ISO/CD 9001.

2(en)
‹š–Š‡†‹–‹‘

ƒ–‡ǣʹͲʹͷǦͲͳǦʹͶ

Quality management systems — Requirements

T EE
AF T
R IT

2
D M M
O
C
 ISO/CD 9001.2:2025(en)

̹ ʹͲʹͷ

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

ƒ›„‡”‡’”‘†— ‡†‘”—–‹Ž‹œ‡†‘–Š‡”™‹•‡‹ƒ›ˆ‘”‘”„›ƒ›‡ƒ•ǡ‡Ž‡ –”‘‹ ‘”‡ Šƒ‹ ƒŽǡ‹ Ž—†‹‰’Š‘–‘ ‘’›‹‰ǡ
‘”’‘•–‹‰‘–Š‡‹–‡”‡–‘”ƒ‹–”ƒ‡–ǡ™‹–Š‘—–’”‹‘”™”‹––‡’‡”‹••‹‘Ǥ‡”‹••‹‘ ƒ„‡”‡“—‡•–‡†ˆ”‘‡‹–Š‡” 
ƒ––Š‡ƒ††”‡••„‡Ž‘™‘” ǯ•‡„‡”„‘†›‹–Š‡ ‘—–”›‘ˆ–Š‡”‡“—‡•–‡”Ǥ

 ‘’›”‹‰Š–‘ˆˆ‹ ‡
ͶͲͳȈŠǤ†‡Žƒ†‘‡–ͺ
 ǦͳʹͳͶ‡”‹‡”ǡ ‡‡˜ƒ
Š‘‡ǣΪͶͳʹʹ͹ͶͻͲͳͳͳ
Ǧƒ‹Žǣ ‘’›”‹‰Š–̷‹•‘Ǥ‘”‰
‡„•‹–‡ǣ™™™Ǥ‹•‘Ǥ‘”‰

—„Ž‹•Š‡†‹™‹–œ‡”Žƒ†

 

T EE
AF T
R IT

2
D M M
O
C

̹ ʹͲʹͷȂŽŽ”‹‰Š–•”‡•‡”˜‡†
‹‹
 ISO/CD 9001.2:2025(en)

Foreword
 ȋ–Š‡ –‡”ƒ–‹‘ƒŽ ”‰ƒ‹œƒ–‹‘ ˆ‘” –ƒ†ƒ”†‹œƒ–‹‘Ȍ ‹• ƒ ™‘”Ž†™‹†‡ ˆ‡†‡”ƒ–‹‘ ‘ˆ ƒ–‹‘ƒŽ •–ƒ†ƒ”†•
„‘†‹‡•ȋ ‡„‡”„‘†‹‡•ȌǤŠ‡™‘”‘ˆ’”‡’ƒ”‹‰ –‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†•‹•‘”ƒŽŽ› ƒ””‹‡†‘—––Š”‘—‰Š
–‡ Š‹ ƒŽ ‘‹––‡‡•Ǥƒ Š‡„‡”„‘†›‹–‡”‡•–‡†‹ƒ•—„Œ‡ –ˆ‘”™Š‹ Šƒ–‡ Š‹ ƒŽ ‘‹––‡‡Šƒ•„‡‡
‡•–ƒ„Ž‹•Š‡†Šƒ•–Š‡”‹‰Š––‘„‡”‡’”‡•‡–‡†‘–Šƒ– ‘‹––‡‡Ǥ –‡”ƒ–‹‘ƒŽ‘”‰ƒ‹œƒ–‹‘•ǡ‰‘˜‡”‡–ƒŽƒ†
‘Ǧ‰‘˜‡”‡–ƒŽǡ ‹ Ž‹ƒ‹•‘ ™‹–Š ǡ ƒŽ•‘ –ƒ‡ ’ƒ”– ‹ –Š‡ ™‘”Ǥ  ‘ŽŽƒ„‘”ƒ–‡• Ž‘•‡Ž› ™‹–Š –Š‡
–‡”ƒ–‹‘ƒŽŽ‡ –”‘–‡ Š‹ ƒŽ‘‹••‹‘ȋ Ȍ‘ƒŽŽƒ––‡”•‘ˆ‡Ž‡ –”‘–‡ Š‹ ƒŽ•–ƒ†ƒ”†‹œƒ–‹‘Ǥ

Š‡’”‘ ‡†—”‡•—•‡†–‘†‡˜‡Ž‘’–Š‹•†‘ —‡–ƒ†–Š‘•‡‹–‡†‡†ˆ‘”‹–•ˆ—”–Š‡”ƒ‹–‡ƒ ‡ƒ”‡†‡• ”‹„‡†

‹–Š‡ Ȁ ‹”‡ –‹˜‡•ǡƒ”–ͳǤ ’ƒ”–‹ —Žƒ”–Š‡†‹ˆˆ‡”‡–ƒ’’”‘˜ƒŽ ”‹–‡”‹ƒ‡‡†‡†ˆ‘”–Š‡†‹ˆˆ‡”‡––›’‡•‘ˆ
 †‘ —‡–• •Š‘—Ž† „‡ ‘–‡†Ǥ Š‹• †‘ —‡– ™ƒ• †”ƒˆ–‡† ‹ ƒ ‘”†ƒ ‡ ™‹–Š –Š‡ ‡†‹–‘”‹ƒŽ ”—Ž‡• ‘ˆ –Š‡
Ȁ ‹”‡ –‹˜‡•ǡƒ”–ʹȋ•‡‡™™™Ǥ‹•‘Ǥ‘”‰Ȁ†‹”‡ –‹˜‡•ȌǤ

––‡–‹‘‹•†”ƒ™–‘–Š‡’‘••‹„‹Ž‹–›–Šƒ–•‘‡‘ˆ–Š‡‡Ž‡‡–•‘ˆ–Š‹•†‘ —‡–ƒ›„‡–Š‡•—„Œ‡ –‘ˆ’ƒ–‡–

”‹‰Š–•Ǥ •ŠƒŽŽ‘–„‡Š‡Ž†”‡•’‘•‹„Ž‡ˆ‘”‹†‡–‹ˆ›‹‰ƒ›‘”ƒŽŽ•— Š’ƒ–‡–”‹‰Š–•Ǥ‡–ƒ‹Ž•‘ˆƒ›’ƒ–‡–”‹‰Š–•
‹†‡–‹ˆ‹‡††—”‹‰–Š‡†‡˜‡Ž‘’‡–‘ˆ–Š‡†‘ —‡–™‹ŽŽ„‡‹–Š‡ –”‘†— –‹‘ƒ†Ȁ‘”‘–Š‡ Ž‹•–‘ˆ’ƒ–‡–
†‡ Žƒ”ƒ–‹‘•”‡ ‡‹˜‡†ȋ•‡‡™™™Ǥ‹•‘Ǥ‘”‰Ȁ’ƒ–‡–•ȌǤ

T EE
› –”ƒ†‡ ƒ‡ —•‡† ‹ –Š‹• †‘ —‡– ‹• ‹ˆ‘”ƒ–‹‘ ‰‹˜‡ ˆ‘” –Š‡ ‘˜‡‹‡ ‡ ‘ˆ —•‡”• ƒ† †‘‡• ‘–
‘•–‹–—–‡ƒ‡†‘”•‡‡–Ǥ
AF T
‘”ƒ‡š’Žƒƒ–‹‘‘–Š‡‡ƒ‹‰‘ˆ •’‡ ‹ˆ‹ –‡”•ƒ†‡š’”‡••‹‘•”‡Žƒ–‡†–‘ ‘ˆ‘”‹–›ƒ••‡••‡–ǡƒ•
™‡ŽŽƒ•‹ˆ‘”ƒ–‹‘ƒ„‘—– ̵•ƒ†Š‡”‡ ‡–‘–Š‡‘”Ž†”ƒ†‡”‰ƒ‹œƒ–‹‘ȋȌ’”‹ ‹’Ž‡•‹–Š‡‡ Š‹ ƒŽ
R IT

2
ƒ””‹‡”•–‘”ƒ†‡ȋȌ•‡‡–Š‡ˆ‘ŽŽ‘™‹‰ǣ™™™Ǥ‹•‘Ǥ‘”‰Ȁ‹•‘Ȁˆ‘”‡™‘”†ǤŠ–ŽǤ
D M

Š‡ ‘‹––‡‡”‡•’‘•‹„Ž‡ˆ‘”–Š‹•†‘ —‡–‹•‡ Š‹ ƒŽ‘‹––‡‡ Ȁͳ͹͸ǡQuality management and

quality assuranceǡ—„ ‘‹––‡‡ʹǡQuality systemsǤ
M

Š‹••‹š–Š‡†‹–‹‘ ƒ ‡Ž•ƒ†”‡’Žƒ ‡•–Š‡ˆ‹ˆ–Š‡†‹–‹‘ȋ ͻͲͲͳǣʹͲͳͷȌǤ

O
C

̹ ʹͲʹͷȂŽŽ”‹‰Š–•”‡•‡”˜‡†
‹˜
 ISO/CD 9001.2:2025(en)

Introduction

0.1 General

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

Š‡ ’‘–‡–‹ƒŽ „‡‡ˆ‹–• –‘ ƒ ‘”‰ƒ‹œƒ–‹‘ ‘ˆ ‹’Ž‡‡–‹‰ ƒ “—ƒŽ‹–› ƒƒ‰‡‡– •›•–‡ „ƒ•‡† ‘ –Š‹•
†‘ —‡–ƒ”‡ǣ

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

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

T EE
Š‹•†‘ —‡– ƒ„‡—•‡†„›‹–‡”ƒŽƒ†‡š–‡”ƒŽ’ƒ”–‹‡•Ǥ

–‹•‘––Š‡‹–‡–‘ˆ–Š‹•†‘ —‡––‘‹’Ž›–Š‡‡‡†ˆ‘”ǣ
AF T
Ȅ —‹ˆ‘”‹–›‹–Š‡•–”— –—”‡‘ˆ†‹ˆˆ‡”‡–“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡•Ǣ
R IT

2
Ȅ ƒŽ‹‰‡–‘ˆ†‘ —‡–ƒ–‹‘–‘–Š‡ Žƒ—•‡•–”— –—”‡‘ˆ–Š‹•†‘ —‡–Ǣ
D M

Ȅ –Š‡—•‡‘ˆ–Š‡•’‡ ‹ˆ‹ –‡”‹‘Ž‘‰›‘ˆ–Š‹•†‘ —‡–™‹–Š‹–Š‡‘”‰ƒ‹œƒ–‹‘Ǥ

M

Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡”‡“—‹”‡‡–••’‡ ‹ˆ‹‡†‹–Š‹•†‘ —‡–ƒ”‡ ‘’Ž‡‡–ƒ”›–‘”‡“—‹”‡‡–•

ˆ‘”’”‘†— –•ƒ†•‡”˜‹ ‡•Ǥ
O

Š‹•†‘ —‡–‡’Ž‘›•–Š‡’”‘ ‡••ƒ’’”‘ƒ Šǡ™Š‹ Š‹ ‘”’‘”ƒ–‡•–Š‡ŽƒǦ‘ǦŠ‡ Ǧ –ȋȌ › Ž‡ƒ†

C

”‹•Ǧ„ƒ•‡†–Š‹‹‰Ǥ

Š‡’”‘ ‡••ƒ’’”‘ƒ Š‡ƒ„Ž‡•ƒ‘”‰ƒ‹œƒ–‹‘–‘’Žƒ‹–•’”‘ ‡••‡•ƒ†–Š‡‹”‹–‡”ƒ –‹‘•Ǥ

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

ƒ†–Šƒ–‘’’‘”–—‹–‹‡•ˆ‘”‹’”‘˜‡‡–ƒ”‡†‡–‡”‹‡†ƒ†ƒ –‡†‘Ǥ

‹•Ǧ„ƒ•‡†–Š‹‹‰‡ƒ„Ž‡•ƒ‘”‰ƒ‹œƒ–‹‘–‘†‡–‡”‹‡–Š‡ˆƒ –‘”•–Šƒ– ‘—Ž† ƒ—•‡‹–•’”‘ ‡••‡•ƒ†‹–•

“—ƒŽ‹–› ƒƒ‰‡‡– •›•–‡ –‘ †‡˜‹ƒ–‡ ˆ”‘ –Š‡ ’Žƒ‡† ”‡•—Ž–•ǡ –‘ ’—– ‹ ’Žƒ ‡ ’”‡˜‡–‹˜‡ ‘–”‘Ž• –‘
‹‹‹œ‡‡‰ƒ–‹˜‡‡ˆˆ‡ –•ƒ†–‘ƒ‡ƒš‹——•‡‘ˆ‘’’‘”–—‹–‹‡•ƒ•–Š‡›ƒ”‹•‡Ǥ

‘•‹•–‡–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–ˆ‹†‹– ‡ ‡••ƒ”› –‘ ƒ†‘’– ˜ƒ”‹‘—•ˆ‘”•‘ˆ ‹’”‘˜‡‡– ‹ ƒ††‹–‹‘ –‘ ‘””‡ –‹‘ ƒ†
‘–‹—ƒŽ‹’”‘˜‡‡–ǡ•— Šƒ•„”‡ƒ–Š”‘—‰Š Šƒ‰‡ǡ‹‘˜ƒ–‹‘ƒ†”‡Ǧ‘”‰ƒ‹œƒ–‹‘Ǥ

–Š‹•†‘ —‡–ǡ–Š‡ˆ‘ŽŽ‘™‹‰˜‡”„ƒŽˆ‘”•ƒ”‡—•‡†ǣ

Ȅ Dz•ŠƒŽŽdz‹†‹ ƒ–‡•ƒ”‡“—‹”‡‡–Ǣ

Ȅ Dz•Š‘—Ž†dz‹†‹ ƒ–‡•ƒ”‡ ‘‡†ƒ–‹‘Ǣ

̹ ʹͲʹͷȂŽŽ”‹‰Š–•”‡•‡”˜‡†
˜
 ISO/CD 9001.2:2025(en)

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

‡š’”‘˜‹†‡•‹ˆ‘”ƒ–‹‘ƒ† Žƒ”‹ˆ‹ ƒ–‹‘•–Šƒ– ƒ•—’’‘”–—†‡”•–ƒ†‹‰‘ˆ–Š‡”‡“—‹”‡‡–•‘ˆ–Š‹•

†‘ —‡–ǤŠ‹•‹•ƒ‹ˆ‘”ƒ–‹˜‡ƒ‡šƒ††‘‡•‘–”‡ˆŽ‡ –ƒ›ƒ††‹–‹‘ƒŽ”‡“—‹”‡‡–•Ǥ

Š‡‡š’Žƒƒ–‘”›‹ˆ‘”ƒ–‹‘‹•‰‹˜‡‘Ž›‘ Žƒ—•‡•‡‡†‹‰ Žƒ”‹ˆ‹ ƒ–‹‘Ǥ

‘”‰—‹†ƒ ‡‘–Š‡ƒ’’Ž‹ ƒ–‹‘‘ˆƒŽŽ Žƒ—•‡••‡‡ ͻͲͲʹǣǦ

0.2 Quality management principles

Š‹•†‘ —‡–‹•„ƒ•‡†‘–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–’”‹ ‹’Ž‡•†‡• ”‹„‡†‹ ȀͻͲͲͲǤŠ‡†‡• ”‹’–‹‘•

‹ Ž—†‡ƒ•–ƒ–‡‡–‘ˆ‡ƒ Š’”‹ ‹’Ž‡ǡƒ”ƒ–‹‘ƒŽ‡‘ˆ™Š›–Š‡’”‹ ‹’Ž‡‹•‹’‘”–ƒ–ˆ‘”–Š‡‘”‰ƒ‹œƒ–‹‘ǡ•‘‡

T EE
‡šƒ’Ž‡• ‘ˆ „‡‡ˆ‹–• ƒ••‘ ‹ƒ–‡† ™‹–Š –Š‡ ’”‹ ‹’Ž‡ ƒ† ‡šƒ’Ž‡• ‘ˆ –›’‹ ƒŽ ƒ –‹‘• –‘ ‹’”‘˜‡ –Š‡
‘”‰ƒ‹œƒ–‹‘̵•’‡”ˆ‘”ƒ ‡™Š‡ƒ’’Ž›‹‰–Š‡’”‹ ‹’Ž‡Ǥ

Š‡“—ƒŽ‹–›ƒƒ‰‡‡–’”‹ ‹’Ž‡•ƒ”‡ǣ
AF T
R IT

Ȅ —•–‘‡”ˆ‘ —•Ǣ 2
Ȅ Ž‡ƒ†‡”•Š‹’Ǣ
D M

Ȅ ‡‰ƒ‰‡‡–‘ˆ’‡‘’Ž‡Ǣ
M

Ȅ ’”‘ ‡••ƒ’’”‘ƒ ŠǢ

O

Ȅ ‹’”‘˜‡‡–Ǣ
C

Ȅ ‡˜‹†‡ ‡Ǧ„ƒ•‡††‡ ‹•‹‘ƒ‹‰Ǣ

Ȅ ”‡Žƒ–‹‘•Š‹’ƒƒ‰‡‡–Ǥ

0.3 Process approach

0.3.1 General

Š‹•†‘ —‡–’”‘‘–‡•–Š‡ƒ†‘’–‹‘‘ˆƒ’”‘ ‡••ƒ’’”‘ƒ Š™Š‡†‡˜‡Ž‘’‹‰ǡ‹’Ž‡‡–‹‰ƒ†‹’”‘˜‹‰

–Š‡ ‡ˆˆ‡ –‹˜‡‡•• ‘ˆ ƒ “—ƒŽ‹–› ƒƒ‰‡‡– •›•–‡ǡ –‘ ‡Šƒ ‡ —•–‘‡” •ƒ–‹•ˆƒ –‹‘ „› ‡‡–‹‰ —•–‘‡”
”‡“—‹”‡‡–•Ǥ’‡ ‹ˆ‹ ”‡“—‹”‡‡–• ‘•‹†‡”‡†‡••‡–‹ƒŽ–‘–Š‡ƒ†‘’–‹‘‘ˆƒ’”‘ ‡••ƒ’’”‘ƒ Šƒ”‡‹ Ž—†‡†
‹ͶǤͶǤ

†‡”•–ƒ†‹‰ ƒ† ƒƒ‰‹‰ ‹–‡””‡Žƒ–‡† ’”‘ ‡••‡• ƒ• ƒ •›•–‡ ‘–”‹„—–‡• –‘ –Š‡ ‘”‰ƒ‹œƒ–‹‘̵•
‡ˆˆ‡ –‹˜‡‡••ƒ†‡ˆˆ‹ ‹‡ ›‹ƒ Š‹‡˜‹‰‹–•‹–‡†‡†”‡•—Ž–•ǤŠ‹•ƒ’’”‘ƒ Š‡ƒ„Ž‡•–Š‡‘”‰ƒ‹œƒ–‹‘–‘ ‘–”‘Ž
–Š‡ ‹–‡””‡Žƒ–‹‘•Š‹’• ƒ† ‹–‡”†‡’‡†‡ ‹‡• ƒ‘‰ –Š‡ ’”‘ ‡••‡• ‘ˆ –Š‡ •›•–‡ǡ •‘ –Šƒ– –Š‡ ‘˜‡”ƒŽŽ
’‡”ˆ‘”ƒ ‡‘ˆ–Š‡‘”‰ƒ‹œƒ–‹‘ ƒ„‡‡Šƒ ‡†Ǥ

Š‡’”‘ ‡••ƒ’’”‘ƒ Š‹˜‘Ž˜‡•–Š‡•›•–‡ƒ–‹ †‡ˆ‹‹–‹‘ƒ†ƒƒ‰‡‡–‘ˆ’”‘ ‡••‡•ǡƒ†–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‡

̹ ʹͲʹͷȂŽŽ”‹‰Š–•”‡•‡”˜‡†
˜‹
 ISO/CD 9001.2:2025(en)

ȋ•‡‡Ȍ™‹–Šƒ‘˜‡”ƒŽŽˆ‘ —•‘”‹•Ǧ„ƒ•‡†–Š‹‹‰ȋ•‡‡Ǥ͸ǤͳǤʹȌƒ‹‡†ƒ––ƒ‹‰ƒ†˜ƒ–ƒ‰‡‘ˆ‘’’‘”–—‹–‹‡•
ƒ†’”‡˜‡–‹‰—†‡•‹”ƒ„Ž‡”‡•—Ž–•Ǥ

Š‡ƒ’’Ž‹ ƒ–‹‘‘ˆ–Š‡’”‘ ‡••ƒ’’”‘ƒ Š‹ƒ“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡‡ƒ„Ž‡•ǣ

ƒȌ —†‡”•–ƒ†‹‰ƒ† ‘•‹•–‡ ›‹‡‡–‹‰”‡“—‹”‡‡–•Ǣ

„Ȍ –Š‡ ‘•‹†‡”ƒ–‹‘‘ˆ’”‘ ‡••‡•‹–‡”•‘ˆƒ††‡†˜ƒŽ—‡Ǣ

Ȍ –Š‡ƒ Š‹‡˜‡‡–‘ˆ‡ˆˆ‡ –‹˜‡’”‘ ‡••’‡”ˆ‘”ƒ ‡Ǣ

†Ȍ ‹’”‘˜‡‡–‘ˆ’”‘ ‡••‡•„ƒ•‡†‘‡˜ƒŽ—ƒ–‹‘‘ˆ†ƒ–ƒƒ†‹ˆ‘”ƒ–‹‘Ǥ

‹‰—”‡ ͳ ‰‹˜‡• ƒ • Š‡ƒ–‹  ”‡’”‡•‡–ƒ–‹‘ ‘ˆ ƒ› ’”‘ ‡•• ƒ† •Š‘™• –Š‡ ‹–‡”ƒ –‹‘ ‘ˆ ‹–• ‡Ž‡‡–•Ǥ Š‡
‘‹–‘”‹‰ƒ†‡ƒ•—”‹‰ Š‡ ’‘‹–•ǡ™Š‹ Šƒ”‡‡ ‡••ƒ”›ˆ‘” ‘–”‘Žǡƒ”‡•’‡ ‹ˆ‹ –‘‡ƒ Š’”‘ ‡••ƒ†™‹ŽŽ
˜ƒ”›†‡’‡†‹‰‘–Š‡”‡Žƒ–‡†”‹••Ǥ

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

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0.3.2 Plan-Do-Check-Act cycle

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

‹ŽŽ—•–”ƒ–‡•Š‘™Žƒ—•‡Ͷ–‘Žƒ—•‡ͳͲ‘ˆ–Š‹•†‘ —‡– ƒ„‡‰”‘—’‡†‹”‡Žƒ–‹‘–‘–Š‡ › Ž‡Ǥ

̹ ʹͲʹͷȂŽŽ”‹‰Š–•”‡•‡”˜‡†
˜‹‹
 ISO/CD 9001.2:2025(en)

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2 
 —„‡”•‹„”ƒ ‡–•”‡ˆ‡”–‘–Š‡ Žƒ—•‡•‹–Š‹•†‘ —‡–Ǥ
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Figure 2 — Representation of the structure of this document in the PDCA cycle

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Š‡ › Ž‡ ƒ„‡„”‹‡ˆŽ›†‡• ”‹„‡†ƒ•ˆ‘ŽŽ‘™•ǣ

O

Ȅ Planǣ‡•–ƒ„Ž‹•Š–Š‡‘„Œ‡ –‹˜‡•‘ˆ–Š‡•›•–‡ƒ†‹–•’”‘ ‡••‡•ǡƒ†–Š‡”‡•‘—” ‡•‡‡†‡†–‘†‡Ž‹˜‡””‡•—Ž–•

‹ƒ ‘”†ƒ ‡™‹–Š —•–‘‡”•̵”‡“—‹”‡‡–•ƒ†–Š‡‘”‰ƒ‹œƒ–‹‘̵•’‘Ž‹ ‹‡•ǡƒ†‹†‡–‹ˆ›ƒ†ƒ††”‡••”‹••
C

ƒ†‘’’‘”–—‹–‹‡•Ǣ

Ȅ Doǣ‹’Ž‡‡–™Šƒ–™ƒ•’Žƒ‡†Ǣ

Ȅ Checkǣ ‘‹–‘” ƒ† ȋ™Š‡”‡ ƒ’’Ž‹ ƒ„Ž‡Ȍ ‡ƒ•—”‡ ’”‘ ‡••‡• ƒ† –Š‡ ”‡•—Ž–‹‰ ’”‘†— –• ƒ† •‡”˜‹ ‡•
ƒ‰ƒ‹•–’‘Ž‹ ‹‡•ǡ‘„Œ‡ –‹˜‡•ǡ”‡“—‹”‡‡–•ƒ†’Žƒ‡†ƒ –‹˜‹–‹‡•ǡƒ†”‡’‘”––Š‡”‡•—Ž–•Ǣ

Ȅ Actǣ–ƒ‡ƒ –‹‘•–‘‹’”‘˜‡’‡”ˆ‘”ƒ ‡ǡƒ•‡ ‡••ƒ”›Ǥ

0.4 Relationship with other management system standards

Š‹• †‘ —‡– ƒ’’Ž‹‡• –Š‡ Šƒ”‘‹œ‡† •–”— –—”‡ –‘ ‹’”‘˜‡ ƒŽ‹‰‡– ƒ‘‰ ‹–• ƒƒ‰‡‡– •›•–‡•
•–ƒ†ƒ”†•Ǥ

Š‹•†‘ —‡–‡ƒ„Ž‡•ƒ‘”‰ƒ‹œƒ–‹‘–‘—•‡–Š‡’”‘ ‡••ƒ’’”‘ƒ Šǡ ‘—’Ž‡†™‹–Š–Š‡ › Ž‡ƒ†”‹•Ǧ

„ƒ•‡† –Š‹‹‰ǡ –‘ ƒŽ‹‰ ‘” ‹–‡‰”ƒ–‡ ‹–• “—ƒŽ‹–› ƒƒ‰‡‡– •›•–‡ ™‹–Š –Š‡ ”‡“—‹”‡‡–• ‘ˆ ‘–Š‡”
ƒƒ‰‡‡–•›•–‡•–ƒ†ƒ”†•Ǥ

Š‹•†‘ —‡–”‡Žƒ–‡•–‘ ȀͻͲͲͲƒ† ͻͲͲͶƒ•ˆ‘ŽŽ‘™•ǣ

Ȅ ȀͻͲͲͲQuality management systems — Fundamentals and vocabulary’”‘˜‹†‡•‡••‡–‹ƒŽ„ƒ ‰”‘—†

ˆ‘”–Š‡’”‘’‡”—†‡”•–ƒ†‹‰ƒ†‹’Ž‡‡–ƒ–‹‘‘ˆ–Š‹•†‘ —‡–Ǣ

̹ ʹͲʹͷȂŽŽ”‹‰Š–•”‡•‡”˜‡†
˜‹‹‹
 ISO/CD 9001.2:2025(en)

Ȅ  ͻͲͲͶȏͳȐQuality management – Quality of an organization – Guidance to achieve sustained success

’”‘˜‹†‡•‰—‹†ƒ ‡ˆ‘”‘”‰ƒ‹œƒ–‹‘•–Šƒ– Š‘‘•‡–‘’”‘‰”‡••„‡›‘†–Š‡”‡“—‹”‡‡–•‘ˆ–Š‹•†‘ —‡–Ǥ

Š‹• †‘ —‡– †‘‡• ‘– ‹ Ž—†‡ ”‡“—‹”‡‡–• •’‡ ‹ˆ‹  –‘ ‘–Š‡” ƒƒ‰‡‡– •›•–‡•ǡ •— Š ƒ• –Š‘•‡ ˆ‘”
‡˜‹”‘‡–ƒŽƒƒ‰‡‡–ǡ‘ —’ƒ–‹‘ƒŽŠ‡ƒŽ–Šƒ†•ƒˆ‡–›ƒƒ‰‡‡–ǡ‘”ˆ‹ƒ ‹ƒŽƒƒ‰‡‡–Ǥ

‡ –‘”Ǧ•’‡ ‹ˆ‹ “—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡•–ƒ†ƒ”†•„ƒ•‡†‘–Š‡”‡“—‹”‡‡–•‘ˆ–Š‹•†‘ —‡–Šƒ˜‡„‡‡

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

T EE
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2
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̹ ʹͲʹͷȂŽŽ”‹‰Š–•”‡•‡”˜‡†
‹š
C
O
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2
 ISO/CD 9001.2:2025(en)

Quality management systems — Requirements

1 Scope
Š‹•†‘ —‡–•’‡ ‹ˆ‹‡•”‡“—‹”‡‡–•ˆ‘”ƒ“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡™Š‡ƒ‘”‰ƒ‹œƒ–‹‘ǣ

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—†‹‰’”‘ ‡••‡•

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

ŽŽ–Š‡”‡“—‹”‡‡–•‘ˆ–Š‹•†‘ —‡–ƒ”‡‰‡‡”‹ ƒ†ƒ”‡‹–‡†‡†–‘„‡ƒ’’Ž‹ ƒ„Ž‡–‘ƒ›‘”‰ƒ‹œƒ–‹‘Ǥ

Š‹•†‘ —‡–‹•ƒ’’Ž‹ ƒ„Ž‡–‘ƒ›‘”‰ƒ‹œƒ–‹‘ǡ”‡‰ƒ”†Ž‡••‘ˆ‹–•–›’‡‘”•‹œ‡ǡ‘”–Š‡’”‘†— –•ƒ†•‡”˜‹ ‡•‹–

’”‘˜‹†‡•Ǥ

T EE
ͳ  –Š‹• †‘ —‡–ǡ –Š‡ –‡”• Dz’”‘†— –dz ‘” Dz•‡”˜‹ ‡dz ‘Ž› ƒ’’Ž› –‘ ’”‘†— –• ƒ† •‡”˜‹ ‡• ‹–‡†‡† ˆ‘”ǡ ‘”
”‡“—‹”‡†„›ǡƒ —•–‘‡”Ǥ
AF T
ʹ –ƒ–—–‘”›ƒ†”‡‰—Žƒ–‘”›”‡“—‹”‡‡–• ƒ„‡‡š’”‡••‡†ƒ•Ž‡‰ƒŽ”‡“—‹”‡‡–•Ǥ
R IT

2 Normative references 2
Š‡ˆ‘ŽŽ‘™‹‰†‘ —‡–•ƒ”‡”‡ˆ‡””‡†–‘‹–Š‡–‡š–‹•— Šƒ™ƒ›–Šƒ–•‘‡‘”ƒŽŽ‘ˆ–Š‡‹” ‘–‡– ‘•–‹–—–‡•
D M

”‡“—‹”‡‡–•‘ˆ–Š‹•†‘ —‡–Ǥ ‘”†ƒ–‡†”‡ˆ‡”‡ ‡•ǡ‘Ž›–Š‡‡†‹–‹‘ ‹–‡†ƒ’’Ž‹‡•Ǥ ‘”—†ƒ–‡†”‡ˆ‡”‡ ‡•ǡ

