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    Bo Tieu Chuan Iso 22000

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    Kiều Trang

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    TCVN TIEU CHUAN QUOC GIA TCVN ISO 22000:2018 ISO 22000:2018 Xuat ban lan 2 HE THONG QUAN LY AN TOAN THUC PHAM - YEU CAU BOI VOI CAC TO CHIPC TRONG CHUOI THU'C PHAM Food safety management systems - Requirements for any organization in the food chain HA NOI - 2018 TCVN ISO 22000:2018 4.4 Hidu t8 chire va béi cdnh ota tb chive 4.2, Higu nhu cdu va mong doi cita cdc bén quan tam 4.3. Xacdinh pham vi cla hé théng quan ly an toan thy phéi 4.4 He théng quan Iy an toan thyc phdm. 5 Sylanh dao... 5.1. Sy linh dao va'cam két 52 Chinh séch.. 5.2.1. Thiét lap chinh s4ch an toan thyc pham 5.2.2 Truyén dat chinh séch an toan thyc pham 5.3. Vai tro, trach nhiém va quyén han trong t8 chire 6 Hoach dinh. 6.1. Hanh dong giai quyét rii ro va ndm bat co hoi. 6.2 Myc tiéu cia hé théng quan ly an toan thyc phAm va hoach dinh 48 dat dug muc tidu.. 6.3 Hoach dinh cc thay 68) 7.4.4 Yau cdu chung 74.2 Nhan sy... 7A3. Corst’ha tng, 7.1.4 MBi trurémg lam viée , TA.5. Céc yéu té duc phat trién bén ngoai hé théng quan Iy an toan thyc pham. 7.1.6 Kiém soat qué trinh, sin phdm hoc dich vy do bén ngoai cung cép.. 7.2 Nang lye. 7.3. Nh@n thie... 7.4 Trao bi th6ng tn. 7.4.4 Yeu cdu chung... 7.4.2 Trao 48i thong tin voi bén ngoal 7.4.3. Trao adi théng tin n6i bd. 7.5. Thong tin dang vn bar 7.5.1 Yéu cdu chung.. 7.5.2. Tao lap va cap nat. 7.5.3. Kiém soat thong tin dang van ban. ‘TCVN ISO 22000:2018 8 Thyc hign, 8.1 Hoach dinh va kiém soat vig thy hig 8.2. Churong trinh tién quyét (PRP). 8.3 H6 théng truy xudt ngudn gd. 8.4 Chuan bj sn sang va teng phé cdc tinh huéng kin cp. 8.4.1 Yéu cdu chung 8.4.2. Xirly cdc tinh huéng khan cdp va sy 06. 8.5 Kiém soat méi nguy. 8.5.1 Cc bude ban dau dé phan tich méi nguy. 8.5.2 Phan tich mdi nguy... 8.5.3 Xéc nhén higu lye cdc bién phap kidm sodt va phdi hop cdc bign phap kibm sodt, 8.5.4 Ké hogch kim sodt méi nguy (ké hoach HACCP/OPRP) 8.6 Cp nhat théng tin xéc dinh c&c PRP va ké hoach kim soat méi nguy 8.7 Kiém soat vige gldm sat va do lueng.. 8.8 Tham tra lién quan dén cdc PRP va ké hoach kiém soat méi nguy... 8.8.1 Tham tra.. 8.8.2 Phan tich két qua clia hogt dong tham tra... 8.9 Kiém soat sy khdng phi hgp cla san phdm va qué trinh 8.9.1 Yéu cdu chung 8.9.2 Sy khac phy 8.9.3 Hanh dng khdc phuc... 8.9.4 Xi ly céc san phdm khdng an toan tidm &n.. 8.9.5 Thu hdiltrigu hoi 9 anh gid két qua thyc hién 9.1 Giém sat, do lwéng, phan tich va éanh gid 9.4.4 Yéu cdu chung 9.4.2. Phéin ich va dénh gia. 9.2. Banh gid ngi bO.. 9.3. Xem xét ada Kinh dao. 9.3.1. Yeu cdu chung 9.3.2 Bau vao xem xét cila lan ago, 9.3.3 Dau ra xem xét cla lanh dao. 10 caitié 10.1 Sy khéng phu hgp va hanh d6ng khéc phyc 10.2 Cai tién lién tye, 10.3. C§p nhat hé thdng quan ly an toan thye pham .... Phy Ive A (Tham khdo) So sanh gia HACCP ca CODEX va tiéu chudn na Phy lye B (Tham khdo) So sénh gitra tiéu chuan nay va phién bin TCVN ISO 22000:2007 Thur mye tai ligu tham khdo. TCVN ISO 22000:2018 Contents 0 Introduction. 1 Scope ... 2 Normative reference: 3. Terms and definition: 4 Context of the organization .. 4.1 Understanding the organization and its context 4.2 Understanding the needs and expectations of interested partios 4.3 Determining the soope of the food sefety management system 4.4 Food safety management system.. 5 Leadership. 5.1. Leadership and commitment. 52 Policy. 5.2.1. Establishing the food safety policy 5.2.2 Communicating the food safety policy. 5.3 Organizational roles, responsibilities and authorities 6 Planning... 6.1 Actions to address risks and opportunities. 6.2 Objectives of the food safely management system and planning to achieve them, 63. Planning of changes. 7.4.3. Infrastructure... 7.4.4. Work environme 7.45 Externally developed elements of the food safety management system 7.4.8 Control of externally provided processes, products or services. 72. Competence. 73 Awareness. 7.4 Communication TAA General... 7.4.2 External communication. 7.4.3, Internal communicatior 7.5 Documented information. 7.5.1, General... 7.82. Creating and updating 7.5.3. Control of documented information a ‘TCVN ISO 220002018 8 Operation os 8.1 Operational planning and control 82 Prerequisite programmes (PRPs) 83 Traceability system... 84 Emergency preparedness and response, 8.4.1 General. 8.4.2. Handling of emergencies and incidents. 85 Hazard control . 8.5.1 Preliminary steps to enable hazard analysi 8.5.2 Hazard analysis. 8.5.3. Validation of control measure(s) and combinations of control measures 8.5.4 Hazard control plan (HACCP/OPRP plan).. 8.6 Updating the information specifying the PRPs and the hazard control pla 8.7 Control of monitoring and measuring 8.8 Verification related to PRPs and the hazard control pat 8.8.1 Verification. 8.8.2 Analysis of results of verification activities 8.9 Control of product and process nonconformities 8.8.4 Handling of potentially unsafe products. 