡‘”‰ƒ‹œƒ–‹‘Ǥ
Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ‹†‡–‹ˆ›ǡ˜‡”‹ˆ›ǡ’”‘–‡…–ƒ†•ƒˆ‡‰—ƒ”†…—•–‘‡”•ǯ‘”‡š–‡”ƒŽ’”‘˜‹†‡”•ǯ’”‘’‡”–›
provided for use or incorporation into the products and services.
Š‡ –Š‡ ’”‘’‡”–› ‘ˆ ƒ …—•–‘‡” ‘” ‡š–‡”ƒŽ ’”‘˜‹†‡” ‹• Ž‘•–ǡ †ƒƒ‰‡† ‘” ‘–Š‡”™‹•‡ ˆ‘—† –‘ „‡
unsuitable for use, the organization shall report this to the customer or external provider and retain
documented information on what has occurred.
 …—•–‘‡”ǯ•‘”‡š–‡”ƒŽ’”‘˜‹†‡”ǯ•’”‘’‡”–›…ƒ‹…Ž—†‡ƒ–‡”‹ƒŽ•ǡ…‘’‘‡–•ǡ–‘‘Ž•ƒ†‡“—‹’‡–ǡ
’”‡‹•‡•ǡ‹–‡ŽŽ‡…–—ƒŽ’”‘’‡”–›ƒ†’‡”•‘ƒŽ†ƒ–ƒǤ

8.5.4 Preservation

The organization shall preserve the outputs during production

prod
oduc and service provision, to the extent
‡…‡••ƒ”›–‘‡•—”‡…‘ˆ‘”‹–›–‘”‡“—‹”‡‡–•Ǥ
 ”‡•‡”˜ƒ–‹‘ …ƒ ‹…Ž—†‡ ‹†‡–‹ϐ‹…ƒ–‹‘ǡ Š
Šƒ†Ž‹‰ǡ
ƒ
ƒ†Ž‹ …‘–ƒ‹ƒ–‹‘ …‘–”‘Žǡ ’ƒ…ƒ‰‹‰ǡ •–‘”ƒ‰‡ǡ
transmission or transportation, and protection.

8.5.5 Post-delivery activities

Š‡ ‘”‰ƒ‹œƒ–‹‘ •ŠƒŽŽ ‡‡– ”‡“—‹”‡‡–•

–• ˆ‘” ’‘•–Ǧ†‡Ž‹˜‡”›
• ˆ‘
ˆ‘” – †‡Ž‹˜
‡Ž ˜ ƒ…–‹˜‹–‹‡• ƒ••‘…‹ƒ–‡† ™‹–Š –Š‡ ’”‘†—…–•
and services.
†‡–‡”‹‹‰–Š‡‡š–‡–‘ˆ’‘•–Ǧ†‡Ž‹˜‡”›ƒ…–‹˜‹–‹‡•–Šƒ–ƒ”‡”‡“—‹”‡†ǡ–Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ…‘•‹†‡”ǣ
‹˜‡”›
˜‡ ‹–‹‡•–Š
–‹‡•
–‹
ƒȌ •–ƒ–—–‘”›ƒ†”‡‰—Žƒ–‘”›”‡“—‹”‡‡–•Ǣ
—‹”‡
‡
„Ȍ –Š‡’‘–‡–‹ƒŽ—†‡•‹”‡†…‘•‡“—‡…‡•ƒ••‘…‹ƒ–‡†™‹–Š‹–•’”‘†—…–•ƒ†•‡”˜‹…‡•Ǣ
•‡“— ƒ••‘
…Ȍ –Š‡ƒ–—”‡ǡ—•‡ƒ†‹–‡†‡†Ž‹ˆ‡–‹‡‘ˆ‹–•’”‘†—…–•ƒ†•‡”˜‹…‡•Ǣ
–‡†
‡
†‡† ‡‘
‡‘ˆ
†Ȍ …—•–‘‡””‡“—‹”‡‡–•Ǣ
–•
–•Ǣ
e) customer feedback.
ck.
k.
 ‘•–Ǧ†‡Ž‹˜‡”›ƒ…–‹˜‹–‹‡•…ƒ‹…Ž—†‡ƒ…–‹‘•—†‡”™ƒ””ƒ–›’”‘˜‹•‹‘•ǡ…‘–”ƒ…–—ƒŽ‘„Ž‹‰ƒ–‹‘••—…Š
˜‡”
‡”›ƒ
”› ‡• …
‡•…ƒ
”˜‹…
˜‹…‡ •—’’Ž
ƒ•ƒ‹–‡ƒ…‡•‡”˜‹…‡•ǡƒ†•—’’Ž‡‡–ƒ”›•‡”˜‹…‡••—…Šƒ•”‡…›…Ž‹‰‘”ϐ‹ƒŽ†‹•’‘•ƒŽǤ

8.5.6 Control
ntroll of changes
nge
n ge
ges

The organization
izati shall
all rreview and control changes for production or service provision, to the extent
‡…‡••ƒ”›–‘‡•—”‡…‘–‹—‹‰…‘ˆ‘”‹–›™‹–Š”‡“—‹”‡‡–•Ǥ
The organization shall retain documented information describing the results of the review of changes,
–Š‡’‡”•‘ȋ•Ȍƒ—–Š‘”‹œ‹‰–Š‡…Šƒ‰‡ǡƒ†ƒ›‡…‡••ƒ”›ƒ…–‹‘•ƒ”‹•‹‰ˆ”‘–Š‡”‡˜‹‡™Ǥ

8.6 Release of products and services

Š‡ ‘”‰ƒ‹œƒ–‹‘ •ŠƒŽŽ ‹’Ž‡‡– ’Žƒ‡† ƒ””ƒ‰‡‡–•ǡ ƒ– ƒ’’”‘’”‹ƒ–‡ •–ƒ‰‡•ǡ –‘ ˜‡”‹ˆ› –Šƒ– –Š‡
product and service requirements have been met.
The release of products and services to the customer shall not proceed until the planned arrangements
Šƒ˜‡ „‡‡ •ƒ–‹•ˆƒ…–‘”‹Ž› …‘’Ž‡–‡†ǡ —Ž‡•• ‘–Š‡”™‹•‡ ƒ’’”‘˜‡† „› ƒ ”‡Ž‡˜ƒ– ƒ—–Š‘”‹–› ƒ†ǡ ƒ•
ƒ’’Ž‹…ƒ„Ž‡ǡ„›–Š‡…—•–‘‡”Ǥ

15
IS/ISO 9001 : 2015

The organization shall retain documented information on the release of products and services. The
documented information shall include:
ƒȌ ‡˜‹†‡…‡‘ˆ…‘ˆ‘”‹–›™‹–Š–Š‡ƒ……‡’–ƒ…‡…”‹–‡”‹ƒǢ
„Ȍ –”ƒ…‡ƒ„‹Ž‹–›–‘–Š‡’‡”•‘ȋ•Ȍƒ—–Š‘”‹œ‹‰–Š‡”‡Ž‡ƒ•‡Ǥ

8.7 Control of nonconforming outputs

8.7.1 The organization shall ensure that outputs that do not conform to their requirements are
‹†‡–‹ϐ‹‡†ƒ†…‘–”‘ŽŽ‡†–‘’”‡˜‡––Š‡‹”—‹–‡†‡†—•‡‘”†‡Ž‹˜‡”›Ǥ

Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ–ƒ‡ƒ’’”‘’”‹ƒ–‡ƒ…–‹‘„ƒ•‡†‘–Š‡ƒ–—”‡‘ˆ–Š‡‘…‘ˆ‘”‹–›ƒ†‹–•‡ˆˆ‡…–
ˆ –Š‡
–Š‡
Š
‘ –Š‡ …‘ˆ‘”‹–› ‘ˆ ’”‘†—…–• ƒ† •‡”˜‹…‡•Ǥ Š‹• •ŠƒŽŽ ƒŽ•‘ ƒ’’Ž›
› –‘
‘ ‘…‘ˆ‘”‹‰
–‘ 
‘ ’”‘†—…–• ƒ†
•‡”˜‹…‡•†‡–‡…–‡†ƒˆ–‡”†‡Ž‹˜‡”›‘ˆ’”‘†—…–•ǡ†—”‹‰‘”ƒˆ–‡”–Š‡’”‘˜‹•‹‘‘ˆ•‡”˜‹…‡•Ǥ
‘˜‹•‹‘‘
Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ†‡ƒŽ™‹–Š‘…‘ˆ‘”‹‰‘—–’—–•‹‘‡‘”‘”‡‘ˆ–Š‡ˆ‘ŽŽ‘™‹‰™ƒ›•ǣ
‘”
ƒȌ …‘””‡…–‹‘Ǣ
„Ȍ •‡‰”‡‰ƒ–‹‘ǡ…‘–ƒ‹‡–ǡ”‡–—”‘”•—•’‡•‹‘‘ˆ’”‘˜‹•‹‘‘ˆ’”‘†—…–•ƒ†•‡”˜‹…‡•Ǣ
”‘˜‹
˜‹•‹‘ ’
…Ȍ ‹ˆ‘”‹‰–Š‡…—•–‘‡”Ǣ
d) obtaining authorization for acceptance under conce
concession.
conc
ces
‘ˆ‘”‹–›–‘–Š‡”‡“—‹”‡‡–••ŠƒŽŽ„‡˜‡”‹ϐ‹‡†™Š‡‘…‘ˆ‘”‹‰‘—–’—–•ƒ”‡…‘””‡…–‡†Ǥ
†™Š‡
† …‘
‘ˆ
ˆ‘
ˆ‘

8.7.2 The organization shall retain documented

nt information
ented atio that:
mati

ƒȌ †‡•…”‹„‡•–Š‡‘…‘ˆ‘”‹–›Ǣ
„Ȍ †‡•…”‹„‡•–Š‡ƒ…–‹‘•–ƒ‡Ǣ
…Ȍ †‡•…”‹„‡•ƒ›…‘…‡••‹‘•‘„–ƒ‹‡†Ǣ
–ƒ‹
ƒ‹‡†
†Ȍ ‹†‡–‹ϐ‹‡•–Š‡ƒ—–Š‘”‹–›†‡…‹†‹‰–Š‡ƒ…–‹‘‹”‡•’‡…–‘ˆ–Š‡‘…‘ˆ‘”‹–›Ǥ
…‹†
†‹
†‹ …–‹
–‹‘‹