–Š‡Žƒ–‡•–‡†‹–‹‘‘ˆ–Š‡”‡ˆ‡”‡ ‡††‘ —‡–ȋ‹ Ž—†‹‰ƒ›ƒ‡†‡–•Ȍƒ’’Ž‹‡•Ǥ
M

ȀͻͲͲͲǡQuality management systems — Fundamentals and vocabulary

O

3 Terms and definitions

C

‘”–Š‡’—”’‘•‡•‘ˆ–Š‹•†‘ —‡–ǡ–Š‡–‡”•ƒ††‡ˆ‹‹–‹‘•‰‹˜‡‹ ȀͻͲͲͲ‹ Ž—†‹‰–Š‡ˆ‘ŽŽ‘™‹‰

ƒ’’Ž›Ǥ

 ƒ†  ƒ‹–ƒ‹ –‡”‹‘Ž‘‰› †ƒ–ƒ„ƒ•‡• ˆ‘” —•‡ ‹ •–ƒ†ƒ”†‹œƒ–‹‘ ƒ– –Š‡ ˆ‘ŽŽ‘™‹‰ ƒ††”‡••‡•ǣ Ȉ 
Ž‹‡„”‘™•‹‰’Žƒ–ˆ‘”ǣƒ˜ƒ‹Žƒ„Ž‡ƒ–Š––’•ǣȀȀ™™™Ǥ‹•‘Ǥ‘”‰Ȁ‘„’

Ȉ Ž‡ –”‘’‡†‹ƒǣƒ˜ƒ‹Žƒ„Ž‡ƒ–Š––’•ǣȀȀ™™™Ǥ‡Ž‡ –”‘’‡†‹ƒǤ‘”‰

3.1
organization
’‡”•‘‘”‰”‘—’‘ˆ’‡‘’Ž‡–Šƒ–Šƒ•‹–•‘™ˆ— –‹‘•™‹–Š”‡•’‘•‹„‹Ž‹–‹‡•ǡƒ—–Š‘”‹–‹‡•ƒ†”‡Žƒ–‹‘•Š‹’•–‘
ƒ Š‹‡˜‡‹–•objectivesȋ͵Ǥ͸Ȍ

‘–‡ͳ–‘ ‡–”›ǣŠ‡ ‘ ‡’– ‘ˆ ‘”‰ƒ‹œƒ–‹‘ ‹ Ž—†‡•ǡ „—– ‹• ‘– Ž‹‹–‡† –‘ǡ •‘Ž‡Ǧ–”ƒ†‡”ǡ ‘’ƒ›ǡ ‘”’‘”ƒ–‹‘ǡ ˆ‹”ǡ
‡–‡”’”‹•‡ǡƒ—–Š‘”‹–›ǡ’ƒ”–‡”•Š‹’ǡ Šƒ”‹–›‘”‹•–‹–—–‹‘ǡ‘”’ƒ”–‘” ‘„‹ƒ–‹‘–Š‡”‡‘ˆǡ™Š‡–Š‡”‹ ‘”’‘”ƒ–‡†‘”‘–ǡ
’—„Ž‹ ‘”’”‹˜ƒ–‡Ǥ

‘–‡ʹ–‘‡–”›ǣ ˆ–Š‡‘”‰ƒ‹œƒ–‹‘‹•’ƒ”–‘ˆƒŽƒ”‰‡”‡–‹–›ǡ–Š‡–‡”Dz‘”‰ƒ‹œƒ–‹‘dz”‡ˆ‡”•‘Ž›–‘–Š‡’ƒ”–‘ˆ–Š‡Žƒ”‰‡”
‡–‹–›–Šƒ–‹•™‹–Š‹–Š‡• ‘’‡‘ˆ–Š‡quality management systemȋ͵ǤͶǤͳȌǤ

̹ ʹͲʹͷȂŽŽ”‹‰Š–•”‡•‡”˜‡†
ͳ
 ISO/CD 9001.2:2025(en)

3.2
interested party (preferred term)
•–ƒ‡Š‘Ž†‡”
’‡”•‘‘”organizationȋ͵ǤͳȌ–Šƒ– ƒƒˆˆ‡ –ǡ„‡ƒˆˆ‡ –‡†„›ǡ‘”’‡” ‡‹˜‡‹–•‡Žˆ–‘„‡ƒˆˆ‡ –‡†„›ƒ†‡ ‹•‹‘‘”
ƒ –‹˜‹–›

 —•–‘‡”•ǡ‘™‡”•ǡ’‡‘’Ž‡‹ƒ‘”‰ƒ‹œƒ–‹‘ǡ’”‘˜‹†‡”•ǡ„ƒ‡”•ǡ”‡‰—Žƒ–‘”•ǡ—‹‘•ǡ’ƒ”–‡”•‘”•‘ ‹‡–›

–Šƒ– ƒ‹ Ž—†‡ ‘’‡–‹–‘”•‘”‘’’‘•‹‰’”‡••—”‡‰”‘—’•Ǥ

3.3
top management
’‡”•‘‘”‰”‘—’‘ˆ’‡‘’Ž‡™Š‘†‹”‡ –•ƒ† ‘–”‘Ž•ƒorganizationȋ͵ǤͳȌƒ––Š‡Š‹‰Š‡•–Ž‡˜‡Ž

‘–‡ͳ–‘‡–”›ǣ‘’ƒƒ‰‡‡–Šƒ•–Š‡’‘™‡”–‘†‡Ž‡‰ƒ–‡ƒ—–Š‘”‹–›ƒ†’”‘˜‹†‡”‡•‘—” ‡•™‹–Š‹–Š‡‘”‰ƒ‹œƒ–‹‘Ǥ

‘–‡ʹ–‘‡–”›ǣ ˆ–Š‡• ‘’‡‘ˆ–Š‡management systemȋ͵ǤͶȌ ‘˜‡”•‘Ž›’ƒ”–‘ˆƒ‘”‰ƒ‹œƒ–‹‘ǡ–Š‡–‘’ƒƒ‰‡‡–

”‡ˆ‡”•–‘–Š‘•‡™Š‘†‹”‡ –ƒ† ‘–”‘Ž–Šƒ–’ƒ”–‘ˆ–Š‡‘”‰ƒ‹œƒ–‹‘Ǥ

3.4

T EE
management system
•‡–‘ˆ‹–‡””‡Žƒ–‡†‘”‹–‡”ƒ –‹‰‡Ž‡‡–•‘ˆƒorganizationȋ͵ǤͳȌ–‘‡•–ƒ„Ž‹•Š’‘Ž‹ ‹‡•ȋ͵ǤͷȌƒ†objectives
ȋ͵Ǥ͸Ȍǡƒ•™‡ŽŽƒ•processȋ͵ǤͺȌ–‘ƒ Š‹‡˜‡–Š‘•‡‘„Œ‡ –‹˜‡•
AF T
‘–‡ͳ–‘‡–”›ǣƒƒ‰‡‡–•›•–‡ ƒƒ††”‡••ƒ•‹‰Ž‡†‹• ‹’Ž‹‡‘”•‡˜‡”ƒŽ†‹• ‹’Ž‹‡•Ǥ
R IT

2
‘–‡ʹ–‘ ‡–”›ǣŠ‡ ƒƒ‰‡‡– •›•–‡ ‡Ž‡‡–• ‹ Ž—†‡ –Š‡ ‘”‰ƒ‹œƒ–‹‘ǯ• •–”— –—”‡ǡ ”‘Ž‡• ƒ† ”‡•’‘•‹„‹Ž‹–‹‡•ǡ
’Žƒ‹‰ƒ†‘’‡”ƒ–‹‘Ǥ
D M

‘–‡͵–‘‡–”›ǣŠ‡ƒƒ‰‡‡–•›•–‡‡Ž‡‡–• ƒ‹ Ž—†‡–Š‡‘”‰ƒ‹œƒ–‹‘ǯ•’‘Ž‹ ‹‡•ǡ’”ƒ –‹ ‡•ǡ”—Ž‡•ǡƒ†„‡Ž‹‡ˆ•Ǥ

M

‘–‡Ͷ–‘‡–”›ǣ‘”‰ƒ‹œƒ–‹‘ƒƒ‰‡•‹–•‹–‡””‡Žƒ–‡†‡Ž‡‡–•‹ƒ‘”†‡”Ž›ƒ‡”–‘ƒ Š‹‡˜‡‹–•‘„Œ‡ –‹˜‡•Ǥ

O

‘–‡ͷ–‘‡–”›ǣŠ‡• ‘’‡‘ˆƒƒƒ‰‡‡–•›•–‡ ƒ‹ Ž—†‡–Š‡™Š‘Ž‡‘ˆ–Š‡‘”‰ƒ‹œƒ–‹‘ǡ•’‡ ‹ˆ‹ ƒ†‹†‡–‹ˆ‹‡†

ˆ— –‹‘•‘ˆ–Š‡‘”‰ƒ‹œƒ–‹‘ǡ•’‡ ‹ˆ‹ ƒ†‹†‡–‹ˆ‹‡†•‡ –‹‘•‘ˆ–Š‡‘”‰ƒ‹œƒ–‹‘ǡ‘”‘‡‘”‘”‡ˆ— –‹‘•ƒ ”‘••ƒ‰”‘—’
‘ˆ‘”‰ƒ‹œƒ–‹‘•Ǥ
C

3.4.1
“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡
’ƒ”–‘ˆƒ᩿᩿management systemȋ͵ǤͶȌ᩿™‹–Š”‡‰ƒ”†–‘᩿“—ƒŽ‹–›

3.5
policy
‹–‡–‹‘•ƒ††‹”‡ –‹‘‘ˆƒorganizationȋ͵ǤͳȌƒ•ˆ‘”ƒŽŽ›‡š’”‡••‡†„›‹–•top managementȋ͵Ǥ͵Ȍ

3.5.1
quality policy
policyȋ͵ǤͷȌ”‡Žƒ–‡†–‘“—ƒŽ‹–›

‘–‡ͳ–‘‡–”›ǣ ‡‡”ƒŽŽ›–Š‡“—ƒŽ‹–›’‘Ž‹ ›‹• ‘•‹•–‡–™‹–Š–Š‡‘˜‡”ƒŽŽ’‘Ž‹ ›‘ˆ–Š‡organizationȋ͵ǤͳȌǡ ƒ„‡ƒŽ‹‰‡†

™‹–Š–Š‡‘”‰ƒ‹œƒ–‹‘̵•˜‹•‹‘ƒ†‹••‹‘ƒ†’”‘˜‹†‡•ƒˆ”ƒ‡™‘”ˆ‘”–Š‡•‡––‹‰‘ˆquality objectiveȋ͵Ǥ͸ǤͳȌǤ

‘–‡ʹ–‘‡–”›ǣ—ƒŽ‹–›ƒƒ‰‡‡–’”‹ ‹’Ž‡•’”‡•‡–‡†‹ ȀͻͲͲͲ ƒˆ‘”ƒ„ƒ•‹•ˆ‘”–Š‡‡•–ƒ„Ž‹•Š‡–‘ˆƒ

“—ƒŽ‹–›’‘Ž‹ ›Ǥ

3.6
objective
”‡•—Ž––‘„‡ƒ Š‹‡˜‡†

̹ ʹͲʹͷȂŽŽ”‹‰Š–•”‡•‡”˜‡†
ʹ
 ISO/CD 9001.2:2025(en)

‘–‡ͳ–‘‡–”›ǣ‘„Œ‡ –‹˜‡ ƒ„‡•–”ƒ–‡‰‹ ǡ–ƒ –‹ ƒŽǡ‘”‘’‡”ƒ–‹‘ƒŽǤ

‘–‡ʹ–‘‡–”›ǣ„Œ‡ –‹˜‡• ƒ”‡Žƒ–‡–‘†‹ˆˆ‡”‡–†‹• ‹’Ž‹‡•ȋ•— Šƒ•ˆ‹ƒ ‡ǡŠ‡ƒŽ–Šƒ†•ƒˆ‡–›ǡƒ†‡˜‹”‘‡–ȌǤŠ‡›

ƒ„‡ǡˆ‘”‡šƒ’Ž‡ǡ‘”‰ƒ‹œƒ–‹‘Ǧ™‹†‡‘”•’‡ ‹ˆ‹ –‘ƒ’”‘Œ‡ –ǡ’”‘†— –ǡ•‡”˜‹ ‡ǡ‘”processȋ͵ǤͺȌǤ

‘–‡͵–‘‡–”›ǣ‘„Œ‡ –‹˜‡ ƒ„‡‡š’”‡••‡†‹‘–Š‡”™ƒ›•ǡ‡Ǥ‰Ǥƒ•ƒ‹–‡†‡†”‡•—Ž–ǡƒ•ƒ’—”’‘•‡ǡƒ•ƒ‘’‡”ƒ–‹‘ƒŽ

”‹–‡”‹‘ǡƒ•ƒquality objectiveȋ͵Ǥ͸ǤͳȌ‘”„›–Š‡—•‡‘ˆ‘–Š‡”™‘”†•™‹–Š•‹‹Žƒ”‡ƒ‹‰ȋ‡Ǥ‰Ǥƒ‹ǡ‰‘ƒŽǡ‘”–ƒ”‰‡–ȌǤ

‘–‡Ͷ–‘‡–”›ǣ –Š‡ ‘–‡š–‘ˆquality management systemȋ͵ǤͶǤͳȌǡquality objectiveȋ͵Ǥ͸ǤͳȌƒ”‡•‡–„›–Š‡organization

ȋ͵ǤͳȌǡ ‘•‹•–‡–™‹–Š–Š‡quality policyȋ͵ǤͷǤͳȌǡ–‘ƒ Š‹‡˜‡•’‡ ‹ˆ‹ ”‡•—Ž–•Ǥ

3.6.1
quality objective
objectiveȋ͵Ǥ͸Ȍ”‡Žƒ–‡†–‘“—ƒŽ‹–›

‘–‡ͳ–‘‡–”›ǣ—ƒŽ‹–›‘„Œ‡ –‹˜‡•ƒ”‡‰‡‡”ƒŽŽ›„ƒ•‡†‘–Š‡organization'sȋ͵ǤͳȌquality policyȋ͵ǤͷǤͳȌǤ

‘–‡ʹ–‘ ‡–”›ǣ—ƒŽ‹–› ‘„Œ‡ –‹˜‡• ƒ”‡ ‰‡‡”ƒŽŽ› •’‡ ‹ˆ‹‡† ˆ‘” ”‡Ž‡˜ƒ– ˆ— –‹‘•ǡ Ž‡˜‡Ž• ƒ† processes ȋ͵ǤͺȌ ‹ –Š‡
‘”‰ƒ‹œƒ–‹‘Ǥ

T EE
3.7
risk
‡ˆˆ‡ –‘ˆ— ‡”–ƒ‹–›
AF T
‘–‡ͳ–‘‡–”›ǣ‡ˆˆ‡ –‹•ƒ†‡˜‹ƒ–‹‘ˆ”‘–Š‡‡š’‡ –‡†Ȅ’‘•‹–‹˜‡‘”‡‰ƒ–‹˜‡Ǥ
R IT

2
‘–‡ʹ–‘‡–”›ǣ ‡”–ƒ‹–›‹•–Š‡•–ƒ–‡ǡ‡˜‡’ƒ”–‹ƒŽǡ‘ˆ†‡ˆ‹ ‹‡ ›‘ˆ‹ˆ‘”ƒ–‹‘”‡Žƒ–‡†–‘ǡ—†‡”•–ƒ†‹‰‘”‘™Ž‡†‰‡
‘ˆƒ‡˜‡–ǡ‹–• ‘•‡“—‡ ‡ǡ‘”Ž‹‡Ž‹Š‘‘†Ǥ
D M

‘–‡͵–‘‡–”›ǣriskȋ͵Ǥ͹Ȍ‹•‘ˆ–‡ Šƒ”ƒ –‡”‹œ‡†„›”‡ˆ‡”‡ ‡–‘’‘–‡–‹ƒŽ‡˜‡–•ȋƒ•†‡ˆ‹‡†‹ ͵ͳͲ͹͵ǣʹͲʹʹȏʹȐǡ͵Ǥ͵ǤͳͳȌ

M

ƒ† ‘•‡“—‡ ‡•ȋƒ•†‡ˆ‹‡†‹ ͵ͳͲ͹͵ǣʹͲʹʹȏʹȐǡ͵Ǥ͵ǤͳͺȌǡ‘”ƒ ‘„‹ƒ–‹‘‘ˆ–Š‡•‡Ǥ

‘–‡Ͷ–‘‡–”›ǣ‹•‹•‘ˆ–‡‡š’”‡••‡†‹–‡”•‘ˆƒ ‘„‹ƒ–‹‘‘ˆ–Š‡ ‘•‡“—‡ ‡•‘ˆƒ‡˜‡–ȋ‹ Ž—†‹‰ Šƒ‰‡•‹

O

‹” —•–ƒ ‡•Ȍƒ†–Š‡ƒ••‘ ‹ƒ–‡†Ž‹‡Ž‹Š‘‘†ȋƒ•†‡ˆ‹‡†‹ ͵ͳͲ͹͵ǣʹͲʹʹȏʹȐǡ͵Ǥ͵Ǥͳ͸Ȍ‘ˆ‘ —””‡ ‡Ǥ

C

‘–‡ͷ–‘‡–”›ǣŠ‡™‘”†Dz”‹•dz‹••‘‡–‹‡•—•‡†™Š‡–Š‡”‡‹•–Š‡’‘••‹„‹Ž‹–›‘ˆ‘Ž›‡‰ƒ–‹˜‡ ‘•‡“—‡ ‡•Ǥ

3.8
process
•‡–‘ˆ‹–‡””‡Žƒ–‡†‘”‹–‡”ƒ –‹‰ƒ –‹˜‹–‹‡•–Šƒ–—•‡•‘”–”ƒ•ˆ‘”•‹’—–•–‘†‡Ž‹˜‡”ƒ”‡•—Ž–

‘–‡ͳ–‘‡–”›ǣŠ‡–Š‡”–Š‡”‡•—Ž–‘ˆƒ’”‘ ‡••‹• ƒŽŽ‡†ƒ‘—–’—–ǡƒ’”‘†— –‘”ƒ•‡”˜‹ ‡†‡’‡†•‘–Š‡ ‘–‡š–‘ˆ–Š‡

”‡ˆ‡”‡ ‡Ǥ

‘–‡ʹ–‘‡–”›ǣ ’—–•–‘ƒ’”‘ ‡••ƒ”‡‰‡‡”ƒŽŽ›–Š‡‘—–’—–•‘ˆ‘–Š‡”’”‘ ‡••‡•ƒ†‘—–’—–•‘ˆƒ’”‘ ‡••ƒ”‡‰‡‡”ƒŽŽ›

–Š‡‹’—–•–‘‘–Š‡”’”‘ ‡••‡•Ǥ

‘–‡͵–‘‡–”›ǣ™‘‘”‘”‡‹–‡””‡Žƒ–‡†ƒ†‹–‡”ƒ –‹‰’”‘ ‡••‡•‹•‡”‹‡• ƒƒŽ•‘„‡”‡ˆ‡””‡†–‘ƒ•ƒ’”‘ ‡••Ǥ

‘–‡Ͷ–‘‡–”›ǣ”‘ ‡••‡•‹ƒorganizationȋ͵ǤͳȌƒ”‡‰‡‡”ƒŽŽ›’Žƒ‡†ƒ† ƒ””‹‡†‘—–—†‡” ‘–”‘ŽŽ‡† ‘†‹–‹‘•–‘

ƒ††˜ƒŽ—‡Ǥ

‘–‡ͷ–‘‡–”›ǣ’”‘ ‡••™Š‡”‡–Š‡conformityȋ͵ǤͳͷȌ‘ˆ–Š‡”‡•—Ž–‹‰‘—–’—– ƒ‘–„‡”‡ƒ†‹Ž›‘”‡ ‘‘‹ ƒŽŽ›˜ƒŽ‹†ƒ–‡†

‹•ˆ”‡“—‡–Ž›”‡ˆ‡””‡†–‘ƒ•ƒDz•’‡ ‹ƒŽ’”‘ ‡••dzǤ

3.9
competence
ƒ„‹Ž‹–›–‘ƒ’’Ž›‘™Ž‡†‰‡ƒ†•‹ŽŽ•–‘ƒ Š‹‡˜‡‹–‡†‡†”‡•—Ž–•

̹ ʹͲʹͷȂŽŽ”‹‰Š–•”‡•‡”˜‡†
͵
 ISO/CD 9001.2:2025(en)

‘–‡ͳ–‘‡–”›ǣ‡‘•–”ƒ–‡† ‘’‡–‡ ‡‹••‘‡–‹‡•”‡ˆ‡””‡†–‘ƒ•“—ƒŽ‹ˆ‹ ƒ–‹‘Ǥ

3.10
documented information
‹ˆ‘”ƒ–‹‘”‡“—‹”‡†–‘„‡ ‘–”‘ŽŽ‡†ƒ†ƒ‹–ƒ‹‡†„›ƒorganizationȋ͵ǤͳȌƒ†–Š‡‡†‹—‘™Š‹ Š‹–‹•
‘–ƒ‹‡†

‘–‡ͳ–‘‡–”›ǣ‘ —‡–‡†‹ˆ‘”ƒ–‹‘ ƒ„‡‹ƒ›ˆ‘”ƒ–ƒ†‡†‹ƒƒ†ˆ”‘ƒ›•‘—” ‡Ǥ

‘–‡ʹ–‘‡–”›ǣ‘ —‡–‡†‹ˆ‘”ƒ–‹‘ ƒ”‡ˆ‡”–‘ǣ

Ȅ –Š‡management systemȋ͵ǤͶȌǡ‹ Ž—†‹‰”‡Žƒ–‡†processȋ͵ǤͺȌǢ

Ȅ ‹ˆ‘”ƒ–‹‘ ”‡ƒ–‡†‹‘”†‡”ˆ‘”–Š‡‘”‰ƒ‹œƒ–‹‘–‘‘’‡”ƒ–‡ȋ†‘ —‡–ƒ–‹‘ȌǢ

Ȅ ‡˜‹†‡ ‡‘ˆ”‡•—Ž–•ƒ Š‹‡˜‡†ȋ”‡ ‘”†•ȌǤ

3.11
performance

T EE
‡ƒ•—”ƒ„Ž‡”‡•—Ž–

‘–‡ͳ–‘‡–”›ǣ‡”ˆ‘”ƒ ‡ ƒ”‡Žƒ–‡‡‹–Š‡”–‘“—ƒ–‹–ƒ–‹˜‡‘”“—ƒŽ‹–ƒ–‹˜‡ˆ‹†‹‰•Ǥ
AF T
‘–‡ʹ–‘ ‡–”›ǣ‡”ˆ‘”ƒ ‡ ƒ ”‡Žƒ–‡ –‘ ƒƒ‰‹‰ ƒ –‹˜‹–‹‡•ǡ processes ȋ͵ǤͺȌǡ ’”‘†— –•ǡ •‡”˜‹ ‡•ǡ •›•–‡• ‘”
organizationsȋ͵ǤͳȌǤ
R IT

3.12
2
continual improvement
D M

”‡ —””‹‰ƒ –‹˜‹–›–‘‡Šƒ ‡performanceȋ͵ǤͳͳȌ

M

‘–‡ͳ–‘‡–”›ǣŠ‡processȋ͵ǤͺȌ‘ˆ‡•–ƒ„Ž‹•Š‹‰objectiveȋ͵Ǥ͸Ȍƒ†ˆ‹†‹‰‘’’‘”–—‹–‹‡•ˆ‘”‹’”‘˜‡‡–‹•ƒ ‘–‹—ƒŽ
’”‘ ‡••–Š”‘—‰Š–Š‡—•‡‘ˆƒ—†‹–ˆ‹†‹‰•ƒ†ƒ—†‹– ‘ Ž—•‹‘•ǡƒƒŽ›•‹•‘ˆ†ƒ–ƒǡƒƒ‰‡‡–”‡˜‹‡™•‘”‘–Š‡”‡ƒ•
O

ƒ†‰‡‡”ƒŽŽ›Ž‡ƒ†•–‘corrective actionȋ͵Ǥͳ͹Ȍ‘”’”‡˜‡–‹˜‡ƒ –‹‘Ǥ

3.13
C

effectiveness
‡š–‡––‘™Š‹ Š’Žƒ‡†ƒ –‹˜‹–‹‡•ƒ”‡”‡ƒŽ‹œ‡†ƒ†’Žƒ‡†”‡•—Ž–•ƒ”‡ƒ Š‹‡˜‡†

3.14
requirement
‡‡†‘”‡š’‡ –ƒ–‹‘–Šƒ–‹••–ƒ–‡†ǡ‰‡‡”ƒŽŽ›‹’Ž‹‡†‘”‘„Ž‹‰ƒ–‘”›

‘–‡ͳ–‘‡–”›ǣDz ‡‡”ƒŽŽ›‹’Ž‹‡†dz‡ƒ•–Šƒ–‹–‹• —•–‘‘” ‘‘’”ƒ –‹ ‡ˆ‘”–Š‡organizationȋ͵ǤͳȌƒ†interested

party (preferred term)ȋ͵ǤʹȌ–Šƒ––Š‡‡‡†‘”‡š’‡ –ƒ–‹‘—†‡” ‘•‹†‡”ƒ–‹‘‹•‹’Ž‹‡†Ǥ

‘–‡ʹ–‘‡–”›ǣ•’‡ ‹ˆ‹‡†”‡“—‹”‡‡–‹•‘‡–Šƒ–‹••–ƒ–‡†ǡ‡Ǥ‰Ǥ‹documented informationȋ͵ǤͳͲȌǤ

‘–‡͵–‘ ‡–”›ǣ “—ƒŽ‹ˆ‹‡” ƒ „‡ —•‡† –‘ †‡‘–‡ ƒ •’‡ ‹ˆ‹  –›’‡ ‘ˆ ”‡“—‹”‡‡–ǡ ‡Ǥ‰Ǥ ’”‘†— – ”‡“—‹”‡‡–ǡ “—ƒŽ‹–›
ƒƒ‰‡‡–”‡“—‹”‡‡–ǡ —•–‘‡””‡“—‹”‡‡–ǡ“—ƒŽ‹–›”‡“—‹”‡‡–Ǥ

‘–‡Ͷ–‘‡–”›ǣ‡“—‹”‡‡–• ƒ„‡‰‡‡”ƒ–‡†„›†‹ˆˆ‡”‡–‹–‡”‡•–‡†’ƒ”–‹‡•‘”„›–Š‡‘”‰ƒ‹œƒ–‹‘‹–•‡ŽˆǤ

‘–‡ͷ–‘‡–”›ǣ – ƒ„‡‡ ‡••ƒ”›ˆ‘”ƒ Š‹‡˜‹‰Š‹‰Š —•–‘‡”•ƒ–‹•ˆƒ –‹‘–‘ˆ—Žˆ‹Žƒ‡š’‡ –ƒ–‹‘‘ˆƒ —•–‘‡”‡˜‡‹ˆ

‹–‹•‡‹–Š‡”•–ƒ–‡†‘”‰‡‡”ƒŽŽ›‹’Ž‹‡†‘”‘„Ž‹‰ƒ–‘”›Ǥ

3.15
conformity
ˆ—Žˆ‹Ž‡–‘ˆƒrequirementȋ͵ǤͳͶȌ

̹ ʹͲʹͷȂŽŽ”‹‰Š–•”‡•‡”˜‡†
Ͷ
 ISO/CD 9001.2:2025(en)

‘–‡ͳ–‘‡–”›ǣ ‰Ž‹•Š–Š‡™‘”†Dz ‘ˆ‘”ƒ ‡dz‹••›‘›‘—•„—–†‡’”‡ ƒ–‡†Ǥ  ”‡ Š–Š‡™‘”†Dz ‘’Ž‹ƒ ‡dz‹•

•›‘›‘—•„—–†‡’”‡ ƒ–‡†Ǥ

3.16
nonconformity
‘Ǧˆ—Žˆ‹Ž‡–‘ˆƒrequirementȋ͵ǤͳͶȌ

3.17
corrective action
ƒ –‹‘–‘‡Ž‹‹ƒ–‡–Š‡ ƒ—•‡ȋ•Ȍ‘ˆƒnonconformityȋ͵Ǥͳ͸Ȍƒ†–‘’”‡˜‡–”‡ —””‡ ‡

‘–‡ͳ–‘‡–”›ǣŠ‡”‡ ƒ„‡‘”‡–Šƒ‘‡ ƒ—•‡ˆ‘”ƒ‘ ‘ˆ‘”‹–›Ǥ

‘–‡ʹ–‘ ‡–”›ǣ‘””‡ –‹˜‡ ƒ –‹‘ ‹• –ƒ‡ –‘ ’”‡˜‡– ”‡ —””‡ ‡ ™Š‡”‡ƒ• ’”‡˜‡–‹˜‡ ƒ –‹‘ ‹• –ƒ‡ –‘ ’”‡˜‡–
‘ —””‡ ‡Ǥ

3.18
audit
•›•–‡ƒ–‹ ƒ†‹†‡’‡†‡–processȋ͵ǤͺȌˆ‘”‘„–ƒ‹‹‰‡˜‹†‡ ‡ƒ†‡˜ƒŽ—ƒ–‹‰‹–‘„Œ‡ –‹˜‡Ž›–‘†‡–‡”‹‡

T EE
–Š‡‡š–‡––‘™Š‹ Š–Š‡ƒ—†‹– ”‹–‡”‹ƒƒ”‡ˆ—Žˆ‹ŽŽ‡†

‘–‡ͳ–‘‡–”›ǣƒ—†‹– ƒ„‡ƒ‹–‡”ƒŽƒ—†‹–ȋˆ‹”•–’ƒ”–›Ȍ‘”ƒ‡š–‡”ƒŽƒ—†‹–ȋ•‡ ‘†’ƒ”–›‘”–Š‹”†’ƒ”–›Ȍǡƒ†‹–

ƒ„‡ƒ ‘„‹‡†ƒ—†‹–ȋ ‘„‹‹‰–™‘‘”‘”‡†‹• ‹’Ž‹‡•ȌǤ
AF T
‘–‡ʹ–‘‡–”›ǣ‹–‡”ƒŽƒ—†‹–‹• ‘†— –‡†„›–Š‡organizationȋ͵ǤͳȌ‹–•‡Žˆǡ‘”„›ƒ‡š–‡”ƒŽ’ƒ”–›‘‹–•„‡ŠƒŽˆǤ
R IT

