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ISO 22000:2005 FOR TRAINING PURPOSE ONLY

INTERNATIONAL ISO
STANDARD 22000
FIRST EDITION
2005-09-01

FOOD SAFETY MANAGEMENT SYSTEM


REQUIREMENTS FOR ANY ORGANIZATION IN
THE FOOD CHAIN

Reference number
ISO 22000 : 2005 (E)

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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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ISO 22000:2005 FOR TRAINING PURPOSE ONLY

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

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ISO 22000:2005 FOR TRAINING PURPOSE ONLY

FOREWORD

ISO (the International Organization for Standardization) is a worldwide federation of national


standards bodies (ISO member bodies). The work of preparing International Standards is
normally carried out through ISO technical committees. Each member body interested in a
subject for which a technical committee has been established has the right to be represented on
that committee. International organizations, governmental and non-governmental, in liaison
with ISO, also take part in the work. ISO collaborates closely with the International
Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC
Directives, Part 2.

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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ISO 22000:2005 FOR TRAINING PURPOSE ONLY

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.

This International Standard specifies the Tiu chun ny quy nh cc yu cu cho mt


requirements for a food safety management h thng qun l an ton thc phm c s kt
system that combines the following generally hp cc yu t c xem l chnh yu m
recognized key elements to ensure food safety bo an ton thc phm trong c dy chuyn
along the food chain, up to the point of final thc phm, n tn im tiu dng cui, nh:
consumption:

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ISO 22000:2005 FOR TRAINING PURPOSE ONLY

interactive communication; vic trao i thng tin qua li;


system management; qun l h thng ;
prerequisite programmes; cc chng trnh tin quyt;
HACCP principles cc nguyn tc HACCP;
Communication along the food chain is H thng trao i thng tin trong dy chuyn
essential to ensure that all relevant food safety thc phm l cn thit m bo tt c cc
hazards are identified and adequately mi nguy v an ton thc phm c lin quan
controlled at each step within the food chain. c nhn dng v kim sot y tng
This implies communication between bc trong dy chuyn thc phm. iu ny
organizations both upstream and downstream bao gm vic trao i thong tin xui dng v
in the food chain. Communication with ngc dng gia cc t chc trong dy
customers and suppliers about identified chuyn thc phm. Vic trao i thng tin vi
hazards and control measures will assist in khch hang v nh cung cp v cc mi nguy
clarifying customer and supplier requirements c nhn dng v cc bin php kim sot
(e.g. with regard to the feasibility and need for s gip lm r cc yu cu ca khch hang
these requirements and their impact on the end v nh cung cp ( lin quan n tnh kh thi v
product). s cn thit ca cc yu cu ny v tc ng
ca chng n thnh phm)

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.

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ISO 22000:2005 FOR TRAINING PURPOSE ONLY

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

This International Standard can be applied Tiu chun ny c th c p dng c lp


independently of other management system vi cc tiu chun qun l khc.Vic p dng
standards. Its implementation can be aligned tiu chun ny c th c kt hp hay tch
or integrated with existing related hp vi cc yu cu ca h thng qun l lin
management system requirements, while quan hin c khi t chc mun s dng (cc)
organizations may utilize existing h thng qun l hin c thit lp h
management system(s) to establish a food thng qun l an ton thc phm ph hp
safety management system that complies with theo yu cu ca tiu chun ny
the requirements of this International Standard

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ISO 22000:2005 FOR TRAINING PURPOSE ONLY

This International Standard integrates the Control Point (HACCP) system and
principles of the Hazard Analysis and Critical application steps developed by the Codex

Alimentarius Commission. By means of Tiu chun ny tch hp cc nguyn tc ca


auditable requirements, it combines the h thng Phn tch cc mi nguy v im
HACCP plan with prerequisite programmes kim sot ti hn (HACCP) v cc bc thc
(PRPs). Hazard analysis is the key to an hin HACCP c Codex Alimentarius
effective food safety management system, Commission pht trin. Tiu chun ny kt
since conducting a hazard analysis assists in hp k hoch HACCP vi cc chng trnh
organizing the knowledge required to establish tin quyt (PRPs) thnh cc yu cu c th
an effective combination of control measures. s dng cho vic nh gi. Phn tch mi
nguy l ni dung chnh yu ca mt h thng
qun l an ton thc phm hiu qu, v vic
thc hin phn tch mi nguy gip t chc
h thng ho cc kin thc cn thit thit
lp mt t hp c hiu qu cc bin php
kim sot.

