Cactieuchuan s190 PDF
Cactieuchuan s190 PDF
INTERNATIONAL                            ISO
            STANDARD                               22000
                                                FIRST EDITION
                                                  2005-09-01
                                              Reference number
                                             ISO 22000 : 2005 (E)
                                                            Page 1 of 75
 ISO 22000:2005  FOR TRAINING PURPOSE ONLY
Contents                                                                                                                                                           Page
1 Scope ................................................................................................................................. ...........................13
2 Normative reference .................................................................................................................................15
3 Terms and definitions ...................................................................................................... ..........................16
4 Food safety management system ..............................................................................................................23
4.1 General requirements ..................................................................................................... .......................23
4.2 Documentation requirements ............................................................................................... .................25
5 Management responsibility .......................................................................................................................27
5.1 Management commitment .................................................................................................... .................27
5.2 Food safety policy ....................................................................................................................................28
5.3 Food safety management system planning ...........................................................................................29
5.4 Responsibility and authority ............................................................................................. .....................29
5.5 Food safety team leader .................................................................................................. .......................30
5.6 Communication............................................................................................................ ............................31
5.7 Emergency preparedness and response ...............................................................................................34
5.8 Management review ........................................................................................................ .......................35
6 Resource management ..............................................................................................................................37
6.1 Provision of resources................................................................................................... ..........................37
6.2 Human resources.......................................................................................................... ...........................37
6.3 Infrastructure ..........................................................................................................................................39
6.4 Work environment ......................................................................................................... .........................39
7 Planning and realization of safe products................................................................................................39
7.1 General.................................................................................................................. ...................................39
7.2 Prerequisite programs (PRPs) ............................................................................................. ..................39
7.3 Preliminary steps to enable hazard analysis ........................................................................................42
7.4 Hazard analysis .......................................................................................................... ..............................48
7.5 Establishing the operational Prerequisite programs (PRPs)..............................................................53
7.6 Establishing the HACCP plan .............................................................................................. ..................53
7.7 Updating of preliminary information and documents specifying the PRP(s) and the
HACCP plan ............................................................................................................................. ......................57
7.8 Verification planning ............................................................................................................................. .57
7.9 Traceability system ...................................................................................................... ...........................59
7.10 Control of nonconformity ..................................................................................................................... .59
8 Validation, verification and improvement of the food safety management system............................66
8.1 General.................................................................................................................. ...................................66
8.2 Validation of control measure combinations ........................................................................................66
8.3 Control of monitoring and measuring...................................................................................................68
8.4 Food safety management system verification ......................................................................................69
8.5 Improvement .............................................................................................................. .............................73
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                                                                                                                                                       Trang
1 Phm vi ........................................................................................................................................................13
2 Tiu chun trch dn..................................................................................................................................15
3 Thut ng v nh ngha ............................................................................................................................16
4 H thng qun l an ton thc phm.......................................................................................................23
4.1 Yu cu chung .........................................................................................................................................23
4.2 Yu cu v h thng ti liu ..................................................................................................................25
5 Trch nhim ca lnh o ........................................................................................................................27
5.1 Cam kt ca lnh o .............................................................................................................................27
5.2 Chnh sch an ton thc phm ..............................................................................................................28
5.3 Hoch nh H thng qun l an ton thc phm...............................................................................29
5.4 Trch nhim v quyn hn ....................................................................................................................29
5.5 Trng nhm an ton thc phm..........................................................................................................30
5.6 Trao i thng tin ...................................................................................................................................31
5.7 S chun b v ng ph vi tnh hung khn cp ................................................................................34
5.8 Xem xt ca lnh o .............................................................................................................................35
6 Qun l ngun lc ......................................................................................................................................37
6.1 Cung cp ngun lc.................................................................................................................................37
6.2 Ngun nhn lc........................................................................................................................................37
6.3 C s h tng ...........................................................................................................................................39
6.4 Mi trng lm vic................................................................................................................................39
7 Hoch nh v to sn phm an ton.......................................................................................................39
7.1 Khi qut..................................................................................................................................................39
7.2 Chng trnh tin quyt (PRPs) ............................................................................................................39
7.3 Cc bc chun b cho hot ng phn tch mi nguy ........................................................................42
7.4 Phn tch mi nguy ..................................................................................................................................48
7.5 Xy dng cc chng trnh vn hnh tin quyt (PRPs) ....................................................................53
7.6 Xy dng k hoch HACCP...................................................................................................................53
7.7 Cp nht cc thng tin ban u v cc ti liu m t cc chng trnh tin quyt
v k hoch HACCP ......................................................................................................................................57
7.8 Hoch nh vic thm tra .......................................................................................................................57
7.9 H thng truy tm ngun gc .................................................................................................................59
7.10 Kim sot s khng ph hp ................................................................................................................59
8 Thm nh, thm tra v ci tin h thng qun l an ton thc phm ...............................................66
8.1 Khi qut..................................................................................................................................................66
8.2 Thm nh t hp cc bin php kim sot .........................................................................................66
8.3 Kim sot theo di v o lng .............................................................................................................68
8.4 Thm tra h thng qun l an ton thc phm ...................................................................................69
8.5 Ci tin .....................................................................................................................................................73
                                                                                                                                                   Page 3 of 75
 ISO 22000:2005  FOR TRAINING PURPOSE ONLY
FOREWORD
The main task of technical committees is to prepare International Standards. Draft International
Standards adopted
by the technical committees are circulated to the member bodies for voting. Publication
as an International
Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this International Standard
may be the subject of patent rights. ISO shall not be held responsible for identifying any or all
such patent rights.
ISO 22000 was prepared by Technical Committee ISO/TC 34, Food products.
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INTRODUCTION
                                                       LI GII THIU
Food safety is related to the presence of food-
                                                       An ton thc phm lin quan ti s c mt ca
borne hazards in food at the               point of
                                                       cc mi nguy trong thc phm ti thi im s
consumption (intake by the consumer). As the
                                                       dng (ngi tiu dng n thc phm). S xut
introduction of food safety hazards can occur
                                                       hin ca cc mi nguy v an ton thc phm
at any stage of the food chain, adequate
                                                       c th   xy ra  bt c giai on no trong
control throughout the food chain is essential.
                                                       dy chuyn thc phm, do  vic kim sot
Thus, food safety is ensured through the
                                                       mt cch y  trong c dy chuyn thc
combined     efforts   of      all   the     parties
                                                       phm l rt cn thit. Nh , an ton thc
participating in the food chain
                                                       phm c m bo thng qua n lc tng
                                                       hp ca tt c cc bn tham gia vo dy
                                                       chuyn               thc               phm
Organizations within the food chain range              Cc t chc trong dy chuyn thc phm, bao
from feed producers and primary producers              gm t sn xut thc n chn nui, khu ban
through food manufacturers, transport and              u n cc n v sn xut thc phm, vn
storage operators and subcontractors to retail         chuyn v iu hnh kho bi v cc nh thu
and food service outlets (together with inter-         ph n n v bn l, v cc im phc v
related organizations such as producers of             n ung (cng vi cc t chc c lin quan
equipment,     packaging    material,      cleaning    nh cc n v sn xut thit b, bao b, cht
agents, additives and ingredients). Service            ty ra, ph gia v cc thnh phn), bao gm
providers are also included.                           c cc n v cung cp dch v.
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Recognition of the organization's role and          Vic nhn bit vai tr v v tr ca t chc
position within the food chain is essential to      trong dy chuyn thc phm l cn thit cho
ensure effective interactive communication          vic m bo s trao i thng tin hiu qu
throughout the chain in order to deliver safe       trong c dy chuyn nhm chuyn giao thc
food products to the final consumer. An             phm an ton n ngi tiu dng cui. Hnh1
example of the communication channels               l v d v cc knh thng tin gia cc bn
among interested parties of the food chain is       hu quan trong dy chuyn thc phm
shown in Figure 1.
