TIU CHUN QUC T * INTERNATIONAL STANDARD

ISO 9001:2015
https://goo.gl/qUXO3i
https://goo.gl/qUXO3i
Xut bn ln 5
Fifth edition

H THNG QUN L CHT LNG CC YU CU

QUALITY MANAGEMENT SYSTEMS REQUIREMENTS

H NI 9.2015
ISO 9001:2015

2 TM
 ISO 9001:2015

Mc lc
Li gii thiu....................................................................................................................................................... 5
0.1 Khi qut ............................................................................................................................................... 5
0.2 Cc nguyn tc qun l cht lng ...................................................................................................... 6
0.3 Tip cn theo qu trnh ......................................................................................................................... 7
0.4 Quan h vi cc tiu chun h thng qun l khc............................................................................ 11
1 Phm vi p dng .......................................................................................................................................... 13
2 Ti liu vin dn ........................................................................................................................................... 13
3 Thut ng v nh ngha .............................................................................................................................. 13
4 Bi cnh ca t chc.................................................................................................................................... 14
4.1 Hiu t chc v bi cnh ca t chc ................................................................................................ 14
4.2 Hiu nhu cu v mong i ca cc bn quan tm ............................................................................. 14
4.3 Xc nh phm vi ca h thng qun l cht lng ........................................................................... 14
4.4 H thng qun l cht lng v cc qu trnh ca h thng.............................................................. 15
5 S lnh o .................................................................................................................................................. 16
5.1 S lnh o v cam kt ..................................................................................................................... 16
5.2 Chnh sch cht lng ...................................................................................................................... 17
5.3 Vai tr, trch nhim v quyn hn trong t chc............................................................................. 18
6 Hoch nh ................................................................................................................................................... 18
6.1 Hnh ng gii quyt ri ro v c hi .............................................................................................. 18
6.2 Mc tiu cht lng v hoch nh t c mc tiu ............................................................. 19
6.3 Hoch nh s thay i...................................................................................................................... 20
7 H tr............................................................................................................................................................ 20
7.1 Ngun lc ........................................................................................................................................... 20
7.2 Nng lc ............................................................................................................................................. 23
7.3 Nhn thc ........................................................................................................................................... 23
7.4 Trao i thng tin ............................................................................................................................... 23
7.5 Thng tin c lp vn bn .............................................................................................................. 23
8 iu hnh ..................................................................................................................................................... 25
8.1 Hoch nh v kim sot iu hnh ................................................................................................. 25
8.2 Yu cu i vi sn phm v dch v .............................................................................................. 26
8.3 Thit k v pht trin sn phm v dch v ..................................................................................... 27
8.4 Kim sot cc sn phm v dch v do bn ngoi cung cp.......................................................... 30
8.5 Sn xut v cung cp dch v ........................................................................................................... 32
8.6 Chuyn giao sn phm v dch v ...................................................................................................... 34
8.7 Kim sot u ra khng ph hp........................................................................................................ 35
9 nh gi kt qu hot ng ......................................................................................................................... 35
9.1 Theo di, o lng, phn tch v nh gi ......................................................................................... 35
9.2 nh gi ni b ................................................................................................................................... 37
9.3 Xem xt ca lnh o.......................................................................................................................... 37
10 Ci tin ........................................................................................................................................................ 38
10.1 Khi qut ........................................................................................................................................... 38
10.2 S khng ph hp v hnh ng khc phc.................................................................................... 39
10.3 Ci tin lin tc .................................................................................................................................. 40
Ph lc A .......................................................................................................................................................... 41
Ph lc B .......................................................................................................................................................... 47
Ti liu tham kho ............................................................................................................................................ 53

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ISO 9001:2015

Li ni u

Tiu chun ISO 9001:2015 do T chc Tiu chun ha quc t (ISO) ban hnh ngy 15-9-2015 thay th
ISO 9001:2008. https://goo.gl/qUXO3i

Bn dch ting Vit tiu chun ISO 9001:2015 ny do nhm chuyn gia thc hin nhm cung cp
thng tin tham kho cho cc ging vin, chuyn gia, nh qun l v nhng ngi quan tm.

Mi gp hon thin bn dch ny nu c xin gi v cho chng ti theo a ch: info@topmanjsc.com

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ISO 9001:2015 ISO 9001:2015

ISO 9001:2015 ISO 9001:2015

4
 ISO 9001:2015

Li gii thiu Introduction

0.1 Khi qut 0.1 General

Chp nhn p dng h thng qun l cht lng l The adoption of a quality management system is a
mt quyt nh chin lc ca t chc c th ci strategic decision for an organization that can help to
tin kt qu hot ng tng th v cung cp mt nn improve its overall performance and provide a sound
tng vng chc cho cc sng kin pht trin bn basis for sustainable development initiatives.
vng.

Nhng li ch tim nng t chc trin khai mt The potential benefits to an organization of
h thng qun l cht lng da trn Tiu chun implementing a quality management system based
quc t ny l: on this International Standard are:

a) kh nng lun cung cp sn phm v dch v a) the ability to consistently provide products and
p ng cc yu cu khch hng v yu cu services that meet customer and applicable
lut nh v ch nh thch hp; statutory and regulatory requirements;
b) to iu kin cho cc c hi nng cao s hi b) facilitating opportunities to enhance customer
lng ca khch hng; satisfaction;
c) gii quyt cc ri ro v c hi kt hp vi bi c) addressing risks and opportunities associated
cnh v mc tiu ca t chc; with its context and objectives;
d) kh nng chng minh s ph hp vi cc d) the ability to demonstrate conformity to specified
yu cu h thng qun l cht lng quy nh. quality management system requirements.

Tiu chun quc t ny c th c s dng bi This International Standard can be used by internal
cc bn, bn trong v bn ngoi t chc. and external parties.
Tiu chun quc t ny khng nhm dn n nhu It is not the intent of this International Standard to
cu v: imply the need for:

s ng nht trong cu trc ca cc h thng
uniformity in the structure of different quality

qun l cht lng khc nhau;

s ng nht ca h thng ti liu theo cu trc
iu khon ca Tiu chun quc t ny;

vic s dng cc thut ng c th ca Tiu
chun quc t ny trong t chc.
management systems;

alignment of documentation to the clause
structure of this International Standard;

the use of the specific terminology of this
International Standard within the organization.

Cc yu cu ca h thng qun l cht lng c The quality management system requirements

quy nh trong Tiu chun quc t ny b sung cho specified in this International Standard are
cc yu cu i vi cc sn phm v dch v. complementary to requirements for products and
services.

Tiu chun quc t ny s dng cch tip cn qu This International Standard employs the process
trnh, trong kt hp chu trnh Plan- Do-Check-Act approach, which incorporates the Plan-Do-Check-
(PDCA) v t duy da trn ri ro. Act (PDCA) cycle and risk-based thinking.
Cch tip cn qu trnh cho php t chc lp k The process approach enables an organization to
hoch cc qu trnh v tng tc ca chng. plan its processes and their interactions

Chu trnh PDCA cho php t chc m bo rng cc The PDCA cycle enables an organization to ensure
qu trnh ca t chc c ngun lc v c qun that its processes are adequately resourced and

5
ISO 9001:2015
l y , v cc c hi ci tin c xc nh managed, and that opportunities for improvement are
v thc hin.
T duy da trn ri ro cho php t chc xc nh
cc yu t c th lm cho cc qu trnh ca t chc
v h thng qun l cht lng ca t chc i chch
khi cc kt qu d kin, v a ra cc bin php
kim sot phng nga nhm gim thiu cc tc
ng tiu cc v tn dng ti a cc c hi khi
chng xut hin (xem khon A.4).
Vic p ng mt cch n nh cc yu cu v
hng n cc nhu cu v mong i trong tng lai
t ra mt thch thc i vi cc t chc trong mt
mi trng ngy cng nng ng v phc tp.
t c mc tiu ny, t chc c th cn vn dng
cc hnh thc ci tin, bn cnh vic khc phc v
ci tin lin tc, chng hn nh thay i mang tnh
t ph, i mi v ti c cu.
Trong Tiu chun quc t ny, cc mu cu sau
y c s dng:

"phi" ch ra mt yu cu;

"nn" ch ra mt khuyn ngh;

"c th" ch ra mt s cho php;

"c th lm" ch ra mt kh nng/mt nng lc
Thng tin c nh du "CH THCH" l hng
dn hiu hoc lm r yu cu lin quan.
0.2 Cc nguyn tc qun l cht lng
Tiu chun quc t ny c da trn cc nguyn
tc qun l cht lng c m t trong ISO 9000.
Cc m t bao gm mt din gii ca mi nguyn
tc, l do ti sao cc nguyn tc rt quan trng i
vi t chc, mt s v d v li ch gn lin vi cc
nguyn tc v cc v d in hnh ca cc hnh
ng nng cao hiu lc thc hin ca t chc khi
p dng nguyn tc.
Cc nguyn tc qun l cht lng l:

hng vo khch hng;

s lnh o;

s cam kt ca mi ngi;

tip cn theo qu trnh;
6
determined and acted on.
Risk-based thinking enables an organization to
determine the factors that could cause its processes
and its quality management system to deviate from
the planned results, to put in place preventive
controls to minimize negative effects and to make
maximum use of opportunities as they arise (see
Clause A.4).
Consistently meeting requirements and addressing
future needs and expectations poses a challenge for
organizations in an increasingly dynamic and
complex environment. To achieve this objective, the
organization might find it necessary to adopt various
forms of improvement in addition to correction and
continual improvement, such as breakthrough
change, innovation and re-organization.
In this International Standard, the following verbal
forms are used:

shall indicates a requirement;

should indicates a recommendation;

may indicates a permission;

can indicates a possibility or a capability.
Information marked as NOTE is for guidance in
understanding or clarifying the associated
requirement
0.2 Quality management principles
This International Standard is based on the quality
management principles described in ISO 9000. The
descriptions include a statement of each principle, a
rationale of why the principle is important for the
organization, some examples of benefits associated
with the principle and examples of typical actions to
improve the organizations performance when
applying the principle.
The quality management principles are:

customer focus;

leadership;

engagement of people;

process approach;
 ISO 9001:2015

ci tin;
improvement;

a ra quyt nh da trn bng chng;
evidence-based decision making;

qun l mi quan h.
relationship management.
0.3 Tip cn theo qu trnh 0.3 Process approach

0.3.1 Khi qut 0.3.1 General

Tiu chun quc t ny khuyn khch vic vn dng This International Standard promotes the adoption of
cch tip cn theo qu trnh khi trin khai, thc hin a process approach when developing, implementing
v ci tin tnh hiu lc ca h thng qun l cht and improving the effectiveness of a quality
lng, nng cao s hi lng ca khch hng thng management system, to enhance customer
qua p ng cc yu cu ca khch hng. Yu cu satisfaction by meeting customer requirements.
c th c xem l thit yu cho vic p dng cch Specific requirements considered essential to the
tip cn theo qu trnh c m t trong iu 4.4. adoption of a process approach are included in 4.4.

Vic hiu r v qun l cc qu trnh c mi tng Understanding and managing interrelated processes
tc vi nhau nh mt h thng gp phn vo tnh as a system contributes to the organizations
hiu lc v hiu qu ca t chc trong vic t c effectiveness and efficiency in achieving its intended
cc kt qu mong i. Cch tip cn ny cho php results. This approach enables the organization to
t chc kim sot cc mi quan h v s ph thuc control the interrelationships and interdependencies
ln nhau gia cc qu trnh trong h thng, do among the processes of the system, so that the
kt qu hot ng tng th ca t chc c th c overall performance of the organization can be
nng cao. enhanced.
Cch tip cn theo qu trnh bao gm vic xc nh The process approach involves the systematic
v qun l mt cch c h thng cc qa trnh, v definition and management of processes, and their
cc mi tng tc ca chng, t c kt qu interactions, so as to achieve the intended results in
d nh ph hp vi cc chnh sch cht lng v accordance with the quality policy and strategic
nh hng chin lc ca t chc. direction of the organization.
Qun l cc qu trnh v h thng nh mt tng th Management of the processes and the system as a
c th t c bng cch s dng chu trnh PDCA whole can be achieved using the PDCA cycle (see
(xem 0.3.2) vi tp trung tng th vo t duy da 0.3.2) with an overall focus on risk-based thinking
trn ri ro (xem 0.3.3) nhm tn dng c hi v ngn (see 0.3.3) aimed at taking advantage of
nga cc kt qu khng mong mun. opportunities and preventing undesirable results.

Vic p dng cch tip cn theo qu trnh trong h The application of the process approach in a quality
thng qun l cht lng cho php: management system enables:

a) hiu r v nht qun trong vic p ng cc yu a) understanding and consistency in meeting

cu; requirements;
b) vic xem xt cc qu trnh v mt gi tr gia tng; b) the consideration of processes in terms of added
c) t c kt qu hot ng ca qu trnh mt value;
cch hiu lc; c) the achievement of effective process
d) ci tin cc qu trnh da trn vic nh gi cc performance;
d liu v thng tin. d) improvement of processes based on evaluation
of data and information.

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ISO 9001:2015

Hnh 1 cho thy biu ca mi qu trnh v cho Figure 1 gives a schematic representation of any
thy s tng tc ca cc yu t ca qu trnh. Vic process and shows the interaction of its elements.
theo di v o lng cc im kim sot, cc im The monitoring and measuring check points, which
cn thit kim sot, c th i vi mi qu trnh are necessary for control, are specific to each
v s khc nhau ty thuc vo cc ri ro lin quan. process and will vary depending on the related risks.

ng

TRC SAU

Hnh 1 S biu din cc yu t ca mt qu trnh

Figure 1 Schematic representation of the elements of a single process

0.3.2 Chu trnh PDCA 0.3.2 Plan-Do-Check-Act cycle

Chu trnh PDCA c th p dng cho tt c cc The PDCA cycle can be applied to all processes
qu trnh v cho tng th H thng qun l cht and to the quality management system as a whole.
lng. Hnh 2 minh ha cc iu khon t 4 n Figure 2 illustrates how Clauses 4 to 10 can be
10 c th nhm theo chu trnh PDCA. grouped in relation to the PDCA cycle.

Chu trnh PDCA c th m t ngn gn nh sau: The PDCA cycle can be briefly described as
follows:

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 ISO 9001:2015

Plan: thit lp cc mc tiu ca h thng v
Plan: establish the objectives of the system and
cc qu trnh, v ngun lc cn to ra cc its processes, and the resources needed to
kt qu ph hp vi cc yu cu ca khch deliver results in accordance with customers
hng v chnh sch ca t chc; v xc nh requirements and the organizations policies,
v gii quyt cc ri ro v c hi; and identify and address risks and
opportunities;

o: thc hin cc hng mc hoch nh;
D Do: implement what was planned;

Check: monitor and (where applicable)

Check: gim st v (khi c th) o lng cc
measure processes and the resulting products
qu trnh v cc sn phm, dch v u ra
and services against policies, objectives,
theo cc chnh sch, mc tiu v cc yu cu
requirements and planned activities, and report
v bo co cc kt qu;
the results;

Act: thc hin cc bin php ci tin kt qu

Act: take actions to improve performance, as
hot ng khi cn thit.
necessary.

ca ca

Hnh 2 S cu trc Tiu chun quc t theo chu trnh PDCA

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ISO 9001:2015

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

0.3.3 T duy da trn ri ro 0.3.3 Risk-based thinking

T duy da trn ri ro (xem mc A.4) l thit yu Risk-based thinking (see Clause A.4) is essential for
t c tnh hiu lc h thng qun l cht achieving an effective quality management system.
lng. The concept of risk-based thinking has been implicit
Khi nim t duy da trn ri ro c ngm in previous editions of this International Standard
nh trong cc phin bn trc ca Tiu chun including, for example, carrying out preventive action
quc t ny bao gm, v d, thc hin cc hnh to eliminate potential nonconformities, analysing any
ng phng nga loi b s khng ph hp nonconformities that do occur, and taking action to
tim n, phn tch bt k s khng ph hp xy ra, prevent recurrence that is appropriate for the effects
v hnh ng ngn nga s ti din ph hp of the nonconformity.
vi cc nh hng ca s khng ph hp.

p ng cc yu cu ca Tiu chun quc t To conform to the requirements of this International

ny, t chc cn lp k hoch v thc hin cc Standard, an organization needs to plan and
hnh ng gii quyt cc ri ro v c hi. Vic implement actions to address risks and opportunities.
gii quyt c nhng ri ro v c hi s to c s Addressing both risks and opportunities establishes a
tng tnh hiu lc ca h thng qun l cht basis for increasing the effectiveness of the quality
lng, t c kt qu ci thin v ngn nga management system, achieving improved results and
cc tc ng tiu cc. preventing negative effects.
C hi c th pht sinh nh l kt qu ca mt tnh Opportunities can arise as a result of a situation
hung thun li t kt qu mong mun, v d, favourable to achieving an intended result, for

10
 ISO 9001:2015

hon cnh cho php cc t chc thu ht khch
hng, pht trin sn phm v dch v mi, gim
lng ph hoc ci tin nng sut. Cc hnh ng
gii quyt cc c hi cng c th bao gm vic
xem xt cc ri ro lin quan.
example, a set of circumstances that allow the
organization to attract customers, develop new
products and services, reduce waste or improve
productivity. Actions to address opportunities can
also include consideration of associated risks.