This International Standard requires that all Tiu chun ny yu cu tt c cc mi nguy


hazards that may be reasonably expected to c kh nng xy ra trong dy chuyn thc
occur in the food chain, including hazards that phm, bao gm c cc mi nguy c lin
may be associated with the type of process quan ti quy trnh sn xut v cc tin ch
and facilities used, are identified and assessed. c s dng, c nhn dng v nh gi.
Thus it provides the means to determine and Do tiu chun ny cung cp phng tin
document why certain identified hazards need xc nh v vn bn ho l do v sao cc
to be controlled by a particular organization mi nguy c nhn dng cn c kim sot
and why others need not t chc ny m khng cn t chc khc.

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),

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ISO 22000:2005 FOR TRAINING PURPOSE ONLY

chng trnh vn hnh tin quyt (operational PRPs) v k hoch HACCP

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 is intended to Tiu chun ny ch nhm xc nh cc kha


address aspects of food safety concerns only. cnh lin quan n an ton thc phm. Cch
The same approach as provided by this tip cn tng t nh c cung cp trong
International Standard can be used to organize tiu chun ny c th c s dng t
and respond to other food specific aspects chc v ng ph vi cc kha cnh c th
(e.g. ethical issues and consumer awareness) khc (nh cc vn v o c v nhn
thc ca ngi tiu dng)

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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ISO 22000:2005 FOR TRAINING PURPOSE ONLY

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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ISO 22000:2005 FOR TRAINING PURPOSE ONLY

Producers of pesticides, fertilizers, and


veterinary drugs
Crop producers
Food chain for the production of
ingredients and additives
Statutory and regulatory authorities

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.

Figure 1 Example of communication within the food chain

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ISO 22000:2005 FOR TRAINING PURPOSE ONLY

Cc n v sn xut thuc tr su,


phn bn, thuc th y
Sn xut nng sn
Dy chuyn sn xut cc thnh
Cc c quan thm quyn v c quan chc nng

phn v ph gia thc phm


Sn xut thc n chn nui
Figure 1 Example of
Cc n v vn chuyn v kho bi
communication within the food
Khuchain
ban u

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

Ngi tiu dng

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.

Hnh 1 V d v h thng trao i thng tin trong dy chuyn thc phm.

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ISO 22000:2005 FOR TRAINING PURPOSE ONLY

Food safety management systems H Thng Qun L An Ton Thc Phm


Requirements for any organization in the Cc Yu Cu Cho Tt C Cc T Chc
food chain Trong Dy Chuyn Thc Phm

1 Scope 1. Pham vi

This International Standard specifies Tiu chun ny quy nh cc yu cu i vi


requirements for a food safety management h thng qun l an ton thc phm khi mt
system where an organization in the food t chc trong dy chuyn thc phm cn
chain needs to demonstrate its ability to chng t kh nng kim sot cc mi nguy
control food safety hazards in order to ensure v an ton thc phm nhm m bo thc
that food is safe at the time of human phm an ton cho con ngi ti thi im s
consumption. dng

Tiu chun ny c th p dng cho mi t


It is applicable to all organizations, regardless
chc, khng phn bit quy m, tham gia vo
of size, which are involved in any aspect of
bt k kha cnh no ca dy chuyn thc
the food chain and want to implement systems
phm v mun p dng h thng nhm cung
that consistently provide safe products. The
cp mt cch n nh cc sn phm an ton.
means of meeting any requirements of this
Vic p ng tt c cc yu cu ca tiu
International Standard can be accomplished
chun ny c th c thc hin thng qua
through the use of internal and/or external
vic s dng cc ngun lc bn trong v
resources.
/hoc bn ngoi
This International Standard specifies Tiu chun ny qui nh cc yu cu cho
requirements to enable an organization php mt t chc

