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01 Tieu Chuan ISO 9001 2015 Tieng Viet
01 Tieu Chuan ISO 9001 2015 Tieng Viet
01 Tieu Chuan ISO 9001 2015 Tieng Viet
ISO 9001:2015
https://goo.gl/qUXO3i
https://goo.gl/qUXO3i
Xut bn ln 5
Fifth edition
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.
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ISO 9001:2015
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:
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
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ISO 9001:2015
Trong Tiu chun quc t ny, cc mu cu sau In this International Standard, the following verbal
y c s dng: forms are used:
!"phi" ch ra mt yu cu; !shall indicates a requirement;
!"nn" ch ra mt khuyn ngh; !should indicates a recommendation;
!"c th" ch ra mt s cho php; !may indicates a permission;
!"c th lm" ch ra mt kh nng/mt nng lc !can indicates a possibility or a capability.
Thng tin c nh du "CH THCH" l hng Information marked as NOTE is for guidance in
dn hiu hoc lm r yu cu lin quan. understanding or clarifying the associated
requirement
0.2 Cc nguyn tc qun l cht lng 0.2 Quality management principles
Tiu chun quc t ny c da trn cc nguyn This International Standard is based on the quality
tc qun l cht lng c m t trong ISO 9000. management principles described in ISO 9000. The
Cc m t bao gm mt din gii ca mi nguyn descriptions include a statement of each principle, a
tc, l do ti sao cc nguyn tc rt quan trng i rationale of why the principle is important for the
vi t chc, mt s v d v li ch gn lin vi cc organization, some examples of benefits associated
nguyn tc v cc v d in hnh ca cc hnh with the principle and examples of typical actions to
ng nng cao hiu lc thc hin ca t chc khi improve the organizations performance when
p dng nguyn tc. applying the principle.
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ISO 9001:2015
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:
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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
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;
!Do: thc hin cc hng mc hoch nh; Do: implement what was planned;
ca ca
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ISO 9001:2015
Figure 2 - Representation of the structure of this International Standard in the PDCA cycle
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.
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ISO 9001:2015
hon cnh cho php cc t chc thu ht khch example, a set of circumstances that allow the
hng, pht trin sn phm v dch v mi, gim organization to attract customers, develop new
lng ph hoc ci tin nng sut. Cc hnh ng products and services, reduce waste or improve
gii quyt cc c hi cng c th bao gm vic productivity. Actions to address opportunities can
xem xt cc ri ro lin quan. 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 This International Standard applies the framework
chc ISO pht trin ci tin s thng nht gia developed by ISO to improve alignment among its
cc Tiu chun quc t v cc h thng qun l International Standards for management systems
(xem mc A.1). (see Clause A.1).
Tiu chun quc t ny gip cc t chc s dng This International Standard enables an organization
cch tip cn theo qu trnh, kt hp vi chu trnh to use the process approach, coupled with the PDCA
PDCA v t duy da trn ri ro, thng nht cycle and risk-based thinking, to align or integrate its
hoc tch hp h thng qun l cht lng ca t quality management system with the requirements of
chc vi cc yu cu ca cc tiu chun h thng other management system standards.
qun l khc.
Tiu chun quc t ny lin quan n ISO 9000 v This International Standard relates to ISO 9000 and
ISO 9004 nh sau: ISO 9004 as follows:
! ISO 9000 H thng qun l cht lng - C s ! ISO 9000 Quality management systems -
v t vng, cung cp nn tng ct yu hiu Fundamentals and vocabulary provides essential
ng v p dng Tiu chun quc t ny; background for the proper understanding and
! ISO 9004 Qun l thnh cng bn vng cho implementation of this International Standard;
t chc Tip cn trong qun l cht lng, ! ISO 9004 Managing for the sustained success of
cung cp cc hng dn cho t chc la an organization A quality management
chn cc tin b vt ngoi cc yu cu ca approach provides guidance for organizations
Tiu chun quc t ny. 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
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.