9 Performance evaluation
ua
uat
atio
ti

ͻǤͳ ‘‹–‘”‹‰ǡ‡ƒ•—”‡‡–ǡƒƒŽ›•‹•ƒ†‡˜ƒŽ—ƒ–‹‘
‡ƒ•
‡ƒ•—
‡ƒ ‡
–ǡ

9.1.1 General

The organization shall determine:

ƒȌ ™Šƒ–‡‡†•–‘„‡‘‹–‘”‡†ƒ†‡ƒ•—”‡†Ǣ
„Ȍ –Š‡‡–Š‘†•ˆ‘”‘‹–‘”‹‰ǡ‡ƒ•—”‡‡–ǡƒƒŽ›•‹•ƒ†‡˜ƒŽ—ƒ–‹‘‡‡†‡†–‘‡•—”‡˜ƒŽ‹†”‡•—Ž–•Ǣ
…Ȍ ™Š‡–Š‡‘‹–‘”‹‰ƒ†‡ƒ•—”‹‰•ŠƒŽŽ„‡’‡”ˆ‘”‡†Ǣ
†Ȍ ™Š‡–Š‡”‡•—Ž–•ˆ”‘‘‹–‘”‹‰ƒ†‡ƒ•—”‡‡–•ŠƒŽŽ„‡ƒƒŽ›•‡†ƒ†‡˜ƒŽ—ƒ–‡†Ǥ
Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ‡˜ƒŽ—ƒ–‡–Š‡’‡”ˆ‘”ƒ…‡ƒ†–Š‡‡ˆˆ‡…–‹˜‡‡••‘ˆ–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǥ
The organization shall retain appropriate documented information as evidence of the results.

16
 IS/ISO 9001 : 2015

9.1.2 Customer satisfaction

The organization shall monitor customers’ perceptions of the degree to which their needs and
‡š’‡…–ƒ–‹‘• Šƒ˜‡ „‡‡ ˆ—Žϐ‹ŽŽ‡†Ǥ Š‡ ‘”‰ƒ‹œƒ–‹‘ •ŠƒŽŽ †‡–‡”‹‡ –Š‡ ‡–Š‘†• ˆ‘” ‘„–ƒ‹‹‰ǡ
monitoring and reviewing this information.
 šƒ’Ž‡• ‘ˆ ‘‹–‘”‹‰ …—•–‘‡” ’‡”…‡’–‹‘• …ƒ ‹…Ž—†‡ …—•–‘‡” •—”˜‡›•ǡ …—•–‘‡” ˆ‡‡†„ƒ…
‘ †‡Ž‹˜‡”‡† ’”‘†—…–• ƒ† •‡”˜‹…‡•ǡ ‡‡–‹‰• ™‹–Š …—•–‘‡”•ǡ ƒ”‡–Ǧ•Šƒ”‡ ƒƒŽ›•‹•ǡ …‘’Ž‹‡–•ǡ ™ƒ””ƒ–›
claims and dealer reports.

9.1.3 Analysis and evaluation

Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽƒƒŽ›•‡ƒ†‡˜ƒŽ—ƒ–‡ƒ’’”‘’”‹ƒ–‡†ƒ–ƒƒ†‹ˆ‘”ƒ–‹‘ƒ”‹•‹‰ˆ”‘‘‹–‘”‹‰
†‹
†‹
and measurement.
Š‡”‡•—Ž–•‘ˆƒƒŽ›•‹••ŠƒŽŽ„‡—•‡†–‘‡˜ƒŽ—ƒ–‡ǣ
ƒȌ …‘ˆ‘”‹–›‘ˆ’”‘†—…–•ƒ†•‡”˜‹…‡•Ǣ
„Ȍ –Š‡†‡‰”‡‡‘ˆ…—•–‘‡”•ƒ–‹•ˆƒ…–‹‘Ǣ
…Ȍ –Š‡’‡”ˆ‘”ƒ…‡ƒ†‡ˆˆ‡…–‹˜‡‡••‘ˆ–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǣ
Ž‹–›
 ‡
†Ȍ ‹ˆ’Žƒ‹‰Šƒ•„‡‡‹’Ž‡‡–‡†‡ˆˆ‡…–‹˜‡Ž›Ǣ
‡Ž›Ǣ
›Ǣ
‡Ȍ –Š‡‡ˆˆ‡…–‹˜‡‡••‘ˆƒ…–‹‘•–ƒ‡–‘ƒ††”‡••”‹••ƒ†‘’’‘”–—‹–‹‡•Ǣ
†”‡•
†”‡•• †
†‘
ˆȌ –Š‡’‡”ˆ‘”ƒ…‡‘ˆ‡š–‡”ƒŽ’”‘˜‹†‡”•Ǣ
‡”•
”•Ǣ
‰Ȍ –Š‡‡‡†ˆ‘”‹’”‘˜‡‡–•–‘–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǥ
‡“—ƒŽ
“— ƒƒ
ƒƒ
ƒ‰‡
 ‡–Š‘†•–‘ƒƒŽ›•‡†ƒ–ƒ…ƒ‹…Ž—†‡•–ƒ–‹•–‹…ƒŽ–‡…Š‹“—‡•Ǥ
ƒ‹
‹ –ƒ–
ƒ–‹•–‹
‹•

9.2 Internal audit

9.2.1 The organization shall

h conduct
hall uct
ct in
internal
nte audits at planned intervals to provide information on
™Š‡–Š‡”–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡ǣ
ƒƒ‰‡
‰‡ ›•–
•–‡ǣ

a) conforms to:
ͳȌ –Š‡‘”‰ƒ‹œƒ–‹‘ǯ•‘™”‡“—‹”‡‡–•ˆ‘”‹–•“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǣ
‹œƒ–
ƒ–‹‘ ™
 ”‡
ʹȌ –Š‡”‡“—‹”‡‡–•‘ˆ–Š‹•–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†Ǣ
“—‹‹”‡
“—‹” •‘
•‘ˆ
‘ˆ–Š
„Ȍ ‹•‡ˆˆ‡…–‹˜‡Ž›‹’Ž‡‡–‡†ƒ†ƒ‹–ƒ‹‡†Ǥ
–‹‹˜‡Ž
˜‡Ž› ‡‡
‡‡–

9.2.2 The organization shall:

ƒȌ ’Žƒǡ‡•–ƒ„Ž‹•Šǡ‹’Ž‡‡–ƒ†ƒ‹–ƒ‹ƒƒ—†‹–’”‘‰”ƒ‡ȋ•Ȍ‹…Ž—†‹‰–Š‡ˆ”‡“—‡…›ǡ‡–Š‘†•ǡ
responsibilities, planning requirements and reporting, which shall take into consideration the
importance of the processes concerned, changes affecting the organization, and the results of
’”‡˜‹‘—•ƒ—†‹–•Ǣ
„Ȍ †‡ϐ‹‡–Š‡ƒ—†‹–…”‹–‡”‹ƒƒ†•…‘’‡ˆ‘”‡ƒ…Šƒ—†‹–Ǣ
…Ȍ •‡Ž‡…–ƒ—†‹–‘”•ƒ†…‘†—…–ƒ—†‹–•–‘‡•—”‡‘„Œ‡…–‹˜‹–›ƒ†–Š‡‹’ƒ”–‹ƒŽ‹–›‘ˆ–Š‡ƒ—†‹–’”‘…‡••Ǣ
†Ȍ ‡•—”‡–Šƒ––Š‡”‡•—Ž–•‘ˆ–Š‡ƒ—†‹–•ƒ”‡”‡’‘”–‡†–‘”‡Ž‡˜ƒ–ƒƒ‰‡‡–Ǣ
‡Ȍ –ƒ‡ƒ’’”‘’”‹ƒ–‡…‘””‡…–‹‘ƒ†…‘””‡…–‹˜‡ƒ…–‹‘•™‹–Š‘—–—†—‡†‡Žƒ›Ǣ

17
IS/ISO 9001 : 2015

f) retain documented information as evidence of the implementation of the audit programme and the
audit results.
NOTE See ISO 19011 for guidance.

9.3 Management review

9.3.1 General

‘’ƒƒ‰‡‡–•ŠƒŽŽ”‡˜‹‡™–Š‡‘”‰ƒ‹œƒ–‹‘ǯ•“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡ǡƒ–’Žƒ‡†‹–‡”˜ƒŽ•ǡ–‘
‡•—”‡‹–•…‘–‹—‹‰•—‹–ƒ„‹Ž‹–›ǡƒ†‡“—ƒ…›ǡ‡ˆˆ‡…–‹˜‡‡••ƒ†ƒŽ‹‰‡–™‹–Š–Š‡•–”ƒ–‡‰‹…†‹”‡…–‹‘‘ˆ
the organization.