2
‘–‡͵–‘‡–”›ǣDz—†‹–‡˜‹†‡ ‡dzƒ†Dzƒ—†‹– ”‹–‡”‹ƒdzƒ”‡†‡ˆ‹‡†‹ ͳͻͲͳͳǤ
D M

‘–‡Ͷ–‘‡–”›ǣŠ‡ˆ—†ƒ‡–ƒŽ‡Ž‡‡–•‘ˆƒƒ—†‹–‹ Ž—†‡–Š‡†‡–‡”‹ƒ–‹‘‘ˆ–Š‡ conformityȋ͵ǤͳͷȌ‘ˆƒ‘„Œ‡ –

ƒ ‘”†‹‰–‘ƒ’”‘ ‡†—”‡ ƒ””‹‡†‘—–„›’‡”•‘‡Ž‘–„‡‹‰”‡•’‘•‹„Ž‡ˆ‘”–Š‡‘„Œ‡ –ƒ—†‹–‡†Ǥ
M

‘–‡ͷ–‘‡–”›ǣ –‡”ƒŽƒ—†‹–•ƒ”‡ ‘†— –‡†ˆ‘”ƒƒ‰‡‡– ”‡˜‹‡™ƒ†‘–Š‡”‹–‡”ƒŽ ’—”’‘•‡•ƒ† ƒˆ‘”–Š‡

O

„ƒ•‹• ˆ‘” ƒ ‘”‰ƒ‹œƒ–‹‘ǯ• †‡ Žƒ”ƒ–‹‘ ‘ˆ ‘ˆ‘”‹–›Ǥ †‡’‡†‡ ‡ ƒ „‡ †‡‘•–”ƒ–‡† „› –Š‡ ˆ”‡‡†‘ ˆ”‘
”‡•’‘•‹„‹Ž‹–›ˆ‘”–Š‡ƒ –‹˜‹–›„‡‹‰ƒ—†‹–‡†Ǥ
C

‘–‡͸–‘‡–”›ǣ‡ ‘†’ƒ”–›ƒ—†‹–•ƒ”‡ ‘†— –‡†„›’ƒ”–‹‡•Šƒ˜‹‰ƒ‹–‡”‡•–‹–Š‡‘”‰ƒ‹œƒ–‹‘ǡ•— Šƒ• —•–‘‡”•ǡ

‘”„›‘–Š‡”’‡”•‘•‘–Š‡‹”„‡ŠƒŽˆǤŠ‹”†Ǧ’ƒ”–›ƒ—†‹–•ƒ”‡ ‘†— –‡†„›‡š–‡”ƒŽǡ‹†‡’‡†‡–ƒ—†‹–‹‰‘”‰ƒ‹œƒ–‹‘•
•— Šƒ•–Š‘•‡’”‘˜‹†‹‰ ‡”–‹ˆ‹ ƒ–‹‘Ȁ”‡‰‹•–”ƒ–‹‘‘ˆ ‘ˆ‘”‹–›‘”‰‘˜‡”‡–ƒŽƒ‰‡ ‹‡•Ǥ

‘–‡͹–‘‡–”›ǣƒ—†‹– ƒƒŽ•‘„‡ƒŒ‘‹–ƒ—†‹– ƒ””‹‡†‘—–ƒ–ƒ•‹‰Ž‡ƒ—†‹–‡‡„›–™‘‘”‘”‡ƒ—†‹–‹‰‘”‰ƒ‹œƒ–‹‘•Ǥ

3.19
measurement
processȋ͵ǤͺȌ–‘†‡–‡”‹‡ƒ˜ƒŽ—‡

‘–‡ͳ–‘‡–”›ǣ ‘”†‹‰–‘ ͵ͷ͵ͶǦʹǡ͵ǤʹǤͳǡ–Š‡˜ƒŽ—‡†‡–‡”‹‡†‹•‰‡‡”ƒŽŽ›–Š‡˜ƒŽ—‡‘ˆƒ“—ƒ–‹–›Ǥ

3.20
monitoring
†‡–‡”‹‹‰–Š‡•–ƒ–—•‘ˆƒ•›•–‡ǡƒprocessȋ͵ǤͺȌ‘”ƒƒ –‹˜‹–›

‘–‡ͳ–‘‡–”›ǣ‘†‡–‡”‹‡–Š‡•–ƒ–—•ǡ–Š‡”‡ ƒ„‡ƒ‡‡†–‘ Š‡ ǡ•—’‡”˜‹•‡‘” ”‹–‹ ƒŽŽ›‘„•‡”˜‡Ǥ

‘–‡ʹ–‘‡–”›ǣ‘‹–‘”‹‰ ƒƒŽ•‘†‡–‡”‹‡–Š‡•–ƒ–—•‘ˆƒ’”‘†— –‘”ƒ•‡”˜‹ ‡Ǥ

‘–‡͵–‘‡–”›ǣ‘‹–‘”‹‰‹•‰‡‡”ƒŽŽ›ƒ†‡–‡”‹ƒ–‹‘‘ˆ–Š‡•–ƒ–—•‘ˆƒ‘„Œ‡ – ƒ””‹‡†‘—–ƒ–†‹ˆˆ‡”‡–•–ƒ‰‡•‘”ƒ–
†‹ˆˆ‡”‡––‹‡•Ǥ

̹ ʹͲʹͷȂŽŽ”‹‰Š–•”‡•‡”˜‡†
ͷ
 ISO/CD 9001.2:2025(en)

4 Context of the organization

4.1 Understanding the organization and its context

Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ†‡–‡”‹‡‡š–‡”ƒŽƒ†‹–‡”ƒŽ‹••—‡•–Šƒ–ƒ”‡”‡Ž‡˜ƒ––‘‹–•’—”’‘•‡ƒ†–Šƒ–ƒˆˆ‡ –
‹–•ƒ„‹Ž‹–›–‘ƒ Š‹‡˜‡–Š‡‹–‡†‡†”‡•—Ž–ȋ•Ȍ‘ˆ‹–•“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǥ

Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ†‡–‡”‹‡™Š‡–Š‡” Ž‹ƒ–‡ Šƒ‰‡‹•ƒ”‡Ž‡˜ƒ–‹••—‡Ǥ

Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ‘‹–‘”ƒ†”‡˜‹‡™‹ˆ‘”ƒ–‹‘ƒ„‘—––Š‡•‡‡š–‡”ƒŽƒ†‹–‡”ƒŽ‹••—‡•Ǥ

ͳ ••—‡• ƒ‹ Ž—†‡’‘•‹–‹˜‡ƒ†‡‰ƒ–‹˜‡ˆƒ –‘”•‘” ‘†‹–‹‘•ˆ‘” ‘•‹†‡”ƒ–‹‘Ǥ

ʹ †‡”•–ƒ†‹‰–Š‡‡š–‡”ƒŽ ‘–‡š– ƒ„‡ˆƒ ‹Ž‹–ƒ–‡†„› ‘•‹†‡”‹‰‹••—‡•ƒ”‹•‹‰ˆ”‘Ž‡‰ƒŽǡ–‡ Š‘Ž‘‰‹ ƒŽǡ

‘’‡–‹–‹˜‡ǡƒ”‡–ǡ —Ž–—”ƒŽǡ•‘ ‹ƒŽƒ†‡ ‘‘‹ ‡˜‹”‘‡–•ǡ™Š‡–Š‡”‹–‡”ƒ–‹‘ƒŽǡƒ–‹‘ƒŽǡ”‡‰‹‘ƒŽ‘”Ž‘ ƒŽǤ

͵ †‡”•–ƒ†‹‰ –Š‡ ‹–‡”ƒŽ ‘–‡š– ƒ „‡ ˆƒ ‹Ž‹–ƒ–‡† „› ‘•‹†‡”‹‰ ‹••—‡• ”‡Žƒ–‡† –‘ –Š‡ ‘”‰ƒ‹œƒ–‹‘̵•
•–”ƒ–‡‰‹ †‹”‡ –‹‘ǡ˜ƒŽ—‡•ǡ —Ž–—”‡ǡ”‡•‘—” ‡•ǡ‘™Ž‡†‰‡ƒ†’‡”ˆ‘”ƒ ‡‘ˆ–Š‡‘”‰ƒ‹œƒ–‹‘Ǥ

T EE
4.2 Understanding the needs and expectations of interested parties

Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ†‡–‡”‹‡ǣ
AF T
ƒȌ –Š‡‹–‡”‡•–‡†’ƒ”–‹‡•–Šƒ–ƒ”‡”‡Ž‡˜ƒ––‘–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǣ
R IT

2
„Ȍ –Š‡”‡Ž‡˜ƒ–”‡“—‹”‡‡–•‘ˆ–Š‡•‡‹–‡”‡•–‡†’ƒ”–‹‡•Ǣ
D M

Ȍ ™Š‹ Š‘ˆ–Š‡•‡”‡“—‹”‡‡–•™‹ŽŽ„‡ƒ††”‡••‡†–Š”‘—‰Š–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǥ

Š‡ ‘”‰ƒ‹œƒ–‹‘ •ŠƒŽŽ ‘‹–‘” ƒ† ”‡˜‹‡™ ‹ˆ‘”ƒ–‹‘ ƒ„‘—– –Š‡•‡ ‹–‡”‡•–‡† ’ƒ”–‹‡• ƒ† –Š‡‹” ”‡Ž‡˜ƒ–
M

”‡“—‹”‡‡–•Ǥ
O

 ‡Ž‡˜ƒ–‹–‡”‡•–‡†’ƒ”–‹‡• ƒŠƒ˜‡”‡“—‹”‡‡–•”‡Žƒ–‡†–‘ Ž‹ƒ–‡ Šƒ‰‡Ǥ

C

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‰‡‡– •›•–‡ –‘
‡•–ƒ„Ž‹•Š‹–•• ‘’‡Ǥ

Š‡†‡–‡”‹‹‰–Š‹•• ‘’‡ǡ–Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ ‘•‹†‡”ǣ

ƒȌ –Š‡‡š–‡”ƒŽƒ†‹–‡”ƒŽ‹••—‡•”‡ˆ‡””‡†–‘‹ͶǤͳǢ

„Ȍ –Š‡”‡“—‹”‡‡–•‘ˆ”‡Ž‡˜ƒ–‹–‡”‡•–‡†’ƒ”–‹‡•”‡ˆ‡””‡†–‘‹ͶǤʹǢ

Ȍ –Š‡’”‘†— –•ƒ†•‡”˜‹ ‡•‘ˆ–Š‡‘”‰ƒ‹œƒ–‹‘Ǥ

Š‡• ‘’‡•ŠƒŽŽ„‡ƒ˜ƒ‹Žƒ„Ž‡ƒ•†‘ —‡–‡†‹ˆ‘”ƒ–‹‘Ǥ

Š‡• ‘’‡•ŠƒŽŽ•–ƒ–‡–Š‡–›’‡•‘ˆ’”‘†— –•ƒ†•‡”˜‹ ‡• ‘˜‡”‡†ǡƒ†’”‘˜‹†‡Œ—•–‹ˆ‹ ƒ–‹‘ˆ‘”ƒ›”‡“—‹”‡‡–

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

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

̹ ʹͲʹͷȂŽŽ”‹‰Š–•”‡•‡”˜‡†
͸
 ISO/CD 9001.2:2025(en)

‘ˆ‘”‹–›–‘–Š‹•†‘ —‡–ƒ›‘Ž›„‡ Žƒ‹‡†‹ˆ–Š‡”‡“—‹”‡‡–•†‡–‡”‹‡†ƒ•‘–„‡‹‰ƒ’’Ž‹ ƒ„Ž‡†‘

‘–ƒˆˆ‡ ––Š‡‘”‰ƒ‹œƒ–‹‘ǯ•ƒ„‹Ž‹–›‘””‡•’‘•‹„‹Ž‹–›–‘‡•—”‡–Š‡ ‘ˆ‘”‹–›‘ˆ‹–•’”‘†— –•ƒ†•‡”˜‹ ‡•ƒ†
–Š‡‡Šƒ ‡‡–‘ˆ —•–‘‡”•ƒ–‹•ˆƒ –‹‘Ǥ

4.4 Quality management system

4.4.1 The organization shall establish, implement, maintain and continually improve a quality
management system, including the processes needed and their interactions, in accordance with the
requirements of this document.

Š‡ ‘”‰ƒ‹œƒ–‹‘ •ŠƒŽŽ †‡–‡”‹‡ –Š‡ ’”‘ ‡••‡• ‡‡†‡† ˆ‘” –Š‡ “—ƒŽ‹–› ƒƒ‰‡‡– •›•–‡ ƒ† –Š‡‹”
ƒ’’Ž‹ ƒ–‹‘–Š”‘—‰Š‘—––Š‡‘”‰ƒ‹œƒ–‹‘ǡƒ†•ŠƒŽŽǣ

ƒȌ †‡–‡”‹‡–Š‡‹’—–•”‡“—‹”‡†ƒ†–Š‡‘—–’—–•‡š’‡ –‡†ˆ”‘–Š‡•‡’”‘ ‡••‡•Ǣ

„Ȍ †‡–‡”‹‡–Š‡•‡“—‡ ‡ƒ†‹–‡”ƒ –‹‘‘ˆ–Š‡•‡’”‘ ‡••‡•Ǣ

Ȍ †‡–‡”‹‡ ƒ† ƒ’’Ž› –Š‡ ”‹–‡”‹ƒ ƒ† ‡–Š‘†• ȋ‹ Ž—†‹‰ ‘‹–‘”‹‰ǡ ‡ƒ•—”‡‡–• ƒ† ”‡Žƒ–‡†
’‡”ˆ‘”ƒ ‡‹†‹ ƒ–‘”•Ȍ‡‡†‡†–‘‡•—”‡–Š‡‡ˆˆ‡ –‹˜‡‘’‡”ƒ–‹‘ƒ† ‘–”‘Ž‘ˆ–Š‡•‡’”‘ ‡••‡•Ǣ

T EE
†Ȍ †‡–‡”‹‡–Š‡”‡•‘—” ‡•‡‡†‡†ˆ‘”–Š‡•‡’”‘ ‡••‡•ƒ†‡•—”‡–Š‡‹”ƒ˜ƒ‹Žƒ„‹Ž‹–›Ǣ

‡Ȍ ƒ••‹‰–Š‡”‡•’‘•‹„‹Ž‹–‹‡•ƒ†ƒ—–Š‘”‹–‹‡•ˆ‘”–Š‡•‡’”‘ ‡••‡•Ǣ
AF T
ˆȌ ƒ††”‡••–Š‡”‹••ƒ†‘’’‘”–—‹–‹‡•ƒ•†‡–‡”‹‡†‹ƒ ‘”†ƒ ‡™‹–Š–Š‡”‡“—‹”‡‡–•‘ˆ͸ǤͳǢ
R IT

2
‰Ȍ ‡˜ƒŽ—ƒ–‡–Š‡•‡’”‘ ‡••‡•ƒ†‹’Ž‡‡–ƒ› Šƒ‰‡•‡‡†‡†–‘‡•—”‡–Šƒ––Š‡•‡’”‘ ‡••‡•ƒ Š‹‡˜‡–Š‡‹”
D M

‹–‡†‡†”‡•—Ž–•Ǣ
M

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

4.4.2 ‘ —‡–‡†‹ˆ‘”ƒ–‹‘•ŠƒŽŽ„‡ƒ˜ƒ‹Žƒ„Ž‡–‘–Š‡‡š–‡–‡ ‡••ƒ”›ǣ

O

ƒȌ –‘•—’’‘”––Š‡‘’‡”ƒ–‹‘‘ˆ‹–•’”‘ ‡••‡•Ǣ
C

„Ȍ ƒ•‡˜‹†‡ ‡–Šƒ––Š‡’”‘ ‡••‡•ƒ”‡„‡‹‰ ƒ””‹‡†‘—–ƒ•’Žƒ‡†Ǥ

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 ‡•—”‹‰ –Šƒ– –Š‡ “—ƒŽ‹–› ’‘Ž‹ › ƒ† “—ƒŽ‹–› ‘„Œ‡ –‹˜‡• ƒ”‡ ‡•–ƒ„Ž‹•Š‡† ƒ† ƒ”‡ ‘’ƒ–‹„Ž‡ ™‹–Š –Š‡
•–”ƒ–‡‰‹ †‹”‡ –‹‘‘ˆ–Š‡‘”‰ƒ‹œƒ–‹‘Ǣ

„Ȍ ‡•—”‹‰–Š‡‹–‡‰”ƒ–‹‘‘ˆ–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡”‡“—‹”‡‡–•‹–‘–Š‡‘”‰ƒ‹œƒ–‹‘ǯ•„—•‹‡••
’”‘ ‡••‡•Ǣ

Ȍ ‡•—”‹‰–Šƒ––Š‡”‡•‘—” ‡•‡‡†‡†ˆ‘”–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡ƒ”‡ƒ˜ƒ‹Žƒ„Ž‡Ǣ

†Ȍ ‘—‹ ƒ–‹‰ –Š‡ ‹’‘”–ƒ ‡ ‘ˆ ‡ˆˆ‡ –‹˜‡ “—ƒŽ‹–› ƒƒ‰‡‡– ƒ† ‘ˆ ‘ˆ‘”‹‰ –‘ –Š‡ “—ƒŽ‹–›
ƒƒ‰‡‡–•›•–‡”‡“—‹”‡‡–•Ǣ

̹ ʹͲʹͷȂŽŽ”‹‰Š–•”‡•‡”˜‡†
͹
 ISO/CD 9001.2:2025(en)

‡Ȍ ‡•—”‹‰–Šƒ––Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡ƒ Š‹‡˜‡•‹–•‹–‡†‡†”‡•—Ž–•Ǣ

ˆȌ †‹”‡ –‹‰ƒ†•—’’‘”–‹‰’‡”•‘•–‘ ‘–”‹„—–‡–‘–Š‡‡ˆˆ‡ –‹˜‡‡••‘ˆ–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǣ

‰Ȍ ’”‘‘–‹‰ ‘–‹—ƒŽ‹’”‘˜‡‡–Ǣ

ŠȌ •—’’‘”–‹‰ ‘–Š‡” ”‡Ž‡˜ƒ– ”‘Ž‡• –‘ †‡‘•–”ƒ–‡ –Š‡‹” Ž‡ƒ†‡”•Š‹’ ƒ• ‹– ƒ’’Ž‹‡• –‘ –Š‡‹” ƒ”‡ƒ• ‘ˆ
”‡•’‘•‹„‹Ž‹–›Ǣ

‹Ȍ ’”‘‘–‹‰“—ƒŽ‹–› —Ž–—”‡ƒ†‡–Š‹ ƒŽ„‡Šƒ˜‹‘—”Ǣ

ŒȌ ’”‘‘–‹‰–Š‡—•‡‘ˆ–Š‡’”‘ ‡••ƒ’’”‘ƒ Šƒ†”‹•Ǧ„ƒ•‡†–Š‹‹‰Ǣ

Ȍ –ƒ‹‰ƒ ‘—–ƒ„‹Ž‹–›ˆ‘”–Š‡‡ˆˆ‡ –‹˜‡‡••‘ˆ–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǥ

ͳ ‡ˆ‡”‡ ‡–‘Dz„—•‹‡••dz‹–Š‹•†‘ —‡– ƒ„‡‹–‡”’”‡–‡†„”‘ƒ†Ž›–‘‡ƒ–Š‘•‡ƒ –‹˜‹–‹‡•–Šƒ–ƒ”‡ ‘”‡–‘

–Š‡’—”’‘•‡•‘ˆ–Š‡‘”‰ƒ‹œƒ–‹‘ǯ•‡š‹•–‡ ‡Ǥ

ʹ Š‡‘”‰ƒ‹œƒ–‹‘ǯ• —Ž–—”‡ƒ†‡–Š‹ • ƒ„‡†‡‘•–”ƒ–‡†–Š”‘—‰Š•Šƒ”‡†˜ƒŽ—‡•ǡ„‡Ž‹‡ˆ•ǡŠ‹•–‘”›ǡƒ––‹–—†‡•

T EE
ƒ†‘„•‡”˜‡†„‡Šƒ˜‹‘—”•Ǥ

5.1.2 Customer focus

AF T
‘’ƒƒ‰‡‡–•ŠƒŽŽ†‡‘•–”ƒ–‡Ž‡ƒ†‡”•Š‹’ƒ† ‘‹–‡–™‹–Š”‡•’‡ ––‘ —•–‘‡”ˆ‘ —•„›‡•—”‹‰
–Šƒ–ǣ
R IT

ƒȌ
2
—•–‘‡” ƒ† ƒ’’Ž‹ ƒ„Ž‡ •–ƒ–—–‘”› ƒ† ”‡‰—Žƒ–‘”› ”‡“—‹”‡‡–• ƒ”‡ †‡–‡”‹‡†ǡ —†‡”•–‘‘† ƒ†
D M

‘•‹•–‡–Ž›‡–Ǣ

„Ȍ –Š‡”‹••ƒ†‘’’‘”–—‹–‹‡•–Šƒ– ƒƒˆˆ‡ – ‘ˆ‘”‹–›‘ˆ’”‘†— –•ƒ†•‡”˜‹ ‡•ƒ†–Š‡ƒ„‹Ž‹–›–‘‡Šƒ ‡

M

—•–‘‡”•ƒ–‹•ˆƒ –‹‘ƒ”‡†‡–‡”‹‡†ƒ†ƒ††”‡••‡†Ǣ
O

Ȍ –Š‡ˆ‘ —•‘‡Šƒ ‹‰ —•–‘‡”•ƒ–‹•ˆƒ –‹‘‹•ƒ‹–ƒ‹‡†Ǥ

C

5.2 Quality policy

5.2.1 Top management shall establish a quality policy that:

ƒȌ ‹•ƒ’’”‘’”‹ƒ–‡–‘–Š‡’—”’‘•‡‘ˆ–Š‡‘”‰ƒ‹œƒ–‹‘Ǣ

„Ȍ ’”‘˜‹†‡•ƒˆ”ƒ‡™‘”ˆ‘”•‡––‹‰“—ƒŽ‹–›‘„Œ‡ –‹˜‡•Ǣ

Ȍ ‹ Ž—†‡•ƒ ‘‹–‡––‘‡‡–ƒ’’Ž‹ ƒ„Ž‡”‡“—‹”‡‡–•Ǣ

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

Š‡ “—ƒŽ‹–› ’‘Ž‹ › •ŠƒŽŽ „‡ ‹’Ž‡‡–‡† ƒ† ƒ‹–ƒ‹‡† –‘ –ƒ‡ ‹–‘ ƒ ‘—– –Š‡ ‘–‡š– ƒ† •–”ƒ–‡‰‹ 
†‹”‡ –‹‘‘ˆ–Š‡‘”‰ƒ‹œƒ–‹‘Ǥ

5.2.2 The quality policy shall:

ƒȌ „‡ƒ˜ƒ‹Žƒ„Ž‡ƒ•†‘ —‡–‡†‹ˆ‘”ƒ–‹‘Ǣ

„Ȍ „‡ ‘—‹ ƒ–‡†™‹–Š‹–Š‡‘”‰ƒ‹œƒ–‹‘Ǣ

Ȍ „‡ƒ˜ƒ‹Žƒ„Ž‡–‘‹–‡”‡•–‡†’ƒ”–‹‡•ǡƒ•ƒ’’”‘’”‹ƒ–‡Ǥ

̹ ʹͲʹͷȂŽŽ”‹‰Š–•”‡•‡”˜‡†
ͺ
 ISO/CD 9001.2:2025(en)

5.3 Roles, responsibilities and authorities

‘’ ƒƒ‰‡‡– •ŠƒŽŽ ‡•—”‡ –Šƒ– –Š‡ ”‡•’‘•‹„‹Ž‹–‹‡• ƒ† ƒ—–Š‘”‹–‹‡• ˆ‘” ”‡Ž‡˜ƒ– ”‘Ž‡• ƒ”‡ ƒ••‹‰‡†ǡ
‘—‹ ƒ–‡†ƒ†—†‡”•–‘‘†™‹–Š‹–Š‡‘”‰ƒ‹œƒ–‹‘Ǥ

‘’ƒƒ‰‡‡–•ŠƒŽŽƒ••‹‰–Š‡”‡•’‘•‹„‹Ž‹–›ƒ†ƒ—–Š‘”‹–›ˆ‘”ǣ

ƒȌ ‡•—”‹‰–Šƒ––Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡ ‘ˆ‘”•–‘–Š‡”‡“—‹”‡‡–•‘ˆ–Š‹•†‘ —‡–Ǣ

„Ȍ ”‡’‘”–‹‰‘–Š‡’‡”ˆ‘”ƒ ‡‘ˆ–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡–‘–‘’ƒƒ‰‡‡–Ǣ

Ȍ ‡•—”‹‰–Šƒ––Š‡’”‘ ‡••‡•ƒ”‡†‡Ž‹˜‡”‹‰–Š‡‹”‹–‡†‡†‘—–’—–•Ǣ

†Ȍ ‡•—”‹‰–Š‡’”‘‘–‹‘‘ˆ —•–‘‡”ˆ‘ —•–Š”‘—‰Š‘—––Š‡‘”‰ƒ‹œƒ–‹‘Ǣ

‡Ȍ ‡•—”‹‰–Šƒ––Š‡‹–‡‰”‹–›‘ˆ–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡‹•ƒ‹–ƒ‹‡†™Š‡ Šƒ‰‡•–‘–Š‡“—ƒŽ‹–›
ƒƒ‰‡‡–•›•–‡ƒ”‡’Žƒ‡†ƒ†‹’Ž‡‡–‡†Ǥ

6 Planning
T EE
AF T
R IT

6.1 Actions to address risks and opportunities

2
6.1.1 General
D M

Š‡’Žƒ‹‰ˆ‘”–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡ǡ–Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ ‘•‹†‡”–Š‡‹••—‡•”‡ˆ‡””‡†–‘‹
M

ͶǤͳ ƒ† –Š‡ ”‡“—‹”‡‡–• ”‡ˆ‡””‡† –‘ ‹ ͶǤʹ ƒ† †‡–‡”‹‡ –Š‡ ”‹•• ƒ† ‘’’‘”–—‹–‹‡• –Šƒ– ‡‡† –‘ „‡
ƒ††”‡••‡†–‘ǣ
O

ƒȌ ‰‹˜‡ƒ••—”ƒ ‡–Šƒ––Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡ ƒƒ Š‹‡˜‡‹–•‹–‡†‡†”‡•—Ž–ȋ•ȌǢ

C

„Ȍ ’”‡˜‡–ǡ‘””‡†— ‡ǡ—†‡•‹”‡†‡ˆˆ‡ –•Ǣ

Ȍ ƒ Š‹‡˜‡ ‘–‹—ƒŽ‹’”‘˜‡‡–Ǥ

6.1.2 Actions to address risk

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

Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ’Žƒǣ

ƒȌ ƒ –‹‘•–‘ƒ††”‡••–Š‡•‡”‹••Ǣ

„Ȍ Š‘™–‘ǣ

Ȅ ‹–‡‰”ƒ–‡ƒ†‹’Ž‡‡––Š‡ƒ –‹‘•‹–‘‹–•“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡’”‘ ‡••‡•Ǣ

Ȅ ‡˜ƒŽ—ƒ–‡–Š‡‡ˆˆ‡ –‹˜‡‡••‘ˆ–Š‡•‡ƒ –‹‘•Ǥ

 ‡–‡”‹‡†”‹•• ƒ‹ Ž—†‡”‹••”‡Žƒ–‡†–‘–Š‡ƒ„‹Ž‹–›–‘’”‘˜‹†‡ ‘ˆ‘”‹‰’”‘†— –•ƒ†•‡”˜‹ ‡•ƒˆ–‡”ƒ

†‹•”—’–‹‘–‘‹–•‘’‡”ƒ–‹‘Ǥ

̹ ʹͲʹͷȂŽŽ”‹‰Š–•”‡•‡”˜‡†
ͻ
 ISO/CD 9001.2:2025(en)

6.1.3 Actions to address opportunities

Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ‡•–ƒ„Ž‹•Š’”‘ ‡••‡•–‘†‡–‡”‹‡–Š‡‘’’‘”–—‹–‹‡•–Šƒ– ƒŠƒ˜‡ƒ†‡•‹”ƒ„Ž‡‡ˆˆ‡ –‘

‹–•ƒ„‹Ž‹–›–‘ ‘–‹—ƒŽŽ›ƒ† ‘•‹•–‡–Ž›’”‘˜‹†‡ ‘ˆ‘”‹‰’”‘†— –•ƒ†•‡”˜‹ ‡•Ǥ

Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ’Žƒǣ

ƒȌ ƒ –‹‘•–‘ƒ††”‡••–Š‡•‡‘’’‘”–—‹–‹‡•Ǣ

„Ȍ Š‘™–‘ǣ

Ȅ ‹–‡‰”ƒ–‡ƒ†‹’Ž‡‡––Š‡ƒ –‹‘•‹–‘‹–•“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡’”‘ ‡••‡•Ǣ

Ȅ ‡˜ƒŽ—ƒ–‡–Š‡‡ˆˆ‡ –‹˜‡‡••‘ˆ–Š‡•‡ƒ –‹‘•Ǥ

  –‹‘ –‘ ƒ††”‡•• ‘’’‘”–—‹–‹‡• ƒ ‹ Ž—†‡ –Š‡ ƒ†‘’–‹‘ ‘ˆ ‡™ ’”ƒ –‹ ‡•ǡ Žƒ— Š‹‰ ‡™ ’”‘†— –•ǡ
‘’‡‹‰‡™ƒ”‡–•ǡƒ††”‡••‹‰‡™ —•–‘‡”•ǡ„—‹Ž†‹‰’ƒ”–‡”•Š‹’•ǡ—•‹‰‡™–‡ Š‘Ž‘‰›ƒ†‘–Š‡”†‡•‹”ƒ„Ž‡
ƒ†˜‹ƒ„Ž‡’‘••‹„‹Ž‹–‹‡•–‘ƒ††”‡••–Š‡‘”‰ƒ‹œƒ–‹‘̵•‘”‹–• —•–‘‡”•̵‡‡†•Ǥ

T EE
6.2 Quality objectives and planning to achieve them
6.2.1 The organization shall establish quality objectives at relevant functions and levels.
AF T
Š‡“—ƒŽ‹–›‘„Œ‡ –‹˜‡••ŠƒŽŽǣ
R IT