                                                                                          Page 6 of 75
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The most effective food safety systems are              H thng qun l an ton thc phm hiu
established, operated and updated within the            qu nht c thit lp, vn hnh v cp nht
framework of a structured management                    trn c s cu trc ca h thng qun l v
system and incorporated into the overall                hp nht vi cc hot ng qun l chung
management activities of the organization.              ca t chc. iu ny em li li ch ti a
This provides maximum benefit for the                   cho t chc v cc bn hu quan. Tiu
organization and interested parties. This               chun ny c lin kt vi tiu chun ISO
International Standard has been aligned with            9001 nhm tng  tng thch ca hai tiu
ISO   9001      in   order     to   enhance      the    chun. Bng so snh tng quan gia tiu
compatibility of the two standards. Cross-              chun ny v ISO 9000 c th hin  Ph
references between this International Standard          lc A.
and ISO 9001 are provided in Annex A
                                                                                             Page 7 of 75
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This International Standard integrates the          Control      Point   (HACCP)   system    and
principles of the Hazard Analysis and Critical      application steps developed by the Codex
During hazard analysis, the organization            Trong qu trnh phn tch mi nguy, t chc
determines the strategy to be used to ensure        xc nh phng thc c s dng  m
hazard control by combining the PRP(s),             bo mi nguy c kim sot thng qua s
operational PRP(s) and the HACCP plan               kt hp gia chng trnh tin quyt (PRPs),
                                                                                      Page 8 of 75
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Cross-references          between     the         Codex    Bng so snh tng quan gia cc nguyn
Alimentarius Commission HACCP principles                   tc HACCP v cc bc thc hin ca Codex
and application steps (see Reference [11]) and             Alimentarius Commission (xem ti liu tham
this International Standard are provided in                kho s [11]) v tiu chun ny c trnh
Annex B                                                    by  ph lc B.
To     facilitate   the     application      of     this    thun tin cho vic p dng, tiu chun
International Standard, it has been developed              ny c xy dng thnh tiu chun c th s
as an auditable standard. However, individual              dng cho hot ng nh gi. Tuy nhin, mi
organizations are free to choose the necessary             t chc c t do chn la phng php v
methods      and    approaches      to     fulfil   the    cch tip cn cn thit  thc hin cc yu
requirements of this International Standard.               cu ca tiu chun ny. Nhm h tr cc t
To assist individual organizations with the                chc trong vic p dng tiu chun ny, mt
implementation of this International Standard,             bn hng dn cch s dng tiu chun c
guidance on its use is provided in ISO/TS                  trnh by trong ISO/TS 22004
22004
This    International      Standard       allows     an    Tiu chun ny cho php mt t chc (nh
organization (such as a small and/or less                  cc t chc nh v/hoc t        chc cha
developed organization) to implement an                    pht   trin)   p dng mt t hp cc bin
externally developed combination of control                php     kim      sot     t   bn    ngoi
measures.
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The aim of this International Standard is to             Mc tiu ca tiu chun ny l tiu chun ho
harmonize on a global level the requirements              quy m quc t cc yu cu v h thng
for food safety management for businesses                qun l an ton thc phm cho cc doanh
within the food chain. It is particularly                nghip trong dy chuyn thc phm. Tiu
intended for application by organizations that           chun ny ch yu hng n vic p dng 
seek a more focused, coherent and integrated             cc t chc cn tm kim mt h thng qun
food safety management system than is                    l hp l, c tch hp v tp trung hn
normally required by law. It requires an                 vo an ton thc phm ch khng n thun
organization to meet any applicable food                 l p ng cc yu cu lut nh. Tiu chun
safety   related    statutory         and   regulatory   ny yu cu mt t chc p ng tt c cc
requirements       through      its     food    safety   yu cu lut nh v an ton thc phm thng
management system.                                       qua h thng qun l an ton thc phm ca
                                                         t chc.
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                                                 Feed producers
                                              Figure 1  Example of           Transport and storage operators
                                           communication within the food
                                                  Primary
                                                      chainfood
                                                                                 Producers of equipments
                                                   producers Food
                                                                           Producersof cleaning and sanitizing
                                                                                         agents
                                                   manufacturers
                                                                            Producers of packaging materials
                                            Secondary food manufacturers
                                                                                     Service providers
                                         Wholesalers Retailers, Food
                                         service operators and caterers
                                                                                        Service
                                                                                    providersprovid
                                                                                          ers
Consumers
     NOTE The figure does not show the type of interactive communications along and across the
     food chain that by pass immediate suppliers and customers.
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                                                                                         Cc n v sn xut thit b
                                                         Sn xut thc phm
                                                                                       Cc n v sn xut cc cht ty
                                                                                                     ra
                                                     Sn xut thc phm (cp 2)
                                                                                         Cc n v sn xut bao b
                                                           Cc nh bn s
                                                                                                 Cc dch v
                                                   Cc nh bn l, dch v n ung,
                                                        cung cp thc phm
Ch thch : Hnh ny khng th hin hnh thc trao i thng tin ngang v dc trong dy
chuyn thc phm khi b qua cc nh cung cp v khch hng trung gian.
                                                                                                               Page 12 of 75
    ISO 22000:2005  FOR TRAINING PURPOSE ONLY
1 Scope 1. Pham vi
a) to plan, implement, operate, maintain and           a) Hoch nh, p dng, vn hnh, duy tr v
   update a food safety management system              cp nht h thng qun l an ton thc
   aimed at providing products that, according to      phm nhm cung cp sn phm an ton,
   their intended use, are safe for the consumer,      theo mc ch s dng ca sn phm, cho
                                                       ngi tiu dng
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g) to seek certification or registration of its               g) Tm kim s chng nhn hoc cng nhn
food safety management system by an                           h thng qun l an ton thc phm t t
external      organization,      or     make     a    self-   chc bn ngoi, hoc t thc hin nh gi
assessment or self-declaration of conformity                  hoc t cng b mc  ph hp vi tiu
to this International Standard.                               chun ny
All requirements of this International Standard               include, but are not limited to, feed producers,
are generic and are intended to be applicable                 harvesters, farmers, producers of ingredients,
to all organizations in the food chain                        food manufacturers, retailers, food services,
regardless of size and complexity. This                       catering services, organizations providing
includes organizations directly or indirectly                 cleaning      and        sanitation      services,
involved in one or more steps of the food                     transportation,     storage   and     distribution
chain. Organizations that are directly involved               services.   Other     organizations    that    are
                                                                                                    Page 14 of 75
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indirectly involved include, but are not limited   tham gia trc tip bao gm, nhng khng
to, suppliers of equipment, cleaning and           gii hn, cc t chc sn xut thc n chn
sanitizing agents, packaging material, and         nui, thu hoch, cc nng dn, cc t chc
other food contact materials.                      sn xut cc thnh phn, cc t chc sn
                                                   xut thc phm, cc nh bn l, cc dch v
Tt c cc yu cu ca tiu chun ny mang
                                                   n ung, dch v cung cp thc phm, cc t
tnh tng qut v nhm  p dng cho mi
                                                   chc cung cp cc dch v v sinh, kh
t chc trong dy chuyn thc phm khng
                                                   trng, vn chuyn, lu kho v phn phi.
phn bit quy m v mc  phc tp. iu
                                                   Cc t chc khc khng tham gia trc tip,
ny bao gm cc t chc trc tip hoc gin
                                                   bao gm nhng khng gii hn, cc t chc
tip tham gia vo mt hoc nhiu cng on
                                                   cung cp thit b, cc cht ty ra, bao b, v
trong dy chuyn thc phm. Cc t chc
                                                   cc vt liu tip xc vi thc phm khc
This     International   Standard   allows   an    Tiu chun ny cho php mt t chc, nh cc
organization, such as a small and/or less          t chc nh v/hoc cha pht trin (nh nng
developed organization (e.g. a small farm, a       tri nh, t chc ng gi-phn phi nh,
small packer-distributor, a small retail or food   im bn l nh, dch v n ung), c p
service outlet), to implement an externally        dng mt t hp cc bin php kim sot t
developed combination of control measures.         bn ngoi
NOTE Guidance on the application of this           Ch thch: Hng dn v vic p dng tiu
International Standard is given in ISO/TS          chun ny c cung cp  ISO/TS22004.
22004.
2 Normative references                             2Tiu chun trch dn.
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For the purposes of this document, the terms      Cc thut ng v nh ngha c nu trong
and definitions given in ISO 9000 and the         ISO 9000 v cc thut ng sau c p dng
following apply.                                  cho tiu chun ny
For the convenience of the users of this           thun tin cho ngi s dng tiu chun,
International     Standard,     some   of   the   mt s nh ngha ca ISO 9000 c trch
definitions in ISO 9000 are quoted with           li v b sung thm cc Ch thch ch c gi
added notes that are applicable only to this      tr p dng cho tiu chun c th ny
special application.