Ri ro l nh hng ca s khng chc chn v Risk is the effect of uncertainty and any such
cng nh bt k s bt nh no cng c th c uncertainty can have positive or negative effects.
nhng tc ng tch cc hay tiu cc.
S chch hng tch cc pht sinh t mt ri ro A positive deviation arising from a risk can provide an
c th cho ra mt c hi, nhng khng phi tt c opportunity, but not all positive effects of risk result in
cc nh hng tch cc ca ri ro. opportunities.
0.4 Quan h vi cc tiu chun h thng qun 0.4 Relationship with other management system
l khc standards

Tiu chun quc t ny p dng khun kh do t
chc ISO pht trin ci tin s thng nht gia
cc Tiu chun quc t v cc h thng qun l
(xem mc A.1).
Tiu chun quc t ny gip cc t chc s dng
cch tip cn theo qu trnh, kt hp vi chu trnh
PDCA v t duy da trn ri ro, thng nht
hoc tch hp h thng qun l cht lng ca t
chc vi cc yu cu ca cc tiu chun h thng
qun l khc.
This International Standard applies the framework
developed by ISO to improve alignment among its
International Standards for management systems
(see Clause A.1).
This International Standard enables an organization
to use the process approach, coupled with the PDCA
cycle and risk-based thinking, to align or integrate its
quality management system with the requirements of
other management system standards.

Tiu chun quc t ny lin quan n ISO 9000 v
ISO 9004 nh sau:

ISO 9000 H thng qun l cht lng - C s

v t vng, cung cp nn tng ct yu hiu
ng v p dng Tiu chun quc t ny;

ISO 9004 Qun l thnh cng bn vng cho
t chc Tip cn trong qun l cht lng,

cung cp cc hng dn cho t chc la
chn cc tin b vt ngoi cc yu cu ca
Tiu chun quc t ny.
This International Standard relates to ISO 9000 and
ISO 9004 as follows:
ISO 9000 Quality management systems -
Fundamentals and vocabulary provides essential
background for the proper understanding and
implementation of this International Standard;
ISO 9004 Managing for the sustained success of
an organization A quality management
approach provides guidance for organizations
that choose to progress beyond the requirements
of this International Standard.

Ph lc B cung cp cc chi tit ca cc Tiu chun Annex B provides details of other International
quc t khc v qun l cht lng v cc h Standards on quality management and quality
thng qun l cht lng c pht trin bi management systems that have been developed by
ISO/ TC 176. ISO/TC 176.
Tiu chun quc t ny khng bao gm cc yu This International Standard does not include
cu c th i vi cc h thng qun l khc, v d requirements specific to other management systems,
nh qun l mi trng, qun l an ton v sc such as those for environmental management,
khe ngh nghip, qun l ti chnh.

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ISO 9001:2015

Cc tiu chun h thng qun l cht lng c th occupational health and safety management, or
cho tng ngnh da trn cc yu cu ca Tiu financial management.
chun quc t ny c pht trin cho mt sSector-specific quality management system
ngnh ngh. Vi tiu chun trong s ny qui nh
standards based on the requirements of this
thm cc yu cu h thng qun l cht lng, mt
International Standard have been developed for a
s khc ch gii hn trong vic cung cp hng number of sectors. Some of these standards specify
dn p dng Tiu chun quc t vo cc ngnh additional quality management system requirements,
c th. while others are limited to providing guidance to the
Mt ma trn v s tng quan gia cc mc ca application of this International Standard within the
phin bn ny v cc phin bn trc y (ISO particular sector.
9001:2008) c th c tm thy trn trang web A matrix showing the correlation between the clauses
ca ISO/TC176/SC2 ti of this edition of this International Standard and the
www.iso.org/tc176/sc02/public 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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 ISO 9001:2015

H thng qun l cht lng Cc yu cu

Quality management systems Requirements

1 Phm vi p dng 1 Scope

Tiu chun quc t ny quy nh cc yu cu cho This International Standard specifies requirements
h thng qun l cht lng khi t chc: for a quality management system when an
a) cn chng t kh nng cung cp mt cch n organization:
nh sn phm hoc dch v p ng cc yu a) needs to demonstrate its ability to consistently
cu ca khch hng cng nh cc yu cu ca provide products and services that meet
lut php v ch nh thch hp, v customer and applicable statutory and regulatory
b ) mun nng cao s tha mn ca khch hng requirements, and
thng qua vic p dng mt cch c hiu lc h b) aims to enhance customer satisfaction through
thng, bao gm c cc qu trnh ci tin h the effective application of the system, including
thng v m bo s ph hp vi cc yu cu processes for improvement of the system and the
ca khch hng, yu cu lut nh v ch nh assurance of conformity to customer and
c p dng. applicable statutory and regulatory requirements.

Tt c cc yu cu ca Tiu chun quc t ny All the requirements of this International Standard

mang tnh tng qut v d kin p dng cho mi are generic and are intended to be applicable to any
t chc, khng phn bit loi hnh, quy m hoc organization, regardless of its type or size, or the
sn phm v dch v cung cp. products and services it provides.
CH THCH 1: Trong Tiu chun quc t ny, thut ng NOTE 1 In this International Standard, the terms product
Sn phm hoc Dch v ch p dng cho sn phm or service only apply to products and services intended
v dch v d kin cung cp cho khch hng, hoc c for, or required by, a customer.
yu cu bi khch hng. NOTE 2 Statutory and regulatory requirements can be
CH THCH 2: Cc yu cu lut nh v ch nh c th expressed as legal requirements.
c th hin nh cc yu cu php l.

2 Ti liu vin dn 2 Normative references

Cc ti liu sau y, ton b hoc mt phn, c
tham chiu trong ti liu ny v khng th tch ri
khi p dng h thng. i vi ti liu ghi ngy thng,
ch p dng bn c trch. i vi ti liu tham
kho khng ghi ngy thng, phin bn mi nht ca
cc ti liu tham chiu (bao gm c cc sa i)
c p dng.
The following documents, in whole or in part, are
normatively referenced in this document and are
indispensable for its application. For dated references,
only the edition cited applies. For undated references,
the latest edition of the referenced document
(including any amendments) applies.

ISO 9000:2015, H thng qun l cht lng - C ISO 9000:2015, Quality management systems
s v t vng Fundamentals and vocabulary

3 Thut ng v nh ngha 3 Terms and definitions

Vi cc mc ch ca tiu chun ny, cc thut ng For the purposes of this document, the terms and
v nh ngha trong ISO 9000: 2015 c p dng. definitions given in ISO 9000:2015 apply.

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ISO 9001:2015

4 Bi cnh ca t chc 4 Context of the organization

4.1 Hiu t chc v bi cnh ca t chc 4.1 Understanding the organization and its
context

T chc phi xc nh cc vn bn trong v bn The organization shall determine external and internal
ngoi c lin quan n mc ch, nh hng chin issues that are relevant to its purpose and its strategic
lc v nhng vn nh hng n kh nng direction and that affect its ability to achieve the
ca t chc trong vic t c (cc) kt qu mong intended result(s) of its quality management system.
i ca h thng qun l cht lng. The organization shall monitor and review information
T chc phi theo di v xem xt thng tin v cc about these external and internal issues.
vn bn ngoi v ni b.
CH THCH 1: Cc vn c th bao gm cc yu t NOTE 1 Issues can include positive and negative factors
tch cc v tiu cc hoc cc iu kin cho vic xem or conditions for consideration.
xt. NOTE 2 Understanding the external context can be
CH THCH 2: C th to iu kin cho vic hiu r bi facilitated by considering issues arising from legal,
cnh bn ngoi bng cch xem xt cc vn pht sinh technological, competitive, market, cultural, social and
t cc mi trng php l, cng ngh, cnh tranh, th economic environments, whether international, national,
trng, vn ha, x hi v kinh t, hoc l quc t, quc regional or local.
gia, khu vc hoc a phng. NOTE 3 Understanding the internal context can be
CH THCH 3: C th to iu kin cho vic hiu r bi facilitated by considering issues related to values, culture,
cnh ni b bng cch xem xt cc vn lin quan knowledge and performance of the organization
n gi tr, vn ha, kin thc v hot ng ca t chc.
4.2 Hiu nhu cu v mong i ca cc bn 4.2 Understanding the needs and expectations of
quan tm interested parties

Do c tc ng hoc tc ng tim n ti kh nng Due to their effect or potential effect on the

ca t chc trong vic cung cp nht qun cc sn organizations ability to consistently provide products
phm v dch v p ng cc yu cu ca khch and services that meet customer and applicable
hng v cc yu cu lut nh v ch nh thch hp, statutory and regulatory requirements, the organization
t chc phi xc nh: shall determine:

a) cc bn quan tm c lin quan n h thng a) the interested parties that are relevant to the
qun l cht lng; quality management system;
b) cc yu cu ca cc bn quan tm ny lin b) the requirements of these interested parties that
quan n h thng qun l cht lng. are relevant to the quality management system.

T chc phi theo di v xem xt thng tin v cc The organization shall monitor and review information
bn quan tm v cc yu cu lin quan ca h. about these interested parties and their relevant
requirements.
4.3 Xc nh phm vi ca h thng qun l cht 4.3 Determining the scope of the quality
lng management system

T chc phi xc nh cc ranh gii v kh nng p The organization shall determine the boundaries and
dng ca h thng qun l cht lng thit lp applicability of the quality management system to
phm vi h thng ca t chc. establish its scope.
Khi xc nh phm vi ny, t chc phi xem xt: When determining this scope, the organization shall
consider:
a) cc vn bn ngoi v ni b nu ti 4.1; a) the external and internal issues referred to in 4.1;

14
 ISO 9001:2015

b) cc yu cu ca cc bn quan tm lin quan b) the requirements of relevant interested parties

nu ti 4.2; referred to in 4.2;
c) cc sn phm v dch v ca t chc. c) the products and services of the organization.
T chc phi p dng tt c cc yu cu ca Tiu The organization shall apply all the requirements of this
chun quc t ny nu chng p dng c trong International Standard if they are applicable within the
phm vi h thng qun l cht lng m t chc xc determined scope of its quality management system.
nh.
Phm vi ca h thng qun l cht lng ca t The scope of the organizations quality management
chc phi sn c v c duy tr dng thng tin system shall be available and be maintained as
bng vn bn. Phm vi phi nu r cc loi sn documented information. The scope shall state the
phm v bao gm dch v, v gii thch cho bt k types of products and services covered, and provide
yu cu no ca Tiu chun quc t ny m t chc justification for any requirement of this International
xc nh l khng p dng trong phm vi p dng h Standard that the organization determines is not
thng qun l cht lng ca t chc. applicable to the scope of its quality management
system.
Tuyn b ph hp vi Tiu chun quc t ny ch Conformity to this International Standard may only be
c khng nh, nu cc yu cu c xc nh l claimed if the requirements determined as not being
khng p dng trong h thng khng lm nh applicable do not affect the organizations ability or
hng n kh nng hoc trch nhim ca t chc responsibility to ensure the conformity of its products
trong vic m bo s ph hp ca sn phm v and services and the enhancement of customer
dch v v nng cao s hi lng ca khch hng. satisfaction.
4.4 H thng qun l cht lng v cc qu 4.4 Quality management system and its
trnh ca h thng processes

4.4.1 T chc phi thit lp, thc hin, duy tr v ci 4.4.1 The organization shall establish, implement,
tin lin tc h thng qun l chtlng, bao gm maintain and continually improve a quality
cc qu trnh cn thit v s tng tc ca cc qu management system, including the processes needed
trnh, theo cc yu cu ca Tiu chun quc t ny. and their interactions, in accordance with the
requirements of this International Standard.
T chc phi xc nh cc qu trnh cn thit ca h The organization shall determine the processes
thng qun l cht lng v vic p dng cc qu needed for the quality management system and their
trnh ny trong ton b t chc, v phi: application throughout the organization, and shall:
a) xc nh cc yu t u vo cn thit v kt a) determine the inputs required and the outputs
qu mong i t cc qu trnh ny; expected from these processes;
b) xc nh trnh t v mi tng tc ca cc b) determine the sequence and interaction of these
qu trnh ny; processes;
c) xc nh v p dng cc tiu ch v phng c) determine and apply the criteria and methods
php (bao gm theo di, o lng v cc ch (including monitoring, measurements and related
s hot ng lin quan) cn thit m bo performance indicators) needed to ensure the
vic iu hnh v kim sot cc qu trnh ny effective operation and control of these
c hiu lc; processes;
d) xc nh cc ngun lc cn thit cho cc qu d) determine the resources needed for these
trnh ny v m bo tnh sn c ca cc processes and ensure their availability;
ngun lc;

15
ISO 9001:2015

e) phn cng trch nhim v quyn hn cho cc e) assign the responsibilities and authorities for
qu trnh ny these processes;
f) gii quyt cc ri ro v c hi c xc nh f) address the risks and opportunities as
theo cc yu cu ca 6.1. determined in accordance with the requirements
g) nh gi cc qu trnh ny v thc hin bt k of 6.1;
thay i no cn thit m bo rng cc qu g) evaluate these processes and implement any
trnh ny t c kt qu nh mong i ca changes needed to ensure that these processes
t chc; achieve their intended results;
h) ci tin cc qu trnh v h thng qun l cht h) improve the processes and the quality
lng. management system.

4.4.2 Theo mc cn thit, t chc phi: 4.4.2 To the extent necessary, the organization shall:

a) duy tr thng tin c lp vn bn h tr a) maintain documented information to support the

vic iu hnh cc qu trnh; operation of its processes;
b) lu gi thng tin c lp vn bn khng b) retain documented information to have
nh rng cc qu trnh ang c tin hnh confidence that the processes are being carried
theo nh hoch nh. out as planned.

5 S lnh o 5 Leadership

5.1 S lnh o v cam kt 5.1 Leadership and commitment

5.1.1 Khi qut 5.1.1 General

Lnh o cao nht phi chng t vai tr lnh o v Top management shall demonstrate leadership and
cam kt i vi h thng qun l cht lng qua commitment with respect to the quality management
vic: system by:

a) chu trch nhim v hiu lc ca h thng qun a) taking accountability for the effectiveness of the
l cht lng; quality management system;
b) m bo chnh sch cht lng v cc mc tiu b) ensuring that the quality policy and quality
cht lng c thit lp cho h thng qun l objectives are established for the quality
cht lng v ph hp vi nh hng chin management system and are compatible with the
lc v bi cnh ca t chc; context and strategic direction of the organization;
c) m bo s tch hp ca cc yu cu trong c) ensuring the integration of the quality management
h thng qun l cht lng vo cc qu system requirements into the organizations
trnh kinh doanh ca t chc; business processes;
d) thc y vic s dng cch tip cn qu trnh d) promoting the use of the process approach and
v t duy da trn ri ro; risk-based thinking;
e) m bo sn c cc ngun lc cn thit cho e) ensuring that the resources needed for the quality
h thng qun l cht lng; management system are available
f) truyn t v tm quan trng ca vic qun l f) communicating the importance of effective quality
cht lng c hiu lc v ph hp vi cc yu management and of conforming to the quality
cu h thng qun l cht lng; management system requirements;
g) m bo h thng qun l cht lng t g) ensuring that the quality management system
c kt qu mong i; achieves its intended results;

16
 ISO 9001:2015

h) tham gia, ch o v h tr cc c nhn ng h) engaging, directing and supporting persons to

gp vo tnh hiu lc ca h thng qun l contribute to the effectiveness of the quality
cht lng;
i) thc y s ci tin;
j) h tr vai tr qun l khc c lin quan j)
chng t vai tr lnh o ca h khi h thng
p dng trong cc phm vi thuc trch nhim.
CH THCH: Thut ng kinh doanh trong Tiu chun
quc t ny c th c din gii theo ngha rng bao
hm tt c cc hot ng mang tnh ct li cho mc ch
tn ti ca t chc; bt k l t chc cng lp, t
nhn, c mc ch v li nhun hay phi li nhun.
management system;
i) promoting improvement;
supporting other relevant management roles to
demonstrate their leadership as it applies to their
areas of responsibility.
NOTE Reference to business in this International
Standard can be interpreted broadly to mean those
activities that are core to the purposes of the organizations
existence, whether the organization is public, private, for
profit or not for profit.

5.1.2 Hng vo khch hng 5.1.2 Customer focus

Lnh o cao nht phi chng t vai tr lnh o v Top management shall demonstrate leadership and
cam kt lin quan n vic hng vo khch hng commitment with respect to customer focus by
bng cch m bo rng: ensuring that:

a) cc yu cu khch hng v lut nh v ch a) customer and applicable statutory and regulatory

nh c xc nh, thu hiu v c p requirements are determined, understood and
ng mt cch nht qun; consistently met;

b) nhng ri ro v c hi c th nh hng n b) the risks and opportunities that can affect

s ph hp ca sn phm v dch v v kh conformity of products and services and the
nng nng cao s hi lng ca khch hng ability to enhance customer satisfaction are
c xc nh v c gii quyt; determined and addressed;
c) s tp trung vo vic nng cao s hi lng ca c) the focus on enhancing customer satisfaction is
khch hng c duy tr. maintained.