8.9.5 Withdrawallrecall 9 Performance evaluator 9.1 Monitoring, measurement, analysis and evaluatio 9.1.1, General 9.1.2. Analysis and evaluation 9.2 Internal audit 9.3. Management revi 9.3.1 General... 9.3.2 Management review input 9.3.3. Management review output 10 Improvement. 10.1 Nonconformity and corrective action 10.2 Continual improvement 10.3 Update of the food safety management system... ‘Annex A (informative) Cross references between the CODEX HACCP and this document. ‘Annex B (informative) Cross references between this document and ISO 22000:2005. Bibliography TCVN ISO 22000:2018 Loi néi dau ‘TCYN ISO 22000:2018 thay thé TCVN ISO 22000:2007; TCVN ISO 22000:2018 hoan toan trong dvong voi ISO 22000:2018; TCVN ISO 22000:2018 do Ban ky thuat tigu chudn quée gia TCVNITCIF3 Nguyén téc chung vé vé sinh the phdm bién soan, Tdng cye Tiéu chudn Do ludng Chat lugng thadm dinh, BO Khoa hoc va COng nghé cing bd. TCVN ISO 22000:2018 0 Loi gidi igu 0.4 Yéucdu chung Vigc 4p dung hé théng quan ly an toan thye phdm (HTQL ATTP) la mét quyt dinh chién luge 446i voi mét 18 chute nham cai tién toan bo két qua thyc hign cia t8 chirc v8 an toan thyc pha, Nhteng (gi Ich tiém ning d6i vei 8 chic thyre hign HTQL ATTP theo tiéu chudn nay la: a) cé kha nding cung cp én dinh thyc phdm an foan va cdc san phdm, dich vy cé lin quan d4p mg yéu cu cla khdch hang, yéu cau luat djnh va ché dinh hign hanh; b) gidi quy&t éuge cae rili ro lién quan 64n myc tidu cla t8 chiro; ©) 66 kh nang ching minh sy phi hop v6i cde yéu cdu cia HTQL ATTP cy thé, Tiéu chun nay van dyng cach tiép cén theo qua {rinh (xem 0.3), két hp chat ché chu trinh Hoach inh - Thyc hign - Kiém tra - Hanh dng (PDCA) (xem 0.3.2) voi tr duy da trén rbi ro (xem 0:3.3). Céch tiép can theo qué trinh nay gidp t& chit hogch dinh céc qué trinh cua 1 chac va su tuong téc cba cdc qua trinh 46. Chu trinh PDCA gitip td chirc dm bao ring céc qua trinh cia t8 chire duge cung cdp ngudn Ive va dug quan ly mét c&ch thda dang, céc co hol ai tién duge xéc dinh va thyc hign, ‘Tu duy dya trén rui ro glip t8 chirc xéc dinh cdc yéu t6 06 thé lam cho cée qué tinh va HTQL ATTP cla td chirc chéch khdi két qua durgc hoach dinh, dua ra cdc bién phdp kim sot 68 ngan gira hod giém thidu nhting téc dng bat Ini. 0 Introduction 0.4 General The adoption of a food safety management system (FSMS) is. a strategic decision for an ‘organization that can help to improve its overall performance in food safety. The potential benefits to an organization of implementing a FSMS based on this document are: a) the ability to consistently provide safe foods and products and services that meet customer and applicable statutory and regulatory requirements; b) addressing risks associated with its objectives; ¢)the ability to demonstrate conformity to specified FSMS requirements. ‘This document employs the process. approach {see 0.3), which incorporates the Plan-Do- Check-Act (PDCA) cycle (see 0.3.2) and risk- based thinking (see 0.3.3). This process approach enables an organization to plan its processes and thelr interactions. ‘The POCA cycle enables an organization to ensure that its processes are adequately fesourced and managed, and that opportunities forimprovement are determined and acted on. Risk-based thinking enables an organization to determine the factors that could cause its processes and its FSMS to deviate from the planned results, and to put in place controls to prevent or minimize adverse effects. Trong tisu chudn nay, céc tu sau day duge sir dung: “phai" chi mét yu edu; ~ "can" chi sy khuyn nghi, = ‘cb thé” chi sy cho phép, kha nding hoe nang lye. "CHU THICH" nhim hung din a8 hidu hoc lam 16 cdc yeu cu néu trong ti6u chudn nay. 0.2 Nguyén the cia HTQL ATTP An toan thyre pham ign quan dén sy 6 mat ola cae méi nguy vd an toan thyc pham tai thoi éim titu thy (legng &n vao cla ngudi tigu ding). Céc méi nguy v8 an toan thye phdm 06 thd xy ra & moi gial doan trong chudl thyc pham. Do dé, viéc kiém soat day di trong suét chudi thye pham [a cn thi6t. An toan thyo phim éuge dam béo thong qua nd lye két hop cba tét cd céc bén trong chudi thy pham. Tiéu chuan nay quy dinh cdc yéu cu déi voi HTQL ATTP két hop cdc yéu t6 co ban 4 duge ofng nhgn nhy sau: — trao dBi thong tin ln nhau; = quan ly hg théng; — cdc chuong trinh tién quyét; — cc nguyén téc phan tich méi nguy va c&c idm kiém soat toi hen (HACCP). Nagoat ra, tisu chudn nay.dya trén cée nguyén tic thong dung d6i v6i c&c tiéu chun hé théng quan ly ISO. Céc nguyén t&c quan ly 1a: = hung vao ktidch hang; — sy lanh digo; = sy tham gia oa moi ngudi; TCVN ISO 22000:2018 In this document, the following verbal forms are ~ "shall" indicates a requirement; —"should” indicates a recommendation; may’ indicates a permission; — “can” indicates a possibilty or a capability. "NOTES" provide guidance in understanding or Clarifying the requirements in this document. 