NOTE Terms are not defined where they             Ch thch : Cc thut ng s khng        c
retain their normal dictionary definition.        nh ngha li nu chng gi nguyn  ngha
Where bold type is used in a definition, this     thng dng c nu trong t in. Khi nh
indicates a cross-reference to another term       ngha c in m ngha l chng c lin h
defined in this clause, and the number            vi     mt   thut ng khc cng trong iu
reference for the term is given in parentheses.   khon ny, v s tham chiu ca thut ng
                                                  c lin h c ghi trong ngoc
Concept that food will not cause harm to the      Khi nim ch thc phm khng lm tn hi
consumer when it is prepared and/or eaten         n ngi s      dng khi c ch bin
according to its intended use                     v/hoc n ng theo mc ch s dng
NOTE 1 Adapted from Reference [11].               Ch thch 1 : Trch t ti liu tham kho s
                                                  [11].
                                                  does not include other human health aspects
NOTE 2 Food safety is related to the
                                                  related to, for example, malnutrition.
occurrence of food safety hazards (3.3) and
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NOTE 2 The food chain also includes the          Ch thch 2 : Dy chuyn thc phm bao
production of materials intended to come into    gm c hot ng sn xut cc vt liu s
contact with food or raw materials.              tip xc trc tip vi thc phm v nguyn
                                                 liu
NOTE 1 Adapted from Reference [11].              Ch thch 1: Trch t ti liu tham kho s
                                                 [11]
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NOTE 4 In the context of feed and feed            Ch thch 4 : Trong phm vi v thc n gia
ingredients, relevant food safety hazards are     sc, cc mi nguy v an ton thc phm c
those that may be present in and/or on feed       lin quan l cc mi nguy c kh nng c
and       feed   ingredients   and   that   may   mt trong thc n gia sc v cc thnh phn
subsequently be transferred to food through       ph v c th c truyn n thc phm
animal consumption of feed and may thus           thng qua vic s dng thc n ca gia sc
have the potential to cause an adverse human      v do  c kh nng gy nh cc hot ng
health effect. In the context of operations       khng thuc nhm trc tip x l thc n
other than those directly handling feed and       gia sc v thc phm (nh sn xut bao b,
food (e.g. producers of packaging materials,      cc cht ty ra..) cc mi nguy v an ton
cleaning agents, etc.), relevant food safety      thc phm c lin quan l cc mi nguy c
hazards are those hazards that can be directly    th c truyn trc tip hoc gin tip ti
or indirectly transferred to food because of      thc phm thng qua mc ch s dng ca
the intended use of the provided products         cc sn phm/dch v ny v do  c kh
and/or services and thus can have the             nng nh hng bt li cho sc kho ca
potential to cause an adverse human health        con ngi.
effect.
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Product   that       will   undergo     no    further   Sn phm khng tri qua thm bt k s ch
processing      or     transformation        by   the   bin hoc bin i no do t chc thc hin
organization
Schematic and systematic presentation of the            Bn trnh by mt cch h thng theo dng
sequence and interactions of steps                      s  trnh t v tng tc ca cc bc
                                                        cng on
food safety action or activity that can be            (an ton thc phm) Hnh ng hoc hot
used to prevent or eliminate a food safety              ng c th c s dng  ngn nga
hazard (3.3) or reduce itto an acceptable level         hoc loi b mt mi nguy (3.3) hoc gim
                                                        thiu n n mc chp nhn
NOTE Adapted from Reference [11] Ch thch : Trch t ti liu tham kho s
                                                                                          Page 19 of 75
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[11].
3.8 PRP - prerequisite programme 3.8. PRP- Chng trnh tin quyt
food safety basic conditions and activities     (an ton thc phm) iu kin c bn v cc
that are necessary to maintain a hygienic         hot ng cn thit  duy tr mi trng v
environment throughout the food chain (3.2)       sinh trong dy chuyn thc phm (3.2) ph
suitable for the production, handling and         hp cho sn xut, x        l v    cung cp
provision of safe end products (3.5) and safe     cc thnh phm (3.5) an ton v thc phm
food for human consumption                        an ton cho ngi s dng
NOTE The PRPs needed depend on the                Ch thch : Cc chng trnh tin quyt cn
segment of the food chain in which the            thit ph thuc vo      phn khc ca dy
organization operates and the type of             chuyn      thc phm    m t chc tham gia
organization (see Annex C). Examples of           v loi t chc (xem ph lc C). Mt s v
equivalent terms are: Good Agricultural           d v cc thut ng tng ng : Thc
Practice (GAP), Good Veterinarian Practice        hnh sn xut nng nghip tt (GAP), Thc
(GVP), Good Manufacturing Practice (GMP),         hnh cng tc th y tt ( GVP), Thc hnh
Good     Hygienic   Practice   (GHP),    Good     sn xut tt (GMP), Thc hnh v sinh tt
Production Practice (GPP), Good Distribution      (GHP), Thc hnh phn phi          tt (GDP),
Practice (GDP) and Good Trading Practice          Thc     hnh   thng    mi       tt   (GTP)
(GTP).
Operational prerequisite programme PRP            Chng trnh tin quyt (3.8) c nhn
(3.8) identified by the hazard analysis as        dng trong qu trnh phn tch mi nguy l
essential in order to control the likelihood of   cn thit  kim sot kh nng xut hin
introducing food safety hazards (3.3) to          ca mi nguy v an ton thc phm (3.3) v/
and/or the contamination or proliferation of      hoc s nhim      bn hoc s pht trin
food safety hazards in the product(s) or in the   ca cc mi nguy v an ton thc phm
processing environment                            trong (cc) sn phm hoc trong mi trng
                                                  sn xut.
                                                                                       Page 20 of 75
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food safety step at which control can be       (an ton thc phm) im ti  c th thc
applied and is essential to prevent or           hin kim sot v cn thit trong vic ngn
eliminate a food safety hazard (3.3) or reduce   nga hoc loi b mt mi nguy v an ton
it to an acceptable level                        thc phm hoc gim thiu n n mc
                                                 chp nhn.
NOTE Adapted from Reference [11].                Ch thch : Trch t ti liu tham kho s
                                                 [11]
criterion which separates acceptability from     Tiu chun phn bit gia chp nhn c
unacceptability                                  v khng chp nhn c
NOTE 1 Adapted from Reference [11].              Ch thch 1: Trch t ti liu tham kho
                                                 s[11]
                                                                                   Page 21 of 75
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NOTE      1     For   the     purposes      of     this   Ch thch 1 : Trong tiu chun ny, s khc
International Standard, a correction relates to           phc lin quan n vic x l cc sn phm
the handling of potentially unsafe products,              c kh nng khng an ton, v do  c s
and can therefore be made in conjunction                  kt hp vi hnh ng khc phc (3.14)
with a corrective action (3.14).