9.3.2 Management review inputs

The management review shall be planned and carried out takingg into
o consideration:
c
ƒȌ –Š‡•–ƒ–—•‘ˆƒ…–‹‘•ˆ”‘’”‡˜‹‘—•ƒƒ‰‡‡–”‡˜‹‡™•Ǣ
•Ǣ
„Ȍ …Šƒ‰‡•‹‡š–‡”ƒŽƒ†‹–‡”ƒŽ‹••—‡•–Šƒ–ƒ”‡”‡Ž‡˜ƒ––‘–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǣ
ƒ
– –
––‘–
…Ȍ ‹ˆ‘”ƒ–‹‘ ‘ –Š‡ ’‡”ˆ‘”ƒ…‡ ƒ† ‡ˆˆ‡…–‹˜‡‡•• –Š‡ “—ƒŽ‹–›
• ‘ˆ –Š ƒŽ‹–› ƒƒ‰‡‡– •›•–‡ǡ ‹…Ž—†‹‰
trends in:
ͳȌ …—•–‘‡”•ƒ–‹•ˆƒ…–‹‘ƒ†ˆ‡‡†„ƒ…ˆ”‘”‡Ž‡˜ƒ–‹–‡”‡•–‡†’ƒ”–‹‡•Ǣ
”‡‡Ž‡˜
”‡Ž‡˜ –‡”‡‡•–
ʹȌ –Š‡‡š–‡––‘™Š‹…Š“—ƒŽ‹–›‘„Œ‡…–‹˜‡•Šƒ˜‡„‡‡‡–Ǣ
Šƒ˜‡
ƒ˜‡ ‡–Ǣ
‡–Ǣ
͵Ȍ ’”‘…‡••’‡”ˆ‘”ƒ…‡ƒ†…‘ˆ‘”‹–›‘ˆ’”‘†—…–•ƒ†•‡”˜‹…‡•Ǣ
–›‘ˆ’
›‘ …–– •ƒ
• ƒ
ͶȌ ‘…‘ˆ‘”‹–‹‡•ƒ†…‘””‡…–‹˜‡ƒ…–‹‘•Ǣ
‡ƒ…–‹‘
‹‘
ͷȌ ‘‹–‘”‹‰ƒ†‡ƒ•—”‡‡–”‡•—Ž–•Ǣ
–
–”‡•—
͸Ȍ ƒ—†‹–”‡•—Ž–•Ǣ
͹Ȍ –Š‡’‡”ˆ‘”ƒ…‡‘ˆ‡š–‡”ƒŽ’”‘˜‹†‡”•Ǣ
–‡‡”ƒ ‹†‡
†‡”•Ǣ
†Ȍ –Š‡ƒ†‡“—ƒ…›‘ˆ”‡•‘—”…‡•Ǣ
‡•Ǣ
•Ǣ
e) the effectiveness of actions
ion taken
ctio en to
to address
a risks and opportunities (see 6.1ȌǢ
f) opportunities for imp
improvement.
mpro ent
nt.

9.3.3 Management
nt review
ment w outputs
ou
out
utp

The outputs of the management review shall include decisions and actions related to:
ƒȌ ‘’’‘”–—‹–‹‡•ˆ‘”‹’”‘˜‡‡–Ǣ
„Ȍ ƒ›‡‡†ˆ‘”…Šƒ‰‡•–‘–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǣ
c) resource needs.
The organization shall retain documented information as evidence of the results of management reviews.

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 IS/ISO 9001 : 2015

10 Improvement

10.1 General
Š‡ ‘”‰ƒ‹œƒ–‹‘ •ŠƒŽŽ †‡–‡”‹‡ ƒ† •‡Ž‡…– ‘’’‘”–—‹–‹‡• ˆ‘” ‹’”‘˜‡‡– ƒ† ‹’Ž‡‡– ƒ›
‡…‡••ƒ”›ƒ…–‹‘•–‘‡‡–…—•–‘‡””‡“—‹”‡‡–•ƒ†‡Šƒ…‡…—•–‘‡”•ƒ–‹•ˆƒ…–‹‘Ǥ
These shall include:
a) improving products and services to meet requirements as well as to address future needs and
‡š’‡…–ƒ–‹‘•Ǣ
„Ȍ …‘””‡…–‹‰ǡ’”‡˜‡–‹‰‘””‡†—…‹‰—†‡•‹”‡†‡ˆˆ‡…–•Ǣ
…Ȍ ‹’”‘˜‹‰–Š‡’‡”ˆ‘”ƒ…‡ƒ†‡ˆˆ‡…–‹˜‡‡••‘ˆ–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǥ
‹–›
NOTE Examples of improvement can include correction,
ion, corrective
co action, continual improvement,
breakthrough change, innovation and re-organization.

10.2 Nonconformity and corrective action

10.2.1 Š‡ƒ‘…‘ˆ‘”‹–›‘……—”•ǡ‹…Ž—†‹‰ƒ›ƒ”‹•‹‰ˆ”‘…‘’Žƒ‹–•ǡ–Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽǣ
‰ ƒ› ‰ ˆ”‘

ƒȌ ”‡ƒ…––‘–Š‡‘…‘ˆ‘”‹–›ƒ†ǡƒ•ƒ’’Ž‹…ƒ„Ž‡ǣ
‹…ƒ„
…ƒ„
ƒ„Ž‡ǣ
ͳȌ –ƒ‡ƒ…–‹‘–‘…‘–”‘Žƒ†…‘””‡…–‹–Ǣ
…–‹–Ǣ
ʹȌ †‡ƒŽ™‹–Š–Š‡…‘•‡“—‡…‡•Ǣ
„Ȍ ‡˜ƒŽ—ƒ–‡–Š‡‡‡†ˆ‘”ƒ…–‹‘–‘‡Ž‹‹ƒ–‡–Š‡…ƒ—•‡ȋ•Ȍ‘ˆ–Š‡‘…‘ˆ‘”‹–›ǡ‹‘”†‡”–Šƒ–‹–†‘‡•‘–
‘‡‡Ž‹‹‹ Š‡…
‡……ƒ
”‡…—”‘”‘……—”‡Ž•‡™Š‡”‡ǡ„›ǣ
›
›ǣ
ͳȌ ”‡˜‹‡™‹‰ƒ†ƒƒŽ›•‹‰–Š‡‘…‘ˆ‘”‹–›Ǣ
•‹‰
‰–Š …‘
…‘
‘ˆ
ʹȌ †‡–‡”‹‹‰–Š‡…ƒ—•‡•‘ˆ–Š‡‘…‘ˆ‘”‹–›Ǣ
ƒ—• • Š‡‘
‘…
‘
͵Ȍ †‡–‡”‹‹‰‹ˆ•‹‹Žƒ”‘…‘ˆ‘”‹–‹‡•‡š‹•–ǡ‘”…‘—Ž†’‘–‡–‹ƒŽŽ›‘……—”Ǣ
•‹‹Ž
‹Ž …‘
‘ˆ‘”
…Ȍ ‹’Ž‡‡–ƒ›ƒ…–‹‘‡‡†‡†Ǣ
–‹‘
–‹‘ ‡†
†Ȍ ”‡˜‹‡™–Š‡‡ˆˆ‡…–‹˜‡‡••‘ˆƒ›…‘””‡…–‹˜‡ƒ…–‹‘–ƒ‡Ǣ
‡…–‹
–‹˜ ‘ˆƒ
ˆ ƒ
‡Ȍ —’†ƒ–‡”‹••ƒ†‘’’‘”–—‹–‹‡•†‡–‡”‹‡††—”‹‰’Žƒ‹‰ǡ‹ˆ‡…‡••ƒ”›Ǣ
•ƒ
•ƒ ‘”” –—
‘”–
ˆȌ ƒ‡…Šƒ‰‡•–‘–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡ǡ‹ˆ‡…‡••ƒ”›Ǥ
…Šƒ‰
‰‡ –Š
Š‡“—
‡“
Corrective actions shall be appropriate to the effects of the nonconformities encountered.

10.2.2 The organization shall retain documented information as evidence of:

ƒȌ –Š‡ƒ–—”‡‘ˆ–Š‡‘…‘ˆ‘”‹–‹‡•ƒ†ƒ›•—„•‡“—‡–ƒ…–‹‘•–ƒ‡Ǣ
„Ȍ –Š‡”‡•—Ž–•‘ˆƒ›…‘””‡…–‹˜‡ƒ…–‹‘Ǥ

10.3 Continual improvement

Š‡ ‘”‰ƒ‹œƒ–‹‘ •ŠƒŽŽ …‘–‹—ƒŽŽ› ‹’”‘˜‡ –Š‡ •—‹–ƒ„‹Ž‹–›ǡ ƒ†‡“—ƒ…› ƒ† ‡ˆˆ‡…–‹˜‡‡•• ‘ˆ –Š‡ “—ƒŽ‹–›
ƒƒ‰‡‡–•›•–‡Ǥ

19
IS/ISO 9001 : 2015

Š‡ ‘”‰ƒ‹œƒ–‹‘ •ŠƒŽŽ …‘•‹†‡” –Š‡ ”‡•—Ž–• ‘ˆ ƒƒŽ›•‹• ƒ† ‡˜ƒŽ—ƒ–‹‘ǡ ƒ† –Š‡ ‘—–’—–• ˆ”‘
management review, to determine if there are needs or opportunities that shall be addressed as part of
continual improvement.

20
 IS/ISO 9001 : 2015

Annex A
(informative)

