TCVN TIEU CHUAN QUOC GIA * NATIONAL STANDARD TCVN ISO 9001:2015 ISO 9001:2015 Xuat ban [an 4 Fourth edition HE THONG QUAN LY CHAT LU'ONNG - CAC YEU CAU QUALITY MANAGEMENT SYSTEMS — REQUIREMENTS HANOI - 2016TCVN ISO 9001:2015 Myc tye Loi néi au... LOI gi6i thiéu.... 1 Pham vip dung nse Tai ligu vign dan 2 3. Thuat ngt va dinh nghfa 4 Béi c&nh olla t6 chire 4.1 Hidu td chire va béi canh cia té chite. 4.2 Hidu nhu cu va mong dai ciia cc bén quan tam... 4.3 Xéc dinh pham vi cla hé théng quan ly chét lugng 4.4 Hé théng quan ly chat long va cdc qua trinh olla hé théng, 5 Sy lanh a0... 5.1 Sy lanh dao va cam ké 5.2 Chinh séch... 5.3 Vai trd, trach nhiém va quyan han trong t6 chic 6 Hoach din... 6.1 Hanh dong giai quy&t ri ro va co hoi 6.2 Muc tiéu chét trong va hoach dinh 6 at doe myc tiéu... 6.3 Hoach dinh thay Géi......... 7 H6 try. 7.1 Nguén lye. 7.2Nang lye... 7.3.Nhan thee 7.4 Trao di thong tn. 7.5 Théng tin dang van ban... 8 Thyc hién. 8.1 Hoach dinh va kiém soat viée thuec hién .. 8.2 Yéu cau di véi san phdm va dich viTCVN ISO 9001:2015 8.3 Thiét ké va phat trién san pham, dich vu. 8.4 Kiém soat qua trinh, san phdm va dich vu do bén ngoai cung cép ... 8.5 San xuat va cung cép dich w.. 8.6 Thong qua sén phdm va dich wu. 8.7 Kiém soat dau ra khong phu hop... 9 Banh gid két qua thie hién 9.1 Theo doi, do lwéng, phan tich va danh gia. 9.2 Banh gid n9ib6... 9.3 Xem xét ctia lénh dao. 10 Cai tién. 10.1 Khai quat. 40.2 Su khdng phil hop va hanh dng khdc phuc ... 10.3 Cai tién lien tuc..... daaeuranne Phu lye A (tham kno) Lam r6 edu tric, thuat ngt va khai niém mdi... Phu luc B (tham khdo) Cc tigu chun khdc vé quan I chat lueng va hé théng quan ly chat lung do Ban ky thuat TCVNITC 176 xay dyng.... 60 Thu myc tai ligu tham Khao... 69TCVN ISO 9001:2015 Table of content 1 Scope... 2 Normative references... 3. Terms and definition 4 Context of the organization... 118 4.1. Understanding the organization and its context. 18 4.2 Understanding the needs and expectations of interested parties. 118 4.3 Determining the scope of the quality management system... 19 4.4 Quality management system and its processes. 7 5 Leadership. 21 5.1 Leadership and commitment... 24 5.2 Policy... ns 22, 5.3 Organizational roles, responsibilities and authorities .....:s:nesmnnnennnenneennnnns 2B 6 Planning. 24 6.1 Actions to address risks and opportunities. 24 6.2 Quality objectives and planning to achieve them eiceanat 3B 6.3. Planning of changes. 26 T Support. 7.4 Resources. Seen anasee ee 7.2 Competence... 29 7.3. Awareness... -30 7.4 Communication... 30 7.5 Documented information . 8 Operation... 8.1 Operational planning and control. 8.2 Requirements for products and services 8.3. Design and development of products and services. 8.4 Control of externally provided processes, products and services... 8.5 Production and service provision..TCVN ISO 9001:2015 8.6 Release of products and services. 8.7 Control of nonconforming outputs... 9 Performance evaluation...... 9.1 Monitoring, measurement, analysis and evaluation. 9.2 Internal audit... 9.3 Management review..... 10 Improvement... 10.1 General... 40.2 Nonconformity and corrective action... 10.3 Continual improvement... Annex A (informative) Clarification of new structure, terminology and concepts. ‘Annex B (informative) Other Intemational Standards on quality management and quality management systems developed by ISO/TC 176. 60 Bibliography‘TCVN ISO 9001:2015 Loi not dau TCVN ISO 9001:2015 (ISO 9001:2015) thay thé TCVN ISO 90012008 (ISO 90012008); TCVN ISO 9001:2015 hoan toan tong duong voi ISO 9001:2015; TCVN ISO 9001:2015 do Ban ky thuat chuan Quéc gia TCVNITC 176 Quan ly cht lugng va dm béo chat lupng bién soan, Téng cue Tiéu chu&n Bo ling Chat lvgng 48 nghi, BG Khoa hoe va Céng nghé cong bé.TCVNISO 9001:2015 Loi gi6i thigu 0.4 Khai quat Ch&p nh@n mét hé théng quan ly chat lgng la quyét dinh chién luge abi véi t8 chite, vige nay 6 thé glip cai tién toan bo két qua hoat déng cua tb chitc va dura ra co sé hyp ly cho sy khdi dau cla phat trién ban ving. Loi ich tiém tang d6i voi t8 che tur viée &p dung h@ théng quan ly chat Ivong theo tiéu chudn nay ta a) khd nang cung cp mot cach én dinh ede san pham va dich vu dap tng yéu cau cla khach hang, yéu cdu lu8t dinh va ché dinh hign hanh; ) tao thuan Igi cho céc co’ hoi nang cao sir théa man olia khach hang; c) gidi quyét ri ro va co hoi lién quan dén béi cnh va myc tiéu ctia t8 chic; d) khd n&ng chung 13 sy phu hop véi cdc yeu ‘cau quy dinh cia hé théng quan ly chat lvgng. Tiéu chudn nay 6 thé duge str dung bdi céc bén noi bo va bén ngoai, Tiéu chun nay khéng ham y nhu eau é6i voi = sy ddng nhét vé cdu tric cia cdc hé théng quan ly chét long khae nhau; = vic sp xép hé théng tai liéu theo cu tric cc didu cia tiéu chudn; = vide sir dung céc thuat ngt cu thé cia tieu chudn trong t8 chive, Cac yéu cdu d6i voi hé théng quan Iy chat luong uc quy dinh trong tiéu chudn nay bé sung cho cdc yéu cau déi voi sén phdm va dich vu. Introduction 0.4 General The adoption of a quality management system is a strategic decision for an organization that can help to improve its overall, performance and provide a basis sustainable development sound for initiatives. The potential benefits to an organization of implementing a quality management system based on this International Standard are: a) the ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements; b) facilitating opportunities to enhance customer satisfaction; ©) addressing risks and opportunities associated with its context and objectives; conformity to system ¢) the ability to demonstrate specified quality management requirements. This Intemational Standard can be used by internal and external parties. It is not the intent of this International Standard to imply the need for: = uniformity in the structure of different quality 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 The quality management system requirements specified in this Intemational Standard are ‘complementary to requirements for products and inTiéu chuan nay van dung cach tiép can theo qua trinh, két hop chat ché chu trinh Hoach dinh — Thue hién — Kiém tra — Hanh dng (PDCA) va tu: duy dya trén rai ro. Céch tiép cn theo qua trinh gidp t8 chwre hoach dinh céc qua trint cla minh va sy tuong tac gitra cae qua trinh Chu trinh PDCA gidp t8 chire dam bdo rang cac qua trinh cia minh durge cung cép ngubn Ive va duge quan ly mét céch théa dang, cAc eo hei cai tién durge xac dinh va thyc hin, Tu duy dua trén ri ro gidp t8 chire xae éinh cae yéu t6 c6 thé la nguyén nhan lam céc qua trinh va hé théng quan ly clia t8 chive chéch kndi két qua dugc hoach dinh, dua ra cdc kiém soat phong ngiza nh&m gidm thiéu tac dong tiéu cue va tan dung t6i da co’ hdi khi nd xuat hign (xem A.4) Vige ap ting mét céch 8n dinh cae yeu cu va giai quyét cae nhu c&u va mong doi trong trong lai @at ra thach thire cho t8 chire trong mét méi trudng ngay cang nang ang va phic tap. BE dat duge.muc tiéu nay, t8 chitc 66 thé thay cn chap nhan cac hinh thie edi tién khae nhau bén canh vige khe phuc va cai tin ign tye, vi dy nhu thay Jot pha, di méi va tai cu tric. Trong tiéu chun nay ti: ~ “phai" chi mot yéu cau; = *caninén® chi sy khuyén nghi; = “duge phép" ct \ot su cho phép; = “c6 thé® chi khd nang hod nang Ive. services. This Intemational Standard employs the process approach, which incorporates the Plan - Do ~ Check — Act (PDGA) cycle and risk-based thinking. ‘The process approach enables an organization to plan its processes and their interactions. The PDCA cycle enables an organization to ensure that its processes are adequately resourced and managed, and that opportunities for improvement are determined and acted on. Risk-based thinking enables an organization to determine the factors that could cause its processes and 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 A4), 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 innovation and re organization. change, In this International Standard, the following verbal forms are used: = ‘shall’ indicates @ requirement; = “should” indicates a recommendation; - *may" indicates a permission; = “can” indicates a possibility or a capability.TCVN ISO 9001:2015 Thong tin néu trong “CHU THICH’ 1a huéng din 66 hiéu hoae lam ré yéu ou lién- quan. 0.2 Cac nguyén tac quan Iy cht lwong Tigu chudn nay dya trén cdc nguyén tde quan ly chat Iugng néu trong TCVN ISO 9000. Phan m6 ta bao gdm néi dung cia tig nguyén tho, ly gidi vi sao nguyén téc 46 quan trong d6i voi té chirc, cdc vi dy vé Igi ich lién quan t6i nguyén tac va cde. vi dy v8 nhting hanh dong dién hinh d& cai tién két qua thye hign cia t8 chic khi 4p dung nguyén tac a6. Cac nguyén téc quan ly chat lrgng la = huéng vao khach hang: - sy linh dao; = sip tham gia cila moi ngudi; ~ tiép cn theo qua trinh; cai tién; = quyét dinh dya trén bang chérng: = quan ly méi quan he, 0.3 Tiép can theo qua trinh 0.3.1 Khai quat Tiéu chuan nay thic day viée chap nhan cach tiép can theo qua trinh khi xay dung, ap dung va cai tién higu Ic cla hé théng quan Iy chdt Iwong nh&m nang cao sy théa man ca khéch hang thong qua vie dap @ng céc yéu cu cia khach hang. Cc yéu cu cu thé durgc col a thiét yéu ai Oi viée chdp nhan cach tiép can theo qua trinh duge neu 8 4.4, Vide hidu va quan ly cc qué trinh 6 lign quan Ian nhau trong mot hé théng s8 déng gép cho viée dat 10 Information marked es “NOTE” is for guidance in understanding the associated requirement. or clarifying 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 the principle and to improve the benefits associated with examples of typical actions ‘organization's performance when applying the principle. The quality management principles are: - customer focus; = leadership; = engagement of people: = process approach; ~ improvement; - evidence-based decision making; - _ felationship management. 0.3 Process approach 0.3.4 General This Intemational Standard promotes the adoption of a process developing, implementing and improving the effectiveness of a approach when quality management system, to enhance customer satisfaction by meeting customer requirements. Specific requirements considered essential to the adoption of a process approach are included in 44 Understanding and managing related processes as a system contributes to theurge mot céch higu Iye va higu qua céc Ket qua dy kién cia t8 chic. Cach tiép can nay gidp t8 chic kiém soat méi quan hé va su phy thudc lan nhau gira cac qua trinh olla hé théng, do dé két qua thyc hign tng thé cia 18 chitc 06 thé duoc nang cao, . Céich tiép cn theo qua trinh di hai vie xac dinh va quan ly mét cach h@ théng céc qua trinh va sir tuong tac gira cdc qué trinh 08 dat durgc cdc két qua dy kién ph hop v6i dinh hyéng chién lvoe va chinh sich cht Iugng ola 18 chite. Viée quan ly cae qué trinh va ting thé he théng c6 thé dat duge thong qua viéc sir dung chu tinh PDCA (xem 0.3.2) v6i trong tam chung [a tw duy dya trén rdi ro (xem 0.3.3) nh&m tan dyng cac co hdi va ngan ngiva két qua khong mong muén. Vig &p dung céch tiép c€n theo qua trinh trong hé théng quan ly chét lugng gid: a) higu va nhét quan trong vige dép tng céc yeu edu; b). xem xét cdc qua trinh vé mat gid tri gia tang; ©) dat duge két qua thyc hign qua trinh mot cach, higu Ic; cai tién cdc qua trinh trén co sé danh gid dt ligu va thong tin dq) h 1 biéu din qua trinh bat ky duéi dang so’ a va thé hign su tong tac gitva cdc yéu 16 ctla qua trinh, Cac diém kiém tra dé theo déi va do lwong can thiét cho viée kiém soat déu cy thé cho ting {qua trinh va s6 thay 66i theo cdc ri ro lién quan. organization's effectiveness and efficiency in achieving its intended results. This approach enables the control the interrelationships and interdependencies among organization to the processes of the system, so that the overall performance of the organization can be enhanced. The process approach involves the systematic definition and management of processes, and their interactions, so as to achieve the intended results in accordance with the quality policy and strategic direction of the organization. Management of the processes and the system as a whole can be achieved using the PDCA cycle (see 0.3.2) with an overall focus on risk-based thinking (see 0.3.3) aimed at taking advantage of opportunities and preventing undesirable results. The application of the process approach in a quality management system enables: a) requirements; understanding and consistency in meeting b) the consideration of processes in terms of added value; ©) the achievement of effective process performance: d) improvement of processes based on evaluation of data and information. Figure 1 gives a schematic representation of any process and shows the interaction of its elements. ‘The monitoring and measuring check points, which fare necessary for control, are specific to each process and will vary depending on the related risks. "TCVNISO 9001:2015 ‘J eee ‘| Nauén ééuva0 Host dong Gee Nguditiép nhgn dura me aS ae ea | vou, xi 1 5 [UATE TRuGc || vir, Ivedy senisengesp! | MANS WONG, | | nde tuon, | (estima! move | income | Sette ta | [ease | ledscacongim | romantics | | Serhan | Keene, | frmneat | [mereen | | | pear | \ | | cena a i; ‘edinet baie Sea Hinh 4 - Biéu dién du6i dang so dé cac yéu t6 cia mét qua trinh Pata te théing quan chat uang (a) Hoch dinh —“" thuchien )) Conan () CHU THICH: Cac sé trong ngode don thé hin thé hien s6 diéu cla tiéu chuan Téchicvabsi_f inh cia t6 chic (a) | Yeucéucia khdch hang ben quanta célién quan a Now cbu ve mong doi el Hinh 2 - Biéu din c4u tric cia tiéu chudn theo chu trinh PDCA 12TCVN ISO 9001:2045 iy S el I | jm | fos tech reer Keeps | trom, | {terotaron, | ' [seein] laren’ | ere | | alla [treme | Seca fess. | | [fare t a J J el feck te mentor stcnesuepesormne| Figure 1 — Schematic representation of the elements of a single process Quality Management § / eae oiecore { Scorer ~ operation ‘aie cuca Results of customer ete requirements Produetsand services NOTE: Number in brackets refer fo the clauses in this International Standard Figure 2 — Representation of the structure of this international standard in the PDCA cycle 18TCVN ISO 9001: 015 0.3.2 Chu trinh Hoach dinh - Thy hign — Kiém tra—Hanh dong Chu trinh POCA cé thé duoc dp dung cho tat c& cdc qué trinh va téng thé hé théng quan ly chét lugng. Hinh 2 minh hoa viéc phan nhém cae Dibu tir 4 dn 10 trong chu trinh PDCA. : Chu trinh PDCA cé thé dug mo ta tom t&t nhur sau: ~ Hoach dink; thiét lap cdc muc teu cia hé théng va cée qué trinh cla he théng, cdc ngudn lye cn thiét 48 cho ra két qua phi hop véi yéu cu cla khéch hang va chinh sch clla té chire va nhan biét va glial quyét cc rai ro va cor hot; - Thye hign: thye hign nhing gi da duge hoach dinh; = Kiém tra: theo d6i va (khi ¢6 thé thye hién) o ludng céc qué trinh va sén pham, dich vu dat duge theo chinh sch, myc tiéu, yéu cu va hoat d6ng 68 hoach dinh va bdo céo két qua; = Hanh d6ng: thyc hién cac hanh Gong 4é cai tién két qué thy hign Khi can, 0.3.3 Tw duy dya trén ruil ro Tu duy dya trén rai ro (xem A.4) la quan trong 48 at duge hé théng quan ly chat Ivgng cé higu ye. Khai niém tw duy dya trén ri ro 4 duge ham y trong céc phién ban tude day cia tieu chudn nay, bao gdm, vi dy nhu thye hién hanh dong phong ngira nh&m loai bd sy khong phir hop tiém 2n, phan tich moi sy khéng phi hop xy ra va thyc hién hanh dong thich hop v6i tac ong olla sw khong phi hop, nh&m ngan ngira su tai di ‘é phi hyp voi cdc yéu cau cilia tiéu chudn nay, 14 0.3.2 Plan-Do-Check-Act cycle The PDCA cycle can be applied to all processes and to the quality management system as a whole. Figure 2 illustrates how Clauses 4 to 10 can be grouped in relation to the POCA cycle. The PDGA cycle can be briefly described as follows: - Plan: establish the objectives of the system and its processes, and the resources needed to deliver results in accordance with customers’ requirements and the organization's policies, and Identity and address risks and opportunities; = Do: implement what was planned; = Check: monitor and (where applicable) measure processes and the resulting products and services against policies, objectives, requirements and planned activities, and report the results; = Act: take actions to improve performance, as necessary. 