2
ƒȌ „‡ ‘•‹•–‡–™‹–Š–Š‡“—ƒŽ‹–›’‘Ž‹ ›Ǣ
D M

„Ȍ „‡‡ƒ•—”ƒ„Ž‡ȋ‹ˆ’”ƒ –‹ ƒ„Ž‡ȌǢ

Ȍ –ƒ‡‹–‘ƒ ‘—–ƒ’’Ž‹ ƒ„Ž‡”‡“—‹”‡‡–•Ǣ

M

†Ȍ „‡‘‹–‘”‡†Ǣ
O

‡Ȍ „‡ ‘—‹ ƒ–‡†Ǣ

C

ˆȌ „‡—’†ƒ–‡†ƒ•ƒ’’”‘’”‹ƒ–‡Ǣ

‰Ȍ „‡ƒ˜ƒ‹Žƒ„Ž‡ƒ•†‘ —‡–‡†‹ˆ‘”ƒ–‹‘Ǣ

ŠȌ „‡”‡Ž‡˜ƒ––‘ ‘ˆ‘”‹–›‘ˆ’”‘†— –•ƒ†•‡”˜‹ ‡•ƒ†–‘‡Šƒ ‡‡–‘ˆ —•–‘‡”•ƒ–‹•ˆƒ –‹‘Ǥ

6.2.2 When planning how to achieve its quality objectives, the organization shall determine:

ƒȌ ™Šƒ–™‹ŽŽ„‡†‘‡Ǣ

„Ȍ ™Šƒ–”‡•‘—” ‡•™‹ŽŽ„‡”‡“—‹”‡†Ǣ

Ȍ ™Š‘™‹ŽŽ„‡”‡•’‘•‹„Ž‡Ǣ

†Ȍ ™Š‡‹–™‹ŽŽ„‡ ‘’Ž‡–‡†Ǣ

‡Ȍ Š‘™–Š‡”‡•—Ž–•™‹ŽŽ„‡‡˜ƒŽ—ƒ–‡†Ǥ

̹ ʹͲʹͷȂŽŽ”‹‰Š–•”‡•‡”˜‡†
ͳͲ
 ISO/CD 9001.2:2025(en)

6.3 Planning of changes

Š‡–Š‡‘”‰ƒ‹œƒ–‹‘†‡–‡”‹‡•–Š‡‡‡†ˆ‘” Šƒ‰‡•–‘–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡ǡ–Š‡ Šƒ‰‡••ŠƒŽŽ

„‡ ƒ””‹‡†‘—–‹ƒ’Žƒ‡†ƒ‡”ȋ•‡‡ͶǤͶȌǤ

‘‡•—”‡–Š‡ Šƒ‰‡‹•‹’Ž‡‡–‡†‡ˆˆ‡ –‹˜‡Ž›–‘ƒ Š‹‡˜‡‹–‡†‡†”‡•—Ž–ȋ•Ȍ–Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ ‘•‹†‡”ǣ

ƒȌ –Š‡’—”’‘•‡‘ˆ–Š‡ Šƒ‰‡•ƒ†–Š‡‹”’‘–‡–‹ƒŽ ‘•‡“—‡ ‡•Ǣ

„Ȍ –Š‡‹–‡‰”‹–›‘ˆ–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǣ

Ȍ –Š‡ƒ˜ƒ‹Žƒ„‹Ž‹–›‘ˆ”‡•‘—” ‡•ƒ†‹ˆ‘”ƒ–‹‘Ǣ

†Ȍ –Š‡ƒŽŽ‘ ƒ–‹‘‘””‡ƒŽŽ‘ ƒ–‹‘‘ˆ”‡•’‘•‹„‹Ž‹–‹‡•ƒ†ƒ—–Š‘”‹–‹‡•Ǣ

‡Ȍ Š‘™–Š‡‡ˆˆ‡ –‹˜‡‡••‘ˆ–Š‡ Šƒ‰‡ȋ•Ȍ™‹ŽŽ„‡‘‹–‘”‡†ƒ†‡˜ƒŽ—ƒ–‡†Ǣ

ˆȌ Š‘™–‘”‡˜‹‡™–Š‡”‡•—Ž–•‘ˆ–Š‡ Šƒ‰‡ȋ•ȌǤ

T EE


7 Support
AF T
7.1 Resources
R IT

7.1.1 General
2
D M

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

Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ ‘•‹†‡”ǣ
O

ƒȌ –Š‡ ƒ’ƒ„‹Ž‹–‹‡•‘ˆǡƒ† ‘•–”ƒ‹–•‘ǡ‡š‹•–‹‰‹–‡”ƒŽ”‡•‘—” ‡•Ǣ

C

„Ȍ ™Šƒ–‡‡†•–‘„‡‘„–ƒ‹‡†ˆ”‘‡š–‡”ƒŽ’”‘˜‹†‡”•Ǥ

7.1.2 People

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

Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ†‡–‡”‹‡ǡ’”‘˜‹†‡ƒ†ƒ‹–ƒ‹–Š‡‹ˆ”ƒ•–”— –—”‡‡ ‡••ƒ”›ˆ‘”–Š‡‘’‡”ƒ–‹‘‘ˆ‹–•

’”‘ ‡••‡• ƒ† –‘ ƒ Š‹‡˜‡ ‘ˆ‘”‹–› ‘ˆ ’”‘†— –• ƒ† •‡”˜‹ ‡• ‹ Ž—†‹‰ǡ ƒ• ƒ’’Ž‹ ƒ„Ž‡ǡ ‹ˆ”ƒ•–”— –—”‡ ˆ‘”
”‡‘–‡ƒ†Š›„”‹†™‘”Ǥ

 ˆ”ƒ•–”— –—”‡ ƒ‹ Ž—†‡ǣ

ƒȌ„—‹Ž†‹‰•ƒ†ƒ••‘ ‹ƒ–‡†—–‹Ž‹–‹‡•Ǣ

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

Ȍ–”ƒ•’‘”–ƒ–‹‘”‡•‘—” ‡•Ǣ

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

̹ ʹͲʹͷȂŽŽ”‹‰Š–•”‡•‡”˜‡†
ͳͳ
 ISO/CD 9001.2:2025(en)

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‹ Ž—†‡ƒ ‘„‹ƒ–‹‘‘ˆˆƒ –‘”•ǡ™Š‹ Š ƒ†‹ˆˆ‡”•—„•–ƒ–‹ƒŽŽ›†‡’‡†‹‰‘–Š‡

’”‘†— –•ƒ†•‡”˜‹ ‡•’”‘˜‹†‡†Ǥ‡Ž‡˜ƒ–ˆƒ –‘”• ƒ‹ Ž—†‡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‹”ˆŽ‘™ǡŠ›‰‹‡‡ǡ‘‹•‡ȌǢ

†Ȍ –‡ Š‘Ž‘‰‹ ƒŽȋ‡Ǥ‰Ǥ—•‡‘ˆ‡‡”‰‹‰–‡ Š‘Ž‘‰‹‡•ȌǢ

‡Ȍ —Ž–—”ƒŽȋ‡Ǥ‰Ǥ‘”‰ƒ‹œƒ–‹‘ƒŽ“—ƒŽ‹–› —Ž–—”‡ǡ‡–Š‹ ƒŽ„‡Šƒ˜‹‘—”ȌǤ

7.1.5 Monitoring and measuring resources

T EE
7.1.5.1 General

Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ†‡–‡”‹‡ƒ†’”‘˜‹†‡–Š‡”‡•‘—” ‡•‡‡†‡†–‘‡•—”‡˜ƒŽ‹†ƒ†”‡Ž‹ƒ„Ž‡”‡•—Ž–•™Š‡
‘‹–‘”‹‰‘”‡ƒ•—”‹‰‹•—•‡†–‘˜‡”‹ˆ›–Š‡ ‘ˆ‘”‹–›‘ˆ’”‘†— –•ƒ†•‡”˜‹ ‡•–‘”‡“—‹”‡‡–•Ǥ
AF T
R IT

Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ‡•—”‡–Šƒ––Š‡”‡•‘—” ‡•’”‘˜‹†‡†ǣ
2
ƒȌ ƒ”‡•—‹–ƒ„Ž‡ˆ‘”–Š‡•’‡ ‹ˆ‹ –›’‡‘ˆ‘‹–‘”‹‰ƒ†‡ƒ•—”‡‡–ƒ –‹˜‹–‹‡•„‡‹‰—†‡”–ƒ‡Ǣ
D M

„Ȍ ƒ”‡ƒ‹–ƒ‹‡†–‘‡•—”‡–Š‡‹” ‘–‹—‹‰ˆ‹–‡••ˆ‘”–Š‡‹”’—”’‘•‡Ǥ
M

’’”‘’”‹ƒ–‡†‘ —‡–‡†‹ˆ‘”ƒ–‹‘•ŠƒŽŽ„‡ƒ˜ƒ‹Žƒ„Ž‡ƒ•‡˜‹†‡ ‡‘ˆˆ‹–‡••ˆ‘”’—”’‘•‡‘ˆ–Š‡‘‹–‘”‹‰

ƒ†‡ƒ•—”‡‡–”‡•‘—” ‡•Ǥ
O

7.1.5.2 Traceability of measurement results

C

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

ƒȌ ƒŽ‹„”ƒ–‡† ‘” ˜‡”‹ˆ‹‡†ǡ ‘” „‘–Šǡ ƒ– •’‡ ‹ˆ‹‡† ‹–‡”˜ƒŽ•ǡ ‘” ’”‹‘” –‘ —•‡ǡ ƒ‰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–‹‘‘”˜‡”‹ˆ‹ ƒ–‹‘•ŠƒŽŽ„‡ƒ˜ƒ‹Žƒ„Ž‡ƒ•†‘ —‡–‡†‹ˆ‘”ƒ–‹‘Ǣ

„Ȍ ‹†‡–‹ˆ‹‡†‹‘”†‡”–‘†‡–‡”‹‡‹–• ƒŽ‹„”ƒ–‹‘‘”˜‡”‹ˆ‹ ƒ–‹‘•–ƒ–—•Ǣ

Ȍ •ƒˆ‡‰—ƒ”†‡†ˆ”‘ƒ†Œ—•–‡–•ǡ†ƒƒ‰‡‘”†‡–‡”‹‘”ƒ–‹‘–Šƒ–™‘—Ž†‹˜ƒŽ‹†ƒ–‡‡ƒ•—”‡‡–”‡•—Ž–•Ǥ

Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ†‡–‡”‹‡‹ˆ–Š‡˜ƒŽ‹†‹–›‘ˆ’”‡˜‹‘—•‡ƒ•—”‡‡–”‡•—Ž–•Šƒ•„‡‡ƒ†˜‡”•‡Ž›ƒˆˆ‡ –‡†
™Š‡‡ƒ•—”‹‰‡“—‹’‡–‹•ˆ‘—†–‘„‡—ˆ‹–ˆ‘”‹–•‹–‡†‡†’—”’‘•‡ǡƒ†•ŠƒŽŽ–ƒ‡ƒ’’”‘’”‹ƒ–‡ƒ –‹‘ƒ•
‡ ‡••ƒ”›Ǥ

7.1.6 Organizational knowledge

Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ†‡–‡”‹‡–Š‡‘™Ž‡†‰‡‡ ‡••ƒ”›ˆ‘”–Š‡‘’‡”ƒ–‹‘‘ˆ‹–•’”‘ ‡••‡•ƒ†–‘ƒ Š‹‡˜‡

–Š‡‹–‡†‡†”‡•—Ž–•‘ˆ‹–•“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǥ

̹ ʹͲʹͷȂŽŽ”‹‰Š–•”‡•‡”˜‡†
ͳʹ
 ISO/CD 9001.2:2025(en)

Š‹•‘™Ž‡†‰‡•ŠƒŽŽ„‡ƒ‹–ƒ‹‡†ƒ†„‡ƒ†‡ƒ˜ƒ‹Žƒ„Ž‡–‘–Š‡‡š–‡–‡ ‡••ƒ”›Ǥ

Š‡ ƒ††”‡••‹‰ Šƒ‰‹‰ ‡‡†• ƒ† –”‡†•ǡ –Š‡ ‘”‰ƒ‹œƒ–‹‘ •ŠƒŽŽ ‘•‹†‡” ‹–• —””‡– ‘™Ž‡†‰‡ ƒ†
†‡–‡”‹‡Š‘™–‘ƒ “—‹”‡‘”ƒ ‡••ƒ›‡ ‡••ƒ”›ƒ††‹–‹‘ƒŽ‘™Ž‡†‰‡ƒ†”‡“—‹”‡†—’†ƒ–‡•Ǥ

ͳ ”‰ƒ‹œƒ–‹‘ƒŽ‘™Ž‡†‰‡‹•‘™Ž‡†‰‡•’‡ ‹ˆ‹ –‘–Š‡‘”‰ƒ‹œƒ–‹‘Ǣ‹–‹•‰‡‡”ƒŽŽ›‰ƒ‹‡†„›‡š’‡”‹‡ ‡Ǥ –‹•

‹ˆ‘”ƒ–‹‘–Šƒ–‹•—•‡†ƒ†•Šƒ”‡†–‘ƒ Š‹‡˜‡–Š‡‘”‰ƒ‹œƒ–‹‘ǯ•‘„Œ‡ –‹˜‡•Ǥ

ʹ ”‰ƒ‹œƒ–‹‘ƒŽ‘™Ž‡†‰‡ ƒ„‡„ƒ•‡†‘ǣ

ƒȌ ‹–‡”ƒŽ•‘—” ‡•ȋ‡Ǥ‰Ǥ‹–‡ŽŽ‡ –—ƒŽ’”‘’‡”–›Ǣ‘™Ž‡†‰‡‰ƒ‹‡†ˆ”‘‡š’‡”‹‡ ‡ǢŽ‡••‘•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”‘ —•–‘‡”• ‘” ‡š–‡”ƒŽ
’”‘˜‹†‡”•ȌǤ

7.2 Competence

T EE
Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽǣ

ƒȌ †‡–‡”‹‡ –Š‡ ‡ ‡••ƒ”› ‘’‡–‡ ‡ ‘ˆ ’‡”•‘ȋ•Ȍ †‘‹‰ ™‘” —†‡” ‹–• ‘–”‘Ž –Šƒ– ƒˆˆ‡ –• –Š‡
’‡”ˆ‘”ƒ ‡ƒ†‡ˆˆ‡ –‹˜‡‡••‘ˆ–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǣ
AF T
„Ȍ ‡•—”‡–Šƒ––Š‡•‡’‡”•‘•ƒ”‡ ‘’‡–‡–‘–Š‡„ƒ•‹•‘ˆƒ’’”‘’”‹ƒ–‡‡†— ƒ–‹‘ǡ–”ƒ‹‹‰ǡ‘”‡š’‡”‹‡ ‡Ǣ
R IT

Ȍ
2
™Š‡”‡ƒ’’Ž‹ ƒ„Ž‡ǡ–ƒ‡ƒ –‹‘•–‘ƒ “—‹”‡–Š‡‡ ‡••ƒ”› ‘’‡–‡ ‡ǡƒ†‡˜ƒŽ—ƒ–‡–Š‡‡ˆˆ‡ –‹˜‡‡••‘ˆ–Š‡
D M

ƒ –‹‘•–ƒ‡Ǥ

’’”‘’”‹ƒ–‡†‘ —‡–‡†‹ˆ‘”ƒ–‹‘•ŠƒŽŽ„‡ƒ˜ƒ‹Žƒ„Ž‡ƒ•‡˜‹†‡ ‡‘ˆ ‘’‡–‡ ‡Ǥ

M

 ’’Ž‹ ƒ„Ž‡ ƒ –‹‘• ƒ ‹ Ž—†‡ǡ ˆ‘” ‡šƒ’Ž‡ǡ –Š‡ ’”‘˜‹•‹‘ ‘ˆ –”ƒ‹‹‰ –‘ǡ –Š‡ ‡–‘”‹‰ ‘ˆǡ ‘” –Š‡ ”‡Ǧ
O

ƒ••‹‰‡–‘ˆ —””‡–Ž›‡’Ž‘›‡†’‡”•‘•Ǣ‘”–Š‡Š‹”‹‰‘” ‘–”ƒ –‹‰‘ˆ ‘’‡–‡–’‡”•‘•Ǥ

7.3 Awareness
C

‡”•‘•†‘‹‰™‘”—†‡”–Š‡‘”‰ƒ‹œƒ–‹‘ǯ• ‘–”‘Ž•ŠƒŽŽ„‡ƒ™ƒ”‡‘ˆǣ

ƒȌ –Š‡“—ƒŽ‹–›’‘Ž‹ ›Ǣ

„Ȍ –Š‡‹” ‘–”‹„—–‹‘ –‘ –Š‡ ‡ˆˆ‡ –‹˜‡‡•• ‘ˆ –Š‡ “—ƒŽ‹–› ƒƒ‰‡‡– •›•–‡ǡ ‹ Ž—†‹‰ –Š‡ „‡‡ˆ‹–• ‘ˆ
‹’”‘˜‡†“—ƒŽ‹–›’‡”ˆ‘”ƒ ‡Ǣ

Ȍ –Š‡‹’Ž‹ ƒ–‹‘•‘ˆ‘– ‘ˆ‘”‹‰™‹–Š–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡”‡“—‹”‡‡–•Ǣ

†Ȍ ”‡Ž‡˜ƒ–“—ƒŽ‹–›‘„Œ‡ –‹˜‡•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

Ȍ ™‹–Š™Š‘–‘ ‘—‹ ƒ–‡Ǣ

̹ ʹͲʹͷȂŽŽ”‹‰Š–•”‡•‡”˜‡†
ͳ͵
 ISO/CD 9001.2:2025(en)

†Ȍ Š‘™–‘ ‘—‹ ƒ–‡Ǣ

‡Ȍ ™Š‘ ‘—‹ ƒ–‡•Ǥ

7.5 Documented information

7.5.1 General

Š‡‘”‰ƒ‹œƒ–‹‘ǯ•“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡•ŠƒŽŽ‹ Ž—†‡ǣ

ƒȌ †‘ —‡–‡†‹ˆ‘”ƒ–‹‘”‡“—‹”‡†„›–Š‹•†‘ —‡–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”‘‘‡‘”‰ƒ‹œƒ–‹‘–‘

ƒ‘–Š‡”†—‡–‘ǣ

T EE
Ȅ–Š‡•‹œ‡‘ˆ‘”‰ƒ‹œƒ–‹‘ƒ†‹–•–›’‡‘ˆƒ –‹˜‹–‹‡•ǡ’”‘ ‡••‡•ǡ’”‘†— –•ƒ†•‡”˜‹ ‡•Ǣ

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

AF T
Ȅ–Š‡ ‘’‡–‡ ‡‘ˆ’‡”•‘•Ǥ
R IT

7.5.2
2
Creating and updating documented information
D M

Š‡ ”‡ƒ–‹‰ƒ†—’†ƒ–‹‰†‘ —‡–‡†‹ˆ‘”ƒ–‹‘ǡ–Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ‡•—”‡ƒ’’”‘’”‹ƒ–‡ǣ

M

ƒȌ ‹†‡–‹ˆ‹ ƒ–‹‘ƒ††‡• ”‹’–‹‘ȋ‡Ǥ‰Ǥƒ–‹–Ž‡ǡ†ƒ–‡ǡƒ—–Š‘”ǡ‘””‡ˆ‡”‡ ‡—„‡”ȌǢ

O

„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
C

7.5.3 Control of documented information

7.5.3.1 Documented information required by the quality management system and by this document
shall be controlled to ensure:

ƒȌ ‹–‹•ƒ˜ƒ‹Žƒ„Ž‡ƒ†•—‹–ƒ„Ž‡ˆ‘”—•‡ǡ™Š‡”‡ƒ†™Š‡‹–‹•‡‡†‡†Ǣ

„Ȍ ‹–‹•ƒ†‡“—ƒ–‡Ž›’”‘–‡ –‡†ȋ‡Ǥ‰Ǥˆ”‘Ž‘••‘ˆ ‘ˆ‹†‡–‹ƒŽ‹–›ǡ‹’”‘’‡”—•‡ǡ‘”Ž‘••‘ˆ‹–‡‰”‹–›ȌǤ

7.5.3.2 For the control of documented information, the organization shall address the following
activities, as applicable:

ƒȌ †‹•–”‹„—–‹‘ǡƒ ‡••ǡ”‡–”‹‡˜ƒŽƒ†—•‡Ǣ

„Ȍ •–‘”ƒ‰‡ƒ†’”‡•‡”˜ƒ–‹‘ǡ‹ Ž—†‹‰’”‡•‡”˜ƒ–‹‘‘ˆŽ‡‰‹„‹Ž‹–›Ǣ

Ȍ ‘–”‘Ž‘ˆ Šƒ‰‡•ȋ‡Ǥ‰Ǥ˜‡”•‹‘ ‘–”‘ŽȌǢ

†Ȍ ”‡–‡–‹‘ƒ††‹•’‘•‹–‹‘Ǥ

̹ ʹͲʹͷȂŽŽ”‹‰Š–•”‡•‡”˜‡†
ͳͶ
 ISO/CD 9001.2:2025(en)

‘ —‡–‡†‹ˆ‘”ƒ–‹‘‘ˆ‡š–‡”ƒŽ‘”‹‰‹†‡–‡”‹‡†„›–Š‡‘”‰ƒ‹œƒ–‹‘–‘„‡‡ ‡••ƒ”›ˆ‘”–Š‡’Žƒ‹‰
ƒ†‘’‡”ƒ–‹‘‘ˆ–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡•ŠƒŽŽ„‡‹†‡–‹ˆ‹‡†ƒ•ƒ’’”‘’”‹ƒ–‡ǡƒ† ‘–”‘ŽŽ‡†Ǥ

‘ —‡–‡†‹ˆ‘”ƒ–‹‘ƒ˜ƒ‹Žƒ„Ž‡ƒ•‡˜‹†‡ ‡‘ˆ ‘ˆ‘”‹–›•ŠƒŽŽ„‡’”‘–‡ –‡†ˆ”‘—‹–‡†‡†ƒŽ–‡”ƒ–‹‘•Ǥ

  ‡•• 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

Š‡ ‘”‰ƒ‹œƒ–‹‘ •ŠƒŽŽ ’Žƒǡ ‹’Ž‡‡– ƒ† ‘–”‘Ž –Š‡ ’”‘ ‡••‡• ‡‡†‡† –‘ ‡‡– ”‡“—‹”‡‡–• ƒ† –‘
‹’Ž‡‡––Š‡ƒ –‹‘•†‡–‡”‹‡†‹Žƒ—•‡͸ǡ„›ǣ

ƒȌ ‡•–ƒ„Ž‹•Š‹‰ ”‹–‡”‹ƒˆ‘”–Š‡’”‘ ‡••‡•Ǣ

„Ȍ ‹’Ž‡‡–‹‰ ‘–”‘Ž‘ˆ–Š‡’”‘ ‡••‡•‹ƒ ‘”†ƒ ‡™‹–Š–Š‡ ”‹–‡”‹ƒǤ

T EE
‘ —‡–‡†‹ˆ‘”ƒ–‹‘•ŠƒŽŽ„‡ƒ˜ƒ‹Žƒ„Ž‡–‘–Š‡‡š–‡–‡ ‡••ƒ”›–‘Šƒ˜‡ ‘ˆ‹†‡ ‡–Šƒ––Š‡’”‘ ‡••‡•Šƒ˜‡
„‡‡ ƒ””‹‡†‘—–ƒ•’Žƒ‡†Ǥ

Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ ‘–”‘Ž’Žƒ‡† Šƒ‰‡•ƒ†”‡˜‹‡™–Š‡ ‘•‡“—‡ ‡•‘ˆ—‹–‡†‡† Šƒ‰‡•ǡ–ƒ‹‰

AF T
ƒ –‹‘–‘‹–‹‰ƒ–‡ƒ›ƒ†˜‡”•‡‡ˆˆ‡ –•ǡƒ•‡ ‡••ƒ”›Ǥ
R IT

2
Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ‡•—”‡–Šƒ–‡š–‡”ƒŽŽ›’”‘˜‹†‡†’”‘ ‡••‡•ǡ’”‘†— –•‘”•‡”˜‹ ‡•–Šƒ–ƒ”‡”‡Ž‡˜ƒ––‘–Š‡
“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡ƒ”‡ ‘–”‘ŽŽ‡†Ǥ
D M

‘”†‡”–‘‡•—”‡–Š‡ ‘–”‘Ž‘ˆ’”‘ ‡••‡•”‡Žƒ–‡†–‘–Š‡’”‘˜‹•‹‘‘ˆ’”‘†— –•ƒ†•‡”˜‹ ‡•ǡ–Š‡‘”‰ƒ‹œƒ–‹‘

M

•ŠƒŽŽǣ
O

Ȅ †‡–‡”‹‡–Š‡”‡“—‹”‡‡–•ˆ‘”–Š‡’”‘†— –•ƒ†•‡”˜‹ ‡•Ǣ

Ȅ †‡–‡”‹‡ ”‹–‡”‹ƒˆ‘”–Š‡ƒ ‡’–ƒ ‡‘ˆ’”‘†— –•ƒ†•‡”˜‹ ‡•

C

Ȅ †‡–‡”‹‡–Š‡”‡•‘—” ‡•‡‡†‡†–‘ƒ Š‹‡˜‡ ‘ˆ‘”‹–›–‘–Š‡’”‘†— –ƒ†•‡”˜‹ ‡”‡“—‹”‡‡–•Ǣ

‘ —‡–‡†‹ˆ‘”ƒ–‹‘•ŠƒŽŽ„‡ƒ˜ƒ‹Žƒ„Ž‡–‘–Š‡‡š–‡–‡ ‡••ƒ”›–‘Šƒ˜‡ ‘ˆ‹†‡ ‡–Šƒ––Š‡’”‘ ‡••‡•Šƒ˜‡

„‡‡ ƒ””‹‡†‘—–ƒ•’Žƒ‡†ƒ†–‘†‡‘•–”ƒ–‡–Š‡ ‘ˆ‘”‹–›‘ˆ’”‘†— –•ƒ†•‡”˜‹ ‡•–‘–Š‡‹””‡“—‹”‡‡–•Ǥ

Š‡‘—–’—–‘ˆ–Š‹•’Žƒ‹‰•ŠƒŽŽ„‡•—‹–ƒ„Ž‡ˆ‘”–Š‡‘”‰ƒ‹œƒ–‹‘ǯ•‘’‡”ƒ–‹‘•Ǥ

8.2 Requirements for products and services

8.2.1 Customer communication

‘—‹ ƒ–‹‘™‹–Š —•–‘‡”••ŠƒŽŽ‹ Ž—†‡ǣ

ƒȌ ’”‘˜‹†‹‰‹ˆ‘”ƒ–‹‘”‡Žƒ–‹‰–‘’”‘†— –•ƒ†•‡”˜‹ ‡•Ǣ

„Ȍ Šƒ†Ž‹‰‡“—‹”‹‡•ǡ ‘–”ƒ –•‘”‘”†‡”•ǡ‹ Ž—†‹‰ Šƒ‰‡•Ǣ

Ȍ ‘„–ƒ‹‹‰ —•–‘‡”ˆ‡‡†„ƒ ”‡Žƒ–‹‰–‘’”‘†— –•ƒ†•‡”˜‹ ‡•ǡ‹ Ž—†‹‰ —•–‘‡” ‘’Žƒ‹–•Ǣ

†Ȍ Šƒ†Ž‹‰‘” ‘–”‘ŽŽ‹‰ —•–‘‡”’”‘’‡”–›Ǣ

̹ ʹͲʹͷȂŽŽ”‹‰Š–•”‡•‡”˜‡†
ͳͷ
 ISO/CD 9001.2:2025(en)

‡Ȍ ‡•–ƒ„Ž‹•Š‹‰•’‡ ‹ˆ‹ ”‡“—‹”‡‡–•ˆ‘” ‘–‹‰‡ ›ƒ –‹‘•ǡ™Š‡”‡Ž‡˜ƒ–Ǥ

 —•–‘‡” ‘—‹ ƒ–‹‘ ƒ‹ Ž—†‡–”ƒ‹‹‰ǡ™‡„•‹–‡ ‘–‡–ǡ’—„Ž‹ ƒ–‹‘•ǡ•‘ ‹ƒŽ‡†‹ƒƒ† ”‡“—‡–Ž›
•‡†—‡•–‹‘•Ǥ

8.2.2 Determining the requirements for products and services

Š‡†‡–‡”‹‹‰–Š‡”‡“—‹”‡‡–•ˆ‘”–Š‡’”‘†— –•ƒ†•‡”˜‹ ‡•–‘„‡‘ˆˆ‡”‡†–‘ —•–‘‡”•ǡ–Š‡‘”‰ƒ‹œƒ–‹‘

•ŠƒŽŽ‡•—”‡–Šƒ–ǣ

ƒȌ –Š‡”‡“—‹”‡‡–•ˆ‘”–Š‡’”‘†— –•ƒ†•‡”˜‹ ‡•ƒ”‡†‡ˆ‹‡†ǡ‹ Ž—†‹‰ǣ

Ȅ ƒ›ƒ’’Ž‹ ƒ„Ž‡•–ƒ–—–‘”›ƒ†”‡‰—Žƒ–‘”›”‡“—‹”‡‡–•Ǣ

Ȅ –Š‘•‡ ‘•‹†‡”‡†‡ ‡••ƒ”›„›–Š‡‘”‰ƒ‹œƒ–‹‘Ǣ

„Ȍ –Š‡‘”‰ƒ‹œƒ–‹‘ ƒ‡‡––Š‡ Žƒ‹•ˆ‘”–Š‡’”‘†— –•ƒ†•‡”˜‹ ‡•‹–‘ˆˆ‡”•Ǥ

8.2.3 Review of the requirements for products and services

T EE
8.2.3.1 Š‡ ‘”‰ƒ‹œƒ–‹‘ •ŠƒŽŽ ‡•—”‡ –Šƒ– ‹– Šƒ• –Š‡ ƒ„‹Ž‹–› –‘ ‡‡– –Š‡ ”‡“—‹”‡‡–• ˆ‘” ’”‘†— –• ƒ†
•‡”˜‹ ‡• –‘ „‡ ‘ˆˆ‡”‡† –‘ —•–‘‡”•Ǥ Š‡ ‘”‰ƒ‹œƒ–‹‘ •ŠƒŽŽ ‘†— – ƒ ”‡˜‹‡™ „‡ˆ‘”‡ ‘‹––‹‰ –‘ •—’’Ž›
’”‘†— –•ƒ†•‡”˜‹ ‡•–‘ƒ —•–‘‡”ǡ–‘‹ Ž—†‡ǣ
AF T
ƒȌ ”‡“—‹”‡‡–• •’‡ ‹ˆ‹‡† „› –Š‡ —•–‘‡”ǡ ‹ Ž—†‹‰ –Š‡ ”‡“—‹”‡‡–• ˆ‘” †‡Ž‹˜‡”› ƒ† ’‘•–Ǧ†‡Ž‹˜‡”›
R IT