Žƒ”‹ϐ‹…ƒ–‹‘‘ˆ‡™•–”—…–—”‡ǡ–‡”‹‘Ž‘‰›ƒ†…‘…‡’–•

A.1 Structure and terminology

Š‡ …Žƒ—•‡ •–”—…–—”‡ ȋ‹Ǥ‡Ǥ …Žƒ—•‡ •‡“—‡…‡Ȍ ƒ† •‘‡ ‘ˆ –Š‡
Š‡
‡ –‡
–‡”‹‘Ž‘‰› ‘ˆ –Š‹• ‡†‹–‹‘ ‘ˆ –Š‹•
International Standard, in comparison with the previous edition ition (ISO
on ((I 9001:2008), have been changed
–‘‹’”‘˜‡ƒŽ‹‰‡–™‹–Š‘–Š‡”ƒƒ‰‡‡–•›•–‡••–ƒ†ƒ”†•Ǥ†ƒ”†
ƒ”†•
Š‡”‡‹•‘”‡“—‹”‡‡–‹–Š‹•–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†ˆ‘”‹–••–”—…–—”‡ƒ†–‡”‹‘Ž‘‰›–‘„‡ƒ’’Ž‹‡†
‘”‹–•
–‘–Š‡†‘…—‡–‡†‹ˆ‘”ƒ–‹‘‘ˆƒ‘”‰ƒ‹œƒ–‹‘ǯ•“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǥ
—ƒŽ‹–›
›
The structure of clauses is intended to provide a coherent
he en presentation of requirements, rather than a
oheren
‘†‡Žˆ‘”†‘…—‡–‹‰ƒ‘”‰ƒ‹œƒ–‹‘ǯ•’‘Ž‹…‹‡•ǡ‘„Œ‡…–‹˜‡•ƒ†’”‘…‡••‡•ǤŠ‡•–”—…–—”‡ƒ†…‘–‡–
ǡ‘„
„Œ‡…
‘ˆ†‘…—‡–‡†‹ˆ‘”ƒ–‹‘”‡Žƒ–‡†–‘ƒ“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡…ƒ‘ˆ–‡„‡‘”‡”‡Ž‡˜ƒ––‘‹–•
ƒ ƒ –•›
—•‡”•‹ˆ‹–”‡Žƒ–‡•–‘„‘–Š–Š‡’”‘…‡••‡•‘’‡”ƒ–‡†„›–Š‡‘”‰ƒ‹œƒ–‹‘ƒ†‹ˆ‘”ƒ–‹‘ƒ‹–ƒ‹‡†ˆ‘”
ƒ–‡†
† „› ‘”‰ƒ
”‰‰ƒ
other purposes.
Š‡”‡‹•‘”‡“—‹”‡‡–ˆ‘”–Š‡–‡”•—•‡†„›ƒ‘”‰ƒ‹œƒ–‹‘–‘„‡”‡’Žƒ…‡†„›–Š‡–‡”•—•‡†‹–Š‹•
‡†„›
„› ƒ ”‰ƒ‹
”‰‰ƒ
ƒ‹œ
–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†–‘•’‡…‹ˆ›“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡”‡“—‹”‡‡–•Ǥ”‰ƒ‹œƒ–‹‘•…ƒ…Š‘‘•‡
›ƒ
ƒ ‡–
‡––•
to use terms which suit their operations
ion ((e.g. us
tions using
ing ““records”, “documentation” or “protocols” rather
–ŠƒDz†‘…—‡–‡†‹ˆ‘”ƒ–‹‘dzǢ‘”Dz•—’’Ž‹‡”dzǡDz’ƒ”–‡”dz‘”Dz˜‡†‘”dz”ƒ–Š‡”–ŠƒDz‡š–‡”ƒŽ’”‘˜‹†‡”dzȌǤ
•—’ Dz’ƒ
’ƒ” –
Table A.1 •Š‘™• –Š‡ ƒŒ‘” †‹ˆˆ‡”‡…‡•
‡”‡
‡…‡ ‹ –‡”‹‘Ž‘‰›
‡”‹ „‡–™‡‡ –Š‹• ‡†‹–‹‘ ‘ˆ –Š‹• –‡”ƒ–‹‘ƒŽ
on
on.
Standard and the previous edition.

erenc in term
Table A.1 — Major differences errm
terminology between ISO 9001:2008 and ISO 9001:2015
ISO 9001:2008
:20 ISO 9001:2015
Products Products and services
Exclusions Not used
(See Clause A.5ˆ‘”…Žƒ”‹ϐ‹…ƒ–‹‘‘ˆƒ’’Ž‹…ƒ„‹Ž‹–›Ȍ
Management representative
epr
pres ve Not used
(Similar responsibilities and authorities are assigned
but no requirement for a single management repre-
sentative)
‘…—‡–ƒ–‹‘ǡ“—ƒŽ‹–›ƒ—ƒŽǡ†‘…—‡–‡†’”‘- Documented information
cedures, records
Work environment Environment for the operation of processes
Monitoring and measuring equipment Monitoring and measuring resources
Purchased product š–‡”ƒŽŽ›’”‘˜‹†‡†’”‘†—…–•ƒ†•‡”˜‹…‡•
Supplier External provider

A.2 Products and services

ISO 9001:2008 used the term “product” to include all output categories. This edition of this International
Standard uses “products and services”. “Products and services” include all output categories (hardware,
services, software and processed materials).
21
IS/ISO 9001 : 2015

Š‡ •’‡…‹ϐ‹… ‹…Ž—•‹‘ ‘ˆ Dz•‡”˜‹…‡•dz ‹• ‹–‡†‡† –‘ Š‹‰ŠŽ‹‰Š– –Š‡ †‹ˆˆ‡”‡…‡• „‡–™‡‡ ’”‘†—…–• ƒ†
services in the application of some requirements. The characteristic of services is that at least part of
–Š‡‘—–’—–‹•”‡ƒŽ‹œ‡†ƒ––Š‡‹–‡”ˆƒ…‡™‹–Š–Š‡…—•–‘‡”ǤŠ‹•‡ƒ•ǡˆ‘”‡šƒ’Ž‡ǡ–Šƒ–…‘ˆ‘”‹–›–‘
”‡“—‹”‡‡–•…ƒ‘–‡…‡••ƒ”‹Ž›„‡…‘ϐ‹”‡†„‡ˆ‘”‡•‡”˜‹…‡†‡Ž‹˜‡”›Ǥ
In most cases, products and services are used together. Most outputs that organizations provide to
…—•–‘‡”•ǡ ‘” ƒ”‡ •—’’Ž‹‡† –‘ –Š‡ „› ‡š–‡”ƒŽ ’”‘˜‹†‡”•ǡ ‹…Ž—†‡ „‘–Š ’”‘†—…–• ƒ† •‡”˜‹…‡•Ǥ ‘”
example, a tangible or intangible product can have some associated service or a service can have some
associated tangible or intangible product.

A.3 Understanding the needs and expectations of interested parties

Subclause 4.2 •’‡…‹ϐ‹‡• ”‡“—‹”‡‡–• ˆ‘” –Š‡ ‘”‰ƒ‹œƒ–‹‘ –‘ †‡–‡”‹‡
”
‹‡ –Š‡ ‹–‡”‡•–‡† ’ƒ”–‹‡• –Šƒ–
‹‡
ƒ”‡ ”‡Ž‡˜ƒ– –‘ –Š‡ “—ƒŽ‹–› ƒƒ‰‡‡– •›•–‡ ƒ† –Š‡ ”‡“—‹”‡‡–•
‡– ‘ˆ –Š‘•‡ ‹–‡”‡•–‡† ’ƒ”–‹‡•Ǥ
However, 4.2†‘‡•‘–‹’Ž›‡š–‡•‹‘‘ˆ“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡”‡“—‹”‡‡–•„‡›‘†–Š‡•…‘’‡
–‡”
of this International Standard. As stated in the scope, this International
rnati Standard is applicable where
ƒ ‘”‰ƒ‹œƒ–‹‘ ‡‡†• –‘ †‡‘•–”ƒ–‡ ‹–• ƒ„‹Ž‹–› –‘ …‘•‹•–‡–Ž›
‡–Ž› ’”‘˜‹†‡ ’”‘†—…–• ƒ† •‡”˜‹…‡• –Šƒ–
Ž› ’
‡‡–…—•–‘‡”ƒ†ƒ’’Ž‹…ƒ„Ž‡•–ƒ–—–‘”›ƒ†”‡‰—Žƒ–‘”›”‡“—‹”‡‡–•ǡƒ†ƒ‹•–‘‡Šƒ…‡…—•–‘‡”
“—‹”‡
‹”‡
satisfaction.
There is no requirement in this International Standard ardd for
f the organization
organ to consider interested
’ƒ”–‹‡•™Š‡”‡‹–Šƒ•†‡…‹†‡†–Šƒ––Š‘•‡’ƒ”–‹‡•ƒ”‡‘–”‡Ž‡˜ƒ––‘‹–•“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǥ–‹•
–”‡
”‡Ž‡˜ ‘‹–
‹–•“
ˆ‘”–Š‡‘”‰ƒ‹œƒ–‹‘–‘†‡…‹†‡‹ˆƒ’ƒ”–‹…—Žƒ””‡“—‹”‡‡–‘ˆƒ”‡Ž‡˜ƒ–‹–‡”‡•–‡†’ƒ”–›‹•”‡Ž‡˜ƒ––‘‹–•
‡– Ž‡˜ƒ
˜ƒ
“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǥ

A.4 Risk-based thinking

The concept of risk-based thinking has been en
n imp
implicit inn previous
pr
p
pre editions of this International Standard,
e.g. through requirements for planning, review and
ng, rre nd improvement. This International Standard
•’‡…‹ϐ‹‡•”‡“—‹”‡‡–•ˆ‘”–Š‡‘”‰ƒ‹œƒ–‹‘–‘—†‡”•–ƒ†‹–•…‘–‡š–ȋ•‡‡4.1)
œƒ–‹‘
‹‘ †‡”•”• and determine risks as
a basis for planning (see 6.1). This repr
represents
pre the
he aapplication of risk-based thinking to planning and
‹’Ž‡‡–‹‰“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡’”‘…‡••‡•ȋ•‡‡4.4)
–•›
–••›•–‡ ‘…‡•
…‡• and will assist in determining the extent
of documented information.
‡‘ˆ–Š‡‡›’—”’‘•‡•‘ˆƒ“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡‹•–‘ƒ…–ƒ•ƒ’”‡˜‡–‹˜‡–‘‘ŽǤ‘•‡“—‡–Ž›ǡ
“—ƒŽ
ƒŽ‹– ƒ‰
ƒ‰‡
this International Standard does
doe not have
do ve a separate clause or subclause on preventive action. The
haave
…‘…‡’–‘ˆ’”‡˜‡–‹˜‡ƒ…–‹‘‹•‡š’”‡••‡†–Š”‘—‰Š–Š‡—•‡‘ˆ”‹•Ǧ„ƒ•‡†–Š‹‹‰‹ˆ‘”—Žƒ–‹‰“—ƒŽ‹–›
‹•
‹
‹• ‡ ••‡†
‡†
ƒƒ‰‡‡–•›•–‡”‡“—‹”‡‡–•Ǥ
—‹”‡‡
The risk-based thinking ng applied
king
in edd in this International Standard has enabled some reduction in
’”‡•…”‹’–‹˜‡”‡“—‹”‡‡–•ƒ†–Š‡‹””‡’Žƒ…‡‡–„›’‡”ˆ‘”ƒ…‡Ǧ„ƒ•‡†”‡“—‹”‡‡–•ǤŠ‡”‡‹•‰”‡ƒ–‡”
”‡‡‡– † –Š‡
– Š‡
Š‡‹”
ϐŽ‡š‹„‹Ž‹–› –Šƒ ‹
 