5.2 Chnh sch cht lng 5.2 Policy

5.2.1 Thit lp chnh sch cht lng 5.2.1 Establishing the quality policy
Lnh o cao nht phi thit lp, thc hin v duy Top management shall establish, implement and
tr chnh sch cht lng, m bo rng: maintain a quality policy that:

a) ph hp vi mc ch v bi cnh ca t chc a) is appropriate to the purpose and context of the

v h tr cc nh hng chin lc ca t organization and supports its strategic direction;
chc; b) provides a framework for setting quality
b) cung cp khun kh cho vic thit lp cc mc objectives;
tiu cht lng; c) includes a commitment to satisfy applicable
c) bao gm cam kt tha mn cc yu cu thch requirements;
hp; d) includes a commitment to continual improvement
d) bao gm cam kt ci tin lin tc h thng of the quality management system.
qun l cht lng.

5.2.2 Truyn t chnh sch cht lng 5.2.2 Communicating the quality policy

Chnh sch cht lng phi: The quality policy shall:

17
ISO 9001:2015

a) sn c v c duy tr di dng thng tin a) be available and be maintained as documented

bng vn bn; information;
b) c truyn t, thu hiu v c p dng b) be communicated, understood and applied within
trong t chc; the organization;
c) sn c cho cc bn lin quan, khi thch hp. c) be available to relevant interested parties, as
appropriate.

5.3 Vai tr, trch nhim v quyn hn trong 5.3 Organizational roles, responsibilities and
t chc authorities

Lnh o cao nht phi m bo rng cc trch Top management shall ensure that the responsibilities
nhim v quyn hn cho cc vai tr thch hp c and authorities for relevant roles are assigned,
phn cng, truyn t v thu hiu trong t chc. communicated and understood within the organization

Lnh o cao nht phi phn cng trch nhim v Top management shall assign the responsibility and
quyn hn : authority for:
a) m bo rng h thng qun l cht lng a) ensuring that the quality management system
ph hp vi cc yu cu ca Tiu chun Quc conforms to the requirements of this International
t ny; Standard;
b) m bo rng cc qu trnh ang cung cp b) ensuring that the processes are delivering their
cc kt qu u ra nh d kin; intended outputs;
c) bo co v vic thc hin h thng qun l c) reporting on the performance of the quality
cht lng v cc c hi ci tin (xem management system and on opportunities for
10.1), bo co n lnh o cao nht. improvement (see 10.1), in particular to top
d) m bo thc y vic hng vo khch management;
hng trong ton b t chc; d) ensuring the promotion of customer focus
e) m bo rng tnh nht qun ca h thng throughout the organization;
qun l cht lng c duy tr khi c s thay e) ensuring that the integrity of the quality
i i vi h thng qun l cht lng c management system is maintained when
hoch nh v thc hin. changes to the quality management system are
planned and implemented.

6 Hoch nh 6 Planning

6.1 Hnh ng gii quyt ri ro v c hi 6.1 Actions to address risks and opportunities

6.1.1 Khi hoch nh h thng qun l cht lng, 6.1.1 When planning for the quality management
t chc phi xem xt cc vn c cp ti system, the organization shall consider the issues
im 4.1 v cc yu cu nu trong mc 4.2 v xc referred to in 4.1 and the requirements referred to in
nh cc ri ro v c hi cn phi c gii quyt 4.2 and determine the risks and opportunities that
: need to be addressed to:

a) cung cp s bo m rng h thng qun l a) give assurance that the quality management
cht lng c th t c (cc) kt qu nh system can achieve its intended result(s);
d kin; b) enhance desirable effects;
b) nng cao cc tc ng mong mun;

18

c) ngn nga, hoc gim cc tc ng khng
mong mun;
d) t c s ci tin.
6.1.2 T chc phi hoch nh:
a) cc hnh ng gii quyt cc ri ro v c
hi;
b) lm th no :
1] tch hp v thc hin cc hnh ng vo
trong cc qu trnh ca h thng qun l cht
lng ca t chc (xem 4.4);
2] nh gi hiu lc ca cc hnh ng ny.
Cc hnh ng c thc hin gii quyt cc ri Actions taken to address risks and opportunities shall
ro v c hi phi tng xng vi tc ng tim n
n s ph hp ca sn phm v dch v.
CH THCH 1: Cc la chn gii quyt nhng ri ro
v c hi c th bao gm vic trnh ri ro, chp nhn
ri ro theo ui mt c hi, loi b cc ngun ri ro,
thay i kh nng hoc hu qu, chia s ri ro, hoc gi
li ri ro bng cc quyt nh khi c thng tin.
CH THCH 2: Cc c hi c th dn n vic chp
nhn cc thc thc hnh mi, tung ra cc sn phm
mi, m rng th trng mi, tip cn cc khch hng
mi, xy dng quan h i tc, s dng cng ngh mi
v cc kh nng mong mun v kh thi p ng nhu
cu ca t chc hoc khch hng ca t chc.
6.2 Mc tiu cht lng v hoch nh t 6.2 Quality objectives and planning to achieve
c mc tiu them
6.2.1 T chc phi thit lp cc mc tiu cht
lng ti cc cp, b phn chc nng v cc qu
trnh cn thit ca h thng qun l cht lng.
Mc tiu cht lng phi:
a) nht qun vi chnh sch cht lng;
b) o lng c;
c) c tnh n cc yu cu c th p dng;
d) lin quan n s ph hp ca sn phm v dch
v v nng cao s tha mn ca khch hng;
e) c gim st;
f) c truyn t;
g) c cp nht khi thch hp.
T chc phi duy tr thng tin dng vn bn v cc
mc tiu cht lng.
6.2.2 Khi hoch nh cch thc t c cc mc
tiu cht lng ca t chc, t chc phi xc nh:
ISO 9001:2015
c) prevent, or reduce, undesired effects;
d) achieve improvement.
6.1.2 The organization shall plan:
a) actions to address these risks and opportunities;
b) how to:
1] integrate and implement the actions into its
quality management system processes (see
4.4);
2] evaluate the effectiveness of these actions.
be proportionate to the potential impact on the
conformity of products and services.
NOTE 1 Options to address risks can include avoiding risk,
taking risk in order to pursue an opportunity, eliminating the
risk source, changing the likelihood or consequences,
sharing the risk, or retaining risk by informed decision.
NOTE 2 Opportunities can lead to the adoption of new
practices, launching new products, opening new markets,
addressing new customers, building partnerships, using
new technology and other desirable and viable possibilities
to address the organizations or its customers needs.
6.2.1 The organization shall establish quality
objectives at relevant functions, levels and processes
needed for the quality management system.
The quality objectives shall:
a) be consistent with the quality policy;
b) be measurable;
c) take into account applicable requirements;
d) be relevant to conformity of products and services
and to enhancement of customer satisfaction;
e) be monitored;
f) be communicated;
g) be updated as appropriate.
The organization shall maintain documented
information on the quality objectives.
6.2.2 When planning how to achieve its quality
objectives, the organization shall determine:
19
ISO 9001:2015

a) ci g s c thc hin; a) what will be done;

b) nhng ngun lc no s c yu cu;
c) ai s chu trch nhim;
d) khi no chng s c hon thnh;
e) kt qu s c nh gi nh th no.
6.3 Hoch nh s thay i
b) what resources will be required;
c) who will be responsible;
d) when it will be completed;
e) how the results will be evaluated.
6.3 Planning of changes

Khi t chc xc nh nhu cu cho cc thay i i When the organization determines the need for
vi h thng qun l cht lng, cc thay i phi changes to the quality management system, the
c tin hnh mt cch h thng v c k hoch changes shall be carried out in a planned manner (see
(xem 4.4). 4.4).

T chc phi xem xt: The organization shall consider:

a) mc ch ca s thay i v cc hu qu tim a) the purpose of the changes and their potential

n ca s thay i; consequences;
b) tnh ton vn ca h thng qun l cht lng; b) the integrity of the quality management system;
c) s sn c cc ngun lc; c) the availability of resources;
d) vic phn b hoc ti phn b trch nhim v d) the allocation or reallocation of responsibilities and
quyn hn. authorities.

7 H tr 7 Support

7.1 Ngun lc 7.1 Resources

7.1.1 Khi qut 7.1.1 General

T chc phi xc nh v cung cp cc ngun lc The organization shall determine and provide the
cn thit cho vic thit lp, thc hin, duy tr v ci resources needed for the establishment,
tin lin tc h thng qun l cht lng. implementation, maintenance and continual
improvement of the quality management system.

T chc phi xem xt: The organization shall consider:

a) kh nng, v nhng hn ch ca cc ngun lc a) the capabilities of, and constraints on, existing
ni b hin c; internal resources;
b) nhng g cn phi cung cp t cc nh cung cp b) what needs to be obtained from external providers.
bn ngoi.

7.1.2 Nhn lc 7.1.2 People

T chc phi xc nh v cung cp nhn lc cn The organization shall determine and provide the
thit vic thc hin c hiu lc h thng qun l persons necessary for the effective implementation of
cht lng ca t chc v cho hot ng v kim its quality management system and for the operation
sot cc qu trnh ca h thng. and control of its processes.

7.1.3 C s h tng 7.1.3 Infrastructure

T chc phi xc nh, cung cp v duy tr c s h The organization shall determine, provide and maintain
tng thit yu cho vic vn hnh cc qu trnh ca the infrastructure necessary for the operation of its
t chc t c s ph hp ca sn phm v processes and to achieve conformity of products and
dch v. services.

20
 ISO 9001:2015

CH THCH: C s h tng c th bao gm: NOTE Infrastructure can include:

a) Nh xng v phng tin km theo; a) buildings and associated utilities;
b) Trang thit b, gm c phn cng ln phn mm; b) equipment, including hardware and software;
c) ngun lc vn chuyn; c) transportation resources;
d) cng ngh thng tin v truyn thng. d) information and communication technology.

7.1.4 Mi trng cho vic vn hnh cc qu trnh 7.1.4 Environment for the operation of processes
T chc phi xc nh, cung cp v duy tr mi The organization shall determine, provide and maintain
trng cn thit cho vn hnh ca cc qu trnh ca the environment necessary for the operation of its
t chc v t c s ph hp ca sn phm processes and to achieve conformity of products and
v dch v. services.
CH THCH: Mi trng thch hp c th l mt s kt NOTE A suitable environment can be a combination of
hp ca yu t con ngi v vt cht, chng hn nh: human and physical factors, such as:
a) x hi (v d nh khng phn bit i x, bnh tnh, a) social (e.g. non-discriminatory, calm, non-
khng i u); confrontational);
b) tm l (v d nh gim cng thng, phng nga kit b) psychological (e.g. stress-reducing, burnout
sc, bo v cm xc); prevention, emotionally protective);
c) vt l (v d nh nhit , nng, m, nh sng, c) physical (e.g. temperature, heat, humidity, light,
lung khng kh, v sinh, ting n). airflow, hygiene, noise).
Nhng yu t ny c th khc nhau ng k ty These factors can differ substantially depending on the
thuc vo cc sn phm, dch v cung cp. products and services provided.
7.1.5 Cc ngun lc theo di v o lng 7.1.5 Monitoring and measuring resources

7.1.5.1 Khi qut 7.1.5.1 General

T chc phi xc nh v cung cp cc ngun lc The organization shall determine and provide the
cn thit m bo cc kt qu xc thc v ng resources needed to ensure valid and reliable results
tin cy khi s dng hot ng theo di hoc o when monitoring or measuring is used to verify the
lng xc nhn s ph hp ca cc sn phm conformity of products and services to requirements.
v dch v i vi cc yu cu.
T chc phi m bo rng cc ngun lc c The organization shall ensure that the resources
cung cp: provided:
a) ph hp vi cc loi hnh c th ca cc hot a) are suitable for the specific type of monitoring and
ng gim st v o lng ang c thc measurement activities being undertaken;
hin; b) are maintained to ensure their continuing fitness
b) c duy tr m bo chng lin tc ph for their purpose.
hp vi mc ch ca t chc.
T chc phi lu gi li cc thng tin dng vn bn The organization shall retain appropriate documented
thch hp nh l bng chng ca s ph hp vi information as evidence of fitness for purpose of the
mc ch ca cc ngun lc theo di v o lng. monitoring and measurement resources.
7.1.5.2 Lin kt chun o lng 7.1.5.2 Measurement traceability
Khi lin kt chun o lng l mt yu cu, hoc When measurement traceability is a requirement, or
khi t chc xem xt rng y l mt phn thit yu is considered by the organization to be an essential
ca vic cung cp s tin cy v tnh xc thc ca part of providing confidence in the validity of
cc kt qu o, th thit b o phi: measurement results, measuring equipment shall
be:

21
ISO 9001:2015

a) c hiu chun hoc kim tra xc nhn, hoc a) calibrated or verified, or both, at specified
c hai, nh k, hoc trc khi s dng, da intervals, or prior to use, against measurement
trn tiu chun o lng c lin kt vi cc standards traceable to international or national
tiu chun o lng quc gia hay quc t; khi measurement standards; when no such
khng c cc chun ny, th cn c c s standards exist, the basis used for calibration or
dng hiu chun hoc kim tra xc nhn verification shall be retained as documented
phi c lu gi thng tin dng vn bn; information;
b) c nhn bit xc nh tnh trng; b) identified in order to determine their status;
c) gi gn trnh b iu chnh, h hng hoc c) safeguarded from adjustments, damage or
xung cp c th lm mt hiu lc cc tnh deterioration that would invalidate the calibration
trng hiu chun v cc kt qu tip o lng status and subsequent measurement results.
sau .

T chc phi xc nh tnh xc thc ca cc kt qu
o lng trc c b nh hng xu khi c thit
b o lng c xc nh l khng thch hp vi
mc ch d kin, v phi c hnh ng thch hp
khi cn thit.
The organization shall determine if the validity of
previous measurement results has been adversely
affected when measuring equipment is found to be unfit
for its intended purpose, and shall take appropriate
action as necessary.

7.1.6 Tri thc ca t chc 7.1.6 Organizational knowledge

T chc phi xc nh tri thc cn thit cho vic The organization shall determine the knowledge
vn hnh cc qu trnh ca t chc v t necessary for the operation of its processes and to
c s ph hp ca cc sn phm v dch v. achieve conformity of products and services.
Tri thc ny phi c duy tr v phi sn c ty This knowledge shall be maintained and be made
mc cn thit. available to the extent necessary.
Khi gii quyt cc nhu cu v xu hng thay i, When addressing changing needs and trends, the
t chc phi xem xt tri thc hin ti ca t chc organization shall consider its current knowledge
v xc nh lm th no c c hoc tip cn and determine how to acquire or access any
bt k kin thc b sung v cp nht tri thc cn necessary additional knowledge and required
thit. updates.
CH THCH 1: Tri thc ca t chc l kin thc c NOTE 1 Organizational knowledge is knowledge specific
trng i vi t chc; c thu thp t kinh nghim. to the organization; it is generally gained by experience. It
N l thng tin c s dng v chia s t c is information that is used and shared to achieve the
cc mc tiu ca t chc. organizations objectives.
CH THCH 2: Tri thc ca t chc c th da trn: NOTE 2 Organizational knowledge can be based on:
ngun ni b (v d nh s hu tr tu, kin thc thu internal sources (e.g. intellectual property; knowledge
c t kinh nghim; bi hc kinh nghim t cc d n gained from experience; lessons learned from failures and
tht bi v thnh cng; nm bt v chia s kinh nghim successful projects; capturing and sharing undocumented
v kin thc khng c lp vn bn; cc kt qu ca knowledge and experience; the results of improvements in
nhng ci tin trong cc qu trnh, sn phm v dch processes, products and services);
v); external sources (e.g. standards; academia; conferences;
Cc ngun bn ngoi (v d nh cc tiu chun; hc gathering knowledge from customers or external
vin; hi ngh; thu thp kin thc t khch hng hoc providers).
cc nh cung cp bn ngoi).

