Hkkjrh; ekud IS/ISO 9001 : 2015

(Reaffirmed 0)
Indian Standard

xq.krk çcaèk i¼fr;k¡ — vis{kk,¡

(pkSFkk iqujh{k.k)

Quality Management Systems —

Requirements
( 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 parties .............................................................. 2
ͶǤ͵ ‡–‡”‹‹‰–Š‡•…‘’‡‘ˆ–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡............................................................................. 2
‡–‡”‹‹‰–Š‡•…‘’‡‘ˆ–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›
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‹…›............................................................................................................................. 4
ͷǤʹǤʹ ‘—‹…ƒ–‹‰–Š‡“—ƒŽ‹–›’‘Ž‹…› .................................................................................................................... 4
5.3 Organizational roles, oles, responsibilities and authorities.......................................................................................... 4
6 Planning.........................................................................................................................................................................................................................
............................................................................................................................... 4
6.1 Actions to address ess risks and opportunities ................................................................................................................... 4
͸Ǥʹ —ƒŽ‹–›‘„Œ‡…–‹˜‡•ƒ†’Žƒ‹‰–‘ƒ…Š‹‡˜‡–Š‡...................................................................................................... 5
—ƒŽ‹–›‘„Œ‡…–‹˜‡•ƒ†’Žƒ‹‰–
6.3 Planning of changes ............................................................................................................................................................................
............................................................................................................................... 5
7 Support ...........................................................................................................................................................................................................................
............................................................................................................................... 6
7.1 Resources.....................................................................................................................................................................................................
............................................................................................................................... 6
7.1.1 General...............................................................................................................................
...................................................................................................................................................................................... 6
7.1.2 People ........................................................................................................................................................................................
............................................................................................................................... 6
7.1.3 Infrastructur
Infrastructure .....................................................................................................................................................................
............................................................................................................................... 6
7.1.4 Environment ffor or the operation of processes ........................................................................................... 6
7.1.5 Monitoring and measuring resour resources ........................................................................................................... 7
7.1.6 Organizational kno knowledge....................................................................................................................................... 7
7.2 Competence ...............................................................................................................................................................................................
............................................................................................................................... 8
7.3 Awareness eness ...................................................................................................................................................................................................
............................................................................................................................... 8
7.4 Communication ......................................................................................................................................................................................
............................................................................................................................... 8
7.5 Documented information............................................................................................................................................................... 8
7.5.1 General...................................................................................................................................................................................... 8
7.5.2 Creating and updating ................................................................................................................................................. 9
7.5.3 Control of documented inf 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 ............................................................................................................................... 18
Management review inputs .................................................................................................................................
9.3.3 Management review view outputs ............................................................................................................................. 18
10 Improvement .........................................................................................................................................................................................................
............................................................................................................................... 19
10.1 General ........................................................................................................................................................................................................
............................................................................................................................... 19
ͳͲǤʹ ‘…‘ˆ‘”‹–›ƒ†…‘””‡…–‹˜‡ƒ…–‹‘ ˜‡ƒ…–‹‘ .............................................................................................................................. 19
10.3 Continual improvement ...............................................................................................................................................................
............................................................................................................................... 19
‘ˆ ‡™ •–”—…–—”‡
Annex A (informative)Žƒ”‹ϐ‹…ƒ–‹‘‘ˆ‡™•–”—…–—”‡ǡ–‡”‹‘Ž‘‰›ƒ†…‘…‡’–• ............................................21
Annex B (informative) Other International Standards on quality management and quality
management systems developed by ISO/TC 176 .............................................................................................................25
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‹–› ƒƒ‰‡‡– ‡…–‹‘ƒŽ
‘‹––‡‡ƒ†ƒ’’”‘˜ƒŽ‘ˆ–Š‡ƒƒ‰‡‡–ƒ†›•–‡•‹˜‹•‹‘‘—…‹ŽǤ
ƒ‰‡‡–ƒ†›•–‡•‹˜‹•‹‘

Š‹• •–ƒ†ƒ”† ™ƒ• ˆ‹”•– ’—„Ž‹•Š‡†† ‹ ͳͻͺͺ ƒ† •—„•‡“—‡–Ž› ”‡˜‹•‡†
”‡˜‹ ‹ ͳͻͻͶǡ
ƒ†‘’–‹‘ ‘ˆ  ͻͲͲͳ ǣ
ʹͲͲͲ ƒ† ʹͲͲͺǤ Š‹• •–ƒ†ƒ”† ‹• „‡‹‰ ”‡˜‹•‡† ƒ‰ƒ‹ ˆ‘” ƒ†‘’–‹‘
ʹͲͳͷ˜‡”•‹‘Ǥ

’—„Ž‹…ƒ–‹‘ ƒ• ƒ
Š‡ –‡š– ‘ˆ  –ƒ†ƒ”† Šƒ• „‡‡ ƒ’’”‘˜‡† ƒ• •—‹–ƒ„Ž‡ ˆ‘” ’—„Ž
†‹ƒ –ƒ†ƒ”† ™‹–Š‘—– †‡˜‹ƒ–‹‘•Ǥ ‡”–ƒ‹ …‘˜‡–‹‘• ƒ”‡ǡ Š‘ Š‘™‡˜‡”ǡ ‘–
’ƒ”–‹…—Žƒ”Ž› †”ƒ™ –‘
‹†‡–‹…ƒŽ –‘ –Š‘•‡ —•‡† ‹ †‹ƒ –ƒ†ƒ”†•Ǥ ––‡–‹‘ ‹• ’ƒ”–‹
–Š‡ˆ‘ŽŽ‘™‹‰ǣ
Ǯ–‡”ƒ–‹‘ƒŽ –ƒ†ƒ”†ǯ ƒ’’‡ƒ” ”‡ˆ‡””‹‰ –‘ –Š‹•
ǮǮŠ‡”‡˜‡” –Š‡ ™‘”†• Ǯ–‡”ƒ–‹‘ƒ
•–ƒ†ƒ”†ǡ–Š‡›•Š‘—Ž†„‡”‡ƒ†ƒ•Ǯ†‹ƒ–ƒ†ƒ”†ǯǤǯǯ

 –Š‹• ƒ†‘’–‡† •–ƒ†ƒ”†ǡ ”‡ˆ‡”‡…‡ ƒ’’‡ƒ”• –‘ –Š‡ ˆ‘ŽŽ‘™‹‰  –‡”ƒ–‹‘ƒŽ
–ƒ†ƒ”† ˆ‘” ™Š‹…Š †‹ƒ –ƒ†ƒ”†
–ƒ†ƒ ƒŽ•‘ ‡š‹•–•Ǥ Š‡ …‘””‡•’‘†‹‰
…‘””‡•’‘†‹ †‹ƒ
„‡Ž‘™ ƒŽ‘‰ ™‹–Š ‹–•
–ƒ†ƒ”†ǡ ™Š‹…Š ‹• –‘ „‡ •—„•–‹–—–‡† ‹ ‹–• ’Žƒ…‡ǡ ‹• ‰‹˜‡ „‡Ž
†‡‰”‡‡‘ˆ‡“—‹˜ƒŽ‡…‡ˆ‘”–Š‡‡†‹–‹‘‹†‹…ƒ–‡†ǣ
–Š‡‡†‹–‹‘‹†‹…ƒ–‡†ǣ

InternationalStandard CorrespondingIndianStandard DegreeofEquivalence
Standard Corresponding
ͻͲͲͲǣʹͲͳͷ—ƒŽ‹–› Ȁ ͻͲͲͲ ǣ ʹͲͳͷ —ƒŽ‹–› †‡–‹…ƒŽ
ƒƒ‰‡‡–   •›•–‡• ƒƒ‰‡‡– •›•–‡• Ȅ
Ȅ     —†ƒ‡–ƒŽ• —†ƒ‡–ƒŽ• ƒ† ˜‘…ƒ„—Žƒ”›
ƒ†˜‘…ƒ„—Žƒ”› ȋȋfourth  revisionȌ   ȋunder
adoptionȌ