0.2 FSMS principles Food safety is related to the presence of food safety hazards at the time of consumption (intake by the consumer). Food safety hazards can ‘occur at any stage of the food chain. Therefore, adequate control throughout the food chain is essential. Food safely is ensured through the combined efforts of all the parties in the food chain. This document specifies the requirements for a FSMS that combines the following generally recognized key elements: — Interactive communication; ~ system management; — prerequisite programmes; hazard analysis and cttical control point (HACCP) principles. tn addition, this document js based on the principles that are common to [SO management system standards. The management principles are: — customer focus; leadership; ~ engagement of people; TCVN ISO 22000:2018 ~ tiép c€n theo qué trinh; = Al tién; = quyét dinh dya trén bang chieng; quan ty méi quan ha. 0.3. Tiép c4n theo qué trinh 0.3.1 Yéu cdu chung Tidu chudn nay siv dung céch tiép can theo qua (tinh khi xay dyng, ap dung HTQL ATTP va khi ci tién higu Ic cila hé thong nay 48 tang cong ‘sdn xudt céc sn phdm va dich.vy an toan ding thoi dap tng durgc céc yéu cau hign hanh. Vie hidu va quan ly cc qua trinh ¢6 twong quan nh 1a mot hé théng 88 gép phan vao higu lye va higu qua aia 8 chic nhdim dat Suge céc két qua dy kién, Cach tiép cn theo qua trinh bao gdm vite x4e dinh mot cach h@ théng va quan Iy céc qua trinh va cdc tuong tac ctia ching, 48 dat duge két qud mong mudh phi hop véi chinh sach an toan thye phdm va dinh huéng chién luge cia td hire. Vide quan If c&c qué trinh va toan b6 he | théng c6 thé dat duge bang cach sir dung chu trinh PDCA huéng toan bd vao tw duy dyea trén rai ro 48 ndm bat co hoi va ngan ngira céc két qua khéng mong muén. ‘Vide céng nhén val trd va vj trl cia td chirc trong chudi thyc phdm la didu cn thiét 48 dm bao trao 681 théng tin c6 higu iyc trong suét chubi thye pha, 0.3.2 Chu trinh Hogch djnh - Thye hign - Kiém tra - Hanh dng Chu trinh PDCA cé thé duge mé ta tém tt nhy sau: — process approach; — improvement; — evidence-based decision making; ~ relationship management. 0.3. Process approach 0.3.1 General This document adopts a process approach when developing and implementing a FSMS and improving its effectiveness to enhance production of safe products and services while meeting applicable requirements. Understanding and managing interrelated processes as a system contributes to the organization's effectiveness and. efficiency in achieving its intended resuts. 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 food safety policy and. strategic direction of the organization. Management of the processes and the system as ‘a whole can be achieved using the PDCA cycle, with an overall focus on risk-based thinking aimed at taking advantage of opportunities and preventing undesirable results. The recognition of the organization's role and Position within the food chain is essential to ensure effective interactive communication ‘throughout the food chain. 0.3.2 Plan-Do-Check-Act cycle ‘The PDCA cycle can be described briefly as follows: Hoach dinh: thiét fap cdc myc tiéu cla hé théng va cdc qué trinh cla hé théng, cung cdp cdc ngudn lye can thiét 68 dat duoc két qua, xac dinh va gial quyét rui ro, ndm bat co hoi; Thye hign: thyc hign nhieng gl d& hoach dinh; Kiém tra: giém sat va do (& nhting noi c6 lién quan) cdc qua trinh va céc san pham, dich vy duge tao ra, phan tich va danh gia thong tin va do ligu tir cc hoat dong glam sat, do luéng va thdm tra, béo cdo két qua; Ci tién: thyc hign cdc hanh dong 48 cai tién két qua thyc hign, néu can. ‘TCVN ISO 22000:2018 Plan: establish the objectives of the system and its processes, provide the resources needed to deliver the results, and identify and address risks and opportunities; Do: — implement what was planned; Check:monitor and (Where relevant) measure processes and the resulting products and services, analyse and evaluate information and data from monitoring, measuring and verification activities, and report the results; Act: take actions to improve performance, as necessary. Hogeh dinh va kidm sodt td chire 1 ig yl on - calf] mA nguy hap ln dng wang phd ain ag kde cd it nea ; NH Cai tah thie phan): (COp ett tng tr ban dls vi edt itu quy doh PRP, 1 hogeh hike sat m4 mg Xiao nhbn TET ca hoech kidm soa PA] Phanteh [il rituivecis [Etat may cd each Hinh 4 — Minh hoa chu trinh Hoach dinh - Thye hign - Kiém tra - Hanh dong & hai cdp 4 4 ‘TCVN ISO 22000:2018 Organizational planning and control “Traceability system a aes. Hazard P| analysis llaning and control Hazard contro plan {qeaccr,oPRe pian esa #1 validation oF control "| measures veritication| planning Emergency preparedness & response 2a, a - Updating of preliminary information and H} documents specilying the H] PRPs and the havard contsol plan Verification activities ~ Analysis of results of verification activities: ‘Controd af reduc aud xs nonconfarmites Figure 4 ~ Illustration of the Plan-Do-Check-Act cycle at the two levels Trong tiéu chuan nay va nhu due minh hoa trong Hinh 1, cach tiép cn theo qué trinh sir yng khai nigm chu trinh PDCA & hai cdp 49. Cép 4 thir nhét bao gdm khung chung cia HTQL ATTP (Didu 4 dén Bidu 7 va Didu 9 dén Didu 10). C4p 66 the hai (hogch dinh va kim oat hoat dng) bao gém cc qua trinh hoat dong trong h@ thdng an toan thyc phdm néu trong Didu 8. Vigc trao ddi théng tin gidra hai cép 46 1a rt cAn thidt. 