0.3.3 Risk-based thinking Risk-based thinking (see Clause A.4) is essential for achieving an effective quality management system. The concept of risk-based thinking has been implicit in previous editions of this International Standard including, for example, carrying out preventive action to eliminate potential nonconformities, analysing any nonconformities that do occur, and taking action to prevent recurrence that is appropriate for the effects of the nonconformity To conform to the requirements of this16 chic cn hoach dinh va thc hign cae hanh dong 48 gidi quyét roi ro va co hoi Vide giai quyét ca ri ro va co héi tao nén tang cho viéc nang cao higu iyo cla hé théng quan ly chat long, dat duge céc két qua cai tién va ngan ngiva cde téc dong tiéu cue. Co hoi o6 thé nay sinh tty két qua ca cée tinh hhudng thuan Igi cho viée dat durgc két qua dy kién, vi dy nhu tap hgp cc truéng hep cho phép t6 chic thu hit khach hang, phat trién san phdm, dich vu méi, gidm lang phi hoc nang cao nang sudt. Hanh dong 48 gi 66 thé cing bao gdm vige xem xét ede rai ro fién quan. Rui ro quyét co hi la anh hudng cla sy khong chéc chén va sy khong chdc chan bat ky d6 déu cé thé 6 anh hung tich cwe hode tidu ce. Sy chéch huéng tich cue nay sinh tir rii ro 6 thé mang lai co hoi, nhung khéng phai tat cd cac anh hung tich cve ro du mang lai co hei. ola 0.4 Méi quan hé vi cdc tigu chuan vé hg théng quan ly khac ‘Tiéu chuan nay ap dung khuén khé do ISO thiét lap nham nang cao su théng nhét gitra cae tiéu chudn vé hé théng quan ly (xem A.1). Tieu chudn nay gidp t6 chize sip dung cach tiép can theo qua trinh két hop véi chu trinh PDCA va tu duy diya trén ri ro 48 théng nh&t hoae tich hop h@ théng quan Ij chét Ivgng cia minh véi cdc yéu cau cilia tiéu chudn vé hé théng quan ly khac. Tiéu chuan nay lién quan dén TCVN ISO 9000 va TCVN ISO 9004 nh sau: = TCVN ISO 9000 Hé théng quan Iy chdt lung — Co sé va tl wing cung cap nén tang quan TCVN ISO 9001:2015 International Standard, an organization needs to plan and implement actions to address risks and opportunities, both risks and opportunities establishes a basis for increasing the effectiveness of the quality management Addressing system, achieving improved results and preventing negative effects, Opportunities can arise as a result of a situation favourable to achieving an intended result, for example, a set of circumstances that allow the organization to attract customers, develop new products and services, reduce waste or improve productivity. Actions to address opportunities can also include consideration of associated risks, Risk is the effect of uncertainty and any such uncertainty can have positive or negative effects. A positive deviation arising from a risk can provide an opportunity, but not all positive effects of risk result in opportunities 0.4 Relationship with other management system standards This Intern: nal Standard applies the framework developed by ISO to improve alignment among its Intemational Standards for management systems (see Clause A.1), This Standard 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 International enables an other management system standards. This Intemational Standard relates to ISO 9000 and ISO 9004 as follows: = ISO 9000 Quality management systems - Fundamentals and vocabulary provides essential 15TCVN ISO 9001:2015 trong cho viéc higu va 4p dyng diing tiéu chudn nay; - TCVN ISO 9004 Quan Iy 16 chize a8 thanh o6ng bén ving — Phuong phdp tiép cin quan Iy cht luong dua ra huéng d&n cho cae t6 chte Iva chon vugt xa hon cdc yéu cau cla tieu chudn nay. Phu Ive B néu chi tiét cdc tiéu chudin kno ve quan ly chAt lugng va hé théng quan ly chat lwong do Ban kj thuat tigu chuén TCVN/TC 176 xéy dung. ‘Tiéu chudn nay khéng bao gdm 4c yéu cdu cu thé d6i v6i hé théng quan ly khéc nh quan Wy moi trréng, quan ly an toan va sire khbe ngh& nghiép hay quan ly tai chinh, Cée tiéu chudn v8 hé théng quan ly chét long cho inh vyre cy thé diva trén céc yéu cdu olla tiéu chudn nay duge xay dyng cho mét sé finh vue. Mét trong s6 cac tiéu chudn nay quy dinh céc yéu cdu bd sung 461 véi hé théng quan ly cht lueng, trong khi s6 khac chi gidi han & viée dua ra huéng d&n cho viéc 4p dung tiéu chudn nay ‘rong Minh wy cu thé. Bang thé hién sy tuong quan gira céc diéu cla tigu chudn nay voi céc cac digu cia phién ban true 6 thé thay trén trang dign tit cong khai cla tidu ban ky thuat ISO/TC 176/SC 2: own. iso ora/tet 76/sc02/public. 16 background for the proper understanding and implementation of this International Standard; = 180 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. Annex B provides details of other International Standards on quality management and quality management systems that have been developed by ISO/TC 176. This Intemational Standard does not include requirements specific to other management systems, such as those for environmental management, occupational health and safety management, or financial management. Sector-specific quality management system standards based on the requirements of this International Standard have been developed for a number of sectors. Some of these standards specify additional quality management system requirements, while others are limited to providing guidance to the application of this International ‘Standard within the particular sector. A matrix showing the correlation between the clauses of this edition of this International Standard and the previous edition (ISO ‘9001:2008) can be found on the ISO/TC 176/SC 2 open access web site at www.iso.ora/tc176/sc02/public.TIEU CHUAN QUOC GIA * NATIONAL STANDARD TCVN ISO 9001:2015 Hé théng quan ly chat lweng — Cac yéu cau Quality management systems — Requirements 41 Pham vi ap dung Tiéu chudn nay quy dinh céc yeu cau ai voi he théng quan ly chat lugng khi mét t8 chire: a) can ching té kha nang cung c&p mét cach 4n dinh cdc san phdm va dich vu dap Ung yéu cdu cila khach hang cing nhu yéu cdu cila Wat dinh va ché dinh hign han; va b) _muén nang cao su thod man ola Khach hang thong qua vige ap dung o6 higu lye hé théng, bao gdm cd cdc qué trinh 48 cai tién he théng va dam bao sy phi hop voi cdc yéu cau clla khach hang, yéu cdu luat dinh va ché dinh hign hann. (Cae yéu cau trong tigu chuan nay mang tinh khai quat va nh’m ap dung cho mei 8 chire khéng phan biét loai hinh, quy mé ho&e san pham, dich vu cung cap. CHU THICH 1: Trong tiéu chuan nay, thuat ngt “san ph&m” hoe “dich vy" chi ap dyng cho cdc san pham, dich vu dy kién cung cap cho khéch hang ho&e duge khach hang yéu cau. CHU THICH 2: Cac yéu cau luat dinh va ché cinh 06 thé duge thé hign I cc yéu clu phép ly. 2 Tai ligu vign din Tai ligu vign d&n dui day rat cn thiét cho viee 4p dung tigu chudn nay. D6i voi cdc tai ligu ghi nam céng bé thi ap dung ban duge néu. Déi voi 4 Scope This ‘Standard specifies requirements for 2 quality management system when an organization: International a) needs to demonstrate its ability to consistently provide products and services that meet customer and regulatory requirements, and applicable statutory and b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. All the requirements ofthis International Standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides. NOTE 1 In this Intemational Standard, the terms “product” or ‘service’ only apply to products and services intended for, or required by, a customer. NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for i application. For dated 7TCVN ISO 9001:2015 cc tai Neu khong ghi nam céng bé thi 4p dung ban moi nhét, bao gbm ca cae stra adi, TCVN ISO 9000:2015, Hé théng quan ly chat ugg — Co sé va tt vung 3. Thuat ng va dinh nghia Tiéu chudn nay sir dung cée thuat ngtr va inh ghia trong TCVN ISO 9000:2015, 4 Béicanh cia td choc 4.4 Hidu té chic va béi canh cia té chic Té chic phai xéc dinh cac van d& bén ngoai va di b6 lién quan dén myc dich va dinh hung chién ge ca minh va anh huéng dén kha ning ta t8 chite trong viée dat dug (cdc) két qua dy kién cia hé théng quan ly chat lugng. 6 chite phai theo doi va xem xét théng tin vé nhGng van dé bén ngoai va ndi bo nay. CHU THIGH 1: Cac vin a8 06 thé bao gdm ning yu +16 node diéu kién tich oye va tiéu crc cho viée xem xét. CHU THICH 2: Hidu béi cdnh bén ngoai 66 thé dé dang hon théng qua viée xem xét cdc van dé nay sinh tir méi {rung phap ly, c6ng nghé, canh tranh, thi trong, van héa, xa hoi va kinh t8 & cp quéc t6, quéc gia, khu vyc hay dia phuong. CHU THICH 3: Higu b6i cénh néi bo 66 thé d& dang hon théng qua vige xem xét cdc van 48 fién quan aén cc gia tr, van hoa, tr thire va KBt qua thuec hin ota chic. 4.2 Higu nhu cau va mong dgi cla céc bén quan tam Do tc dong hoae tac dong tiém an cila céc ben quan tam {61 kha nang cla t8 chite trong viée ‘cung cp mét cach én dinh san phdm va dich vu 18 references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 9000:2015, Quality management systems — Fundamentals and vocabulary 3. Terms and definitions For the purposes of this document, the terms and definitions given in ISO 9000:2015 apply. 4 Context of the organization 4.1 Understanding the organization and its context The organization shall determine external and that relevant to its issues are internal purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system. The organization shall monitor and review information about these extemal and intemal issues. NOTE 1 Issues can include positive and negative factors or conditions for consideration. NOTE 2 Understanding the extemal context can be facilitated by considering issues arising from legal, technological, competitive, market, cultural, and environments, whether social economic international, national, regional or local NOTE 3 Understanding the intemal context can be facilitated by considering issues related to values, culture, knowledge and performance of the organization, 4.2 Understanding the needs and expectations of interested parties Due to their effect or potential effect on the organization's ability to consistently provideap tng yéu céu cla khéch hang, yéu cu luat inh va ché dinh hién hanh, nén té chire phai x4c inh: a) céc bén quan tam c6 lién quan t6i hé théng quan ly chat lrgng; b) yéu cdu ctia cde bén quan tém lién quan t6i hé théng quan ly chat long, Té chire phai theo d6i va xem xét théng tin v8 cdc bén quan tam va yéu cu lién quan cia ho. 4,3 Xée dinh pham vi cla hé théng quan ly chat lvgng Té chire phai xac dinh ranh giéi va kha nang 4p dyng cia hé théng quan ly chat Iuong a8 thiét lap pham vi ela hé théng. Khi xéc dinh pham vi nay, t8 chirc phai xem xét a) cae van dé ben ngoai va néi bo dé cap 6 4.1; b)_yéu cau cia cae bén quan tam lién quan a8 cap 84.2; ©) san phdm va dich vy cia t8 chite. Té chic phai ap dung tét cd céc yeu cdu cia tiéu chudn nay néu nhéng yéu cau 46 4p dung dugc trong pham vi da xac dinh ciia hé théng quan ly chat Iyong. Pham vi hé théng quan ly chat luong cia t6 chite phai sn c6 va duc duy tr blng théng tin dang van ban, Pham vi nay phai néu loai san phdm va dich vu duge bao trim va phai dua ra I gidi cho céc yéu cdu cia tiéu chudn duge 18 chirc xc dinh la khong thé ap dung cho pham vi lia hé théng quan I chat lvong. TCVN ISO 9001:2015 products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine: a) the interested parties that are relevant to the quality management system; b) the requirements of these interested parties that are relevant to the quality management system The organization shall monitor and review information about these interested parties and their relevant requirements. 4.3 Determining the scope of the quality management system ‘The organization shall determine the boundaries and applicability of the quality management system to establish its scope. When determining this scope, the organization shall consider: a) the external and internal issues referred to in 44 b) the requirements of relevant interested parties referred to in 4.2; €) the products and services of the organization The organization shall apply all the requirements of this Intemational Standard if they are applicable within the determined scope of its quality management system. The scope of the organization's quality management system shall be available and be maintained as documented information. The scope shall state the types of products and services covered, and provide justification for any requirement of this International Standard that the organization determines is not applicable to the ‘scope of its quality management system. 19TCVN ISO 9001:2015 Sy phi hop v6i tiéu chudn nay chi cé thé duoc Ong bé khi yéu cu durge xa dinh la khéng thé 4p dung dug khéng kam anh hung 161 kha nang hay tréch nhiém cia t8 chit trong vigc Gam bao sy phii hop cla sén phdm va dich vu eda t8 chic va ngng cao sy tha man cla khch hang, 4.4 H@ théng quan ly chat lugng va céc qua trinh cia hé théng 4.4.1 T6 chirc phai thiét lap, ap dung, duy tri va i tién Tien tuc he théng quan ly chdt lugng, bao gdm céc qué trinh cn thiét va sy twong téc gira céc qua trinh, phu hop voi cae yéu cau cla tieu chudn nay. Té chite phai x4e dinh cae qua tinh can thiét 6i véi hé théng quan Iy chat Itong va vige 4p dung cae qué trinh nay trong toan bé 18 chic va phai a) x4c inh du vao cn thiét va Au ra mong muén eda cdc qua trinh nay; b) xé¢ dinh trinh ty va sy tuong tac gida cdc qua trinh; ©) xéc dinh va 4p dung céc tidu chi va phyong phap (bao gém theo di, do lwéng va chi sé két qua thye hién c6 lién quan) cn thiét a8 dam bao thyc hign va kiém soat 6 higu Ive cc qua trinh nay; 4) xéc dinh ngudn Iyc cn thiét cho céc qué trinh nay va dam bao s&n o6 cae nguén lye 46; €) phan cOng trach nhigm va quyén han d6i voi (cdc qua trinh; f)_gidi quyét cdc ri ro va co hoi duge xéc dinh theo cac yéu cau olla 6.1; 20 Conformity to this International Standard may only be claimed if the requirements determined as not being applicable do affect the organization's ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction. not 44 Quality management system and its processes 4.4.1 The organization shall establish, implement, maintain and continually management system, including the processes needed and their interactions, in accordance with improve a quality the requirements of this International Standard. The organization shall determine the processes needed for the quality management system and their application throughout the organization, and shall a) determine the inputs required and the outputs expected from these processes; b) determine the sequence and interaction of these processes; ©) determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the of these effective operation and control processes; d) determine the resources needed for these processes and ensure their availability; ) assign the responsibilities and authorities for these processes; f) address the risks and opportunities as determined in accordance with the requirements of 6.4;9) danh gia cdc qué trinh nay va thye hign moi thay di can thiét d& dm bao c4c qua trinh nay dat dug két qua dy kién ctia n6; h) cai tién cdc qua trinh va hé théng quan ly chat lvgng. 