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 ISO 9001 : 2015

7.2 Nng lc 7.2 Competence

T chc phi: The organization shall:

a) xc nh nng lc cn thit ca (nhng) ngi a) determine the necessary competence of
lm vic di s kim sot ca t chc c nh person(s) doing work under its control that affects
hng n kt qu hot ng v hiu lc ca the performance and effectiveness of the quality
h thng qun l cht lng; management system;
b) m bo rng nhng ngi ny c nng lc b) ensure that these persons are competent on the
da trn gio dc, o to, hoc kinh nghim basis of appropriate education, training, or
thch hp; experience;
c) khi thch hp, phi c nhng hnh ng t c) where applicable, take actions to acquire the
c cc nng lc cn thit, v nh gi tnh necessary competence, and evaluate the
hiu lc ca cc hnh ng ny; effectiveness of the actions taken;
d) duy tr thng tin c lp vn bn thch hp d) retain appropriate documented information as
nh bng chng chng minh nng lc. evidence of competence.
CH THCH: Cc hnh ng thch hp c th bao gm, NOTE Applicable actions can include, for example, the
v d, vic cung cp o to, hng dn, hoc b tr li provision of training to, the mentoring of, or the re-
nhng ngi hin ang lm vic; hoc thu mn hoc assignment of currently employed persons; or the hiring or
thu hp ng vi ngi c nng lc. contracting of competent persons.
7.3 Nhn thc 7.3 Awareness

T chc phi m bo rng nhng ngi lm vic The organization shall ensure that persons doing work
di s kim sot ca t chc nhn thc c: under the organizations control are aware of:
a) chnh sch cht lng; a) the quality policy;
b) cc mc tiu cht lng lin quan; b) relevant quality objectives;
c) ng gp ca h i vi hiu lc ca h thng c) their contribution to the effectiveness of the
qun l cht lng, bao gm cc li ch khi kt quality management system, including the
qu hot ng cht lng c ci tin; benefits of improved performance;
d) nhng tc ng ca s khng ph hp vi cc d) the implications of not conforming with the quality
yu cu h thng qun l cht lng. management system requirements.
7.4 Trao i thng tin 7.4 Communication

T chc phi xc nh vic trao i thng tin ni b The organization shall determine the internal and
v bn ngoi lin quan n h thng qun l cht external communications relevant to the quality
lng, bao gm: management system, including:
a) iu g t chc s truyn t; a) on what it will communicate;
b) khi no phi truyn t; b) when to communicate;
c) truyn t cho ai; c) with whom to communicate;
d) truyn t nh th no; d) how to communicate;
e) ai truyn t. e) who communicates.
7.5 Thng tin c lp vn bn 7.5 Documented information

7.5.1 Khi qut 7.5.1 General

H thng qun l cht lng ca t chc phi bao The organizations quality management system shall
gm: include:

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ISO 9001 : 2015

a) cc thng tin c lp vn bn theo yu cu a) documented information required by this

ca Tiu chun quc t ny; International Standard;
b) cc thng tin c lp vn bn c t chc b) documented information determined by the
xc nh l cn thit m bo tnh hiu lc organization as being necessary for the
ca h thng qun l cht lng. effectiveness of the quality management system.
CH THCH: Mc thng tin c lp vn bn ca NOTE: The extent of documented information for a quality
mt h thng qun l cht lng c th khc nhau gia management system can differ from one organization to
cc t chc bi: another due to:

quy m v loi hnh hot ng, cc qu trnh, sn
the size of organization and its type of activities,
phm v dch v ca t chc; processes, products and services;

mc phc tp ca cc qu trnh v s tng tc
the complexity of processes and their interactions;
ca chng;

the competence of persons.

nng lc nhn s.
7.5.2 To mi v cp nht 7.5.2 Creating and updating
Khi to mi v cp nht thng tin c lp vn When creating and updating documented
bn, t chc phi m bo: information, the organization shall ensure
a) vic nhn bit v m t thch hp (v d: tiu appropriate:
, ngy, tc gi hoc s tham chiu); a) identification and description (e.g. a title, date,
b) nh dng trnh by thch hp (v d: ngn ng, author, or reference number);
phin bn phn mm, hnh nh) v dng pht b) format (e.g. language, software version,
hnh (v d: giy, in t); graphics) and media (e.g. paper, electronic);
c) xem xt v ph duyt cho s thch hp v tha c) review and approval for suitability and adequacy.
ng

7.5.3 Kim sot thng tin c lp vn bn 7.5.3 Control of documented information

7.5.3.1 Thng tin c lp vn bn c yu cu 7.5.3.1 Documented information required by the

bi h thng qun l cht lng v bi Tiu chun
quc t ny phi c kim sot m bo:
a) n sn c v thch hp cho vic s dng, bt
c khi no v bt c u khi cn thit;
b) n c bo v y (v d: trnh mt tnh
trng bo mt, s dng sai mc ch, hoc mt
tnh ton vn).
quality management system and by this International
Standard shall be controlled to ensure:
a) it is available and suitable for use, where and
when it is needed;
b) it is adequately protected (e.g. from loss of
confidentiality, improper use, or loss of integrity).

7.5.3.2 kim sot thng tin c lp vn bn, 7.5.3.2 For the control of documented information, the
t chc phi gii quyt cc hot ng sau, khi thch organization shall address the following activities, as
hp: applicable:

a) phn phi, truy cp, thu hi v s dng;
b) lu tr, bo qun, bao gm c vic bo qun
mc r rng;
c) kim sot s thay i (v d kim sot phin
bn);
d) lu gi v hy b.
a) distribution, access, retrieval and use;
b) storage and preservation, including preservation
of legibility;
c) control of changes (e.g. version control);
d) retention and disposition.

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 ISO 9001 : 2015

Thng tin c lp vn bn c ngun gc bn Documented information of external origin

ngoi c t chc xc nh l cn thit cho vic determined by the organization to be necessary for
hoch nh v iu hnh h thng qun l cht the planning and operation of the quality
lng phi c nhn bit khi thch hp v management system shall be identified as
c kim sot. appropriate, and be controlled.

Thng tin c lp vn bn c lu gi li lm Documented information retained as evidence of

bng chng ca s ph hp phi c bo v
trnh b sa i ngoi mun.
CH THCH: Truy cp c th bao hm mt quyt nh
lin quan n vic ch cho php xem thng tin c lp
vn bn, hoc s cho php v thm quyn xem v
sa i thng tin c lp vn bn.
conformity shall be protected from unintended
alterations.
NOTE: Access can imply a decision regarding the
permission to view the documented information only, or
the permission and authority to view and change the
documented information.

8 iu hnh 8 Operation

8.1 Hoch nh v kim sot iu hnh 8.1 Operational planning and control

T chc phi lp k hoch, thc hin v kim sot
cc qu trnh cn thit (xem 4.4), p ng cc
yu cu cung cp cc sn phm v dch v, v
thc hin cc hnh ng xc nh trong iu 6, bng
cch:
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 6, by:

a) xc nh cc yu cu i vi sn phm v dch a) determining the requirements for the products

v; and services;
b) thit lp chun mc cho: b) establishing criteria for:
1] cc qu trnh; 1] the processes;
2] vic chp nhn sn phm v dch v; 2] the acceptance of products and services;

c) xc nh cc ngun lc cn thit t c c) determining the reso2urces needed to achieve

s ph hp vi cc yu cu ca sn phm v conformity to the product and service
dch v; requirements;
d) thc hin vic kim sot cc qu trnh theo cc d) implementing control of the processes in
chun mc; accordance with the criteria;
e) xc nh v lu gi cc thng tin c lp vn e) determining, maintaining and retaining
bn mc cn thit: documented information to the extent necessary:
1] c s tin tng rng cc qu trnh 1] to have confidence that the processes have
c thc hin nh hoch nh; been carried out as planned
2] chng minh s ph hp vi cc yu 2] to demonstrate the conformity of products
cu ca sn phm v dch v. and services to their requirements.

u ra ca vic hoch nh ny phi thch hp vi The output of this planning shall be suitable for the
cc hot ng ca t chc. organizations operations.
T chc phi kim sot cc thay i theo k hoch The organization shall control planned changes and
v phi xem xt hu qu ca cc thay i khng review the consequences of unintended changes,
mong mun, thc hin cc hnh ng gim taking action to mitigate any adverse effects, as
thiu bt k nh hng tiu cc no, khi cn thit. necessary.

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ISO 9001 : 2015

T chc phi m bo rng cc qu trnh thu The organization shall ensure that outsourced
ngoi c kim sot (xem 8.4). processes are controlled (see 8.4).
8.2 Yu cu i vi sn phm v dch v 8.2 Requirements for products and services

8.2.1 Trao i thng tin vi khch hng 8.2.1 Customer communication

Trao i thng tin vi khch hng phi bao gm: Communication with customers shall include:
a) cung cp thng tin lin quan n sn phm v a) providing information relating to products and
dch v; services;
b) x l cc yu cu, hp ng hoc n t b) handling enquiries, contracts or orders, including
hng, bao gm c nhng thay i; changes;
c) thu thp thng tin phn hi ca khch hng lin c) obtaining customer feedback relating to products
quan n cc sn phm v dch v, bao gm and services, including customer complaints;
c cc khiu ni ca khch hng; d) handling or controlling customer property;
d) x l hoc kim sot ti sn ca khch hng; e) establishing specific requirements for
e) thit lp cc yu cu c th i vi cc hnh contingency actions, when relevant.
ng d phng, khi thch hp.

8.2.2 Xc nh cc yu cu lin quan n sn 8.2.2 Determining the requirements for products

phm v dch v and services

Khi xc nh cc yu cu i vi cc sn phm v When determining the requirements for the products

dch v s cung cp cho khch hng, t chc phi and services to be offered to customers, the
m bo rng: organization shall ensure that:

a) cc yu cu i vi cc sn phm v dch v a) the requirements for the products and services

c xc nh, bao gm: are defined, including:
b) cc yu cu lut nh v ch nh thch hp; b) any applicable statutory and regulatory
c) nhng yu cu m t chc xem xt l cn thit; requirements;

d) t chc c kh nng p ng cc tuyn b v c) those considered necessary by the organization;

sn phm v dch v m t chc cung cp. d) the organization can meet the claims for the
products and services it offers.

8.2.3 Xem xt cc yu cu lin quan n sn 8.2.3 Review of the requirements for products and
phm v dch v services

8.2.3.1 T chc phi m bo rng t chc c kh 8.2.3.1 The organization shall ensure that it has the
nng p ng cc yu cu i vi cc sn phm ability to meet the requirements for products and
v dch v cung cp cho khch hng. T chc phi services to be offered to customers. The
tin hnh xem xt trc khi cam kt cung cp sn organization shall conduct a review before
phm v dch v cho khch hng, bao gm: committing to supply products and services to a
customer, to include:

a) cc yu cu a ra bi khch hng, bao gm a) requirements specified by the customer, including

cc yu cu i vi cc hot ng giao hng the requirements for delivery and post- delivery
v sau giao hng; activities;

26
 ISO 9001 : 2015

b) cc yu cu khch hng khng a ra, nhng b) requirements not stated by the customer, but
cn thit cho mc ch s dng, khi bit; necessary for the specified or intended use, when
c) cc yu cu do t chc xc nh; known;

d) cc yu cu ch nh v lut php p dng i c) requirements specified by the organization;

vi cc sn phm v dch v; d) statutory and regulatory requirements applicable
e) cc yu cu trong hp ng hoc n t to the products and services;
hng khc bit so vi nhng yu cu a e) contract or order requirements differing from
ra trc . those previously expressed.

T chc phi m bo rng hp ng hoc n The organization shall ensure that contract or order
t hng c cc yu cu khc bit vi nhng g requirements differing from those previously
a ra trc phi c xc nh v gii defined are resolved.
quyt.

T chc phi xc nhn yu cu ca khch hng The customers requirements shall be confirmed
trc khi chp nhn, khi khch hng khng cung by the organization before acceptance, when the
cp yu cu ca h bng vn bn. customer does not provide a documented statement
of their requirements.
CH THCH: Trong mt s trng hp, nh bn hng NOTE In some situations, such as internet sales, a
qua internet, vi mi ln t hng, vic xem xt chnh formal review is impractical for each order. Instead, the
thc l khng thc t cho mi n hng. Thay vo , review can cover relevant product information, such as
vic xem xt c th thc hin vi cc thng tin lin quan catalogues.
v sn phm, nh ti liu cho hng.

8.2.3.2 T chc phi lu tr cc thng tin c 8.2.3.2 The organization shall retain documented
lp vn bn, khi thch hp: information, as applicable:
a) v kt qu xem xt; a) on the results of the review;
b) v bt k yu cu mi cho cc sn phm v b) on any new requirements for the products and
dch v services.

8.2.4 Cc thay i yu cu i vi sn phm v 8.2.4 Changes to requirements for products and

dch v services
T chc phi m bo cc thng tin c lp vn The organization shall ensure that relevant
bn lin quan c hiu chnh, v cc c nhn lin documented information is amended, and that
quan nhn thc c cc yu cu b thay i, relevant persons are made aware of the changed
khi cc yu cu v sn phm v dch v thay i. requirements, when the requirements for products
and services are changed.
8.3 Thit k v pht trin sn phm v dch 8.3 Design and development of products and
v services

8.3.1 Khi qut 8.3.1 General

T chc phi thit lp, thc hin v duy tr qu The organization shall establish, implement and
trnh thit k v pht trin thch hp m bo maintain a design and development process that is
vic cung cp sn phm v dch v sau . appropriate to ensure the subsequent provision of
products and services.

8.3.2 Hoch nh thit k v pht trin 8.3.2 Design and development planning

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ISO 9001 : 2015

Khi xc nh cc giai on v bin php kim sot In determining the stages and controls for design and
thit k v pht trin, t chc phi xem xt: development, the organization shall consider:
a) bn cht, thi gian v mc phc tp ca a) the nature, duration and complexity of the design
cc hot ng thit k v pht trin; and development activities;
b) cc giai on thit k cn thit, bao gm cc b) the required process stages, including applicable
hot ng xem xt thit k v pht trin ph design and development reviews;
hp; c) the required design and development verification
c) cc hot ng xc nhn gi tr s dng v kim and validation activities
tra xc nhn thit k v pht trin cn thit; d) the responsibilities and authorities involved in the
d) trch nhim v quyn hn trong qu trnh thit design and development process;
k v pht trin; e) the internal and external resource needs for the
e) ngun lc ni b v bn ngoi cn thit cho design and development of products and
vic thit k v pht trin sn phm v dch v; services;
f) nhu cu kim sot cc mi tng giao gia f) the need to control interfaces between persons
nhng ngi tham gia vo qu trnh thit k v involved in the design and development process;
pht trin; g) the need for involvement of customers and users
g) nhu cu tham gia ca khch hng v ngi s in the design and development process;
dng trong qu trnh thit k v pht trin; h) the requirements for subsequent provision of
h) cc yu cu i vi vic cung cp ca sn products and services;
phm v dch v sau ; i) the level of control expected for the design and
i) mc kim sot d kin cho qu trnh thit development process by customers and other
k v pht trin bi cc khch hng v cc bn relevant interested parties;
quan tm khc c lin quan; j) the documented information needed to
j) cc thng tin c lp vn bn cn thit demonstrate that design and development
chng minh rng cc yu cu thit k v pht requirements have been met.
trin c p ng.
8.3.3 u vo ca thit k v pht trin 8.3.3 Design and development inputs
T chc phi xc nh cc yu cu thit yu cho The organization shall determine the requirements
cc loi hnh c th ca sn phm v dch v s essential for the specific types of products and
c thit k v pht trin. T chc phi xem xt: services to be designed and developed. The
organization shall consider:
a) cc yu cu chc nng v kt qu hot ng; a) functional and performance requirements;
b) thng tin t cc hot ng thit k v pht trin b) information derived from previous similar design
tng t trc ; and development activities;
c) cc yu cu ch nh v lut nh; c) statutory and regulatory requirements;
d) tiu chun hoc quy phm thc hnh m t d) standards or codes of practice that the
chc cam kt thc hin; organization has committed to implement;
e) nhng hu qu tim n ca s tht bi do bn e) potential consequences of failure due to the
cht ca cc sn phm v dch v. nature of the products and services.
u vo phi y cho cc mc ch thit k v Inputs shall be adequate for design and development
pht trin, ton vn, v khng m h. Mu thun purposes, complete and unambiguous. Conflicting
trong u vo thit k v pht trin phi c gii design and development inputs shall be resolved.
quyt.

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 ISO 9001 : 2015

T chc phi lu gi li cc thng tin c lp The organization shall retain documented

vn bn u vo thit k v pht trin.
8.3.4 Kim sot thit k v pht trin
T chc phi p dng cc bin php kim sot
qu trnh thit k v pht trin nhm m bo
rng:
information on design and development inputs
8.3.4 Design and development controls
The organization shall apply controls to the design
and development process to ensure that:

a) cc kt qu cn t c xc nh; a) the results to be achieved are defined;

b) cc hot ng xem xt c tin hnh nh b) reviews are conducted to evaluate the ability of
gi cc kt qu thit k v pht trin nhm p the results of design and development to meet
ng cc yu cu; requirements;
c) cc hot ng thm tra xc nhn c tin c) verification activities are conducted to ensure that
hnh m bo rng cc kt qu u ra thit the design and development outputs meet the
k v pht trin p ng cc yu cu u vo; input requirements;
d) cc hot ng xc nhn gi tr s dng c d) validation activities are conducted to ensure that
tin hnh m bo rng cc sn phm v the resulting products and services meet the
dch v sau cng p ng cc yu cu ng requirements for the specified application or
dng c th hoc s dng d kin; intended use;
e) bt k hnh ng cn thit no c thc hin e) any necessary actions are taken on problems
i vi cc vn c xc nh trong qu determined during the reviews, or verification and
trnh xem xt, hoc cc hot ng kim tra xc validation activities;
nhn v xc nhn gi tr s dng; f) documented information of these activities is
f) thng tin c lp vn bn ca cc hot ng retained.
ny c lu gi.
CH THCH: Xem xt thit k v pht trin, kim tra NOTE Design and development reviews, verification
xc nhn v xc nhn gi tr s dng c cc mc ch and validation have distinct purposes. They can be
ring bit. Cc vic ny th c tin hnh ring r conducted separately or in any combination, as is suitable
hoc kt hp, khi thch hp cho cc sn phm v dch for the products and services of the organization.
v ca t chc.