 ͻͲͲͳǣʹͲͲͺ

 ǣʹ
ʹͲͲͺͲͺ ‹ –Š‡ ”‡“—‹”‡‡–• ˆ‘” ’”‘…‡••‡•ǡ †‘…—‡–‡† ‹ˆ‘”ƒ–‹‘ ƒ†
organizational responsibilities.
pon es.
Although 6.1•’‡…‹ϐ‹‡•–Šƒ––Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ’Žƒƒ…–‹‘•–‘ƒ††”‡••”‹••ǡ–Š‡”‡‹•‘”‡“—‹”‡‡–
for formal methods for risk management or a documented risk management process. Organizations can
†‡…‹†‡™Š‡–Š‡”‘”‘––‘†‡˜‡Ž‘’ƒ‘”‡‡š–‡•‹˜‡”‹•ƒƒ‰‡‡–‡–Š‘†‘Ž‘‰›–Šƒ‹•”‡“—‹”‡†„›
this International Standard, e.g. through the application of other guidance or standards.
‘–ƒŽŽ–Š‡’”‘…‡••‡•‘ˆƒ“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡”‡’”‡•‡––Š‡•ƒ‡Ž‡˜‡Ž‘ˆ”‹•‹–‡”•‘ˆ–Š‡
‘”‰ƒ‹œƒ–‹‘ǯ• ƒ„‹Ž‹–› –‘ ‡‡– ‹–• ‘„Œ‡…–‹˜‡•ǡ ƒ† –Š‡ ‡ˆˆ‡…–• ‘ˆ —…‡”–ƒ‹–› ƒ”‡ ‘– –Š‡ •ƒ‡ ˆ‘” ƒŽŽ
organizations. Under the requirements of 6.1, the organization is responsible for its application of risk-
based thinking and the actions it takes to address risk, including whether or not to retain documented
information as evidence of its determination of risks.

22
 IS/ISO 9001 : 2015

A.5 Applicability
Š‹• –‡”ƒ–‹‘ƒŽ –ƒ†ƒ”† †‘‡• ‘– ”‡ˆ‡” –‘ Dz‡š…Ž—•‹‘•dz ‹ ”‡Žƒ–‹‘ –‘ –Š‡ ƒ’’Ž‹…ƒ„‹Ž‹–› ‘ˆ ‹–•
”‡“—‹”‡‡–•–‘–Š‡‘”‰ƒ‹œƒ–‹‘ǯ•“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǥ‘™‡˜‡”ǡƒ‘”‰ƒ‹œƒ–‹‘…ƒ”‡˜‹‡™
–Š‡ ƒ’’Ž‹…ƒ„‹Ž‹–› ‘ˆ ”‡“—‹”‡‡–• †—‡ –‘ –Š‡ •‹œ‡ ‘” …‘’Ž‡š‹–› ‘ˆ –Š‡ ‘”‰ƒ‹œƒ–‹‘ǡ –Š‡ ƒƒ‰‡‡–
model it adopts, the range of the organization’s activities and the nature of the risks and opportunities
it encounters.
Š‡ ”‡“—‹”‡‡–• ˆ‘” ƒ’’Ž‹…ƒ„‹Ž‹–› ƒ”‡ ƒ††”‡••‡† ‹ 4.3ǡ ™Š‹…Š †‡ϐ‹‡• …‘†‹–‹‘• —†‡” ™Š‹…Š ƒ
‘”‰ƒ‹œƒ–‹‘…ƒ†‡…‹†‡–Šƒ–ƒ”‡“—‹”‡‡–…ƒ‘–„‡ƒ’’Ž‹‡†–‘ƒ›‘ˆ–Š‡’”‘…‡••‡•™‹–Š‹–Š‡•…‘’‡
‘ˆ‹–•“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡ǤŠ‡‘”‰ƒ‹œƒ–‹‘…ƒ‘Ž›†‡…‹†‡–Šƒ–ƒ”‡“—‹”‡‡–‹•‘–ƒ’’Ž‹…ƒ„Ž‡
‹ˆ‹–•†‡…‹•‹‘™‹ŽŽ‘–”‡•—Ž–‹ˆƒ‹Ž—”‡–‘ƒ…Š‹‡˜‡…‘ˆ‘”‹–›‘ˆ’”‘†—…–•ƒ†•‡”˜‹…‡•Ǥ

A.6 Documented information

•’ƒ”–‘ˆ–Š‡ƒŽ‹‰‡–™‹–Š‘–Š‡”ƒƒ‰‡‡–•›•–‡•–ƒ†ƒ”†•ǡƒ…‘‘…Žƒ—•‡‘Dz†‘…—‡–‡†
•–ƒ†
‹ˆ‘”ƒ–‹‘dz Šƒ• „‡‡ ƒ†‘’–‡† ™‹–Š‘—– •‹‰‹ϐ‹…ƒ– …Šƒ‰‡
‰‡ ‘”
Šƒ‰‡ ‘ ƒ††‹–‹‘ ȋ•‡‡ 7.5). Where appropriate,
–‡š– ‡Ž•‡™Š‡”‡ ‹ –Š‹• –‡”ƒ–‹‘ƒŽ –ƒ†ƒ”† Šƒ• „‡‡
‡ ƒŽ‹‰‡†
‡‡ ƒŽ‹ ™‹–Š ‹–• ”‡“—‹”‡‡–•Ǥ ‘•‡“—‡–Ž›ǡ
“documented information” is used for all document requirements.
requir
requi
Š‡”‡  ͻͲͲͳǣʹͲͲͺ —•‡† •’‡…‹ϐ‹… –‡”‹‘Ž‘‰›
‰› •—…Š ƒ• Dz†‘…
› ••— Dz†‘…—‡–dz ‘” Dz†‘…—‡–‡† ’”‘…‡†—”‡•dzǡ
Dz“—ƒŽ‹–›ƒ—ƒŽdz‘”Dz“—ƒŽ‹–›’Žƒdzǡ–Š‹•‡†‹–‹‘‘ˆ–Š‹•–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”††‡ϐ‹‡•”‡“—‹”‡‡–•–‘
‘ˆ
‘ˆ–Š ‡”
”ƒ–
“maintain documented information”.
Where ISO 9001:2008 used the term “records” ord to
recor
cord denote
o denno documents needed to provide evidence
en
‘ˆ …‘ˆ‘”‹–› ™‹–Š ”‡“—‹”‡‡–•ǡ –Š‹• ‹• ‘
‘™ ‡š’”‡••‡†
’”‡•
’”‡
”‡• ƒ• ƒ ”‡“—‹”‡‡– –‘ Dz”‡–ƒ‹ †‘…—‡–‡†
information”. The organization is responsible
pon ib for dete
po determining
eter
t what documented information needs to
be retained, the period of time for which
ich it is to b
hich bee retained
rre and the media to be used for its retention.
 ”‡“—‹”‡‡– –‘ Dzƒ‹–ƒ‹dz †‘…—‡–‡†
†‘…—   ‹ˆ‘”ƒ–‹‘
‹ˆ
ˆ‘
ˆ‘ †‘‡• ‘– ‡š…Ž—†‡ –Š‡ ’‘••‹„‹Ž‹–› –Šƒ– –Š‡
organization might also need to “re “retain”
“ret that
hatt same
s documented information for a particular purpose,
e.g. to retain previous versions
nss of it.
o it
Where this International Standard
tand
an refers
eferss to
t “information” rather than “documented information” (e.g. in
4.1: “The organization shall
ll m
monitor
mon and
d review
rev
r the information about these external and internal issues”),
there is no requirementt tha
ha this info
that information
nfor is to be documented. In such situations, the organization
…ƒ†‡…‹†‡™Š‡–Š‡”‘”‘–‹–‹•‡…‡••ƒ”›‘”ƒ’’”‘’”‹ƒ–‡–‘ƒ‹–ƒ‹†‘…—‡–‡†‹ˆ‘”ƒ–‹‘Ǥ
”‘–
‘ ‹– ‡…‡••ƒ
॥

A.7 Organizational
atio
ion knowledge
now
In 7.1.6, this In
International
nt
nter onal
naal Standard addresses the need to determine and manage the knowledge
ƒ‹–ƒ‹‡† „›
„› –Š‡
„ – ‘”‰ƒ‹œƒ–‹‘ǡ
‰ƒ
‰ƒ ‹œ –‘ ‡•—”‡ –Š‡ ‘’‡”ƒ–‹‘ ‘ˆ ‹–• ’”‘…‡••‡• ƒ† –Šƒ– ‹– …ƒ ƒ…Š‹‡˜‡
…‘ˆ‘”‹–›‘ˆ’”‘†—…–•ƒ†•‡”˜‹…‡•Ǥ
›‘ˆ’ –•ƒƒ
Requirements regarding organizational knowledge were introduced for the purpose of:
a) safeguarding the organization from loss of knowledge, e.g.
Ȅ –Š”‘—‰Š•–ƒˆˆ–—”‘˜‡”Ǣ
Ȅ ˆƒ‹Ž—”‡–‘…ƒ’–—”‡ƒ†•Šƒ”‡‹ˆ‘”ƒ–‹‘Ǣ
b) encouraging the organization to acquire knowledge, e.g.
Ȅ Ž‡ƒ”‹‰ˆ”‘‡š’‡”‹‡…‡Ǣ
Ȅ ‡–‘”‹‰Ǣ
— benchmarking.