12 In this document, and as illustrated in Figure 4, the process approach uses the concept of the POCA cycle at two levels. The first covers the overall frame of the FSMS (Ciause4 to Clause 7 and Cause 9 to Clause 10). The other level (operational planning and control) covers the operational processes within the food safety system as described in Clause 8. Communication between the two levels is therefore essential. 0.3.3. Tu duy dya trén riiro 0.3.3.4 Yéu cdu chung Tu duy dya trén ri ro lA didu can thidt 48 dat duge HTQL ATTP 6 higu Ive. Trong tiéu chuadn nay, tu duy dya tran rii ro dug gidi quyét trén hai cp 66 [a t8 chire (xem 0.3.3.2) va hoat dong (xem 0.3.3.3), phi hgp voi cach tiép c&n theo qua trinh dug néu trong 0.3.2. 0.3.3.2 Quan ro cia 8 chite Rili ro la téc dong ola sy khéng chéc chén va moi sy khong chdc chén nhu vay 06 thé cé tac dng tich eye hoc tiéu cy. Trong béi cdnh quan ly rai ro cia t8 chic, sy chéch hudng tich oye nay sinh tly ri ro 06 thé mang Iai co hdi, nhung khéng phai moi téc dng tich eye cita rit ro dbu mang lai cor héi. 8 phu hop voi yéu cau cla tiéu chudn nay, tb chiro c&n hoach dinh va thye hign cae hanh dng nham giai quyét ri ro (Biéu 6). Vide giai quyét rit to la co s& a8 nang cao higu lye cla HTQL ATTP, dat duge két qua c6 cai tién va ngan gira nhOng tac dong tidu cyc. 0.3.3.3 Phfn tich méi nguy - Céc qué trinh hoat déng Khai niém tu duy dya tran ri ro cé nén tang [a cdc nguyén thc HACCP & cép a0 hoat déng éugc ngdm hiéu trong tiéu chudn nay. Cc burés tiép theo trong HACCP cé thé duge col 1a cdc bign phép can thiét 68 ng&in ngiva ho&c glam cée méi nguy dén mic chép nhan due nam dm bao thyre phém an toan khi tiéu thy (Didu 8). Cac quyét dinh dug dua ra khi 4p dung HACCP phai dyea trén oo si khoa hoo, khong sai Iéch va duoc lap thanh van ban. Van ban nay cdn bao gdm mai giai php gid dinh trong qué trinh ra quyét dinh. ‘TCVN ISO 22000:2018 0.3.3 Risk-based thinking 0.3.3.1 General Risk-based thinking is essential for achieving an effective FSMS. In this document, risk-based thinking is addressed on two levels, organizational (s90 0.3.3.2) and operational (see 0.3.3.3), which is consistent with the process approach described in032. 0.3.3.2 Organizational risk management Risk is the effect of uncertainty, and any such uncertainty can have positive or negative effects. In the context of organizational risk management, @ positive deviation arising from a tisk can provide an opportunity, but not all positive effects of risk resutt in opportuni ‘To conform to the requirements of this document, an organization plans end implements actions to address organizational risks (Clause 6). Addressing tisks establishes a basis for increasing the effectiveness of the FSMS, achieving: improved results and preventing negative effacts. 03.3.3 Hazard analysis — Operational processes The concept of risk-based thinking based on the HACCP principles at the operational level is implicit in this document, The subsequent steps in HACCP can be considered 4s the necessary measures to prevent hazards or reduce hazards to acceptable levels to ensure food is safe atthe time of consumption (Clause 8). Decisions taken in the application of HACCP should be based on science, free from bias and documented, The documentation should include any key assumptions in the decision-making process. 13 ‘TCVN ISO 22000:2018 0.4. M6i quan hé voi cac tiéu chuan hé théng quan ly khéc Tiéu chun nay duc xay dyng theo cau tric cép cao (HLS) cia ISO. Myc tiéu olla HLS 1a cai tién m6 tién két gitra céc tiéu chudn hg théng quan Iy ISO. Tidu chudn nay cho phép tb chée sik dung phuong php tiép cn theo qué trinh, cling voi chu trinh PDCA va tu duy dya trén rui ro d& sp xép hod tich hop cach tiép c§n HTQL ATP voi cc yeu cau cia cdc he théng quan ly khéo va cdc tidu chudn hé tr. Tiéu chudn nay la nguyén tac cdt Idi va khudn khd, cho céc HTQL ATTP va dua ra cdc yéu cau HTQL ATTP cy thé cho cdc té chire trong sudt chudi thyc: pham. Cac huéng dan khéc lién quan één an toan thy phim, c&c quy din kj thuat varhoac yéu cau cy thé d6i véi cdc Tinh ec thyc pham cd thd duc sir dyng cing voi khubn khd nay. Ngoai ra, b@ tai ligu lién quan dén tiéu chudn nay bao gdm: - ca chuong trinh tién quyét (nhém TCVN ISO/TS 22002) cho cae Inh vye cy thd cla chudi thyc phdm; — yeu cdu déi vél t8 chic aanh gid va ching han; — truy xudt ngudn géc. Bén canh 48, o8n cb cae huéng dn cho céc td ‘chive c&ch 4p dung tiéu chudn nay va cdc tiéu chudn lién quan, 04 Relationship with other management ‘system standards This document has been developed within the 1SO high level structure (HLS). The objective of the HLS is to improve alignment between ISO management system standards. This document enables an organization to use the process approach, coupled with the POCA cycle and risk based thinking, to align or integrate its FSMS approach with the requirements of other management systems and supporting standards. This document is the core principle and framework for FSMSs and sets out the specific FSMS requirements for organizations throughout the food chain. Other guidance related to