8.3.5 u ra ca thit k v pht trin 8.3.5 Design and development outputs

T chc phi m bo rng cc u ra ca thit The organization shall ensure that design and
k v pht trin: development outputs:

a) p ng cc yu cu u vo; a) meet the input requirements;

b) y cho cc qu trnh tip theo trong vic b) are adequate for the subsequent processes for
cung cp cc sn phm v dch v; the provision of products and services;
c) bao gm hoc vin dn n cc yu cu gim c) include or reference monitoring and measuring
st v o lng, khi thch hp, v cc chun requirements, as appropriate, and acceptance
mc chp nhn; criteria;
d) xc nh r cc c tnh ca sn phm v dch d) specify the characteristics of the products and
v cn thit cho mc ch s dng v vic services that are essential for their intended
chuyn giao chng ng cch v an ton. purpose and their safe and proper provision.

T chc phi lu gi cc thng tin c lp vn The organization shall retain documented

bn v kt qu u ra ca thit k v pht trin. information on design and development outputs.

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ISO 9001 : 2015

8.3.6 Thay i thit k v pht trin 8.3.6 Design and development changes

T chc phi nhn bit, xem xt v kim sot The organization shall identify, review and control
nhng thay i c to ra trong sut, hoc sau, changes made during, or subsequent to, the design
vic thit k v pht trin sn phm v dch v, and development of products and services, to the
mc cn thit m bo rng khng c tc extent necessary to ensure that there is no adverse
ng bt li n s ph hp i vi cc yu cu. impact on conformity to requirements

T chc phi lu gi li cc thng tin c lp The organization shall retain documented information
vn bn v: on:

a) cc thay i thit k v pht trin; a) design and development changes;

b) cc kt qu ca vic xem xt; b) the results of reviews;
c) quyn hn thng qua cc thay i; c) the authorization of the changes;
d) cc hnh ng c thc hin ngn chn d) the actions taken to prevent adverse impacts.
nhng tc ng bt li.
8.4 Kim sot cc sn phm v dch v do 8.4 Control of externally provided processes,
bn ngoi cung cp products and services

8.4.1 Khi qut 8.4.1 General

T chc phi m bo cc qu trnh bn ngoi The organization shall ensure that externally
cung cp sn phm, v dch v ph hp vi cc provided processes, products and services conform
yu cu. to requirements.

T chc phi xc nh vic kim sot c p The organization shall determine the controls to be
dng cho cc quy trnh, sn phm v dch v c applied to externally provided processes, products
bn ngoi cung cp khi: and services when:

a) cc sn phm v dch v t cc nh cung cp a) products and services from external providers

bn ngoi c d kin a vo cho vic cu are intended for incorporation into the
thnh cc sn phm v dch v ca t chc; organizations own products and services;
b) cc sn phm v dch v c cung cp trc b) products and services are provided directly to the
tip cho (cc) khch hng bi cc nh cung customer(s) by external providers on behalf of
cp bn ngoi thay mt cho t chc; the organization;
c) mt qu trnh, hay mt phn ca mt qu trnh, c) a process, or part of a process, is provided by an
c cung cp bi mt nh cung cp bn external provider as a result of a decision by the
ngoi nh l kt qu ca mt quyt nh ca organization.
t chc.

T chc phi xc nh v p dng cc chun mc
nh gi, la chn, gim st kt qu hot ng v
nh gi li cc nh cung cp bn ngoi, da trn
kh nng cung cp cc qu trnh hoc sn phm
v dch v ph hp vi cc yu cu. T chc phi
lu gi li thng tin c lp vn bn ca cc hot
ng ny v mi hnh ng cn thit pht sinh t
cc nh gi.
The organization shall determine and apply criteria
for the evaluation, selection, monitoring of
performance, and re-evaluation of external
providers, based on their ability to provide processes
or products and services in accordance with
requirements. The organization shall retain
documented information of these activities and any
necessary actions arising from the evaluations.

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 ISO 9001 : 2015

8.4.2 Loi hnh v mc kim sot 8.4.2 Type and extent of control

T chc phi m bo rng cc qu trnh, sn
phm v dch v c cung cp t bn ngoi
khng nh hng xu n kh nng ca t chc
trong vic chuyn giao mt cch n nh sn phm
v dch v ph hp khch hng ca t chc.
The organization shall ensure that externally
provided processes, products and services do not
adversely affect the organizations ability to
consistently deliver conforming products and
services to its customers.

T chc phi: The organization shall:

a) m bo rng cc qu trnh c cung cp t a) ensure that externally provided processes

bn ngoi nm trong phm vi kim sot ca remain within the control of its quality
h thng qun l cht lng; management system;
b) xc nh cc kim sot d nh p dng i b) define both the controls that it intends to apply to
vi nh cung cp bn ngoi v cc kt qu an external provider and those it intends to apply
u ra; to the resulting output;
c) tin hnh xem xt: c) take into consideration:
1] cc tc ng tim n ca cc qu trnh, 1] the potential impact of the externally
sn phm v dch v c cung cp t provided processes, products and services
bn ngoi n kh nng ca t chc p on the organizations ability to consistently
ng n nh cc yu cu khch hng v meet customer and applicable statutory and
cc yu cu lut nh v ch nh c p regulatory requirements;
dng; 2] the effectiveness of the controls applied by
2] hiu lc ca cc bin php kim sot p the external provider;
dng i vi cc nh cung cp bn ngoi; d) determine the verification, or other activities,
d) xc nh vic kim tra xc nhn, hoc cc hot necessary to ensure that the externally provided
ng khc, cn thit m bo rng cc qu processes, products and services meet
trnh, sn phm v dch v bn ngoi cung cp requirements.
p ng cc yu cu.

8.4.3 Thng tin cho n v cung cp bn ngoi 8.4.3 Information for external providers

T chc phi m bo s y ca cc yu cu The organization shall ensure the adequacy of

trc khi truyn t n nh cung cp bn ngoi. requirements prior to their communication to the
T chc phi trao i thng tin v cc yu cu ca external provider.
t chc vi cc nh cung cp bn ngoi v: The organization shall communicate to external
providers its requirements for:

a) cc qu trnh, sn phm v dch v s c a) the processes, products and services to be

cung cp; provided;
b) s ph duyt: b) the approval of:
1] cc sn phm v dch v; 1] products and services;
2] phng php, quy trnh v thit b; 2] methods, processes and equipment;
3] Chuyn giao cc sn phm v dch v; 3] the release of products and services;

c) nng lc, bao gm bt k yu cu v trnh c) competence, including any required qualification

ca nhn lc; of persons;
d) cc hot ng tng tc ca nh cung cp d) the external providers interactions with the

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ISO 9001 : 2015

bn ngoi vi t chc; organization;

e) vic kim sot v theo di kt qu hot ng e) control and monitoring of the external providers
ca cc nh cung cp bn ngoi s c t performance to be applied by the organization;
chc p dng; f) verification or validation activities that the
f) cc hot ng kim tra xc nhn hoc xc organization, or its customer, intends to perform
nhn gi tr s dng m t chc, hoc khch at the external providers premises.
hng ca t chc, d nh s thc hin ti cc
c s ca nh cung cp bn ngoi.
8.5 Sn xut v cung cp dch v 8.5 Production and service provision

8.5.1 Kim sot sn xut v cung cp dch v 8.5.1 Control of production and service provision

T chc phi thc hin sn xut v cung ng dch The organization shall implement production and
v trong cc iu kin c kim sot. service provision under controlled conditions.
Khi thch hp, cc iu kin c kim sot phi Controlled conditions shall include, as applicable:
bao gm:

a) s sn c ca cc thng tin c lp vn bn a) the availability of documented information that

nh r: defines:
1] cc c tnh ca sn phm c sn xut, 1] the characteristics of the products to be
cc dch v c cung cp, hoc cc hot produced, the services to be provided, or the
ng c thc hin; activities to be performed;
2] cc kt qu cn t c; 2] the results to be achieved;
b) s sn c v s dng cc ngun lc ph hp b) the availability and use of suitable monitoring and
cho vic theo di v o lng thch hp; measuring resources;
c) thc hin cc hot ng theo di v o lng c) the implementation of monitoring and
cc giai on thch hp xc nhn rng measurement activities at appropriate stages to
cc chun mc kim sot cc qu trnh hoc verify that criteria for control of processes or
cc kt qu u ra, v chun mc chp nhn outputs, and acceptance criteria for products and
cho cc sn phm v dch v, c p services, have been met;
ng; d) the use of suitable infrastructure and
d) vic s dng c s h tng v mi trng ph environment for the operation of processes;
hp cho vic vn hnh cc qu trnh; e) the appointment of competent persons, including
e) vic ch nh nhn s c nng lc, bao gm any required qualification;
bt c bng cp no c yu cu; f) the validation, and periodic revalidation, of the
f) xc nhn gi tr s dng, v ti xc nhn gi tr ability to achieve planned results of the
s dng nh k, kh nng t c cc kt processes for production and service provision,
qu hoch nh ca cc qu trnh sn xut where the resulting output cannot be verified by
v cung cp dch v, khi kt qu u ra khng subsequent monitoring or measurement;
th kim tra xc nhn c bng s gim st g) the implementation of actions to prevent human
hoc o lng tip theo; error;
g) thc hin cc hnh ng ngn nga li do h) the implementation of release, delivery and post-
con ngi; delivery activities.
h) thc hin vic pht hnh, giao hng v cc
hot ng sau giao hng.

32
 ISO 9001 : 2015

8.5.2 Nhn bit v xc nh ngun gc 8.5.2 Identification and traceability

T chc phi s dng cc bin php thch hp The organization shall use suitable means to
nhn bit u ra ca qu trnh khi cn thit identify outputs when it is necessary to ensure the
nhm m bo s ph hp ca sn phm v dch conformity of products and services.
v.

T chc phi nhn bit tnh trng ca cc kt qu The organization shall identify the status of outputs
u ra i vi cc yu cu theo di v o lng with respect to monitoring and measurement
trong sut qu trnh cung cp sn xut v dch requirements throughout production and service
v. provision.

T chc phi kim sot vic nhn dng duy nht
ca cc kt qu u ra khi vic truy xt ngun
gc l mt yu cu, v phi lu gi cc thng tin
c lp vn bn cn thit c th truy xt
c ngun gc.
The organization shall control the unique
identification of the outputs when traceability is a
requirement, and shall retain the documented
information necessary to enable traceability.

8.5.3 Ti sn ca khch hng hoc ca nh 8.5.3 Property belonging to customers or

cung cp bn ngoi external providers

T chc phi gn gi cc ti sn thuc v khch The organization shall exercise care with property
hng hoc nh cung cp bn ngoi khi chng belonging to customers or external providers while
thuc s kim sot ca t chc hay c t it is under the organizations control or being used
chc s dng. by the organization.

T chc phi nhn bit, kim tra xc nhn, bo The organization shall identify, verify, protect and
v v bo qun ti sn ca nh cung cp bn safeguard customers or external providers
ngoi hoc do khch hng cung cp s dng property provided for use or incorporation into the
hoc hp thnh sn phm v dch v. products and services

Khi ti sn ca khch hng hoc ca nh cung
cp bn ngoi b mt, h hng hoc c pht
hin khng ph hp s dng, t chc phi
bo co cho khch hng hoc nh cung cp bn
ngoi v lu gi thng tin c lp vn bn v
vn xy ra
When the property of a customer or external
provider is lost, damaged or otherwise found to be
unsuitable for use, the organization shall report this
to the customer or external provider and retain
documented information on what has occurred

CH THCH: Ti sn ca khch hng hoc nh cung NOTE A customers or external providers property can
cp bn ngoi c th bao gm nguyn vt liu,cc include materials, components, tools and equipment,
thnh phn, cc cng c v trang thit b, c s, s hu premises, intellectual property and personal data.
tr tu v d liu c nhn.

8.5.4 Bo ton 8.5.4 Preservation

T chc phi bo ton cc kt qu u ra trong The organization shall preserve the outputs during
sut qu trnh sn xut v cung cp dch v, production and service provision, to the extent
mc cn thit m bo s ph hp vi cc necessary to ensure conformity to requirements.
yu cu.
CH THCH: Bo ton c th bao gm vic nhn bit, NOTE Preservation can include identification, handling,
xp d, kim sot truyn nhim, bao gi, lu tr, contamination control, packaging, storage, transmission or
chuyn giao hoc vn chuyn v bo v. transportation, and protection.

33
ISO 9001 : 2015
8.5.5 Cc hot ng sau giao hng
T chc phi p ng cc yu cu i vi hot
ng sau giao hng c lin quan n cc sn
phm v dch v.
Khi vic xc nh mc cc hot ng cn thit
sau giao hng, t chc phi xem xt:
a) yu cu ch nh v lut nh;
b) nhng hu qu tim n khng mong mun
lin quan vi cc sn phm v dch v ca t
chc;
c) bn cht, vic s dng v tui th d kin
ca sn phm v dch v ca t chc;
d) cc yu cu khch hng;
e) phn hi ca khch hng.
CH THCH: Ch cc hot ng sau giao hng c th
bao gm cc hnh ng theo quy nh bo hnh, ngha
v hp ng cng nh dch v bo tr, v cc dch v
b tr nh ti ch hoc loi b cui cng.
8.5.6 Kim sot cc thay i
T chc phi xem xt v kim sot nhng thay
i i vi vic sn xut hay cung cp dch v,
vi mc cn thit m bo lin tc s ph
hp vi cc yu cu.
T chc phi lu gi li thng tin c lp vn
bn m t cc kt qu ca vic xem xt cc thay
i, nhng ngi cho php thay i, v mi hnh
ng cn thit ny sinh t vic xem xt.
8.6 Chuyn giao sn phm v dch v
T chc phi thc hin cc b tr c hoch
nh cc giai on thch hp xc nhn rng
cc yu cu sn phm v dch v c p
ng.
Vic chuyn giao cc sn phm v dch v cho
khch hng s khng c tin hnh cho n khi
cc b tr c lp k hoch c hon thnh
mt cch tha ng, tr trng hp c ph
duyt ca cp c thm quyn lin quan v, khi
thch hp, bi khch hng.
T chc phi lu gi li thng tin c lp vn
bn v vic chuyn giao cc sn phm v dch
v.
34
8.5.5 Post-delivery activities
The organization shall meet requirements for post-
delivery activities associated with the products and
services.
In determining the extent of post-delivery activities
that are required, the organization shall consider:
a) statutory and regulatory requirements;
b) the potential undesired consequences
associated with its products and services;
c) the nature, use and intended lifetime of its
products and services;
d) customer requirements;
e) customer feedback.
NOTE Post-delivery activities can include actions under
warranty provisions, contractual obligations such as
maintenance services, and supplementary services such
as recycling or final disposal.
8.5.6 Control of changes
The organization shall review and control changes
for production or service provision, to the extent
necessary to ensure continuing conformity with
requirements
The organization shall retain documented
information describing the results of the review of
changes, the person(s) authorizing the change, and
any necessary actions arising from the review.
8.6 Release of products and services
The organization shall implement planned
arrangements, at appropriate stages, to verify that
the product and service requirements have been
met
The release of products and services to the
customer shall not proceed until the planned
arrangements have been satisfactorily completed,
unless otherwise approved by a relevant authority
and, as applicable, by the customer
The organization shall retain documented
information on the release of products and services.