‡š‡•ƒ†‘ˆ–Š‹••–ƒ†ƒ”†ƒ”‡ˆ‘”‹ˆ‘”ƒ–‹‘‘Ž›Ǥ
















‹‹‹
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†‘’’‘”–—‹–‹‡•ƒ••‘…‹ƒ–‡†™‹–Š‹–•…‘–‡š–ƒ†‘„Œ‡…–‹˜‡•Ǣ
†Ȍ –Š‡ƒ„‹Ž‹–›–‘†‡‘•–”ƒ–‡…‘ˆ‘”‹–›–‘•’‡…‹ϐ‹‡†“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡”‡“—‹”‡‡–•Ǥ
„‹Ž‹–›–‘†‡‘•–”ƒ–‡…‘ˆ‘”‹–›–‘•’‡…‹ϐ‹‡†“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡”‡“—‹”‡‡–•Ǥ
Š‹•–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†…ƒ„‡—•‡†„›‹–‡”ƒŽƒ†‡š–‡”ƒŽ’ƒ”–‹‡•Ǥ
–‹•‘––Š‡‹–‡–‘ˆ–Š‹•–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†–‘‹’Ž›–Š‡‡‡†ˆ‘”ǣ
ˆ‘”‹–›‹–Š‡•–”—…–—”‡‘ˆ†‹ˆˆ‡”‡–“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡•Ǣ
Ȅ —‹ˆ‘”‹–›‹–Š‡•–”—…–—”‡‘ˆ†‹ˆˆ‡”‡–“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡•Ǣ
Ȅ ƒŽ‹‰‡–‘ˆ†‘…—‡–ƒ–‹‘–‘–Š‡…Žƒ—•‡•–”—…–—”‡‘ˆ–Š‹•–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†Ǣ
‰‡–‘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
•‡‘ˆ–Š‡•’‡…‹ϐ‹…–‡”‹‘Ž‘‰›‘ˆ–Š‹•–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†™‹–Š‹–Š‡‘”‰ƒ‹œƒ–‹‘Ǥ
Š‡ “—ƒŽ‹–› ƒƒ‰‡‡– •›•–‡ ”‡“—‹”‡‡–• •’‡…‹ϐ‹‡† ‹ –Š‹• –‡”ƒ–‹‘ƒŽ –ƒ†ƒ”† ƒ”‡
…‘’Ž‡‡–ƒ”›–‘”‡“—‹”‡‡–•ˆ‘”’”‘†—…–•ƒ†•‡”˜‹…‡•Ǥ
Š‹•–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†‡’Ž‘›•–Š‡’”‘…‡••ƒ’’”‘ƒ…Šǡ™Š‹…Š‹…‘”’‘”ƒ–‡•–Š‡ŽƒǦ‘ǦŠ‡…Ǧ…–
ȋȌ…›…Ž‡ƒ†”‹•Ǧ„ƒ•‡†–Š‹‹‰Ǥ
The process approach enables an organization to plan its processes and their interactions.
Š‡  …›…Ž‡ ‡ƒ„Ž‡• ƒ ‘”‰ƒ‹œƒ–‹‘ –‘ ‡•—”‡ –Šƒ– ‹–• ’”‘…‡••‡• ƒ”‡ ƒ†‡“—ƒ–‡Ž› ”‡•‘—”…‡† ƒ†
managed, and that opportunities for improvement are determined and acted on.
Risk-based thinking enables an organization to determine the factors that could cause its processes and
‹–•“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡–‘†‡˜‹ƒ–‡ˆ”‘–Š‡’Žƒ‡†”‡•—Ž–•ǡ–‘’—–‹’Žƒ…‡’”‡˜‡–‹˜‡…‘–”‘Ž•
–‘‹‹‹œ‡‡‰ƒ–‹˜‡‡ˆˆ‡…–•ƒ†–‘ƒ‡ƒš‹——•‡‘ˆ‘’’‘”–—‹–‹‡•ƒ•–Š‡›ƒ”‹•‡ȋ•‡‡Clause
–‘‹‹‹œ‡‡‰ƒ–‹˜‡‡ˆˆ‡…–•ƒ†–‘ƒ‡ƒš‹——•‡‘ˆ‘’’‘”–—‹–‹‡•ƒ•–Š‡›ƒ”‹•‡ȋ•‡‡ 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‹œƒ–‹‘‹‰Š–ϐ‹†‹–‡…‡••ƒ”›–‘ƒ†‘’–˜ƒ”‹‘—•ˆ‘”•‘ˆ‹’”‘˜‡‡–‹ƒ††‹–‹‘–‘…‘””‡…–‹‘
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 promotes the adoption of a process approach when developing,
‹’Ž‡‡–‹‰ƒ†‹’”‘˜‹‰–Š‡‡ˆˆ‡…–‹˜‡‡••‘ˆƒ“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡ǡ–‘‡Šƒ…‡…—•–‘‡”
•ƒ–‹•ˆƒ…–‹‘ „› ‡‡–‹‰ …—•–‘‡” ”‡“—‹”‡‡–•Ǥ ’‡…‹ϐ‹… ”‡“—‹”‡‡–• …‘•‹†‡”‡† ‡••‡–‹ƒŽ –‘ –Š‡
adoption of a process approach are included in 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–‹‘
–‘…‘–”‘Ž–Š‡‹–‡””‡Žƒ–‹‘•Š‹’•ƒ†‹–‡”†‡’‡†‡…‹‡•ƒ‘‰–Š‡’”‘…‡••‡•‘ˆ–Š‡•›•–‡ǡ•‘–Šƒ––Š‡
overall performance of the organization can be enhanced.
Š‡ ’”‘…‡•• ƒ’’”‘ƒ…Š ‹˜‘Ž˜‡• –Š‡ •›•–‡ƒ–‹… †‡ϐ‹‹–‹‘ ƒ† ƒƒ‰‡‡– ‘ˆ ’”‘…‡••‡•ǡ ƒ† –Š‡‹”
‹–‡”ƒ…–‹‘•ǡ•‘ƒ•–‘ƒ…Š‹‡˜‡–Š‡‹–‡†‡†”‡•—Ž–•‹ƒ……‘”†ƒ…‡™‹–Š–Š‡“—ƒŽ‹–›’‘Ž‹…›ƒ†•–”ƒ–‡‰‹…
†‹”‡…–‹‘‘ˆ–Š‡‘”‰ƒ‹œƒ–‹‘Ǥƒƒ‰‡‡–‘ˆ–Š‡’”‘…‡••‡•ƒ†–Š‡•›•–‡ƒ•ƒ™Š‘Ž‡…ƒ„‡ƒ…Š‹‡˜‡†
—•‹‰–Š‡…›…Ž‡ȋ•‡‡ͲǤ͵ǤʹȌ™‹–Šƒ‘˜‡”ƒŽŽˆ‘…—•‘”‹•Ǧ„ƒ•‡†–Š‹‹‰ȋ•‡‡ͲǤ͵Ǥ͵Ȍƒ‹‡†ƒ––ƒ‹‰
advantage of opportunities and preventing undesirable results.
Š‡ƒ’’Ž‹…ƒ–‹‘‘ˆ–Š‡’”‘…‡••ƒ’’”‘ƒ…Š‹ƒ“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡‡ƒ„Ž‡•ǣ
‡”•–ƒ†‹‰ƒ†…‘•‹•–‡…›‹‡‡–‹‰”‡“—‹”‡‡–•Ǣ
ƒȌ —†‡”•–ƒ†‹‰ƒ†…‘•‹•–‡…›‹‡‡–‹‰”‡“—‹”‡‡–•Ǣ
‘•‹†‡”ƒ–‹‘‘ˆ’”‘…‡••‡•‹–‡”•‘ˆƒ††‡†˜ƒŽ—‡Ǣ
„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

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

0.3.2 Plan-Do-Check-Act cycle

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

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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
Ȍ‹•‡••‡–‹ƒŽˆ‘”ƒ…Š‹‡˜‹‰ƒ‡ˆˆ‡…–‹˜‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǥ
Risk-based thinking (see Clause A.4Ȍ‹•‡••‡–‹ƒŽˆ‘”ƒ…Š‹‡˜‹‰ƒ‡ˆˆ‡…–‹˜‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǥ
The concept of risk-based thinking has been implicit in previous editions of this International Standard
‹…Ž—†‹‰ǡˆ‘”‡šƒ’Ž‡ǡ…ƒ””›‹‰‘—–’”‡˜‡–‹˜‡ƒ…–‹‘–‘‡Ž‹‹ƒ–‡’‘–‡–‹ƒŽ‘…‘ˆ‘”‹–‹‡•ǡƒƒŽ›•‹‰
ƒ›‘…‘ˆ‘”‹–‹‡•–Šƒ–†‘‘……—”ǡƒ†–ƒ‹‰ƒ…–‹‘–‘’”‡˜‡–”‡…—””‡…‡–Šƒ–‹•ƒ’’”‘’”‹ƒ–‡ˆ‘”–Š‡
‡ˆˆ‡…–•‘ˆ–Š‡‘…‘ˆ‘”‹–›Ǥ
To conform to the requirements of this International Standard, an organization needs to plan and
implement actions to address risks and opportunities. Addressing both risks and opportunities
‡•–ƒ„Ž‹•Š‡• ƒ „ƒ•‹• ˆ‘” ‹…”‡ƒ•‹‰ –Š‡ ‡ˆˆ‡…–‹˜‡‡•• ‘ˆ –Š‡ “—ƒŽ‹–› ƒƒ‰‡‡– •›•–‡ǡ ƒ…Š‹‡˜‹‰
improved results and preventing negative effects.
Opportunities can arise as a result of a situation favourable to achieving an intended result, for
example, a set of circumstances that allow the organization to attract customers, develop new products
ƒ†•‡”˜‹…‡•ǡ”‡†—…‡™ƒ•–‡‘”‹’”‘˜‡’”‘†—…–‹˜‹–›Ǥ…–‹‘•–‘ƒ††”‡••‘’’‘”–—‹–‹‡•…ƒƒŽ•‘‹…Ž—†‡
…‘•‹†‡”ƒ–‹‘‘ˆƒ••‘…‹ƒ–‡†”‹••Ǥ‹•‹•–Š‡‡ˆˆ‡…–‘ˆ—…‡”–ƒ‹–›ƒ†ƒ›•—…Š—…‡”–ƒ‹–›…ƒŠƒ˜‡
’‘•‹–‹˜‡‘”‡‰ƒ–‹˜‡‡ˆˆ‡…–•Ǥ’‘•‹–‹˜‡†‡˜‹ƒ–‹‘ƒ”‹•‹‰ˆ”‘ƒ”‹•…ƒ’”‘˜‹†‡ƒ‘’’‘”–—‹–›ǡ„—–‘–
all positive effects of risk result in opportunities.
0.4 Relationship
ationship with other management system standards
Š‹•–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†ƒ’’Ž‹‡•–Š‡ˆ”ƒ‡™‘”†‡˜‡Ž‘’‡†„›–‘‹’”‘˜‡ƒŽ‹‰‡–ƒ‘‰‹–•
–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†•ˆ‘”ƒƒ‰‡‡–•›•–‡•ȋ•‡‡Clause
–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†•ˆ‘”ƒƒ‰‡‡–•›•–‡•ȋ•‡‡ A.1).
This
his International Standard enables an organization to use the process approach, coupled with the
 …›…Ž‡ ƒ† ”‹•Ǧ„ƒ•‡† –Š‹‹‰ǡ –‘ ƒŽ‹‰ ‘” ‹–‡‰”ƒ–‡ ‹–• “—ƒŽ‹–› ƒƒ‰‡‡– •›•–‡ ™‹–Š –Š‡
”‡“—‹”‡‡–•‘ˆ‘–Š‡”ƒƒ‰‡‡–•›•–‡•–ƒ†ƒ”†•Ǥ
This International Standard relates to ISO 9000 and ISO 9004 as follows:
9000 Quality management systems — Fundamentals and vocabulary provides essential
— ISO 9000
„ƒ…‰”‘—†ˆ‘”–Š‡’”‘’‡”—†‡”•–ƒ†‹‰ƒ†‹’Ž‡‡–ƒ–‹‘‘ˆ–Š‹•–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†Ǣ
— 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.