NOTE 2 A correction may be, for example,                  Ch thch 2 : S khc phc c th, v d nh,
reprocessing,     further     processing,        and/or   ti ch, ch bin thm, v/hoc loi b hu
elimination of the adverse consequences of                qu bt li ca s khng ph hp (nh s
the nonconformity (such as disposal for other             dng cho mc ch khc hoc ghi nhn c
use or specific labelling).                               bit)
NOTE 2 Corrective action includes cause                   Ch thch 2 : Hnh ng khc phc bao gm
analysis and is taken to prevent recurrence.              phn tch nguyn nhn v       hnh ng 
                                                          ngn nga ti din
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                                                     3.15. Thm nh
3.15 validation
food safety obtaining evidence that the            (an ton      thc phm) Thu thp cc bng
control measures (3.7) managed by the                chng l cc bin php kim sot (3.7)
HACCP plan and by the operational PRPs               c quy nh trong k hoch HACCP v
(3.9) are capable of being effective                 cc chng trnh tin quyt PRPs vn hnh
                                                     c hiu qu
confirmation,     through   the    provision    of   S khng nh, thng qua vic cung cp
objective       evidence,      that      specified   bng chng khch quan, l cc yu cu quy
requirements     have   been      fulfilled   [ISO   nh  c thc hin [ISO 9000, nh ngha
9000:2000, definition 3.8.4]                         3.8.4]
immediate and/or planned activity to ensure          Hot ng kp thi v/hoc theo k hoch
application of the most recent information            m bo vic p dng cc thng tin mi
                                                     nht
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The organization shall establish, document,        T chc PHI (1) xy dng, lp vn bn,
implement and maintain an effective food           thc hin v duy tr mt h thng qun l
safety management system and update it             an ton thc phm hiu qu v cp nht
when necessary in accordance with the              h thng ny khi cn thit theo cc yu cu
requirements of this International Standard.       ca tiu chun ny
The organization shall define the scope of the     T chc PHI (2) xc nh phm vi ca h
food safety management system. The scope           thng qun l an ton thc phm. Phm vi
shall   specify the      products   or   product   PHI (3) nu r cc sn phm hoc nhm
categories, processes and production sites that    sn phm, cc quy trnh v cc a im sn
are addressed by the food safety management        xut c qun l bi h thng qun l
system.                                            an ton thc phm
a) ensure that food safety hazards that may be     a) m bo cc mi nguy v an ton thc
reasonably expected to occur in relation to        phm c kh nng xy ra vi sn phm
products within the scope of the system are        trong phm vi ca h thng qun l c
identified, evaluated and controlled in such a     nhn dng , nh gi v kim sot sao cho
manner that the products of the organization       cc sn phm ca t chc khng, trc tip
do not, directly or indirectly, harm the           hoc gin tip, lm tn hi ngi s dng
consumer,
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Where an organization chooses to outsource          Khi t chc chn ngun bn ngoi cho bt
any process that may affect end product             k qu trnh no nh hng n s ph hp
conformity, the organization shall ensure           ca thnh phm, t chc PHI (5) m bo
control over such processes. Control of such        kim sot c cc qu trnh . Vic kim
outsourced processes shall be identified and        sot cc qu trnh do ngun bn ngoi PHI
documented       within      the   food    safety   (6) c nhn bit v vn bn ho trong h
management system.                                  thng qun l an ton thc phm
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                                                     b) Cc th tc dng vn bn v cc h s
b) documented procedures and records
                                                     theo yu cu ca tiu chun ny, v
required by this International Standard, and
The controls shall ensure that all proposed          Vic kim sot PHI (10) m bo tt c
changes are reviewed prior to implementation         cc  xut thay i c xem xt trc khi
to determine their effects on food safety and        p dng nhm xc nh s nh hng ca
their impact on the food safety management           cc thay i ny v tc ng ca chng i
system.                                              vi H thng qun l an ton thc phm
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g) to prevent the unintended use of obsolete       g. ngn nga vic s dng v tnh cc ti
documents, and to ensure that they are             liu li thi, v p dng cc du hiu nhn
suitably identified as such if they are retained   bit thch hp nu chng c gi li v mc
for any purpose.                                   ch no 
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a) showing food safety is supported by the            a. Chng t an ton thc phm c duy tr
business objectives of the organization,              thng qua cc mc tiu hot ng ca t
                                                      chc
c) establishing the food safety policy, c. Thit lp chnh sch an ton thc phm
5.2 Food safety policy 5.2. Chnh sch an ton thc phm
Top management shall define, document and             Lnh o cao nht PHI (16) xc nh, lp
communicate its food safety policy.                   vn bn v truyn t chnh sch an ton
                                                      thc phm ca t chc
Top management shall ensure that the food             Lnh o cao nht PHI (17) m bo
safety policy                                         chnh sch an ton thc phm
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                                                             b. ph hp vi cc yu cu php lut v ch
b)      conforms      with    both      statutory     and
                                                             nh v cc yu cu  c tho thun vi
regulatory requirements and with mutually
                                                             khch hng v an ton thc phm
agreed         food    safety     requirements         of
customers,
d) is reviewed for continued suitability (see                d. c xem xt  lun thch hp (xem 5.8)
5.8),
5.3     Food      safety     management         system       5.3. Hoch nh h thng qun l an ton
planning                                                     thc phm
Top management shall ensure that Lnh o cao nht PHI (18) m bo
a) planning of the food safety management                    a. tin hnh hoch nh h thng qun l an
system is carried out to meet requirements                   ton thc phm  p ng cc yu cu nu
given in 4.1 as well as the objectives of the                trong 4.1 cng nh cc mc tiu ca t chc
organization that support food safety, and                   v an ton thc phm, v
b)      the    integrity     of   the    food       safety   b. tnh nht qun ca h thng qun l an
management system is maintained when                         ton thc phm c duy tr khi cc thay i
changes to the food safety management                        i vi h thng qun l an ton thc phm
system are planned and implemented.                          c hoch nh v thc hin
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All personnel shall have responsibility to             Tt c cc nhn vin PHI (20) c trch
report    problems     with   the    food     safety   nhim bo co cc vn  v h thng qun
management system to identified person(s).             l an ton thc phm cho (cc)     c nhn
Designated personnel shall have defined                c ch nh. Ngi c ch nh PHI
responsibility and authority to initiate and           (21) c trch nhim v quyn hn khi xng
record actions.                                        v ghi chp cc hnh ng
5.5 Food safety team leader 5.5. Trng nhm an ton thc phm
Top management shall appoint a food safety             Lnh o cao nht PHI (22) ch nh mt
team leader who, irrespective of other                 trng nhm an ton thc phm, ngoi cc
responsibilities, shall have the responsibility        trch nhim khc, PHI (23) c trch nhim
and authority                                          v quyn hn
a) to manage a food safety team (see 7.3.2)            a. qun l nhm an ton thc phm (xem
and organize its work,                                 7.3.2) v t chc cng vic ca nhm
c) to ensure that the food safety management           c. m bo h thng qun l an ton thc
system      is    established,      implemented,       phm c thit lp, thc hin, duy tr v
maintained and updated, and                            cp nht, v
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NOTE The responsibility of the food safety            Ch thch : trch nhim ca trng nhm an
team leader may include liaison with external         ton thc phm c th bao gm c quan h
parties on matters relating to the food safety        vi bn ngoi v cc vn  c lin quan
management system.                                    n an ton thc phm
b) customers or consumers, in particular in           b. khch hng hoc ngi tiu dng, lin
relation to product information (including            quan n cc thng tin v sn phm (bao
instructions regarding intended use, specific         gm hng dn v mc ch s dng, yu
storage requirements and, as appropriate,             cu c th v bo qun, v, khi thch hp,
shelf     life),    enquiries,      contracts    or   thng tin v hn s dng), x l cc yu
orderhandling including amendments, and               cu, cc hp ng hoc n t hng , k c
customer      feedback        including   customer    cc sa i, v phn hi ca khch hng bao
complaints,                                           gm c cc khiu ni
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The organization shall establish, implement             T chc PHI (30) thit lp, thc hin v
and maintain effective arrangements for                 duy tr s sp xp hiu qu vic trao i
communicating with personnel on issues                  thng tin vi cc nhn vin v cc vn  c
having an impact on food safety.                        tc ng n an ton thc phm
In order to maintain the effectiveness of the            duy tr tnh hiu qu ca h thng qun
food    safety      management         system,    the   l an ton thc phm, t chc PHI (31)
organization shall ensure that the food safety          m bo l nhm an ton thc phm c
team is informed in a timely manner of                  thng bo kp thi v cc thay i, bao gm
changes, including but not limited to the               nhng khng gii hn trong
following:
b) raw materials, ingredients and services;             b. cc nguyn liu, thnh phn v cc dch
                                                        v
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                                                 h. cc yu cu php lut v ch nh
h) statutory and regulatory requirements;
i) knowledge regarding food safety hazards       i. cc kin thc lin quan n an ton thc
and control measures;                            phm v cc bin php kim sot
The food safety team shall ensure that this      Nhm an ton thc phm PHI (32) m
information is included in the updating of the   bo cc thng tin ny c a vo hot
food safety management system (see 8.5.2).       ng cp nht h thng     qun l an ton
Top management shall ensure that relevant        thc phm (xem 8.5.2). Lnh o cao nht
information is included as input to the          PHI (33) m bo cc thng tin lin
management review (see 5.8.2).                   quan tr thnh u vo ca xem xt ca lnh
                                                 o (xem 5.8.2)
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Top     management         shall     review    the   Lnh o cao nht PHI (35) nh k xem
organization's     food     safety    management     xt h thng qun l an ton thc phm, 
system at planned intervals to ensure its            m bo n lun thch hp, tho ng v c
continuing       suitability,      adequacy   and    hiu lc. Vic xem xt ny PHI (36) nh
effectiveness. This review shall include             gi c c hi ci tin v nhu cu thay i
assessing opportunities for improvement and          i vi h thng qun l an ton thc phm,
the need for change to the food safety               k c chnh sch v an ton thc phm. H
management system, including the food                s xem xt ca lnh o PHI (37) c
safety policy.      Records     of    management     duy tr (xem 4.2.3)
reviews shall be maintained (see 4.2.3).