Cc thng tin c lp vn bn bao gm:
a) bng chng v s ph hp vi cc chun
mc chp nhn;
b) truy xut ngun gc n (nhng) ngi cho
php chuyn giao.
8.7 Kim sot u ra khng ph hp
8.7.1 T chc phi m bo rng cc kt qu
u ra khng ph hp vi yu cu c nhn
bit v c kim sot ngn nga vic s
dng hoc vic chuyn giao khng mong mun.
T chc phi c hnh ng thch hp da trn
bn cht ca s khng ph hp v nh hng
ca n n s ph hp ca sn phm v dch
v. iu ny cng phi p dng i vi cc sn
phm v dch v khng ph hp c pht hin
sau khi chuyn giao sn phm, trong hoc sau
khi thc hin dch v.
T chc phi x l cc kt qu u ra khng ph
hp bng mt hoc cc cch sau:
a) khc phc;
b) phn tch, lu gi, tr li hoc nh ch vic
cung cp cc sn phm v dch v;
c) thng tin n khch hng;
d) c cho php chp nhn c nhn nhng.
S ph hp vi cc yu cu phi c kim tra
xc nhn khi cc kt qu u ra khng ph hp
c khc phc.
8.7.2 T chc phi lu gi li thng tin c lp
vn bn:
a) m t s khng ph hp;
b) m t cc hnh ng c tin hnh;
c) m t tt c trng hp nhn nhng;
d) xc nh thm quyn quyt nh cc hnh
ng lin quan n s khng ph hp.
9 nh gi kt qu hot ng
9.1 Theo di, o lng, phn tch v nh gi
9.1.1 Khi qut
ISO 9001 : 2015
The documented information shall include:
a) evidence of conformity with the acceptance
criteria;
b) traceability to the person(s) authorizing the
release.
8.7 Control of nonconforming outputs
8.7.1 The organization shall ensure that outputs
that do not conform to their requirements are
identified and controlled to prevent their unintended
use or delivery.
The organization shall take appropriate action
based on the nature of the nonconformity and its
effect on the conformity of products and services.
This shall also apply to nonconforming products
and services detected after delivery of products,
during or after the provision of services.
The organization shall deal with nonconforming
outputs in one or more of the following ways:
a) correction;
b) segregation, containment, return or suspension
of provision of products and services;
c) informing the customer;
d) obtaining authorization for acceptance under
concession.
Conformity to the requirements shall be verified
when nonconforming outputs are corrected.
8.7.2 The organization shall retain documented
information that:
a) describes the nonconformity;
b) describes the actions taken;
c) describes any concessions obtained;
d) identifies the authority deciding the action in
respect of the nonconformity.
9 Performance evaluation
9.1 Monitoring, measurement, analysis and
evaluation
9.1.1 General
35
ISO 9001:2015

T chc phi xc nh: The organization shall determine:

a) iu g cn phi c theo di v o lng; a) what needs to be monitored and measured;

b) cc phng php theo di, o lng, phn tch b) the methods for monitoring, measurement,
v nh gi cn thit m bo c c cc analysis and evaluation needed to ensure valid
kt qu hp l; results;
c) khi no thc hin theo di v o lng; c) when the monitoring and measuring shall be
d) khi no phi phn tch v nh gi cc kt qu performed;
t hot ng theo di v o lng. d) when the results from monitoring and
measurement shall be analysed and evaluated.
T chc phi nh gi kt qu hot ng v tnh The organization shall evaluate the performance and
hiu lc ca h thng qun l cht lng. the effectiveness of the quality management system.
T chc phi lu gi li thng tin c lp vn The organization shall retain appropriate
bn thch hp nh l bng chng ca cc kt qu documented information as evidence of the results.
trn.
9.1.2 S tha mn ca khch hng 9.1.2 Customer satisfaction
T chc phi theo di cm nhn ca khch hng The organization shall monitor customers
v mc nhu cu v mong i ca h c perceptions of the degree to which their needs and
p ng. T chc phi xc nh cc phng expectations have been fulfilled. The organization
php cho vic thu thp, theo di v xem xt thng shall determine the methods for obtaining,
tin ny. monitoring and reviewing this information.
CH THCH: V d v hot ng theo di cm nhn ca NOTE Examples of monitoring customer perceptions can
khch hng c th bao gm kho st khch hng, phn include customer surveys, customer feedback on
hi ca khch hng v cc sn phm v dch v cung delivered products and services, meetings with customers,
cp, cc cuc hp vi khch hng, phn tch th phn, market-share analysis, compliments, warranty claims and
thm hi, yu cu bo hnh v cc bo co ca i l. dealer reports.
9.1.3 Phn tch v nh gi 9.1.3 Analysis and evaluation
T chc phi phn tch v nh gi cc d liu The organization shall analyse and evaluate
v thng tin thch hp pht sinh t hot ng appropriate data and information arising from
theo di v o lng. monitoring and measurement.
Kt qu phn tch phi c s dng nh gi: The results of analysis shall be used to evaluate:
a) s ph hp ca cc sn phm v dch v; a) conformity of products and services;
b) mc hi lng ca khch hng; b) the degree of customer satisfaction;
c) kt qu hot ng v hiu lc ca h thng c) the performance and effectiveness of the quality
qun l cht lng; management system;
d) liu rng vic hoch nh c thc hin d) if planning has been implemented effectively;
c hiu lc; e) the effectiveness of actions taken to address risks
e) tnh hiu lc ca cc hnh ng c thc and opportunities;
hin gii quyt cc ri ro v c hi; f) the performance of external providers
f) Kt qu hot ng ca cc nh cung cp bn g) the need for improvements to the quality
ngoi; management system.
g) nhu cu ci tin h thng qun l cht lng.
CH THCH: Cc phng php phn tch d liu c NOTE Methods to analyse data can include statistical
th bao gm cc k thut thng k. techniques.

36
 ISO 9001:2015

9.2 nh gi ni b 9.2 Internal audit

9.2.1 T chc phi thc hin vic nh gi ni 9.2.1 The organization shall conduct internal audits
b nh k nh hoch nh cung cp thng at planned intervals to provide information on
tin v h thng qun l cht lng c: whether the quality management system:

a) ph hp vi: a) conforms to:

1] cc yu cu ca t chc i vi h thng 1] the organizations own requirements for its
qun l cht lng; quality management system;
2] cc yu cu ca Tiu chun quc t ny; 2] the requirements of this International
b) c thc hin v duy tr mt cch c hiu lc; Standard;
b) is effectively implemented and maintained.
9.2.2 T chc phi: 9.2.2 The organization shall:

a) lp k hoch, thit lp, thc hin v duy tr mt a) plan, establish, implement and maintain an audit
(cc) chng trnh nh gi bao gm tn sut, programme(s) including the frequency, methods,
phng php, trch nhim, cc yu cu hoch responsibilities, planning requirements and
nh v bo co, c xem xt n tm quan trng reporting, which shall take into consideration the
ca cc qu trnh c lin quan, s thay i nh importance of the processes concerned, changes
hng n t chc, v cc kt qu nh gi affecting the organization, and the results of
trc ; previous audits;
b) xc nh chun mc v phm vi cho mi ln b) define the audit criteria and scope for each audit;
nh gi; c) select auditors and conduct audits to ensure
c) vic la chn cc nh gi vin v thc hin objectivity and the impartiality of the audit process;
nh gi phi m bo tnh khch quan v v t d) ensure that the results of the audits are reported to
ca qu trnh nh gi; relevant management;
d) m bo rng cc kt qu nh gi c e) take appropriate correction and corrective actions
bo co n cp qun l lin quan; without undue delay;
e) tin hnh khng chm tr vic khc phc v f) retain documented information as evidence of the
cc hnh ng khc phc thch hp; implementation of the audit programme and the
f) lu gi li thng tin c lp vn bn nh audit results.
bng chng ca vic thc hin cc chng
trnh nh gi v cc kt qu nh gi.
CH THCH: Xem hng dn trong ISO 19011. NOTE See ISO 19011 for guidance.

9.3 Xem xt ca lnh o 9.3 Management review

9.3.1 Khi qut 9.3.1 General

Lnh o cao nht phi xem xt nh k h thng qun Top management shall review the organizations quality
l cht lng ca t chc m bo tnh lin tc ph management system, at planned intervals, to ensure its
hp, tha ng, hiu lc v lin kt vi nh hng continuing suitability, adequacy, effectiveness and
chin lc ca t chc. alignment with the strategic direction of the organization.
9.3.2 u vo ca xem xt lnh o 9.3.2 Management review inputs
Vic xem xt ca lnh o phi c lp k hoch The management review shall be planned and
v c thc hin: carried out taking into consideration:

37
ISO 9001:2015
a) tnh trng ca cc hnh ng t ln xem xt
trc;
b) cc thay i bn trong v bn ngoi c lin
quan n h thng qun l cht lng;
c) thng tin v kt qu hot ng v hiu lc
ca h thng qun l cht lng, bao gm
c cc xu hng v:
1] s hi lng ca khch hng v phn hi t
cc bn quan tm;
2] mc m cc mc tiu cht lng t
c;
3] kt qu hot ng v s ph hp ca sn
phm v dch v;
4] s khng ph hp v cc hnh ng khc
phc;
5] cc kt qu theo di v o lng;
6] cc kt qu nh gi;
7] kt qu hot ng ca cc nh cung cp
bn ngoi;
d) s y cc ngun lc;
e) tnh hiu lc ca cc hnh ng c thc hin
gii quyt ri ro v c hi (xem 6.1);
f) cc c hi ci tin.
9.3.3 u ra ca xem xt lnh o
u ra ca xem xt ca lnh o phi bao gm
cc quyt nh v hnh ng lin quan n:
a) cc c hi ci tin;
b) bt k nhu cu thay i no i vi h thng
qun l cht lng;
c) cc nhu cu ngun lc.
T chc phi lu gi thng tin c lp vn bn
nh bng chng v cc kt qu xem xt ca lnh
o.
10 Ci tin
10.1 Khi qut
T chc phi xc nh v la chn cc c hi
ci tin v thc hin mi hnh ng cn thit
p ng cc yu cu ca khch hng v nng
cao s hi lng ca khch hng.
38
a) the status of actions from previous management
reviews;
b) changes in external and internal issues that are
relevant to the quality management system
c) information on the performance and effectiveness
of the quality management system, including
trends in:
1] customer satisfaction and feedback from
relevant interested parties;
2] the extent to which quality objectives have
been met;
3] process performance and conformity of
products and services;
4] nonconformities and corrective actions;
5] monitoring and measurement results;
6] audit results;
7] the performance of external providers;
d) the adequacy of resources;
e) the effectiveness of actions taken to address risks
and opportunities (see 6.1);
f) opportunities for improvement.
9.3.3 Management review outputs
The outputs of the management review shall include
decisions and actions related to:
a) opportunities for improvement;
b) any need for changes to the quality management
system;
c) resource needs.
The organization shall retain documented information
as evidence of the results of management reviews.
10 Improvement
10.1 General
The organization shall determine and select
opportunities for improvement and implement any
necessary actions to meet customer requirements
and enhance customer satisfaction.

Cc iu ny phi bao gm:
a) ci tin cc sn phm v dch v p ng
cc yu cu cng nh gii quyt nhu cu v
mong i trong tng lai;
b) khc phc, ngn nga hoc lm gim cc nh
hng khng mong mun;
c) ci tin kt qu hot ng v hiu lc ca h
thng qun l cht lng.
CH THCH: V d v s ci tin c th bao gm khc NOTE Examples of improvement can include correction,
phc, hnh ng khc phc, ci tin lin tc, thay i corrective action, continual improvement, breakthrough
mang tnh t ph, i mi v ti cu trc t chc.
10.2 S khng ph hp v hnh ng khc 10.2 Nonconformity and corrective action
phc
10.2.1 Khi s khng ph hp xy ra, k c pht
sinh t cc khiu ni, t chc phi:
a) Khi thch hp, x l s khng ph hp:
1] thc hin hnh ng kim sot v khc
phc s khng ph hp;
2] gii quyt cc hu qu;
b) nh gi nhu cu thc hin hnh ng loi b) evaluate the need for action to eliminate the
b (cc) nguyn nhn ca s khng ph hp,
khng ti din hoc xy ra ni khc, bng
cch:
1] xem xt v phn tch s khng ph hp;
2] xc nh cc nguyn nhn ca s khng
ph hp;
3] xc nh xem liu s khng ph hp
tng t c tn ti hay khng, hoc c th
tim n xy ra;
c) thc hin bt k hnh ng no cn thit;
d) xem xt tnh hiu lc ca bt k hnh ng khc
phc c thc hin;
e) cp nht cc ri ro v c hi c xc nh trong
qu trnh hoch nh, nu cn thit;
f) To s thay i i vi h thng qun l cht
lng, nu cn thit.
Hnh ng khc phc phi tng xng vi tc
ng ca cc s khng ph hp gp phi.
10.2.2 T chc phi lu gi li thng tin c lp
vn bn nh bng chng v:
ISO 9001:2015
These shall include:
a) improving products and services to meet
requirements as well as to address future needs
and expectations;
b) correcting, preventing or reducing undesired
effects;
c) improving the performance and effectiveness of
the quality management system
change, innovation and re-organization.
10.2.1 When a nonconformity occurs, including any
arising from complaints, the organization shall:
a) react to the nonconformity and, as applicable:
1] take action to control and correct it;
2] deal with the consequences;
cause(s) of the nonconformity, in order that it
does not recur or occur elsewhere, by:
1] reviewing and analysing the nonconformity;
2] determining the causes of the
nonconformity;
3] determining if similar nonconformities exist,
or could potentially occur;
c) implement any action needed;
d) review the effectiveness of any corrective action
taken;
e) update risks and opportunities determined during
planning, if necessary;
f) make changes to the quality management
system, if necessary.
Corrective actions shall be appropriate to the effects
of the nonconformities encountered.
10.2.2 The organization shall retain documented
information as evidence of:
39
ISO 9001:2015
a) bn cht ca s khng ph hp v bt k hnh
ng tip theo c thc hin;
b) cc kt qu ca mi hnh ng khc phc.
10.3 Ci tin lin tc
T chc phi ci tin lin tc s ph hp, tha
ng v hiu lc ca h thng qun l cht lng.
T chc phi xem xt cc kt qu phn tch v
nh gi, v cc kt qu u ra t xem xt ca
lnh o, xc nh xem c nhu cu hay c hi
no phi c gii quyt nh mt phn ca ci
tin lin tc.
40
a) the nature of the nonconformities and any
subsequent actions taken;
b) the results of any corrective action.
10.3 Continual improvement
The organization shall continually improve the
suitability, adequacy and effectiveness of the quality
management system.
The organization shall consider the results of
analysis and evaluation, and the outputs from
management review, to determine if there are needs
or opportunities that shall be addressed as part of
continual improvement.
 ISO 9001:2015

Ph lc A
(Tham kho)
Gii thch cu trc, thut ng v cc khi nim mi

A.1 B cc v thut ng
B cc cc iu khon (VD: trnh t cc iu khon) v mt s thut ng trong phin bn ny ca tiu chun,
trong s so snh vi phin bn trc (ISO 9001:2008), c thay i ci tin s lin kt vi cc tiu
chun h thng qun l khc.
Khng c yu cu no ca Tiu chun quc t ny v vic cu trc v thut ng ca n phi c p dng i
vi cc thng tin bng vn bn trong H thng qun l cht lng ca mt t chc.
Cu trc ca cc iu khon trong tiu chun ny nhm a ra mt s trnh by mch lc cc yu cu, hn l
mt m hnh vn bn ha cc chnh sch, mc tiu v qu trnh ca t chc. Cu trc v ni dung ca cc thng
tin bng vn bn lin quan n mt h thng qun l cht lng thng lin quan nhiu hn vi ngi s
dng nu gn lin vi c cc qu trnh thc hin bi t chc v thng tin c duy tr cho cc mc ch khc.
Khng c yu cu no cho vic cc thut ng s dng bi mt t chc phi c thay th bng thut ng s
dng trong tiu chun quc t ny quy nh cc yu cu ca h thng qun l cht lng. Cc t chc c
th la chn v s dng cc t vng thch hp vi hot ng ca mnh (VD: s dng h s, ti liu hoc
d tho hn l thng tin bng vn bn; hoc nh cung cp, i tc hoc ngi bn thay cho nh cung
cp bn ngoi). Bng A.1 ch ra nhng khc bit ln trong thut ng gia phin bn ny ca Tiu chun so
vi phin bn trc.
Bng A.1 Cc s khc bit ln v thut ng gia ISO 9001:2008 v ISO 9001:2015
ISO 9001:2008 ISO 9001:2015
Sn phm Sn phm v dch v
iu khon loi tr Khng s dng
(Xem thm iu khon A.5 c gii thch chi tit
v kh nng p dng)
i din lnh o v cht lng Khng s dng
(Cc trch nhim v quyn hn c phn cng
nhng khng c yu cu cho mt i din lnh o
ring r)
Vn bn, s tay cht lng, cc th tc bng vn bn, Thng tin bng vn bn
h s
Mi trng lm vic Mi trng cho vic vn hnh cc qu trnh
Sn phm c mua Cc sn phm v dch v c cung cp t bn
ngoi
Nh cung cp Nh cung cp bn ngoi
Sn phm Sn phm v dch v
A.2 Sn phm v dch v
ISO 9001:2008 s dng thut ng sn phm bao gm tt c cc nhm u ra. Phin bn ny ca tiu
chun s dng sn phm v dch v. Thut ng sn phm v dch v bao gm ton b cc nhm u ra
(phn cng, dch v, phn mm v cc vt liu c ch bin).
Vic bao gm mt cch c th dch v c mc ch nhm nhn mnh s khc bit gia sn phm v dch v
trong p dng mt s yu cu. c tnh ca dch v l t nht mt phn ca u ra c thc hin c s tng
tc vi khch hng. iu ny c ngha, v d, s ph hp vi cc yu cu c th khng nht thit phi c
xc nhn trc khi chuyn giao sn phm.