food safety, specifications andior requirements specific to food sectors can be used together with this framework. In addition, ISO has developed a family of associated documents. These include documents for: = prerequisite programmes (ISO/TS 22002 series) for specific sectors of the food chain; = requirements for auditing and cetification bodies; = traceability. ISO also provides guidance documents for ‘organizations on how to implement this document and related standards. TIEU CHUAN QUOC GIA * NATIONAL STANDARD TCVN ISO 22000:2018 Hé théng quan ly an toan thc pham — Yéu cau déi voi cdc té chive trong chudi thie pham Food safety management systems — Requirements for any organization in the food chain 1 Pham vi 4p dung Tiéu chun nay quy dinh cac ydu cu adi vii he théng quan ly an toan thye pham (HTQL ATTP) cho td chive tnye tiép hoac gian tiép hoat déng trong chudi thyc phdm: a) dé hoach dinh, 4p dyng, thyc hign, duy tri va cap nhat HTQL ATTP nhdm cung cép céc san phdm va dich vy an toan theo myc dich sir dung dy kién ca san phdm; b) 48 ching minh sy pha hep voi céc yeu cdu an toan thy phdm theo luat dinh va ché dinh hign han; ©) 48 woe lugng va Génh gié ode yeu cau v8 an toan the phdm a théa thuan vol khdch hang va ching minh sy phil hyp véi cdc yu clu a6; d) 8 truy8n dat 06 hiu Ive cdc vin dé vé an toan thye phdm véi céc bén quan tam trong chuéi thye phdm; 4 Scope This document specifies requirements for a food safety management system (FSMS) to enable an organization that is directly or indirectly involved in the food chain: ) to plan, implement, operate, maintain and update a FSMS providing products and services that are safe, in accordance with their intended use; b) to demonstrate compliance with applicable statutory and regulatory food safety requirements; ©) to evaluate and assess mutually agreed customer food safety requirements and to demonstrate conformity with them; ) to effectively communicate food safety issues to interested parties within the food chain; ‘TCVN ISO 22000:2018 8) 48 dam bao rang té chirc tuan thi chinh sach vé an toan thyrc pham ma ho céng bd; f) 48 chéng minh sy phi hop nay voi cdc bén quan tam 6 lign quan; g) 48 8 nghj t3 chtre bén ngoai chémg nhan HTQL ATTP hode thyc hin vigc ty dénh gié hay tyr céng bé sy phd hep voi tléu chudn nay. Tt cd cdc yeu cu ata tiéu chudn nay 1a yéu cdu chung va nhdm 4p dung cho tét cd cdc td chire trong chudi thye phdm, khéng phan biét quy mo ‘va mite 69 phic tap iia 18 chite. Trong dé bao gdm cc t8 chirc lién quan tryc tiép ho&e gién tiép: nha sn xuét thre &n chan nudi, ngudi thu hoach cdc dgng vat va thy vat hoang da, néng dan, nha san xudt cc thanh phan nguyén liu, ‘nha san xuét thyc phdm, nha ban 18, c4c t8 chive: cung cdp dich vy thye pham, dich vy lam sach va ¥@ sinh, dich vy van chuyén, bdo quan va phan phéi, nha cung cp thidt bj, chat lam sach, chat Khir tring, vat ligu bao géi va céc vat ligu khac tiép xtic v6i thye phim. Tiéu chudn nay cho phép mol td chire, gbm céc 18 chirc nhé varhode kém phat tridn (vi dy: trang trai nhé, co sé déng g6i-phan phdi nha, ngudi ban I8 ho&e dai ly dich vy thye phdm quy md nhé) 4p dung céc bién phdp kim soat tir ban ngoai trong HTQL ATTP ola ho. C6 thé sir dyng cac ngudn lye ndi bd valhodic b&n ngoai 48 dap ng oc yéu cdu cila tiéu chudn nay. 2. Tai ligu vign din rong du chudn nay Khéng ob ca tl gu vign dn. 6 ) to ensure that the organization conforms to its stated food safety policy; f) to demonstrate conformity to relevant interested parties; 9) to seek certification or registration of its FSMS by an external organization, or make a selfassessment or self-declaration of conformity to this document, ‘All requirements of this document are generic and are intended to be applicable to all organizations In the’ food chain, regardiess of size and complexity, Organizations that are directly or indirectly involved include, but are not limited to, feed producers, animal food producers, harvesters of wid plants and animals, farmers, producers of ingredients, food manufacturers, retailers, and organizations providing food services, catering services, cleaning and sanitalion services, transportation, storage and distribution services, suppliers of equipment, cleaning and disinfectants, packaging materials and other food contact materials. ‘This document allows any organization, Including smail and/or less developed orgenizations (6.9.2 ‘small farm, a small packer-distributor, @ small retail or food service outlet) to. implement externally- developed elements in thelr FMS. intemal and/or external resources can be used to meet the requirements of this document. 2 Normative references ‘There are no normative references in this document. 3. Thuat ngée va dinh nghia Tiéu chudn nay ap dung cac thuat ngi va dinh nghia sau day: 34 Miec chdp nhgn duge Mic clia méi nguy vé an toan the phdm (3.22) khong bi vugt qua trong san phdm oudi cling (8.15) do #8 chic (3.31) cung cp 32 Tiéu chi hanh dng Céc quy dinh kf thuat o6 thé do dure hoae 06 thd quan sat due 68 giém sat (3.27) OPRP (3.30) CHU THICH: Mot tiéu chi hanh d6ng dire thidt lap 68 xée dinh litu mot OPRP cd cin kiém soat duge hay khéng va phn biét gia nhOng gl cd thé chdp nhén dugc (8p tng hoae dat duge tidu chi cb nghte 1a OPRP hogt dong nhu dy inh) va khong thé chép han dirge (khong dap dng hod dat duge tibu chi cb nghta la OPRP khing hoat dong nhu dy dinh). 