2
ƒ –‹˜‹–‹‡•™Š‡ƒ’’Ž‹ ƒ„Ž‡Ǣ

„Ȍ ”‡“—‹”‡‡–•‘–•–ƒ–‡†„›–Š‡ —•–‘‡”ǡ„—–‡ ‡••ƒ”›ˆ‘”–Š‡•’‡ ‹ˆ‹‡†‘”‹–‡†‡†—•‡ǡ™Š‡‘™Ǣ

D M

Ȍ ”‡“—‹”‡‡–••’‡ ‹ˆ‹‡†„›–Š‡‘”‰ƒ‹œƒ–‹‘Ǣ
M

†Ȍ •–ƒ–—–‘”›ƒ†”‡‰—Žƒ–‘”›”‡“—‹”‡‡–•ƒ’’Ž‹ ƒ„Ž‡–‘–Š‡’”‘†— –•ƒ†•‡”˜‹ ‡•Ǣ

O

‡Ȍ ‘–”ƒ –‘”‘”†‡””‡“—‹”‡‡–•†‹ˆˆ‡”‹‰ˆ”‘–Š‘•‡’”‡˜‹‘—•Ž›‡š’”‡••‡†Ǥ
C

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

”‡•‘Ž˜‡†Ǥ

Š‡ —•–‘‡”ǯ•”‡“—‹”‡‡–••ŠƒŽŽ„‡ ‘ˆ‹”‡†„›–Š‡‘”‰ƒ‹œƒ–‹‘„‡ˆ‘”‡ƒ ‡’–ƒ ‡ǡ™Š‡–Š‡ —•–‘‡”

†‘‡•‘–’”‘˜‹†‡ƒ†‘ —‡–‡†•–ƒ–‡‡–‘ˆ–Š‡‹””‡“—‹”‡‡–•Ǥ

 •‘‡•‹–—ƒ–‹‘•ǡ•— Šƒ•‹–‡”‡–•ƒŽ‡•ǡƒˆ‘”ƒŽ”‡˜‹‡™‹•‹’”ƒ –‹ ƒŽˆ‘”‡ƒ Š‘”†‡”Ǥ •–‡ƒ†ǡ–Š‡”‡˜‹‡™

ƒ ‘˜‡””‡Ž‡˜ƒ–’”‘†— –‹ˆ‘”ƒ–‹‘ǡ•— Šƒ•™‡„•‹–‡•‘” ƒ–ƒŽ‘‰—‡•Ǥ

8.2.3.2 ‘ —‡–‡†‹ˆ‘”ƒ–‹‘•ŠƒŽŽ„‡ƒ˜ƒ‹Žƒ„Ž‡ƒ•ƒ’’Ž‹ ƒ„Ž‡ǡƒ•‡˜‹†‡ ‡‘ˆǣ

ƒȌ –Š‡”‡•—Ž–•‘ˆ–Š‡”‡˜‹‡™Ǣ

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

8.2.4 Changes to requirements for products and services

Š‡ ”‡“—‹”‡‡–• ˆ‘” ’”‘†— –• ƒ† •‡”˜‹ ‡• ƒ”‡ Šƒ‰‡†ǡ –Š‡ ‘”‰ƒ‹œƒ–‹‘ •ŠƒŽŽ ‡•—”‡ –Šƒ– ”‡Ž‡˜ƒ–
†‘ —‡–‡†‹ˆ‘”ƒ–‹‘‹•—’†ƒ–‡†ƒ† ‘—‹ ƒ–‡†–‘”‡Ž‡˜ƒ–’‡”•‘•Ǥ

̹ ʹͲʹͷȂŽŽ”‹‰Š–•”‡•‡”˜‡†
ͳ͸
 ISO/CD 9001.2:2025(en)

8.3 Design and development of products and services

8.3.1 General

Š‡‘”‰ƒ‹œƒ–‹‘ǯ•†‡•‹‰ƒ††‡˜‡Ž‘’‡–’”‘ ‡•••ŠƒŽŽ„‡ƒ’’”‘’”‹ƒ–‡–‘‡•—”‡–Š‡•—„•‡“—‡–’”‘˜‹•‹‘
‘ˆ’”‘†— –•ƒ†•‡”˜‹ ‡•Ǥ

8.3.2 Design and development planning

†‡–‡”‹‹‰–Š‡•–ƒ‰‡•ƒ† ‘–”‘Ž•ˆ‘”†‡•‹‰ƒ††‡˜‡Ž‘’‡–ǡ–Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ ‘•‹†‡”ǣ

ƒȌ –Š‡ƒ–—”‡ǡ†—”ƒ–‹‘ƒ† ‘’Ž‡š‹–›‘ˆ–Š‡†‡•‹‰ƒ††‡˜‡Ž‘’‡–ƒ –‹˜‹–‹‡•Ǣ

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

Ȍ –Š‡”‡“—‹”‡††‡•‹‰ƒ††‡˜‡Ž‘’‡–˜‡”‹ˆ‹ ƒ–‹‘ƒ†˜ƒŽ‹†ƒ–‹‘ƒ –‹˜‹–‹‡•Ǣ

†Ȍ –Š‡”‡•’‘•‹„‹Ž‹–‹‡•ƒ†ƒ—–Š‘”‹–‹‡•‹˜‘Ž˜‡†‹–Š‡†‡•‹‰ƒ††‡˜‡Ž‘’‡–’”‘ ‡••Ǣ

T EE
‡Ȍ –Š‡‹–‡”ƒŽƒ†‡š–‡”ƒŽ”‡•‘—” ‡‡‡†•ˆ‘”–Š‡†‡•‹‰ƒ††‡˜‡Ž‘’‡–‘ˆ’”‘†— –•ƒ†•‡”˜‹ ‡•Ǣ

ˆȌ –Š‡‡‡†–‘ ‘–”‘Ž‹–‡”ˆƒ ‡•„‡–™‡‡’‡”•‘•‹˜‘Ž˜‡†‹–Š‡†‡•‹‰ƒ††‡˜‡Ž‘’‡–’”‘ ‡••Ǣ

AF T
‰Ȍ –Š‡‡‡†ˆ‘”‹˜‘Ž˜‡‡–‘ˆ —•–‘‡”•ƒ†—•‡”•‹–Š‡†‡•‹‰ƒ††‡˜‡Ž‘’‡–’”‘ ‡••Ǣ
R IT

2
ŠȌ –Š‡”‡“—‹”‡‡–•ˆ‘”•—„•‡“—‡–’”‘˜‹•‹‘‘ˆ’”‘†— –•ƒ†•‡”˜‹ ‡•Ǣ
D M

‹Ȍ –Š‡Ž‡˜‡Ž‘ˆ ‘–”‘Ž‡š’‡ –‡†ˆ‘”–Š‡†‡•‹‰ƒ††‡˜‡Ž‘’‡–’”‘ ‡••„› —•–‘‡”•ƒ†‘–Š‡””‡Ž‡˜ƒ–

‹–‡”‡•–‡†’ƒ”–‹‡•Ǣ
M

ŒȌ –Š‡†‘ —‡–‡†‹ˆ‘”ƒ–‹‘‡‡†‡†ƒ•‡˜‹†‡ ‡–Šƒ–†‡•‹‰ƒ††‡˜‡Ž‘’‡–”‡“—‹”‡‡–•Šƒ˜‡„‡‡

‡–Ǥ
O

8.3.3 Design and development inputs

C

Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ†‡–‡”‹‡–Š‡”‡“—‹”‡‡–•‡••‡–‹ƒŽˆ‘”–Š‡•’‡ ‹ˆ‹ –›’‡•‘ˆ’”‘†— –•ƒ†•‡”˜‹ ‡•–‘

„‡†‡•‹‰‡†ƒ††‡˜‡Ž‘’‡†ǤŠ‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ ‘•‹†‡”ǣ

ƒȌ ˆ— –‹‘ƒŽƒ†’‡”ˆ‘”ƒ ‡”‡“—‹”‡‡–•Ǣ

„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

‡Ȍ ’‘–‡–‹ƒŽ ‘•‡“—‡ ‡•‘ˆˆƒ‹Ž—”‡†—‡–‘–Š‡ƒ–—”‡‘ˆ–Š‡’”‘†— –•ƒ†•‡”˜‹ ‡•Ǥ

’—–••ŠƒŽŽ„‡ƒ†‡“—ƒ–‡ˆ‘”†‡•‹‰ƒ††‡˜‡Ž‘’‡–’—”’‘•‡•ǡ ‘’Ž‡–‡ƒ†—ƒ„‹‰—‘—•Ǥ

‘ˆŽ‹ –‹‰†‡•‹‰ƒ††‡˜‡Ž‘’‡–‹’—–••ŠƒŽŽ„‡”‡•‘Ž˜‡†Ǥ

‘ —‡–‡†‹ˆ‘”ƒ–‹‘•ŠƒŽŽ„‡ƒ˜ƒ‹Žƒ„Ž‡ƒ•‡˜‹†‡ ‡‘ˆ†‡•‹‰ƒ††‡˜‡Ž‘’‡–‹’—–•Ǥ

8.3.4 Design and development controls

Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽƒ’’Ž› ‘–”‘Ž•–‘–Š‡†‡•‹‰ƒ††‡˜‡Ž‘’‡–’”‘ ‡••–‘‡•—”‡–Šƒ–ǣ

̹ ʹͲʹͷȂŽŽ”‹‰Š–•”‡•‡”˜‡†
ͳ͹
 ISO/CD 9001.2:2025(en)

ƒȌ –Š‡”‡•—Ž–•–‘„‡ƒ Š‹‡˜‡†ƒ”‡†‡ˆ‹‡†Ǣ

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

Ȍ ˜‡”‹ˆ‹ ƒ–‹‘ƒ –‹˜‹–‹‡•ƒ”‡ ‘†— –‡†–‘‡•—”‡–Šƒ––Š‡†‡•‹‰ƒ††‡˜‡Ž‘’‡–‘—–’—–•‡‡––Š‡‹’—–

”‡“—‹”‡‡–•Ǣ

†Ȍ ˜ƒŽ‹†ƒ–‹‘ ƒ –‹˜‹–‹‡• ƒ”‡ ‘†— –‡† –‘ ‡•—”‡ –Šƒ– –Š‡ ”‡•—Ž–‹‰ ’”‘†— –• ƒ† •‡”˜‹ ‡• ‡‡– –Š‡
”‡“—‹”‡‡–•ˆ‘”–Š‡•’‡ ‹ˆ‹‡†ƒ’’Ž‹ ƒ–‹‘‘”‹–‡†‡†—•‡Ǣ

‡Ȍ ‡ ‡••ƒ”› ƒ –‹‘• ƒ”‡ –ƒ‡ –‘ ƒ††”‡•• ’”‘„Ž‡• †‡–‡”‹‡† †—”‹‰ –Š‡ ”‡˜‹‡™•ǡ ‘” ˜‡”‹ˆ‹ ƒ–‹‘ ƒ†
˜ƒŽ‹†ƒ–‹‘ƒ –‹˜‹–‹‡•Ǣ

ˆȌ †‘ —‡–‡†‹ˆ‘”ƒ–‹‘‹•ƒ˜ƒ‹Žƒ„Ž‡ƒ•‡˜‹†‡ ‡‘ˆ–Š‡•‡ƒ –‹˜‹–‹‡•Ǥ

 ‡•‹‰ƒ††‡˜‡Ž‘’‡–”‡˜‹‡™•ǡ˜‡”‹ˆ‹ ƒ–‹‘ƒ†˜ƒŽ‹†ƒ–‹‘Šƒ˜‡†‹•–‹ –’—”’‘•‡•ǤŠ‡› ƒ„‡ ‘†— –‡†

•‡’ƒ”ƒ–‡Ž›‘”‹ƒ› ‘„‹ƒ–‹‘ǡƒ•‹••—‹–ƒ„Ž‡ˆ‘”–Š‡’”‘†— –•ƒ†•‡”˜‹ ‡•‘ˆ–Š‡‘”‰ƒ‹œƒ–‹‘Ǥ

T EE
8.3.5 Design and development outputs

Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ‡•—”‡–Šƒ–†‡•‹‰ƒ††‡˜‡Ž‘’‡–‘—–’—–•ǣ
AF T
ƒȌ ‡‡––Š‡‹’—–”‡“—‹”‡‡–•Ǣ
R IT

2
„Ȍ ƒ”‡ƒ†‡“—ƒ–‡ˆ‘”–Š‡•—„•‡“—‡–’”‘ ‡••‡•ˆ‘”–Š‡’”‘˜‹•‹‘‘ˆ’”‘†— –•ƒ†•‡”˜‹ ‡•Ǣ
D M

Ȍ ‹ Ž—†‡‘””‡ˆ‡”‡ ‡‘‹–‘”‹‰ƒ†‡ƒ•—”‹‰”‡“—‹”‡‡–•ǡƒ•ƒ’’”‘’”‹ƒ–‡ǡƒ†ƒ ‡’–ƒ ‡ ”‹–‡”‹ƒǢ

M

†Ȍ •’‡ ‹ˆ›–Š‡ Šƒ”ƒ –‡”‹•–‹ •‘ˆ–Š‡’”‘†— –•ƒ†•‡”˜‹ ‡•–Šƒ–ƒ”‡‡••‡–‹ƒŽˆ‘”–Š‡‹”‹–‡†‡†’—”’‘•‡ƒ†

–Š‡‹”•ƒˆ‡ƒ†’”‘’‡”’”‘˜‹•‹‘Ǥ
O

‘ —‡–‡†‹ˆ‘”ƒ–‹‘•ŠƒŽŽ„‡ƒ˜ƒ‹Žƒ„Ž‡ƒ•‡˜‹†‡ ‡‘ˆ†‡•‹‰ƒ††‡˜‡Ž‘’‡–‘—–’—–•Ǥ
C

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

‘ —‡–‡†‹ˆ‘”ƒ–‹‘•ŠƒŽŽ„‡ƒ˜ƒ‹Žƒ„Ž‡ƒ•‡˜‹†‡ ‡‘ˆǣ

ƒȌ †‡•‹‰ƒ††‡˜‡Ž‘’‡– Šƒ‰‡•Ǣ

„Ȍ –Š‡”‡•—Ž–•‘ˆ”‡˜‹‡™•Ǣ

Ȍ –Š‡ƒ—–Š‘”‹œƒ–‹‘‘ˆ–Š‡ Šƒ‰‡•Ǣ

†Ȍ –Š‡ƒ –‹‘•–ƒ‡–‘’”‡˜‡–ƒ†˜‡”•‡‹’ƒ –•Ǥ

8.4 Control of externally provided processes, products and services

8.4.1 General

Š‡ ‘”‰ƒ‹œƒ–‹‘ •ŠƒŽŽ ‡•—”‡ –Šƒ– ‡š–‡”ƒŽŽ› ’”‘˜‹†‡† ’”‘ ‡••‡•ǡ ’”‘†— –• ƒ† •‡”˜‹ ‡• ‘ˆ‘” –‘
”‡“—‹”‡‡–•Ǥ

̹ ʹͲʹͷȂŽŽ”‹‰Š–•”‡•‡”˜‡†
ͳͺ
 ISO/CD 9001.2:2025(en)

Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ†‡–‡”‹‡–Š‡ ‘–”‘Ž•–‘„‡ƒ’’Ž‹‡†–‘‡š–‡”ƒŽŽ›’”‘˜‹†‡†’”‘ ‡••‡•ǡ’”‘†— –•ƒ†

•‡”˜‹ ‡•™Š‡ǣ

ƒȌ ’”‘†— –•ƒ†•‡”˜‹ ‡•ˆ”‘‡š–‡”ƒŽ’”‘˜‹†‡”•ƒ”‡‹–‡†‡†ˆ‘”‹ ‘”’‘”ƒ–‹‘‹–‘–Š‡‘”‰ƒ‹œƒ–‹‘ǯ•‘™

’”‘†— –•ƒ†•‡”˜‹ ‡•Ǣ

„Ȍ ’”‘†— –• ƒ†•‡”˜‹ ‡• ƒ”‡ ’”‘˜‹†‡† †‹”‡ –Ž› –‘ –Š‡ —•–‘‡”ȋ•Ȍ „› ‡š–‡”ƒŽ ’”‘˜‹†‡”• ‘ „‡ŠƒŽˆ ‘ˆ –Š‡
‘”‰ƒ‹œƒ–‹‘Ǣ

Ȍ ƒ ’”‘ ‡••ǡ ‘” ’ƒ”– ‘ˆ ƒ ’”‘ ‡••ǡ ‹• ’”‘˜‹†‡† „› ƒ ‡š–‡”ƒŽ ’”‘˜‹†‡” ƒ• ƒ ”‡•—Ž– ‘ˆ ƒ †‡ ‹•‹‘ „› –Š‡
‘”‰ƒ‹œƒ–‹‘Ǥ

Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ†‡–‡”‹‡ƒ†ƒ’’Ž› ”‹–‡”‹ƒˆ‘”–Š‡‡˜ƒŽ—ƒ–‹‘ǡ•‡Ž‡ –‹‘ǡ‘‹–‘”‹‰‘ˆ’‡”ˆ‘”ƒ ‡ǡ

ƒ†”‡Ǧ‡˜ƒŽ—ƒ–‹‘‘ˆ‡š–‡”ƒŽ’”‘˜‹†‡”•ǡ„ƒ•‡†‘–Š‡‹”ƒ„‹Ž‹–›–‘’”‘˜‹†‡’”‘ ‡••‡•‘”’”‘†— –•ƒ†•‡”˜‹ ‡•
‹ƒ ‘”†ƒ ‡™‹–Š”‡“—‹”‡‡–•Ǥ

‘ —‡–‡†‹ˆ‘”ƒ–‹‘•ŠƒŽŽ„‡ƒ˜ƒ‹Žƒ„Ž‡ƒ•‡˜‹†‡ ‡‘ˆ–Š‡•‡ƒ –‹˜‹–‹‡•ƒ†ƒ›‡ ‡••ƒ”›ƒ –‹‘•ƒ”‹•‹‰

ˆ”‘–Š‡‡˜ƒŽ—ƒ–‹‘•Ǥ

T EE
8.4.2 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†•‡”˜‹ ‡•–‘‹–• —•–‘‡”•Ǥ
AF T
R IT

Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽǣ 2
ƒȌ ‡•—”‡–Šƒ–‡š–‡”ƒŽŽ›’”‘˜‹†‡†’”‘ ‡••‡•”‡ƒ‹™‹–Š‹–Š‡ ‘–”‘Ž‘ˆ‹–•“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǣ
D M

„Ȍ †‡ˆ‹‡„‘–Š–Š‡ ‘–”‘Ž•–Šƒ–‹–‹–‡†•–‘ƒ’’Ž›–‘ƒ‡š–‡”ƒŽ’”‘˜‹†‡”ƒ†–Š‘•‡‹–‹–‡†•–‘ƒ’’Ž›–‘
M

–Š‡”‡•—Ž–‹‰‘—–’—–Ǣ
O

Ȍ –ƒ‡‹–‘ ‘•‹†‡”ƒ–‹‘ǣ

ͳȌ –Š‡’‘–‡–‹ƒŽ‹’ƒ –‘ˆ–Š‡‡š–‡”ƒŽŽ›’”‘˜‹†‡†’”‘ ‡••‡•ǡ’”‘†— –•ƒ†•‡”˜‹ ‡•‘–Š‡‘”‰ƒ‹œƒ–‹‘ǯ•

C

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‡˜‡”‹ˆ‹ ƒ–‹‘ǡ‘”‘–Š‡”ƒ –‹˜‹–‹‡•ǡ‡ ‡••ƒ”›–‘‡•—”‡–Šƒ––Š‡‡š–‡”ƒŽŽ›’”‘˜‹†‡†’”‘ ‡••‡•ǡ

’”‘†— –•ƒ†•‡”˜‹ ‡•‡‡–”‡“—‹”‡‡–•Ǥ

8.4.3 Information for external providers

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

Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ ‘—‹ ƒ–‡–‘‡š–‡”ƒŽ’”‘˜‹†‡”•‹–•”‡“—‹”‡‡–•ǡƒ•ƒ’’Ž‹ ƒ„Ž‡ǡˆ‘”ǣ

ƒȌ –Š‡’”‘ ‡••‡•ǡ’”‘†— –•ƒ†•‡”˜‹ ‡•–‘„‡’”‘˜‹†‡†Ǣ

„Ȍ –Š‡ƒ’’”‘˜ƒŽ‘ˆǣ

ͳȌ ’”‘†— –•ƒ†•‡”˜‹ ‡•Ǣ

ʹȌ ‡–Š‘†•ǡ’”‘ ‡••‡•ƒ†‡“—‹’‡–Ǣ

̹ ʹͲʹͷȂŽŽ”‹‰Š–•”‡•‡”˜‡†
ͳͻ
 ISO/CD 9001.2:2025(en)

͵Ȍ –Š‡”‡Ž‡ƒ•‡‘ˆ’”‘†— –•ƒ†•‡”˜‹ ‡•Ǣ

Ȍ ‘’‡–‡ ‡ǡ‹ Ž—†‹‰ƒ›”‡“—‹”‡†“—ƒŽ‹ˆ‹ 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 ˜‡”‹ˆ‹ ƒ–‹‘ ‘” ˜ƒŽ‹†ƒ–‹‘ ƒ –‹˜‹–‹‡• –Šƒ– –Š‡ ‘”‰ƒ‹œƒ–‹‘ǡ ‘” ‹–• —•–‘‡”ǡ ‹–‡†• –‘ ’‡”ˆ‘” ƒ– –Š‡
‡š–‡”ƒŽ’”‘˜‹†‡”•ǯ’”‡‹•‡•Ǥ

8.5 Production and service provision

8.5.1 Control of production and service provision

Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ‹’Ž‡‡–’”‘†— –‹‘ƒ†•‡”˜‹ ‡’”‘˜‹•‹‘—†‡” ‘–”‘ŽŽ‡† ‘†‹–‹‘•Ǥ

‘–”‘ŽŽ‡† ‘†‹–‹‘••ŠƒŽŽ‹ Ž—†‡ǡƒ•ƒ’’Ž‹ ƒ„Ž‡ǣ

T EE
ƒȌ –Š‡ƒ˜ƒ‹Žƒ„‹Ž‹–›ƒ†—•‡‘ˆ†‘ —‡–‡†‹ˆ‘”ƒ–‹‘–Šƒ–†‡ˆ‹‡•ǣ

ͳȌ –Š‡ Šƒ”ƒ –‡”‹•–‹ •‘ˆ–Š‡’”‘†— –•–‘„‡’”‘†— ‡†ǡ–Š‡•‡”˜‹ ‡•–‘„‡’”‘˜‹†‡†ǡ‘”–Š‡ƒ –‹˜‹–‹‡•–‘„‡

’‡”ˆ‘”‡†Ǣ
AF T
R IT

ʹȌ –Š‡”‡•—Ž–•–‘„‡ƒ Š‹‡˜‡†Ǣ
2
„Ȍ –Š‡ƒ˜ƒ‹Žƒ„‹Ž‹–›ƒ†—•‡‘ˆ•—‹–ƒ„Ž‡‘‹–‘”‹‰ƒ†‡ƒ•—”‹‰”‡•‘—” ‡•Ǣ
D M

Ȍ –Š‡‹’Ž‡‡–ƒ–‹‘‘ˆ‘‹–‘”‹‰ƒ†‡ƒ•—”‡‡–ƒ –‹˜‹–‹‡•ƒ–ƒ’’”‘’”‹ƒ–‡•–ƒ‰‡•–‘˜‡”‹ˆ›–Šƒ– ”‹–‡”‹ƒ

M

ˆ‘” ‘–”‘Ž‘ˆ’”‘ ‡••‡•‘”‘—–’—–•ǡƒ†ƒ ‡’–ƒ ‡ ”‹–‡”‹ƒˆ‘”’”‘†— –•ƒ†•‡”˜‹ ‡•ǡŠƒ˜‡„‡‡‡–Ǣ

†Ȍ –Š‡—•‡‘ˆ•—‹–ƒ„Ž‡‹ˆ”ƒ•–”— –—”‡ƒ†‡˜‹”‘‡–ˆ‘”–Š‡‘’‡”ƒ–‹‘‘ˆ’”‘ ‡••‡•Ǣ

O

‡Ȍ –Š‡ƒ’’‘‹–‡–‘ˆ ‘’‡–‡–’‡”•‘•ǡ‹ Ž—†‹‰ƒ›”‡“—‹”‡†“—ƒŽ‹ˆ‹ ƒ–‹‘Ǣ

C

ˆȌ –Š‡ ˜ƒŽ‹†ƒ–‹‘ǡ ƒ† ’‡”‹‘†‹  ”‡˜ƒŽ‹†ƒ–‹‘ǡ ‘ˆ –Š‡ ƒ„‹Ž‹–› –‘ ƒ Š‹‡˜‡ ’Žƒ‡† ”‡•—Ž–• ‘ˆ –Š‡ ’”‘ ‡••‡• ˆ‘”
’”‘†— –‹‘ ƒ† •‡”˜‹ ‡ ’”‘˜‹•‹‘ǡ ™Š‡”‡ –Š‡ ”‡•—Ž–‹‰ ‘—–’—– ƒ‘– „‡ ˜‡”‹ˆ‹‡† „› •—„•‡“—‡–
‘‹–‘”‹‰‘”‡ƒ•—”‡‡–Ǣ

‰Ȍ –Š‡‹’Ž‡‡–ƒ–‹‘‘ˆƒ –‹‘•–‘’”‡˜‡–Š—ƒ‡””‘”Ǣ

ŠȌ –Š‡‹’Ž‡‡–ƒ–‹‘‘ˆ”‡Ž‡ƒ•‡ǡ†‡Ž‹˜‡”›ƒ†’‘•–Ǧ†‡Ž‹˜‡”›ƒ –‹˜‹–‹‡•Ǥ

 ‘‡•—”‡–Šƒ––Š‡†‡ˆ‹‡† ”‡“—‹”‡‡–•ƒ”‡‡–ǡ ‘”‰ƒ‹œƒ–‹‘• ƒ Š‘‘•‡–‘‡‰ƒ‰‡‹’”‘†— –ƒ†

•‡”˜‹ ‡ ˜‡”‹ˆ‹ ƒ–‹‘ ‘” ’”‘ ‡•• ˜ƒŽ‹†ƒ–‹‘ ƒ –‹˜‹–‹‡•ǡ ‘” „‘–Šǡ ƒ• ƒ’’”‘’”‹ƒ–‡Ǥ Š‡ ƒ„‹Ž‹–› –‘ ‡‰ƒ‰‡ ‹ ˜‡”‹ˆ‹ ƒ–‹‘
ƒ –‹˜‹–‹‡•†‘‡•‘–’”‡˜‡–‘”‰ƒ‹œƒ–‹‘•ˆ”‘ Š‘‘•‹‰˜ƒŽ‹†ƒ–‹‘‘ˆƒ’”‘ ‡••ƒ•ƒ•—‹–ƒ„Ž‡ƒŽ–‡”ƒ–‹˜‡Ǥ

8.5.2 Identification and traceability

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

̹ ʹͲʹͷȂŽŽ”‹‰Š–•”‡•‡”˜‡†
ʹͲ
 ISO/CD 9001.2:2025(en)

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

•ŠƒŽŽ‡•—”‡–Šƒ–†‘ —‡–‡†‹ˆ‘”ƒ–‹‘‡ ‡••ƒ”›–‘‡ƒ„Ž‡–”ƒ ‡ƒ„‹Ž‹–›‹•ƒ˜ƒ‹Žƒ„Ž‡ƒ•‡˜‹†‡ ‡Ǥ

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 ’”‘’‡”–›
’”‘˜‹†‡†ˆ‘”—•‡‘”‹ ‘”’‘”ƒ–‹‘‹–‘–Š‡’”‘†— –•ƒ†•‡”˜‹ ‡•Ǥ

Š‡–Š‡’”‘’‡”–›‘ˆƒ —•–‘‡”‘”‡š–‡”ƒŽ’”‘˜‹†‡”‹•Ž‘•–ǡ†ƒƒ‰‡†‘”‘–Š‡”™‹•‡ˆ‘—†–‘„‡—•—‹–ƒ„Ž‡
ˆ‘”—•‡ǡ–Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ”‡’‘”––Š‹•–‘–Š‡ —•–‘‡”‘”‡š–‡”ƒŽ’”‘˜‹†‡”ƒ†‡•—”‡–Šƒ–†‘ —‡–‡†
‹ˆ‘”ƒ–‹‘‹•ƒ˜ƒ‹Žƒ„Ž‡ƒ•‡˜‹†‡ ‡‘ˆ™Šƒ–Šƒ•‘ —””‡†Ǥ

  —•–‘‡”ǯ• ‘” ‡š–‡”ƒŽ ’”‘˜‹†‡”ǯ• ’”‘’‡”–› ƒ ‹ Ž—†‡ ƒ–‡”‹ƒŽ•ǡ ‘’‘‡–•ǡ –‘‘Ž• ƒ† ‡“—‹’‡–ǡ
’”‡‹•‡•ǡ‹–‡ŽŽ‡ –—ƒŽ’”‘’‡”–›ƒ†’‡”•‘ƒŽ†ƒ–ƒǤ

8.5.4 Preservation

T EE
Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ’”‡•‡”˜‡–Š‡‘—–’—–•†—”‹‰’”‘†— –‹‘ƒ†•‡”˜‹ ‡’”‘˜‹•‹‘ǡ–‘–Š‡‡š–‡–‡ ‡••ƒ”›
–‘‡•—”‡ ‘ˆ‘”‹–›–‘”‡“—‹”‡‡–•Ǥ
AF T
 ”‡•‡”˜ƒ–‹‘ ƒ‹ Ž—†‡‹†‡–‹ˆ‹ ƒ–‹‘ǡŠƒ†Ž‹‰ǡ ‘–ƒ‹ƒ–‹‘ ‘–”‘Žǡ’ƒ ƒ‰‹‰ǡ•–‘”ƒ‰‡ǡ–”ƒ•‹••‹‘‘”
–”ƒ•’‘”–ƒ–‹‘ǡƒ†’”‘–‡ –‹‘Ǥ
R IT

8.5.5
2
Post-delivery activities
D M

Š‡ ‘”‰ƒ‹œƒ–‹‘ •ŠƒŽŽ ‡‡– ”‡“—‹”‡‡–• ˆ‘” ’‘•–Ǧ†‡Ž‹˜‡”› ƒ –‹˜‹–‹‡• ƒ••‘ ‹ƒ–‡† ™‹–Š –Š‡ ’”‘†— –• ƒ†
•‡”˜‹ ‡•Ǥ
M

†‡–‡”‹‹‰–Š‡‡š–‡–‘ˆ’‘•–Ǧ†‡Ž‹˜‡”›ƒ –‹˜‹–‹‡•–Šƒ–ƒ”‡”‡“—‹”‡†ǡ–Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ ‘•‹†‡”ǣ