41
ISO 9001:2015

Trong phn ln cc trng hp, sn phm v dch v c s dng cng nhau. Phn ln u ra ca cc t
chc cung cp n khc hng, hoc c cung cp n t chc bi nh cung ng bn ngoi, bao gm c sn
phm v dch v. V d, mt sn phm hu hnh hoc v hnh c th c mt s dch v lin quan hoc mt
dch v c th c mt s sn phm hu hnh hoc v hnh lin quan.
A.3 Thu hiu nhu cu v mong i ca cc bn quan tm
iu khon ph 4.2 a ra yu cu t chc phi xc nh cc bn quan tm c lin quan n h thng qun l
cht lng v cc yu cu ca nhng bn quan tm ny. Tuy nhin, iu khon 4.2 khng m ch s m rng
cc yu cu ca h thng qun l cht lng bn ngoi phm vi ca Tiu chun ny. Nh tuyn b trong
phm vi, Tiu chun ny c th p dng c khi mt t chc cn chng t kh nng ca mnh cung cp mt
cch n nh cc sn phm v dch v p ng yu cu ca khch hng v cc yu cu ch nh v lut php
c th p dng c, v nhm nng cao s tha mn ca khch hng.
Khng c yu cu no trong tiu chun ny buc t chc phi xem xt n cc bn quan tm khi t chc
quyt nh rng nhng t chc ny khng lin quan n h thng qun l cht lng ca mnh. T chc t
quyt nh nu c yu cu c th ca mt bn quan tm c lin quan n h thng qun l cht lng ca
mnh.
A.4 T duy da trn ri ro
Khi nim v t duy da trn ri ro ngm cha trong cc phin bn trc ca tiu chun quc t ny, v
d nh thng qua cc yu cu v hoch nh, xem xt v ci tin. Tiu chun quc t ny quy nh cc yu cu
t chc thu hiu bi cnh ca mnh (xem iu khon 4.1) v xc nh cc ri ro nh l c s ca vic hoch
nh (xem iu khon 6.1). iu ny miu t vic ng dng tip cn qun l ri ro trong hoch nh v thc
hin cc qu trnh ca H thng qun l cht lng (xem iu khon 4.4) v s h tr vic xc nh mc
thng tin bng vn bn.
Mt trong nhng mc ch chnh ca H thng qun l cht lng l hot ng nh mt cng c phng nga.
Do , Tiu chun quc t ny khng c mt iu khon hoc iu khon ph ring r v hnh ng phng
nga. Khi nim hnh ng phng nga c th hin thng qua vic s dng t duy da trn ri ro trong
hnh thnh cc yu cu ca H thng qun l cht lng.
Tip cn qun l ri ro p dng trong Tiu chun quc t ny cho php gim bt mt s yu cu bt buc
v thay th chng bng cc yu cu da trn kt qu hot ng. C s linh hot hn so vi ISO 9001:2008
trong yu cu v cc qu trnh, thng tin bng vn bn v trch nhim ca t chc.
Mc d iu khon 6.1 quy nh rng t chc phi hoch nh cc hnh ng nhm gii quyt ri ro, khng
c yu cu no v cc phng php chnh thc cho qun l ri ro v qu trnh qun l ri ro bng vn bn. T
chc c th quyt nh c hoc khng pht trin mt phng php qun l ri ro y hn so vi yu cu
bi Tiu chun, VD: thng qua vic p dng vic p dng cc ti liu ch dn hoc tiu chun khc.
Khng phi mi qu trnh ca h thng qun l cht lng u tng ng vi mt mc ri ro nh nhau
lin quan n kh nng ca t chc t c cc mc tiu ca mnh v cc nh hng ca s khng chc chn
khng ging nhau cho tt c cc t chc. Vi cc yu cu ca iu khon 6.1, t chc phi chu trch nhim
cho vic p dng tip cn qun l ri ro v cc hng ng m t chc thc hin gii quyt ri ro, bao gm
vic c hay khng duy tr thng tin bng vn bn nh l bng chng cho vic xc nh ri ro ca mnh.
A.5 Kh nng p dng
Tiu chun quc t ny khng cp n ngoi l v mt kh nng p dng cc yu cu ca mnh trong H
thng qun l cht lng ca t chc. Tuy nhin, mt t chc c th xem xt kh nng p dng ca cc tiu
chun ty theo quy m hoc mc phc tp ca t chc, m hnh qun l p dng, lnh vc cc hot ng
ca t chc v bn cht ca cc ri ro v c hi m t chc gp phi.
Yu cu v kh nng p dng c cp trong iu khon 4.3, xc nh cc iu kin m mt t chc c th
quyt nh rng mt yu cu c th khng c p dng i vi bt k qu trnh no trong phm vi H thng

42
 ISO 9001:2015

qun l cht lng ca mnh. T chc ch c th quyt nh rng mt yu cu khng c kh nng p dng nu
quyt nh ca t chc khng gy ra tnh trng khng t c s ph hp ca sn phm v dch v.
A.6 Thng tin c lp vn bn
Nh l mt phn ca s lin kt vi cc tiu chun h thng qun l khc, mt iu khon chung v thng
tin c lp vn bn c chp nhn m khng c s thay i hoc b sung ng k no (xem iu khon
7.5). Khi thch hp, ni dung vit nhng ch khc trong Tiu chun quc t ny c lin kt vi cc yu
cu ca tiu chun. Do vy, thng tin c lp vn bn c s dng cho tt c cc yu cu v ti liu.
nhng ch m ISO 9001:2008 s dng cc thut ng nh ti liu hoc th tc bng vn bn, s tay cht
lng hoc k hoch cht lng, phin bn ny ca tiu chun quy nh yu cu duy tr thng tin c
lp vn bn.
Mt yu cu v duy tr thng tin bng vn bn khng loi tr kh nng l t chc c th cng cn gi li
thng tin bng vn bn nh vy cho mt mc ch c th, VD: gi li phin bn trc ca n.
Khi Tiu chun cp n thng tin thay v thng tin c lp vn bn (VD: trong iu khon 4.1: T
chc phi theo di v xem xt thng tin v nhng vn ni b v bn ngoi ny), khng c yu cu no v
vic cc thng tin phi c lp thnh vn bn. Trong nhng tnh hung nh vy, t chc c th quyt
nh vic c hoc khng cn thit hoc thch hp duy tr thng tin bng vn bn.
A.7 Tri thc ca t chc
Trong iu khon 7.1.6, Tiu chun ny cp nhu cu xc nh v qun l tri thc duy tr bi t chc,
m bo rng t chc c th t c s ph hp ca sn phm v dch v.
Cc yu cu lin quan n tri thc ca t chc c a ra cho mc ch:
a) Bo v t chc khi b mt tri thc, VD:

do thay i nhn s;

thiu kh nng nm bt v chia s thng tin.
b) Khuyn khch t chc thu c c kin thc, VD:

hc hi t kinh nghim;

hng dn;

chun so snh.
A.8 Kim sot cc sn phm v dch v c cung cp t bn ngoi
Mi hnh thc sn phm v dch v c cung cp t bn ngoi c cp trong iu khon 8.4, VD: cho
thng qua:
a) Mua t mt nh cung cp;
b) Mt tha thun vi mt cng ty lin kt;
c) Cc qu trnh c thu ngoi n mt nh cung cp bn ngoi.
Thu ngun bn ngoi lun c cc c tnh ct yu ca mt dch v, v iu ny s c t nht mt hot ng
cn c thc hin ti giao din gia bn cung cp v t chc.
Cc bin php kim sot c yu cu vi s cung cp t bn ngoi c th khc nhau nhiu ty thuc vo
bn cht ca sn phm v dch v. T chc phi p dng tip cn qun l ri ro xc nh hnh thc v mc
ca hot ng kim sot tng ng cc nh cung cp bn ngoi v sn phm v dch v c cung cp t
bn ngoi c th.

43
ISO 9001:2015

Annex A
(informative)
Clarification of new structure, terminology and concepts
A.1 Structure and terminology
The clause structure (i.e. clause sequence) and some of the terminology of this edition of this
International Standard, in comparison with the previous edition (ISO 9001:2008), have been changed to
improve alignment with other management systems standards.
There is no requirement in this International Standard for its structure and terminology to be applied
to the documented information of an organizations quality management system.
The structure of clauses is intended to provide a coherent presentation of requirements, rather than a
model for documenting an organizations policies, objectives and processes. The structure and content
of documented information related to a quality management system can often be more relevant to its
users if it relates to both the processes operated by the organization and information maintained for
other purposes.
There is no requirement for the terms used by an organization to be replaced by the terms used in this
International Standard to specify quality management system requirements. Organizations can choose
to use terms which suit their operations (e.g. using records, documentation or protocols rather
than documented information; or supplier, partner or vendor rather than external provider).
Table A.1 shows the major differences in terminology between this edition of this International Standard
and the previous edition.

Table A.1 Major differences in terminology between ISO 9001:2008 and ISO 9001:2015

ISO 9001:2008 ISO 9001:2015

Products Products and services
Exclusions Not used
(See Clause A.5 for clarification of applicability)
Management representative Not used
(Similar responsibilities and authorities are assigned
but no requirement for a single management repre-
sentative)
Documentation, quality manual, documented pro- Documented information
cedures, records
Work environment Environment for the operation of processes
Monitoring and measuring equipment Monitoring and measuring resources
Purchased product Externally provided products and services
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).
The specific inclusion of services is intended to highlight the differences between products and
services in the application of some requirements. The characteristic of services is that at least part of
the output is realized at the interface with the customer. This means, for example, that conformity to
requirements cannot necessarily be confirmed before service delivery.
In most cases, products and services are used together. Most outputs that organizations provide to

44
 ISO 9001:2015

customers, or are supplied to them by external providers, include both products and services. For
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 specifies requirements for the organization to determine the interested parties that
are relevant to the quality management system and the requirements of those interested parties.
However, 4.2 does not imply extension of quality management system requirements beyond the scope of
this International Standard. As stated in the scope, this International Standard is applicable where an
organization needs to demonstrate its ability to consistently provide products and services that meet
customer and applicable statutory and regulatory requirements, and aims to enhance customer
satisfaction.
There is no requirement in this International Standard for the organization to consider interested
parties where it has decided that those parties are not relevant to its quality management system. It is
for the organization to decide if a particular requirement of a relevant interested party is relevant to its
quality management system.
A.4 Risk-based thinking
The concept of risk-based thinking has been implicit in previous editions of this International Standard,
e.g. through requirements for planning, review and improvement. This International Standard
specifies requirements for the organization to understand its context (see 4.1) and determine risks as a
basis for planning (see 6.1). This represents the application of risk-based thinking to planning and
implementing quality management system processes (see 4.4) and will assist in determining the extent of
documented information.
One of the key purposes of a quality management system is to act as a preventive tool. Consequently,
this International Standard does not have a separate clause or subclause on preventive action. The
concept of preventive action is expressed through the use of risk-based thinking in formulating quality
management system requirements.
The risk-based thinking applied in this International Standard has enabled some reduction in
prescriptive requirements and their replacement by performance-based requirements. There is greater
flexibility than in ISO 9001:2008 in the requirements for processes, documented information and
organizational responsibilities.
Although 6.1 specifies that the organization shall plan actions to address risks, there is no requirement
for formal methods for risk management or a documented risk management process. Organizations can
decide whether or not to develop a more extensive risk management methodology than is required by
this International Standard, e.g. through the application of other guidance or standards.
Not all the processes of a quality management system represent the same level of risk in terms of the
organizations ability to meet its objectives, and the effects of uncertainty are not the same for all
organizations. Under the requirements of 6.1, the organization is responsible for its application of 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.
A.5 Applicability
This International Standard does not refer to exclusions in relation to the applicability of its
requirements to the organizations quality management system. However, an organization can review
the applicability of requirements due to the size or complexity of the organization, the management
model it adopts, the range of the organizations activities and the nature of the risks and opportunities it
encounters.
The requirements for applicability are addressed in 4.3, which defines conditions under which an
organization can decide that a requirement cannot be applied to any of the processes within the scope
of its quality management system. The organization can only decide that a requirement is not applicable if
its decision will not result in failure to achieve conformity of products and services.

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ISO 9001:2015

A.6 Documented information

As part of the alignment with other management system standards, a common clause on documented
information has been adopted without significant change or addition (see 7.5). Where appropriate,
text elsewhere in this International Standard has been aligned with its requirements. Consequently,
documented information is used for all document requirements.
Where ISO 9001:2008 used specific terminology such as document or documented procedures,
quality manual or quality plan, this edition of this International Standard defines requirements to
maintain documented information.
Where ISO 9001:2008 used the term records to denote documents needed to provide evidence of
conformity with requirements, this is now expressed as a requirement to retain documented
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.
A requirement to maintain documented information does not exclude the possibility that the
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
can decide whether or not it is necessary or appropriate to maintain documented information.
A.7 Organizational knowledge
In 7.1.6, this International Standard addresses the need to determine and manage the knowledge
maintained by the organization, to ensure the operation of its processes and that it can achieve
conformity of products and services.
Requirements regarding organizational knowledge were introduced for the purpose of:
a) safeguarding the organization from loss of knowledge, e.g.
through staff turnover;
failure to capture and share information;
b) encouraging the organization to acquire knowledge, e.g.
learning from experience;
mentoring;
benchmarking.
A.8 Control of externally provided processes, products and services
All forms of externally provided processes, products and services are addressed in 8.4, e.g. whether
through:
a) purchasing from a supplier;
b) an arrangement with an associate company;
c) outsourcing processes to an external provider.
Outsourcing always has the essential characteristic of a service, since it will have at least one activity
necessarily performed at the interface between the provider and the organization.
The controls required for external provision can vary widely depending on the nature of the processes,
products and services. The organization can apply risk-based thinking to determine the type and extent of
controls appropriate to particular external providers and externally provided processes, products and
services.

46
 ISO 9001:2015

Ph lc B
(Tham kho)

Cc tiu chun quc t khc v qun l cht lng v H thng qun l

cht lng pht trin bi ISO/TC 176

Cc tiu chun quc t c m t trong ph lc ny c pht trin bi ISO/TC 176 nhm cung cp cc
thng tin h tr cho t chc p dng Tiu chun quc t ny, v cung cp cc ch dn cho t chc la chn
tin ti xa hn cc yu cu ca Tiu chun. Ch dn hoc yu cu bao gm trong cc ti liu lit k trong ph
lc ny khng b sung, hoc iu chnh, cc yu cu ca Tiu chun quc t ny.
Bng B.1 th hin mi lin h gia cc tiu chun vi nhng iu khon lin quan ca Tiu chun ny.
Ph lc ny khng bao gm vic tham chiu n cc tiu chun h thng qun l cht lng cho cc lnh vc
c th c pht trin bi ISO/TC 176.
Tiu chun quc t ny l mt trong ba tiu chun chnh c pht trin bi ISO/TC 176.

ISO 9000 H thng qun l cht lng C s v t vng cung cp cc nn tng ct yu cho s thu hiu
v thc hin mt cch thch hp vi tiu chun quc t ny. Cc nguyn tc qun l cht lng c m
t chi tit trong ISO 9000 v c xem xt n trong pht trin Tiu chun quc t ny. Cc nguyn
tc ny khng phi l nhng yu cu, nhng to thnh nn tng ca cc yu cu c a ra trong Tiu
chun. ISO 9000 cng nh r cc thut ng, nh ngha v khi nim c s dng trong Tiu chun quc
t ny.

ISO 9001 (Tiu chun quc t ny) nh r cc yu cu hng ch yu n cung cp nim tin vo cc sn
phm v dch v cung cp bi t chc v qu nng cao tha mn khch hng. Vic thc hin thch hp
cng mong mun mang n cc li ch khc cho t chc, nh l ci tin trao i thng tin ni b, s thu
hiu v kim sot tt hn cc qu trnh ca t chc.

ISO 9004 Qun l cho s thnh cng bn vng ca mt t chc Tip cn trong qun l cht lng cung
cp cc ch dn cho nhng t chc mun tin ti xa hn cc yu cu ca tiu chun quc t ny gii
quyt cc ch phm vi rng hn m c th dn n ci tin hiu qu hot ng tng th ca t chc.
ISO 9004 bao gm ch dn v phng php t nh gi mt t chc c th nh gi mc pht trin
ca H thng qun l cht lng ca mnh.
Cc tiu chun quc t c tm tt di y c th cung cp s h tr cho t chc khi xc lp hoc tm kim
s ci tin v h thng qun l cht lng, cc qu trnh v hot ng ca mnh.

ISO 10001 Qun l cht lng S tha mn khch hng S tha mn ca khch hng Hng dn v
quy phm o c i vi t chc cung cp cc ch dn mt t chc xc nh xem s cung cp cho tha
mn khch hng p ng cc nhu cu v mong i ca khch hng. Vic s dng tiu chun ny c th
nng cao nim tin ca khch hng vo mt t chc v ci tin s thu hiu ca khch hng v nhng iu
c th trong i t t chc, v vy, gim thiu kh nng ca s hiu nhm v khiu ni.

ISO 10002 Qun l cht lng S tha mn ca khch hng Hng dn v gii quyt khiu ni trong
trong t chc cung cp cc ch dn v qu trnh x l cc khiu ni thng qua nhn ra v gii quyt cc
nhu cu v mong i ca khii ni v x l mi khiu ni nhn c. Tiu chun ny cung cp mt qu
trnh khiu ni m, hiu qu v d s dng, bao gm vic o to nhn s. Tiu chun cng cung cp cc
ch dn cho doanh nghip nh.

47
ISO 9001:2015

ISO 10003 Qun l cht lng S tha mn ca khch hng Hng dn gii quyt tranh chp bn ngoi
t chc cung cp ch dn cho vic gii quyt mt cch hiu qu v hiu lc cc tranh chp bn ngoi i
vi cc khiu ni lin quan n sn phm. Gii quyt tranh chp cung cp mt cch thc n b khi t
chc khng khc phc c mt khiu ni trong ni b. Phn ln cc khiu ni c x l thnh cng
trong t chc, khng cn n cc th tc i khng.

ISO 10004 Qun l cht lng S tha mn ca khch hng Hng dn theo di v o lng cung cp
cc ch dn cho hnh ngnng cao tha mn ca khch hng v nhn din cc c hi cho vic ci tin sn
phm, qu trnh v cc c tnh c gi tr vi khch hng. Cc hnh ng nh vy c th cng c s trung
thnh ca khch hng v gip gi khch hng.

