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