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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b) to demonstrate compliance with applicable b) Chng t s ph hp vi cc yu cu lut


statutory and regulatory food safety nh thch hp v an ton thc phm
requirements,

c) to evaluate and assess customer c) Lng ho v nh gi cc yu cu ca


requirements and demonstrate conformity khch hng v chng t s ph hp vi cc
with those mutually agreed customer yu cu tha thun vi khch hng v an
requirements that relate to food safety, in ton thc phm nhm nng cao s tha mn
order to enhance customer satisfaction, ca khch hng

d) to effectively communicate food safety d) Trao i thng tin c hiu qu cc vn


issues to their suppliers, customers and v an ton thc phm vi cc nh cung cp ,
relevant interested parties in the food chain, khch hng, v cc bn hu quan trong dy
chuyn thc phm
e) to ensure that the organization conforms to e) m bo s ph hp vi cc chnh sch v
its stated food safety policy, an ton thc phm cng b

f) to demonstrate such conformity to relevant f) Chng t s ph hp vi cc bn hu


interested parties, and quan, v

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

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ISO 22000:2005 FOR TRAINING PURPOSE ONLY

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.

The following referenced documents are Cc ti liu c trch dn sau y cn thit


indispensable for the application of this cho vic p dng tiu chun ny. Vi cc ti
document. For dated references, only the liu trch dn c ghi ngy, ch p dng phin
edition cited applies. For undated references, bn c trch dn. Vi cc ti liu khng c
the latest edition of the referenced document ghi ngy, phin bn mi nht ca ti liu
(including any amendments) applies. c trch dn (bao gm tt c cc ni dung
iu chnh) s c p dng.

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ISO 9000 : 2000, H thng qun l cht


ISO 9000:2000, Quality management systems
lng C s v t vng
Fundamentals and vocabulary

3 Terms and definitions 3. Thut ng v nh ngha

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

3.1 food safety 3.1. An ton thc phm

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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thc phm v khng bao gm cc kha cnh


Ch thch 2 : An ton thc phm lin quan
v sc kho khc c lin quan, v d nh suy
ti s xut hin ca cc mi nguy v an ton
dinh dng

3.2 Food chain 3.2. Dy chuyn thc phm

Sequence of the stages and operations Mt chui cc giai on v hot ng ni


involved in the production, processing, tip nhau bao gm sn xut, ch bin, phn
distribution, storage and handling of a food phi, lu tr, bo qun thc phm v cc
and its ingredients, from primary production thnh phn thc phm, t khu ban u
to consumption n ngi s dng

NOTE 1 This includes the production of feed Ch thch 1 : iu ny bao gm hot ng


for food-producing animals and for animals sn xut thc n cho cc loi ng vt sn
intended for food production. xut ra thc phm v ng vt nui vi mc
ch dng lm thc phm

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

3.3 food safety hazard 3.3. Mi nguy v an ton thc phm

Biological, chemical or physical agent in Cc tc nhn sinh hc, ho hc, hoc vt l


food, or condition of food, with the potential trong thc phm, hoc tnh trng ca thc
to cause an adverse health effect phm, c kh nng gy cc nh hng bt
li cho sc kho

NOTE 1 Adapted from Reference [11]. Ch thch 1: Trch t ti liu tham kho s
[11]

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NOTE 2 The term hazard is not to be Ch thch 2 : Khng nhm ln thut ng


confused with the term risk which, in the mi nguy vi thut ng Ri ro. Trong
context of food safety, means a function of phm vi v an ton thc phm, ri ro l mt
the probability of an adverse health effect hm s ca kh nng gy nh hng bt li
(e.g. becoming diseased) and the severity of n sc kho (nh gy bnh) v mc
that effect (death, hospitalization, absence nghim trng ca hu qu (t vong, nhp
from work, etc.) when exposed to a specified vin, ngh lm...) khi mt mi nguy c th
hazard. Risk is defined in ISO/IEC Guide 51 xut hin. Ri ro c nh ngha trong
as the combination of the probability of ISO/IEC 51 l s kt hp ca kh nng xy
occurrence of harm and the severity of that ra ca tc hi v mc nghim trng ca
harm. tc hi