ISO 10005 H thng qun l cht lng Hng dn k hoch cht lng cung cp cc ch dn v thit lp
v s dng cc k hoch cht lng nh mt cng c gn kt cc yu cu ca qu trnh, sn phm, d n
hoc hp ng vi phng thc thc hin cn vic v cc thc hnh h tr qu trnh to sn phm. Cc
li ch ca thit lp k hoch cht lng l nng cao nim tin rng cc yu cu s c p ng, cc qu
trnh c kim sot v ng lc m iu ny c th to ra cho nhng ngi lin quan.

ISO 10006 H thng qun l cht lng Hng dn qun l cht lng trong d n p dng vi cc d
n t nh n ln, t n gin n phc tp, t d n ring l n mt phn ca danh mc cc d n. Cc
ch dn ny c s dng bi nhn s qun l d n v nhng ni cn m bo rng t chc ca mnh
ang p dng cc thc hnh bao gm trong danh mc cc tiu chun v h thng qun l ca ISO.

ISO 10007 H thng qun l cht lng Hng dn qun l cu hnh h tr t chc p dng qun l cu
hnh cho i vi cc nh hng k thut v hnh chnh trong chu trnh sng ca sn phm. Qun l cu
hnh c th c s dng p ng cc yu cu v nhn bit v truy vt sn phm quy nh bi Tiu
chun quc t ny.

ISO 10008 Qun l cht lng S tha mn ca khch hng Hng dn cho cc giao dch thng mi
in t gia doanh nghip vi ngi tiu dng cung cp cc ch dn v cch thc m t chc c th thc
hin mt h thng giao dch in t gia doanh nghip vi ngi tiu (B2C ETC) dng mt cch hiu lc
v hiu qu, v v th cung cp c s cho khch hng c c s tin tng hn vi B2C ECT, nng cao kh
nng ca t chc tha mn khch hng v gip gim thiu cc khiu ni v tranh chp.

ISO 10012 H thng qun l o lng Cc yu cu i vi qu trnh o lng v thit b o lng cung
cp cc ch dn cho vic qun l cc qu trnh o lng v vic xc nhn v mt o lng vi cc thit b
o c s dng xc nhn v chng t s tun th vi cc yu cu v o lng. Tiu chun quy nh
cc yu cu qun l cht lng ca mt h thng qun l o lng nhm m bo cc yu cu v o lng
c p ng.

ISO/TR 10013 Hng dn v ti liu ca h thng qun l cht lng cung cp cc ch dn v vic pht
trin v duy tr ti liu cn thit cho mt h thng qun l cht lng. Tiu chun c th c s dng
vn bn ha h thng qun l ngoi nhng h thng trong danh mc cc tiu chun h thng qun l ca
ISO, VD: h thng qun l mi trng v h thng qun l an ton.

ISO 10014 Qun l cht lng Hng dn v hin thc ha cc li ch kinh t v ti chnh c dnh cho
lnh o cp cao. Tiu chun cung cp cc hng dn cho hin thc ha cc li ch v kinh t v ta chnh
thng qua vic p dng cc nguyn tc qun l cht lng. Tiu chun thc y vic p dng cc nguyn
tc qun l v la chn cc phng php v cng c cho php s thnh cng bn vng ca t chc.

ISO 10015 Qun l cht lng Hng dn v o to cung cp cc hng dn h tr t chc v gii quyt
cc vn lin quan n o to. Tiu chun c th c p dng bt k khi no s ch dn c yu cu
din gii s tham chiu n gio dc v o to trong dan mc cc tiu chun v h thng qun l
ca ISO. Bt k s tham chiu no n o to u bao gm mi hnh thc gio dc v o to.

48
 ISO 9001:2015

ISO/TR 10017 Ch dn v cc cng c thng k cho ISO 9001:2000 gii thch cc cng c thng k pht sinh
bi s bin thin c th quan st c trong din bin ca qu trnh v cc u ra, thm ch l trong iu
kin tng nh l n nh. Cc cng c thng k cho php s dng mt cch tt hn cc d liu nhm h
tr qu trnh ra quyt nh, v v vy gip ci tin lin tc cht lng ca sn phm, qu trnh nhm t
c s tha mn ca khch hng.

ISO 10018 Qun l cht lng Hng dn v s tham gia ca mi ngi v nng lc cung cp cc hng
tc ng n s tham gia ca mi ngi v nng lc. Mt h thng qun l cht lng ph thuc vo
s tham gia ca nhng ngi c nng lc v cch thc m h c a vo v tch hp trong t chc.
iu trng yu l phi xc nh, pht trin v nh gi tri thc, k nng, hnh vi v mi trng lm vic
c yu cu.

ISO 10019 Hng dn cho vic la chn t vn h thng qun l cht lng v s dng cc dch v t vn
cung cp cc ch dn cho vic la chn t vn h thng qun l cht lng v s dng dch v ca h. Tiu
chun ny cung cp cc ch dn v qu trnh nh gi nng lc ca mt t chc t vn h thng qun l
v cung cp s tin tng rng cc nhu cu v mong i ca t chc i vi dch v t vn c p ng.

ISO 19011 Hng dn nh gi cc h thng qun l cung cp cc ch dn v qun l chng trnh nh
gi, hoch nh v thc hin mt cuc nh gi h thng qun l, cng nh nng lc v nh gi chuyn
gia nh gi v on nh gi. Tiu chun ny d kin p dng vi cc nh gi vin, cc t chc p dng
h thng qun l, v t chc cn thc hin nh gi h thng qun l.

Bng B.1 Mi quan h gia cc tiu chun quc t v qun l cht lng v h thng qun l cht
lng vi cc iu khon ca Tiu chun quc t ny

Tiu chun iu khon trong tiu chun quc t ny

quc t khc
4 5 6 7 8 9 10
ISO 9000 Tt c Tt c Tt c Tt c Tt c Tt c Tt c
ISO 9004 Tt c Tt c Tt c Tt c Tt c Tt c Tt c
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 Tt c Tt c 9.1 10.2
ISO 10006 Tt c Tt c Tt c Tt c Tt c Tt c Tt c
ISO 10007 8.5.2
ISO 10008 Tt c Tt c Tt c Tt c Tt c Tt c Tt c
ISO 10012 7.1.5
ISO/TR 10013 7.5
ISO 10014 Tt c Tt c Tt c Tt c Tt c Tt c Tt c
ISO 10015 7.2
ISO/TR 10017 6.1 7.1.5 9.1
ISO 10018 Tt c Tt c Tt c Tt c Tt c Tt c Tt c
ISO 10019 8.4
ISO 19011 9.2
CH THCH: Tt c th hin rng tt c cc iu khon ph trong iu khon c cp ca Tiu chun quc t ny u
lin quan n Tiu chun quc t khc.

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ISO 9001:2015

Annex B
(informative)

Other International Standards on quality management and quality

management systems developed by ISO/TC 176

The International Standards described in this annex have been developed by ISO/TC 176 to provide
supporting information for organizations that apply this International Standard, and to provide
guidance for organizations that choose to progress beyond its requirements. Guidance or requirements
contained in the documents listed in this annex do not add to, or modify, the requirements of this
International Standard.
Table B.1 shows the relationship between these standards and the relevant clauses of this
International Standard.
This annex does not include reference to the sector-specific quality management system standards
developed by ISO/TC 176.
This International Standard is one of the three core standards developed by ISO/TC 176.

ISO 9000 Quality management systems Fundamentals and vocabulary provides an essential
background for the proper understanding and implementation of this International Standard.
The quality management principles are described in detail in ISO 9000 and have been taken into
consideration during the development of this International Standard. These principles are not
requirements in themselves, but they form the foundation of the requirements specified by this
International Standard. ISO 9000 also defines the terms, definitions and concepts used in this
International Standard.
ISO 9001 (this International Standard) specifies requirements aimed primarily at giving confidence in
the products and services provided by an organization and thereby enhancing customer satisfaction.
Its proper implementation can also be expected to bring other organizational benefits, such as
improved internal communication, better understanding and control of the organizations processes.
ISO 9004 Managing for the sustained success of an organization A quality management approach
provides guidance for organizations that choose to progress beyond the requirements of this
International Standard, to address a broader range of topics that can lead to improvement of the
organizations overall performance. ISO 9004 includes guidance on a self-assessment methodology
for an organization to be able to evaluate the level of maturity of its quality management system.
The International Standards outlined below can provide assistance to organizations when they are
establishing or seeking to improve their quality management systems, their processes or their activities.
ISO 10001 Quality management Customer satisfaction Guidelines for codes of conduct for
organizations provides guidance to an organization in determining that its customer satisfaction
provisions meet customer needs and expectations. Its use can enhance customer confidence in an
organization and improve customer understanding of what to expect from an organization, thereby
reducing the likelihood of misunderstandings and complaints.
ISO 10002 Quality management Customer satisfaction Guidelines for complaints handling in
organizations provides guidance on the process of handling complaints by recognizing and
addressing the needs and expectations of complainants and resolving any complaints received.
ISO 10002 provides an open, effective and easy-to-use complaints process, including training of
people. It also provides guidance for small businesses.
ISO 10003 Quality management Customer satisfaction Guidelines for dispute resolution external to
organizations provides guidance for effective and efficient external dispute resolution for
product-related complaints. Dispute resolution gives an avenue of redress when organizations do
not remedy a complaint internally. Most complaints can be resolved successfully within the

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 ISO 9001:2015

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
improvement of products, processes and attributes that are valued by customers. Such actions can
strengthen customer loyalty and help retain customers.
ISO 10005 Quality management systems Guidelines for quality plans provides guidance on
establishing and using quality plans as a means of relating requirements of the process, product,
project or contract, to work methods and practices that support product realization. Benefits of
establishing a quality plan are increased confidence that requirements will be met, that processes
are in control and the motivation that this can give to those involved.
ISO 10006 Quality management systems Guidelines for quality management in projects is applicable to
projects from the small to large, from simple to complex, from an individual project to being part of a
portfolio of projects. ISO 10006 is to be used by personnel managing projects and who need to ensure
that their organization is applying the practices contained in the ISO quality management system
standards.
ISO 10007 Quality management systems Guidelines for configuration management is to assist
organizations applying configuration management for the technical and administrative direction
over the life cycle of a product. Configuration management can be used to meet the product
identification and traceability requirements specified in this International Standard.
ISO 10008 Quality management Customer satisfaction Guidelines for business-to-consumer
electronic commerce transactions gives guidance on how organizations can implement an effective
and efficient business-to-consumer electronic commerce transaction (B2C ECT) system, and
thereby provide a basis for consumers to have increased confidence in B2C ECTs, enhance the ability of
organizations to satisfy consumers and help reduce complaints and disputes.
ISO 10012 Measurement management systems Requirements for measurement processes and
measuring equipment provides guidance for the management of measurement processes and
metrological confirmation of measuring equipment used to support and demonstrate compliance
with metrological requirements. ISO 10012 provides quality management criteria for a measurement
management system to ensure metrological requirements are met.
ISO/TR 10013 Guidelines for quality management system documentation provides guidelines for
the development and maintenance of the documentation necessary for a quality management
system. ISO/TR 10013 can be used to document management systems other than those of the
ISO quality management system standards, e.g. environmental management systems and safety
management systems.
ISO 10014 Quality management Guidelines for realizing financial and economic benefits is addressed to
top management. It provides guidelines for realizing financial and economic benefits through the
application of quality management principles. It facilitates application of management principles
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 to
interpret references to education and training within the ISO quality management system
standards. Any reference to training includes all types of education and training.
ISO/TR 10017 Guidance on statistical techniques for ISO 9001:2000 explains statistical techniques
which follow from the variability that can be observed in the behaviour and results of processes,
even under conditions of apparent stability. Statistical techniques allow better use of available data
to assist in decision making, and thereby help to continually improve the quality of products and
processes to achieve customer satisfaction.
ISO 10018 Quality management Guidelines on people involvement and competence provides
guidelines which influence people involvement and competence. A quality management system
depends on the involvement of competent people and the way that they are introduced and
integrated into the organization. It is critical to determine, develop and evaluate the knowledge,
skills, behaviour and work environment required.

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ISO 9001:2015

ISO 10019 Guidelines for the selection of quality management system consultants and use of their services
provides guidance for the selection of quality management system consultants and the use of their
services. It gives guidance on the process for evaluating the competence of a quality management
system consultant and provides confidence that the organizations needs and expectations for the
consultants services will be met.
ISO 19011 Guidelines for auditing management systems provides guidance on the management of an
audit programme, on the planning and conducting of an audit of a management system, as well as
on the competence and evaluation of an auditor and an audit team. ISO 19011 is intended to apply to
auditors, organizations implementing management systems, and organizations needing to conduct
audits of management systems.

Table B.1 Relationship between other International Standards on quality management and
quality management systems and the clauses of this International Standard

Other Interna- Clause in this International Standard

tional Standard
4 5 6 7 8 9 10
ISO 9000 All All All All All All All
ISO 9004 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 All All 9.1 10.2
ISO 10006 All 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
ISO 10015 7.2
ISO/TR 10017 6.1 7.1.5 9.1
ISO 10018 All All All All All All All
ISO 10019 8.4
ISO 19011 9.2
NOTE All indicates that all the subclauses in the specific clause of this International Standard are related to the other
International Standard.

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 ISO 9001:2015

Ti liu tham kho

[1] ISO 9004, Qun l cho s thnh cng bn vng ca mt t chc Tip cn trong qun l cht lng
[2] ISO 10001, Qun l cht lng S tha mn khch hng S tha mn ca khch hng Hng dn
v quy phm o c i vi t chc
[3] ISO 10002, Qun l cht lng S tha mn ca khch hng Hng dn v gii quyt khiu ni trong
trong t chc
[4] ISO 10003, Qun l cht lng S tha mn ca khch hng Hng dn gii quyt tranh chp bn
ngoi t chc
[5] ISO 10004, Qun l cht lng S tha mn ca khch hng Hng dn theo di v o lng
[6] ISO 10005, H thng qun l cht lng Hng dn k hoch cht lng
[7] ISO 10006, H thng qun l cht lng Hng dn qun l cht lng trong d n
[8] ISO 10007, H thng qun l cht lng Hng dn qun l cu hnh
[9] ISO 10008, Qun l cht lng S tha mn ca khch hng Hng dn cho cc giao dch thng
mi in t gia doanh nghip vi ngi tiu dng
[10] ISO 10012, H thng qun l o lng Cc yu cu i vi qu trnh o lng v thit b o lng
[11] ISO/TR 10013, Hng dn v ti liu ca h thng qun l cht lng
[12] ISO 10014, Qun l cht lng Hng dn v hin thc ha cc li ch kinh t v ti chnh
[13] ISO 10015, Qun l cht lng Hng dn v o to
[14] ISO/TR 10017, Ch dn v cc cng c thng k cho ISO 9001:2000
[15] ISO 10018, Qun l cht lng Hng dn v s tham gia ca mi ngi v nng lc
[16] ISO 10019, Hng dn la chn t vn h thng qun l cht lng v s dng cc dch v t vn
[17] ISO 14001, H thng qun l mi trng Cc yu cu v hng dn s dng
[18] ISO 19011, Hng dn nh gi cc h thng qun l
[19] ISO 31000, Qun l ri ro Nguyn tc v hng dn
[20] ISO 37500, Hng dn v thu ngoi
[21] ISO/IEC 90003, K thut phn mm Hng dn p dng ISO 9001:2008 trong phn mm my tnh
[22] ISO/IEC 60300-1, Qun l tin cy Phn 1: Hng dn qun l v p dng
[23] IEC 61160, Xem xt thit k
[24] Cc nguyn tc qun l cht lng, ISO1)
[25] Sa chn v s dng b tiu chun ISO 9000, ISO1)
[26] ISO 9001 cho cc doanh nghip nh - Vic cn lm, ISO1)
[27] Tch hp cc tiu chun h thng qun l, ISO1)
[28] www.iso.org/tc176/sc02/public
[29] www.iso.org/tc176/iso9001 Auditing Practices Group

[30] c o to v t vn p dng tiu chun ISO 9001:2015, vui lng lin h www.TopManJsc.com

1) C sn ti website: www.iso.org. www.TopManJsc.com https://goo.gl/qUXO3i

53
ISO 9001:2015

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[2] ISO 10001, Quality management Customer satisfaction Guidelines for codes of conduct for
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[3] ISO 10002, Quality management Customer satisfaction Guidelines for complaints handling in
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[4] ISO 10003, Quality management Customer satisfaction Guidelines for dispute resolution
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[8] ISO 10007, Quality management systems Guidelines for configuration management
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[10] ISO 10012, Measurement management systems Requirements for measurement processes and
measuring equipment
[11] ISO/TR 10013, Guidelines for quality management system documentation
[12] ISO 10014, Quality management Guidelines for realizing financial and economic benefits
[13] ISO 10015, Quality management Guidelines for training
[14] ISO/TR 10017, Guidance on statistical techniques for ISO 9001:2000
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[16] ISO 10019, Guidelines for the selection of quality management system consultants and use of
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[17] ISO 14001, Environmental management systems Requirements with guidance for use
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[25] Selection and use of the ISO 9000 family of standards, ISO1)
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1) Available from website: www.iso.org. www.TopManJsc.com https://goo.gl/qUXO3i

54