Cc ti liu sau y, ton b hoc mt phn, c The following documents, in whole or in part, are
tham chiu trong ti liu ny v khng th tch ri normatively referenced in this document and are
khi p dng h thng. i vi ti liu ghi ngy thng, indispensable for its application. For dated references,
ch p dng bn c trch. i vi ti liu tham only the edition cited applies. For undated references,
kho khng ghi ngy thng, phin bn mi nht ca the latest edition of the referenced document
cc ti liu tham chiu (bao gm c cc sa i) (including any amendments) applies.
c p dng.
ISO 9000:2015, H thng qun l cht lng - C ISO 9000:2015, Quality management systems
s v t vng Fundamentals and vocabulary
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
4.1 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
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;
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ISO 9001:2015
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;
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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:
5 S lnh o 5 Leadership
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;
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ISO 9001:2015
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:
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:
5.2.2 Truyn t chnh sch cht lng 5.2.2 Communicating the quality policy
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ISO 9001:2015
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;
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ISO 9001:2015
6.2.1 T chc phi thit lp cc mc tiu cht 6.2.1 The organization shall establish quality
lng ti cc cp, b phn chc nng v cc qu objectives at relevant functions, levels and processes
trnh cn thit ca h thng qun l cht lng. needed for the quality management system.
a) nht qun vi chnh sch cht lng; a) be consistent with the quality policy;
b) o lng c; b) be measurable;
c) c tnh n cc yu cu c th p dng; c) take into account applicable requirements;
d) lin quan n s ph hp ca sn phm v dch d) be relevant to conformity of products and services
v v nng cao s tha mn ca khch hng; and to enhancement of customer satisfaction;
e) c gim st; e) be monitored;
f) c truyn t; f) be communicated;
g) c cp nht khi thch hp. g) be updated as appropriate.
T chc phi duy tr thng tin dng vn bn v cc The organization shall maintain documented
mc tiu cht lng. information on the quality objectives.
6.2.2 Khi hoch nh cch thc t c cc mc 6.2.2 When planning how to achieve its quality
tiu cht lng ca t chc, t chc phi xc nh: objectives, the organization shall determine:
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ISO 9001:2015
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).
7 H tr 7 Support
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 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.
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.
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ISO 9001:2015
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
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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 The organization shall determine if the validity of
o lng trc c b nh hng xu khi c thit previous measurement results has been adversely
b o lng c xc nh l khng thch hp vi affected when measuring equipment is found to be unfit
mc ch d kin, v phi c hnh ng thch hp for its intended purpose, and shall take appropriate
khi cn thit. action as necessary.
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ISO 9001 : 2015
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
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) n sn c v thch hp cho vic s dng, bt a) it is available and suitable for use, where and
c khi no v bt c u khi cn thit; when it is needed;
b) n c bo v y (v d: trnh mt tnh b) it is adequately protected (e.g. from loss of
trng bo mt, s dng sai mc ch, hoc mt confidentiality, improper use, or loss of integrity).
tnh ton vn).
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; a) distribution, access, retrieval and use;
b) lu tr, bo qun, bao gm c vic bo qun b) storage and preservation, including preservation
mc r rng; of legibility;
c) kim sot s thay i (v d kim sot phin c) control of changes (e.g. version control);
bn); d) retention and disposition.
d) lu gi v hy b.
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ISO 9001 : 2015
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 The organization shall plan, implement and control the
cc qu trnh cn thit (xem 4.4), p ng cc processes (see 4.4) needed to meet the requirements
yu cu cung cp cc sn phm v dch v, v for the provision of products and services, and to
thc hin cc hnh ng xc nh trong iu 6, bng implement the actions determined in Clause 6, by:
cch:
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
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.
8.2.3 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:
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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;
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.