23
IS/ISO 9001 : 2015

Ǥͺ ‘–”‘Ž‘ˆ‡š–‡”ƒŽŽ›’”‘˜‹†‡†’”‘…‡••‡•ǡ’”‘†—…–•ƒ†•‡”˜‹…‡•
ŽŽ ˆ‘”• ‘ˆ ‡š–‡”ƒŽŽ› ’”‘˜‹†‡† ’”‘…‡••‡•ǡ ’”‘†—…–• ƒ† •‡”˜‹…‡• ƒ”‡ ƒ††”‡••‡† ‹ 8.4, e.g. whether
through:
ƒȌ ’—”…Šƒ•‹‰ˆ”‘ƒ•—’’Ž‹‡”Ǣ
„Ȍ ƒƒ””ƒ‰‡‡–™‹–Šƒƒ••‘…‹ƒ–‡…‘’ƒ›Ǣ
c) outsourcing processes to an external provider.
—–•‘—”…‹‰ƒŽ™ƒ›•Šƒ•–Š‡‡••‡–‹ƒŽ…Šƒ”ƒ…–‡”‹•–‹…‘ˆƒ•‡”˜‹…‡ǡ•‹…‡‹–™‹ŽŽŠƒ˜‡ƒ–Ž‡ƒ•–‘‡ƒ…–‹˜‹–›
‰
‡…‡••ƒ”‹Ž›’‡”ˆ‘”‡†ƒ––Š‡‹–‡”ˆƒ…‡„‡–™‡‡–Š‡’”‘˜‹†‡”ƒ†–Š‡‘”‰ƒ‹œƒ–‹‘Ǥ
Š‡…‘–”‘Ž•”‡“—‹”‡†ˆ‘”‡š–‡”ƒŽ’”‘˜‹•‹‘…ƒ˜ƒ”›™‹†‡Ž›†‡’‡†‹‰‘–Š‡ƒ–—”‡‘ˆ–Š‡’”‘…‡••‡•ǡ
†‹‰
‰‘
‰ ‘
’”‘†—…–•ƒ†•‡”˜‹…‡•ǤŠ‡‘”‰ƒ‹œƒ–‹‘…ƒƒ’’Ž›”‹•Ǧ„ƒ•‡†–Š‹‹‰–‘†‡–‡”‹‡–Š‡–›’‡ƒ†‡š–‡–
‹‰–
‰ –‘
‘ˆ…‘–”‘Ž•ƒ’’”‘’”‹ƒ–‡–‘’ƒ”–‹…—Žƒ”‡š–‡”ƒŽ’”‘˜‹†‡”•ƒ†‡š–‡”ƒŽŽ›’”‘˜‹†‡†’”‘…‡••‡•ǡ’”‘†—…–•
”ƒŽŽ
and services.

24
 IS/ISO 9001 : 2015

Annex B
(informative)

Other International Standards on quality management and quality

management systems developed by ISO/TC 176

Š‡ –‡”ƒ–‹‘ƒŽ –ƒ†ƒ”†• †‡•…”‹„‡† ‹ –Š‹• ƒ‡š Šƒ˜‡ „‡‡ †‡˜‡Ž‘’‡† „› Ȁ ͳ͹͸ –‘ ’”‘˜‹†‡
•—’’‘”–‹‰ ‹ˆ‘”ƒ–‹‘ ˆ‘” ‘”‰ƒ‹œƒ–‹‘• –Šƒ– ƒ’’Ž› –Š‹• –‡”ƒ–‹‘ƒŽ
–‡”
–‡” –ƒ†ƒ”†ǡ ƒ† –‘ ’”‘˜‹†‡
‰—‹†ƒ…‡ˆ‘”‘”‰ƒ‹œƒ–‹‘•–Šƒ–…Š‘‘•‡–‘’”‘‰”‡••„‡›‘†‹–•”‡“—‹”‡‡–•Ǥ
—‹†ƒ…‡‘””‡“—‹”‡‡–•
”‡‡“—‹
”‡“—‹
…‘–ƒ‹‡† ‹ –Š‡ †‘…—‡–• Ž‹•–‡† ‹ –Š‹• ƒ‡š †‘ ‘– ƒ††
† –‘ǡ
–‘ǡ ‘” ‘†‹ˆ›ǡ –Š‡ ”‡“—‹”‡‡–• ‘ˆ –Š‹•
International Standard.
Table B.1 shows the relationship between these standards
sta
tand and the relevant clauses of this
International Standard.
Š‹• ƒ‡š †‘‡• ‘– ‹…Ž—†‡ ”‡ˆ‡”‡…‡ –‘ –Š‡ •‡…–‘”Ǧ•’‡…‹ϐ‹…
…–‘
–‘”Ǧ•’
‘” “—ƒŽ‹–› ƒƒ‰‡‡– •›•–‡ •–ƒ†ƒ”†•
†‡˜‡Ž‘’‡†„›Ȁͳ͹͸Ǥ
Š‹•–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†‹•‘‡‘ˆ–Š‡–Š”‡‡…‘”‡•–ƒ†ƒ”†•†‡˜‡Ž‘’‡†„›Ȁͳ͹͸Ǥ
‡…‘” †ƒƒ”†
ƒ”†
— ISO 9000 Quality management systems mss — Fundamentals
dame
me and vocabulary provides an essential
background for the proper understandingtandin and
sta nd implementation
d imp
im
m of this International Standard.
Š‡“—ƒŽ‹–›ƒƒ‰‡‡–’”‹…‹’Ž‡•ƒ”‡†‡•…”‹„‡†‹†‡–ƒ‹Ž‹ͻͲͲͲƒ†Šƒ˜‡„‡‡–ƒ‡‹–‘
‡• ƒ”‡‡ ”‹„‡
„‡†
„‡†
consideration during the development
opmen
pm of this
thhis IInternational Standard. These principles are not
”‡“—‹”‡‡–• ‹ –Š‡•‡Ž˜‡•ǡ „—–
—– –Š‡›
–Š‡ ˆ‘”
–Š  –Š‡
 – Š ˆ‘—†ƒ–‹‘ ‘ˆ –Š‡ ”‡“—‹”‡‡–• •’‡…‹ϐ‹‡† „› –Š‹•
–Š
–‡”ƒ–‹‘ƒŽ –ƒ†ƒ”†Ǥ  ͻͲͲͲ
ͲͲ ƒŽ•‘ †‡ϐ‹‡•
ͻͲͲͲ ϐ‹ –Š‡ –‡”•ǡ †‡ϐ‹‹–‹‘• ƒ† …‘…‡’–• —•‡† ‹ –Š‹•
†‡ϐ‹
‡ϐ‹
International Standard.
— ISO 9001ȋ–Š‹•–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†Ȍ•’‡…‹ϐ‹‡•”‡“—‹”‡‡–•ƒ‹‡†’”‹ƒ”‹Ž›ƒ–‰‹˜‹‰…‘ϐ‹†‡…‡‹
ƒŽ–– †Ȍ•
†Ȍ
Ȍ ••’
–Š‡’”‘†—…–•ƒ†•‡”˜‹…‡•’”‘˜‹†‡†„›ƒ‘”‰ƒ‹œƒ–‹‘ƒ†–Š‡”‡„›‡Šƒ…‹‰…—•–‘‡”•ƒ–‹•ˆƒ…–‹‘Ǥ
…‡•’”‘ ‡†„›
…‡• „›ƒƒ
„›
–• ’”‘’‡” ‹’Ž‡‡–ƒ–‹‘
–ƒ–‹‘ …ƒ ƒŽ•‘
Ž•‘ „‡ ‡š’‡…–‡† –‘ „”‹‰ ‘–Š‡” ‘”‰ƒ‹œƒ–‹‘ƒŽ „‡‡ϐ‹–•ǡ •—…Š ƒ•
improved internal com
communication,
mm tio
ion better understanding and control of the organization’s processes.
n be
— ISO 9004 Managingginng ffor the sus
sustained
sttai success of an organization — A quality management approach
’”‘˜‹†‡• ‰—‹†ƒ…‡
… ˆ‘” ‘”‰ƒ‹œƒ–‹‘•
ƒ…
…‡ ”‰‰ƒ‹ –Šƒ– …Š‘‘•‡ –‘ ’”‘‰”‡•• „‡›‘† –Š‡ ”‡“—‹”‡‡–• ‘ˆ –Š‹•
International
all Standard,
St
SSta , to address
a a broader range of topics that can lead to improvement of the
‘”‰ƒ‹œƒ–‹‘ǯ•‘˜‡”ƒŽŽ’‡”ˆ‘”ƒ…‡ǤͻͲͲͶ‹…Ž—†‡•‰—‹†ƒ…‡‘ƒ•‡ŽˆǦƒ••‡••‡–‡–Š‘†‘Ž‘‰›
‘
ǯ•‘
• ’ ˆ
’‡”
ˆ‘”ƒ‘”‰ƒ‹œƒ–‹‘–‘„‡ƒ„Ž‡–‘‡˜ƒŽ—ƒ–‡–Š‡Ž‡˜‡Ž‘ˆƒ–—”‹–›‘ˆ‹–•“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǥ
‰ƒ
‹œ –‘„‡
–‘
‘„
Š‡ –‡”ƒ–‹‘ƒŽ
ƒ–‹‘ –ƒ†ƒ”†•
ƒ†
†ƒ
†ƒ ‘—–Ž‹‡† „‡Ž‘™ …ƒ ’”‘˜‹†‡ ƒ••‹•–ƒ…‡ –‘ ‘”‰ƒ‹œƒ–‹‘• ™Š‡ –Š‡› ƒ”‡
‡•–ƒ„Ž‹•Š‹‰‘”•‡‡‹‰–‘‹’”‘˜‡–Š‡‹”“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡•ǡ–Š‡‹”’”‘…‡••‡•‘”–Š‡‹”ƒ…–‹˜‹–‹‡•Ǥ
— ISO 10001 Quality management — Customer satisfaction — Guidelines for codes of conduct for
organizations provides guidance to an organization in determining that its customer satisfaction
’”‘˜‹•‹‘•‡‡–…—•–‘‡”‡‡†•ƒ†‡š’‡…–ƒ–‹‘•Ǥ–•—•‡…ƒ‡Šƒ…‡…—•–‘‡”…‘ϐ‹†‡…‡‹ƒ
‘”‰ƒ‹œƒ–‹‘ƒ†‹’”‘˜‡…—•–‘‡”—†‡”•–ƒ†‹‰‘ˆ™Šƒ––‘‡š’‡…–ˆ”‘ƒ‘”‰ƒ‹œƒ–‹‘ǡ–Š‡”‡„›
reducing the likelihood of misunderstandings and complaints.
— ISO 10002 Quality management — Customer satisfaction — Guidelines for complaints handling
in organizations ’”‘˜‹†‡• ‰—‹†ƒ…‡ ‘ –Š‡ ’”‘…‡•• ‘ˆ Šƒ†Ž‹‰ …‘’Žƒ‹–• „› ”‡…‘‰‹œ‹‰ ƒ†
ƒ††”‡••‹‰ –Š‡ ‡‡†• ƒ† ‡š’‡…–ƒ–‹‘• ‘ˆ …‘’Žƒ‹ƒ–• ƒ† ”‡•‘Ž˜‹‰ ƒ› …‘’Žƒ‹–• ”‡…‡‹˜‡†Ǥ
 ͳͲͲͲʹ ’”‘˜‹†‡• ƒ ‘’‡ǡ ‡ˆˆ‡…–‹˜‡ ƒ† ‡ƒ•›Ǧ–‘Ǧ—•‡ …‘’Žƒ‹–• ’”‘…‡••ǡ ‹…Ž—†‹‰ –”ƒ‹‹‰ ‘ˆ
people. It also provides guidance for small businesses.
— ISO 10003 Quality management — Customer satisfaction — Guidelines for dispute resolution external
to organizations ’”‘˜‹†‡• ‰—‹†ƒ…‡ ˆ‘” ‡ˆˆ‡…–‹˜‡ ƒ† ‡ˆϐ‹…‹‡– ‡š–‡”ƒŽ †‹•’—–‡ ”‡•‘Ž—–‹‘ ˆ‘”
25
IS/ISO 9001 : 2015

product-related complaints. Dispute resolution gives an avenue of redress when organizations