4.4.2.0’ mirc 08 can thiét,t8 chite phai: a) duy tri théng tin dang van ban 8 hi tro vie thyc hign cc qua trinh ciia 18 chive; ) luu gitr théng tin dang van ban 48 c6 su tin cay ring cae qué trinh duoc thy hién nhw 48 hoaeh inh. 5 Swlinh dao 8.4. Sy linh dao va cam két 5.1.1 Khai quat Lanh dao cao nhét pha chitng t8 su lanh dao va cam két ddi vei h@ théng quan ly chat Iuong thong qua vige: a) chiu trach nhiém giai trinh d6i véi higu Ize eda hé théng quan ly chat wong; b) dam bao rang chinh s4ch chat Itong va myc tiéu chat Iwgng duoc thiét lap déi voi hé théng quan Iy chat long va turong thich véi béi canh va dinh huéng chién luge cia 18 chic; ©) dam bao tich hgp cde yéu cu cia hé théng quan ly chat Ivong vo céc qué trinh hoat ong chi chét ctia 8 chive; d) thie day viée st dung céch tiép can theo qué trinh va ty duy dya trén ri ro; €) dam bao sn 06 céc nguén lye cn thiét cho hé théng quan Iy chat long; f) trao 461 théng tin vé tam quan trong cia quan ly chat lwgng c6 higu lye va cla sy. TCVN ISO 9001:2015 9) evaluate these processes and implement any changes needed to ensure that these processes achieve their intended resutts; h) improve the processes and the quality management system 4.4.2 To the extent necessary, the organization shall ) maintain documented information to support the operation ofits processes; b) retain documented to. have confidence that the processes are being carried out as planned. formation 5 Leadership 5.1 Leadership and commitment 5.1.1 General Top management shall demonstrate leadership and commitment with respect to the quality management system by: a) taking account the quality management system; y for the effectiveness of b) ensuring that the quality policy and quality objectives are established for the quality management system and are compatible with the context and strategic direction of the organization; integration of the quality the ©) ensuring the management system into requirements organization's business processes; ) promoting the use of the process approach and risk-based thinking; ) ensuring that the resources needed for the quality management system are available; f) communicating the importance of effective quality management and of conforming to the 2TCVN ISO 9001:2015 phi hp v6i cdc yéu cdu cila hé théng quan Iy cht wong, g) dam bao hé théng quan ly chat Ivgng dat duge cdc két qua dy kién; h) 61 cudn sy tham gia, dinh huéng va hd tre nhan sy cing déng gép cho higu yc cla hé théng quan Ij chat lveng; i) thie day cai tién; i) n& tre cae vi tri quan ly lién quan khac ching t8 su lénh dao cla ho va thye hién val tro lanh dao 6 céc khu vyc ho chiu trach nhigm. CHO THICH: Te “hoat dong chi chét" due nhde én trong tiéu chun nay c6 thé duge dién giai theo ighta rong gim cac hoat dng cét I6i trong muc dich t8n tal cla t8 chire, du la t8 chite cong hay tu, loi ‘nhuan hay phi loi nhuan, 5.1.2 Hwéng vao khach hang Lanh dao cao nhét phai chizng 18 sw lanh dao va cam két di véi ndi dung huéng vao khach hang thong qua vige dam bao ring: a) cac yéu cau ctia khéch hang, yéu cau luat Ginh va ché dinh hign hanh duge xée dinh, hidu 16 va dap ting mét cach nhat quan; ac rili ro va co hdi co thé anh hudng aén sy phd hgp cla san phdm, dich vu va. kha b) ng nang cao sy théa man ela khach hang dure xéc dinh va giai quyét; ©) duy trl viée tap trung vao nang cao sy théa man cia khach hang. 6.2 Chinh sach 5.2.4 Thiét lap chinh séch chat lugng Lénh dao cao nhat phai thiét lap, thu hién va duy tri chinh sch chat lwong: quality management system requirements; 9) ensuring that the quality management system achieves its intended results; hy engaging, directing and supporting persons to contribute to the effectiveness of the quality management system; 1) promoting improvement; 1) supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility. NOTE Reference to ‘business’ in this Intemational Standard can be interpreted broadly to mean those activities that are core to the purposes of the organization's existence, whether the organization is public, private, for profit or not for profit. 6.1.2 Customer focus Top management shall demonstrate leadership and commitment with respect to customer focus by ensuring that: a) customer and applicable statutory and regulatory requirements are _ determined, understood and consistently met; b) the risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed; ©) the focus on enhancing customer satisfaction is maintained 5.2 Policy 6.2.1 Establishing the quality policy Top management shall establish, implement and maintain a quality policy that:a) phii hop véi muc dich va béi canh ca t8 chire va hé tro dinh huéng chién luge cia té chi; b) dua ra khuén khd cho viée thiét lap cdc myc tigu chat lvong: ©) bao gdm vige cam két thda man céc yéu cdu dug dp dung: d) bao gdm vic cam két cai tién lién tue h théng quan ly chat Itong. 6.2.2. Trao adi thong tin v8 chinh sach chdt lwong Chinh sach ch&t luong phai: sin 6 va duge duy tri bang thong tin dang van ban; a) b) duge truyén det, thdu higu va thye hign trong 18 che; c) s8n c6 cho cdc bén quan tam lién quan, khi thich hop. 5.3 Val trd, tréch nhigm va quyén han trong t chic Lanh dao cao nhat phai dim bao rang trach nhigm va quyén han ela cac vi tri thich hop, dugc phan cng, truyén dat va hiéu 16 trong t6 chic. Lanh Gao cao nhét phai phan céng tréch nhiém va quyén han 8: a) dm bao ring hé théng quan ly chat lung phi hop véi cdc yéu cau cila tiéu chuan nay; b) dam bao rang céc qua trinh mang Iai dau ra dy kién; ©) béo céo vé két qua thure hign hé théng quan ly chat lugng va céc co hoi cai tién (xem TCVN ISO 9001:2015 2) is appropriate to the purpose and context of the organization and supports its strategic direction; b) provides a framework for. setting quality objectives; ©) includes @ commitment to satisfy applicable requirements; 4) includes a commitment to continual improvement of the quality management system. 6.2.2 Communicating the quality policy The quality policy shall a) be available and be maintained as documented information; b) be communicated, understood and applied within the organization; ©) be available to relevant interested parties, as appropriate. 6.3 Organizational roles, responsibilities and authorities Top management shall ensure that the ies and authorities for relevant roles responsi are assigned, communicated and understood within the organization. Top management shall assign the responsibility and authority for: a) ensuring that the quality management system conforms to the this International Standard; requirements of ) ensuring that the processes are delivering their intended outputs; ©) reporting on the performance of the quality management system and on opportunities for 23‘TCVN ISO 9001:2015 10.1), cy thé Id cho Ianh dao cao nhat; d) dam bao thuc dy vige huéng vo khdch hang trong toan bé 8 chic; @) dam bao duy tri duge tinh toan ven cla he th6ng quan ly chat lvgng khi nhGng thay 61 461 vi he théng quan ly chét luong dugc hoach dinh va thuc hién. 6 Hoach dinh 6.1 Hanh d6ng gia quyét rl ro va co hot 6.1.4 Khi hoach dinh hé théng quan ly chat luong, 18 chire phai xem xét cdc vin a8 duge da cap 0 4.1 va cdc yéu cdu duge dé cap & 4.2 va xc dinh cc rai ro va co hoi can gidi quyét nhdm: a) mang lai sy dam bao rang hé théng quan Iy chat Iugng 06 thé dat duge (cac) két qua dy: kién; b) nang cao nhing tée déng mong muén; ©) ngan ngira ho&c gidm bét nhGng tac dong khong mong muén; d) dat duoc cai tién, 6.1.2 T6 chite phai hoach dinh: a) cdc hanh déng gidi quyét nhing rdi ro va co hoi nay; b) cach thite a8: 1) tich hgp va thye hign cae hanh dng vao cde qua trinh ca hé théng quan ly chat lwgng (xem 4.4); 2) xem xét dénh gid higu ive cua nhéng hanh dong nay. Hanh dong duge thyc hign 4é gidi quyét ri ro. va co héi phai tuong tng véi tac déng tiém an 24 improvement (see 10.1), in particular to top management; d) ensuring the promotion of customer focus throughout the organization; e) ensuring that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented. 6 Planning 6.1 Actions to address risks and opportunities 6.1.1 When planning for the quality management system, the organization shall consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed to: @) give assurance that the quality management system can achieve its intended result(s); b) enhance desirable effects; ©) prevent, or reduce, undesired effects; 4) achieve improvement. 6.1.2 The organization shall plan: a) actions to address these risks and opportunities; b) howto: 4) integrate and implement the’ actions into its quality management system processes (see 2) evaluate the effectiveness of these actions. Actions taken to address risks and opport shall be proportionate to the potential impact on61 su phi hyp cia san phdm va dich vy. CHU THICH 1: Cac phuong an giai quyét ri ro 66 thd bao gm tranh rai ro, chép nhan ri ro 48 theo Bi co’ hol, al Bé ngudn ri ro, thay Bi kha nang xdy ra hodc h6 qua, chia s@ ri ro hog duy tel ri ro bing quyét ainh ding 38 CHU THICH 2: Go’ hei 66 thé dn an vige chép nhan thye hanh mdi, tung ra san pham mdi, me thi trwéng méi, tiép.cén khéch hang méi, xy dung quan hé déi tac, sir dung cong nghé méi va céc kha ning mong muén, Kha thi khéc 48 gidi quyét nhu cdu cia té chire hoac khach hang cila té chive. 6.2 Myc tiéu chat Iugng va hogch dinh aé dat duge myc tiéu 6.2.4 T6 chite phai thiét lap cdc myc tiéu chat lugng 6 cdc cdp va bd phan chic nang thich hop va cdc qué trinh cn thiét di v6i he théng quan ly chat leng. Mue tiéu chat long phait a) nhat quén véi chinh séch chat wong; b) do aug, ©) tinh a&n cdc yéu c&u duge 4p dung: d) lien quan aén sy phi hop ca san phim va dich vu va nang cao sy théa man ea khach hang: ©) duge theo doi; f) duge truyén dat; 9) duge cp nhat khi thich hop. 8 chic phai duy tri théng tin dang van ban v8 myc tiéu chat long. 6.2.2 Khi hoach dinh och thire dat duge cae muc tiéu chat lwong cila minh, t6 chic phai xAe inh: a) vige gi s8 thyc hién; TCVN ISO 9001:2015 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 ew practices, launching new products, opening new markets, addressing new customers, building partnerships, using desirable and viable possibilities to address the organization's or its customers’ needs. new technology and other 6.2 Quality objectives and planning to achieve them 6.24 objectives at relevant functions, Processes needed for the quality management system, The organization shall establish quality levels and The quality objectives shall: a) be consistent with the quality policy; b) be measurable; ©) take into account applicable requirements; d) be relevant to conformity of products and services and to enhancement of customer satisfaction; 2) be monitored; f) be communicated; 9) 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: 2) what will be done; 25TCYN ISO 9001:2015 b) ngudn lye nao la can thiét; ) ai ngudi chiu trach nhiém; d) khi nao 88 hoan thanh; @) kt qua s8 duge dénh gia nhu thé nao. 6.3 Hoach dinh céc thay adi Khi 18 chive xée dinh nhu cau thay 481 461 voi he théng quan ly chat Ivong, thi nhing thay 481 nay phai duge thye hién theo cach thie a hoach dinh (xem 4.4). 6 chite phai xem xét a) muc dich cila nhtng thay di va hé qua tiem n ciia ching; tinh toan ven cia hé théng quan ly chat long; b) ¢) sy s&n c6 cac ngudn lye; 4d) viée phan céng va phan cng lai tréch nhiém va quyén han. 7 Hb tro 7.41 Nguén lye 74.4 Khai quat TS chive phi xac dinh va cung c&p ngudn lye can thiét cho viéc thiét lap, 4p dung, duy tri va cai tidn lian tue hé théng quan ly chét lvong. TS chic phai xem xét a) kha nang va nhtrng han ché cla cdc nguén lye noi b6 hign 6; b) nh@ng ngudn Ive nao c&n 6 duge tir cac nha cung cdp bén ngoai. 7.4.2 Con ngwoi Té chirc phai xc dinh va cung cép nhan sy can 26 b) what resources will be required; ©) who will be responsible; )_ when it will be completed; €) how the results will be evaluated. 6.3 Planning of changes When the organization determines the need for changes to the quality management system, the changes shall be carried out in a planned manner (see 4.4). The organization shall consider: a) the purpose of the changes and their potential consequences; b) the integrity of the quality management system; ) the availability of resources; 4) the allocation or reallocation of responsibi and authorities, 7 Support TA Resources TAA General The organization shall determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system. ‘The organization shall consider: a) the capabilities of, and constraints on, existing internal resources; b) what needs to be obtained from external providers. 7.1.2 People The organization shall determine and provide thethiét cho vie 4p dung 6 higu lye hé théng quan ly chat lweng va cho vige thye hién va kiém soat cdc qué trinh cia minh. 7.4.3 Co s& ha tang Té chive phai xdc dinh, cung cdp va duy ti co s@ ha tng can thiét cho vige thyc hién cc qua trinh cla minh 'va 48 dat duoc su phi hop cia san ham va dich vu. CHU THICH: Cor 88 ha tang cé thé bao gdm: a) nha cira va ede phuong tién kém theo; trang thiét bj, Bao gm cd phn cémg va phin mém; ©) nguan lye van chuyén; ) cng nghé théng tin va truyén théng. 7.1.4 M6i truéng cho vigc thye hign cée qua trinh 6 chire phai xée dinh, cung cp va duy tri méi truong can thiét cho viée thye hién cée qua trinh ca minh va dé dat duge sy phu hop olla san pham va dich vu. CHU THICH: Mei truéng phi hgp cé thé la sy két hop cila cdc yéu t6 con ngudi va yéu tb vat ly nhu: a) x8 h6i (vi dy khéng phan biét 46i xix, yén bn, khong 461 dau); b) tam 17 (vi du giém ap iwc, ngan gia kigt sir, bao vé cam xiic); ©). vat (vi du nhigt a9, hot néng, a6 &m, anh séng, ding khéng ki, vé sinh, tiéng én). NhGng yéu t6 nay 6 thé rét khéo nhau tly thudc vao san phdm va dich vy cung cép. 7.1.5 Ngudn lye theo dai va do long 7.1.5.1 Khai quat Té chic phai xac dinh va cung cép nguén Ie cn thiét a8 dam bao két qua ding va tin cay khi vide theo déi hoac do luéng duge sit dung 6& TCVN ISO 9001:2015 persons necessary the implementation of its quality management system for effective ‘and for the operation and control of its processes. 74.3 Infrastructure The organization shall determine, provide and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products and services. NOTE Infrastructure can include 2) buildings and associated utiles; ) equipment, including hardware and software; €) transportation resources; €) information and communication technology. 7.1.4 Environment for processes the operation The organization shall determine, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services. NOTE A suitable environment can be a combination of human and physical factors, such as: a) social (@.g. nondiscriminatory, calm, non confrontational); b) psychological (e.g. stress-reducing, burnout prevention, emotionally protective); ©) physical (e.g. temperature, heat, humidity light, ir flow, hygiene, noise). ‘These factors can differ substantially depending on the products and services provided. 7.4.8 Monitoring and measuring resources 7ASA General The organization’ shall determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is 27TCVN ISO 9001:2015 kiém tra xac nhan sy phi hop cla sn phdm va dich vu véi cdc yéu cdu. 6 chite phai dam bao rang cae ngudn lye duge cung cép: a) thich hgp véi loai hinh hoat dong theo doi va do Iwong cy thé duge thyc hién; . b) duoc duy tr 48 dam bao sy phd hop lién tue Oi mye dich ea ching. T& chic phdi luu gir théng tin dang van ban thich hop lam b&ng ching vé sy phi hgp vi muc dich cla cdc nguén lye theo doi va do long TAB2 két chuan do lveng Khi viée lién két chudn do lvéng la mot yéu cau ho&e duoc t3 chire coi la mét phan thiét yéu trong viée mang lai sy tin cay vé tinh dung aén cilia két qua do, thi thiét bj do phait a) dugc higu chuan hodc kiém tra xac nhan, hoe cA hai theo cdc khong thoi gian quy Ginh hoae treée khi sit dung, dya tren cde chudn do Iuong cé kha nang lién két toi chudn do lweng quéc gia hoac quéc té; khi khéng c6 cdc chudn nay, thi c&n oo 68 higu chun hoa kiém tra xac nan phai duoc Iu git? b&ng théng tin dang van ban; b) ©) duge gi gin trénh bj higu chinh, lam hu hai hoac suy gidm chat lugng lam mét tinh ding dn cla tinh trang higu chuan va két qua do sau d6. dugc nhan biét nham xéc dinh tinh trang; Té chive phai xac dinh tinh dung dan cua céc két qua do truéc 46 c6 bi anh huéng hay khng khi thiét bi do duoc phat hign khéng phii hop véi muc dich dy kién va phai thyc hién hanh dong 28 used to verify the conformity of products and services to requirements. The organization shall ensure that the resources provided: a) are suitable for the specific type of monitoring ‘and measurement activities being undertaken; b) are maintained to ensure their continuing fitness for their purpose. shall The organization retain appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources, 7.1.8.2 Measurement traceability When measurement traceability is a requirement, or is considered by the organization to be an essential part of providing confidence in the validity of measurement results, measuring equipment shall be: a) calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; when no such standards exist, the basis used for calibration or verification shall be retained as documented information; b) identified in order to determine their status; ©) safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results. 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thich hop khi can. 7.4.8 Tri thiec cla td chive T6 chute phai xée dinh tri thirc cn thiét cho vie thye hign céc qua trinh cia minh va dé dat duoc sy phi hop cla san phdm va dich vu. Tri thirc nay phai duoc duy trl va sn c6 & mic 6 can thiét. Ki giai quyét nhdng nhu cdu va xu huréng thay 48i, t8 chive phai xem xét tri thire hién tai cia minh va xéc dinh cdch thuc a8 thu duoc hoac tiép cn tri thire bd sung va théng tin cap nhat cn thiét CHU THICH 1: Tri thie cba 18 chic 18 tri thie cu thd V6 t8 chite; hung thu due bang kinh nghigm. Day la thong tin duge sir dung va chia sé d8 dat duoc mye tiéu cia t8 chic. CHU THICH 2: Tri thirc cia t8 chire c6 thé da trén: a) nguén n6i bé (vi dy s& hou tri tue, kién thie the duge tir kinh nghiém; cae bai hoc rit ra tir thét bai va cdc dy an thanh cong; ném bat va chia s& kién thire va kinh nghiém bat thanh van; két qua cia vige cai tién qué trinh, san phém va dich vuy; b)_ nguén bén ngoai (vi du tiéu chudn; gli hoe vien; hei nghi, thu nhgn kién there tir khach hang hoe nha cung cp bén ngoai. 7.2. Nang lye T6 chute phi a) xéc dinh nang lye c&n thiét cia (nhGng) ngudi thyc hign cong vic dudi sy kiém sot cla t8 chic c6 anh hung téi két qua thyc hign va higu lye cla hé théng quan Ij chét wong; b) Gam bao rang nhiing ngudi nay 66 nang lye trén co s& giéo duc, 40 tao ho&e kinh TCVN ISO 9001:2015 shall take appropriate action as necessary. 