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
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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:
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:
T chc phi xc nh v p dng cc chun mc The organization shall determine and apply criteria
nh gi, la chn, gim st kt qu hot ng v for the evaluation, selection, monitoring of
nh gi li cc nh cung cp bn ngoi, da trn performance, and re-evaluation of external
kh nng cung cp cc qu trnh hoc sn phm providers, based on their ability to provide processes
v dch v ph hp vi cc yu cu. T chc phi or products and services in accordance with
lu gi li thng tin c lp vn bn ca cc hot requirements. The organization shall retain
ng ny v mi hnh ng cn thit pht sinh t documented information of these activities and any
cc nh gi. 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 The organization shall ensure that externally
phm v dch v c cung cp t bn ngoi provided processes, products and services do not
khng nh hng xu n kh nng ca t chc adversely affect the organizations ability to
trong vic chuyn giao mt cch n nh sn phm consistently deliver conforming products and
v dch v ph hp khch hng ca t chc. services to its customers.
8.4.3 Thng tin cho n v cung cp bn ngoi 8.4.3 Information for external providers
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ISO 9001 : 2015
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:
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ISO 9001 : 2015
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 The organization shall control the unique
ca cc kt qu u ra khi vic truy xt ngun identification of the outputs when traceability is a
gc l mt yu cu, v phi lu gi cc thng tin requirement, and shall retain the documented
c lp vn bn cn thit c th truy xt information necessary to enable traceability.
c ngun gc.
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 When the property of a customer or external
cp bn ngoi b mt, h hng hoc c pht provider is lost, damaged or otherwise found to be
hin khng ph hp s dng, t chc phi unsuitable for use, the organization shall report this
bo co cho khch hng hoc nh cung cp bn to the customer or external provider and retain
ngoi v lu gi thng tin c lp vn bn v documented information on what has occurred
vn xy ra
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.
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.
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ISO 9001 : 2015
T chc phi p ng cc yu cu i vi hot The organization shall meet requirements for post-
ng sau giao hng c lin quan n cc sn delivery activities associated with the products and
phm v dch v. services.
Khi vic xc nh mc cc hot ng cn thit In determining the extent of post-delivery activities
sau giao hng, t chc phi xem xt: that are required, the organization shall consider:
T chc phi xem xt v kim sot nhng thay The organization shall review and control changes
i i vi vic sn xut hay cung cp dch v, for production or service provision, to the extent
vi mc cn thit m bo lin tc s ph necessary to ensure continuing conformity with
hp vi cc yu cu. requirements
T chc phi thc hin cc b tr c hoch The organization shall implement planned
nh cc giai on thch hp xc nhn rng arrangements, at appropriate stages, to verify that
cc yu cu sn phm v dch v c p the product and service requirements have been
ng. met
Vic chuyn giao cc sn phm v dch v cho The release of products and services to the
khch hng s khng c tin hnh cho n khi customer shall not proceed until the planned
cc b tr c lp k hoch c hon thnh arrangements have been satisfactorily completed,
mt cch tha ng, tr trng hp c ph unless otherwise approved by a relevant authority
duyt ca cp c thm quyn lin quan v, khi and, as applicable, by the customer
thch hp, bi khch hng.
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ISO 9001 : 2015
8.7.1 T chc phi m bo rng cc kt qu 8.7.1 The organization shall ensure that outputs
u ra khng ph hp vi yu cu c nhn that do not conform to their requirements are
bit v c kim sot ngn nga vic s identified and controlled to prevent their unintended
dng hoc vic chuyn giao khng mong mun. use or delivery.
T chc phi c hnh ng thch hp da trn The organization shall take appropriate action
bn cht ca s khng ph hp v nh hng based on the nature of the nonconformity and its
ca n n s ph hp ca sn phm v dch effect on the conformity of products and services.
v. iu ny cng phi p dng i vi cc sn This shall also apply to nonconforming products
phm v dch v khng ph hp c pht hin and services detected after delivery of products,
sau khi chuyn giao sn phm, trong hoc sau during or after the provision of services.
khi thc hin dch v.