NOTE 3 Food safety hazards include Ch thch 3 : Mi nguy v an ton thc


allergens. phm bao gm c cc tc nhn gy d ng

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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3.4. Chnh sch an ton thc phm


3.4 Food safety policy

Overall intentions and direction of an v nh hng chung ca mt t chc


organization related to food safety (3.1) as lin quan n an ton thc phm (3.1) c
formally expressed by top management lnh o cao nht cng b chnh thc

3.5 End product 3.5. Thnh phm

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

NOTE A product that undergoes further Ch thch A : mt sn phm tri qua s ch


processing or transformation by another bin, bin i 1 t chc khc l thnh
organization is an end product in the context phm trong phm vi ca t chc u tin v
of the first organization and a raw material or l nguyn liu hoc thnh phn ph trong
an ingredient in the context of the second phm vi ca t chc th hai
organization.

3.6 Flow diagram 3.6. S quy trnh sn


xut

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

3.7 Control measure 3.7. Bin php kim sot

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

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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).

3.9 operational PRP 3.9. Chng trnh vn hnh tin quyt

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.

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3.10. im kim sot ti hn CCP


3.10 CCP - critical control point

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]

3.11 critical limit 3.11. Gii hn ti hn

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]

NOTE 2 Critical limits are established to Ch thch 2 : Gii hn ti hn c thit lp


determine whether a CCP (3.10) remains in xc nh im kim sot ti hn (CCP)
control. If a critical limit is exceeded or (3.10) cn trong s kim sot hay khng.
violated, the products affected are deemed to Nu gii hn ti hn b vt mc hoc b vi
be potentially unsafe. phm, sn phm b nh hng c xem l
c kh nng khng an ton
3.12. Gim st
3.12 monitoring

conducting a planned sequence of Vic tin hnh theo k hoch mt chui cc


observations or measurements to assess quan st hay o lng nh gi xem bin
whether control measures (3.7) are operating php kim sot (3.7) c ang c thc hin
as intended nh quy nh

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3.13. S khc phc


3.13correction

action to eliminate a detected nonconformity Hnh ng loi b s khng ph hp


c pht hin

[ISO 9000:2000, definition 3.6.6] (ISO 9000:2000, nh ngha 3.6.6]

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)

3.14 corrective action 3.14. Hnh ng khc phc

Action to eliminate the cause of a detected Hnh ng loi b nguyn nhn ca s


nonconformity or other undesirable situation khng ph hp c pht hin hoc cc
tnh trng khng mong mun khc

NOTE 1 There can be more than one cause Ch thch 1 : Mt s khng ph hp c th


for a nonconformity. do nhiu nguyn nhn

[ISO 9000:2000, definition 3.6.5] [ ISO 9000:2000, nh ngha 3.6.5]

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

NOTE This definition is based on Reference Ch thch : nh ngha ny da trn ti liu


[11] and is more suitable for the field of food tham kho [11] v ph hp hn vi lnh vc
safety (3.1) than the definition given in ISO an ton thc phm so vi nh ngha trong
9000. ISO 9000

3.16 verification 3.16. Thm tra

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]

3.17 updating 3.17. Cp nht

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

4 Food safety management system 4. H thng qun l an ton thc phm

4.1 General requirements 4.1. Yu cu chung

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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

The organization shall T chc PHI

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,

b) communicate appropriate information b) Trao i cc thng tin thch hp trong dy


throughout the food chain regarding safety chuyn thc phm v n cc vn an
issues related to its products, ton lin quan n sn phm ca t chc ,