33 Banh gid Qué trinh (3.36) c6 hg théng, dc lap va duge lap thanh vn ban 68 thu duge bing ching dénh gid va 68 xem x6t dénh gia khach quan nhdm xc Ginh mete 46 thy hign cde chudn myc dénh gié CHO THICH 1; Mét cude danh gid od thé la dénh gid 1ngi bO (b8n thér nhét) hoe Banh gié bén ngodl (ben thi hal hod bén thir ba) va cb thé la dainh gid ket hop (k6t hop hat hod nhidu tah vyc). CHU THICH 2: Banh gid ndi b§ do chinh’t8 chirc a6 thyc hign hoa do don vj danh gié bén ngoal thyc hign, CHU THICH 3: "Bing chteng danh gia va "chun myc dénh gia” duye dinh nghia trong TCVN ISO 19011. CHU THICH 4: Vi dy va cde mn vz lidn quan la quan ly an toan thye phdm, quan ly chat lugng ho&c quan Wy m6i trurdmg. TCVN ISO 22000:2018 3. Terms and definitions For the purposes of this document, the following terms and definitions apply. 34 acceptable level level of a food safety hazard (3.22) not to be exceeded in the end product (3.15) provided by the organization (3.31) 32 action criterion measurable or observable specification for the ‘monitoring (3.27) of an OPRP (3.30) Note 4 to entry: An action ailerion is established to determine whether an OPRP remains in contol, and distinguishes between what fs acceptable (criterion met or achieved means the OPRP is operating as intended) and unacceptable (criterion not met nor achieved means the OPRP is not operating as intended). a3 audit systematic, independent and documented process (3.36) for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are futilled Note 4 to entry: An audit can be ain intemal audit (frst party) or an extemal audit (second party or third party), and it can be a combined audit (combining two ‘or more disciplines). Note 2 to eniry: An internal audit Is conducted by the ‘organization itself, or by an extemal party on its behat Note 3 to entry: “Audit evidence” and “audit criteria” are defined in ISO 19011. Note 4 to enty: Relevant disciplines are, for example, food safety management, quality management or environmental management. TCVN ISO 22000:2018 34 Nang lye Kha n&ing ap dung kién thre va kj nang dé dat duoc két qua dy kién Sy pha hop Vigc dap ting mét yéu céu (3.38) 36 ‘Sy 6nhiém Vigc dura vao hoge sy xudt hign chét 6 nhiém bao gém mdi nguy vé an toan thye pham (3.22) trong san phdm (3.97) hoc mél trréng ché bién ar Cai tién fién tye Hoat dng lp Iai d8 nang cao Két qué thc Algn (3.33) 38 Bign phap kiém soat Hanh déng hoc hogt dong can thiét 68 ngan ngira mdi nguy vé an toan thy phdm (3.22) dang kB hod gidm thidu né én mde chdp nhén durge (3.1). CHU THICH 4; Xem thém dinh nghta vé mdi nguy dang ké vé an toan thyc phdm (3.40). CHU THICH 2: Cac bign phap kim soat duge xdc inh bang phan tich méi nguy. 39 ‘Sy khdc phyc Hanh dong nham fogi bd sy khéng phi hop (3.28) duge phat hign, CHU THICH 1; Vige khde phyc bao gdm xir ly cdc san phdm khong an toan tiém dn va do 4 cb thd durge thyc hin cing véi hanh dng khéo phy (3.10). CHU THICH 2: VI dy v8 vige knde phy c6 thé la: ta cché, ché bién thém va/hodc loal fr hau qua bat loi ceba sy khong phil hgp (nhu ding cho myc dich six ‘dyng khdc hode dan nhéin ring). 18 34 competence ability to apply knowledge and skills to achieve intended results 35 conformity {fulfilment of a requirement (3.38) 36 contamination introduction or occurrence of a contaminant including @ food safety hazard (3.22) in a product (8.37) or processing environment 37 continual Improvement recurring activity to enhance performance (3.33) 38 control measure action or activity that is essential to prevent a significant food safety hazard (3.22) or réduce it to an acceptable level (3.1) Note 1 fo enty: See also significant food safety hazard (3.40). Note 2 to entry: Control measure(s) is (are) identified by hazard analysis. 39 correction : action to eliminate a detected nonconformity (3.28) Note 1 to enty: A comecton Includes the handling of potentially unsafe products and can therefore be ‘made In conjunction with a corrective action (3.10). Note 2 to entry: A correction may be, for example, reprocessing, further processing andlor elimination of the adverse consequences of the nonconformity (Guch as disposal for other use or specific labeling). 3.10 Hanh dgng khdc phyc Hanh 66ng nh&m loal bo nguyén nhan ola sy kh6ng phi hop (3.28) va nhdm ngan ngvva tai dién. CHU THICH 1: Sy khéng phd hop cé thé do mot hoc nhibu nguyén nhan. CHU THICH 2: Hanh @$ng khdc phyc beo gdm ca \Viée phan tich nguyén nhan. 344 Diém kiém soat toi han cop Bute trong qué trinh (3.36) tai d6 ap dung cde bién phép kidm soat (3.8) 48 ngan ngira ho&c giam méi nguy dang ké vé an toan thye phdm (340) dén mifc. chp nhan dugc va xdc dinh duge gidi han t61 han (3.12), viéc do luéng (3.26) 06 thé dn dén &p dyng sy khée phyc (3.9). 