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

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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—†‹‰
–‘‡Šƒ…‡…—•–‘‡”•ƒ–‹•ˆƒ…–‹‘–Š”‘—‰Š–Š‡‡ˆˆ‡…–‹˜‡ƒ’’Ž‹…ƒ–‹‘‘ˆ–Š‡•›•–‡ǡ‹…Ž—†‹‰
’”‘…‡••‡• ˆ‘” ‹’”‘˜‡‡– ‘ˆ –Š‡ •›•–‡ ƒ† –Š‡ ƒ••—”ƒ…‡ ‘ˆ …‘ˆ‘”‹–› –‘ …—•–‘‡” ƒ†
ƒ’’Ž‹…ƒ„Ž‡•–ƒ–—–‘”›ƒ†”‡‰—Žƒ–‘”›”‡“—‹”‡‡–•Ǥ
ŽŽ–Š‡”‡“—‹”‡‡–•‘ˆ–Š‹•–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†ƒ”‡‰‡‡”‹…ƒ†ƒ”‡‹–‡†‡†–‘„‡ƒ’’Ž‹…ƒ„Ž‡–‘ƒ›
‘”‰ƒ‹œƒ–‹‘ǡ”‡‰ƒ”†Ž‡••‘ˆ‹–•–›’‡‘”•‹œ‡ǡ‘”–Š‡’”‘†—…–•ƒ†•‡”˜‹…‡•‹–’”‘˜‹†‡•Ǥ
ͳ –Š‹•–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†ǡ–Š‡–‡”•Dz’”‘†—…–dz‘”Dz•‡”˜‹…‡dz‘Ž›ƒ’’Ž›–‘’”‘†—…–•ƒ†•‡”˜‹…‡•
‹•–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†ǡ–Š‡–‡”•Dz’”‘†—…–dz‘”Dz•‡”˜‹…‡dz‘Ž›ƒ’’Ž›–‘’”‘†—…–•ƒ†•‡”˜‹…‡•
‹–‡†‡†ˆ‘”ǡ‘””‡“—‹”‡†„›ǡƒ…—•–‘‡”Ǥ

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

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

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

4 Context of the organization

4.1 Understanding the organization and its context

cont
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.

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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

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

4.4 Quality management system

system and its processes

4.4.1 Š‡ ‘”‰ƒ‹œƒ–‹‘ •ŠƒŽŽ ‡•–ƒ„Ž‹•Šǡ ‹’Ž‡‡–ǡ ƒ‹–ƒ‹ ƒ† …‘–‹—ƒŽŽ› ‹’”‘˜‡ ƒ “—ƒŽ‹–›
ƒƒ‰‡‡– •›•–‡ǡ ‹…Ž—†‹‰ –Š‡ ’”‘…‡••‡• ‡‡†‡† ƒ† –Š‡‹” ‹–‡”ƒ…–‹‘•ǡ ‹ ƒ……‘”†ƒ…‡ ™‹–Š –Š‡
requirements of this International Standard.

Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ†‡–‡”‹‡–Š‡’”‘…‡••‡•‡‡†‡†ˆ‘”–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡ƒ†–Š‡‹”
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
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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
‰ƒ……‘—–ƒ„‹Ž‹–›ˆ‘”–Š‡‡ˆˆ‡…–‹˜‡‡••‘ˆ–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǣ
„Ȍ ‡•—”‹‰–Šƒ––Š‡“—ƒŽ‹–›’‘Ž‹…›ƒ†“—ƒŽ‹–›‘„Œ‡…–‹˜‡•ƒ”‡‡•–ƒ„Ž‹•Š‡†ˆ‘”–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–
”‹‰–Šƒ––Š‡“—ƒŽ‹–›’‘Ž‹…›ƒ†“—ƒŽ‹–›‘„Œ‡…–‹˜‡•ƒ”‡‡•–ƒ„Ž‹•Š‡†ˆ‘”–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–
•›•–‡ƒ†ƒ”‡…‘’ƒ–‹„Ž‡™‹–Š–Š‡…‘–‡š–ƒ†•–”ƒ–‡‰‹…†‹”‡…–‹‘‘ˆ–Š‡‘”‰ƒ‹œƒ–‹‘Ǣ
…Ȍ ‡•—”‹‰–Š‡‹–‡‰”ƒ–‹‘‘ˆ–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡”‡“—‹”‡‡–•‹–‘–Š‡‘”‰ƒ‹œƒ–‹‘ǯ•
”‹‰–Š‡‹–‡‰”ƒ–‹‘‘ˆ–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡”‡“—‹”‡‡–•‹–‘–Š‡‘”‰ƒ‹œƒ–‹‘ǯ•
„—•‹‡••’”‘…‡••‡•Ǣ
†Ȍ ’”‘‘–‹‰–Š‡—•‡‘ˆ–Š‡’”‘…‡••ƒ’’”‘ƒ…Šƒ†”‹•Ǧ„ƒ•‡†–Š‹‹‰Ǣ
‘–‹‰–Š‡—•‡‘ˆ–Š‡’”‘…‡••ƒ’’”‘ƒ…Šƒ†”‹•Ǧ„ƒ•‡†–Š‹‹‰Ǣ
‡Ȍ ‡•—”‹‰–Šƒ––Š‡”‡•‘—”…‡•‡‡†‡†ˆ‘”–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡ƒ”‡ƒ˜ƒ‹Žƒ„Ž‡Ǣ
”‹‰–Šƒ––Š‡”‡•‘—”…‡•‡‡†‡†ˆ‘”–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡ƒ”‡ƒ˜ƒ‹Žƒ„Ž‡Ǣ
—‹…ƒ–‹‰–Š‡‹’‘”–ƒ…‡‘ˆ‡ˆˆ‡…–‹˜‡“—ƒŽ‹–›ƒƒ‰‡‡–ƒ†‘ˆ…‘ˆ‘”‹‰–‘–Š‡“—ƒŽ‹–›
ˆȌ …‘—‹…ƒ–‹‰–Š‡‹’‘”–ƒ…‡‘ˆ‡ˆˆ‡…–‹˜‡“—ƒŽ‹–›ƒƒ‰‡‡–ƒ†‘ˆ…‘ˆ‘”‹‰–‘–Š‡“—ƒŽ‹–›
ƒƒ‰‡‡–•›•–‡”‡“—‹”‡‡–•Ǣ
‰Ȍ ‡•—”‹‰–Šƒ––Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡ƒ…Š‹‡˜‡•‹–•‹–‡†‡†”‡•—Ž–•Ǣ
”‹‰–Šƒ––Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡ƒ…Š‹‡˜‡•‹–•‹–‡†‡†”‡•—Ž–•Ǣ
ŠȌ ‡‰ƒ‰‹‰ǡ
‰‹‰ǡ †‹”‡…–‹‰ ƒ† •—’’‘”–‹‰ ’‡”•‘• –‘ …‘–”‹„—–‡ –‘ –Š‡ ‡ˆˆ‡…–‹˜‡‡•• ‘ˆ –Š‡ “—ƒŽ‹–›
ƒƒ‰‡‡–•›•–‡Ǣ
‹Ȍ ’”‘‘–‹‰‹’”‘˜‡‡–Ǣ
–‹‰‹’”‘˜‡‡–Ǣ
ŒȌ •—’’‘”–‹‰‘–Š‡””‡Ž‡˜ƒ–ƒƒ‰‡‡–”‘Ž‡•–‘†‡‘•–”ƒ–‡–Š‡‹”Ž‡ƒ†‡”•Š‹’ƒ•‹–ƒ’’Ž‹‡•–‘–Š‡‹”
‘”–‹‰‘–Š‡””‡Ž‡˜ƒ–ƒƒ‰‡‡–”‘Ž‡•–‘†‡‘•–”ƒ–‡–Š‡‹”Ž‡ƒ†‡”•Š‹’ƒ•‹–ƒ’’Ž‹‡•–‘–Š‡‹”
ƒ”‡ƒ•‘ˆ”‡•’‘•‹„‹Ž‹–›Ǥ
 ‡ˆ‡”‡…‡
‡ˆ‡”‡…‡ –‘ Dz„—•‹‡••dz ‹ –Š‹• –‡”ƒ–‹‘ƒŽ –ƒ†ƒ”† …ƒ „‡ ‹–‡”’”‡–‡† „”‘ƒ†Ž› –‘ ‡ƒ –Š‘•‡
activities that are core to the 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.

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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

5.2.2 Communicating the quality policy

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

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

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.

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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
‡Ž‹‹ƒ–‹‰ –Š‡ ”‹• •‘—”…‡ǡ …Šƒ‰‹‰ –Š‡ Ž‹‡Ž‹Š‘‘† ‘” …‘•‡“—‡…‡•ǡ •Šƒ”‹‰ –Š‡ ”‹•ǡ ‘” ”‡–ƒ‹‹‰ ”‹• „›
informed decision.

NOTE 2 Opportunities
rtunities can lead to the adoption of new practices, launching new products, opening new
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’ needs.

ve them
6.2 Quality objectives and planning to achieve

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

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

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

ƒȌ ™Šƒ–™‹ŽŽ„‡†‘‡Ǣ
ŽŽ„‡†‘‡Ǣ
„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).

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

7.1.2 People

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

7.1.3 Infrastructure

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

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

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

•’‘”–ƒ–‹‘”‡•‘—”…‡•Ǣ
…Ȍ–”ƒ•’‘”–ƒ–‹‘”‡•‘—”…‡•Ǣ

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

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

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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
the monitoring and measurement resources.