7A.6 Organizational knowledge The organization shall determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services. This knowledge shall be maintained and be made available to the extent necessary. When addressing changing needs and trends, the organization shall_consider its current knowledge and determine how to acquire or access any necessary additional knowledge and required updates. NOTE 1 Organizational knowiedge is knowledge ‘specific to the organization; it is generally gained by ‘experience. Its information that is used and shared to achieve the organization's objectives. NOTE 2 Organizational knowiedge can be based on: @)_ internal (@.9. intellectual property; knowledge gained from experience; lessons learned from failures and successful projects; capturing and sharing undocumented knowledge and experience; the results of improvements in processes, products and services): sources b) external sources (e.g. conferences; gathering knowledge from customers or standards; academia; external providers). 7.2 Competence ‘The organization shall a) determine the necessary competence of person(s) doing work under its control that affects the performance and effectiveness of the quality management system; b) ensure that these persons are competent on the basis of appropriate education, training, or 29‘TCVN ISO 9001:2015 nghiém thich hop; c) khi cé thé, thy hign c&c hanh déng 6é dat duce nang lyc cn thiét va danh gid higu lye ca nhtng hanh dong duge thyc hign; 4) lwu git’ thong tin dang van ban thich hop lam bang ching v nang lye. CHU THICH: Hanh agng thich hop ¢6 thé bao gdm, Vi du cung cép dao tao, kém c&p ho&e phan céng lai nhén sw dang duoc sir dung; hay thué hoe ky hop dng véi nhan sy 6 nang lye. 7.3 Nhfn thie Té chive phai dam bao rang nguéi thyc hién céng vie dudi sy kiém sodt ca t8 chic nhan thire duge ve: a) chinh séch chat lugng; b) myc tiéu chat long lién quan; ©) déng gép cita ho cho higu lye cia hé théng quan Ij chat lgng, bao gdm ca Igi ich cia két qua thye hign duge cai tién; d) hau qua olla vie khong tuan thi cae yeu cau cila hé théng quan ly chét long 7.4 Trao 46i thong tin Té chirc phai x4c dinh hoat dong trao di thong tin n6i b@ va bén ngoai thich hyp véi hé théng quan ly chat long, bao gdm: a) trao 46i thong tin gi b) trao déi thong khi nao; ©) trao di thong tin véi ai d) trao déi théng tin nhu thé nao; )_ngudi thyc hign trao d6i thong tin. experience; ©) where applicable, take actions to acquire the necessary competence, effectiveness of the actions taken; and evaluate the ) retain appropriate documented information as evidence of competence. NOTE Applicable actions can include, for example, the provision of training to, the mentoring of, or the re-assignment of currently employed persons; or the hiring or contracting of competent persons. 7.3 Awareness The organization shall ensure that persons doing work under the organization's control are aware of: a) the quality policy; b) relevant quality objectives; ©) their contribution to the effectiveness of the quality management system, including the benefits of improved performance; 4) the implications of not conforming with the quality management system requirements. 7.4 Communication The organization shall determine the internal and external communications relevant to the quality management system, including: a) on what it wll communicate; b) when to communicate; ©) with whom to communicate; 4) howto communicate; ©) who communicates,7.8. Théng tin dang van ban 7.5.4 Khai quat Hé théng quan ly chat long cia té chic phai bao gdm: a) théng tih dang van ban theo yéu cau cia ti chudn nay; « b) théng tin dang van ban dugc té chire x4c Ginh 18 c&n thiét 4 dam bdo tinh higu Ive eda hé théng quan ly chat lvong. CHU THICH: Mic 4 théng tin dang van ban a6i vei he théng quan ly chat lweng cé thé khac nhau gitra 8c 8 chire do: = quy mé cia t8 chite va loai hinh hoat déng, qué trinh, san phém va dich vy eda 16 chic; = mie dO phic tap ca cc qua trinh va sy tong tac gira cae qua trinh; = nang lwo cba nhan su. 7.5.2 Tao lap va cap nhat Khi tao lap va cap nhét théng tin dang van ban, 8 chic phai ddm bao sy thich hop cia: a) viée nhan biét va mo t8 (vi dy tiéu a8, thoi gian, tac gid hoac s6 tham chiéu); b) dinh dang (vi dy ng6n ng, phién ban phan mém, 66 thi) va phuong tién truyén théng (ban gidy, ban dign to): ©) vige xem xét val phé duyét sy phi hop va théa dang 7.8.3 Kiém soat théng tin dang van ban 7.8.3.1 Thng tin dang van ban theo theo yéu cau cilia he théng quan ly chét lvgng va cia tiéu chuain nay phai dug kiém soat hm dam bao: TCVN ISO 9001:2015 7.8 Documented information 7.81 General The organization's quality management system shall include: a) documented information required by this International Standard; b) documented information determined by the organization as being necessary for the effectiveness of the quality management system. NOTE The extent of documented information for @ quality management system can differ from one ‘organization to another due to: = the size of organization and its type of activities, processes, products and services; ~ the complexity of processes and their interactions; ~ the competence of persons, 7.8.2 Creating and updating When creating and updating documented information, the organization shall ensure appropriate: ) identification and description (e.g. a title, date, author, or reference number) b) format (e.g. language, software version, graphics) and media (e.g. paper, electronic); ©) review and approval for suitability and adequacy. 7.8.3 Control of documented information 7.5.3.1 Documented information required by the quality management system and by this Intemational Standard shall be controlled to ensure: 34TOVN ISO 9001:2015 a) sn cé va phi hop dé sir dung tai noi va khi can; b) éugc bdo vé mot céch thda dang (trénh mat tinh bao mat, sir dung sai mye dich hoae mat tinh toan ven). 7.8.3.2 Bé kiém soat thong tin dang van ban, t6 chive phai gidi quyét cc hoat Gong sau, khi thich hyp: a) phan phéi, tiép can, khdi phuc va str dung; b) lwu troy va bao quan, bao gdm ca gil? gin 68 €6 thé doc duc; ©) kiém soat cdc thay déi (vi du kiém soat phién ban); d) lu git va hiy bd. Th6ng tin dang van ban c6 nguén géc ben ngoai Gugc 1 chic xac dinh la can thiét cho viéc hoach dinh va thyc hign hé théng quan ly chat lwong phai duoc nhan biét khi thich hop va duoc kiém soat Thong tin dang van ban duge Iwu git lam bang ching v8 sy phi hop phai duoc bdo ve khdi vige siva 461 ngoai du kién. CHU THICH: Tiép can c6 thé ham y mot quyét inh vé viéc chi cho phép xem théng tin dang van ban hhode cho phép va giao quyén xem va thay dBi théng tin dang van ban, 8 Thye hign 8.1 Hoach dinh va kiém soat vigc thyc hign T6 chire phai hoach dinh, thye hién va kiém soat cdc qué trinh (xem 4.4) can thiét 48 dap tng cdc yéu cau déi voi viée cung cdp san pham va dich vy va 4 thyc hién cae hanh dong xéc dinh tai Bidu 6, thong qua: a) xac dinh c&c yéu cau 46i voi san phdm va 32 a) itis 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). 7.8.3.2 For the control of documented Information, the organization shall address the following activities, as applicable: a) distribution, access, retrieval and use; b) storage and including preservation of legibility; preservation, ©) control of changes (e.g. version control); d) retention and disposition. Documented information of external origin determined by the organization to be necessary for the planning and operation of the quality management system shall be identified as appropriate, and be controlled Documented information retained as evidence of conformity shall be protected from unintended alterations. NOTE Access can imply a decision regarding the permission to view the documented information only, fr the permission and authority to view and change the documented information. 8 Operation 8.1. Operational planning and control ‘The organization shall plan, implement and control the processes (ee 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) determining the requirements for the productsdich vu: b) thiét lap tieu chi a6i voit 41) cae qua trinh; 2) vige chdp nh@n san pham va dich vu; c) xd dinh cae ngudn Ive can thiét d& Gat dugc su phil hop véi céc yéu cdu cla san phim va dich vu; d) thye hign vic kiém soat cac qua trinh theo cc tiéu chi nay; e) xée dinh, duy trl va luu gitr théng tin dang van ban & mite 46 cn thiét: 4) 48 c6 sy tin tuéng rang cae qua trinh ‘uge thyc hién nhu d& hoach dinh; 2) 48 chiing 13 sy phi hgp cla san pham va dich vu véi cc yu cau ctia ching Au ra clia viée hoach dinh nay phai thich hop Véi cc hoat dong ctia td hire. T8 chire phai kiém soat nhing thay dBi theo hoach dinh va xem xét cde hé qua cla nhing thay 081 ngoai dy kién, thyc hién hanh dong 48 gid nhe moi tée dong bat loi Khi cn, Té chic phai dim bao rng cde qué trinh thué ngoai du dugc kiém soat (xem 8.4). 8.2 Yéu cau d6i voi san pham va dich vu 8.2.1 Trao déi thong tin véi khach hang Trao dBi théng tin véi khach hang phai bao gdm vige: a) cung cp théng tin lién quan dén san pham va dich vy; b) xi ly cdc yeu cu, hop dng hoae dat hang ké c8 cc thay di; ) thu nhan théng tin phan hdi cila khach hang ign quan één san phdm va dich vu, bao gdm TCVN ISO 9001:2015 and services; b) establishing criteria for: 1) the processes; 2) the acceptance of products and services; ©) determining the resources needed to achieve conformity to the product and service requirements; 4) implementing control of the processes in accordance with the criteria; retaining ©) determining, maintaining and documented information to the extent necessary: 1) to have confidence that the processes have been carried out as planned; 2) to demonstrate the conformity of products and services to their requirements. The output of this planning shall be suitable for the organization's operations. The organization shall control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary. The organization shall ensure that outsourced processes are controlled (see 8.4). 8.2 Requirements for products and services 8.2.1 Customer communication Communication with customers shall include: 2) providing information relating to products and services; b) handling enquiries, contracts or orders, including changes: ©) obtaining customer products and services, feedback relating to including customer 33TCVN ISO 9001:2015 cd khiéu nal cila khéich hang: d) xt ly hoac kiém soat tai sn cila khach hang; ) thiét lap cdc yéu cdu cy thé d6i voi hanh ong tng phé vdi tinh hudng bat ngé, Khi thich hop. : 8.2.2 Xac dinh cdc yéu cau déi voi san phim va dich vu Khi xac dinh cae yéu cu 461 véi sin phdm va dich vy cung cp cho khéch hang, t8 chic phai am bao rang a) cde yéu edu 46i véi sin phdm va dich vu dug dinh 16, bao gbm: 1) moi yéu cau Iuat dinh va ché dinh hién hanh; 2) céc yéu cdu dug t8 chitc cho la can thiét; b) 18 chite 6 thé dap tng nhiing cong bé 461 v6i sén phdm va dich vy minh cung cp. 8.2.3 Xem xét yéu cau déi voi san phdm va dich vy 8.2.3.1 TO chibe phai dam bao rng minh c6 kha ning dap Ung c&c yéu cau d6i véi sén phdm va dich vu cung cp cho khach hang. Té chire phai tién hanh xem xét tréc khi cam két cung eng san phdm va dich vy cho khach hang, dé tinh dén: a) cac yéu cdu quy dinh ca khach hang bao gém céc yéu cdu abi v6i hoat dong giao hang va sau giao hang; b) cae yéu cu khong dug khach hang néu ra nhung cn thigt cho vige sit dung xée dinh hoac du kién, néu a4 biét; ©) cdc yéu cau do té chire quy dinh; 34 complaints; ) handling or controlling customer property; for ©) establishing requirements contingency actions, when relevant. specific 8.2.2 Determining the requirements for products and services When determining the requirements for the products and services to be offered to customers, the organization shall ensure that a) the requirements for the products and services are defined, including: 1) any applicable statutory and regulatory requirements; 2) those considered necessary by the organization; b) the organization can meet the claims for the products and services it offers. 8.2.3 Review of the requirements for products and services 8.2.3.1 The organization shall ensure that it has the ability to meet the requirements for products and services to be offered to customers. The organization shall conduct a review before committing to supply products and services to a customer, to include: a) requirements specified by the customer, including the requirements for delivery and post- delivery activities; b) requirements not stated by the customer, but necessary for the specified or intended use, when known; ©) requirements specified by the organization;d) cdc yéu c&u luat dinh va ché dinh ap dung 661 vei sn phim va dich vu; e) cdc yéu cau clia hop déng hoae don hang kde v6i nhéng yeu c&u da thé hign truée 46. Té chire phai dim bao rang cac yeu cau cia hop ding ho&e don hang khac voi yeu cdu 6& duge xac dinh trac 66 dBu duc gial quyét. ‘Yeu cu cia khdch hang phai duge t6 chire xe nhan trvée khi chép nhan, néu khach hang khéng dua ra tuyén bé bang van ban vé cac yéu cau cia minh. CHU THICH: Trong mét s6 trudng hop, nhu ban hang qua mang, vige xem xét chinh thite cho timng don hang I khéng thy 18. Thay vao 66, xem xét nay 06 th bao trim théng tin thich hop vé san phém ny 18 cc ban ca-tad. 8.2.3.2 Khi thich hop, t8 chive phai lwu gitt théng tin dang van ban ve: a) két qua cla viéc xem xét; b) moi yéu cau méi d6i véi san phdm va dich vu. 8.2.4 Thay di yeu cdu déi voi san phdm va dich vy Té chize phai dam bao rang théng tin dang van ban cé lién quan duge siza ai va nhan sy co ign quan nhan thir duge nhiing yeu cau da thay dBi khi yeu cau 46i véi san phém va dich vw thay adi. 8.3. Thidt ké va phat trién san phdm, dich vu 8.3.4 Khai quat Té chic phai thiét lap, thye hién va duy tri qua trinh thiét ké va phat tridn thich hop dé dam bao viée cung cp san pham va dich vu sau dé, TEVN 180 9001:2015 d) statutory and regulatory requirements applicable to the products and services; ) contract or order requirements differing from those previously expressed ‘The organization shall ensure that contract or order requirements differing from those previously defined are resolved. The customer's requirements shall be confirmed by the organization before acceptance, when the customer does not provide a documented statement of their requirements. NOTE sales, a formal review is impractical for each order. In some situations, such as internet Instead, the review can cover relevant product information, such as catalogues. 8.2. information, as applicable: 2 The organization shall retain documented a) onthe results of the review: b) on any new requirements for the products and services. 8.2.4 Changes to requirements for products and services The organization shall ensure that relevant documented information is amended, and that relevant persons are made aware of the changed requirements, when the requirements for products and services are changed, 8.3 Design and development of products and services 8.3.1 General ‘The organization shall establish, implement and maintain a design and development process that is appropriate to ensure the subsequent provision 36TCVN ISO 9001:2015 8.3.2 Hoach dinh thiét ké va phat trién Khi x4e dinh cac giai doan va noi dung kiém soat thiét ké va phat trign, 8 chive phai xem xét: a) tinh cht, khodng thdi gian va mirc 46 phuc tap cia hoat dng thiét ké va phat tridn; b) cdc giai doan cn thiét cia qua trinh, gdm cd vige xem xét mét cach thich hop thiét ké va phat trién; ©) hoat dng kiém tra xéc nhan va xde nh&n gid tri si? dung can thiét cia thidt k8 va phat trién; d) tréch nhiém va quyén han ign quan trong qua trinh thiét ké va phat trién; e) nhu cau vé nguén lye n6i bé va bén ngoai 46i voi thiét ké va phat trién san phdm va dich vy; f) nhu cau kiém soat sy tuong giao gitta cdc nhan su tham gia vao qua trinh thiét ké va phat trién; 9) nhu cau déi véi sy tham gia cla khach hang va ngudi sir dung vao qué trinh thidt ké va phat trién; fh) yéu cu di véi viée cung cp san phdm va dich vu sau a6; 1) mae 4 kim so’t mong muén cla knach hang va cde bén quan tém thich hop khac 461 v6i qua trinh thiét ké va phat trién; i) théng tin dang van ban can thiét a8 chiing t8 rang cc yéu cdu thiét ké va phat trién due dap eng. 8.3.3 Dau vao cia thiét ké va phat trién 6 chtre phai xéc dinh cdc yéu cau thiét yéu d6i of products and services 8.3.2 Design and development planning In determining the stages and controls for design ‘and development, the organization shall consider: a) the nature, duration and complexity of the design and development activities; b) the required process stages, including applicable design and development reviews; ©) the required design and development verification and validation activities; d)_ the responsibilities and authorities involved in the design and development process; ©) the internal and external resource needs for the design and development of products and services; {) the need to control interfaces between persons involved in the design and development process; g) the need for involvement of customers and users in the design and development process; h) the requirements for subsequent provision of products and services; i) the level of control expected for the design and development process by customers and other relevant interested parties: information needed to design and development i) the documented demonstrate that requirements have been met. 8.3.3 Design and development inputs The organization shall determine thev6i loai san pham va dich vy cy thé duge thiét ké vva phat tri6n, TS chire phai xem xét a) yéu cdu vé chirc nang va c6ng dung; ) thong tin tir hoat dong thiét ké va phat trién trién tong ty trée 66; ©) yéu cu luat dinh va ché dink; tiéu chuan hoac quy téc thue hanh ma 18 chic cam két 4p dung; dq) hé qua tiém An cila sai I8i do dac tinh cila san phém va dich vu. CO} ‘au vao nay phai phi: hyp cho myc dich thiét ké vva phat trién, phai dy 0, 16 rang. Cae ddu vao cia thiét ké va phat trién mau thuan voi nhau du phai dug giai quyét. 