†‘ ‘– ”‡‡†› ƒ …‘’Žƒ‹– ‹–‡”ƒŽŽ›Ǥ ‘•– …‘’Žƒ‹–• …ƒ „‡ ”‡•‘Ž˜‡† •—……‡••ˆ—ŽŽ› ™‹–Š‹ –Š‡
organization, without adversarial procedures.
— ISO 10004 Quality management — Customer satisfaction — Guidelines for monitoring and measuring
provides guidelines for actions to enhance customer satisfaction and to determine opportunities for
‹’”‘˜‡‡–‘ˆ’”‘†—…–•ǡ’”‘…‡••‡•ƒ†ƒ––”‹„—–‡•–Šƒ–ƒ”‡˜ƒŽ—‡†„›…—•–‘‡”•Ǥ—…Šƒ…–‹‘•…ƒ
•–”‡‰–Š‡…—•–‘‡”Ž‘›ƒŽ–›ƒ†Š‡Ž’”‡–ƒ‹…—•–‘‡”•Ǥ
— ISO 10005 Quality management systems — Guidelines for quality plans provides guidance on
‡•–ƒ„Ž‹•Š‹‰ƒ†—•‹‰“—ƒŽ‹–›’Žƒ•ƒ•ƒ‡ƒ•‘ˆ”‡Žƒ–‹‰”‡“—‹”‡‡–•‘ˆ–Š‡’”‘…‡••ǡ’”‘†—…–ǡ
’”‘Œ‡…– ‘” …‘–”ƒ…–ǡ –‘ ™‘” ‡–Š‘†• ƒ† ’”ƒ…–‹…‡• –Šƒ– •—’’‘”– ’”‘†—…– ”‡ƒŽ‹œƒ–‹‘Ǥ ‡‡ϐ‹–• ‘ˆ
‡•–ƒ„Ž‹•Š‹‰ƒ“—ƒŽ‹–›’Žƒƒ”‡‹…”‡ƒ•‡†…‘ϐ‹†‡…‡–Šƒ–”‡“—‹”‡‡–•™‹ŽŽ„‡‡–ǡ–Šƒ–’”‘…‡••‡•
‡–
‡
are in control and the motivation that this can give to those involved.
lve
ved.
ed.
— ISO 10006 Quality management systems — Guidelines for qualityy management
man in projects is applicable
–‘’”‘Œ‡…–•ˆ”‘–Š‡•ƒŽŽ–‘Žƒ”‰‡ǡˆ”‘•‹’Ž‡–‘…‘’Ž‡šǡˆ”‘ƒ‹†‹˜‹†—ƒŽ’”‘Œ‡…––‘„‡‹‰’ƒ”–
ˆ”‘ ƒ
‘ˆƒ’‘”–ˆ‘Ž‹‘‘ˆ’”‘Œ‡…–•ǤͳͲͲͲ͸‹•–‘„‡—•‡†„›’‡”•‘‡Žƒƒ‰‹‰’”‘Œ‡…–•ƒ†™Š‘‡‡†–‘
‘‡Ž
‡Ž
‡•—”‡–Šƒ––Š‡‹”‘”‰ƒ‹œƒ–‹‘‹•ƒ’’Ž›‹‰–Š‡’”ƒ…–‹…‡•…‘–ƒ‹‡†‹–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–
…‘
…‘–ƒ
•›•–‡•–ƒ†ƒ”†•Ǥ
— ISO 10007 —ƒŽ‹–› ƒƒ‰‡‡– •›•–‡• Ȅ
—‹†‡Ž‹‡• ‡• ˆ‘”
Ž‹‡• ˆ …‘ϔ‹‰—”ƒ–‹‘
ϔ‹‰—” ƒƒ‰‡‡– is to assist
‘”‰ƒ‹œƒ–‹‘•ƒ’’Ž›‹‰…‘ϐ‹‰—”ƒ–‹‘ƒƒ‰‡‡–ˆ‘”–Š‡–‡…Š‹…ƒŽƒ†ƒ†‹‹•–”ƒ–‹˜‡†‹”‡…–‹‘
–
–ˆ‘” ‡…Š
…Š‹…
‘˜‡” –Š‡ Ž‹ˆ‡ …›…Ž‡ ‘ˆ ƒ ’”‘†—…–Ǥ ‘ϐ‹‰—”ƒ–‹‘ ƒƒ‰‡‡–
 ƒ – ……ƒ „‡ —•‡† –‘ ‡‡– –Š‡ ’”‘†—…–
‡–
‹†‡–‹ϐ‹…ƒ–‹‘ƒ†–”ƒ…‡ƒ„‹Ž‹–›”‡“—‹”‡‡–••’‡…‹ϐ‹‡†‹–Š‹•–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†Ǥ
’
’‡…‹ϐ – ••
— ISO 10008 Quality management — Customer satisfaction
mer sa ion — Guidelines for business-to-consumer
ction
tio
electronic commerce transactions gives guidance
uid nc on how wo organizations can implement an effective
ƒ† ‡ˆϐ‹…‹‡– „—•‹‡••Ǧ–‘Ǧ…‘•—‡” ‡Ž‡…–”‘‹…
‡…–”‘
‡…– …‘‡”…‡
‘ –”ƒ•ƒ…–‹‘ ȋʹ Ȍ •›•–‡ǡ ƒ†
–Š‡”‡„›’”‘˜‹†‡ƒ„ƒ•‹•ˆ‘”…‘•—‡”•–‘Šƒ˜‡‹…”‡ƒ•‡†…‘ϐ‹†‡…‡‹ʹ•ǡ‡Šƒ…‡–Š‡ƒ„‹Ž‹–›
•––‘Šƒ˜ ”‡ƒ•
‡ƒƒ•‡
‘ˆ‘”‰ƒ‹œƒ–‹‘•–‘•ƒ–‹•ˆ›…‘•—‡”•ƒ†Š‡Ž’”‡†—…‡…‘’Žƒ‹–•ƒ††‹•’—–‡•Ǥ
”•ƒ†
† ”‡†—
†—…
— ISO 10012 Measurement management emen systems
gem ms — Requirements for measurement processes and
ems
em
measuring equipment provides guidance for
ess guid or the management of measurement processes and
‡–”‘Ž‘‰‹…ƒŽ…‘ϐ‹”ƒ–‹‘‘ˆ‡ƒ•—”‹‰‡“—‹’‡–—•‡†–‘•—’’‘”–ƒ††‡‘•–”ƒ–‡…‘’Ž‹ƒ…‡
‡ ‰‡“—
‡“—‹’
™‹–Š‡–”‘Ž‘‰‹…ƒŽ”‡“—‹”‡‡–•ǤͳͲͲͳʹ’”‘˜‹†‡•“—ƒŽ‹–›ƒƒ‰‡‡–…”‹–‡”‹ƒˆ‘”ƒ‡ƒ•—”‡‡–
‡–•
–  Ͳͳʹ
Ͳͳʹ’”
ƒƒ‰‡‡–•›•–‡–‘‡•—”‡‡–”‘Ž‘‰‹…ƒŽ”‡“—‹”‡‡–•ƒ”‡‡–Ǥ
•—”‡
—”‡
”‡ ‘Ž‘‰
Ž‘‰
‘‰‹
— ISO/TR 10013 Guidelines
nes for quality
ess ffo ality management system documentation provides guidelines for
ityy m
–Š‡ †‡˜‡Ž‘’‡– ƒ†
† ƒ‹–‡ƒ…‡
ƒ
 ƒ……‡ ‘ˆ –Š‡ †‘…—‡–ƒ–‹‘ ‡…‡••ƒ”› ˆ‘” ƒ “—ƒŽ‹–› ƒƒ‰‡‡–
…‡
•›•–‡Ǥ ISO/TR ͳͲͲͳ͵
͵ ……ƒ „‡
Ͳͳ͵ —•‡† –‘ †‘…—‡– ƒƒ‰‡‡– •›•–‡• ‘–Š‡” –Šƒ –Š‘•‡ ‘ˆ –Š‡
‡ —•‡
—
“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡•–ƒ†ƒ”†•ǡ‡Ǥ‰Ǥ‡˜‹”‘‡–ƒŽƒƒ‰‡‡–•›•–‡•ƒ†•ƒˆ‡–›
‰‡‡
‰‡ ›•–‡
•––‡
ƒƒ‰‡‡–•›•–‡•Ǥ
•›•–‡
›•
— ISO 10014 —ƒŽ‹–›ƒƒ‰‡‡–Ȅ
—‹†‡Ž‹‡•ˆ‘””‡ƒŽ‹œ‹‰ϔ‹ƒ…‹ƒŽƒ†‡…‘‘‹…„‡‡ϔ‹–•
ƒŽ‹–› ‰‡ is addressed
–‘–‘’ƒƒ‰‡‡–Ǥ–’”‘˜‹†‡•‰—‹†‡Ž‹‡•ˆ‘””‡ƒŽ‹œ‹‰ϐ‹ƒ…‹ƒŽƒ†‡…‘‘‹…„‡‡ϐ‹–•–Š”‘—‰Š–Š‡
ƒ’’Ž‹…ƒ–‹‘ ‘ˆ “—ƒŽ‹–› ƒƒ‰‡‡– ’”‹…‹’Ž‡•Ǥ – ˆƒ…‹Ž‹–ƒ–‡• ƒ’’Ž‹…ƒ–‹‘ ‘ˆ ƒƒ‰‡‡– ’”‹…‹’Ž‡•
and selection of methods and tools that enable the sustainable success of an organization.
— ISO 10015 Quality management — Guidelines for training provides guidelines to assist organizations
in addressing issues related to training. ISO 10015 can be applied whenever guidance is required
–‘ ‹–‡”’”‡– ”‡ˆ‡”‡…‡• –‘ Dz‡†—…ƒ–‹‘dz ƒ† Dz–”ƒ‹‹‰dz ™‹–Š‹ –Š‡  “—ƒŽ‹–› ƒƒ‰‡‡– •›•–‡
•–ƒ†ƒ”†•Ǥ›”‡ˆ‡”‡…‡–‘Dz–”ƒ‹‹‰dz‹…Ž—†‡•ƒŽŽ–›’‡•‘ˆ‡†—…ƒ–‹‘ƒ†–”ƒ‹‹‰Ǥ
— ISO/TR 10017 Guidance on statistical techniques for ISO 9001:2000 explains statistical techniques
™Š‹…Šˆ‘ŽŽ‘™ˆ”‘–Š‡˜ƒ”‹ƒ„‹Ž‹–›–Šƒ–…ƒ„‡‘„•‡”˜‡†‹–Š‡„‡Šƒ˜‹‘—”ƒ†”‡•—Ž–•‘ˆ’”‘…‡••‡•ǡ
‡˜‡—†‡”…‘†‹–‹‘•‘ˆƒ’’ƒ”‡–•–ƒ„‹Ž‹–›Ǥ–ƒ–‹•–‹…ƒŽ–‡…Š‹“—‡•ƒŽŽ‘™„‡––‡”—•‡‘ˆƒ˜ƒ‹Žƒ„Ž‡†ƒ–ƒ
–‘ƒ••‹•–‹†‡…‹•‹‘ƒ‹‰ǡƒ†–Š‡”‡„›Š‡Ž’–‘…‘–‹—ƒŽŽ›‹’”‘˜‡–Š‡“—ƒŽ‹–›‘ˆ’”‘†—…–•ƒ†
processes to achieve customer satisfaction.