7.1.5.2 Measurement traceability

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

7.1.6 Organizational knowledge

know

Š‡ ‘”‰ƒ‹œƒ–‹‘ •ŠƒŽŽ †‡–‡”‹‡ –Š‡ ‘™Ž‡†‰‡ ‡…‡••ƒ”› ˆ‘” –Š‡ ‘’‡”ƒ–‹‘ ‘ˆ ‹–• ’”‘…‡••‡• ƒ† –‘
ƒ…Š‹‡˜‡…‘ˆ‘”‹–›‘ˆ’”‘†—…–•ƒ†•‡”˜‹…‡•Ǥ
Š‹•‘™Ž‡†‰‡•ŠƒŽŽ„‡ƒ‹–ƒ‹‡†ƒ†„‡ƒ†‡ƒ˜ƒ‹Žƒ„Ž‡–‘–Š‡‡š–‡–‡…‡••ƒ”›Ǥ
When addressing changing needs and trends, the organization shall consider its current knowledge
ƒ††‡–‡”‹‡Š‘™–‘ƒ…“—‹”‡‘”ƒ……‡••ƒ›‡…‡••ƒ”›ƒ††‹–‹‘ƒŽ‘™Ž‡†‰‡ƒ†”‡“—‹”‡†—’†ƒ–‡•Ǥ
ͳ ”‰ƒ‹œƒ–‹‘ƒŽ
”‰ƒ‹œƒ–‹‘ƒŽ ‘™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).

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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.
NOTE Applicable
icable actions can include, for example, the provision of training to, the mentoring of, or the re-
ƒ••‹‰‡–‘ˆ…—””‡–Ž›‡’Ž‘›‡†’‡”•‘•Ǣ‘”–Š‡Š‹”‹‰‘”…‘–”ƒ…–‹‰‘ˆ…‘’‡–‡–’‡”•‘•Ǥ

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

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

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

ƒ–‹‘”‡“—‹”‡†„›–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡ƒ†„›–Š‹•–‡”ƒ–‹‘ƒŽ
7.5.3.1 ‘…—‡–‡†‹ˆ‘”ƒ–‹‘”‡“—‹”‡†„›–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡ƒ†„›–Š‹•–‡”ƒ–‹‘ƒŽ
Standard shall be controlled to ensure:

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

nted information, the organization shall address the following

7.5.3.2 For the control of documented
activities, as applicable:

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

8 Operation

8.1 Operational planning and control

The organization shall plan, implement and control the processes (see 4.4) needed to meet the
requirements for the provision of products and services, and to implement the actions determined in
Clause 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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†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 (see 8.4).

8.2 Requirements for products and services

8.2.1 Customer communication

Communication with customers shall include:

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

8.2.2 Determining the requirements for products

products and services

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

8.2.3 Review of the requirements

requirements for products and services

8.2.3.1 Š‡‘”‰ƒ‹œƒ–‹‘ •ŠƒŽŽ‡•—”‡–Šƒ–‹–Šƒ•–Š‡ƒ„‹Ž‹–›–‘‡‡––Š‡”‡“—‹”‡‡–•ˆ‘”’”‘†—…–•ƒ†

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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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

oducts and services

The organization shall ensure that relevant documented information is amended, and that relevant
persons are made aware of the changed requirements, when the requirements for products and
services are changed.

8.3 Design and development of products and services

s

8.3.1 General

The organization
rganization shall establish, implement and maintain a design and development process that is
appropriate to ensure the subsequent provision of products and services.

8.3.2 Design and development planning

In determining the stages and controls for design and development, the organization shall consider:
ƒȌ –Š‡ƒ–—”‡ǡ†—”ƒ–‹‘ƒ†…‘’Ž‡š‹–›‘ˆ–Š‡†‡•‹‰ƒ††‡˜‡Ž‘’‡–ƒ…–‹˜‹–‹‡•Ǣ
—”‡ǡ†—”ƒ–‹‘ƒ†…‘’Ž‡š‹–›‘ˆ–Š‡†‡•‹‰ƒ††‡˜‡Ž‘’‡–ƒ…–‹˜‹–‹‡•Ǣ
“—‹”‡†’”‘…‡•••–ƒ‰‡•ǡ‹…Ž—†‹‰ƒ’’Ž‹…ƒ„Ž‡†‡•‹‰ƒ††‡˜‡Ž‘’‡–”‡˜‹‡™•Ǣ
„Ȍ –Š‡”‡“—‹”‡†’”‘…‡•••–ƒ‰‡•ǡ‹…Ž—†‹‰ƒ’’Ž‹…ƒ„Ž‡†‡•‹‰ƒ††‡˜‡Ž‘’‡–”‡˜‹‡™•Ǣ
…Ȍ –Š‡”‡“—‹”‡††‡•‹‰ƒ††‡˜‡Ž‘’‡–˜‡”‹ϐ‹…ƒ–‹‘ƒ†˜ƒŽ‹†ƒ–‹‘ƒ…–‹˜‹–‹‡•Ǣ
“—‹”‡††‡•‹‰ƒ††‡˜‡Ž‘’‡–˜‡”‹ϐ‹…ƒ–‹‘ƒ†˜ƒŽ‹†ƒ–‹‘ƒ…–‹˜‹–‹‡•Ǣ
•’‘•‹„‹Ž‹–‹‡•ƒ†ƒ—–Š‘”‹–‹‡•‹˜‘Ž˜‡†‹–Š‡†‡•‹‰ƒ††‡˜‡Ž‘’‡–’”‘…‡••Ǣ
†Ȍ –Š‡”‡•’‘•‹„‹Ž‹–‹‡•ƒ†ƒ—–Š‘”‹–‹‡•‹˜‘Ž˜‡†‹–Š‡†‡•‹‰ƒ††‡˜‡Ž‘’‡–’”‘…‡••Ǣ
–‡”ƒŽƒ†‡š–‡”ƒŽ”‡•‘—”…‡‡‡†•ˆ‘”–Š‡†‡•‹‰ƒ††‡˜‡Ž‘’‡–‘ˆ’”‘†—…–•ƒ†•‡”˜‹…‡•Ǣ
‡Ȍ –Š‡‹–‡”ƒŽƒ†‡š–‡”ƒŽ”‡•‘—”…‡‡‡†•ˆ‘”–Š‡†‡•‹‰ƒ††‡˜‡Ž‘’‡–‘ˆ’”‘†—…–•ƒ†•‡”˜‹…‡•Ǣ
ˆȌ –Š‡‡‡†–‘…‘–”‘Ž‹–‡”ˆƒ…‡•„‡–™‡‡’‡”•‘•‹˜‘Ž˜‡†‹–Š‡†‡•‹‰ƒ††‡˜‡Ž‘’‡–’”‘…‡••Ǣ
‡†–‘…‘–”‘Ž‹–‡”ˆƒ…‡•„‡–™‡‡’‡”•‘•‹˜‘Ž˜‡†‹–Š‡†‡•‹‰ƒ††‡˜‡Ž‘’‡–’”‘…‡••Ǣ
‰Ȍ –Š‡‡‡†ˆ‘”‹˜‘Ž˜‡‡–‘ˆ…—•–‘‡”•ƒ†—•‡”•‹–Š‡†‡•‹‰ƒ††‡˜‡Ž‘’‡–’”‘…‡••Ǣ
‡†ˆ‘”‹˜‘Ž˜‡‡–‘ˆ…—•–‘‡”•ƒ†—•‡”•‹–Š‡†‡•‹‰ƒ††‡˜‡Ž‘’‡–’”‘…‡••Ǣ
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–• ‘ˆ †‡•‹‰ ƒ† †‡˜‡Ž‘’‡– –‘ ‡‡–
”‡“—‹”‡‡–•Ǣ
…Ȍ ˜‡”‹ϐ‹…ƒ–‹‘ƒ…–‹˜‹–‹‡•ƒ”‡…‘†—…–‡†–‘‡•—”‡–Šƒ––Š‡†‡•‹‰ƒ††‡˜‡Ž‘’‡–‘—–’—–•‡‡––Š‡
ϐ‹…ƒ–‹‘ƒ…–‹˜‹–‹‡•ƒ”‡…‘†—…–‡†–‘‡•—”‡–Šƒ––Š‡†‡•‹‰ƒ††‡˜‡Ž‘’‡–‘—–’—–•‡‡––Š‡
‹’—–”‡“—‹”‡‡–•Ǣ
dation activities are conducted to ensure that the resulting products and services meet the
d) validation
”‡“—‹”‡‡–•ˆ‘”–Š‡•’‡…‹ϐ‹‡†ƒ’’Ž‹…ƒ–‹‘‘”‹–‡†‡†—•‡Ǣ
‡Ȍ ƒ›‡…‡••ƒ”›ƒ…–‹‘•ƒ”‡–ƒ‡‘’”‘„Ž‡•†‡–‡”‹‡††—”‹‰–Š‡”‡˜‹‡™•ǡ‘”˜‡”‹ϐ‹…ƒ–‹‘ƒ†
‡…‡••ƒ”›ƒ…–‹‘•ƒ”‡–ƒ‡‘’”‘„Ž‡•†‡–‡”‹‡††—”‹‰–Š‡”‡˜‹‡™•ǡ‘”˜‡”‹ϐ‹…ƒ–‹‘ƒ†
˜ƒŽ‹†ƒ–‹‘ƒ…–‹˜‹–‹‡•Ǣ
f) documented
mented information of these activities is retained.
 ‡•‹‰
‰ ƒ† †‡˜‡Ž‘’‡– ”‡˜‹‡™•ǡ ˜‡”‹ϐ‹…ƒ–‹‘ ƒ† ˜ƒŽ‹†ƒ–‹‘ Šƒ˜‡ †‹•–‹…– ’—”’‘•‡•Ǥ Š‡› …ƒ „‡
…‘†—…–‡†•‡’ƒ”ƒ–‡Ž›‘”‹ƒ›…‘„‹ƒ–‹‘ǡƒ•‹••—‹–ƒ„Ž‡ˆ‘”–Š‡’”‘†—…–•ƒ†•‡”˜‹…‡•‘ˆ–Š‡‘”‰ƒ‹œƒ–‹‘Ǥ