3.42 Gidi han toi hen Gia tr| c6 thé do Iudng dug, phan biét gitra sy 06 thé va khéng thé chdp nhan duge. CHU THICH 1: Gidi han 161 han dung thiét lap a8 xc. inh xem CCP (3.11) cdn kiém soat dug hay khéng. Néu ‘yugt qua hae vi pham gisi han 6% han thi sén phd chi te dng dure coi a tém dn sy khdng an ton. INGUON: TCVN 5603 (CAC/RCP 1-1969), c6 stra abi — Binh nghfa da due sta va bd sung CHU THICH 1) 3.43 ‘Théng tin'dang van ban Théng tin cn due t6 chive (3.31) kidm soét, duy trl va phuong tién chira théng tin 46. CHU THICH 1: Théng tin dang van ban c6 thé & moi inh dang, méi truéng va tir bat ky ngudn nao. CHU THICH 2: Thong fin dang van ban 06 thé 68 c&p aén; TCVN ISO 22000:2018 3.40 corrective action action to eliminate the cause of a nonconformity (3.28) and to prevent recurrence Note 1 to entry: There can be more than one cause for a nonconformity. Note 2 to entry: Comective action includes cause analysis. 3M critical control point cop step in the process (3.36) at which controt measure(s) (3.8) is (are) applied to prevent or reduce a significant food safety hazard (3.40) to an acceptable level, and defined critical limit(s) (3.12) and measurement (3.26) enable the application of corrections (3.9) 3.2 critical limit measurable value which separates acceptability from unacceptabilty Note 1 fo entry: Critical limits are established to determine whether a CCP (3.11) remains in control fa catical iit is exceeded or not met, the products affected ‘are tobe handled as potentially unsafe products. ISOURCE: CACIRCP 1-1969, modified - The defnition has been modified and Note 1 to entry has been added.) 343 documented information information required to be controlled and maintained by an organization (3.31) and the medium on which itis contained Note 1 to entry: Documented information can be in any format and media, and from any source. Note 2 to entry: Documented information can refer to: ‘TCVN ISO 22000:2018 ~ h8 théng quan ly (3.25), gdm e8 c&c qué trinh (3.36) lién quan; = thong tin duge tao ra phye vy hoat dong clia chive (hé thdng ts gu); bang ching v8 két qua dat duoc (hd so). 344 Higu lye Mire 4 ma cdc hoat dng 68 hoach dinh duge thyc hién va dat duge cAc két qua 48 hogch dinh 348 San phdm cudi Sdn phdm (3.37) ma 16 chive (3.31) khdng phai ché bin thém hogc chuyén d8i gi them. CHO THICH 4: San phém duge 18 chic Khéc ché bién them hoc chuyén Bl thém la san phim cubi dé} voi 18 chire tha nhdt va [a nguyén figu thé hoge Ia thanh phan 061 voi t3 chére thir hai. 3.46 ‘Thige an cho vat nudi ding lam thyc pham ‘San phdm mdt thanh phan hoc nhidu thanh phan, da qua ché bidn, so ché hodc I nguyén ligu thé, duge dling lam thie &n cho vat nudi san xudt thyre pham CHU THICH 1: Titu chudn nay phan bigt céc thuat git thye phdm (3.18), the &n cho vat nubi ding fam thyc phdm (3.18) va thize 8n cho vat nudi khdng ding (am thye phd (3.18): — thye phdmithac &n ding cho ngudi va dng vat, bao gm of thie &n cho vat nudi ding tam thyc phém va thre &n cho vat nudi dung khdng lam thye phdm; = thie &n cho vat nudi ding lam thye phdm: ding cho dong vat sn xudt thyre pam; — thie &n cho vat nudi ding khéng fam thyc phdm, nnhu dng vat ednh, INGUON: CACIGL 81-2013, cb sira'adi — di to “nguyén ligu" thanh *sén phdm” va x6a tr “tye tiép*] 20 = the management system (3.25), inoluding related processes (3.36); — information created in order for the organization to. ‘operate {documentation}; — evidence of results achieved (records). 3.44 effectiveness extent to which planned activities are realized and planned results achieved 3.15 end product product (3:37) that wil undergo no futher processing or transformation by the organization (3.31) Note 1 to entry: A product that undergoes further processing or transformation by another organization is, an end product in the context of the frst organization and a raw material or an ingredient in the context of the second organization. 3.16 feed single or muttiple product(s), whether processed, semi-processed or raw, which is (are) intended to be fed to food-producing animals Nots 1 to entry: Distinctions are made in this document between the terms food (3.18), feed (3.16) and animal food (3.18): = food Is intended for consumption by humans end animals, and includes feed and animal food; = feed is intended to be fed to food-producing animets; = animal food is intended to be fed to non-food- producing animals, such as pets. [SOURCE: CACIGL 81-2013, modified - The word "materials" has been changed to “products” and “directly’ has been deleted.) 