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'ONG - CAC YEU CAU QUALITY MANAGEMENT SYSTEMS — REQUIREMENTS HANOI - 2016TCVN ISO 9001:2015 Myc lye Loi néi au... LOI gi6i thiéu.... 1 Pham vip dung nse Tai ligu vin dan. 2 3. Thuat ngo 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 qué trinh oila hé théng, 5 Sy lanh a0... 5.1 Sy lanh dao va cam ké 5.2 Chinh séch.... 5.3 Vai trd, tréch nhiém va quyan han trong t6 chic 6 Hoach din... 6.1 Hanh dong giai quy&t ri ro va co hii 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 thuc hién .. 8.2 Yéu cau di voi san phdm va dich v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.s:nesnnnnennneeneennnnnns 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 phdm va dich vu dap tng yéu cau cla khach hang, yéu cdu lu8t dinh va ché dinh hign hanh; b) tao thuan Igi cho céc co’ hoi nang cao sty théa man olia khach hang; c) gidi quyét ri ro va co hoi lién quan dén béi cnh va myc tiéu cia 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 nhdt vé cdu tric cla 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 qué trinh cla 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 olia 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 né xuat hign (xem A.4). Vige dap ing mét céch &n 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 nhur thay Jot pha, di méi va tai cdu tric. Trong tiéu chun nay ti: - “phai" chi mot y@u cau; = *caninén’ chi sy khuyén nghi; = “ug phép” ct \ot su cho phép; = “c6 thé® chi khd nang hoe 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 coi 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 théng qua vigc 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 ééuvao Host dong Gee > Nguditiép nhgn dura = aS at ea | vou, xi 1 5 [QUA TRING TRuGc || vir, Ivedy seinisengesp! | ANG WONG, | | nde tuon, | (eshrmiceads! move | income | Sette ta | [ease | ledscacongim | romantics | | Serhan | Keene, | frmneat | [mereen | | | year | \ | | ead aa I pcemerret Sea Hinh 4 - Biéu dién dur6i dang so dé cac yéu t6 cia mét qua trinh Pci te théing quan chat uang (a) Hoch dinh —“" thuchien )) Cnasia () CHU THICH: Cac sé trong ngode don thé hin thé hien s6 diéu cla tiéu chuan Téchicvabsi_f inh cia t6 chic (4) | Yeucéucia khdch hang ben quanta célién quan a Nou cbu ve mong doi el Hinh 2 - Biéu din c4u tric cia tiéu chudn theo chu trinh PDCA 12TCVN ISO 9001:2015 iy S el I | jm | fos tech reer Keeps | seo, | {terotaron, | ' [seein] leer’ | ere | | alla [treme | Seca feces. | | [fare t Jo ie J J el feck te mentor stcnesuepesormne| Figure 1 — Schematic representation of the elements of a single process Quality Management § / ee aioe { Scorer ~ operation ‘aie cuca Rosults of customer ete requirements Products and 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; = Kim tra: theo d6i va (khi ¢6 thé thye hign) 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 thyc 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 lye 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 du nhu tap hgp cc truéng hep cho phép t8 chic thu hit khach hang, phat trién sn phdm, dich vu méi, gidm lang phi ho&c 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 khéng chéc chén va sv khong ch&c chan bat ky d6 déu cé thé c6 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 cép 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 di véi he 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 tir 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 cla Khaeh hang thong qua vige ap dung 6 higu luc 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 cae san pham, dich vu dy kién cung cap cho khach hang ho&e duge khach hang yéu cau. CHU THICH 2: Cac yéu cau luat dinh va ché cinh 06 thé duge thé hign Ia c&c yéu clu phép ly. 2 Tai ligu vign din Tai ligu vign d&n dui day rat cn thiét cho viée p dung tigu chudn nay. Déi 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 cia 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 4.4 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 chic phai x4c inh: a) céc bén quan tam c6 lién quan t6i hé théng quan ly chat lrgng; b) yéu cu ctia cde bén quan tém lién quan t6i hé théng quan ly chat Iugng, 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 Iy 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 chire 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 8 cap 84.2; ©) san phdm va dich vy cia t8 chite. Té chic phai ap dung tét cd céc yeu cau cila 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 chive phai: a) duy tri théng tin dang van ban 8 hé tro vise 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 déi voi 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 tip 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 khéch 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 eau 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 cia 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, t8 chic phai xem xét cac 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 hdi 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 chic 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 h6i 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 thé bao gdm tranh rai ro, chép nhan rui 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 dung CHU THICH 2: Go’ hei 66 thé dn an vige chép nhan thye hanh mdi, tung ra san pham méi, me thi trwéng méi, tiép.cén khéch hang méi, xy dung quan hé déi tac, six dung cong nghé méi va cac kha ning mong muén, Kha thi khéc 48 gidi quyét nhu cdu clia té chire hoac khach hang cila té chive. 6.2 Myc tiéu chat lugng va hogch dinh aé dat duge myc tiéu 6.2.4 T6 chite phai thiét lap cdc myc tiéu chat lugng 6 cdc cép va bd phan chic nang thich hop va cc qué trinh cn thiét di v6i he théng quan ly chat leng. Mue tiéu chat long phait a) nhdt quén véi chinh séch chat wong; b) do aug, ©) tinh a&n cdc yéu c&u duge 4p dung: d) lién 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 uc tiéu chat lwong cila minh, t6 che phai xée inh: a) vige gi s& 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TCVN 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 adi va hé qua tiém 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 741 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 céc 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: Moi 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. 7.4.4 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 9001:2016 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 thisc cla td chic 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 & mc. 6 can thiét. Ki giai quyét nhdng nhu cdu va xu huréng thay 48i, t8 chive phai xem xét tri thirc 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 noi bo (vi dy s& hou tri tue, kién thie the duge tir kinh nghiém; cae bai hoc rit ra tir thét bai va cdc du an thanh cong; ném bat va chia s& kién thire va kinh nghiém bat thanh van; két qua cia vige c@i 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 ring nhiing nguéi nay 66 nang lye trén co s& giéo duc, 40 tao ho&e kinh TCVN ISO 9001:2015 shall take appropriate action as necessary. 74.6 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 vige 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; ) hau qua olla vie khong tuan thi cae yéu 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 tin dang van ban theo yéu cau cia ti chudn nay; « b) théng tin dang van ban dugc té chire x4c Ginh 1a c&n thiét 48 dam bao tinh higu Ive coda hé théng quan ly chat lvong. CHU THICH: Mic 4 théng tin dang van ban a6i vei he théng quan ly chat lueng cé thé khac nhau gitra 8c t8 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 gitra cae qua trinh; = nang Wwe 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 dm bdo sy thich hop cia: a) viée nhan biét va md 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 dig 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 Théng 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 B& 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 céc 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 thyrc 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 yeu cdu cia 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 & mie d6 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 cdc 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 d4i voi san pham va dich vu 8.2.1 Trao déi théng tin véi khach hang Trao dbi théng tin véi khach hang phai bao gdm vige: a) cung cp théng tin lin 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 gm 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