8.3.5 Design and development outputs

Thee organization shall ensure that design and development outputs:

Š‡‹’—–”‡“—‹”‡‡–•Ǣ
ƒȌ ‡‡––Š‡‹’—–”‡“—‹”‡‡–•Ǣ
‡“—ƒ–‡ˆ‘”–Š‡•—„•‡“—‡–’”‘…‡••‡•ˆ‘”–Š‡’”‘˜‹•‹‘‘ˆ’”‘†—…–•ƒ†•‡”˜‹…‡•Ǣ
„Ȍ ƒ”‡ƒ†‡“—ƒ–‡ˆ‘”–Š‡•—„•‡“—‡–’”‘…‡••‡•ˆ‘”–Š‡’”‘˜‹•‹‘‘ˆ’”‘†—…–•ƒ†•‡”˜‹…‡•Ǣ
—†‡‘””‡ˆ‡”‡…‡‘‹–‘”‹‰ƒ†‡ƒ•—”‹‰”‡“—‹”‡‡–•ǡƒ•ƒ’’”‘’”‹ƒ–‡ǡƒ†ƒ……‡’–ƒ…‡…”‹–‡”‹ƒǢ
…Ȍ ‹…Ž—†‡‘””‡ˆ‡”‡…‡‘‹–‘”‹‰ƒ†‡ƒ•—”‹‰”‡“—‹”‡‡–•ǡƒ•ƒ’’”‘’”‹ƒ–‡ǡƒ†ƒ……‡’–ƒ…‡…”‹–‡”‹ƒǢ
†Ȍ •’‡…‹ˆ›–Š‡…Šƒ”ƒ…–‡”‹•–‹…•‘ˆ–Š‡’”‘†—…–•ƒ†•‡”˜‹…‡•–Šƒ–ƒ”‡‡••‡–‹ƒŽˆ‘”–Š‡‹”‹–‡†‡†’—”’‘•‡
‹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
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…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) ts and services from external providers are intended for incorporation into the organization’s
products
‘™’”‘†—…–•ƒ†•‡”˜‹…‡•Ǣ
—…–•ƒ†•‡”˜‹…‡•ƒ”‡’”‘˜‹†‡††‹”‡…–Ž›–‘–Š‡…—•–‘‡”ȋ•Ȍ„›‡š–‡”ƒŽ’”‘˜‹†‡”•‘„‡ŠƒŽˆ‘ˆ
„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‡
…‡••ǡ‘”’ƒ”–‘ˆƒ’”‘…‡••ǡ‹•’”‘˜‹†‡†„›ƒ‡š–‡”ƒŽ’”‘˜‹†‡”ƒ•ƒ”‡•—Ž–‘ˆƒ†‡…‹•‹‘„›–Š‡
organization.
Š‡ ‘”‰ƒ‹œƒ–‹‘ •ŠƒŽŽ †‡–‡”‹‡ ƒ† ƒ’’Ž› …”‹–‡”‹ƒ ˆ‘” –Š‡ ‡˜ƒŽ—ƒ–‹‘ǡ •‡Ž‡…–‹‘ǡ ‘‹–‘”‹‰ ‘ˆ
’‡”ˆ‘”ƒ…‡ǡ ƒ† ”‡Ǧ‡˜ƒŽ—ƒ–‹‘ ‘ˆ ‡š–‡”ƒŽ ’”‘˜‹†‡”•ǡ „ƒ•‡† ‘ –Š‡‹” ƒ„‹Ž‹–› –‘ ’”‘˜‹†‡ ’”‘…‡••‡• ‘”
products and services in accordance with requirements. The organization shall retain documented
‹ˆ‘”ƒ–‹‘‘ˆ–Š‡•‡ƒ…–‹˜‹–‹‡•ƒ†ƒ›‡…‡••ƒ”›ƒ…–‹‘•ƒ”‹•‹‰ˆ”‘–Š‡‡˜ƒŽ—ƒ–‹‘•Ǥ

8.4.2 ontrol
Type and extent of control

Š‡ ‘”‰ƒ‹œƒ–‹‘ •ŠƒŽŽ ‡•—”‡ –Šƒ– ‡š–‡”ƒŽŽ› ’”‘˜‹†‡† ’”‘…‡••‡•ǡ ’”‘†—…–• ƒ† •‡”˜‹…‡• †‘ ‘–
ƒ†˜‡”•‡Ž›ƒˆˆ‡…––Š‡‘”‰ƒ‹œƒ–‹‘ǯ•ƒ„‹Ž‹–›–‘…‘•‹•–‡–Ž›†‡Ž‹˜‡”…‘ˆ‘”‹‰’”‘†—…–•ƒ†•‡”˜‹…‡•–‘
its customers.
The organization shall:
ƒȌ ‡•—”‡
”‡ –Šƒ– ‡š–‡”ƒŽŽ› ’”‘˜‹†‡† ’”‘…‡••‡• ”‡ƒ‹ ™‹–Š‹ –Š‡ …‘–”‘Ž ‘ˆ ‹–• “—ƒŽ‹–› ƒƒ‰‡‡–
•›•–‡Ǣ
‡„‘–Š–Š‡…‘–”‘Ž•–Šƒ–‹–‹–‡†•–‘ƒ’’Ž›–‘ƒ‡š–‡”ƒŽ’”‘˜‹†‡”ƒ†–Š‘•‡‹–‹–‡†•–‘ƒ’’Ž›
„Ȍ †‡ϐ‹‡„‘–Š–Š‡…‘–”‘Ž•–Šƒ–‹–‹–‡†•–‘ƒ’’Ž›–‘ƒ‡š–‡”ƒŽ’”‘˜‹†‡”ƒ†–Š‘•‡‹–‹–‡†•–‘ƒ’’Ž›
–‘–Š‡”‡•—Ž–‹‰‘—–’—–Ǣ
c) take into consideration:
ͳȌ –Š‡ ’‘–‡–‹ƒŽ
’‘–‡–‹ƒŽ ‹’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
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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 under controlled conditions.
Controlled conditions shall include, as applicable:
ƒȌ –Š‡ƒ˜ƒ‹Žƒ„‹Ž‹–›‘ˆ†‘…—‡–‡†‹ˆ‘”ƒ–‹‘–Šƒ–†‡ϐ‹‡•ǣ
ƒ‹Žƒ„‹Ž‹–›‘ˆ†‘…—‡–‡†‹ˆ‘”ƒ–‹‘–Šƒ–†‡ϐ‹‡•ǣ
aracteristics of the products to be produced, the services to be provided, or the activities
1) the characteristics
–‘„‡’‡”ˆ‘”‡†Ǣ
ʹȌ –Š‡”‡•—Ž–•–‘„‡ƒ…Š‹‡˜‡†Ǣ
„Ȍ –Š‡ƒ˜ƒ‹Žƒ„‹Ž‹–›ƒ†—•‡‘ˆ•—‹–ƒ„Ž‡‘‹–‘”‹‰ƒ†‡ƒ•—”‹‰”‡•‘—”…‡•Ǣ
ƒ‹Žƒ„‹Ž‹–›ƒ†—•‡‘ˆ•—‹–ƒ„Ž‡‘‹–‘”‹‰ƒ†‡ƒ•—”‹‰”‡•‘—”…‡•Ǣ
…Ȍ –Š‡‹’Ž‡‡–ƒ–‹‘‘ˆ‘‹–‘”‹‰ƒ†‡ƒ•—”‡‡–ƒ…–‹˜‹–‹‡•ƒ–ƒ’’”‘’”‹ƒ–‡•–ƒ‰‡•–‘˜‡”‹ˆ›–Šƒ–
‹’Ž‡‡–ƒ–‹‘‘ˆ‘‹–‘”‹‰ƒ†‡ƒ•—”‡‡–ƒ…–‹˜‹–‹‡•ƒ–ƒ’’”‘’”‹ƒ–‡•–ƒ‰‡•–‘˜‡”‹ˆ›–Šƒ–
criteria for control of processes or outputs, and acceptance criteria for products and services,
Šƒ˜‡„‡‡‡–Ǣ
†Ȍ –Š‡—•‡‘ˆ•—‹–ƒ„Ž‡‹ˆ”ƒ•–”—…–—”‡ƒ†‡˜‹”‘‡–ˆ‘”–Š‡‘’‡”ƒ–‹‘‘ˆ’”‘…‡••‡•Ǣ
‡‘ˆ•—‹–ƒ„Ž‡‹ˆ”ƒ•–”—…–—”‡ƒ†‡˜‹”‘‡–ˆ‘”–Š‡‘’‡”ƒ–‹‘‘ˆ’”‘…‡••‡•Ǣ
’‘‹–‡–‘ˆ…‘’‡–‡–’‡”•‘•ǡ‹…Ž—†‹‰ƒ›”‡“—‹”‡†“—ƒŽ‹ϐ‹…ƒ–‹‘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‡’”‘…‡••‡•
ƒŽ‹†ƒ–‹‘ǡƒ†’‡”‹‘†‹…”‡˜ƒŽ‹†ƒ–‹‘ǡ‘ˆ–Š‡ƒ„‹Ž‹–›–‘ƒ…Š‹‡˜‡’Žƒ‡†”‡•—Ž–•‘ˆ–Š‡’”‘…‡••‡•
ˆ‘”’”‘†—…–‹‘ƒ†•‡”˜‹…‡’”‘˜‹•‹‘ǡ™Š‡”‡–Š‡”‡•—Ž–‹‰‘—–’—–…ƒ‘–„‡˜‡”‹ϐ‹‡†„›•—„•‡“—‡–
‘‹–‘”‹‰‘”‡ƒ•—”‡‡–Ǣ
‰Ȍ –Š‡‹’Ž‡‡–ƒ–‹‘‘ˆƒ…–‹‘•–‘’”‡˜‡–Š—ƒ‡””‘”Ǣ
’Ž‡‡–ƒ–‹‘‘ˆƒ…–‹‘•–‘’”‡˜‡–Š—ƒ‡””‘”Ǣ
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

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

8.5.6 Control of changes

The organization shall review 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

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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‡…–
‘ –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
‡‰ƒ–‹‘ǡ…‘–ƒ‹‡–ǡ”‡–—”‘”•—•’‡•‹‘‘ˆ’”‘˜‹•‹‘‘ˆ’”‘†—…–•ƒ†•‡”˜‹…‡•Ǣ
…Ȍ ‹ˆ‘”‹‰–Š‡…—•–‘‡”Ǣ
d) obtaining
ining authorization for acceptance under concession.
‘ˆ‘”‹–›–‘–Š‡”‡“—‹”‡‡–••ŠƒŽŽ„‡˜‡”‹ϐ‹‡†™Š‡‘…‘ˆ‘”‹‰‘—–’—–•ƒ”‡…‘””‡…–‡†Ǥ

8.7.2 ed information that:

The organization shall retain documented

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

9 Performance evaluation

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

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.