O

ƒȌ •–ƒ–—–‘”›ƒ†”‡‰—Žƒ–‘”›”‡“—‹”‡‡–•Ǣ
C

„Ȍ –Š‡’‘–‡–‹ƒŽ—†‡•‹”‡† ‘•‡“—‡ ‡•ƒ••‘ ‹ƒ–‡†™‹–Š‹–•’”‘†— –•ƒ†•‡”˜‹ ‡•Ǣ

Ȍ –Š‡ƒ–—”‡ǡ—•‡ƒ†‹–‡†‡†Ž‹ˆ‡–‹‡‘ˆ‹–•’”‘†— –•ƒ†•‡”˜‹ ‡•Ǣ

†Ȍ —•–‘‡””‡“—‹”‡‡–•Ǣ

‡Ȍ —•–‘‡”ˆ‡‡†„ƒ Ǥ

 ‘•–Ǧ†‡Ž‹˜‡”› ƒ –‹˜‹–‹‡• ƒ ‹ Ž—†‡ ƒ –‹‘• —†‡” ™ƒ””ƒ–› ’”‘˜‹•‹‘•ǡ ‘–”ƒ –—ƒŽ ‘„Ž‹‰ƒ–‹‘• •— Š ƒ•
ƒ‹–‡ƒ ‡•‡”˜‹ ‡•ǡƒ†•—’’Ž‡‡–ƒ”›•‡”˜‹ ‡••— Šƒ•”‡ › Ž‹‰‘”ˆ‹ƒŽ†‹•’‘•ƒŽǤ

8.5.6 Control of changes

Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ”‡˜‹‡™ƒ† ‘–”‘Ž Šƒ‰‡•ˆ‘”’”‘†— –‹‘‘”•‡”˜‹ ‡’”‘˜‹•‹‘ǡ–‘–Š‡‡š–‡–‡ ‡••ƒ”›

–‘‡•—”‡ ‘–‹—‹‰ ‘ˆ‘”‹–›™‹–Š”‡“—‹”‡‡–•Ǥ

‘ —‡–‡† ‹ˆ‘”ƒ–‹‘ •ŠƒŽŽ „‡ ƒ˜ƒ‹Žƒ„Ž‡ –‘ †‡• ”‹„‡ –Š‡ ”‡•—Ž–•‘ˆ –Š‡ ”‡˜‹‡™ ‘ˆ Šƒ‰‡•ǡ –Š‡ ’‡”•‘ȋ•Ȍ
ƒ—–Š‘”‹œ‹‰–Š‡ Šƒ‰‡ǡƒ†ƒ›‡ ‡••ƒ”›ƒ –‹‘•ƒ”‹•‹‰ˆ”‘–Š‡”‡˜‹‡™Ǥ

̹ ʹͲʹͷȂŽŽ”‹‰Š–•”‡•‡”˜‡†
ʹͳ
 ISO/CD 9001.2:2025(en)

8.6 Release of products and services

Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ‹’Ž‡‡–’Žƒ‡†ƒ””ƒ‰‡‡–•ǡƒ–ƒ’’”‘’”‹ƒ–‡•–ƒ‰‡•ǡ–‘˜‡”‹ˆ›–Šƒ––Š‡’”‘†— –ƒ†
•‡”˜‹ ‡”‡“—‹”‡‡–•Šƒ˜‡„‡‡‡–Ǥ

Š‡”‡Ž‡ƒ•‡‘ˆ’”‘†— –•ƒ†•‡”˜‹ ‡•–‘–Š‡ —•–‘‡”•ŠƒŽŽ‘–’”‘ ‡‡†—–‹Ž–Š‡’Žƒ‡†ƒ””ƒ‰‡‡–•Šƒ˜‡

„‡‡•ƒ–‹•ˆƒ –‘”‹Ž› ‘’Ž‡–‡†ǡ—Ž‡••‘–Š‡”™‹•‡ƒ’’”‘˜‡†„›ƒ”‡Ž‡˜ƒ–ƒ—–Š‘”‹–›ƒ†ǡƒ•ƒ’’Ž‹ ƒ„Ž‡ǡ„›–Š‡
—•–‘‡”Ǥ

‘ —‡–‡† ‹ˆ‘”ƒ–‹‘ •ŠƒŽŽ „‡ ƒ˜ƒ‹Žƒ„Ž‡ ƒ• ‡˜‹†‡ ‡ ‘ –Š‡ ”‡Ž‡ƒ•‡ ‘ˆ ’”‘†— –• ƒ† •‡”˜‹ ‡•Ǥ Š‡
†‘ —‡–‡†‹ˆ‘”ƒ–‹‘•ŠƒŽŽ‹ Ž—†‡ǣ

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 Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ‡•—”‡–Šƒ–‘—–’—–•–Šƒ–†‘‘– ‘ˆ‘”–‘”‡“—‹”‡‡–•ƒ”‡‹†‡–‹ˆ‹‡†ƒ†

T EE
‘–”‘ŽŽ‡†–‘’”‡˜‡––Š‡‹”—‹–‡†‡†—•‡‘”†‡Ž‹˜‡”›Ǥ

Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ–ƒ‡ƒ’’”‘’”‹ƒ–‡ƒ –‹‘„ƒ•‡†‘–Š‡ƒ–—”‡‘ˆ–Š‡‘ ‘ˆ‘”‹–›ƒ†‹–•‡ˆˆ‡ –‘–Š‡

‘ˆ‘”‹–›‘ˆ’”‘†— –•ƒ†•‡”˜‹ ‡•ǤŠ‹••ŠƒŽŽƒŽ•‘ƒ’’Ž›–‘‘ ‘ˆ‘”‹‰’”‘†— –•ƒ†•‡”˜‹ ‡•†‡–‡ –‡†
AF T
ƒˆ–‡”†‡Ž‹˜‡”›‘ˆ’”‘†— –•ǡ†—”‹‰‘”ƒˆ–‡”–Š‡’”‘˜‹•‹‘‘ˆ•‡”˜‹ ‡•Ǥ
R IT

2
Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ†‡ƒŽ™‹–Š‘ ‘ˆ‘”‹‰‘—–’—–•‹‘‡‘”‘”‡‘ˆ–Š‡ˆ‘ŽŽ‘™‹‰™ƒ›•ǣ
D M

ƒȌ ‘””‡ –‹‘Ǣ
M

„Ȍ •‡‰”‡‰ƒ–‹‘ǡ ‘–ƒ‹‡–ǡ”‡–—”‘”•—•’‡•‹‘‘ˆ’”‘˜‹•‹‘‘ˆ’”‘†— –•ƒ†•‡”˜‹ ‡•Ǣ

Ȍ ‹ˆ‘”‹‰–Š‡ —•–‘‡”Ǣ
O

†Ȍ ‘„–ƒ‹‹‰ƒ—–Š‘”‹œƒ–‹‘ˆ‘”ƒ ‡’–ƒ ‡—†‡” ‘ ‡••‹‘Ǥ

C

‘ˆ‘”‹–›–‘–Š‡”‡“—‹”‡‡–••ŠƒŽŽ„‡˜‡”‹ˆ‹‡†™Š‡‘ ‘ˆ‘”‹‰‘—–’—–•ƒ”‡ ‘””‡ –‡†Ǥ

8.7.2 ‘ —‡–‡†‹ˆ‘”ƒ–‹‘•ŠƒŽŽ„‡ƒ˜ƒ‹Žƒ„Ž‡ƒ•‡˜‹†‡ ‡–‘ǣ

ƒȌ †‡• ”‹„‡–Š‡‘ ‘ˆ‘”‹–›Ǣ

„Ȍ †‡• ”‹„‡–Š‡ƒ –‹‘•–ƒ‡Ǣ

Ȍ †‡• ”‹„‡ƒ› ‘ ‡••‹‘•‘„–ƒ‹‡†Ǣ

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

9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General

Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ†‡–‡”‹‡ǣ

ƒȌ ™Šƒ–‡‡†•–‘„‡‘‹–‘”‡†ƒ†‡ƒ•—”‡†Ǣ

̹ ʹͲʹͷȂŽŽ”‹‰Š–•”‡•‡”˜‡†
ʹʹ
 ISO/CD 9001.2:2025(en)

„Ȍ –Š‡‡–Š‘†•ˆ‘”‘‹–‘”‹‰ǡ‡ƒ•—”‡‡–ǡƒƒŽ›•‹•ƒ†‡˜ƒŽ—ƒ–‹‘ǡƒ•ƒ’’Ž‹ ƒ„Ž‡ǡ‡‡†‡†–‘‡•—”‡˜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

‘ —‡–‡†‹ˆ‘”ƒ–‹‘•ŠƒŽŽ„‡ƒ˜ƒ‹Žƒ„Ž‡ƒ•‡˜‹†‡ ‡‘ˆ–Š‡”‡•—Ž–•Ǥ

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

9.1.2 Customer satisfaction

Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ‘‹–‘”–Š‡ —•–‘‡”•ǯ•ƒ–‹•ˆƒ –‹‘ǡ™Š‹ Š‹•†‡–‡”‹‡†„›–Š‡ —•–‘‡”•ǯ’‡” ‡’–‹‘

‘ˆ–Š‡†‡‰”‡‡–‘™Š‹ Š–Š‡‹”‡‡†•ƒ†‡š’‡ –ƒ–‹‘•Šƒ˜‡„‡‡ˆ—Žˆ‹ŽŽ‡†ǤŠ‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ†‡–‡”‹‡–Š‡
‡–Š‘†•ˆ‘”‘„–ƒ‹‹‰ǡ‘‹–‘”‹‰ƒ†”‡˜‹‡™‹‰–Š‹•‹ˆ‘”ƒ–‹‘Ǥ

 ‘—” ‡• ‘ˆ ‹ˆ‘”ƒ–‹‘ –‘ •—’’‘”– —†‡”•–ƒ†‹‰ ‘ˆ —•–‘‡” •ƒ–‹•ˆƒ –‹‘ ƒ ‹ Ž—†‡ —•–‘‡” •—”˜‡›•ǡ
—•–‘‡”ˆ‡‡†„ƒ ‘†‡Ž‹˜‡”‡†’”‘†— –•ƒ†•‡”˜‹ ‡•ǡ‡‡–‹‰•™‹–Š —•–‘‡”•ǡƒ”‡–Ǧ•Šƒ”‡ƒƒŽ›•‹•ǡ ‘’Ž‹‡–•ǡ

T EE
™ƒ””ƒ–› Žƒ‹•ƒ††‡ƒŽ‡””‡’‘”–•ǡ ‘’Žƒ‹–•ƒ†•‘ ‹ƒŽ‡†‹ƒǤ

9.1.3 Analysis and evaluation

AF T
Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽƒƒŽ›•‡ƒ†‡˜ƒŽ—ƒ–‡ƒ’’”‘’”‹ƒ–‡†ƒ–ƒƒ†‹ˆ‘”ƒ–‹‘ƒ”‹•‹‰ˆ”‘‘‹–‘”‹‰ƒ†
‡ƒ•—”‡‡–Ǥ
R IT

2
Š‡”‡•—Ž–•‘ˆƒƒŽ›•‹••ŠƒŽŽ„‡—•‡†–‘‡˜ƒŽ—ƒ–‡ǣ
D M

ƒȌ ‘ˆ‘”‹–›‘ˆ’”‘†— –•ƒ†•‡”˜‹ ‡•Ǣ

M

„Ȍ –Š‡†‡‰”‡‡‘ˆ —•–‘‡”•ƒ–‹•ˆƒ –‹‘Ǣ

O

Ȍ –Š‡’‡”ˆ‘”ƒ ‡ƒ†‡ˆˆ‡ –‹˜‡‡••‘ˆ–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǣ

C

†Ȍ ‹ˆ’Žƒ‹‰Šƒ•„‡‡‹’Ž‡‡–‡†‡ˆˆ‡ –‹˜‡Ž›Ǣ

‡Ȍ –Š‡‡ˆˆ‡ –‹˜‡‡••‘ˆƒ –‹‘•–ƒ‡–‘ƒ††”‡••”‹••ƒ†‘’’‘”–—‹–‹‡•Ǣ

ˆȌ –Š‡’‡”ˆ‘”ƒ ‡‘ˆ‡š–‡”ƒŽ’”‘˜‹†‡”•Ǣ

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

 ‡–Š‘†•–‘ƒƒŽ›•‡†ƒ–ƒ ƒ‹ Ž—†‡•–ƒ–‹•–‹ ƒŽ–‡ Š‹“—‡•Ǥ

9.2 Internal audit

9.2.1 General

Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ ‘†— –‹–‡”ƒŽƒ—†‹–•ƒ–’Žƒ‡†‹–‡”˜ƒŽ•–‘’”‘˜‹†‡‹ˆ‘”ƒ–‹‘‘™Š‡–Š‡”–Š‡

“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡ǣ

ƒȌ ‘ˆ‘”•–‘ǣ

ͳǤ–Š‡‘”‰ƒ‹œƒ–‹‘ǯ•‘™”‡“—‹”‡‡–•ˆ‘”‹–•“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǣ

ʹǤ–Š‡”‡“—‹”‡‡–•‘ˆ–Š‹•†‘ —‡–Ǣ

̹ ʹͲʹͷȂŽŽ”‹‰Š–•”‡•‡”˜‡†
ʹ͵
 ISO/CD 9001.2:2025(en)

„Ȍ ‹•‡ˆˆ‡ –‹˜‡Ž›‹’Ž‡‡–‡†ƒ†ƒ‹–ƒ‹‡†Ǥ

9.2.2 Internal Audit Programme

Š‡ ‘”‰ƒ‹œƒ–‹‘ •ŠƒŽŽ ’Žƒǡ ‡•–ƒ„Ž‹•Šǡ ‹’Ž‡‡– ƒ† ƒ‹–ƒ‹ ȋƒȌ ƒ—†‹– ’”‘‰”ƒ‡ȋ•Ȍ ‹ Ž—†‹‰ –Š‡
ˆ”‡“—‡ ›ǡ‡–Š‘†•ǡ”‡•’‘•‹„‹Ž‹–‹‡•ǡ’Žƒ‹‰”‡“—‹”‡‡–•ƒ†”‡’‘”–‹‰Ǥ

Š‡ ‡•–ƒ„Ž‹•Š‹‰ –Š‡‹–‡”ƒŽ ƒ—†‹– ’”‘‰”ƒ‡ȋ•Ȍǡ –Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ ‘•‹†‡” –Š‡ ‹’‘”–ƒ ‡‘ˆ –Š‡
’”‘ ‡••‡• ‘ ‡”‡†ƒ†–Š‡”‡•—Ž–•‘ˆ’”‡˜‹‘—•ƒ—†‹–•Ǥ

Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽǣ

ƒȌ †‡ˆ‹‡–Š‡ƒ—†‹–‘„Œ‡ –‹˜‡•ǡ ”‹–‡”‹ƒƒ†• ‘’‡ˆ‘”‡ƒ Šƒ—†‹–Ǣ

„Ȍ •‡Ž‡ –ƒ—†‹–‘”•ƒ† ‘†— –ƒ—†‹–•–‘‡•—”‡‘„Œ‡ –‹˜‹–›ƒ†–Š‡‹’ƒ”–‹ƒŽ‹–›‘ˆ–Š‡ƒ—†‹–’”‘ ‡••Ǣ

Ȍ ‡•—”‡–Šƒ––Š‡”‡•—Ž–•‘ˆƒ—†‹–•ƒ”‡”‡’‘”–‡†–‘”‡Ž‡˜ƒ–ƒƒ‰‡”•Ǣ

†Ȍ –ƒ‡ƒ’’”‘’”‹ƒ–‡ ‘””‡ –‹‘ƒ† ‘””‡ –‹˜‡ƒ –‹‘•™‹–Š‘—–—†—‡†‡Žƒ›

T EE
‘ —‡–‡†‹ˆ‘”ƒ–‹‘•ŠƒŽŽ„‡ƒ˜ƒ‹Žƒ„Ž‡ƒ•‡˜‹†‡ ‡‘ˆ–Š‡‹’Ž‡‡–ƒ–‹‘‘ˆ–Š‡ƒ—†‹–’”‘‰”ƒ‡ȋ•Ȍƒ†
–Š‡ƒ—†‹–”‡•—Ž–•Ǥ
AF T
 ‡‡ ͳͻͲͳͳˆ‘”‰—‹†ƒ ‡Ǥ
R IT

9.3 Management review

2
D M

9.3.1 General

‘’ƒƒ‰‡‡–•ŠƒŽŽ”‡˜‹‡™–Š‡‘”‰ƒ‹œƒ–‹‘ǯ•“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡ǡƒ–’Žƒ‡†‹–‡”˜ƒŽ•ǡ–‘‡•—”‡
M

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

9.3.2 Management review inputs

C

Š‡ƒƒ‰‡‡–”‡˜‹‡™•ŠƒŽŽ‹ Ž—†‡ǣ

ƒȌ –Š‡•–ƒ–—•‘ˆƒ –‹‘•ˆ”‘’”‡˜‹‘—•ƒƒ‰‡‡–”‡˜‹‡™•Ǣ

„Ȍ Šƒ‰‡•‹‡š–‡”ƒŽƒ†‹–‡”ƒŽ‹••—‡•–Šƒ–ƒ”‡”‡Ž‡˜ƒ––‘–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǣ

Ȍ Šƒ‰‡• ‹ ‡‡†• ƒ† ‡š’‡ –ƒ–‹‘• ‘ˆ ‹–‡”‡•–‡† ’ƒ”–‹‡• –Šƒ– ƒ”‡ ”‡Ž‡˜ƒ– –‘ –Š‡ “—ƒŽ‹–› ƒƒ‰‡‡–
•›•–‡Ǣ

†Ȍ ‹ˆ‘”ƒ–‹‘‘–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–’‡”ˆ‘”ƒ ‡‹ Ž—†‹‰–”‡†•‹ǣ

Ȅ ‘ ‘ˆ‘”‹–‹‡•ƒ† ‘””‡ –‹˜‡ƒ –‹‘•Ǣ

Ȅ ‘‹–‘”‹‰ƒ†‡ƒ•—”‡‡–”‡•—Ž–•Ǣ

Ȅ ƒ—†‹–”‡•—Ž–•Ǣ

Ȅ —•–‘‡”•ƒ–‹•ˆƒ –‹‘ƒ†ˆ‡‡†„ƒ ˆ”‘”‡Ž‡˜ƒ–‹–‡”‡•–‡†’ƒ”–‹‡•Ǣ

Ȅ –Š‡‡š–‡––‘™Š‹ Š“—ƒŽ‹–›‘„Œ‡ –‹˜‡•Šƒ˜‡„‡‡‡–Ǣ

̹ ʹͲʹͷȂŽŽ”‹‰Š–•”‡•‡”˜‡†
ʹͶ
 ISO/CD 9001.2:2025(en)

Ȅ ’”‘ ‡••’‡”ˆ‘”ƒ ‡ƒ† ‘ˆ‘”‹–›‘ˆ’”‘†— –•ƒ†•‡”˜‹ ‡•Ǣ

Ȅ –Š‡’‡”ˆ‘”ƒ ‡‘ˆ‡š–‡”ƒŽ’”‘˜‹†‡”•Ǣ

‡Ȍ ‘’’‘”–—‹–‹‡•ˆ‘” ‘–‹—ƒŽ‹’”‘˜‡‡–Ǥ

ˆȌ –Š‡ƒ†‡“—ƒ ›‘ˆ”‡•‘—” ‡•Ǣ

‰Ȍ –Š‡‡ˆˆ‡ –‹˜‡‡••‘ˆƒ –‹‘•–ƒ‡–‘ƒ††”‡••”‹••ƒ†‘’’‘”–—‹–‹‡•ȋ•‡‡͸ǤͳȌǢ

9.3.3 Management review results

Š‡”‡•—Ž–•‘ˆ–Š‡ƒƒ‰‡‡–”‡˜‹‡™•ŠƒŽŽ‹ Ž—†‡†‡ ‹•‹‘•”‡Žƒ–‡†–‘ ‘–‹—ƒŽ‹’”‘˜‡‡–‘’’‘”–—‹–‹‡•

ƒ†ƒ›‡‡†ˆ‘” Šƒ‰‡•–‘–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǥ

‡ ‹•‹‘••ŠƒŽŽ‹ Ž—†‡

T EE
ƒȌ ‘’’‘”–—‹–‹‡•ˆ‘”‹’”‘˜‡‡–Ǣ

„Ȍ ƒ›‡‡†ˆ‘” Šƒ‰‡•–‘–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǣ
AF T
Ȍ ”‡•‘—” ‡‡‡†•Ǥ
R IT

2
‘ —‡–‡†‹ˆ‘”ƒ–‹‘•ŠƒŽŽ„‡ƒ˜ƒ‹Žƒ„Ž‡ƒ•‡˜‹†‡ ‡‘ˆ–Š‡”‡•—Ž–•‘ˆƒƒ‰‡‡–”‡˜‹‡™•Ǥ
D M


M

10 Improvement
O

10.1 Continual improvement

C

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

Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ ‘•‹†‡”–Š‡”‡•—Ž–•‘ˆƒƒŽ›•‹•ǡ‡˜ƒŽ—ƒ–‹‘‘ˆ‘‹–‘”‹‰ƒ†‡ƒ•—”‡‡–†ƒ–ƒǡƒ†
–Š‡”‡•—Ž–•‘ˆƒƒ‰‡‡–”‡˜‹‡™ǡ–‘†‡–‡”‹‡‹ˆ–Š‡”‡ƒ”‡‡‡†•‘”‘’’‘”–—‹–‹‡•–Šƒ–•ŠƒŽŽ„‡ƒ††”‡••‡†ƒ•
’ƒ”–‘ˆ ‘–‹—ƒŽ‹’”‘˜‡‡–Ǥ

 –‹‘••ŠƒŽŽ‹ Ž—†‡ǣ

ƒȌ ‹’”‘˜‹‰’”‘ ‡••‡•ǡ’”‘†— –•ƒ†•‡”˜‹ ‡•Ǣ

„Ȍ ƒ††”‡••‹‰ˆ—–—”‡‡‡†•ƒ†‡š’‡ –ƒ–‹‘•Ǣ

Ȍ ‘””‡ –‹‰ǡ’”‡˜‡–‹‰‘””‡†— ‹‰—†‡•‹”‡†‡ˆˆ‡ –•Ǥ

 ’”‘˜‡‡– ƒ„‡ƒ Š‹‡˜‡†–Š”‘—‰Š‹ ”‡‡–ƒŽƒ†„”‡ƒ–Š”‘—‰Š Šƒ‰‡ǡ‹‘˜ƒ–‹‘‘””‡Ǧ‘”‰ƒ‹œƒ–‹‘

‹‹–‹ƒ–‹˜‡•ǤŠ‡—•‡‘ˆ‡‡”‰‹‰–‡ Š‘Ž‘‰‹‡• ƒ•—’’‘”–‘‰‘‹‰‹’”‘˜‡‡–‘ˆ–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǥ

̹ ʹͲʹͷȂŽŽ”‹‰Š–•”‡•‡”˜‡†
ʹͷ
 ISO/CD 9001.2:2025(en)

10.2 Nonconformity and corrective action

10.2.1 When a nonconformity occurs, the organization shall:

ƒȌ ”‡ƒ ––‘–Š‡‘ ‘ˆ‘”‹–›ƒ†ǡƒ•ƒ’’Ž‹ ƒ„Ž‡ǣ

Ȅ –ƒ‡ƒ –‹‘–‘ ‘–”‘Žƒ† ‘””‡ –‹–Ǣ

Ȅ †‡ƒŽ™‹–Š–Š‡ ‘•‡“—‡ ‡•Ǣ

„Ȍ ‡˜ƒŽ—ƒ–‡–Š‡‡‡†ˆ‘”ƒ –‹‘–‘‡Ž‹‹ƒ–‡–Š‡ ƒ—•‡ȋ•Ȍ‘ˆ–Š‡‘ ‘ˆ‘”‹–›ǡ‹‘”†‡”–Šƒ–‹–†‘‡•‘–”‡ —”

‘”‘ —”‡Ž•‡™Š‡”‡ǡ„›ǣ

Ȅ ”‡˜‹‡™‹‰–Š‡‘ ‘ˆ‘”‹–›Ǣ

Ȅ †‡–‡”‹‹‰–Š‡ ƒ—•‡•‘ˆ–Š‡‘ ‘ˆ‘”‹–›Ǣ

T EE
Ȅ †‡–‡”‹‹‰‹ˆ•‹‹Žƒ”‘ ‘ˆ‘”‹–‹‡•‡š‹•–ǡ‘” ƒ’‘–‡–‹ƒŽŽ›‘ —”Ǣ

Ȍ ‹’Ž‡‡–ƒ›ƒ –‹‘‡‡†‡†Ǣ
AF T
†Ȍ ”‡˜‹‡™–Š‡‡ˆˆ‡ –‹˜‡‡••‘ˆƒ› ‘””‡ –‹˜‡ƒ –‹‘–ƒ‡Ǣ
R IT

2
‡Ȍ ƒ‡ Šƒ‰‡•–‘–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡ǡ‹ˆ‡ ‡••ƒ”›Ǣ
D M

ˆȌ —’†ƒ–‡”‹••ƒ†‘’’‘”–—‹–‹‡•†‡–‡”‹‡††—”‹‰’Žƒ‹‰ǡ‹ˆ‡ ‡••ƒ”›Ǥ
M

‘””‡ –‹˜‡ƒ –‹‘••ŠƒŽŽ„‡ƒ’’”‘’”‹ƒ–‡–‘–Š‡‡ˆˆ‡ –•‘ˆ–Š‡‘ ‘ˆ‘”‹–‹‡•‡ ‘—–‡”‡†Ǥ


O

10.2.2 Documented information shall be available as evidence of:

C

ƒȌ –Š‡ƒ–—”‡‘ˆ–Š‡‘ ‘ˆ‘”‹–‹‡•ƒ†ƒ›•—„•‡“—‡–ƒ –‹‘•–ƒ‡Ǣ

„Ȍ –Š‡”‡•—Ž–•‘ˆƒ› ‘””‡ –‹˜‡ƒ –‹‘Ǥ

̹ ʹͲʹͷȂŽŽ”‹‰Š–•”‡•‡”˜‡†
ʹ͸
 ISO/CD 9001.2:2025(en)

Annex A
ȋ‹ˆ‘”ƒ–‹˜‡Ȍ

Clarification of structure, terminology and clauses

A.1 General
Š‡‹ˆ‘”ƒ–‹‘‰‹˜‡‹–Š‹•ƒ‡š‹•‹–‡†‡†–‘’”‘˜‹†‡ Žƒ”‹ˆ‹ ƒ–‹‘ƒ†–‘’”‡˜‡–‹•—†‡”•–ƒ†‹‰‘ˆ
–Š‡”‡“—‹”‡‡–• ‘–ƒ‹‡†‹–Š‹•†‘ —‡–ǤŠ‹Ž‡–Š‹•‹ˆ‘”ƒ–‹‘ƒ††”‡••‡•ƒ†‹• ‘•‹•–‡–™‹–Š–Š‡•‡
”‡“—‹”‡‡–•ǡ‹–‹•‘–‹–‡†‡†–‘ƒ††–‘ǡ•—„–”ƒ –ˆ”‘ǡ‘”‹ƒ›™ƒ›‘†‹ˆ›–Š‡Ǥ

Š‡‡š’Žƒƒ–‘”›‹ˆ‘”ƒ–‹‘‹•‰‹˜‡‘Ž›‘ Žƒ—•‡•‡‡†‹‰ Žƒ”‹ˆ‹ ƒ–‹‘Ǥ ‘”‰—‹†ƒ ‡‘–Š‡ƒ’’Ž‹ ƒ–‹‘‘ˆ

ƒŽŽ Žƒ—•‡••‡‡ ͻͲͲʹǤ

Š‡”‡“—‹”‡‡–•‹–Š‹•†‘ —‡–ƒ”‡„‡––‡”˜‹‡™‡†ˆ”‘ƒ•›•–‡•’‡”•’‡ –‹˜‡ƒ†‘–‹‹•‘Žƒ–‹‘ǡ‹Ǥ‡Ǥ–Š‡”‡

ƒ„‡ƒ‹–‡””‡Žƒ–‹‘•Š‹’„‡–™‡‡–Š‡”‡“—‹”‡‡–•‹‘‡ Žƒ—•‡™‹–Š–Š‡”‡“—‹”‡‡–•‹‘–Š‡” Žƒ—•‡•Ǥ

T EE
A.2 Structure and terminology
AF T
Š‡ Žƒ—•‡•–”— –—”‡ȋ‹Ǥ‡Ǥ Žƒ—•‡•‡“—‡ ‡Ȍƒ†•‘‡‘ˆ–Š‡–‡”‹‘Ž‘‰›‘ˆ–Š‹•†‘ —‡–ǡ‹ ‘’ƒ”‹•‘™‹–Š
–Š‡ ’”‡˜‹‘—• ‡†‹–‹‘ ȋ  ͻͲͲͳǣʹͲͳͷȌǡ Šƒ˜‡ „‡‡ Šƒ‰‡† –‘ ‹’”‘˜‡ ƒŽ‹‰‡– ™‹–Š –Š‡ ƒ”‘‹œ‡†
R IT

2
–”— –—”‡ȋ Ȍˆ‘”ƒƒ‰‡‡–›•–‡–ƒ†ƒ”†•ȋȌǤ
D M

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

†‘ —‡–‡†‹ˆ‘”ƒ–‹‘‘ˆƒ‘”‰ƒ‹œƒ–‹‘̵•“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǥ
M

Š‡•–”— –—”‡‘ˆ Žƒ—•‡•‹•‹–‡†‡†–‘’”‘˜‹†‡ƒ ‘Š‡”‡–’”‡•‡–ƒ–‹‘‘ˆ”‡“—‹”‡‡–•ǡ”ƒ–Š‡”–Šƒƒ‘†‡Ž

ˆ‘” †‘ —‡–‹‰ ƒ ‘”‰ƒ‹œƒ–‹‘̵• ’‘Ž‹ ‹‡•ǡ ‘„Œ‡ –‹˜‡• ƒ† ’”‘ ‡••‡•Ǥ Š‡ •–”— –—”‡ ƒ† ‘–‡– ‘ˆ
O

†‘ —‡–‡†‹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‘”‘–Š‡”’—”’‘•‡•Ǥ
C

‘’”‡˜‡–‹•—†‡”•–ƒ†‹‰–Š‡ˆ‘ŽŽ‘™‹‰–‡”•ƒ”‡ Žƒ”‹ˆ‹‡†ǣ

ƒȌ Š‡™‘”†•Dzƒ’’”‘’”‹ƒ–‡dzƒ†Dzƒ’’Ž‹ ƒ„Ž‡dzƒ”‡‘–‹–‡” Šƒ‰‡ƒ„Ž‡ǤDz’’”‘’”‹ƒ–‡dz‡ƒ••—‹–ƒ„Ž‡ȋˆ‘”ǡ–‘Ȍ

ƒ†‹’Ž‹‡••‘‡†‡‰”‡‡‘ˆˆ”‡‡†‘ǡ™Š‹Ž‡Dzƒ’’Ž‹ ƒ„Ž‡dz‡ƒ•”‡Ž‡˜ƒ–‘”’‘••‹„Ž‡–‘ƒ’’Ž›ƒ†‹’Ž‹‡•
–Šƒ–‹ˆ‹– ƒ„‡†‘‡ǡ‹–‡‡†•–‘„‡†‘‡Ǥ