8 chite phai uu git thong tin dang van ban ve ‘du vao cila thiét ké va phat tién. 8.3.4 Kidm sot thiét ké va phat trién 76 chive phai 4p dung cdc kim soat d6i voi qua trinh thiét ké va phat trién d8 d&m bao rng: a) cdc két qua can dat due xéc dinh; b) céc xem xét duge thy hign d& danh gi kha nang két qua thiét ké va phat trién ap Ung cde yeu cau; c) hoat déng kiém tra xéc nhan dugc thyc hién dé Gam bao dau ra cla thiét k6 va phat trién Gap Ug cdc yéu cau dau vao; d)_hoat dong xéc nhan gia tri sir dung due thye hign 48 dim bao san pham va dich vy tao ra dap ug cdc yeu cau d6i voi ting dung xac inh hod viee sir dung dy kién; e) cae hanh déng cn thiét durge thye hién d6i TCVN ISO 9001:2015 requirements essential for the specific types of products and services to be designed and developed. The organization shall consider: a) functional and performance requirements; b) information derived from previous similar design and development activities; ©) statutory and regulatory requirements; d) standards or codes of practice that the organization has committed to implement; €) potential consequences of failure due to the nature of the products and services. Inputs shall be adequate for design and development purposes, complete and unambiguous. Conflicting design and development inputs shall be resolved. shall The organization retain documented 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 2a) the results to be achieved are defined; b) reviews are conducted to evaluate the ability of the results of design and development to meet requirements; ©) verification activities are conducted to ensure that the design and development outputs meet the input requirements; d) validation activities are conducted to ensure that the resulting products and services meet the requirements for the specified application or intended use; ) any necessary actions are taken on problems 37TCVN ISO 9001:2018 v6i nhiing van 88 duge xéc dinh trong qua trinh xem xét hoge trong hoat dong kiém tra xéo nan va xéc nhén gid tr str dung; ) théng tin dang van ban vé nhieng hoat déng nay duge lu gid. CHU THICH: Xem xét,kiém tra xde nin, xdo nan gia tri st dung ole thiét ké va phat trién 6 nhting myc Gich khde bigt. Cac host dong nay c6 thé duge the hign ring biét hodc kat hep sao cho thich hop vei san pham va dich vu ota té chive. 8.3.5 Dau ra cilia thiét ké va phat trién 6 chit phai dam bao rang dau ra cla thiét ké va phat trién: @) dp Ung cae yéu cau dau vao ola thiét ké va phat tid b) dy di cho cdc qua trinh sau 46 a8 cung cép sn phdm va dich vy; c) bao gém hoae vién dan téi cac yéu cAu theo d6i va do Iuéng khi thich hop va cdc chudn mye chdp nhan; d) quy dinh céc dac tinh cla sn phdm va dich vy. la 06t yéu cho myc dich dy kién va sy an toan va viée cung cp thich hop cia sén phdm va dich wu. Té chire phai uu git thong tin dang van ban vé dau ra olla thiét ké va phat trién. 8.3.6 Thay di thiét ké va phat trién 6 chwe phai nhan biét, xem xét va kiém soat nhGing thay di tao ra trong hode sau thiét ké va phat trién san pham va dich vy, & mirc 46 cn thiét 48 dam bdo rang khéng cé tac Gong bat loi 61 sy phu hgp véi cao yéu cu. T6 chire phai Iwu git thong tin dang van ban vé: 38 determined during the reviews, or verification and validation activities; f) documented information of these activities is retained, NOTE Design and development reviews, verification and validation have distinct purposes. They can be conducted separately or in any combination, as is suitable for the products and services of the org tion. 8.3.5 Design and development outputs The organization shall ensure that design and development outputs: 4) meet the input requirements; ) are adequate for the subsequent processes for the provision of products and services; ©) include or reference monitoring and measuring requirements, as appropriate, and acceptance criteria; 4) specify the characteristics of the products and services that are essential for their intended purpose and their safe and proper provision. The organization shall retain documented information on design and development outputs. 8.3.6 Design and development changes The organization shall identify, review and control changes made during, or subsequent to, the design and development of products and services, to the extent necessary to ensure that there is no adverse impact on conformity to requirements. The organization shall retain documented information on:‘a) nhiing thay d8i d6i voi thiét ké va phat trién; b)_két qua xem xét; ©) vige cho phép thay 46i, d) hanh dng duge thye hign 68 ngan nota nhting tae dong bat Iai. 8.4 Kiém soat qué trinh, san pham va dich vu do bén ngoal cung cap 8.4.1 Khai quat Té chive phai dam bao rang cae qua trinh, san phém va dich vy do bén ngoai cung cp phi hop voi cdc yeu cu 78 chive phai xdc dinh cc kiém soat dure ap dung 446i v6i qué trinh, san phdm, dich vu do bén ngoai ‘cung cp khi: a) sin phdm va dich vu eda nha cung cap bén ngoai duge ding 4é hep thanh san phdm va dich vu o¥a chinh #8 hire: b) san ph&m va dich vy duge nha cung cp ben ngoai cung cép true tiép cho knach hang vot danh nghfa cla td chirc; ) qu trinh hoe mét phan cia qua trinh do nha cung cép bén ngoai cung op 18 két qua tir quyét dinh cla t6 chic. TB chite phai xac dinh va ap dyng céc tiéu chi cho viée dénh gia, Iya chon, theo doi két qua thye hign va dénh gia lai nha cung cp ben ngoal trén co’ 88 kha nang clia ho trong viéc cung cép cae qua trinh hoe san pham, dich vu phi hop voi cc yeu cu. 76 chire phai lu gir thong tin dang van ban vé cde hoat déng nay va moi hanh dng can thiét nay sinh tir vige anh gi. TCVN ISO 9001:2015 a) design and development changes; b) the results of reviews; 6) the authorization of the changes; d)__ the actions taken to prevent adverse impacts. 8.4 Control of externally provided processes, products and services 8.4.1 General The ‘organization shall ensure that externally provided processes, products and services conform to requirements. The organization shall determine the controls to be applied to externally provided processes, products and services when a) products and services from external providers intended the organization's own products and services; are for incorporation into b) products and services are provided directly to the customer(s) by extemal providers on behalf of the organization; ©) a process, or part of a process, is provided by an external provider as a result of a decision by the organization. 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 products and services in accordance with requirements. The organization shall retain documented information of these activities and any necessary actions arising from the evaluations. or 39TCVN ISO 9001:2015 8.4.2 Lal hinh va mirc 49 kiém soat Té chize phai dm bao ring cdc qua trinh, sén pham va dich vu do bén ngoai cung cép khéng anh huéng bat Ii dén kha nang cia td chic ‘trong viéc cung cp én dinh san phdm va dich vy phi hgp cho khéch hang cia minh, 8 chive phat @) dam bao rang céc qua trinh do bén ngoai cung cap chiu sy kiém soat cla hé théng quan ly chat lugng clia té chirc; b) xdc dinh ca cae kiém soat t8 chire muén 4p dung cho cae nha cung cp bén ngoai va cdc kiém soat muén 4p dung cho két qua au ra; ¢) tinh dén: 1) te d6ng tim an ca cae qué trinh, san phdm va dich vy do bén ngoai cung op t0i kha nang cla t6 chirc trong vie dap eng mét cach én dinh cdc yeu cdu ofa khach hang, yéu cau luat dinh va ché Ginh hién hanh; 2) higu lye cia cac kiém sodt duge nha cung cp bén ngoai ap dung; qd) xée dinh vic kiém tra xéo nhan hoc cac hoat dong khée can thiét 48 dam bao rang qué trinh, san phdm va dich vu do bén ngoai cung cap dap tng cac yéu cau. 8.4.3 Théng tin cho nha cung cdp bén ngoai Té chire phai dam bao sy théa dang cia cée yéu cau truéc khi trao ai thong tin véi nha cung cp ben ngoai. TS chitc phai trao a6i théng tin véi nha cung cép bén ngoai vé cac yéu cau cia minh déi véi: ) qué trinh, san pham va dich vy duoc cung 40 8.4.2 Type and extent of control The organization shall ensure that externally provided processes, products and services do not adversely affect the organization's ability to consistently deliver conforming products and services to its customers. The organization shall: a) ensure that externally provided processes remain within the control of its quality management system; ») define both the controls that it intends to apply to an external provider and those it intends to apply to the resulting output; ©) take into consideration: 1) the potential impact of the externally provided processes, products and services on the organization's ability to consistently meet statutory and customer and applicable regulatory requirements; 2) the effectiveness of the controls applied by the external provider; 4) determine the verification, or other activities, necessary to ensure that the externally Provided processes, products and services meet requirements. 8.4.3 Information for external providers The organization shall ensure the adequacy of Tequirements prior to their communication to the external provider. The organization shall communicate to external providers its requirements for: 2) the processes, products and services to becap: b) vide phé duyét: 1) san pham va dich vu; 2) phwong phap, qua trinh va thiét bi 3) théng qua sn pham va dich vu; nang le, bao gém trinh d@ chuyén mén e&n thiét da nhan sy 4) sy tvong tac gitta nha cung cap bén ngoal voi té chive; vige kigm soat va theo déi két qué thyc hign cia nha cung cap bén ngoai duge té chore ‘p dung; e) 4) hoat dong kiém tra xc nhan va xae nhan gia tri sir dung ma t8 chire hod khach hang cla td chive du kién thuc hién tai co s6 ela nha cung cp bén ngoai. 8.5 San xudt va cung cép dich vu 8.5.1 Kiém soat san xuat va cung cap dich vy 78 chite phai thyc hign viée san xudt va cung cAp dich vu dudi cdc digu kién dugc kiém soat. Khi c6 thé, didu kign duoc kiém soat phai bao gém' su sn c6 ca thong tin dang van ban xc inh 1) a) ac trung olla san pham duge san xust, dich vu duge cung c&p ho&e hoat dng duge thye hién; 2) két qua can dat duge su s&n cé va vige sit dung cdc nguén luc theo déi va do long thich hop; b) vige thye hign hoat dong theo déi va do luang 6 cée giai Goan thich hop d& kiém tra °) TWN ISO 9001:2015 provided; bythe approval of 4) products and services; 2) methods, processes and equipment; 3) the release of products and services, ©) competence, including any required qualification of persons; ) the external providers’ interactions with the organization; ) control and monitoring of the external providers’ performance to be applied by the organization; {) verification or validation activities that the organization, or its customer, intends to perform at the external providers’ premises. 8.5. Production and service provision 8.5.1 Control of production and service provision ‘The organization shall implement production and service provision under controlled conditions. Controlled conditions shail include, as applicable: 4) the availability of documented information that defines: 4) the characteristics of the products to be produced, the services to be provided, or the activities to be performed 2) the results to be achieved b)_ the availability and use of suitable monitoring and measuring resources; ©) the implementation of monitoring and measurement activities at appropriate stages to aTCVN ISO 9001:2015 xc nhan rang chuan myc kiém soat qué trinh ho&e dau ra va chudn’ myc chap nhan san phdm va dich vy d&u duge dap ing; 4) six dung co sd ha tang va moi trvéng thich hgp cho viée van hanh c&c qua trinh; phan céng nhan sy cé nang lye, gdm c& trinh 46 chuyén mén can thiét; e) f)xde nhan gid tri str dung va xac nhén Iai gi tr] str dung inh ky cia kha nang dat duge két qua hoach ginh ota qua trinh a6i voi viée ‘sn xuat va cung cép dich vu, khi két qué @2u ra khong thé kiém tra xdc nhan duge bang viéc theo d5i va do Ivéng sau 46; g) thre hién cae hanh dong nhadm ngan nga ‘sai Idi ciia con nguéi; h) the hién céc hoat d6ng théng qua, giao hang va sau giao hang. 8.5.2 Nhan biét va truy xudt ngudén géc 6 chit phai sir dung céc phuong tién thich hop 48 nhan biét ddu ra néu cn thiét cho viée dam bao sy phu hyp cla sén phdm va dich vu. 6 chic phai nhén biét tinh trang ciia dau ra lign quan dén céc yéu cau theo di va do lang trong toan b6 qua trinh san xuat va cung c4p dich vu. 8 chive pha kiém soat vige nhan biét duy nhét au ra khi viée truy xudt ngudn géc la mot yeu cau va phai luu gitr thong tin dang van ban can thiét 48 co thé truy xuét ngudn géc. 8.5.3 Tai san cila khach hang hoge nha cung edp bén ngo 6 chite phai git gin ti sdn cia khach hang hoae cua nha cung cdp ben ngoai khi chung thude sy kiém soat cia 8 chirc hay dang dugc 42 Verify that criteria for control of processes or outputs, and acceptance criteria for products and services, have been met; ) the use of suitable infrastructure and environment for the operation of processes; ©) the appointment of competent persons, including any required qualification; f) the validation, and periodic revalidation, of the ability to achieve planned results of the Processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement; 9) the implementation of actions to prevent human error; h) the implementation of release, delivery and postdelivery activities 8.6.2. Identification and traceability The organization shall use suitable means to identify outputs when it is necessary to ensure the conformity of products and services, The organization shall identify the status of outputs with respect to monitoring and measurement requirements throughout production and service provision, 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 Property belonging to customers or external providers The organization shall exercise care with property belonging to customers or external providers while it is under the organization's18 chive str dung. 6 chive phai nhan biét, kiém tra xdc nhan, bao ve, bao dim an toan cho tai san eda khach hang ho&e nha cung cép bén ngoai cung cAp dé str dung hdc dé hgp thanh san phdm va dich vu. Khi tai san cia khéch hang hoe nha cung cdp bi mat mat, hu héng hoac dirgc phat hién khong phi, hop cho viéc sir dung, t8 chirc phai théng bao vige nay cho khéch hang ho&e nha cung cp va phai lu gitr théng tin dang van ban vé cac van 48 xay ra. CHU THIGH: Tal san ca khach hang hoe nha cung cp c6 th8 bao gdm nguyén vat ligu, bo phan edu thanh, dung cu va thiét bi, nha xuéng, quyén s@ hou ‘ri tug va do igu c& nan. 8.5.4 Bao toan 6 chitc phai bao toan dau ra trong suét qué trinh sn xuat va cung cp dich vu & mirc 46 cn thiét 68 cm bo sur phi hgp véi cdc yéu c&u. CHU THICH: Bao toan cé thé bao gém vige nhan biét, xép 40, kibm sodt him bln, bao g6i, bBo quan, chuyén giao hog van chuyén va bao vé. 8.5.5 Hoat déng sau giao hang TB chic phai dap ting cdc yéu cau déi vdi hoat ong sau giao hang lién quan dén sn phim va dich vu Ki xée dinh mirc d6 cn thiét cia hoat dng sau giao hang, t8 chite phai xem xét a) cac yu cu luat dinh va ché dinh; b) cc hé qua tiém &n khéng mong mudn lién quan dén san phdm va dich vu; ) tinh cht, vide sir dung va tudi tho dy kién cla TCVN ISO 9001:2015 control or being used by the organization. The