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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
”ˆ‘”ƒ…‡ƒ†‡ˆˆ‡…–‹˜‡‡••‘ˆ–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǣ
…Ȍ –Š‡’‡”ˆ‘”ƒ…‡ƒ†‡ˆˆ‡…–‹˜‡‡••‘ˆ–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǣ
†Ȍ ‹ˆ’Žƒ‹‰Šƒ•„‡‡‹’Ž‡‡–‡†‡ˆˆ‡…–‹˜‡Ž›Ǣ
‹‰Šƒ•„‡‡‹’Ž‡‡–‡†‡ˆˆ‡…–‹˜‡Ž›Ǣ
‡Ȍ –Š‡‡ˆˆ‡…–‹˜‡‡••‘ˆƒ…–‹‘•–ƒ‡–‘ƒ††”‡••”‹••ƒ†‘’’‘”–—‹–‹‡•Ǣ
ˆ‡…–‹˜‡‡••‘ˆƒ…–‹‘•–ƒ‡–‘ƒ††”‡••”‹••ƒ†‘’’‘”–—‹–‹‡•Ǣ
”ˆ‘”ƒ…‡‘ˆ‡š–‡”ƒŽ’”‘˜‹†‡”•Ǣ
ˆȌ –Š‡’‡”ˆ‘”ƒ…‡‘ˆ‡š–‡”ƒŽ’”‘˜‹†‡”•Ǣ
‰Ȍ –Š‡‡‡†ˆ‘”‹’”‘˜‡‡–•–‘–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǥ
‡†ˆ‘”‹’”‘˜‡‡–•–‘–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǥ
 ‡–Š‘†•–‘ƒƒŽ›•‡†ƒ–ƒ…ƒ‹…Ž—†‡•–ƒ–‹•–‹…ƒŽ–‡…Š‹“—‡•Ǥ
‘†•–‘ƒƒŽ›•‡†ƒ–ƒ…ƒ‹…Ž—†‡•–ƒ–‹•–‹…ƒŽ–‡…Š‹“—‡•Ǥ

9.2 Internal audit

9.2.1 The organization shall conduct internal audits at planned intervals to provide information on
™Š‡–Š‡”–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡ǣ

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

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

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

9.3.3 Management review outputs

he outputs of the management review shall include decisions and actions related to:
The
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
‘˜‹‰–Š‡’‡”ˆ‘”ƒ…‡ƒ†‡ˆˆ‡…–‹˜‡‡••‘ˆ–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǥ
…Ȍ ‹’”‘˜‹‰–Š‡’‡”ˆ‘”ƒ…‡ƒ†‡ˆˆ‡…–‹˜‡‡••‘ˆ–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǥ
NOTE Examples
ples of improvement can include correction, corrective 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
Š‡ƒ‘…‘ˆ‘”‹–›‘……—”•ǡ‹…Ž—†‹‰ƒ›ƒ”‹•‹‰ˆ”

ƒȌ ”‡ƒ…––‘–Š‡‘…‘ˆ‘”‹–›ƒ†ǡƒ•ƒ’’Ž‹…ƒ„Ž‡ǣ
––‘–Š‡‘…‘ˆ‘”‹–›ƒ†ǡƒ•ƒ’’Ž‹…ƒ„Ž‡ǣ
ͳȌ –ƒ‡ƒ…–‹‘–‘…‘–”‘Žƒ†…‘””‡…–‹–Ǣ
…–‹‘–‘…‘–”‘Žƒ†…‘””‡…–‹–Ǣ
ʹȌ †‡ƒŽ™‹–Š–Š‡…‘•‡“—‡…‡•Ǣ
„Ȍ ‡˜ƒŽ—ƒ–‡–Š‡‡‡†ˆ‘”ƒ…–‹‘–‘‡Ž‹‹ƒ–‡–Š‡…ƒ—•‡ȋ•Ȍ‘ˆ–Š‡‘…‘ˆ‘”‹–›ǡ‹‘”†‡”–Šƒ–‹–†‘‡•‘–
—ƒ–‡–Š‡‡‡†ˆ‘”ƒ…–‹‘–‘‡Ž‹‹ƒ–‡–Š‡…ƒ—•‡ȋ•Ȍ‘ˆ–Š‡‘…‘ˆ‘”‹–›ǡ‹‘”†‡”–Šƒ–‹–†‘‡•‘–
”‡…—”‘”‘……—”‡Ž•‡™Š‡”‡ǡ„›ǣ
ͳȌ ”‡˜‹‡™‹‰ƒ†ƒƒŽ›•‹‰–Š‡‘…‘ˆ‘”‹–›Ǣ
‡™‹‰ƒ†ƒƒŽ›•‹‰–Š‡‘…‘ˆ‘”‹–›Ǣ
”‹‹‰–Š‡…ƒ—•‡•‘ˆ–Š‡‘…‘ˆ‘”‹–›Ǣ
ʹȌ †‡–‡”‹‹‰–Š‡…ƒ—•‡•‘ˆ–Š‡‘…‘ˆ‘”‹–›Ǣ
͵Ȍ †‡–‡”‹‹‰‹ˆ•‹‹Žƒ”‘…‘ˆ‘”‹–‹‡•‡š‹•–ǡ‘”…‘—Ž†’‘–‡–‹ƒŽŽ›‘……—”Ǣ
”‹‹‰‹ˆ•‹‹Žƒ”‘…‘ˆ‘”‹–‹‡•‡š‹•–ǡ‘”…‘—Ž†’‘–‡–‹ƒŽŽ›‘……—”Ǣ
…Ȍ ‹’Ž‡‡–ƒ›ƒ…–‹‘‡‡†‡†Ǣ
‡‡–ƒ›ƒ…–‹‘‡‡†‡†Ǣ
†Ȍ ”‡˜‹‡™–Š‡‡ˆˆ‡…–‹˜‡‡••‘ˆƒ›…‘””‡…–‹˜‡ƒ…–‹‘–ƒ‡Ǣ
‡™–Š‡‡ˆˆ‡…–‹˜‡‡••‘ˆƒ›…‘””‡…–‹˜‡ƒ…–‹‘–ƒ‡Ǣ
‡Ȍ —’†ƒ–‡”‹••ƒ†‘’’‘”–—‹–‹‡•†‡–‡”‹‡††—”‹‰’Žƒ‹‰ǡ‹ˆ‡…‡••ƒ”›Ǣ
‡”‹••ƒ†‘’’‘”–—‹–‹‡•†‡–‡”‹‡††—”‹‰’Žƒ‹‰ǡ‹ˆ‡…‡••ƒ”›Ǣ
ˆȌ ƒ‡…Šƒ‰‡•–‘–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡ǡ‹ˆ‡…‡••ƒ”›Ǥ
Šƒ‰‡•–‘–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡ǡ‹ˆ‡…‡••ƒ”›Ǥ
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

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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.

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

Table A.1 — Major

or differences in terminology between ISO 9001:2008 and ISO 9001:2015
ISO 9001:2008 ISO 9001:2015
Products Products and services
Exclusions Not used
(See Clause A.5ˆ‘”…Žƒ”‹ϐ‹…ƒ–‹‘‘ˆƒ’’Ž‹…ƒ„‹Ž‹–›Ȍ
Management representative 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
†‘‡•‘–‹’Ž›‡š–‡•‹‘‘ˆ“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡”‡“—‹”‡‡–•„‡›‘†–Š‡•…‘’‡
However, 4.2†‘‡•‘–‹’Ž›‡š–‡•‹‘‘ˆ“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡”‡“—‹”‡‡–•„‡›‘†–Š‡•…‘’‡
of this International Standard. As stated in the scope, this International Standard is applicable where
ƒ ‘”‰ƒ‹œƒ–‹‘ ‡‡†• –‘ †‡‘•–”ƒ–‡ ‹–• ƒ„‹Ž‹–› –‘ …‘•‹•–‡–Ž› ’”‘˜‹†‡ ’”‘†—…–• ƒ† •‡”˜‹…‡• –Šƒ–
‡‡–…—•–‘‡”ƒ†ƒ’’Ž‹…ƒ„Ž‡•–ƒ–—–‘”›ƒ†”‡‰—Žƒ–‘”›”‡“—‹”‡‡–•ǡƒ†ƒ‹•–‘‡Šƒ…‡…—•–‘‡”
satisfaction.
There is no requirement in this International Standard for the organization to consider interested
’ƒ”–‹‡•™Š‡”‡‹–Šƒ•†‡…‹†‡†–Šƒ––Š‘•‡’ƒ”–‹‡•ƒ”‡‘–”‡Ž‡˜ƒ––‘‹–•“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǥ–‹•
ˆ‘”–Š‡‘”‰ƒ‹œƒ–‹‘–‘†‡…‹†‡‹ˆƒ’ƒ”–‹…—Žƒ””‡“—‹”‡‡–‘ˆƒ”‡Ž‡˜ƒ–‹–‡”‡•–‡†’ƒ”–›‹•”‡Ž‡˜ƒ––‘‹–•
“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǥ