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c) communicate information concerning c) Trao i thng tin trong t chc, phm


development, implementation and updating vi cn thit, v vic xy dng, p dng v
of the food safety management system cp nht h thng qun l an ton thc
throughout the organization, to the extent phm, m bo an ton thc phm nh
necessary to ensure the food safety required yu cu ca tiu chun ny, v
by this International Standard, and

d) evaluate periodically, and update when d) nh gi nh k v cp nht, khi cn


necessary, the food safety management thit, h thng qun l an ton thc phm
system to ensure that the system reflects the nhm m bo h thng phn nh c cc
organization's activities and incorporates the hot ng ca t chc v bao gm cc thng
most recent information on the food safety tin mi nht v cc mi nguy v an ton
hazards subject to control. thc phm cn kim sot

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

4.2 Documentation requirements 4.2. Yu cu v h thng ti liu

4.2.1 General 4.2.1. Khi qut

The food safety management system Cc ti liu ca H thng qun l an ton


documentation shall include thc phm PHI (7) bao gm

a) documented statements of a food safety a) Cc vn bn cng b v chnh sch an


policy and related objectives (see 5.2), ton thc phm v cc mc tiu lin quan
(xem 5.2)

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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

c) documents needed by the organization to c) Cc ti liu cn c ca t chc m


ensure the effective development, bo vic xy dng, p dng v cp nht c
implementation and updating of the food hiu qu h thng qun l an ton thc
safety management system. phm

4.2.2 Control of documents 4.2.2. Kim sot ti liu

Documents required by the food safety Cc ti liu theo yu cu ca h thng qun


management system shall be controlled. l an ton thc phm PHI (8) c kim
Records are a special type of document and sot. H s l mt loi ti liu c bit v
shall be controlled according to the PHI (9) c kim sot theo cc yu cu
requirements given in 4.2.3. nu trong 4.2.3

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

A documented procedure shall be established PHI (11) lp mt th tc dng vn bn


to define the controls needed xc nh vic kim sot cn thit nhm

a) to approve documents for adequacy prior a. ph duyt cc ti liu v s tha ng


to issue, trc khi ban hnh

b) to review and update documents as b. xem xt, cp nht khi cn v ph duyt


necessary, and re-approve documents, li ti liu

c) to ensure that changes and the current c. m bo nhn bit c cc thay i v


revision status of documents are identified, tnh trng sa i hin hnh ca ti liu

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d. m bo cc bn ca ti liu thch hp, sn


d) to ensure that relevant versions of
c ni s dng
applicable documents are available at points
of use,

e) to ensure that documents remain legible e. m bo cc ti liu lun r rng, d


and readily identifiable, nhn bit

f) to ensure that relevant documents of f. m bo cc ti liu c ngun gc bn


external origin are identified and their ngoi c nhn bit v vic phn phi
distribution controlled, and chng c kim sot, v

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

4.2.3 Control of records 4.2.3. Kim sot h s

Records shall be established and maintained PHI (12) lp v duy tr cc h s cung


to provide evidence of conformity to cp bng chng v s ph hp vi cc yu
requirements and evidence of the effective cu v hot ng tc nghip c hiu lc ca
operation of the food safety management h thng qun l an ton thc phm. Cc
system. Records shall remain legible, readily h s PHI (13) r rng, d nhn bit v d
identifiable and retrievable. A documented s dng. PHI (14) lp mt th tc bng
procedure shall be established to define the vn bn xc nh vic kim sot cn thit
controls needed for the identification, storage, i vi vic nhn bit, lu tr, bo v, s
protection, retrieval, retention time and dng thi gian lu gi v hy b cc h s
disposition of records.

5 Management responsibility 5. Trch nhim ca lnh o

5.1 Management commitment 5.1. Cam kt ca lnh o

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Lnh o cao nht PHI (15) cung cp


Top management shall provide evidence of
bng chng v s cam kt ca mnh i vi
its commitment to the development and
vic xy dng v thc hin h thng qun
implementation of the food safety
l an ton thc phm v ci tin thng
management system and to continually
xuyn hiu lc ca h thng bng cch
improving its effectiveness by