organization shall identify, verify, protect and safeguard customers’ providers’ property provided for use or incorporation into the or external products and services. ‘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. NOTE A customer's or external provider's property ‘can include materials, components, tools and equipment, premises, intellectual property and personal data, 8.5.4 Preservation The organization shall preserve the outputs during production and service provision, to the extent necessary to ensure conformity to requirements. NOTE Preservation can include identification, handling, contamination control, packaging, storage, transmission or transportation, and protection, 8.5.5 Post-delivery activities The organization shall meet requirements for postdelivery activities associated with the products and services. In determining the extent activities that are required, the organization shall of postdelivery consider: a) statutory and regulatory requirements; b) the potential undesired associated with its products and services; consequences ©) the nature, use and intended lifetime of its 43TCVN ISO 9001:2015 san phdm va dich wy; 4) yéu cu cila khach hang; e) phan hdi cla khéch hang, CHU THICH: Hoat dong sau giao hang c6 thé bao gm ‘cae hanh dong theo digu kién bdo hanh, nghia vy theo bgp @Bng nhur dich vy bio tr va dich vy bd sung nhur tai ché hod hay b6 cudi cing, 85.6 iém soat thay ddi Té chire phai xem xét va kiém sodt nhGng thay 48) 44 voi sn xudt ho&e cung cp dich vy & mac 6 can thiét 48 dam bao duy tri sy ph hop véi cc yéu du. 6 chirc phai duy tri thong tin dang van ban m6 ta két qua xem xét thay ai, (nhiing) ngudi cho phép thay d6i va moi hanh dong cdn thiét nay sinh ti vige xem xét. 8.6 Thong qua san pham va dich vy Té chive phai thy hign céc sép at theo hoach Ginh & nhtng giai doan thich hop 4é kim tra xac nhan rang cac yéu cau 46i voi sn phdm va dich Wy dug éap ting. Vige thong qua san phdm va dich vy cho khéch hang chi duge tin hanh sau khi & hoan thanh théa dang cac sép dat theo hoach dinh, néu khong thi phai duge sy phé duyét cia ngudi cb thdm quyén va, néu c6 thé, ciia khéich hang. Té chirc phai duy tri thong tin dang van ban ve viée thong qua s8n phdm va dich vu. Thong tin dang van ban phi bao gdm: fa) bang chiing vé sy phi hop véi chudn myc chap nhan; ) kha nang truy xudt én (nhGng) ngudi cho 44 products and services; 4) customer requirements; €) customer feedback. NOTE Postdelivery activites 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. The documented information shall include: 2) evidence of conformity with the acceptance criteria, b) traceability to the person(s) authorizing thephép thong qua. 8.7 Kiém soat dau ra khong phi hp 8.7.1 T8 chive phai dam béo rang dau ra khong phu hop véi cdc yéu cau duro nhan biét va kiém soat nh’m ngan ngiva viée sir dung ho&e chuyén giao ngoai dy Kién. TB chive phai thy hign cdc hanh Gong thich hop dya theo ban chdt ciia sy khéng phis hop va téc d6ng cila né t6i su phi hop olla sén phdm va dich vu. Bidu nay cing phai ap dung déi v6i san phdm vva dich vy khéng phi hgp duoc phét hién sau khi chuyén giao sén phdm va trong qué tinh hog sau khi cung cp dich vu. 6 chire phai xi ly ddu ra khéng phii hop theo mét hode ede cach sau: )_kndc phuc; b) tach riéng, ngan chan, thu hdi hodc tam ding vige cung cp san phdm va dich vy; ©) théng béo cho khéch hang; d) 06 duge sy cho phép chép nhan oO nhan nhvong. Sy phil hop véi céc yéu edu phai 6uoc kiém tra xde nhan khi dau ra khong ph hop dugc khéc phyc. 8.7.2 Té chic phai luu gid théng tin dang van ban a)_mé t& su khong phi hop; b)_mé ta hanh dong thye hién; ) mét& moi sy nhan nhugng dat duc; d) nhan biét tham quyén quyét dinh hanh dong 6i v6i sy khong phi hop. TCVN ISO 9001:2015 release. 8.7 Control of nonconfor ing outputs 8.7.1 The organization shall ensure that outputs that do not conform to their requirements are identified to prevent their Unintended use or delivery. and controlled 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; ©) informing the customer; 4d) obtaining authorization for acceptance under concession. Conformity to the requirements shall be verified when nonconforming outputs are corrected. 87.2 information that: The organization shall retain documented a) describes the nonconformity; b) describes the actions taken; ©) describes any concessions obtained; d) identifies the authority deciding the action in respect of the nonconformity. 45TCVN ISO 9001:2015 9 anh gia két qua thyc hign 9.4 Theo d6i, do lwéng, phan tich va dénh gid 9.4.4 Khai quat Té chirc phai xdc dinh: a) nhiing gi c&n duoc theo déi va do lvang; b) phurong phdp theo di, do luréng, phan tich va danh gia cn thiét 48 4am bao két qua cé gid tris ©) khi nao phai thu hign theo doi va do lang; 1d) khi nao cac két qua theo di va do lvéng phai dugc phan tich va danh gis, 6 chizc phai dénh gid két qua thyc hién va higu lye eda he théng quan ly chat long T8 chic phai lwu gift théng tin dang van ban lam bang chiang v8 nhiing két qua nay. 9.1.2 Sy théa man cila khach hang 8 chite phai theo d6i cam nhan cla khach hang vé mie dO theo 46 nhu cu va mong doi cla ho duge dap ting. T6 chire phai xéc dinh phuong phap 48 thu due, theo doi va xem xét théng tin nay. CHU THICH: Vi dy vé vige theo d6i cam nhan eta kndeh hang ¢6 thé bao gém khdo sat khéch hang, théng tin phan héi cia khdch hang vé sin phém va ich vu duge giao, hoi nghi Khach hang, phan tich thj phan, loi khen nggi, yéu cu blo hanh va béo odo oda nha phan phi. 46 9 Performance evaluation 8.1 Monitoring, measurement, analysis and evaluation 9.1.4. General The organization shall determine: @) what needs to be monitored and measured; b) the methods for monitoring, measurement, analysis and evaluation needed to ensure valid results; ©) when the monitoring and measuring shall be performed; @) when the results from monitoring and measurement shall be analysed and evaluated The organization shall evaluate the performance and the effectiveness of the quality management system, The organization shall retain appropriate documented information as evidence of the results, 9.1.2 Customer satisfaction The organization shall_ monitor customers’ perceptions of the degree to which their needs and expectations have been fulfilled. The organization shall determine the methods for obtaining, monitoring reviewing this information. 2 and NOTE Examples of monitoring customer perceptions can include customer surveys, customer feedback on delivered products and services, meetings with customers, marketshare analysis, compliments, warranty claims and dealer report.9.1.3 Phan tich va danh gid Té chic phai phan tich va danh gia dr ligu va théng tin thich hop tir theo dai va do lwéng. Két qua phan tich phai duoc str dung 48 danh gia: a) sy phi hgp cia sn phdm va dich vu; b) mire d6 thda’man cia khach hang; ©) két qua thyc hign va higu tye oa he théng quan Iy chat wong: d) ndi dung hoach dinh o6 éuoe thye hien mot cach higu lye hay khong; e) higu le eda nhing hanh déng duge thy hién 8 gid quyét rai ro va co di, f) két qua thyc hién cia nha cung cp ben ngoai; g) nhu cdu cai tién hé théng quan ly chat lveng, CHU THICH: Phuong phap phan tich dtr ligu 06 thé bao gdm otic ky thuat théng ke, 9.2. Banh gid ngi bo 9.2.1 TS chive phai tién hanh cdc cube danh gia igi bd theo nhiing khong thdi gian direc hoach dinh 48 cung cp théng tin vé viéc hé théng quan ly chat luong c6 hay khong: a) phihgp véi 1) cae yéu cau cia chinh t8 chive ai voi he théng quan ly chat lng cia minh; 2) céc yeu cdu ciia tiéu chudn nay; b) duge thyc hign va duy tri mét cach higu lye. 9.2.2 Té chic phai a) hoach dink, iét lap, thy hign va duy tri (cdc) TCVN ISO 9001:2015 9.1.3 Analysis and evaluation The organization shall analyse and evaluate appropriate data and information arising from ‘monitoring and measurement. ‘The results of analysis shall be used to evaluate: a) conformity of products and services; b) the degree of customer satisfaction; ©) the performance and effectiveness of the quality management system; )_ if planning has been implemented effectively; @) the effectiveness of actions taken to address risks and opportunities; f) the performance of external providers; g) the need for improvements to the quality management system. NOTE Methods to analyse data can incude statistical techniques. 9.2 Internal audit 9.24 audits at planned intervals to provide information ‘on whether the quality management system: The organization shall conduct internal ) conforms to: 4) the organization's own requirements for its quality management system; 2) the requirements of this International Standard; b) is effectively implemented and maintained. 9.2.2 The organization shalt a) plan, establish, implement and maintain an 47TCVN ISO 9001:2015 chuong trinh danh gia bao gdm tan suat, phuong phép, trach nhiém céc yéu cau hoach inh va vige bao c&o, va 06 tinh én t8m quan trong clia ede qua trinh lién quan, nhting thay Bi Anh huéng t6i t8 chive va két- qua ciia cae cue danh gia trube a6; b) xac dinh chun myc danh gid va pham vi cia ting cube danh gid: ©) Iya chon chuyén gia danh gid va tién hanh cdc cuge danh gid 48 dm bao tinh v6 tu va tinh khéch quan eda qua trinh dann gid, d) dam bao rang két qua danh gia dugc bao c4o t6i cp lanh dao thich hop; ) thy hign khong cham tr vige kh phyo va hanh dong khde phyc thich hop: f) wu gid thong tin dang van ban lam bang chimng vé vige thyc hién chong trinh aanh gi va két qua danh gid. (CHU THICH: Xem héng dn trong TCVN ISO 19011. 9.3 Xem xét ciia lanh dao 9.3.1 Khai quat Lanh dao cao nhat phai xem xét hé théng quan ly chat lang eta t8 chirc theo nhng khodng théi gian urge hoach dinh d& dam bao né lu6n thich hop, théa dang, 06 higu lye va pha hop v6i din huéng chién luge ola t8 chire. 9.3.2 Dau vao xem xét cila Linh dao Xem xét clla Inn dao phai dugc hoach dinh va thyc hién a8 xem xét a) tinh trang cia céc hanh dong tir cdc cude xem xét alia [anh dao trade d6; b) nhiing thay 46i trong cac van 48 ndi bé va bén ngoai lién quan dén hé théng quan ly chat wong; 48 audit programme(s) including the frequency, methods, responsibilities, planning requirements and reporting, which shall take into consideration the importance of the processes concerned, changes affecting the organization, and the results of previous audits; b) define the audit criteria and scope for each audit; ©) select auditors and conduct audits to ensure objectivity and the impartiality of the audit process; d) ensure that the results of the audits are reported to relevant management; ©) take appropriate correction and corrective actions without undue delay; f) retain documented information as evidence of the implementation of the audit programme and the audit results. NOTE See ISO 19011 for guidance. 9.3. Management review 9.3.4 General Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the organization. 9.3.2. Management review inputs . The management review shall be planned and carried out taking into consideration: a) the status of management reviews; actions from previous b) changes in external and internal issues that are relevant to the quality management system;©) théng tin vé két qua thye hién va hiéu lye ca hé théng quan ly chdt lugng, bao gdm céc xu huréng ve: 41) su thda m&n ctia khach hang va théng tin phan hdi tir cdc bén quan tam lién quan; 2) mie 49 thyc hign cée muc teu chdt luong; 3) két qua thyc hién qua trinh va sy phi hop lia san phdm va dich vu; 4) sy khong phi hyp va anh ding knéc phuc; 5) két qua theo doi va do long: 6) két qua danh gia; 7) két qua thy hign cla nha cung cap ben goal; 4) sy day oti olia nguén lye; e) higu lye ca hanh déng thue hign a8 quyét nui ro va co hdi (xem 6.1); f) cdc co’ hoi cai tién. 9.3.3 Dau ra xem xét cila lanh dao Bau ra ella vige xem xét ola lanh dao phai bao gdm céc quyét dinh va hanh dong lign quan dén ién; b) moi nhu cdu thay dBi hé théng quan ly chat luong; a) cae co hoi cc) nhu cdu vé nguén Ive. T8 chite phai luu gitr théng tin dang van ban lam bang chirng vé cdc két qua xem xét ca lanh dao. TCVN ISO 9001:2015 ©) 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; ©) 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; ©) resource needs. The organization shall retain documented Information as evidence of the results of management reviews. 49TEVN ISO 9001:2015 10 Caltién 40.4 Khai quat 6 chite phai xéc dinh va lya chon cac co hoi a8 cdi tién va thyc hién moi hanh dng c&n thiét 48 8p ting yéu cau cla khéch hang va nang cao sy théa man clia khach hang. Bidu n’y phai bao atm: a) cai tién san phdm va dich vy 48 dap tng yeu cu cting nhu giai quyét cdc nhu cu va mong gi trong twong lai: b) kh&c phuc, phong ngia va giém tae déng khéng mong muén; ©) cai tidn két qua thy hign va hieu lve ca he théng quan ly chat long. CHU THICH: VI du vé viée cai tién 06 thé bao gdm viée kde phye, han dong khéc phye, c&itiénlién tue, thay 681 dot pha, 43i mdi va t5 chic Iai. 10.2 Sy khéng phi hop va hanh dong khac phuyc 10.2.1 Khi xdy ra sy khéng phi hop, ké cd sy khéng phi hop bét ky nay sinh tir khiéu nai, t8 chive phai a) Ung phé voi su khéng phil hop va, khi thich hop: 1) thye hign hanh dong 48 kiém soat va kde phyc sw khong phi hop; 2) xiP ly cc hé qua; b) danh gia nhu cdu aéi voi hanh dong nh&m loi bé (cdc) nguyén nhan dan Gén sy khéng phi hop dé khong tai dién hoae xdy ra & noi khac: bang vie: 1) xem xét va phan tich su khong phu hop; 2). xéc dinh nguyén nhén cia sur khéng phi hop; 60 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. These shall include: a) improving products and services to meet requirements as well as to address future needs and expectations; ) correcting, preventing or reducing undesired effects; ©) improving the performance and effectiveness of the quality management system. NOTE Examples of improvement can include correction, corrective action, continual improvement, breakthrough chang innovation and re-organization. 10.2. Nonconformity and corrective action 10.21 When a nonconformity occurs, including any arising from complaints, the organization shall a) react to the nonconformity and, as applicable: 41) take action to control and correct it; 2) deal with the consequencé b) evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does ot recur or occur elsewhere, by: 41) reviewing and analysing the nonconformity; 2) determining the causes of the nonconformity,3) xe inh ligu su khong phi hgp tong ty. 6 thn tai hoe 6 kha nding xay ra hay khong; c) thyc hién mgi hanh déng can thiét; 4) xem xét higu Ive olia moi hanh dng khéc phyc duuge thye hign; e) c&p nhat ri ro va co hoi doc xée dinh trong qué trinh hoach inh, néu cn; f) thye hién nhtng thay déi d6i voi hé théng quan ly chat long néu c&n. Hanh dong khde phuc phai tong éng voi tac dng ca sir khong phi hop gap phai 10.2.2 T8 chirc phai luu git? théng tin dang van ban lam bang ching vé: a) ban cht cia sy khéng phi hop va hanh déng duge thyc hign sau 46; b)_két qua ca mgi hanh Gong khdc phys. 10.3 Cai tidn Hien tue 78 chirc phai cai tién lién tue sy thich hop, théa dang va higu lye cia hé théng quan ly chdt lwong. T} chwe phi xem xét két qua cila phan tich va anh gia va dau ra tir xem xét cila [anh dao a8 xac dinh xem cO nhu cau ho&e co hdl pha duoc giai quyét nhu mét phan cia cai tién lién tuc. TCVN ISO 9001:2015 3) determining if similar nonconformities exist, or could potentially occur, ©) Implement any action needed; d) review the effectiveness of any corrective action taken; €) update risks and opportunities determined during planning, if necessary; f) make changes to the quality management system, ifnecessary. Corrective actions shall be appropriate to the effects of the nonconformities encountered. 10.2.2 The organization shall retain documented information as evidence of: 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. 61TCVN ISO 9001:2015 Phy luc A (tham khao) Lam 16 cu trite, thuat ngt va khai nigm méi Ad Céu triic va thugt ngir Céu triie ciia cdc diu (nghia la trinh ty cdc Gigu) va mot sé thuat ng ciia phién ban tiéu chudn nay so véi phién ban truec (TCVN ISO 8001:2008) 48 dugc thay déi a8 nang cao sy théng nhét véi cac tiéu chudn khac vé hé théng quan ly. Tiéu chudn nay khéng c6 yéu cAu déi voi cdu frdc va thuat ngi cla tiéu chuan dec ap dung 6i v6i théng tin dang van ban cia he théng quan ly ch&t lveng cia 18 che. Céu tric cla céc didu nham mang lai sy thé hign gn két céc yéu cu thay cho mé hinh lap tai liu vé chinh séch, myc tiéu va qué trinh cia t8 chirc, Céu tric va n6i dung cia théng tin dang van ban lién quan dén hé théng quan ly chat lvong c6 thé thich hop hon cho nguéi sir dung tiéu chuan néu no lién quan dén ca cdc qua trinh do t8 chisc thy hién va thong tin duge duy trl cho cc muc dich khac. Khong 6 yéu cdu d6i voi thuat ngo duoc 18 chite sir dung duoc thay thé béi thuat ngtr sir dung trong tiéu chudn nay 42 quy dinh cdc yéu cau d6i voi hé théng quan ly chat lugng. TO chirc cé thé Iya chon sir dung nhiing thuat ngi phi hop voi hoat déng cia minh (vi du sé dung “hd so”, "hé théng tai ligu" ho&e “bién ban" thay cho “théng tin dang van ban” hoe “nha cung ing", "66i tac” hay “ngudi ban hang” thay cho “nha cung c4p bén ngoai"). Bang A.1 chi ra nhiing khac biét chinh vé thuat ngt gita tieu chudn nay va phién ban ci. 52 Annex A (informative) Clarification of new structure, terminology and concepts AA. 