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                                                   c. cc s thay i c th nh hng n an
c) changing circumstances that can affect
                                                   ton thc phm (xem 5.6.2)
food safety (see 5.6.2),
d) emergency situations, accidents (see 5.7)       d. cc tnh hung khn cp, cc s c (xem
and withdrawals (see 7.10.4),                      5.7) v cc trng hp thu hi sn phm
                                                   (xem 7.10.4)
The data shall be presented in a manner that       Cc d liu PHI (39) c trnh by sao
enables top management to relate the               cho lnh o cao nht c th kt ni cc
information to stated objectives of the food       thng tin ny vi cc mc tiu   ra cho
safety management system.                          h thng qun l an ton thc phm
The output from the management review              u ra ca vic xem xt ca lnh o PHI
shall include decisions and actions related to     (40) bao gm cc quyt nh v hnh ng
                                                   lin quan n
a) assurance of food safety (see 4.1), a. m bo an ton thc phm (xem 4.1)
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The organization shall provide adequate             T chc PHI (41) cung cp cc ngun lc
resources       for     the        establishment,   y   thit lp, thc hin, duy tr v cp
implementation, maintenance and updating of         nht h thng qun l an ton thc phm
the food safety management system.
The food safety team and the other personnel        Nhm an ton thc phm v cc nhn vin
carrying out activities having an impact on         thc hin cc cng vic c tc ng n an
food safety shall be competent and shall have       ton thc phm PHI (42) c nng lc v
appropriate education, training, skills and         PHI (43) c gio dc, o to, c k
experience.                                         nng v kinh nghim thch hp
                                                    experts shall be available.
Where the assistance of external experts is
required        for     the        development,     Khi cn c s h tr ca cc chuyn gia bn
implementation, operation or assessment of          ngoi trong vic xy dng, thc hin, vn
the food safety management system, records          hnh hoc nh gi h thng an ton thc
of agreement or contracts defining the              phm, PHI (44) c h s v cc tho thun
responsibility and authority of external            hoc hp ng xc nh r trch nhim v
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6.2.2 Competence, awareness and training 6.2.2. Nng lc, nhn thc v o to
b) provide training or take other action to         b. tin hnh o to hay nhng hnh ng
ensure     personnel     have     the   necessary   khc  m bo ngi lao ng c  nng
competencies,                                       lc cn thit
e) ensure that the personnel are aware of the       e. m bo ngi lao ng nhn thc c
relevance and importance of their individual        mi lin quan v tm quan trng ca cc
activities in contributing to food safety,          hot ng ca h i vi an ton thc phm
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                                                  6.3. C s h tng
6.3 Infrastructure
The organization shall provide the resources      T chc PHI (46) cung cp ngun lc cho
for the establishment and maintenance of the      vic thit lp v duy tr c s h tng cn
infrastructure needed to implement the            thit    thc hin cc yu cu ca tiu
requirements of this International Standard.      chun ny
The organization shall provide the resources      T chc PHI (47) cung cp ngun lc cho
for the establishment, management and             vic thit lp, qun l v duy tr mi trng
maintenance of the work environment needed        lm vic cn thit  thc hin cc yu cu
to implement the requirements of this             ca tiu chun ny
International Standard.
The organization shall plan and develop the       T chc PHI (48) hoch nh v trin khai
processes needed for the realization of safe      cc qu trnh cn thit cho vic to sn
products.                                         phm an ton
The organization shall implement, operate         T chc PHI (49) p dng, thc hin v
and ensure the effectiveness of the planned       m bo tnh hiu qu/hiu lc ca cc hot
activities and any changes to those activities.   ng  hoch nh cng nh bt k s thay
This includes PRP(s) as well as operational       i no. iu ny bao gm cc chng trnh
PRP(s) and/or the HACCP plan.                     tin quyt (PRPs) v cc chng trnh vn
                                                  hnh tin quyt (Operation PRPs) v /hoc
                                                  k hoch HACCP
7.2 Prerequisite programmes (PRPs) 7.2. Chng trnh tin quyt (PRPs)
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b) be appropriate to the size and type of the                 b. ph hp vi quy m v loi hnh hot
operation and the nature of the products being                ng cng nh bn cht ca sn phm c
manufactured and/or handled,                                  sn xut v /hoc x l
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7.2.3 When selecting and/or establishing           7.2.3. Khi la chn v/hoc xy dng cc
PRP(s), the organization shall consider and        chng trnh tin quyt t chc PHI (53)
utilize appropriate information [e.g. statutory    xem xt v s dng cc thng tin cn thit
and     regulatory      requirements,   customer   (nh cc yu cu lut nh, yu cu ca
requirements, recognized guidelines, Codex         khch hng, cc hng dn c cng nhn,
Alimentarius Commission (Codex) principles         cc nguyn tc ca Codex, cc quy tc thc
and codes of practices, national, international    hnh, cc tiu chun quc gia, quc t, hoc
or sector standards].                              tiu chun ngnh)
The organization shall consider the following      Khi xy dng cc chng trnh trn, t chc
when establishing these programmes:                PHI (54) xem xt cc iu sau y
c) supplies of air, water, energy and other        c. h thng cung cp kh, nc, nng lng
utilities;                                         v cc tin ch khc
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g) measures for the prevention of cross         g. cc bin php ngn nga s nhim bn
contamination;                                  cho
Verification of PRP(s) shall be planned (see    Vic thm tra cc chng trnh tin quyt
7.8) and PRP(s) shall be modified as            PHI (55) c hoch nh (Xem 7.8) v
necessary (see 7.7). Records of verifications   cc chng trnh tin quyt PHI (56) c
and modifications shall be maintained.          iu chnh khi cn thit (xem 7.7). H s
                                                thm tra v h s ghi nhn cc iu chnh
                                                PHI (57) c duy tr
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A food safety team shall be appointed.                  PHI (60) thit lp nhm An ton         thc
                                                        phm
The   food    safety   team        shall   have     a   Nhm An ton thc phm PHI (61) gm
combination of multi-disciplinary knowledge             nhng thnh vin c nhng kin thc v kinh
and    experience      in     developing          and   nghim a dng trong vic xy dng v p
implementing the food safety management                 dng h thng qun l an ton thc phm.
system. This includes, but need not be limited          Kin thc ny bao gm, nhng khng gii
to, the organization's products, processes,             hn, cc sn phm ca t chc, cc quy
equipment and food safety hazards within the            trnh, thit b, cc mi nguy v an ton thc
scope of the food safety management system.             phm trong phm vi ca h thng qun l an
                                                        ton thc phm
Records shall be maintained that demonstrate            H s chng t nhm An ton thc phm c
that the food safety team has the required               kin thc v kinh nghim theo yu cu
knowledge and experience (see 6.2.2).                   (xem 6.2.2) PHI (62) c duy tr
7.3.3.1 Raw materials, ingredients and                  7.3.3.1. Nguyn liu, cc thnh phn v
product-contact materials                               vt liu tip xc vi sn phm
All raw materials, ingredients and product-             Tt c cc nguyn liu , cc thnh phn v
contact materials shall be described in                 vt liu tip xc vi sn phm PHI (63)
documents to the extent needed to conduct               c m t trong cc ti liu  mc cn thit
the hazard analysis (see 7.4), including the            cho vic phn tch cc mi nguy (xem 7.4),
following, as appropriate:                              khi thch hp bao gm nhng iu sau y
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The organization shall identify statutory and      T chc PHI (64) nhn dng cc yu cu
regulatory food safety requirements related to     php lut v ch nh v an ton thc phm
the above.                                         lin quan n cc ni dung trn
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e) packaging; e. bao gi
f) labelling relating to food safety and/or       f. cc thng tin trn nhn lin quan n an
instructions for handling, preparation and        ton thc phm v/hoc hng dn cch x
usage;                                            l, chun b v s dng;
The organization shall identify statutory and     T chc PHI (67) nhn bit cc yu cu
regulatory food safety requirements related to    php lut v ch nh v an ton thc phm
the above.                                        lin quan n cc vn  trn
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                                                     7.3.4. Mc ch s dng
7.3.4 Intended use
The intended use, the reasonably expected            Mc ch s dng sn phm, bao gm cch
handling of the end product, and any                 s dng ng v nhng kh nng sai st , s
unintended        but   reasonably     expected      dng nhm ln thnh phm PHI (69) c
mishandling and misuse of the end product            xem xt v m t bng vn bn,  mc 
shall be considered and shall be described in        cn thit cho vic thc hin phn tch mi
documents to the extent needed to conduct            nguy.(xem 7.4)
the hazard analysis (see 7.4).