347 Luu 4 ‘Sy thé hién 06 hé théng duéi dang bidu 4 trinh ty ‘va mdi tong quan gidra cc buéc trong qué trinh 3.48 Thyc pham Chét (thdnh phan), 68 qua ché bién, & dang ban thanh phAm hoac lé nguyén ligu thd, dling dé feu thy, bao gdm cd 4d udng, keo cao su va bat ky chdt ndo 68 duge str dung trong san xudt, chudn bi hay xir ly "thy phdm*, khéng bao gdm my phdm hod thudc la ho&e chat (thanh phan) cht éuge sir dung lam thude CHU THICH 1: Tigu chudn nay phén bigt céc thugt gt’ thye phdm (3.18), thizc &n cho vat nu6i diing lam the phd (3.18) va thire &n cho vat nubi khéng dling Jam thye phdm (3.19): = thye phamithire &n ding cho ngudi va dong vat, bao gdm cd thire &n cho vat nubi dng lam thy phd va thie &n cho vat nubi ding khdng lém thye phd = thie an cho vat nudl ding lam thyc pham: ding cho dng vat s&n xual thyre phim; — thie n cho vat nudi ding kh6ng lam thye phdm, nhy dng vat canh. INGUON: CACIGL 81-2013, cb sta abi — Xéa tir “con ngudl"} 3.49 Thirc an cho vat nudl khéng ding lam thyc phim ‘San phdm mét thanh phan hode nhiéu thanh phan, 68 qua ché bién, so ché hodc la nguyén ligu thd, duge ding lam thi &n cho vat nudi khong ding 48 sn xudt thyc pham CHU THICH 4: Tiéu chudn nay phan bigt cdc thudt gt thye phdm (3.18), thie din cho vat nui ding fam thye phdm (3.16) va thirc dn cho vat nudi khong ding fam thre phd (3.19): TCVN ISO 22000:2018 37 flow diagram schematic and systematic presentation of the ‘sequence and interactions of steps in the process 3.48 food substance (Ingredient), whether processed, semi-processed or raw, which is intended for consumption, and includes drink, chewing gum and any substance which has been used in the manufacture, preparation or treatment of “food” but does not include cosmetics or tobacco or substances (Ingredients) used only as drugs Note 1 to entry: Distinctions are made in this document between the terms food (3.18), feed (3.16) and animal food (3.49): ~ food is intended for consumption by humans and ‘animals, and includes feed and animal food; = feed is intended to be fed 10 food-producing animals; ~ animal food is intended to be fed to non-food- producing animals, such as pets. [SOURCE: CACIGL 81-2013, modified - The word human’ has been deleted.) 3.19 animal food single or multiple product(s), whether processed, semi-processed or raw, which is (are) intended to be fed to non-food-producing animals Note 1 to entry: Distinctions are made in this document between the terms food (3.18), feed (3.16) and animal food (3.19): 21 ‘TCVN ISO 22000:2018 — thye phanvthirc an dung cho nguéi va Gong vat, bao gdm 8 thie &n cho vat nudi ding fam thy phdm va ‘thire &n cho vat nudi ding khéng lam thye pham; ~ thire &n cho vat nuéi ding lm thye phdm: dang ‘cho d9ng vat san xudt thy phdm; = this Zn cho vail nudl dung khéng lam thyc pham, inhu dong vat cénh, INGUON: CACIGL 81-2013, co sta abi - di tir “nguyén tigu" thanh "sén phdm*, bd sung “khong” va xa tir"tryo tpt] 3.20 ‘Chudl thye phdm Trinh ty céc giai doan trong san xudt, ché bién, phan phéi, bdo quan va xii ly thuve phd (3.18) va ‘thanh phan olla thyc phdm dé, tir khau sdn xuét ban dau dén tigu thy CHU THICH 4; Thu8t ng nay bao gdm od vige san xudt thike &n cho vat nudl ding tam thyre phdm (3.16) va thike in cho vat nud ding Krdng lam thye phdm (3.19). CHU THICH 2: Chui thyc phim bao g8m c8 vig ‘sin xudt cdc nguyén ligu tiép xc voi thye phdm hoge nguyén tu thd, CHU THICH 3: Chudi thyc phdm cting bao gm cée ‘nha cung cp dich vy, 324 An toan thyc phim Vide dim bao ring thyc phdm sé khdng gay guy hal dén sire khée ngudi tiéu ding khi dug ché bién va/hodc tiéu thy theo ding myc dich siv dung dy kién . CHO THICH 4: An toan thyc phdm lin quan dén sy cd mat cae mdi nguy v8 an toén thye phdm (3.22) trong sén phdm cudi cing (3.15) va khéng bao gdm ‘ca khia canh khée lién quan én sire khée, vi dy: suy dinh duéng. CHU THICH 2: Khong nhdm ln véi thugt ngg “an riinh lwong thye”, 22 = food Is Intended for consumption by humans and animals, and includes feed and animal food; = feed is intended to be fed 10 food-producing animals; = animal food is intended to be fed to non-food- Producing animals, such as pels. [SOURCE: CAC/GL 81-2013, modified - The word “materials” has been changed to "products", “non” has been added and “directly” has been deleted.) 3.20 food chain sequence of the stages in the production, processing, distribution, storage and handling of a food (318) and its ingredients, from primary production to consumption Note 1 to entry: This includes the production of feed (6.16) and animal food (3.18). Note 2 to entry: The food chain also includes the production of materials inended to come into contact with food or raw materials. Note 3 to entry: The food chain also includes service providers. 324 food safety assurance that food will not cause an adverse health effect for the consumer when it is prepared and/or consumed in accordance with Its intended use Note 1 to entry: Food safely is related to the occurrence of food safely hazards (322) in end products (3.18) and does not include other health aspects related to, for example, malnutrition. Note 2 to entry: It is not to be confused with the avaitabilly of, and access to, food ("Tood security’). CHU THICH 3: Thuat ngir nay bao gdm ca thie én chan nub. INGUON: TCVN 5603 (CACIRCP 1-1969), 06 sira abi = Thay tir "gy hai" bang "lac dong xdu dén strc khoe* vva thém oe chi thich} 3.22 Méi nguy v8 an toan thye phdm ‘Tac nhan sinh hoc, héa hgc hoc vat ly trong thy phdm (3.18) ob kha ning gay tac dong xdu 61 vii sire Kho’, CHU THICH 1: Khong nh&m tn thuat ngt "mdi nguy* voi thuat ngO “rll ro” ("nguy co’) (3.39), ma trong béi enh an toan thye pham, rif ro la ham xée sudt cls téc dng xu v8 site kho’ (vi dy: mac bénh) va miro 6 nghiém trong cba tée dong 6 (vi du: bj chét, phat

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