„Ȍ Š‡™‘”†Dz ‘•‹†‡”dz‡ƒ•‹–‹•‡ ‡••ƒ”›–‘–Š‹ƒ„‘—––Š‡–‘’‹ ǡ„—–‹– ƒ„‡‡š Ž—†‡†Ǣ™Š‡”‡ƒ•Dz–ƒ‡

‹–‘ƒ ‘—–dz‡ƒ•‹–‹•‡ ‡••ƒ”›–‘–Š‹ƒ„‘—––Š‡–‘’‹ ǡ„—–‹– ƒ‘–„‡‡š Ž—†‡†Ǥ

Ȍ Dz‘–‹—ƒŽdz‹†‹ ƒ–‡•†—”ƒ–‹‘–Šƒ–‘ —”•‘˜‡”ƒ’‡”‹‘†‘ˆ–‹‡ǡ„—–™‹–Š‹–‡”˜ƒŽ•‘ˆ‹–‡””—’–‹‘ȋ—Ž‹‡

Dz ‘–‹—‘—•dz ™Š‹ Š ‹†‹ ƒ–‡• †—”ƒ–‹‘ ™‹–Š‘—– ‹–‡””—’–‹‘ȌǤ Dz‘–‹—ƒŽdz ‹• –Š‡”‡ˆ‘”‡ –Š‡ ƒ’’”‘’”‹ƒ–‡
™‘”†–‘—•‡™Š‡”‡ˆ‡””‹‰–‘‹’”‘˜‡‡–Ǥ

†Ȍ Š‡™‘”†Dz‡•—”‡dz‡ƒ•–Š‡”‡•’‘•‹„‹Ž‹–› ƒ„‡†‡Ž‡‰ƒ–‡†ǡ„—–‘––Š‡ƒ ‘—–ƒ„‹Ž‹–›Ǥ

‡Ȍ ‘ƒŽ‹‰–Š‡‡ƒ‹‰‘ˆDz†‘ —‡–‡†‹ˆ‘”ƒ–‹‘dz–‘–Š‡ ƒ”‘‹œ‡†–”— –—”‡ǡ–™‘ Šƒ‰‡•Šƒ˜‡„‡‡

ƒ†‡Ǥ ‹”•–ǡ–Š‡’Š”ƒ•‡Dz•ŠƒŽŽ„‡ƒ˜ƒ‹Žƒ„Ž‡ƒ•†‘ —‡–‡†‹ˆ‘”ƒ–‹‘dz”‡’Žƒ ‡•Dzƒ‹–ƒ‹†‘ —‡–‡†
‹ˆ‘”ƒ–‹‘dz ™Š‹ Š ’”‡˜‹‘—•Ž› ”‡ˆ‡””‡† –‘ †‘ —‡–ƒ–‹‘ ‘–Š‡” –Šƒ ”‡ ‘”†•Ǥ ‡ ‘†ǡ Dz†‘ —‡–‡†
‹ˆ‘”ƒ–‹‘•ŠƒŽŽ„‡ƒ˜ƒ‹Žƒ„Ž‡ƒ•‡˜‹†‡ ‡‘ˆdz”‡’Žƒ ‡•Dz”‡–ƒ‹†‘ —‡–‡†‹ˆ‘”ƒ–‹‘ƒ•‡˜‹†‡ ‡‘ˆdz
™Š‹ Š ’”‡˜‹‘—•Ž› ”‡ˆ‡””‡† –‘ ”‡ ‘”†•Ǥ – ‹• ™‘”–Š ‘–‹‰ –Šƒ– –Š‡ ’Š”ƒ•‡dz ƒ• ‡˜‹†‡ ‡ ‘ˆdz ‹• ‘– ƒ
”‡“—‹”‡‡––‘‡‡–Ž‡‰ƒŽ‡˜‹†‡–‹ƒŽ”‡“—‹”‡‡–•Ǣ‹–•‹–‡–‹•‘Ž›–‘‹†‹ ƒ–‡‘„Œ‡ –‹˜‡‡˜‹†‡ ‡‡‡†•

̹ ʹͲʹͷȂŽŽ”‹‰Š–•”‡•‡”˜‡†
ʹ͹
 ISO/CD 9001.2:2025(en)

–‘„‡”‡–ƒ‹‡†Ǥ –Š‡ ‘–‡š–‘ˆ†‘ —‡–‡†‹ˆ‘”ƒ–‹‘ǡ–Š‡–‡”Dzƒ˜ƒ‹Žƒ„Ž‡dz‡ƒ•–Š‡‘”‰ƒ‹œƒ–‹‘ ƒ

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

 ‘”†‘ —‡–‡†‹ˆ‘”ƒ–‹‘•‡‡ ͳͲͲͳ͵Ǥ

A.3 Applicability
Š‡”‡“—‹”‡‡–•‘ˆ–Š‹••–ƒ†ƒ”†ˆ‘”ƒ’’Ž‹ ƒ„‹Ž‹–›ƒ”‡ƒ††”‡••‡†‹ͶǤ͵ǡ™Š‹ Š†‡ˆ‹‡• ‘†‹–‹‘•—†‡”™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.4 Context of the organization

A.4.1 Understanding the organization and its context

ƒ˜‹‰ ƒ ˆ—ŽŽ —†‡”•–ƒ†‹‰ ‘ˆ –Š‡ ‹–‡”ƒŽ ƒ† ‡š–‡”ƒŽ ‹••—‡• ƒ† –Š‡ ”‡Ž‡˜ƒ– ”‡“—‹”‡‡–• ‘ˆ ”‡Ž‡˜ƒ–

T EE
‹–‡”‡•–‡† ’ƒ”–‹‡• ‡ƒ„Ž‡• ƒ ‘”‰ƒ‹œƒ–‹‘ –‘ †‡ˆ‹‡ –Š‡ • ‘’‡ ‘ˆ ‹–• “—ƒŽ‹–› ƒƒ‰‡‡– •›•–‡ ƒ†
†‡–‡”‹‡ –Š‡ ’”‘ ‡••‡• ‡‡†‡† –‘ ‡•—”‡ –Šƒ– –Š‡ ‘”‰ƒ‹œƒ–‹‘ ˆ—Žˆ‹Ž• ‹–• ’—”’‘•‡ǡ ˆ‘ŽŽ‘™• ‹–• •–”ƒ–‡‰‹ 
†‹”‡ –‹‘ƒ†ƒ Š‹‡˜‡•‹–•‹–‡†‡†”‡•—Ž–•Ǥ
AF T
š–‡”ƒŽƒ†‹–‡”ƒŽ‹••—‡•”‡Ž‡˜ƒ––‘–Š‡‘”‰ƒ‹œƒ–‹‘ǯ•’—”’‘•‡ƒ†•–”ƒ–‡‰‹ †‹”‡ –‹‘ ƒƒˆˆ‡ –’‘•‹–‹˜‡Ž›
R IT

2
‘”‡‰ƒ–‹˜‡Ž›–Š‡‘”‰ƒ‹œƒ–‹‘ǯ•ƒ„‹Ž‹–›–‘ƒ Š‹‡˜‡–Š‡‹–‡†‡†”‡•—Ž–•‘ˆ‹–•“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡ǡƒ†
‹–‹•”‡ ‘‡†‡†–‘‘‹–‘”ƒ†”‡˜‹‡™–Š‡ Šƒ‰‡•‹–Š‡‡š–‡”ƒŽƒ†‹–‡”ƒŽ‹••—‡•Ǥ
D M

 ‘”†‡” –‘ †‡–‡”‹‡ ™Š‡–Š‡” Ž‹ƒ–‡ Šƒ‰‡ ‹• ƒ ”‡Ž‡˜ƒ– ‹••—‡ǡ ‹– ƒ „‡ ‘•‹†‡”‡† ‹ ”‡Žƒ–‹‘ –‘ –Š‡
’‘–‡–‹ƒŽ‹’ƒ –‘–Š‡‹–‡†‡†”‡•—Ž–•‘ˆ–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡ǡ‡Ǥ‰Ǥ–Š‡‹’ƒ –‘–Š‡ƒ„‹Ž‹–›‘ˆ
M

–Š‡‘”‰ƒ‹œƒ–‹‘–‘ ‘•‹•–‡–Ž›’”‘˜‹†‡’”‘†— –•ƒ†•‡”˜‹ ‡•–Šƒ–‡‡– —•–‘‡”ƒ†ƒ’’Ž‹ ƒ„Ž‡•–ƒ–—–‘”›

ƒ†”‡‰—Žƒ–‘”›”‡“—‹”‡‡–•ƒ†–Š‡‡Šƒ ‡‡–‘ˆ —•–‘‡”•ƒ–‹•ˆƒ –‹‘ǤŠ‡‘”‰ƒ‹œƒ–‹‘ƒ›†‡–‡”‹‡
O

‹–‹•‡‹–Š‡””‡Ž‡˜ƒ–‘”‘–”‡Ž‡˜ƒ–Ǥ –‹•‘–”‡“—‹”‡†ˆ‘”ƒ‘”‰ƒ‹œƒ–‹‘–‘Šƒ˜‡ Ž‹ƒ–‡ Šƒ‰‡‹‹–‹ƒ–‹˜‡•

—Ž‡••‹–Šƒ•†‡–‡”‹‡†‹–ƒ•ƒ”‡Ž‡˜ƒ–‹••—‡™‹–Š‹–Š‡ ‘–‡š–‘ˆ–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǥ
C

š–‡”ƒŽƒ†‹–‡”ƒŽ‹••—‡•ƒ›„‡†‡–‡”‹‡†„ƒ•‡†‘‹ˆ‘”ƒ–‹‘ˆ”‘†‹ˆˆ‡”‡–•‘—” ‡••— Šƒ•‹–‡”ƒŽ

†‘ —‡–‡† ‹ˆ‘”ƒ–‹‘ ƒ† ‡‡–‹‰•ǡ ’—„Ž‹ ƒ–‹‘• ˆ”‘ ƒ–‹‘ƒŽ •–ƒ–‹•–‹ • ‘ˆˆ‹ ‡• ƒ† ‘–Š‡” ‰‘˜‡”‡–
†‡’ƒ”–‡–•ǡ ’”‘ˆ‡••‹‘ƒŽ ƒ† –‡ Š‹ ƒŽ ’—„Ž‹ ƒ–‹‘•ǡ ‡‡–‹‰• ™‹–Š —•–‘‡”• ƒ† ”‡Ž‡˜ƒ– ‹–‡”‡•–‡†
’ƒ”–‹‡•Ǥ‡–‡”‹‹‰–Š‡‡š–‡”ƒŽƒ†‹–‡”ƒŽ‹••—‡•–Šƒ–ƒ”‹•‡ˆ”‘‡‡”‰‹‰–‡ Š‘Ž‘‰‹‡•‹•˜‡”›‹’‘”–ƒ–
ˆ‘”—†‡”•–ƒ†‹‰–Š‡ ‘–‡š–‘ˆ–Š‡‘”‰ƒ‹œƒ–‹‘Ǥ

A.4.2 Understanding the needs and expectations of interested parties

‡Ž‡˜ƒ– ”‡“—‹”‡‡–•‘ˆ ”‡Ž‡˜ƒ– ‹–‡”‡•–‡† ’ƒ”–‹‡• ƒ Šƒ˜‡ ƒ ‡ˆˆ‡ –‘” ’‘–‡–‹ƒŽ ‡ˆˆ‡ – ‘ ‹–• ƒ„‹Ž‹–› –‘
’”‘˜‹†‡’”‘†— –•ƒ†•‡”˜‹ ‡•–Šƒ–‡‡– —•–‘‡”ƒ†ƒ’’Ž‹ ƒ„Ž‡•–ƒ–—–‘”›ƒ†”‡‰—Žƒ–‘”›”‡“—‹”‡‡–•Ǥ

–‹•‹’‘”–ƒ––Šƒ–‹ˆ‘”ƒ–‹‘ƒ„‘—––Š‡•‡‹–‡”‡•–‡†’ƒ”–‹‡•ƒ†–Š‡‹””‡Ž‡˜ƒ–”‡“—‹”‡‡–•ƒ”‡‘‹–‘”‡†
ƒ† ”‡˜‹‡™‡† –‘ ƒ‹–ƒ‹ ƒ™ƒ”‡‡•• ‘ˆ ƒ› Šƒ‰‡• –Šƒ– ƒ› ‹’ƒ – –Š‡ ‡ˆˆ‡ –‹˜‡‡•• ‘ˆ –Š‡ “—ƒŽ‹–›
ƒƒ‰‡‡–•›•–‡Ǥ

—•–‘‡”• ƒ”‡ –Š‡ ƒ‹ ȋ„—– ‘– –Š‡ ‘Ž›Ȍ ‹–‡”‡•–‡† ’ƒ”–› ˆ‘” –Š‡ “—ƒŽ‹–› ƒƒ‰‡‡– •›•–‡Ǥ ‘– ƒŽŽ
‹–‡”‡•–‡†’ƒ”–›”‡“—‹”‡‡–•‡ ‡••ƒ”‹Ž›„‡ ‘‡”‡“—‹”‡‡–•ˆ‘”–Š‡‘”‰ƒ‹œƒ–‹‘‹ˆ–Š‡›ƒ”‡‘–ƒ’’Ž‹ ƒ„Ž‡
–‘–Š‡‘”‰ƒ‹œƒ–‹‘‘””‡Ž‡˜ƒ––‘–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡Ǥ–Š‡”•ƒ”‡Dzƒ†ƒ–‘”›dz„‡ ƒ—•‡–Š‡›Šƒ˜‡
„‡‡‹ ‘”’‘”ƒ–‡†‹–‘Žƒ™•ǡ”‡‰—Žƒ–‹‘•ǡ’‡”‹–•ƒ†Ž‹ ‡•‡•ǡ„›‰‘˜‡”‡–ƒŽ‘” ‘—”–ƒ –‹‘ǡ‘”„‡ ƒ—•‡

̹ ʹͲʹͷȂŽŽ”‹‰Š–•”‡•‡”˜‡†
ʹͺ
 ISO/CD 9001.2:2025(en)

–Š‡›Šƒ˜‡„‡‡•’‡ ‹ˆ‹‡†„›ƒŠ‹‰Š‡”Ž‡˜‡Ž‘ˆ–Š‡ ‘”’‘”ƒ–‡‡–‹–›–‘™Š‹ Š–Š‡‘”‰ƒ‹œƒ–‹‘„‡Ž‘‰•ǤŠ‡”‡ ƒ

„‡‘–Š‡”•–Šƒ–ƒ‘”‰ƒ‹œƒ–‹‘ƒ›†‡ ‹†‡–‘ƒ†‘’–˜‘Ž—–ƒ”‹Ž›‘”„›‡–‡”‹‰‹–‘ƒƒ‰”‡‡‡–‘” ‘–”ƒ –Ǥ
 ‡ƒ†‘’–‡†‘”ƒ‰”‡‡†–‘ǡ–Š‡•‡„‡ ‘‡”‡“—‹”‡‡–•ˆ‘”–Š‡‘”‰ƒ‹œƒ–‹‘ȋ•‡‡ͶǤ͵ȌǤ

‘–‡‹ Žƒ—•‡ͶǤʹ”‡‹†•‘”‰ƒ‹œƒ–‹‘•–Šƒ–”‡Ž‡˜ƒ–‹–‡”‡•–‡†’ƒ”–‹‡• ƒŠƒ˜‡”‡“—‹”‡‡–•”‡Žƒ–‡†–‘

Ž‹ƒ–‡ Šƒ‰‡Ǥ

A.4.3 Determining the scope of the quality management system

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

ƒ†•‡”˜‹ ‡•†‡Ž‹˜‡”‡†ƒ† ‘˜‡”‡†„›–Š‡“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡ƒ†‹–•„‘—†ƒ”‹‡•Ǥ ‘”†‡”–‘ƒ˜‘‹†
‘ˆ—•‹‘ƒ†–‘‡ƒ„Ž‡ Ž‡ƒ”‹†‡–‹ˆ‹ ƒ–‹‘ǡ–Š‡• ‘’‡ ƒ†‡ˆ‹‡ǡ–Š‡–›’‡•‘ˆƒ –‹˜‹–‹‡•ǡ’”‘†— –•ƒ†•‡”˜‹ ‡•
‘˜‡”‡†Ǣ”‡Žƒ–‡†•‹–‡•™Š‡”‡–Š‡•‡ƒ –‹˜‹–‹‡•ƒ”‡’‡”ˆ‘”‡†ƒ†•’‡ ‹ˆ‹ • ‘’‡•ǡ‹ˆ”‡Ž‡˜ƒ–Ǥ‘Ǧ‹•Ž‡ƒ†‹‰
ƒ† Ž‡ƒ”• ‘’‡”‡‹ˆ‘” ‡•‹–‡‰”‹–›ƒ†‡–Š‹ •‘ˆ–Š‡‘”‰ƒ‹œƒ–‹‘Ǥ

A.4.4 Quality management system

T EE
Š‡”‡‹•‘”‡“—‹”‡‡–‹–Š‹• –‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†ˆ‘”‹–••–”— –—”‡ƒ†–‡”‹‘Ž‘‰›–‘„‡ƒ’’Ž‹‡†–‘ƒ
‘”‰ƒ‹œƒ–‹‘̵•“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡‘”†‘ —‡–ƒ–‹‘Ǥ
AF T
– ‹• ‹’‘”–ƒ– –‘ ‡•–ƒ„Ž‹•Šǡ ‹’Ž‡‡–ǡ ƒ‹–ƒ‹ ƒ† ‘–‹—ƒŽŽ› ‹’”‘˜‡ –Š‡ •–”— –—”‡ ƒ† ‘–‡– ‘ˆ ƒ
‘”‰ƒ‹œƒ–‹‘ǯ•“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡—•‹‰–Š‡’”‘ ‡••ƒ’’”‘ƒ Š•‘–Šƒ–‹– ‘•‹•–•‘ˆƒŽŽ–Š‡’”‘ ‡••‡•
R IT

‡‡†‡†ƒ†‹•”‡Ž‡˜ƒ––‘‹–•—•‡”•Ǥ
2
ŽŽ’”‘ ‡••‡•‹–‡”ƒ –ƒ†‹–‡””‡Žƒ–‡–‘ ”‡ƒ–‡ƒƒŽ‹‰‡†“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡–Š‡”‡ˆ‘”‡‹–‹•‹’‘”–ƒ–
D M

–‘†‡–‡”‹‡–Š‡•‡“—‡ ‡ǡ‹–‡”ƒ –‹‘ƒ†‹–‡‰”ƒ–‹‘‘ˆ“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡’”‘ ‡••‡•™‹–Š‡ƒ Š

‘–Š‡”ƒ†™‹–Š‘–Š‡”„—•‹‡••’”‘ ‡••‡•Ǥ –‹•‹’‘”–ƒ––‘†‡ˆ‹‡–Š‡‹’—–•”‡“—‹”‡†ƒ†–Š‡‹–‡†‡†”‡•—Ž–•
M

‘ˆ‡ƒ Š’”‘ ‡••ƒ†–‘ƒ••‹‰–Š‡”‡•’‘•‹„‹Ž‹–‹‡•ƒ†ƒ—–Š‘”‹–‹‡•ˆ‘”ƒŽŽ’”‘ ‡••‡•Ǥ

O

A.5 ‡ƒ†‡”•Š‹’
C

A.5.1 ‡ƒ†‡”•Š‹’ƒ† ‘‹–‡–

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

“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡ƒ†–Š‡Ž‡ƒ†‡”•Š‹’ ‘‹–‡––‘„—‹Ž†‹‰–”—•–‹–Š‡‘”‰ƒ‹œƒ–‹‘•ƒ„‹Ž‹–›–‘
†‡‘•–”ƒ–‡‹–•ƒ„‹Ž‹–›–‘ǣ

ƒȌ ’”‘˜‹†‡’”‘†— –•ƒ†•‡”˜‹ ‡•–Šƒ–‡‡– —•–‘‡”ƒ†ƒ’’Ž‹ ƒ„Ž‡•–ƒ–—–‘”›ƒ†”‡‰—Žƒ–‘”›”‡“—‹”‡‡–•ǡ

„Ȍ ‡Šƒ ‡ —•–‘‡”•ƒ–‹•ˆƒ –‹‘ǡ

Ȍ ’”‘–‡ –ƒ†‹’”‘˜‡‹–•”‡’—–ƒ–‹‘Ǥ

ˆ †‡ ‹•‹‘•ǡ ƒ –‹‘• ƒ† ‹–‡”ƒ –‹‘• ™‹–Š ‡’Ž‘›‡‡•ǡ ‡š–‡”ƒŽ ’”‘˜‹†‡”•ǡ —•–‘‡”• ƒ† ‘–Š‡” ‹–‡”‡•–‡†
’ƒ”–‹‡•ƒ”‡‘–‰—‹†‡†„›‡–Š‹ ƒŽ„‡Šƒ˜‹‘—”ǡƒŽŽƒ•’‡ –•‘ˆ“—ƒŽ‹–› ƒ„‡—†‡”‹‡†Ǥ

 ‡‡ ͳͲͲͳͲˆ‘”ˆ—”–Š‡”‰—‹†ƒ ‡‘—ƒŽ‹–› —Ž–—”‡Ǥ

A.5.2 —ƒŽ‹–›’‘Ž‹ ›

Š‡ “—ƒŽ‹–› ’‘Ž‹ › ”‡ˆŽ‡ –• –Š‡ ‘”‰ƒ‹œƒ–‹‘̵• “—ƒŽ‹–› —Ž–—”‡ ƒ† ‡š’‡ –ƒ–‹‘• ˆ‘” ‡–Š‹ ƒŽ „‡Šƒ˜‹‘—” ƒ† ‹•
‘—‹ ƒ–‡†–‘”‡Ž‡˜ƒ–‹–‡”‡•–‡†’ƒ”–‹‡•Ǥƒ›•–‘ ‘—‹ ƒ–‡–Š‡’‘Ž‹ › ƒ‹ Ž—†‡–”ƒ‹‹‰ǡ•‹‰ƒ‰‡ǡ
‘–”ƒ –•ǡ‡‡–‹‰•ǡƒ†‘–Š‡””‡’‘”–‹‰ Šƒ‡Ž•Ǥ

̹ ʹͲʹͷȂŽŽ”‹‰Š–•”‡•‡”˜‡†
ʹͻ
 ISO/CD 9001.2:2025(en)

A.5.3 ‘Ž‡•ǡ”‡•’‘•‹„‹Ž‹–‹‡•ƒ†ƒ—–Š‘”‹–‹‡•

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

A.6 Planning
A.6.1  –‹‘•–‘ƒ††”‡••”‹••ƒ†‘’’‘”–—‹–‹‡•

A.6.1.1 General

‘†‡–‡”‹‡ƒ†ƒ††”‡••–Š‡”‹••ƒ†–Š‡‘’’‘”–—‹–‹‡•–Š‡‘”‰ƒ‹œƒ–‹‘ ƒ‹’Ž‡‡––Š‡ ‘ ‡’–•‘ˆ

”‹•Ǧ„ƒ•‡†–Š‹‹‰ƒ†‘’’‘”–—‹–›Ǧ„ƒ•‡†–Š‹‹‰–‘‡Šƒ ‡‹–•ƒ„‹Ž‹–›–‘‡‡––Š‡‘„Œ‡ –‹˜‡•‘ˆ‹–•“—ƒŽ‹–›
ƒƒ‰‡‡– •›•–‡ ƒ• •—ƒ”‹œ‡† ‹ –Š‡ • ‘’‡ ‘ˆ –Š‹• –‡”ƒ–‹‘ƒŽ –ƒ†ƒ”†Ǥ Š‡•‡ –™‘ ‘ ‡’–• ƒ”‡
‡š’Žƒ‹‡†‹–Š‡ˆ‘ŽŽ‘™‹‰–™‘’ƒ”ƒ‰”ƒ’Š•Ǥ

A.6.1.2 ‹•Ǧ„ƒ•‡†–Š‹‹‰

T EE
Š‡ ‘ ‡’–‘ˆ”‹•Ǧ„ƒ•‡†–Š‹‹‰Šƒ•„‡‡‹’Ž‹ ‹–‹’”‡˜‹‘—•‡†‹–‹‘•‘ˆ–Š‹• –‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†ǡ‡Ǥ‰Ǥ
–Š”‘—‰Š ”‡“—‹”‡‡–• ˆ‘” ’Žƒ‹‰ǡ ”‡˜‹‡™ ƒ† ‹’”‘˜‡‡– ƒ† “—ƒŽ‹–› •’‡ ‹ˆ‹  ”‡“—‹”‡‡–• –Šƒ–
Š‹•–‘”‹ ƒŽŽ›Šƒ˜‡„‡‡†‡•‹‰‡†–‘’”‡˜‡––Š‡†‡Ž‹˜‡”›‘ˆ‘ ‘ˆ‘”‹‰’”‘†— –•–‘‹–• Ž‹‡–•Ǥ
AF T
Š‹• –‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†•’‡ ‹ˆ‹‡•”‡“—‹”‡‡–•ˆ‘”–Š‡‘”‰ƒ‹œƒ–‹‘–‘—†‡”•–ƒ†‹–• ‘–‡š–ȋ•‡‡ ͶǤͳȌ
R IT

ƒ††‡–‡”‹‡”‹••ƒ•ƒ„ƒ•‹•ˆ‘”’Žƒ‹‰ȋ•‡‡͸ǤͳȌǤŠ‹•”‡’”‡•‡–•–Š‡ƒ’’Ž‹ ƒ–‹‘‘ˆ”‹•Ǧ„ƒ•‡†–Š‹‹‰–‘
2
’Žƒ‹‰ƒ†‹’Ž‡‡–‹‰“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡’”‘ ‡••‡•ȋ•‡‡ͶǤͶȌƒ†™‹ŽŽƒ••‹•–‹†‡–‡”‹‹‰–Š‡
D M

‡š–‡–‘ˆ†‘ —‡–‡†‹ˆ‘”ƒ–‹‘Ǥ

‡‘ˆ–Š‡‡›’—”’‘•‡•‘ˆƒ“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡‹•–‘ƒ –ƒ•ƒ’”‡˜‡–‹˜‡–‘‘ŽǤ‘•‡“—‡–Ž›ǡ–Š‹•
M

–‡”ƒ–‹‘ƒŽ –ƒ†ƒ”† †‘‡• ‘– Šƒ˜‡ ƒ •‡’ƒ”ƒ–‡ Žƒ—•‡ ‘” •—„ Žƒ—•‡ ‘ ’”‡˜‡–‹˜‡ ƒ –‹‘Ǥ Š‡ ‘ ‡’– ‘ˆ
’”‡˜‡–‹˜‡ƒ –‹‘‹•‡š’”‡••‡†–Š”‘—‰Š–Š‡—•‡‘ˆ”‹•Ǧ„ƒ•‡†–Š‹‹‰‹‹’Ž‡‡–‹‰“—ƒŽ‹–›ƒƒ‰‡‡–
O

•›•–‡”‡“—‹”‡‡–•Ǥ
C

‘– ƒŽŽ –Š‡ ’”‘ ‡••‡• ‘ˆ ƒ “—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
‘”‰ƒ‹œƒ–‹‘•Ǥ

†‡”–Š‡”‡“—‹”‡‡–•‘ˆ͸Ǥͳǡ–Š‡‘”‰ƒ‹œƒ–‹‘‹•”‡•’‘•‹„Ž‡ˆ‘”–Š‡ƒ’’Ž‹ ƒ–‹‘‘ˆ”‹•Ǧ„ƒ•‡†–Š‹‹‰ƒ†
–Š‡ƒ –‹‘•‹––ƒ‡•–‘ƒ††”‡••”‹••ǡ™Š‹ Š™‹ŽŽ†‡–‡”‹‡‹–•’”‘ ‡••‡•ƒ†–Š‡†‹ˆˆ‡”‡–Ž‡˜‡Ž•‘ˆ ‘–”‘Ž–Šƒ–
ƒ”‡ƒ’’Ž‹‡†Ǥ

Ž–Š‘—‰Š͸Ǥͳ•’‡ ‹ˆ‹‡•–Šƒ––Š‡‘”‰ƒ‹œƒ–‹‘•ŠƒŽŽ’Žƒƒ –‹‘•–‘ƒ††”‡••”‹••ǡ–Š‡”‡‹•‘”‡“—‹”‡‡–ˆ‘”

ˆ‘”ƒŽ‡–Š‘†•ˆ‘””‹•ƒƒ‰‡‡–‘”ƒ†‘ —‡–‡†”‹•ƒƒ‰‡‡–’”‘ ‡••Ǥ”‰ƒ‹œƒ–‹‘• ƒ†‡ ‹†‡
™Š‡–Š‡” ‘” ‘– –‘ †‡˜‡Ž‘’ ƒ ‘”‡ ‡š–‡•‹˜‡ ”‹• ƒƒ‰‡‡– ‡–Š‘†‘Ž‘‰› –Šƒ ‹• ”‡“—‹”‡† „› –Š‹•
–‡”ƒ–‹‘ƒŽ–ƒ†ƒ”†ǡ‡Ǥ‰Ǥ–Š”‘—‰Š–Š‡ƒ’’Ž‹ ƒ–‹‘‘ˆ‘–Š‡”‰—‹†ƒ ‡‘”•–ƒ†ƒ”†•Ǥ

 ‡‡ ͵ͳͲͲͲˆ‘”ˆ—”–Š‡”‰—‹†ƒ ‡‘”‹•ƒƒ‰‡‡–Ǥ

A.6.1.3 ’’‘”–—‹–›„ƒ•‡†–Š‹‹‰

†‡–‹ˆ›‹‰ ƒ† ƒƒ‰‹‰ ”‹•• ƒ† ‘’’‘”–—‹–‹‡• ƒ”‡ •‡’ƒ”ƒ–‡ ’”‘ ‡••‡•Ǥ ‹•• ƒ”‡ ‘– ‘’’‘”–—‹–‹‡•Ǥ
’’‘”–—‹–‹‡•”‡•—Ž–ˆ”‘ƒ••‡••‡–‘ˆ–Š‡‹–‡”ƒŽƒ†‡š–‡”ƒŽ ‘–‡š–‹ Ž—†‹‰‹–‡”‡•–‡†’ƒ”–‹‡•ǯ‡‡†•
ƒ† ‡š’‡ –ƒ–‹‘•ǡ –Š‡ ‘”‰ƒ‹œƒ–‹‘ǯ• ƒ’ƒ„‹Ž‹–›ǡ ƒ’ƒ ‹–› ƒ† ‘’‡–‡ ‡ –‘ Ž‡˜‡”ƒ‰‡ ‹–• •–”‡‰–Š• ƒ†
™‡ƒ‡••‡•ǡƒ•™‡ŽŽƒ•–Š‡”‡•—Ž–•‘ˆ˜ƒ”‹‘—•‘‹–‘”‹‰ƒ –‹˜‹–‹‡•ƒ†‡›’‡”ˆ‘”ƒ ‡‹†‹ ƒ–‘”•Ǥ