A.4 Risk-based thinking

The concept of risk-based thinking has been implicit in previous editions of this International Standard,
e.g. through requirements for planning, review and improvement. This International Standard
•’‡…‹ϐ‹‡•”‡“—‹”‡‡–•ˆ‘”–Š‡‘”‰ƒ‹œƒ–‹‘–‘—†‡”•–ƒ†‹–•…‘–‡š–ȋ•‡‡4.1) and determine risks as
•’‡…‹ϐ‹‡•”‡“—‹”‡‡–•ˆ‘”–Š‡‘”‰ƒ‹œƒ–‹‘–‘—†‡”•–ƒ†‹–•…‘–‡š–ȋ•‡‡
a basis for planning (see 6.1).
). This represents the application of risk-based thinking to planning and
‹’Ž‡‡–‹‰“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡’”‘…‡••‡•ȋ•‡‡
‹’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
this International Standard does not have a separate clause or subclause on preventive action. The
…‘…‡’–‘ˆ’”‡˜‡–‹˜‡ƒ…–‹‘‹•‡š’”‡••‡†–Š”‘—‰Š–Š‡—•‡‘ˆ”‹•Ǧ„ƒ•‡†–Š‹‹‰‹ˆ‘”—Žƒ–‹‰“—ƒŽ‹–›
ƒƒ‰‡‡–•›•–‡”‡“—‹”‡‡–•Ǥ
The risk-based thinking applied in this International Standard has enabled some reduction in
’”‡•…”‹’–‹˜‡”‡“—‹”‡‡–•ƒ†–Š‡‹””‡’Žƒ…‡‡–„›’‡”ˆ‘”ƒ…‡Ǧ„ƒ•‡†”‡“—‹”‡‡–•ǤŠ‡”‡‹•‰”‡ƒ–‡”
ϐŽ‡š‹„‹Ž‹–› –Šƒ ‹ 
 ͻͲͲͳǣʹͲͲͺ
ǣʹͲͲͺ ‹ –Š‡ ”‡“—‹”‡‡–• ˆ‘” ’”‘…‡••‡•ǡ †‘…—‡–‡† ‹ˆ‘”ƒ–‹‘ ƒ†
organizational responsibilities.
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.

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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†‘…—‡–‡†
‹ˆ‘”ƒ–‹‘dz Šƒ• „‡‡ ƒ†‘’–‡† ™‹–Š‘—– •‹‰‹ϐ‹…ƒ– …Šƒ‰‡ ‘” ƒ††‹–‹‘ ȋ•‡‡ 7.5). Where appropriate,
–‡š– ‡Ž•‡™Š‡”‡ ‹ –Š‹• –‡”ƒ–‹‘ƒŽ –ƒ†ƒ”† Šƒ• „‡‡ ƒŽ‹‰‡† ™‹–Š ‹–• ”‡“—‹”‡‡–•Ǥ ‘•‡“—‡–Ž›ǡ
“documented information” is used for all document requirements.
ǣʹͲͲͺ —•‡† •’‡…‹ϐ‹… –‡”‹‘Ž‘‰› •—…Š ƒ• Dz†‘…—‡–dz ‘” Dz†‘…—‡–‡† ’”‘…‡†—”‡•dzǡ
Š‡”‡  ͻͲͲͳǣʹͲͲͺ
Dz“—ƒŽ‹–›ƒ—ƒŽdz‘”Dz“—ƒŽ‹–›’Žƒdzǡ–Š‹•‡†‹–‹‘‘ˆ–Š‹•–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”††‡ϐ‹‡•”‡“—‹”‡‡–•–‘
“maintain documented information”.
Where ISO 9001:2008
1:2008 used the term “records” to denote documents needed to provide evidence
‘ˆ …‘ˆ‘”‹–› ™‹–Š ”‡“—‹”‡‡–•ǡ –Š‹• ‹• ‘™ ‡š’”‡••‡† ƒ• ƒ ”‡“—‹”‡‡– –‘ Dz”‡–ƒ‹ †‘…—‡–‡†
information”. The organization is responsible for determining what documented information needs to
be retained, the period of time for which it is to be retained and the media to be used for its retention.
 ”‡“—‹”‡‡– –‘ Dzƒ‹–ƒ‹dz †‘…—‡–‡† ‹ˆ‘”ƒ–‹‘ †‘‡• ‘– ‡š…Ž—†‡ –Š‡ ’‘••‹„‹Ž‹–› –Šƒ– –Š‡
organization might also need to “retain” that same documented information for a particular purpose,
e.g. to retain previous versions of it.
Where this International Standard refers to “information” rather than “documented information” (e.g. in
4.1:: “The organization shall monitor and review the information about these external and internal issues”),
there is no requirement that this information is to be documented. In such situations, the organization
…ƒ†‡…‹†‡™Š‡–Š‡”‘”‘–‹–‹•‡…‡••ƒ”›‘”ƒ’’”‘’”‹ƒ–‡–‘ƒ‹–ƒ‹†‘…—‡–‡†‹ˆ‘”ƒ–‹‘Ǥ

A.7 Organizational knowledge

In 7.1.6,, this International Standard addresses the need to determine and manage the knowledge
ƒ‹–ƒ‹‡† „› –Š‡ ‘”‰ƒ‹œƒ–‹‘ǡ –‘ ‡•—”‡ –Š‡ ‘’‡”ƒ–‹‘ ‘ˆ ‹–• ’”‘…‡••‡• ƒ† –Šƒ– ‹– …ƒ ƒ…Š‹‡˜‡
…‘ˆ‘”‹–›‘ˆ’”‘†—…–•ƒ†•‡”˜‹…‡•Ǥ
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.

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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’”‘†—…–•
and services.