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 management systems standards. improve alignment with other There is no requirement in this International Standard for its structure and terminology to be applied to the documented information of an organization's quality management system. The structure of clauses is intended to provide a coherent presentation of requirements, rather than a model for documenting an organization's 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. Qrganizations can choose to use terms which suit their ‘operations (¢.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,Bang A.1 — Khéc bigt chinh vé thuat ngir gilra TCVN ISO 9001:2008 vaTCVN ISO 9001:2015 TCVN ISO 9001:2015 TEVN ISO 9001:2008 TEVN ISO 9001:2015 ‘San pham ‘San phAm va dich vy (Ce ngoai Ie Khéng sit dung (A.5 lam r8 ve kha nang ap dung) ‘Dai dién lanh dao Khéng sir dung (Tréch nhigm va quyén han tong ty duge 4 inh nhung khéng ¢6 yéu cau d6i véi dai diér tinh Aan dined Hé théng tai ligu, sé tay chdt Iuong, thd tue dang van ban, hd so ‘Théng tin dang van ban Méi trong lam viee ‘Mai triréng cho viée thye hién cc qua trinh ‘Thiét bi theo déi va do lwong Ngudn luc theo doi va do long San phim mua vao ‘San phdm va dich vy do bén ngoai cung cap ‘Nha cung tng Nha cung cp bén ngoai Table A1 — Major differences in terminology between ISO 9001: 108 and ISO 9001:2015 1S0 9007:2008 150 9001:2015 Products Products and services Exclusions Not used (Gee Clause A.5 for clartication of applicability) Management representative Notused (Similar responsibilities and authorities are assigned but no requirement for a single management representative) Documentation, quality manual, documented) pro- cedures, records Documented information Work environment Environment for the operation of processes Moniforing and measuring equipment Monitoring and measuring resources Purchased product Externally provided products and services: ‘Supplier External provider 53TCVN ISO 9001:2015 A2 San phdm va hvu TCVN ISO 9001:2008 sir dyng thuat ngo “san pham" bao gdm tét cd cdc loai dau ra. Tiéu chuan nay si dyng "san phdm va dich vu" bao gdm tét cA céc loai du ra (phn cing, dich vy, phan mém va vat ligu d& duge xi i). Vige duva thém “dich vy" vao nm nhén manh sy nae bit gta sén phdm va dich vy trong vige ap dung mét sé yéu cu, Bac treng cia dich vy la it nhét phan du ra duge thyc hign tai noi tong giao v6i khdch hang, Bigu nay 6 nghfa la, vi du, sy phil hop v6i céc yéu cu khong nhdt thiét urge xée nhan truée khi chuyn giao dich vy. Trong phan lon cdc truéng hop, san phdm va dich vu duge sir dung ding thdi. Phan lon cde du ra 6 chite cung cép cho khach hang hoSc dugc cung ting béi nha cung Ap bén ngo: bm ca san phdm va dich vu. Vi du, mét san pha hiu hinh hode vé hinh cé thé 6 dich vy nhat inh kém theo ho&e mét dich vy 6 thé cb san phdm hizu hinh hay v6 hinh kém theo. iu bao A3 Hiéu nhu cdu va mong doi cla cac bén quan tam Didu 4.2 quy dinh cac yéu cdu di véi t8 chire a8 xc dinh cac bén quan tam lién quan dén hé théng quan ly chat long va céc yéu cdu cia cdc ben quan tam nay. Tuy nhién, 4.2 khong ham ¥ viée md rong cac yéu cau déi véi hé théng quan ly chat lvong vuot qué pham vi cla tiéu chudn nay. Nhu duoc néu trong phan pham vi, tiéu chuan nay 06 thé ap dung khi t8 chire can ching t6 kha nang cla minh trong viée cung cép mot cach én Ginh san phdm va dich vy dap tng yeu cau ciia khéich hang va yéu cau luat dinh, ché dinh hién 54 2. Products and services ISO 9001:2008 used the term "product" to include output categories. This edition of this International Standard uses “products and “Products and_ services’ all 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 for example, that conformity to requirements cannot necessarily be confirmed before service delivery. customer. This means, In most cases, products and services are used together. Most outputs that organizations provide to 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 ments of those interested system and the req Parties. However, 4.2 does not imply extension of quality management system requirements beyond the scope of this International Standard. in the scope, this International Standard is applicable where an organization needs to demonstrate its ability to consistently As stated provide products and services that meet customerhanh va nh&ém nang cao sy théa man ctia khdch hang. Khéng cé yéu cu nao trong tiéu chudn aéi voi té chic [a xem xét cdc bén quan tam Khi 16 chic quyét dinh rng cée bén quan tam 46 khéng tién quan dén hé théng quan ly ch&t Ivong ca minh. Chinh t8 chive I ngudi quyét dinh xem yéu cdu cu thé oda bén quan tam 06 lién quan dén he théng quan ly ch&t long ota minh hay khong. Ad Tu duy dya trén ral ro Khai nigm vé tu duy dua trén rii ro 63 duro hm ¥ trong nhiing phién ban trée cia tiéu chun, vi dy théng qua cdc yéu cu déi véi viée hoach dinh, xem xét va cai tign, Tiéu chun nay quy dinh cae yéu cu di v6i t8 chive trong viée hiéu bdi canh tia t8 chtre (xem 4.1) va xac dinh ca riii ro lam co’ sé cho vige hoach dinh (xem 6.1). Bidu nay thé hién vige 4p dung tw duy dya tren ri ro cho viée hoach dinh va thye hign cdc qua trinh cla he théng quan ly chét long (xem 4.4) va sé hé tro” trong vige xéc dinh mirc d6 atia cc théng tin dang van ban. Met trong nhGing myc dich chinh cla he théng quan ly chét long la hanh 66ng nhu mét cng cu phong ngiza. Theo 46, tiéu chudn nay khéng cd Giu rigng biet ve hanh dong phéng ngira. Khai nigm vé hanh dong phng ngtra duge thé hién thong qua viée sir dung ty duy dya trén ri ro trong viéc tao lap céc yéu cau cla hé théng quan ly chat luong. Tu duy dya trén mdi ro duoc ap dung trong tiéu chun nay da gidp giém phan nao cac yéu cau mang tinh quy tac va thay bang céc yeu cau dua tren két qua thyc hign. Cé sy link hoat hon rét TCVN ISO 9001:2015 and applicable statutory and regulatory requirements, and aims to enhance customer satisfaction There is no requirement in this Intemational Standard for the organization to interested parties where it has decided that those parties are not relevant to its quality managément system. It is for the organization to decide if a particular requirement of a relevant interested consider party is relevant to its quality management system. A Risk-based thinking The concept of risk-based thinking has been implicit in previous editions of this International Standard, e.g for planning, improvement. This International Standard specifies requirements for through requirements review and the organization to understand its context (eee 4.1) and determine risks as a basis for planining (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 Intemational 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 Intemational Standard has reduction in prescriptive requirements and their applied in this enabled some replacement by performance-based requirements.TCVN ISO 9001:2015 nhidu so voi TCVN ISO 9001:2008 va cac yéu cu 6i voi cde qua trinh, thong tin dang van ban va trach nhiém cia 6 chu, Mae dil 6.1 quy dinh t8 chirc phai hoach dinh cae. hanh dng dé gidi quyét ri ro, nhung khong co yéu cu nao déi véi phuong phap chinh thie a& quan Indi ro ho&e qué trinh quan ly rii ro dang van ban. Té chirc 6 thé quyét dinh xay dung ho&c khong xay dung phuong phap quan ly rui ro rong hon so véi tiéu chuan yéu cau, vi du théng qua viée ap dyng céc tiéu chudn khdc. Khéng phai tét cd cc qua trinh cita he théng quan ly chat lwgng déu thé hign mie rai ro nhy nhau 6i voi kha nang cla t8 chizc trong viée dap tng ede mye figu lia minh va anh huéng cla sy khéng chdc ch4n cng khéng giéng nhau di voi tat c8 cdc 18 chizc. Theo yéu cdu cla 6.1, t8 chire chiu trach nhigm 4éi véi vige 4p dung ty duy dya {rn riiro va hanh dong thyc hign 48 giai quyét ri ro, bao gém vige ¢6 hay khong lu git théng tin dang van ban lam bang chieng cho vige xée dinh rai ro cla té chiro. A Kha nang 4p dung eu chuan nay khong d& cép dén “cdc ngoai Is” lign quan aén kha néng 4p dung cae yeu cau di voi hé théng quan ly chat Iveng ctia té chirc. Tuy nhién, t8 chirc 06 thé xem xét kha nang ap dung cac yeu cdu theo quy mé hog mirc 46 phitc tap iia t8 chitc, m6 hinh quan ly t8 chire chap nhan, pham vi cae hoet dong clia t8 chute va tinh chét ila cae ri ro va co hOi gap pha ‘Yéu cau v8 kha nng ap dung duoc a8 cap 6 4.3, Gidu nay xae dinh cac didu kién theo dé t8 chive 66 thé quyét dinh mét yéu cau khéng thé ap dung 58 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 methods for management or a documented risk management process. Organizations can decide whether or not management is International formal risk to develop a more extensive methodology than is required by 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 organization's 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 its documented information as evidence of determination of risks, AS Applicability This International Standard does not refer to “exclusions” in relation to the applicability of its requirements to the organization's 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 organization's activities and the nature of the risks and opportunities it encounters. The addressed in Tequirements for applicability are 4.3, which defines conditions under which an organization can decide that acho qua trinh bat ky trong pham vi cua he théng quan ly chét lvgng cia minh. TS chire chi cb thé quyét dinh rang mot yeu cu khong thé 4p dung néu quyét dinh ca t8 chire khong din dén viée khéng dat duge sy phi hgp ciia sin phdm va dich wy. A6 Thong tin dang van ban La mt phan su'théng nhét voi cdc tieu chudn vé he théng quan ly, 4idu khodn chung v8 “théng tin dang van ban" duoc chap nhan ma kh6ng c6 thay 481 ho&c bS sung dang ké (xem 7.5). Khi thich hgp, néi dung van ban & ch6 knac ota tiéu chudn duge théng nhat véi yéu cau nay. Vi vay, “thong tin dang van ban’ durge sir dung d6i véi tét ca cae yeu cdu vé tai ligu. Nhting ché trong TCVN ISO 9001:2008 sir dung thuat ngtr oy thé nhu “tai ligu” hay “thi-tye dang vvan ban’, “s8 tay chdt lvgng” hoe *ké hoach chat urong®, thi tigu chun nay xée dinh cdc yéu cu ve “duy tr théng tin dang van ban". Nang ché trong TCVN ISO 9001:2008 sir dung thuat ng “hd 60” 48 chi tai igu cn thiét cung ofp b&ng chimg vé sy phi: hyp véi céc yéu cau, thi tigu chuan nay thé hién bang yéu cdu vé “uu gift théng tin dang van ban’. Té chirc chiu tréch nhigm xée inh nhting théng tin dang van ban nao cin durgc wu gif, théi gian luu git va phuong tien sir dyng cho vide liu git? ala minh. ‘Yéu cau “duy trl" théng tin dang van ban khong loai trir kha nang t8 chirc 6 thé cing can “wu gi” chinh théng tin dang van ban 66 cho myc dich cu thé, vi dy luu gitr phién ban truéc dé cla thong tin dang van ban. Khi tiéu chu&n nay 48 cap aén “thong tin’ cher TCVN ISO 9001:2015 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 fallure to achieve conformity of products and services. AS Documented information As part of the alignment with other management system standards, @ 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 “documented document requirements. Consequently, information’ is used for all 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 900%: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TCVN ISO 90012015 khéng phai la “théng tin dang van ban" (vi du & 4.1: "TB chite phai theo doi va kem xet thong tin V8 cdc van dé néi bo va bén ngoai nay’), thi khong 6 yéu cdu Ia théng tin nay duge lap thanh van ban. Trong trvéng hop nay, t8 chire o6 thé quyét Ginh c6 c&n ho8e 66 thich hep 48 duy tri théng tin dang van ban hay khéng. ALT Trithiec cia td chire 7.1.6 d8 c&p én nhu cdu xéc dinh va quan ly tri thie duge 18 chirc duy ti a8 dim bao viée van hanh céc qué trinh cia minh va c6 thé dat duge ‘sy phil hop ctia sn phdm va dich vu. ‘Yeu cu vé tri thire cila t8 chic due dua vao véi muc dich: a) bdo v6 t8 chit khdi sw mat mat vé tri thie, vi du = do thay 48i nhan vién; ~ khong dat éuge vigc ndm gitr va chia sé thong tin; b) khuyén khich 16 chive dat duoc tr thie, vi du = hoc héi tly kinh nghiém; ~ kem cap: = d6isanh chun, A.8 Kiém soét qué trinh, san pham, dich vy do bén ngoai cung cdp Tt cd cdc hinh thirc cia cdc qué trinh, san pham va dich vy do bén ngoai cung cép du due néu & 8.4, vi dy thong qua: a) mua tir nha cung tng; b) sy sép dat vdi mot céng ty lién Kt; 58 “information” rather than “documented information (@.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. Organizational knowledge In 7.4.6, 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: @) 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. A8 Control of externally provide! 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;@) qua trinh thu phy tir nha cung cép bén ngoal ‘Thus ngoai ludn ludn cb dac diém dac biet cla dich vu, vi nd s& 06 ft nhat mét hoat dong can duge thyc hign tal noi twong giao gid nha cung cp va té chic. Cac kiém soat cn thiét d6i voi viee cung cap cla ben ngoai 06 thé rt khéc nhau tuy thude vao tinh chét oda qua trinh, san phdm va dich vu. TB chic 6 thé dp dung tu duy dya trén rll ro d8 xée éinh Joai hinh va mize 46 kiém sodt thich hop vol céc nha cung cp bén ngoai cy thé va cac qua trinh, san phdm va dich vy do bén ngoai cung cap. TCVN ISO 9001:2015 ©) 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. 59‘TCVN ISO 9001:2015 Phu luc B (tham kno) Céc teu chudn khac va quan ly chat wong va hg théng quan ly chat lweng do Ban kj thuat TCVNITC 176 xay dyng Céc tiéu chun dugc néu trong phy Ive nay do Ban kj thugt TCVN/TC 176 xay dung nh&m cung cp théng tin hB tro cho t6 chitc 4p dung tigu chudin nay va dua ra huéng dn cho cdc t8 chire muén dat due cao hon cdc yéu cau cla tiéu chun. Céc huéng d&n hoge yéu cau duoc néu ‘trong nhting tiéu chun liét ké trong phu Iuc nay kh6ng bé sung hoa sira di cac yéu cau cia tiéu chudn nay. Bang B.1 chi ra méi quan hé gitta cde tiéu chun va diéu lién quan cia tidu chun nay. Phu ye nay khéng bao gém viée vign d&n dén ede tieu chudn vé hé théng quan Iy chdt lueng cho Minh vuc ey thé do Ban kj thuat TCVN/TC 176 xay dung Tiéu chudn nay 1a mét trong ba tiéu chuan cét [6i do Ban kj thuat TCVNITC 176 xay dung, = TCVN ISO 9000 H¢ théng quén Iy chét lurong ~ Co sé va tt vung cung cAp nén tang co ban cho vigc hiéu va ép dung phu hgp tigu chudn nay. Cac nguyén téc quan ly chat lvgng duge. ‘mé ta chi tiét trong TCVN ISO 9000 va duoc ua vao xem xét trong qué trinh xay dung tiéu chudn nay. Nhiing nguyén tde nay khéng phai a cae yéu cdu nhung ching tao nén ting cho cc yéu cu duge quy Ginh trong tigu chudn nay. TCVN ISO 9000 cting xée inh céc thuat ngG, dinh nghfa va kai nigm str dung trong 60 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.4 shows the relationship between these standards and the relevant clauses of this International Standard. This annex does not inchide reference to the sector-specific quality management system standards developed by ISOITC 176. This International Standard is one of the three Core standards developed by ISO/TC 176, - 180 9000 Quality management systems - Fundamentals and vocabulary provides an background forthe —_ proper implementation of this essential understanding and 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. |S 9000tigu chun nay. = TCVNISO 9001 (tiéu chun nay) quy éinh cae yéu edu cha yéu nh&m mang lai lng tin vo cc san phim va dich vy do t8 chive cung cp va do 46 nang cao sy théa mn cia khach hang, Vie ap dung ding tigu chuan 6 thé cng nh&m-mang Iai e&c lol Ich Kn cho t8 chitc nhu cai tién viéc trao d&i théng tin ngi bd, hidu va kim soat t6t hon cae qué trinh cia t8 chic. = TCVN ISO 9004 Quan Iy t8 chite 48 thanh céng bén ving — Phuong phap tiép cn quan Wy chdt luong da ra hung dan cho cae t8 chic muén vuot xa cdc yeu cu cla tiéu chudn nay, nham giai quyét pham vi céc chi 8 lén hon cé thé mang Iai sw cai tién toan bo két qua thye hign ca t8 chirc. TCVN ISO 9004 bao gdm huéng dan vé phuong phap ty anh gia cho mét t6 chic 8 c6 thé danh gia mie 66 nhuan nhuyén ca hé théng quan ly chat lugng. Céc tigu chudn duge néu du6i day cé thé hd tro” t8 chic khi dang thiét lap hoae huéng dén viéc cai tin hé théng quan ly chat long, cac qua trinh hod hoat dong cia minh, = TCVN ISO 10001 Quén Ij chdt luyng - Su théa m&n cla khach hang — Hudng d&n ve quy pham thye hanh cia 18 chire da ra huéng dn cho 16 chite trong vige xae dinh rng vig mang lai sy théa man cla khdch hang olla t6 chic dép ting c&c nhu cau va mong dgi olla khach hang. Vige sir dung tiéu chudn 6 thé nang cao léng tin olla khach hang vao 18 chirc va cdi thién sy hiéu biét cia khéch hang v8 nhOng 6isu mong muén tir mot TOVN ISO 9001:2015 also defines the terms, definitions and concepts used in this International Standard. = 180 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 organization's processes. = 180 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 organization's overall performance. SO 9004 includes guidance self assessment methodology for an organization to be able to evaluate the level of maturity of its quality on a management system. The Intemational 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 to an organization in determining that its customer provides guidance 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. 