Groups of users and, where appropriate,              Nhm i tng s dng, v khi cn thit,
groups of consumers shall be identified for          nhm i tng tiu th PHI (70) c
each product, and consumer groups known to           nhn   dng cho tng loi sn       phm, va(
be especially vulnerable to specific food            PHI (71) xem xt n cc nhm i tng
safety hazards shall be considered.                  nhy cm vi cc mi nguy c th
7.3.5 Flow diagrams, process steps and               7.3.5. S  quy trnh sn xut, cc cng
control measures                                     on v cc bin php kim sot
Flow diagrams shall be prepared for the              S  quy trnh sn xut PHI (73) c
products or process categories covered by the        thit lp cho cc nhm sn phm hoc nhm
food   safety management          system.     Flow   quy trnh thuc phm vi ca h thng qun
diagrams shall provide a basis for evaluating        l an ton thc phm. S  quy trnh sn
the    possible     occurrence,    increase     or   xut PHI (74) cung cp c s  nh gi
introduction of food safety hazards.                 kh nng xy ra, s pht trin hoc xut
                                                     hin cc mi nguy v an ton thc phm
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In accordance with 7.8, the food safety team      Theo yu cu ca iu khon 7.8, nhm An
shall verify the accuracy of the flow diagrams    ton thc phm PHI (77) thm tra ti ch
by on-site checking. Verified flow diagrams       tnh chnh xc ca s  quy trnh sn xut.
shall be maintained as records.                   S  quy trnh sn xut  thm tra PHI
                                                  (78) c lu h s
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The food safety team shall conduct a hazard         Nhm an ton thc phm PHI (82) thc
analysis to determine which hazards need to         hin vic phn tch mi nguy  xc nh
be controlled, the degree of control required       mi nguy no cn c         kim sot, mc
to ensure food safety, and which combination         kim sot yu cu  m bo an ton
of control measures is required.                    thc phm, cng nh s cn thit phi phi
                                                    hp cc bin php kim sot
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a) the preliminary information and data            a. cc thng tin ban u v d liu c thu
collected according to 7.3,                        thp theo yu cu ca 7.3
d) information from the food chain on food         d. Cc thng tin t dy chuyn thc phm
safety hazards that may be of relevance for        lin quan n cc mi nguy c kh nng nh
the safety of the end products, intermediate       hng n an ton ca thnh phm, bn
products and the food at consumption.              thnh phm v vic s dng thc phm
The step(s) (from raw materials, processing        PHI (85) ch ra cc cng on (t nguyn
and distribution) at which each food safety        liu, sn xut v phn phi) m mi nguy v
hazard may be introduced shall be indicated.       an ton thc phm c kh nng xut hin
7.4.2.2 When identifying the hazards,              7.4.2.2 Khi nhn dng cc mi nguy,
consideration shall be given to                    PHI (86) xem xt
a) the steps preceding and following the           a. cc cng on trc v sau cng on
specified operation,                               ang xem xt
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7.4.2.3 For each of the food safety hazards         7.4.2.3 Khi c th, PHI (87) xc nh mc
identified, the acceptable level of the food        chp nhn  thnh phm i vi tng mi
safety hazard in the end product shall be           nguy v an ton thc phm c nhn dng.
determined      whenever       possible.     The    Khi xc nh mc  chp nhn PHI(88)
determined level shall take into account            quan tm n cc yu cu lut nh , yu
established     statutory      and   regulatory     cu v an ton thc phm ca khch hng,
requirements,     customer       food      safety   mc ch s dng do khch hng xc nh
requirements, the intended use by the               v cc thng tin khc c lin quan. Cc lp
customer and other relevant data. The               lun v kt qu xc nh mc chp nhn
justification for, and the result of, the           PHI (89) c lu h s
determination shall be recorded.
Each food safety hazard shall be evaluated          Mi mi nguy v an ton thc phm PHI
according to the possible severity of adverse       (91) c nh gi da trn c s mc 
health effects and the likelihood of their          nghim trng ca cc nh hng bt li n
occurrence. The methodology used shall be           sc khe v kh nng xy ra ca cc mi
described, and the results of the food safety       nguy. Phng php nh gi c s dng
hazard assessment shall be recorded.                PHI (92) c m t , v kt qu nh gi
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In this selection, each of the control measures   Trong qu trnh l chn, mi bin php kim
as described in 7.3.5.2 shall be reviewed with    sot c nu trong 7.3.5.2, PHI (95) c
respect to its effectiveness against the          xem xt v tnh hiu qu ca n i vi cc
identified food safety hazards.                   mi nguy  c nhn dng
The control measures selected shall be            Cc bin php kim sot c la chn
categorized as to whether they need to be         PHI (96) c phn loi theo mc  cn
managed through operational PRP(s) or by          thit phi qun l bng k hoch HACCP
the HACCP plan.                                   hay bng cc chng trnh vn hnh tin
                                                  quyt (operational PRPs)
The selection and categorization shall be         S chn la v phn   loi PHI (97) c
carried out using a logical approach that         thc hin thng qua vic tip cn mt cch
includes assessments with regard to the           hp l bao gm vic nh gi cc vn 
following:                                        sau
a) its effect on identified food safety hazards   a. s tc ng ca bin php kim sot i
relative to the strictness applied;               vi mi nguy v an ton thc phm tng
                                                  ng vi mc  nghim ngt c p dng
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b) its feasibility for monitoring (e.g. ability to   b. tnh kh thi ca vic gim st (V d: kh
be monitored in a timely manner to enable            nng gim st kp thi  m bo cc bin
immediate corrections);                              php khc phc c thc hin tc thi)
c) its place within the system relative to other     c. v tr ca bin php kim sot trong h
control measures;                                    thng tng xng vi cc bin php khc
d) the likelihood of failure in the functioning      d. kh nng sai lch ca bin php kim
of a control measure or significant processing       sot hoc cc s bin thin ng k ca quy
variability;                                         trnh sn xut
f) whether the control measure is specifically       f. bin php kim sot c c thit k v
established and applied to eliminate or              c p dng c bit  loi b hoc
significantly reduce the level of hazard(s);         gim thiu ng k mc  ca cc mi nguy
Control measures categorized as belonging to         Cc bin php kim sot thuc k hoch
the HACCP plan shall be implemented in               HACCP PHI (98) c trin khai theo yu
accordance with 7.6. Other control measures          cu ca 7.6. Cc bin php khc PHI (99)
shall be implemented as operational PRPs             c thc hin  chng trnh vn hnh tin
according to 7.5.                                    quyt nh yu cu ca 7.5
The methodology and parameters used for              Phng php v cc tiu ch s dng cho
this categorization shall be described in            vic phn loi PHI (100) c m t bng
documents, and the results of the assessment         vn bn, v kt qu ca vic nh gi
shall be recorded.                                   PHI (101) c lu h s
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The operational PRPs shall be documented             (Cc) chng trnh vn      hnh tin      quyt
and shall include the following information          PHI (102) c vn bn ha v mi
for each programme:                                  chng trnh PHI (103) bao gm cc thong
                                                     tin sau y
The HACCP plan shall be documented and               K hoch HACCP PHI (104) c vn
shall include the following information for          bn ho v PHI (105) bao gm cc thng
each identified critical control point (CCP):        tin sau y cho mi CCP c xc nh
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The rationale for the chosen critical limits            L do chn Gii hn ti hn PHI (110)
shall be documented.                                    c vn bn ho
7.6.4 System for the monitoring of critical             7.6.4. H thng gim st cc im kim
control points                                          sot ti hn
The monitoring system shall consist of                  H thng gim st PHI (114) bao gm
relevant procedures, instructions and records           cc th tc, hng dn v cc h s lien
that cover the following:                               quan, bao gm cc vn  sau
a) measurements or observations that provide            a. vic o lng hoc quan st nhm cung
results within an adequate time frame;                  cp kt qu trong thi gian yu cu
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                                                      d. tn xut gim st
d) monitoring frequency;
The monitoring methods and frequency shall            Cc bin php gim st & tn xut gim st
be capable of determining when the critical           PHI (115) c kh nng xc nh kp thi
limits have been exceeded in time for the             thi im thng s vt gii hn ti hn 
product to be isolated before it is used or           thc hin c lp sn phm trc khi chng
consumed.                                             c s dng hoc tiu dng
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(xem7.10.3)
e) control measures (see 7.3.5.2). e. cc bin php kim sot (xem 7.3.5.2)
If necessary, the HACCP plan (see 7.6.1) and        Khi cn thit, k hoch HACCP (xem 7.6.1)
the procedures and instructions specifying the      v cc th tc, cc hng dn v chng
PRP(s) (see 7.2) shall be amended.                  trnh tin quyt PRPs (xem 7.2) PHI (120)
                                                    c iu chnh
Verification    planning    shall    define   the   Hoch nh vic thm tra PHI (121) xc
purpose,       methods,     frequencies       and   nh mc ch, cc phng php, tn xut v
responsibilities for the verification activities.   cc trch nhim cho cc hot ng thm tra.