̹ ʹͲʹͷȂŽŽ”‹‰Š–•”‡•‡”˜‡†
͵Ͳ
 ISO/CD 9001.2:2025(en)

••‡–‹ƒŽŽ› ‘’’‘”–—‹–‹‡• ƒ ‘‡ ˆ”‘ ƒ› •‘—” ‡•Ǥ • •— Š ‹– ‹• ”‹–‹ ƒŽ –‘ Ž‡ƒ”Ž› ‹†‡–‹ˆ› –Š‡
‘’’‘”–—‹–‹‡•ǡ‹†‡–‹ˆ›–Š‡‡‡†•ƒ†‘„Œ‡ –‹˜‡•ǡ‹†‡–‹ˆ›–Š‡”‹•ƒ••‘ ‹ƒ–‡†™‹–Š–Š‡‘’’‘”–—‹–›‹–•‡Žˆƒ†
ˆ‘”—Žƒ–‡ƒ•–”ƒ–‡‰›ƒ†’Žƒ–‘•—’’‘”––Š‡ƒ Š‹‡˜‡‡–‘ˆ†‡•‹”‡†”‡•—Ž–•Ǥ

‘”‡šƒ’Ž‡ǡ ‹” —•–ƒ ‡•ƒ”‹•‡–Šƒ–ƒŽŽ‘™–Š‡‘”‰ƒ‹œƒ–‹‘–‘ƒ––”ƒ – —•–‘‡”•ǡ†‡˜‡Ž‘’‡™’”‘†— –•ƒ†

•‡”˜‹ ‡•ǡ‘”‹’”‘˜‡’”‘†— –‹˜‹–›Ǥ

A.6.2 —ƒŽ‹–›‘„Œ‡ –‹˜‡•ƒ†’Žƒ‹‰–‘ƒ Š‹‡˜‡–Š‡

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

 ‘™–‘’”‡’ƒ”‡ƒ“—ƒŽ‹–›’Žƒ‹•‡š’Žƒ‹‡†‹ ͳͲͲͲͷǤ

A.6.3 Žƒ‹‰‘ˆ Šƒ‰‡•

Šƒ‰‡•–‘–Š‡‘”‰ƒ‹œƒ–‹‘ƒ”‡‹‡˜‹–ƒ„Ž‡ƒ† ƒƒˆˆ‡ ––Š‡‘”‰ƒ‹œƒ–‹‘‹†‹ˆˆ‡”‡–™ƒ›•ǡ•‘‡‘ˆ™Š‹ Š

ƒƒ†˜‡”•‡Ž›‹’ƒ –‹–•ƒ„‹Ž‹–›–‘ƒ Š‹‡˜‡‘„Œ‡ –‹˜‡•ƒ†•‘‡ ƒ‹†‹ ƒ–‡ƒ’‘–‡–‹ƒŽ‘’’‘”–—‹–›–Šƒ– ƒ
†”‹˜‡‹’”‘˜‡‡–•Ǥ

Šƒ‰‡• ƒ‹ Ž—†‡ǣ

T EE
ƒȌ ƒ‡š–‡”ƒŽ‹••—‡–Šƒ– ƒ—•‡•ƒ Šƒ‰‡–‘–Š‡‘”‰ƒ‹œƒ–‹‘
AF T
R IT

„Ȍ –Š‡‘”‰ƒ‹œƒ–‹‘†‡ ‹†‡•–‘‹‹–‹ƒ–‡ƒ Šƒ‰‡

2
 ‘™–‘ƒƒ‰‡ Šƒ‰‡‹•‡š’Žƒ‹‡†‹ ȀͳͲͲʹͲǤ
D M

A.7 —’’‘”–
M

A.7.1 ‡•‘—” ‡•
O

A.7.1.1 General
C

‘ Žƒ”‹ˆ‹ ƒ–‹‘‘ˆ–Š‡”‡“—‹”‡‡–’”‘˜‹†‡†Ǥ

A.7.1.2 People

‘ Žƒ”‹ˆ‹ ƒ–‹‘‘ˆ–Š‡”‡“—‹”‡‡–’”‘˜‹†‡†Ǥ

A.7.1.3 Infrastructure

ˆ”ƒ•–”— –—”‡‹ Ž—†‡•ƒŽŽ’Š›•‹ ƒŽ”‡•‘—” ‡•‡‡†‡†ˆ‘”–Š‡‘’‡”ƒ–‹‘‘ˆ–Š‡‘”‰ƒ‹œƒ–‹‘ǯ•’”‘ ‡••‡•Ǥ

•‡”˜‹ ‡‘”‰ƒ‹œƒ–‹‘•ǡ‹ˆ”ƒ•–”— –—”‡‹•ˆ”‡“—‡–Ž›ƒ‹’‘”–ƒ– ‘’‘‡–‘ˆ–Š‡•‡”˜‹ ‡–‘™Š‹ Šƒ›

•–ƒ–—–‘”› ƒ† ”‡‰—Žƒ–‘”› ”‡“—‹”‡‡–• ƒ’’Ž‹ ƒ„Ž‡ –‘ –Š‡ •‡”˜‹ ‡ ƒ ƒ’’Ž› ȋ‡Ǥ‰Ǥ Š‡ƒŽ–Š ƒ”‡ ‘”‰ƒ‹œƒ–‹‘•ǡ
”‡•–ƒ—”ƒ–•ǡ•–‘”‡•Ȍ

Š‡ ƒ –‹‘• ‘ˆ Dz†‡–‡”‹‡dzǡ Dz’”‘˜‹†‡dz ƒ† Dzƒ‹–ƒ‹dz ”‡Žƒ–‡ –‘ –Š”‡‡ †‹ˆˆ‡”‡– ƒ –‹˜‹–‹‡• –Šƒ– ‹‰Š– „‡
’‡”ˆ‘”‡†„›†‹ˆˆ‡”‡–’”‘ ‡••‡•‘”ˆ— –‹‘•‘ˆƒ‘”‰ƒ‹œƒ–‹‘Ǥ

A.7.1.4 Environment for the operation of processes

‘ Žƒ”‹ˆ‹ ƒ–‹‘‘ˆ–Š‡”‡“—‹”‡‡–’”‘˜‹†‡†Ǥ

̹ ʹͲʹͷȂŽŽ”‹‰Š–•”‡•‡”˜‡†
͵ͳ
 ISO/CD 9001.2:2025(en)

A.7.1.5 Monitoring and measuring resources

‘”ƒ›‘”‰ƒ‹œƒ–‹‘•ǡ‘‹–‘”‹‰ƒ†‡ƒ•—”‡‡–”‡•‘—” ‡•ƒ”‡‡••‡–‹ƒŽ–‘†‡‘•–”ƒ–‡ ‘ˆ‘”‹–›‘ˆ

–Š‡’”‘†— –•ƒ†•‡”˜‹ ‡•‘”–‘‡•—”‡ ‘–”‘Ž‘ˆ–Š‡’”‘ ‡••‡•–‘ƒ Š‹‡˜‡‹–‡†‡†”‡•—Ž–•Ǥ‡“—‹”‡‡–•‹
–Š‹• Žƒ—•‡ƒ‹–‘‡•—”‡–Šƒ––Š‡”‡•‘—” ‡•‡•—”‡˜ƒŽ‹†”‡•—Ž–•Ǥ

ͳ ‡‡ ͳͲͲͳʹˆ‘””‡“—‹”‡‡–•ˆ‘”‡ƒ•—”‡‡–’”‘ ‡••‡•ƒ†‡ƒ•—”‹‰‡“—‹’‡–Ǥ

ʹ ‡‡ ͳͲͲͲͻˆ‘”‰—‹†ƒ ‡ˆ‘”“—ƒŽ‹–›–‘‘Ž•ƒ†–Š‡‹”ƒ’’Ž‹ ƒ–‹‘Ǥ

͵ ‡‡ ͳͲͲͳ͹ˆ‘”‰—‹†ƒ ‡‘•–ƒ–‹•–‹ ƒŽ–‡ Š‹“—‡•ˆ‘” ͻͲͲͳǣʹͲͳͷǤ

A.7.1.6 Organizational knowledge

‡“—‹”‡‡–•”‡‰ƒ”†‹‰‘”‰ƒ‹œƒ–‹‘ƒŽ‘™Ž‡†‰‡™‡”‡‹–”‘†— ‡†ˆ‘”–Š‡’—”’‘•‡‘ˆǣ

ƒȌ •ƒˆ‡‰—ƒ”†‹‰–Š‡‘”‰ƒ‹œƒ–‹‘ˆ”‘Ž‘••‘ˆ‘™Ž‡†‰‡ǡ‡Ǥ‰Ǥ–Š”‘—‰Š•–ƒˆˆ–—”‘˜‡”Ǣˆƒ‹Ž—”‡–‘ ƒ’–—”‡ƒ†
•Šƒ”‡‹ˆ‘”ƒ–‹‘Ǣ

T EE
„Ȍ ‡ ‘—”ƒ‰‹‰–Š‡‘”‰ƒ‹œƒ–‹‘–‘ƒ “—‹”‡‘™Ž‡†‰‡ǡ‡Ǥ‰ǤŽ‡ƒ”‹‰ˆ”‘‡š’‡”‹‡ ‡Ǣ

‡–‘”‹‰Ǣ„‡ Šƒ”‹‰Ǥ
AF T
”‰ƒ‹œƒ–‹‘ƒŽ‘™Ž‡†‰‡ ‘„‹‡•’”‘ ‡••‡•ǡƒ –‹‘•ƒ†‡–Š‘†‘Ž‘‰‹‡•–‘‡ƒ„Ž‡ ”‡ƒ–‹‘ǡƒ‹–‡ƒ ‡ǡ
†‹•–”‹„—–‹‘ ƒ† ƒ ‡•• –‘ ‘”‰ƒ‹œƒ–‹‘ƒŽ ‘™Ž‡†‰‡Ǥ ƒƒ‰‡‡– ‘ˆ –Š‹• ‘™Ž‡†‰‡ ‹• ‡••‡–‹ƒŽ ˆ‘”
R IT

•—•–ƒ‹ƒ„Ž‡•— ‡••Ǥ
2
D M

ƒ˜‹‰ ƒ •›•–‡ƒ–‹  ƒ’’”‘ƒ Š Š‡Ž’• –‘ ‹†‡–‹ˆ›ǡ ƒ’–—”‡ǡ ƒƒŽ›•‡ǡ ”‡–”‹‡˜‡ǡ ƒ‹–ƒ‹ ƒ† ’”‘–‡ – ‡š‹•–‹‰
‘™Ž‡†‰‡ǡ ‹†‡–‹ˆ› ‹••‹‰ ‘™Ž‡†‰‡ ƒ† ‘—–‡” Ž‘•• ‘ˆ ‘™Ž‡†‰‡ ȋ‡Ǥ‰Ǥ ƒ—•‡† „› ’‡‘’Ž‡ Ž‡ƒ˜‹‰ ƒ
M

‘”‰ƒ‹œƒ–‹‘ȌǤ

•–‡ Š‘Ž‘‰›†‡˜‡Ž‘’•‹–‹•‹’‘”–ƒ––‘–ƒ‡‹–‘ƒ ‘—––Š‡’‘–‡–‹ƒŽƒ†ƒ –—ƒŽ‹’ƒ –•‘ˆǡˆ‘”‡šƒ’Ž‡ǡ

O

„‹‰†ƒ–ƒǡƒ Š‹‡Ž‡ƒ”‹‰ǡ„Ž‘  Šƒ‹ǡƒ†–Š‡—•‡‘ˆ‹–‡ŽŽ‡ –—ƒŽ’”‘’‡”–›Ǥ

C

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

 ‘™Ž‡†‰‡ƒƒ‰‡‡–•›•–‡••‡‡ ͵ͲͶͲͳǤ

A.7.2 ‘’‡–‡ ‡

‘ Žƒ”‹ˆ‹ ƒ–‹‘‘ˆ–Š‡”‡“—‹”‡‡–’”‘˜‹†‡†Ǥ

 ‡‡ ͳͻͲͳͳˆ‘”ˆ—”–Š‡”‹ˆ‘”ƒ–‹‘‘ƒ—†‹–‘” ‘’‡–‡ ‡Ǥ

A.7.3 ™ƒ”‡‡••

™ƒ”‡‡••‹•ƒ––ƒ‹‡†™Š‡’‡”•‘•—†‡”•–ƒ†–Š‡‹””‡•’‘•‹„‹Ž‹–‹‡•ƒ†ƒ—–Š‘”‹–‹‡•ƒ†Š‘™–Š‡‹”ƒ –‹‘•
‘–”‹„—–‡ –‘ –Š‡ ƒ Š‹‡˜‡‡– ‘ˆ –Š‡ ‘”‰ƒ‹œƒ–‹‘ǯ• “—ƒŽ‹–› ‘„Œ‡ –‹˜‡•Ǥ ”‰ƒ‹œƒ–‹‘• ƒ †‡‘•–”ƒ–‡
‹‹–‹ƒ–‹˜‡• –ƒ‡ –‘ ‡•—”‡ ƒ™ƒ”‡‡•• ‘ˆ ’‡”•‘ ƒ† –Š‡‹” ‡ˆˆ‡ –‹˜‡‡••Ǥ ‡”•‘• †‘‹‰ ™‘” —†‡” –Š‡
‘”‰ƒ‹œƒ–‹‘ǯ• ‘–”‘Ž ƒ†‡‘•–”ƒ–‡–Š‡‹”ƒ™ƒ”‡‡••‹†ƒ›Ǧ–‘Ǧ†ƒ›ƒ –‹˜‹–‹‡•„›†‹•–‹‰—‹•Š‹‰„‡–™‡‡
™Šƒ–‹•ƒ ‡’–ƒ„Ž‡ƒ†™Šƒ–‹•‘–ǡƒ†„›–ƒ‹‰ƒ’’”‘’”‹ƒ–‡ƒ –‹‘™Š‡’”‘ ‡••‡•ǡ’”‘†— –•ƒ†•‡”˜‹ ‡•
†‘‘–‡‡–ƒ‰”‡‡†•’‡ ‹ˆ‹ ƒ–‹‘•Ǥ

̹ ʹͲʹͷȂŽŽ”‹‰Š–•”‡•‡”˜‡†
͵ʹ
 ISO/CD 9001.2:2025(en)

A.7.4 ‘—‹ ƒ–‹‘

‘„‡‡ˆˆ‡ –‹˜‡ǡ–Š‡‘”‰ƒ‹œƒ–‹‘ǯ• ‘—‹ ƒ–‹‘’”‘ ‡••‡•’”‘˜‹†‡•‹–ƒ†‹–•’‡”•‘•™‹–Š

–Š‡ƒ„‹Ž‹–›–‘ǣ

Ȅ –”ƒ•‹–ƒ†”‡ ‡‹˜‡‹ˆ‘”ƒ–‹‘“—‹ Ž›ƒ†–‘ƒ –‘‹–Ǣ

Ȅ „—‹Ž†–”—•–ƒ‘‰•–‡ƒ Š‘–Š‡”Ǣ

Ȅ –”ƒ•‹––Š‡‹’‘”–ƒ ‡‘ˆ —•–‘‡”•ƒ–‹•ˆƒ –‹‘ǡ’”‘ ‡••’‡”ˆ‘”ƒ ‡ǡ‡– ǤǢ

Ȅ †‡–‹ˆ›‘’’‘”–—‹–‹‡•ˆ‘”‹’”‘˜‡‡–

A.7.5 ‘ —‡–‡†‹ˆ‘”ƒ–‹‘

‡‡Žƒ—•‡Ǥʹ‡Ȍˆ‘”–‡”‹‘Ž‘‰›”‡Ž‡˜ƒ––‘Ǯ‘ —‡–‡†‹ˆ‘”ƒ–‹‘ǯ



A.8 ’‡”ƒ–‹‘
T EE
‘™–‘ƒƒ‰‡†‘ —‡–‡†‹ˆ‘”ƒ–‹‘‹•‡š’Žƒ‹‡†‹ ͳͲͲͳ͵Ǥ
AF T
R IT

A.8.1 ’‡”ƒ–‹‘ƒŽ’Žƒ‹‰ƒ† ‘–”‘Ž

2
‘ Žƒ”‹ˆ‹ ƒ–‹‘‘ˆ–Š‡”‡“—‹”‡‡–’”‘˜‹†‡†Ǥ
D M

A.8.2 ‡“—‹”‡‡–•ˆ‘”’”‘†— –•ƒ†•‡”˜‹ ‡•

M

‘ Žƒ”‹ˆ‹ ƒ–‹‘‘ˆ–Š‡”‡“—‹”‡‡–’”‘˜‹†‡†Ǥ

O

A.8.3 ‡•‹‰ƒ††‡˜‡Ž‘’‡–‘ˆ’”‘†— –•ƒ†•‡”˜‹ ‡•

C

‘ Žƒ”‹ˆ‹ ƒ–‹‘‘ˆ–Š‡”‡“—‹”‡‡–’”‘˜‹†‡†Ǥ

 ‡‡ ͳͲͲͲ͹ˆ‘”‰—‹†ƒ ‡‘ ‘ˆ‹‰—”ƒ–‹‘ ‘–”‘Ž”‡Ž‡˜ƒ––‘ͺǤ͵Ǥ͸‡•‹‰ƒ††‡˜‡Ž‘’‡– Šƒ‰‡•Ǥ

A.8.4 ‘–”‘Ž‘ˆ‡š–‡”ƒŽŽ›’”‘˜‹†‡†’”‘ ‡••‡•ǡ’”‘†— –•ƒ†•‡”˜‹ ‡•

Š‡ ‘”‰ƒ‹œƒ–‹‘ ‹• ”‡•’‘•‹„Ž‡ ˆ‘” ‡•—”‹‰ –Šƒ– ‡š–‡”ƒŽŽ› ’”‘˜‹†‡† ’”‘ ‡••‡•ǡ ’”‘†— –• ƒ† •‡”˜‹ ‡•
‘ˆ‘”–‘”‡“—‹”‡‡–•ȋ‡Ǥ‰Ǥ–Š”‘—‰Š‹ ‘‹‰‰‘‘†•‹•’‡ –‹‘ǡ‘”•—”˜‡‹ŽŽƒ ‡‘ˆƒ‘—–•‘—” ‡†•‡”˜‹ ‡ȌǤ
Š‡”‡ˆ‘”‡ǡ‡•–ƒ„Ž‹•Š‹‰ƒ†ƒ‹–ƒ‹‹‰’”‘’‡” ‘–”‘Ž‘ˆ‡š–‡”ƒŽ’”‘˜‹†‡”•‹•‡••‡–‹ƒŽˆ‘”–Š‡‘”‰ƒ‹œƒ–‹‘
–‘‡‡–‹•“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡‘„Œ‡ –‹˜‡•Ǥ

‘–”‘Ž‘ˆ‡š–‡”ƒŽŽ›’”‘˜‹†‡†’”‘ ‡••‡•ǡ’”‘†— –•ƒ†•‡”˜‹ ‡•ƒ”‡ƒ††”‡••‡†ǡ‡Ǥ‰Ǥ™Š‡–Š‡”–Š”‘—‰Šǣ

ƒȌ ’—” Šƒ•‹‰ˆ”‘ƒ•—’’Ž‹‡”Ǣ

„Ȍ ƒƒ””ƒ‰‡‡–™‹–Šƒƒ••‘ ‹ƒ–‡ ‘’ƒ›Ǣ

Ȍ ’”‘ ‡••‡•’”‘˜‹†‡†‡š–‡”ƒŽŽ›Ǥ

”‘ ‡••‡•’”‘˜‹†‡†‡š–‡”ƒŽŽ›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

̹ ʹͲʹͷȂŽŽ”‹‰Š–•”‡•‡”˜‡†
͵͵
 ISO/CD 9001.2:2025(en)

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 ’”‘†— –• ƒ†
•‡”˜‹ ‡•Ǥ

 ‡‡ ͵͹ͷͲͲˆ‘”‰—‹†ƒ ‡‘‘—–•‘—” ‹‰Ǥ

A.8.5 ”‘†— –‹‘ƒ†•‡”˜‹ ‡’”‘˜‹•‹‘

‘ Žƒ”‹ˆ‹ ƒ–‹‘‘ˆ–Š‡”‡“—‹”‡‡–’”‘˜‹†‡†Ǥ

A.8.6 ‡Ž‡ƒ•‡‘ˆ’”‘†— –•ƒ†•‡”˜‹ ‡•

‘ Žƒ”‹ˆ‹ ƒ–‹‘‘ˆ–Š‡”‡“—‹”‡‡–’”‘˜‹†‡†Ǥ

A.8.7 ‘–”‘Ž‘ˆ‘ ‘ˆ‘”‹‰‘—–’—–•

‘ Žƒ”‹ˆ‹ ƒ–‹‘‘ˆ–Š‡”‡“—‹”‡‡–’”‘˜‹†‡†Ǥ

T EE
A.9 ‡”ˆ‘”ƒ ‡‡˜ƒŽ—ƒ–‹‘
A.9.1 ‘‹–‘”‹‰ǡ‡ƒ•—”‡‡–ǡƒƒŽ›•‹•ƒ†‡˜ƒŽ—ƒ–‹‘
AF T
‘ Žƒ”‹ˆ‹ ƒ–‹‘‘ˆ–Š‡”‡“—‹”‡‡–’”‘˜‹†‡†Ǥ
R IT


2
‡ƒ•—”‡‡–’”‘ ‡••‡•ƒ†‡ƒ•—”‹‰‡“—‹’‡–•‡‡ ͳͲͲͳʹǤ
D M

A.9.2 –‡”ƒŽƒ—†‹–
M

‘ Žƒ”‹ˆ‹ ƒ–‹‘‘ˆ–Š‡”‡“—‹”‡‡–’”‘˜‹†‡†Ǥ

 “—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡•ƒ—†‹–‹‰•‡‡ ͳͻͲͳͳǤ

O

A.9.3 ƒƒ‰‡‡–”‡˜‹‡™
C

‘ Žƒ”‹ˆ‹ ƒ–‹‘‘ˆ–Š‡”‡“—‹”‡‡–’”‘˜‹†‡†Ǥ

A.10 ’”‘˜‡‡–
A.10.1 ‘–‹—ƒŽ‹’”‘˜‡‡–

Š‡ —•‡ ‘ˆ ‡‡”‰‹‰ –‡ Š‘Ž‘‰› ƒ ˆƒ ‹Ž‹–ƒ–‡ ‘–‹—ƒŽ ‹’”‘˜‡‡–Ǥ ‡”‰‹‰ –‡ Š‘Ž‘‰‹‡• ƒ ‹ Ž—†‡
†‹‰‹–‹œƒ–‹‘ǡƒ Š‹‡Ž‡ƒ”‹‰ǡ„‹‰†ƒ–ƒǡƒ—‰‡–‡†”‡ƒŽ‹–›ƒ†˜‹”–—ƒŽ”‡ƒŽ‹–›ǡ†‹‰‹–ƒŽ–™‹•ǡ Ž‘—† ‘’—–‹‰ǡ
‹–‡”‡–‘ˆ–Š‹‰•ȋ ‘Ȍƒ†ƒ”–‹ˆ‹ ‹ƒŽ‹–‡ŽŽ‹‰‡ ‡Ǥ

‡”‰‹‰–‡ Š‘Ž‘‰‹‡•™‹ŽŽ‹’ƒ –ƒ‘”‰ƒ‹œƒ–‹‘ǯ•“—ƒŽ‹–›ƒƒ‰‡‡–•›•–‡‹–Š‡ˆ—–—”‡ǡƒ†–Š‡‹’ƒ –

™‹ŽŽ‘–„‡ ‘‡ˆ—ŽŽ›ƒ’’ƒ”‡–—–‹Ž•— Š–‡ Š‘Ž‘‰‹‡•ƒ”‡‘”‡ƒ–—”‡Ǥ

Š‹Ž‡–Š‡•‡–‡ Š‘Ž‘‰‹‡•ƒ”‡‘–‡™–‘ƒŽŽ‘”‰ƒ‹œƒ–‹‘•ǡ–Š‡‹”‹’ƒ –‹•‰”‘™‹‰ǡ‡Ǥ‰Ǥ†‹‰‹–‹œƒ–‹‘ȋ†‡˜‡Ž‘’‹‰

–Š‡’”‘ ‡••‡•ƒ†„—•‹‡••‘ˆƒ‘”‰ƒ‹œƒ–‹‘„ƒ•‡†‘†‹‰‹–ƒŽ–‡ Š‘Ž‘‰›Ȍǡ™‹–Š‹ƒ†„‡–™‡‡‘”‰ƒ‹œƒ–‹‘•
ƒ†ƒƒ‰‡‡–•›•–‡•‹• ‡–”ƒŽ–‘ Šƒ‰‹‰™ƒ›•‘ˆ™‘”‹‰Ǥ‹‰‹–‹œƒ–‹‘‹ Ž—†‡•„‘–Š–Š‡†‹‰‹–‹œƒ–‹‘
‘ˆ‘™Ž‡†‰‡ƒ†‹ˆ‘”ƒ–‹‘ǡƒ†–Š‡‹–‡ŽŽ‹‰‡–‡–™‘”‹‰‘ˆƒ Š‹‡•ƒ†’”‘ ‡••‡•Ǥ

‡‘’Ž‡ ƒ† ’”‘†— –• ƒ‡ †‡ ‹•‹‘• „ƒ•‡† ‘ ‡š‹•–‹‰ †ƒ–ƒ ƒ† ‹ˆ‘”ƒ–‹‘Ǥ ”–‹ˆ‹ ‹ƒŽ ‹–‡ŽŽ‹‰‡ ‡ ƒ‡•
†‡ ‹•‹‘•‘ƒ”ƒ’‹†Ž› Šƒ‰‹‰†ƒ–ƒ•‹–—ƒ–‹‘ǣƒ•ƒ”‡•—Ž–ǡ†‡ ‹•‹‘•ƒ”‡‘–ƒŽ™ƒ›• ‘’”‡Š‡•‹„Ž‡–‘’‡‘’Ž‡
‘”ƒƒ‰‡‡–•›•–‡•ƒ† ƒ„‡ƒ ŠƒŽŽ‡‰‡Ǥ

̹ ʹͲʹͷȂŽŽ”‹‰Š–•”‡•‡”˜‡†
͵Ͷ
 ISO/CD 9001.2:2025(en)

‡’‡†‡ ›‘˜ƒŽ‹†ƒ†”‡Ž‹ƒ„Ž‡†ƒ–ƒ‹•†”ƒƒ–‹ ƒŽŽ›‹ ”‡ƒ•‹‰ǡ•‘–Š‡—•‡‘ˆ‡‡”‰‹‰–‡ Š‘Ž‘‰‹‡•™‹–Š‹

‘”‰ƒ‹œƒ–‹‘•ƒ†•‘ ‹‡–›‹•‡••‡–‹ƒŽǤ

Š‡ ‹’”‘˜‡‡– ‹• ƒ††”‡••‡† †‡–‡”‹‹‰ ™Š‹ Š ‘ˆ –Š‡ ‡‡”‰‹‰ –‡ Š‘Ž‘‰‹‡• ƒ ‡Šƒ ‡ –Š‡
‹’”‘˜‡‡–‡‡†‡† ƒŠƒ˜‡ƒŠ‹‰Šƒ††‡†˜ƒŽ—‡Ǥ

A.10.2 ‘ ‘ˆ‘”‹–›ƒ† ‘””‡ –‹˜‡ƒ –‹‘

‘ Žƒ”‹ˆ‹ ƒ–‹‘‘ˆ–Š‡”‡“—‹”‡‡–’”‘˜‹†‡†Ǥ

T EE
AF T
R IT

2
D M M
O
C

̹ ʹͲʹͷȂŽŽ”‹‰Š–•”‡•‡”˜‡†
͵ͷ
 ISO/CD 9001.2:2025(en)

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ȏͺȐ ȀͳͲͲͳ͹ǡGuidance on statistical techniques for ISO 9001:2000

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ȏͳ͵Ȑ ͵ͳͲͲͲǡRisk management — Guidelines

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ȏͳͶȐ ͳͲͲͲͻǡQuality management — Guidance for quality tools and their application
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ȏʹͲȐ ͻͲͲͳˆ‘”ƒŽŽ—•‹‡••‡•ȄŠƒ––‘†‘ǡ ͳȌ

ȏʹͳȐ ͳͲͲͲͶǡQuality management — Customer satisfaction — Guidelines for monitoring and measuring

ȏʹʹȐ ͳͲͲͳͻǡGuidelines for the selection of quality management system consultants and use of their
services

ȏʹ͵Ȑ ͳͲͲͲͷǡQuality management — Guidelines for quality plans

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 ISO/CD 9001.2:2025(en)

ȏʹͷȐ ͳͲͲͲͻǣʹͲʹͶǡQuality management — Guidance for quality tools and their application

ȏʹ͸Ȑ ͳͶͲͲͳǡEnvironmental management systems — Requirements with guidance for use

ȏʹ͹Ȑ ™™™Ǥ‹•‘Ǥ‘”‰Ȁ– ͳ͹͸Ȁ• ͲʹȀ’—„Ž‹ 

ȏʹͺȐ ͳͲͲͳͲǡQuality management — Guidance to understand, evaluate and improve organizational

quality culture

ȏʹͻȐ ͳͲͲͳʹǡMeasurement management systems — Requirements for measurement processes and

measuring equipment

ȏ͵ͲȐ Ȁ ͻͲͲͲ͵ǡSoftware engineering — Guidelines for the application of ISO 9001:2008 to computer
software

ȏ͵ͳȐ ͵͹ͷͲͲǡGuidance on outsourcing

ȏ͵ʹȐ ͳͲͲͲ͸ǡQuality management systems — Guidelines for quality management in projects

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ȏ͵͵Ȑ ȀͻͲͲͲǡQuality management systems — Fundamentals and vocabulary

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ȏ͵ͷȐ ͳͲͲͳ͹ǡQuality management — Guidance on statistical techniques for ISO 9001:2015
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͸Ͳ͵ͲͲǦͳǡDependability management — Part 1: Guidance for management and application
D M

ȏ͵͹Ȑ ͳͲͲͳͶǡQuality management — Guidelines for realizing financial and economic benefits
M

ȏ͵ͺȐ ͸ͳͳ͸ͲǡDesign review

ȏ͵ͻȐ ͳͲͲͲͺǡQuality management — Customer satisfaction — Guidelines for business-to-consumer

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electronic commerce transactions

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