26
 IS/ISO 9001 : 2015

— ISO 10018 Quality management — Guidelines on people involvement and competence provides
‰—‹†‡Ž‹‡• ™Š‹…Š ‹ϐŽ—‡…‡ ’‡‘’Ž‡ ‹˜‘Ž˜‡‡– ƒ† …‘’‡–‡…‡Ǥ  “—ƒŽ‹–› ƒƒ‰‡‡– •›•–‡
†‡’‡†• ‘ –Š‡ ‹˜‘Ž˜‡‡– ‘ˆ …‘’‡–‡– ’‡‘’Ž‡ ƒ† –Š‡ ™ƒ› –Šƒ– –Š‡› ƒ”‡ ‹–”‘†—…‡† ƒ†
integrated into the organization. It is critical to determine, develop and evaluate the knowledge,
skills, behaviour and work environment required.
— ISO 10019 Guidelines for the selection of quality management system consultants and use of their services
’”‘˜‹†‡•‰—‹†ƒ…‡ˆ‘”–Š‡•‡Ž‡…–‹‘‘ˆ“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡…‘•—Ž–ƒ–•ƒ†–Š‡—•‡‘ˆ–Š‡‹”
•‡”˜‹…‡•Ǥ–‰‹˜‡•‰—‹†ƒ…‡‘–Š‡’”‘…‡••ˆ‘”‡˜ƒŽ—ƒ–‹‰–Š‡…‘’‡–‡…‡‘ˆƒ“—ƒŽ‹–›ƒƒ‰‡‡–
•›•–‡…‘•—Ž–ƒ–ƒ†’”‘˜‹†‡•…‘ϐ‹†‡…‡–Šƒ––Š‡‘”‰ƒ‹œƒ–‹‘ǯ•‡‡†•ƒ†‡š’‡…–ƒ–‹‘•ˆ‘”–Š‡
consultant’s services will be met.
— ISO 19011 Guidelines for auditing management systems provides
d guidance on the management of an
ides
ƒ—†‹–’”‘‰”ƒ‡ǡ‘–Š‡’Žƒ‹‰ƒ†…‘†—…–‹‰‘ˆƒƒ—†‹–‘ˆƒƒƒ‰‡‡–•›•–‡ǡƒ•™‡ŽŽƒ•
ƒ—
—†‹–‘
—†‹–
‘–Š‡…‘’‡–‡…‡ƒ†‡˜ƒŽ—ƒ–‹‘‘ˆƒƒ—†‹–‘”ƒ†ƒƒ—†‹––‡ƒǤͳͻͲͳͳ‹•‹–‡†‡†–‘ƒ’’Ž›–‘
—†‹––
ƒ—†‹–‘”•ǡ‘”‰ƒ‹œƒ–‹‘•‹’Ž‡‡–‹‰ƒƒ‰‡‡–•›•–‡•ǡƒ†‘”‰ƒ‹œƒ–‹‘•‡‡†‹‰–‘…‘†—…–
–‡•
ƒ—†‹–•‘ˆƒƒ‰‡‡–•›•–‡•Ǥ

Table B.1 — Relationship between other International

ati na Standards on quality management and
tion
quality management systems and the clauses of this International Standard
e ccla
claus
Other Interna- Clause
e in th
this
i International
rnati Standard
tional Standard
4 5 6 7 8 9 10
ISO 9000 All All All
A ll All
Al All All All
ISO 9004 All All All All
A
Al All All All
ISO 10001 8.2.2, 8.5.1 9.1.2
ISO 10002 8.2.1, 9.1.2 10.2.1
ISO 10003 9.1.2
ISO 10004 9.1.2, 9.1.3
ISO 10005 5.3 6.1, 6.2
6 All All 9.1 10.2
ISO 10006 All All
A All All All All All
ISO 10007 8.5.2
ISO 10008 All Alll All All All All All
ISO 10012 7.1.5
ISO/TR 10013 7.5
ISO 10014 A
All All All All All All All
ISO 10015
5 7.2
ISO/TR 10017 6.1 7.1.5 9.1
ISO 10018 All All All All All All All
ISO 10019 8.4
ISO 19011 9.2
 DzŽŽdz‹†‹…ƒ–‡•–Šƒ–ƒŽŽ–Š‡•—„…Žƒ—•‡•‹–Š‡•’‡…‹ϐ‹……Žƒ—•‡‘ˆ–Š‹•–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†ƒ”‡”‡Žƒ–‡†–‘–Š‡‘–Š‡”
International Standard.

27
IS/ISO 9001 : 2015

Bibliography

[1] ISO 9004, Managing for the sustained success of an organization — A quality management approach
[2] ISO 10001, Quality management — Customer satisfaction — Guidelines for codes of conduct for
organizations
[3] ISO 10002, Quality management — Customer satisfaction — Guidelines for complaints handling in
organizations
[4] ISO 10003, Quality management — Customer satisfaction — Guidelines for dispute resolution
external to organizations
[5] ISO 10004, Quality management — Customer satisfaction — Guidelines
deline for monitoring and measuring
[6] ISO 10005, Quality management systems — Guidelines for quality plans
[7] ISO 10006, Quality management systems — Guidelines for
or quality
fo qua management in projects
[8] ISO 10007, —ƒŽ‹–›ƒƒ‰‡‡–•›•–‡•Ȅ
—‹†‡Ž‹‡•ˆ‘”…‘ϔ‹‰—”ƒ–‹‘ƒƒ‰‡‡–
‡•• ˆ‘
‡•ˆ‘”…
[9] ISO 10008, Quality management — Customer satisfaction
tisfact — Guidelines
Gui for business-to-consumer
electronic commerce transactions
[10] ISO 10012, Measurement management systems
em — Requirements
teems quirem
rem for measurement processes and
measuring equipment
[11] ISO/TR 10013, Guidelines for quality manag
management
an ge t system
stem documentation
syste
[12] ISO 10014, —ƒŽ‹–›ƒƒ‰‡‡–Ȅ
—‹†‡Ž‹‡•ˆ‘””‡ƒŽ‹œ‹‰ϔ‹ƒ…‹ƒŽƒ†‡…‘‘‹…„‡‡ϔ‹–•

—‹†‡Ž ‘””‡
”‡ƒ
[13] ISO 10015, Quality management — Gu
Guidelines
ess for
fo training
[14] ISO/TR 10017, Guidance on statistical
tic techniques
tatisti chn
niq for ISO 9001:2000
[15] ISO 10018, Quality management
men — Guidelines
uidelin
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[16] ISO 10019, Guideliness ffor the selection
orr tth ectt io of quality management system consultants and use of
lecti
their services
[17] ISO 14001, Environmental
men management
nme anag
age
ge systems — Requirements with guidance for use
[18] ISO 19011, Guidelines
eline for aud
delin auditing
au
udit management systems
[19] ISO 31000,, Risk
R sk management
m men — Principles and guidelines
geeme
[20] ISO 37500, Guidance on outsourcing
[21] ISO/IEC 90003, Software engineering — Guidelines for the application of ISO 9001:2008 to
computer software
[22] IEC 60300-1, Dependability management — Part 1: Guidance for management and application
[23] IEC 61160, Design review
ȏʹͶȐ —ƒŽ‹–›ƒƒ‰‡‡–’”‹…‹’Ž‡•ǡ1)
ȏʹͷȐ ‡Ž‡…–‹‘ƒ†—•‡‘ˆ–Š‡ͻͲͲͲˆƒ‹Ž›‘ˆ•–ƒ†ƒ”†•ǡ1)
[26] ISO 9001 for Small Businesses — What to do, ISO1)

1) Available from website: http://www.iso.org.

28
 IS/ISO 9001 : 2015

ȏʹ͹Ȑ –‡‰”ƒ–‡†—•‡‘ˆƒƒ‰‡‡–•›•–‡•–ƒ†ƒ”†•ǡ1)

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

29
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