The verification activities shall confirm that      Hot ng thm tra PHI (122) xc nhn
                                                    cc iu sau
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c) the operational PRP(s) (see 7.5) and the           c. cc chng trnh vn hnh tin quyt
elements within the HACCP plan (see 7.6.1)            (operational PRPs) (xem 7.5) v cc yu t
are implemented and effective,                        trong k hoch HACCP (xem 7.6.1) c
                                                      trin khai p dng v c hiu qu
The output of this planning shall be in a form        u ra ca vic hoch nh PHI (123) 
suitable for the organization's method of             dng ph hp vi phng thc hot ng ca
operations.                                           t chc
Verification results shall be recorded and            Kt qu thm tra PHI (124) c ghi h s
shall be communicated to the food safety              v PHI (125) c thng tin cho Nhm An
team. Verification results shall be provided to       Ton Thc Phm. Kt qu thm tra PHI
enable the analysis of the results of the             (126) c cung cp  thc hin hot ng
verification activities (see 8.4.3).                  phn tch kt qu ca cc hot ng thm tra
                                                      (xem 8.4.3).
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The organization shall establish and apply a                T chc PHI (128) thit lp v p dng
traceability    system       that      enables       the    mt h thng truy tm ngun gc sn phm
identification of product lots and their                    c kh nng nhn dng cc l sn phm v
relation   to   batches      of     raw     materials,      lin h ca l sn phm vi cc l nguyn
processing and delivery records.                            liu, l sn xut v cc h s v giao hng
The traceability system shall be able to                    H thng truy vt PHI (129) c kh nng
identify    incoming        material       from      the    nhn dng nguyn liu u vo t cc nh
immediate       suppliers     and         the     initial   cung cp trung gian v ni phn phi u
distribution route of the end product.                      tin ca thnh phm
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b) a review of the corrections carried out.       b. vic xem xt s khc phc  c thc
                                                  hin
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Corrective actions shall be initiated when                     Hnh ng khc phc PHI (141) c 
critical limits are exceeded (see 7.6.5) or                    xng khi gii hn ti hn vt chun
when there is a lack of conformity with                        (xem 7.6.5) hoc khi c cc thiu st trong
operational PRP(s).                                            p dng cc chng trnh vn hnh tin
                                                               quyt
The organization shall establish and maintain                  T chc PHI(142) thit lp v duy tr th
documented        procedures            that      specify      tc dng vn bn, xc nh c th cc hnh
appropriate actions to identify and eliminate                  ng thch hp  nhn dng v        loi b
the cause of detected nonconformities, to                      nguyn nhn ca cc khng ph hp c
prevent recurrence, and to bring the process                   pht hin, nhm ngn nga s ti din, v
or     system     back         into     control        after    ti lp li s kim sot i vi quy trnh
nonconformity is encountered. These actions                    v h thng sau khi s khng ph hp xy
include                                                        ra. Cc hnh ng ny bao gm
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b) the food safety hazard(s) of concern will         b. cc mi nguy v an ton thc phm cn
be reduced to identified acceptable levels (see      quan tm s c     gim thiu       n mc
7.4.2) prior to entering into the food chain, or     chp nhn  xc nh, trc khi tham gia
                                                     vo dy chuyn thc phm, hoc
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a) evidence other than the monitoring system          a. c bng chng b sung bn cnh h
demonstrates that the control measures have           thng gim st chng t l cc bin
been effective;                                       php kim sot c hiu qu
b) evidence shows that the combined effect of         b. bng chng chng minh hiu qu tng
the control measures for that particular              hp ca cc bin php kim sot cho sn
product complies with the performance                 phm ang xem xt ph hp vi kt qu
intended (i.e. identified acceptable levels as        mong i ( vd mc chp nhn  xc nh
identified in accordance with 7.4.2);                 ph hp vi mc c xc nh  7.4.2)
Following evaluation, if the lot of product is        Sau khi nh gi, nu l sn phm khng
not acceptable for release it shall be handled        c chp nhn cho       xut xng, chng
by one of the following activities:                   PHI (148) c x l bng mt trong cc
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hot ng sau
To enable and facilitate the complete and            c th thc hin thun li vic thu hi
timely withdrawal of lots of end products           mt cch ton din v kp thi cc l sn
which have been identified as unsafe                phm  c nhn bit l khng an ton
a) top management shall appoint personnel           a. lnh o cao nht PHI (149) ch nh
having the authority to initiate a withdrawal       thnh vin c     thm quyn  quyt nh
and personnel responsible for executing the         vic thu hi v thnh vin thc hin vic thu
withdrawal, and                                     hi, v
b) the organization shall establish and             b. t chc PHI (150) thit lp v duy tr
maintain a documented procedure for                 mt th tc dng vn bn cho vic
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The cause, extent and result of a withdrawal             Nguyn nhn, phm vi v kt qu ca vic
shall be recorded and reported to top                    thu hi PHI (152) c lu h s v bo
management as input to the management                    co cho lnh o cao nht nh l thng tin
review (see 5.8.2).                                      u vo cho vic xem xt ca lnh o
                                                         (xem5.8.2)
The organization shall verify and record the             T chc PHI (153) thm tra v ghi h s
effectiveness of the withdrawal programme                tnh hiu qu ca chng trnh thu hi thng
through the use of appropriate techniques                qua vic s dng mt s k thut thch hp
(e.g.    mock    withdrawal           or      practice   (nh cc t thu hi th nghim/ thc hnh
withdrawal).                                             thu hi.)
The food safety team shall plan and                      Nhm An Ton Thc Phm PHI (154) lp
implement the processes needed to validate               k hoch v thc hin vic thm nh cc
control measures and/or control measure                  bin php kim v tin hnh thm tra v ci
combinations, and to verify and improve the              tin h thng qun l an ton thc phm
food safety management system.
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a) the selected control measures are capable          a. bin php kim sot c chn  kh
of achieving the intended control of the food         nng em li s kim sot mong mun vi
safety   hazard(s)     for      which    they   are   cc mi nguy v an ton thc phm c
designated, and                                       kim sot bng bin php ang xt, v
b) the control measures are effective and             b. cc bin php kim sot khi phi hp vi
capable of, in combination, ensuring control          nhau, c hiu qu v  kh nng m bo
of the identified food safety hazard(s) to            s kim sot vi cc mi nguy v an ton
obtain end products that meet the defined             thc phm sao cho thnh phm p         ng
acceptable levels.                                    c mc chp nhn  xc nh
If the result of the validation shows that one        Trong trng hp kt qu thm nh cho
or both of the above elements cannot be               thy mt hoc c hai vn  trn khng
confirmed,    the     control    measure    and/or    c xc nhn, cc bin php kim sot 
combinations thereof shall be modified and            v/ hoc t hp cc bin php kim sot
re-assessed (see 7.4.4).                              PHI (156) c iu chnh v nh gi
                                                      li (xem 7.4.4)
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The organization shall provide evidence that              T chc PHI (157) cung cp bng chng
the specified monitoring and measuring                    v s y  v cc phng php v thit b
methods and equipment are adequate to                     theo di v o lng  m bo vic thc
ensure the performance of the monitoring and              hin cc th tc theo di v o lng
measuring procedures.
a) shall be calibrated or verified at specified           a. PHI (158) c hiu chun hoc kim
intervals,      or        prior   to    use,    against   tra xc nhn nh k, hoc trc khi s dng,
measurement           standards         traceable    to   da trn cc chun o lng quc gia hay
international        or      national    measurement      quc t; khi khng        c cc chun ny th
standards; where no such standards exist, the             cn c c s dng  hiu chun hoc
basis used for calibration or verification shall          kim tra xc nhn PHI (159) c lu h s
be recorded,
c) shall be identified to enable the calibration          c. PHI (161) c nhn bit  gip xc
status to be determined,                                  nh trng thi hiu chun
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In addition, the organization shall assess the    Ngoi ra, khi thit b hoc quy trnh c
validity of the previous measurement results      pht hin khng ph hp vi yu cu, t
when the equipment or process is found not        chc PHI (165) nh gi gi tr hiu lc
to conform to requirements. If the measuring      ca cc kt qu o trc . Nu thit b o
equipment       is      nonconforming,      the   khng ph hp, t chc PHI (166) tin
organization shall take action appropriate for    hnh cc hnh ng thch hp i vi thit
the equipment and any product affected.           b  v bt k sn phm no b nh hng.