61TCVN ISO 9001:2015 62 48 chite, do 6 gid kha nding xdy ra vie higu sai va khiéu nai, . TCVN ISO 10002 Quén ly chdt luong - Su théa mén cila khéch hang — Huéng dan xiv ly Khiéu nai bén trong té chic dua ra huéng dan vé qué trinh xr ty Khidu nai thong qua viée ghi han va giai quyét nhu cdu va mong doi cla bén khiéu nai va giai quyét moi khiéu nai duge tip nhan. TCVN ISO 10002 dua ra qua trinh xir ly khiéu nai mang tinh mé, 6 hiéu lye va d& six dung, qua trinh nay bao gdm ca viéc dao tao con ngudi. Tiéu chudn cing dua ra huéng dan cho doanh nghigp nhd. TCVN ISO 10003 Quan iy chét luong - Sy théa man ola khéch hang — Huréng dan gidi quyét tranh chép bén ngoai 6 chic dua ra huréng din cho vige giai quyét tranh chap bén ‘goal cdc Khiéu nai lign quan dén san phdm mét cach higu lye va hiéu qua. Gidi quyét tranh ch4p dua ra cach xiv ly khi t8 chirc khéng ty gidi quyét khi6u nal, Phan lon cde khiéu nai cé thé duge giai quyét thanh cong trong pham vi t8 chirc ma khéng c6 thi tue tranh tung. TOVN ISO 10004 Quén ly chdt Ivong - Sw théa man cla khéch hang — Huéng dn theo 61 va do lueng dura ra huéng dn ai voi eae hanh dng nhdm nang cao sy théa man cia khach hang va xéc dinh céc co hoi cai tién san pham, qua trinh va céc dac trung ctia t8 chive duc tao dung gia tri bai khach hang, Nhtng hanh Ong nay cé thé thc ddy sy gan bé cia khach hang va gdp git auee khach hang TCVN ISO 10005 H6 théng quan ly chat rong — Huéng dén v8 ké hoach chét long dua ra huéng dan trong vigc thiét lap va sir dung cde ké hoach chat lurong nhur mét cach aap img - 180 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 productrelated complaints. Dispute resolution gives an avenue of redress when organizations do not remedy a complaint internally. Most complaints can be resolved successfully within the organization, without adversarial procedures. = 180 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 strengthen customer loyalty and help retain customers. can - 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,Ac yeu cau v8 qua tinh, san ph&m, dy an ho&c hop ééng, dé thyc hign cac phuong phap va thyc hanh hd tro vige tao san pham. Loi ich cita vige thiét lap ké hoach chat lvong 1a lam gia tng lng tin v8 vige cdc yeu cau duge d4p Ung, cdc qua trinh dugc kiém soat va thie ddy rang viée nay 6 thé dua ra cho hing ngué@j lién quan. TCVN ISO 10008 Hé théng quan ly chat Ivong — Huréng dn quan ly chét long dy én co thé ‘p dung cho cac dy 4n tir nhé één 16n, tir don gin dén phir tap, tir dy an rigng 18 dén mot phan cla téng thé céc dy an, TCVN ISO 10006 dug sir dung béi ngurdi quan Iy dy’ én va nguei muén ddm bam bao rang t6 chic ‘Ga minh dang 4p dung thye hanh duge néu trong céc tigu chuan vé hé théng quan ly chat long. TCVN ISO 10007 Hé théng quan ly chét long = Huéng dn quan ly cu hinh nham hb tro #6 chic ap dung vige quan ly c&u hinh a6i voi cdc dinh huéng ky thuat va quan tr trong toan b6 vong déi san pm. Quan ly céu hinh 66 thé duge sir dung d8 dap ting cae yeu cdu ve nhan biét va try xudt ngudn géc sin phdm ‘dug quy dinh trong tiéu chudn nay. TCVN ISO 10008 Quan I ohét lung - Su tha man cia knéch hang — Huéng dén vé giao djch throng mai aién tir gid doanh nghiép va nguéi tiéu ding dua ra hwéng dan vé cach thirc t8 chire ¢6 thé thyc hién mot cach higu lye va higu qua hé théng giao dich thvong mai dién tir gia doanh nghiep va ngudi isu dung (B2C ECT) va do 46 ava ra co 88 cho ngudi tiéu ding e6 ling tin cao hon vao B2C ECT, nang cao kha nang cia t6 chirc TCVN ISO 9001:2015 project or contract, to work methods and practices Benefits of increased that support product realization. establishing a quality plan are confidence that requirements will be met, that processes are in control and the motivation that this can give to those involved. = 180 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 10008 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. = 180 10007 Quelty management systems - Guidelines for configuration management is to organizations applying configuration management for the technical and administrative life cycle of a product. assist direction over the Configuration management can be used to meet the product identification and traceability this requirements specified in International Standard. = 180 10008 Quality management - Customer satisfaction - Guidelines for business-(o-consumer electronic commerce transactions gives guidance on how organizations can implement an effective and efficient business-o-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. 63TCVN ISO 9001:2015 trong vige théa man ngud’ tieu ding va gidp lam gidm khiéu nai va tranh chp. = TCVN ISO 10012 Hé thdng quan iy do luéng ~ Yéu cdu di v6i qué trinh do va thiét bj do dua ra huéng dn d6i voi viée quan ly cdc qua {inh do va xée nhan do Iuéng cia thiét bj do dung 8 hé tre va ching té sy phi hop voi cc yéu cau do lwong. TCVN ISO 10012 dua ra cac chudn myc quan ly chat lugng adi voi he théng quan ly do luéng 48 dm bao céc yeu c&u do Iwong durge dap tng, = TCVNISO/TR 10013 Hung an vé tai liéu he théng quan 17 cht lvong da ra huéng dan 6i voi vide xay dyng va duy tr tai ligu can thiét d6i vOi hé théng quan Iy chat Iuong. TCVN ISO/TR 10013 cé thé due sir dung 48 xy dung tai ligu hé théng quan ly khdc ngoai tigu chudn vé he théng quan ly chét luong, vi dy he théng quan Iy moi treéng va he théng quan Wy an toan = TCVNISO 10014 Quan ly chét lupng— Huong dén dé thu duge céc Igi ich tai chinh va kinh té hung t6i lanh dao cao nhat, Tiéu chudn dua ra huéng dan 48 thc hién cdc toi Ich tai chinh va kinh 16 théng qua viéc ap dung ode Aguyén tc quan ly chat lwong. N6 hé try vie 4p dung céc nguyén tc quan ly va la chon ac phuong phap, cong cu gidp t8 chic thanh ‘e6ng bén viing. = TEVN ISO 10015 Quan Ij cht lngng — Huréng dén dao tao dua ra huéng dan a8 hé tro td chire trong viée gidi quyét cc van 4é lién quan Gén dao tao. TCVN ISO 10015 cé thé Surge ap dung bat ky khi nao cn huéng dan 48 din gidi lién quan dén “giéo duc’ va "a0 = 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. - ISOTR 10013 Guidelines for management system documentation provides guidelines forthe development maintenance of the documentation necessary for a quality management system. ISOITR 10013 can be used to document management quality and systems other than those of the ISO quality standards, e.g. environmental management systems and safety management system, management systems. = 180 10014 Quaiity 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tao” trong cac tidu chuan vé hé théng quan ly chat Ivong. Bat cir khi nao a8 cap aén “dao tao” déu bao gdm tat ca cac logi giao duc va 0 tao. TCVN ISO/TR 10017 Hudng din vé ky thuat théng ké trong TCVN ISO 9001:2000 din gia cdc ky thuat théng ké theo cae bién déng c6 th quan sat duge tir biéu hién va két qué ca cdc qué trinh, k8 c trong cée digu kign én inh 15 rang. Cac kj thuat théng ké cho phép sir dung tét hon df ligu s8n 06 68 hé tro vige ra quyét dinh va do 46 gitip edi tién lien tuc chat lugng cla sin pham va qua trinh 8 dat due sy théa man clia khach hang TCVN ISO 10018 Quan If chdt lwong — Huréng dn vé su tham gia va néng lye cia con ngusi dua ra hwéng dn 48 tao anh hung di voi su tham gia va nang lye oa nhan sy. HE théng quan ly chdt long phy thuée vao sv tham gia ca nhan sy c6 nang lye va cach ho duoc Gua vao va gan két voi t8 chirc, Bidu thiét yéu [a phai xac dinh, xay dyng va danh i kién thite, ky nang, hanh vi va méi truéng lam vige cn thiét. TCVN ISO 10019 Huréng dn lure chon va sir dung dich vu tir vin hé théng quan ly chét lugng dua ra huéng dan aéi voi vic Iva chon tu van hé théng quan ly chat Ivong va sir dung dich vu cla ho. Tiéu chun dua ra huéng d&n vé qua trinh danh gia nang le cha tu van hé théng quan Ij chat lrgng va mang Iai long tin rng nhu cau va mong doi cia td chive di véi dich vy tur van sé dug dap ting. TCVN ISO 19011 Hudng dan danh gid hé théng quan ly dua ra huéng dan vé viée quan ly mét chong trinh danh gid, hoach dinh va TCVN ISO 9001:2015 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. = 180 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. = 180 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 2 quality management system consultant and provides confidence that the organization's needs and expectations for the consultant's services will be met. = 180 19011 Guidelines for auditing management systems provides guidance on the management of an audit programme, on the planning and 65TCVN ISO 9001:2015 66 tién hanh dénh gia hé théng quan ly, eting nhu vé nang lye va danh gia chuyén gia danh gid va doan danh gié. TCVN ISO 19011 duge ap dung cho chuyén gia danh gid, t6 chic 4p dung hé théng quan Iy va t6 chit c6 nhu cdu thyc hin c&c cudc dénh gia he théng quan Ij. 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.Bang B.1 — Méi quan hé gita cdc tiéu chuan khac vé quan ly chat lvong ‘TCVN ISO 90012015 va hé théng quan ly chat Ivgng véi cac diéu cia tiéu chudn nay Tiéu chuan khac Dibu cila tiéu chudn nay 4 5 6 7 8 9 10 rovniso.9000 | Tétcd | Tétea | Tétod | Tétea Tat ca Tovnisosod4 | Tétca | Tétcd | Tatcd | Tat cd Tat ca TCVN ISO 10001 TOWN ISO 10002 10.2.4 TOVN ISO 10003 TOVN ISO 10004 ; 94.3 TCVN ISO 10005 53 | 61,62 | Tatca | Tatca | 94 | 102 TCVN ISO 10008 Tatca | Tatca | Tétcd | Tétcd | Tétea | Tétea | Tétcd [TCVN ISO 10007 85.2 TCVN ISO 10008 Tatea | Tatca | Tétca | Tétcd | Tétea | Tatca | Tétcd TCVN ISO 10012 118 TCVN ISOTR 10013, 18 Tovniso 10014 | Tétcd | Tatcd | Tétca | Tétca | Tétcd | Tétca | Tatcd TCVN ISO 10015 22 TCVNISOITR 10017 et | 748 at TCVN ISO 10018 Tatca | Tétca | Tatcd | Tétcd | Tétcad | Tétoa | Tatcd TCVNISO 10019 84 TCVN ISO 19011 [chun kha. CHU THIGH: TW “tAt ca” thé hign tt c8 cdc didu con eta aidu trong tléu chun nay du lién quan dén teu 67TCVN ISO 9001:2015 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 nae 4 6 6 7 8 8 10 180 9000 al All All Al All All All 1S 9004 All All All All all All All 180 10001 so 10002 40.24 180 10003 180 10004 S 10 10005 83 | 6162] All Al at | 102 180 10006 All All All All all All All 180 10007 852 180 10008 All All All All All All all 180 10012 718 sore 10013 | i 18 10 10014 all All Al All All Al All Iso 10015 12 ISO/TR 10017 et | ms | et Iso 10018 All All All all All All All ISO 10019 84 F 180 19011 92 NOTE “Al” indicates that all the subslauses in the specific clause of this International Standard are related to the other International Standard. 68‘Thu myc tai ligu tham khao [i] TCVN ISO 9004, Quén Ij t6 choc dé thanh céng bén ving — Phuong phdp tigp can quan Iy chdt lung [2] TCVN ISO 10001, Quan Jy chat long - Sw théa man cla khéch hang ~ Huéng dn vé quy pham dao disc [3] TCVN ISO 10002, Quan Ij chét lugng - Sv théa man clla khdch hang — Hudng o&n xt ly khiéu nai bén trong t6 chic [Al TCVN ISO 10003, Quan iy chat luong — Sv théa mén cia khdch hang - Hudng dan gidi quyét tranh chdp bén ngoai #6 chive [5] TCVN ISO 10004, Quén Iy chdt Ivong - Su théa mén cila khdch hang — Huéng dn theo doi va do lueng [6] TOVN ISO 10005, Hé théng quan Iy chét long = Huéng dén vé ké hoach chat Iuong [71 TCVN ISO 10008, H8 théng quén ly chat Iuong, = Huéng dan quan ly chat Ivong dir an [8] TCVN ISO 10007, He théng quan Iy chAt lreng — Hung dan quan ly céu hinh [9] TCVN ISO 10008, Quan Wy chét lrong ~ Su théa mén cia khéch hang — Huréng dn vé giao dich thuong mai dién tir gta doanh nghiép va gue tu ding [10] TCVNN ISO 10012, H¢ thdng quan Iv do luéng = Cc yéu cdu ai v6i qui trinh do va thiét bj do [11] TCVN ISOITR 10013, Huong dn vé tai ligu he théng quan ly chat lugng TCVN ISO 9001:2015 Bibliography [1] ISO 9004, Managing for the sustained success of an organization — A quality management approach [21180 10001, Quality management — Customer satisfaction — Guidelines for codes of conduct for organizations [3] ISO 10002, Quality management — Customer satisfaction — Guidelines for complaints handling in organizations 4) ISO 10003, Quality management Customer satisfaction — Guidelines for dispute resolution extemal to organizations 15] ISO 10004, Quality management — Customer satisfaction — Guidelines for monitoring and ‘measuring {5} ISO 10008, Quality management systems — Guidelines for quality plans [7] ISO 10006, Quality management systems — Guidelines for quality management in projects [8] ISO 10007, Quality management systems — Guidelines for configuration management [9] ISO 10008, Quality management — Customer for business-to- satisfaction — Guidelines consumer electronic commerce transactions [10] ISO 10012, Measurement management systems — Requirements for measurement processes and measuring equipment [if] ISO/TR 10013, Guidelines for quality ‘management system documentation 69TCVN ISO 9001:2015 [12] TCVN ISO 10014, Quan Wy chét luong - Huréng dén thyc hién cdc oi ich tai chinh va kinh 6 [13] TCVN ISO 10015, Quan ly chdt Iugng - Huréng dn dao tao [14] TCVN ISO/TR 10017, Hudng dan vé ky thuét théng ké cho ISO 9001:2000 [15] TCVN ISO 10018, Quén Iy chét Iueng - Huéng dn v8 nang Ive va sy tham gia cila moi nguéi [16] TCVN ISO 10019, Hung dan Ia chon va sir dung tu vn hé théng quén ly chdt long [17] TCVN ISO 14001, Hé théng quan ly moi tradng ~ Cée yéu cau va huéng dn sir dung [18] TCVN ISO 19011, Huéng d&n danh gié he théng quan ly [18] TCVN ISO 31000, Quén Ij rif ro — Nguyén te va huéng adn [20] ISO 37500, Hutng dn thué ngoar [21] TCVN ISONEC $0003, Ky thuat phdn mém— Huéng d&n dp dung TCVN ISO 9001:2008 cho phan mém may tinh [22] IEC 60300-1, Quén ly tinh tin cay - Phan 1: Huong dn quan ly va ép dung [23] IEC 61160, Xem xét thidt ké [24] Cac nguyén t&c quan ly chat lugng, ISO" [25] Lya chon va sir dung b6 tiéu chudn ISO 9000, ISO" [28] ISO 9001 cho doanh nghigp nhé — Nhieng ngi dung cn thy hign, ISO" [12] 180 10014, Quality management Guidelines for realizing financial and economic benefits [13] 180 10015, Guidelines for training Quality management — [14] ISOITR 10017, Guidance on statistical techniques for ISO 9001:2000 [15] Iso - Guidelines competence [18] ISO 10019, Guidelines for the selection of qualit y management system consultants and 10018, Quality management on people involvement and Use of their services [17] 180. 14001, Environmental management systems — Requirements with guidance for use [18] sO 19011, for management systems Guidelines auditing [19] ISO 31000, Risk management — Principles and guidelines [20] ISO 37500, Guidance on outsourcing [21] ISONEC 90003, Software engineering — Guidelines for the application Iso 9001:2008 to computer software of [22] IEC 60300-1, Dependability management — Part 1: Guidance for management and application [23] IEC 61160, Design review [24] Quality management principles, ISO* [25] Selection and use of the ISO 9000 family of standards, ISO" [26] ISO 90001 for Small Businesses — What to do, ISO" * 06 tai trang tin cign tc http wuwiso.org ( Avaliable from website: hit:/Mnniso.ora) 70TEVN ISO 9001:2016 [27] Sir dung tich hop cae tiéu chun v8 hé théng [27] Integrated use of management system quan ly, ISO" standards, ISO" [28] wwwniso.org/tet76/sc02/public [28] wwwiso.ora/tet76/sc02/public [29] wwwiso orgie! 76/ISOS00 tAudtingPracicesGroup [28] wwwviso.on/tct 7/ISO9001 PradicesGrou nVU eer AC CRC om) .uat ban, phat hanh va git ban quyén Tiéu chuan Quéc gia UN Gra Ra Mee aC Maren ee ene Pi eM OR ent re ata ha tay Pee ae) All rights reserved. No part of this publication may be reproduce Cr ce em ae Cl Macey s Lr Mc munecolla ean) Standards and Quality Institut