8.7.2 T chc phi lu gi li thng tin c lp 8.7.2 The organization shall retain documented
vn bn: information that:
9.1 Theo di, o lng, phn tch v nh gi 9.1 Monitoring, measurement, analysis and
evaluation
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ISO 9001:2015
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ISO 9001:2015
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) 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.
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ISO 9001:2015
a) tnh trng ca cc hnh ng t ln xem xt a) the status of actions from previous management
trc; reviews;
b) cc thay i bn trong v bn ngoi c lin b) changes in external and internal issues that are
quan n h thng qun l cht lng; relevant to the quality management system
c) thng tin v kt qu hot ng v hiu lc c) information on the performance and effectiveness
ca h thng qun l cht lng, bao gm of the quality management system, including
c cc xu hng v: trends in:
u ra ca xem xt ca lnh o phi bao gm The outputs of the management review shall include
cc quyt nh v hnh ng lin quan n: decisions and actions related to:
T chc phi lu gi thng tin c lp vn bn The organization shall retain documented information
nh bng chng v cc kt qu xem xt ca lnh as evidence of the results of management reviews.
o.
10 Ci tin 10 Improvement
38
ISO 9001:2015
b) khc phc, ngn nga hoc lm gim cc nh b) correcting, preventing or reducing undesired
hng khng mong mun; effects;
c) ci tin kt qu hot ng v hiu lc ca h c) improving the performance and effectiveness of
thng qun l cht lng. the quality management system
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. change, innovation and re-organization.
10.2.1 Khi s khng ph hp xy ra, k c pht 10.2.1 When a nonconformity occurs, including any
sinh t cc khiu ni, t chc phi: arising from complaints, the organization shall:
a) Khi thch hp, x l s khng ph hp: a) react to the nonconformity and, as applicable:
1] thc hin hnh ng kim sot v khc 1] take action to control and correct it;
phc s khng ph hp;
2] gii quyt cc hu qu; 2] deal with the consequences;
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, cause(s) of the nonconformity, in order that it
khng ti din hoc xy ra ni khc, bng does not recur or occur elsewhere, by:
cch: 1] reviewing and analysing the nonconformity;
1] xem xt v phn tch s khng ph hp; 2] determining the causes of the
2] xc nh cc nguyn nhn ca s khng nonconformity;
ph hp; 3] determining if similar nonconformities exist,
3] xc nh xem liu s khng ph hp or could potentially occur;
tng t c tn ti hay khng, hoc c th
tim n xy ra;
Hnh ng khc phc phi tng xng vi tc Corrective actions shall be appropriate to the effects
ng ca cc s khng ph hp gp phi. of the nonconformities encountered.
10.2.2 T chc phi lu gi li thng tin c lp 10.2.2 The organization shall retain documented
vn bn nh bng chng v: information as evidence of:
39
ISO 9001:2015
T chc phi ci tin lin tc s ph hp, tha The organization shall continually improve the
ng v hiu lc ca h thng qun l cht lng. suitability, adequacy and effectiveness of the quality
management system.
T chc phi xem xt cc kt qu phn tch v The organization shall consider the results of
nh gi, v cc kt qu u ra t xem xt ca analysis and evaluation, and the outputs from
lnh o, xc nh xem c nhu cu hay c hi management review, to determine if there are needs
no phi c gii quyt nh mt phn ca ci or opportunities that shall be addressed as part of
tin lin tc. continual improvement.
40
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.
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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
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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.
45
ISO 9001:2015
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ISO 9001:2015
Ph lc B
(Tham kho)
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.
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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
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ISO 9001:2015
Annex B
(informative)
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
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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
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ISO 9001:2015
[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
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ISO 9001:2015
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[4] ISO 10003, Quality management Customer satisfaction Guidelines for dispute resolution
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[28] www.iso.org/tc176/sc02/public
[29] www.iso.org/tc176/ISO9001AuditingPracticesGroup
54