Records of such assessment and resulting          PHI (167) duy tr h s v kt qu nh
actions shall be maintained.                      gi v cc hnh ng c thc hin sau
                                                  nh gi
When     used     in    the    monitoring   and   Khi s dng phn mm my tnh  theo di
measurement of specified requirements, the        v o lng cc yu cu nht nh, PHI
ability of computer software to satisfy the       (168) khng nh chng c kh nng p
intended application shall be confirmed. This     ng vic p dng d kin. Vic ny PHI
shall be undertaken prior to initial use and      (169) c thc hin trc ln s dng u
shall be reconfirmed as necessary.                tin v PHI (170) c xc nhn li khi
                                                  cn thit
8.4   Food     safety   management       system   8.4. Thm tra h thng qun l an ton
verification                                      thc phm
The organization shall conduct internal audits    T chc PHI (171) tin hnh nh gi ni
at planned intervals to determine whether the     b nh k theo k hoch  xc nh xem
food safety management system                     h thng qun l an ton thc phm
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                                                    a. c ph hp vi cc b tr sp xp  c
a) conforms to the planned arrangements, to
                                                    hoch nh, ph hp vi cc yu cu ca h
the   food      safety   management      system
                                                    thng qun l an ton thc phm do t chc
requirements established bythe organization,
                                                    thit lp v vi cc yu cu ca tiu chun
and to the requirements of this International
                                                    ny, v
Standard, and
An audit programme shall be planned, taking         T chc PHI (172) hoch nh chng
into consideration the importance of the            trnh nh gi c ch  n tm quan trng
processes and areas to be audited, as well as       ca cc qu trnh v khu vc c nh gi,
any updating actions resulting from previous        cng nh cc hnh ng cp nht tip theo
audits (see 8.5.2 and 5.8.2). The audit criteria,   sau cuc nh gi ln trc (xem 8.5.2 v
scope, frequency and methods shall be               5.8.2). Chun mc, phm vi, tn xut v
defined. Selection of auditors and the conduct      phng php nh gi PHI (173) c xc
of audits shall ensure the objectivity and          nh. Vic la chn chuyn gia nh gi v
impartiality of the audit process. Auditors         t chc nh gi PHI (174) m bo tnh
shall not audit their own work.                     khch quan v v t ca qu trnh nh gi.
                                                    Cc chuyn gia nh gi khng c nh
                                                    gi cng vic ca mnh
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The food safety team shall systematically           Nhm an ton thc phm PHI (178) nh
evaluate the individual results of planned          gi mt cch h thng cc kt qu thm tra
verification (see 7.8).                             n l c tin hnh theo hoch nh (xem
                                                    7.8).
b) the conclusions of the hazard analysis (see      b. kt lun ca hot ng phn tch mi
7.4), the established operational PRP(s) (see       nguy (xem 7.4), cc chng trnh vn hnh
7.5) and the HACCP plan (see 7.6.1),                tin quyt (xem 7.5) v k hoch HACCP
                                                    (xem 7.6.1)  c thit lp
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The food safety team shall analyse the results      Nhm an ton thc phm PHI (181) phn
of verification activities, including the results   tch cc kt qu ca cc hot ng thm tra,
of the internal audits (see 8.4.1) and external     bao gm kt qu ca nh gi ni b (xem
audits. The analysis shall be carried out in        8.4.1) v nh gi ca bn ngoi. Hot ng
order                                               phn tch PHI (182) c thc hin 
c) to identify trends which indicate a higher       c. nhn ra xu hng gia tng v kh nng
incidence of potentially unsafe products,           to ra cc sn phm c nguy c khng an
                                                    ton
d) to establish information for planning of the     d. xc nh cc thng tin cho vic hoch
internal audit programme concerning the             nh chng trnh nh gi ni b c ch 
status and importance of areas to be audited,       n tnh trng v tm quan trng ca cc
and                                                 khu vc c nh gi, v
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The results of the analysis and the resulting         Cc kt qu phn tch v cc hnh ng ny
activities shall be recorded and shall be             sinh t vic phn tch PHI (183) c lu
reported, in an appropriate manner, to top            h s v PHI (184) c bo co mt cch
management as input to the management                 thch hp vi lnh o cao nht  lm u
review (see 5.8.2). It shall also be used as an       vo cho vic xem xt ca lnh o (xem
input   for      updating   the    food      safety   5.8.2). Cc kt qu ny PHI (185) c s
management system (see 8.5.2).                        dng lm thng tin cho vic cp nht h
                                                      thng qun      l   an ton thc phm (xem
                                                      8.5.2).
Top management shall ensure that the                  Lnh o cao nht PHI (186) m bo l
organization      continually     improves     the    t chc thng xuyn nng cao hiu lc ca
effectiveness of the food safety management           h thng qun l an ton thc phm thng
system through the use of communication               qua vic trao i thng tin (xem 5.6), xem
(see 5.6), management review (see 5.8),               xt ca lnh o (xem 5.8), nh gi ni b
internal audit (see 8.4.1), evaluation of             (xem 8.4.1), nh gi cc kt qu thm tra
individual verification results (see 8.4.2),          n l (xem 8.4.2), phn tch cc kt qu
analysis of results of verification activities        ca cc hot ng thm tra (xem 8.4.3),
(see 8.4.3), validation of control measure            thm nh s t hp cc bin php kim
combinations (see 8.2), corrective actions            sot (xem 8.2), cc hnh ng khc phc
(see 7.10.2) and food safety management               (xem 7.10.2) v vic cp nht h thng qun
system updating (see 8.5.2).                          l an ton thc phm (xem 8.5.2).
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8.5.2      Updating      the     food         safety    8.5.2. Cp nht h thng qun l an ton
management system                                       thc phm
Top management shall ensure that the food               Lnh o cao nht PHI (187) m bo
safety management system is continually                 rng h thng qun l an ton thc phm
updated.                                                c cp nht thng xuyn
In order to achieve this, the food safety team           thc hin iu ny, nhm an ton thc
shall evaluate the food safety management               phm PHI (188) nh         gi h thng
system at planned intervals. The team shall             qun l an ton thc phm theo k hoch
then consider whether it is necessary to                nh k. Sau , nhm PHI(189) xem
review the hazard analysis (see 7.4), the               xt s cn thit PHI (190) xem xt li bn
established operational PRP(s) (see 7.5) and            phn tch mi nguy (xem 7.4), cc chng
the HACCP plan (see 7.6.1).                             trnh vn hnh tin quyt (xem 7.5) v k
                                                        hoch HACCP (xem 7.6.1)
The evaluation and updating activities shall            Vic nh gi v cp nht PHI (191) da
be based on                                             trn c s
b) input from other information concerning              b. u vo ca cc thng tin khc lin quan
the suitability, adequacy and effectiveness of          n s ph hp, tho ng v hiu qu ca
the food safety management system,                      h thng qun l an ton thc phm
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System updating activities shall be recorded   Hot ng cp nht h thng PHI (192)
and reported, in an appropriate manner, as     c lu h s v bo co mt cch thch
input to the management review (see 5.8.2).    hp  lm u vo cho xem xt ca lnh
                                               o ( xem 5.8.2)
Page 75 of 75