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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 ‘” ‘†‹ˆ›ǡ –Š‡ ”‡“—‹”‡‡–• ‘ˆ –Š‹•
International Standard.
Table B.1 shows
hows the relationship between these standards and the relevant clauses of this
International Standard.
Š‹• ƒ‡š †‘‡• ‘– ‹…Ž—†‡ ”‡ˆ‡”‡…‡ –‘ –Š‡ •‡…–‘”Ǧ•’‡…‹ϐ‹… “—ƒŽ‹–› ƒƒ‰‡‡– •›•–‡ •–ƒ†ƒ”†•
†‡˜‡Ž‘’‡†„›Ȁͳ͹͸Ǥ
Š‹•–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†‹•‘‡‘ˆ–Š‡–Š”‡‡…‘”‡•–ƒ†ƒ”†•†‡˜‡Ž‘’‡†„›Ȁͳ͹͸Ǥ
Š‹•–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†‹•‘‡‘ˆ–Š‡–Š”‡‡…‘”‡•–ƒ†ƒ”†•†‡˜‡Ž‘’‡†„›Ȁ
— ISO 9000 Quality management systems — Fundamentals
Fun and vocabulary provides an essential
background for the proper understanding and implementation of this International Standard.
Š‡“—ƒŽ‹–›ƒƒ‰‡‡–’”‹…‹’Ž‡•ƒ”‡†‡•…”‹„‡†‹†‡–ƒ‹Ž‹ͻͲͲͲƒ†Šƒ˜‡„‡‡–ƒ‡‹–‘
Š‡“—ƒŽ‹–›ƒƒ‰‡‡–’”‹…‹’Ž‡•ƒ”‡†‡•…”‹„‡†‹†‡–ƒ‹Ž‹
consideration during the development of this International Standard. These principles are not
”‡“—‹”‡‡–• ‹ –Š‡•‡Ž˜‡•ǡ „—– –Š‡› ˆ‘” –Š‡ ˆ‘—†ƒ–‹‘ ‘ˆ –Š‡ ”‡“—‹”‡‡–• •’‡…‹ϐ‹‡† „› –Š‹•
–‡”ƒ–‹‘ƒŽ –ƒ†ƒ”†Ǥ  ͻͲͲͲ ƒŽ•‘ †‡ϐ‹‡• –Š‡ –‡”•ǡ †‡ϐ‹‹–‹‘• ƒ† …‘…‡’–• —•‡† ‹ –Š‹•
International Standard.
ȋ–Š‹•–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†Ȍ•’‡…‹ϐ‹‡•”‡“—‹”‡‡–•ƒ‹‡†’”‹ƒ”‹Ž›ƒ–‰‹˜‹‰…‘ϐ‹†‡…‡‹
— ISO 9001ȋ–Š‹•–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†Ȍ•’‡…‹ϐ‹‡•”‡“—‹”‡‡–•ƒ‹‡†’”‹ƒ”‹Ž›ƒ–‰‹˜‹‰…‘ϐ‹†‡…‡‹
–Š‡’”‘†—…–•ƒ†•‡”˜‹…‡•’”‘˜‹†‡†„›ƒ‘”‰ƒ‹œƒ–‹‘ƒ†–Š‡”‡„›‡Šƒ…‹‰…—•–‘‡”•ƒ–‹•ˆƒ…–‹‘Ǥ
–• ’”‘’‡” ‹’Ž‡‡–ƒ–‹‘ …ƒ ƒŽ•‘ „‡ ‡š’‡…–‡† –‘ „”‹‰ ‘–Š‡” ‘”‰ƒ‹œƒ–‹‘ƒŽ „‡‡ϐ‹–•ǡ •—…Š ƒ•
improved internal communication, better understanding and control of the organization’s processes.
— ISO 9004 Managing for the sustained success of an organization — A quality management approach
’”‘˜‹†‡• ‰—‹†ƒ…‡ ˆ‘” ‘”‰ƒ‹œƒ–‹‘• –Šƒ– …Š‘‘•‡ –‘ ’”‘‰”‡•• „‡›‘† –Š‡ ”‡“—‹”‡‡–• ‘ˆ –Š‹•
International Standard, to address 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‘‰›
‘”‰ƒ‹œƒ–‹‘ǯ•‘˜‡”ƒŽŽ’‡”ˆ‘”ƒ…‡Ǥ
ˆ‘”ƒ‘”‰ƒ‹œƒ–‹‘–‘„‡ƒ„Ž‡–‘‡˜ƒŽ—ƒ–‡–Š‡Ž‡˜‡Ž‘ˆƒ–—”‹–›‘ˆ‹–•“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǥ
Š‡ –‡”ƒ–‹‘ƒŽ –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‘”
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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.
— ISO 10006 Quality management systems — Guidelines
delines for quality management in projects is applicable
–‘’”‘Œ‡…–•ˆ”‘–Š‡•ƒŽŽ–‘Žƒ”‰‡ǡˆ”‘•‹’Ž‡–‘…‘’Ž‡šǡˆ”‘ƒ‹†‹˜‹†—ƒŽ’”‘Œ‡…––‘„‡‹‰’ƒ”–
‘ˆƒ’‘”–ˆ‘Ž‹‘‘ˆ’”‘Œ‡…–•ǤͳͲͲͲ͸‹•–‘„‡—•‡†„›’‡”•‘‡Žƒƒ‰‹‰’”‘Œ‡…–•ƒ†™Š‘‡‡†–‘
͸‹•–‘„‡—•‡†„›’‡”•‘‡Žƒƒ‰‹‰’”‘Œ‡…–•ƒ†™Š‘‡‡†–‘
‡•—”‡–Šƒ––Š‡‹”‘”‰ƒ‹œƒ–‹‘‹•ƒ’’Ž›‹‰–Š‡’”ƒ…–‹…‡•…‘–ƒ‹‡†‹–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–
•›•–‡•–ƒ†ƒ”†•Ǥ
— ISO 10007 —ƒŽ‹–› ƒƒ‰‡‡– •›•–‡• Ȅ
—‹†‡Ž‹‡•†‡Ž‹‡• ˆ‘” …‘ϔ‹‰—”ƒ–‹‘ ƒƒ‰‡‡– is to assist
‘”‰ƒ‹œƒ–‹‘•ƒ’’Ž›‹‰…‘ϐ‹‰—”ƒ–‹‘ƒƒ‰‡‡–ˆ‘”–Š‡–‡…Š‹…ƒŽƒ†ƒ†‹‹•–”ƒ–‹˜‡†‹”‡…–‹‘
‘˜‡” –Š‡ Ž‹ˆ‡ …›…Ž‡ ‘ˆ ƒ ’”‘†—…–Ǥ ‘ϐ‹‰—”ƒ–‹‘ ƒƒ‰‡‡– …ƒ „‡ —•‡† –‘ ‡‡– –Š‡ ’”‘†—…–
‹†‡–‹ϐ‹…ƒ–‹‘ƒ†–”ƒ…‡ƒ„‹Ž‹–›”‡“—‹”‡‡–••’‡…‹ϐ‹‡†‹–Š‹•–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†Ǥ
— ISO 10008 Quality management — Customer stomer satisfaction — Guidelines for business-to-consumer
electronic commerce transactions gives guidance on how 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‹–›
‘ˆ‘”‰ƒ‹œƒ–‹‘•–‘•ƒ–‹•ˆ›…‘•—‡”•ƒ†Š‡Ž’”‡†—…‡…‘’Žƒ‹–•ƒ††‹•’—–‡•Ǥ
— ISO 10012 Measurement management systems — Requirements
Re for measurement processes and
measuring equipment provides guidance for 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•—”‡‡–
™‹–Š‡–”‘Ž‘‰‹…ƒŽ”‡“—‹”‡‡–•Ǥ ͳͲͲͳʹ’”‘˜‹†‡•“—ƒŽ‹–›ƒƒ‰‡‡–…”‹–‡”‹ƒˆ‘”ƒ‡ƒ•—”‡‡–
ʹ’”‘˜‹†‡•“—ƒŽ‹–›ƒƒ‰‡‡–…”‹–‡”‹ƒˆ‘”ƒ‡ƒ•—”‡‡–
ƒƒ‰‡‡–•›•–‡–‘‡•—”‡‡–”‘Ž‘‰‹…ƒŽ”‡“—‹”‡‡–•ƒ”‡‡–Ǥ
— ISO/TR 10013 Guidelines for quality management system documentation provides guidelines for
–Š‡ †‡˜‡Ž‘’‡– ƒ† ƒ‹–‡ƒ…‡ ‘ˆ –Š‡ †‘…—‡–ƒ–‹‘ ‡…‡••ƒ”› ˆ‘” ƒ “—ƒŽ‹–› ƒƒ‰‡‡–
•›•–‡Ǥ ISO/TR ͳͲͲͳ͵
͵ …ƒ „‡ —•‡† –‘ †‘…—‡– ƒƒ‰‡‡– •›•–‡• ‘–Š‡” –Šƒ –Š‘•‡ ‘ˆ –Š‡
“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡•–ƒ†ƒ”†•ǡ‡Ǥ‰Ǥ‡˜‹”‘‡–ƒŽƒƒ‰‡‡–•›•–‡•ƒ†•ƒˆ‡–›
ƒƒ‰‡‡–•›•–‡•Ǥ
—ƒŽ‹–›ƒƒ‰‡‡–Ȅ
—‹†‡Ž‹‡•ˆ‘””‡ƒŽ‹œ‹‰ϔ‹ƒ…‹ƒŽƒ†‡…‘‘‹…„‡‡ϔ‹–• is addressed
— ISO 10014 —ƒŽ‹–›ƒƒ‰‡‡–
–‘–‘’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 guidance on the management of an
ƒ—†‹–’”‘‰”ƒ‡ǡ‘–Š‡’Žƒ‹‰ƒ†…‘†—…–‹‰‘ˆƒƒ—†‹–‘ˆƒƒƒ‰‡‡–•›•–‡ǡƒ•™‡ŽŽƒ•
‘–Š‡…‘’‡–‡…‡ƒ†‡˜ƒŽ—ƒ–‹‘‘ˆƒƒ—†‹–‘”ƒ†ƒƒ—†‹––‡ƒǤͳͻͲͳͳ‹•‹–‡†‡†–‘ƒ’’Ž›–‘
‘–Š‡…‘’‡–‡…‡ƒ†‡˜ƒŽ—ƒ–‹‘‘ˆƒƒ—†‹–‘”ƒ†ƒƒ—†‹––‡ƒǤ
ƒ—†‹–‘”•ǡ‘”‰ƒ‹œƒ–‹‘•‹’Ž‡‡–‹‰ƒƒ‰‡‡–•›•–‡•ǡƒ†‘”‰ƒ‹œƒ–‹‘•‡‡†‹‰–‘…‘†—…–
ƒ—†‹–•‘ˆƒƒ‰‡‡–•›•–‡•Ǥ

Table B.1 — Relationship

ationship between other International Standards on quality management and
quality management systems and the clauses of this International Standard
Other Interna- Clause in this International Standard
tional Standard
4 5 6 7 8 9 10
ISO 9000 All All All All All All All
ISO 9004 ll
All All All All All All All
ISO 10001 8.2.2, 8.5.1 9.1.2
ISO 10002 8.2.1, 9.1.2 10.2.1
ISO 10003 9.1.2
ISO 10004 9.1.2, 9.1.3
ISO 10005 5.3 6.1, 6.2
6.1 All All 9.1 10.2
ISO 10006 All
ll All All All All All All
ISO 10007 8.5.2
ISO 10008 All All All All All All All
ISO 10012 7.1.5
ISO/TR 10013 7.5
ISO 10014 All All All All All All All
5
ISO 10015 7.2
ISO/TR 10017
1001 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
delines for monitoring and measuring
[6] ISO 10005, Quality management systems — Guidelines
delines for quality plans
[7] ISO 10006, Quality management systems — Guidelines
delines for quality management in projects
[8] †‡Ž‹‡•ˆ‘”…‘ϔ‹‰—”ƒ–‹‘ƒƒ‰‡‡–
ISO 10007, —ƒŽ‹–›ƒƒ‰‡‡–•›•–‡•Ȅ
—‹†‡Ž‹‡•ˆ‘”…‘ϔ‹‰—”ƒ–‹‘ƒƒ‰‡‡–
[9] ISO 10008, Quality management — Customer
stomer satisfaction — Guidelines for business-to-consumer
electronic commerce transactions
[10] ISO 10012, Measurement management systems — Requirements
Re for measurement processes and
measuring equipment
[11] ISO/TR 10013, Guidelines for quality management system documentation
[12] Ȅ
—‹†‡Ž‹‡•ˆ‘””‡ƒŽ‹œ‹‰ϔ‹ƒ…‹ƒŽƒ†‡…‘‘‹…„‡‡ϔ‹–•
†‡Ž‹‡•ˆ‘””‡ƒŽ‹œ‹‰ϔ‹ƒ…‹ƒŽƒ†‡…‘‘‹…„‡‡ϔ‹–•
ISO 10014, —ƒŽ‹–›ƒƒ‰‡‡–Ȅ
—‹†‡Ž‹‡•ˆ‘””‡ƒŽ‹œ‹‰ϔ‹ƒ…‹ƒŽƒ†‡…‘‘‹…„‡‡ϔ‹–•
[13] ISO 10015, Quality management — Guidelines
Guidelines for training
[14] ISO/TR 10017, Guidance on statistical techniques for ISO 9001:2000
[15] ISO 10018, Quality management — Guidelines on people involvement and competence
[16] ISO 10019, Guidelines for the selection of quality management system consultants and use of
their services
[17] ISO 14001, Environmental management systems — Requirements with guidance for use
[18] ISO 19011, Guidelines for auditing management systems
[19] 00, Risk management — Principles and guidelines
ISO 31000,
[20] 00, Guidance on outsourcing
ISO 37500,
[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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