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

b) communicating to the organization the b. Truyn t cho t chc v tm quan trng


importance of meeting the requirements of ca vic p ng cc yu cu ca tiu chun
this International Standard, any statutory and ny, tt c cc yu cu ca php lut v ch
regulatory requirements, as well as customer nh, cng nh cc yu cu ca khch hng
requirements relating to food safety, v an ton thc phm

c) establishing the food safety policy, c. Thit lp chnh sch an ton thc phm

d) conducting management reviews, and d. Tin hnh vic xem xt ca lnh o, v

e) ensuring the availability of resources. e. m bo sn c cc ngun lc

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

a) is appropriate to the role of the a. ph hp vi vai tr ca t chc trong dy


organization in the food chain, chuyn 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,

c) is communicated, implemented and c. c truyn t, p dng v duy tr tt


maintained at all levels of the organization, c cc cp trong t chc

d) is reviewed for continued suitability (see d. c xem xt lun thch hp (xem 5.8)
5.8),

e) adequately addresses communication (see e. c truyn t y (xem 5.6) v


5.6), and

f) is supported by measurable objectives. f. c h tr bi cc mc tiu o lng


c

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

5.4 Responsibility and authority 5.4. Trch nhim v quyn hn

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Lnh o cao nht PHI (19) m bo cc


Top management shall ensure that
trch nhim v quyn hn c xc nh
responsibilities and authorities are defined
v thng tin trong t chc m bo s
and communicated within the organization to
vn hnh v duy tr hiu qu h thng qun
ensure the effective operation and
l an ton thc phm
maintenance of the food safety management
system.

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

b) to ensure relevant training and education b. m bo vic o to v gio dc thch


of the food safety team members (see 6.2.1), hp cho cc thnh vin nhm an ton thc
phm (xem 6.2.1)

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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d. bo co cho lnh o cao nht ca t


d) to report to the organization's top
chc v hiu qu v s ph hp ca h
management on the effectiveness and
thng qun l an ton thc phm
suitability of the food safety management
system.

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

5.6 Communication 5.6. Trao i thng tin

5.6.1 External communication 5.6.1. Trao i thng tin vi bn ngoi

To ensure that sufficient information on m bo cc thng tin y v cc vn


issues concerning food safety is available lin quan n an ton thc phm lun sn
throughout the food chain, the organization c trong dy chuyn thc phm, t chc
shall establish, implement and maintain PHI (24) thit lp, thc hin v duy tr s
effective arrangements for communicating sp xp c hiu qu vic trao i thng tin
with vi

a) suppliers and contractors, a. cc nh cung cp v nh thu

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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c. cc c quan php lut c thm quyn, v


c) statutory and regulatory authorities, and

d) other organizations that have an impact on, d. cc t chc khc c tc ng n hoc b


or will be affected by, the effectiveness or nh hng bi hiu lc hoc vic cp nht
updating of the food safety management ca h thng qun l an ton thc phm
system.

Such communication shall provide Cc hot ng trao i thng tin ni trn


information on food safety aspects of the PHI (25) cung cp thng tin v cc kha
organization's products that may be relevant cnh an ton thc phm ca cc sn phm
to other organizations in the food chain. This ca t chc khi n c lin quan n t chc
applies especially to known food safety khc trong dy chuyn thc phm. iu ny
hazards that need to be controlled by other c bit c p dng vi cc mi nguy
organizations in the food chain. Records of bit v cn thit phi c kim sot bi
communications shall be maintained. (cc) t chc khc trong dy chuyn thc
phm. H s ca vic trao i thng tin
PHI (26) c duy tr

Food safety requirements from statutory and Cc yu cu ca cc c quan php lut c


regulatory authorities and customers shall be thm quyn v cc yu cu ca khch hang
available. PHI (27) sn c

Designated personnel shall have defined Ngi c ch nh PHI (28) c cc trch


responsibility and authority to communicate nhim v quyn hn thc hin trao i
externally any information concerning food thng tin vi bn ngoi v tt c cc thng
safety. Information obtained through external tin lin quan n an ton thc phm. Cc
communication shall be included as input to thng tin thu thp c t vic trao i thng
system updating (see 8.5.2) and management tin vi bn ngoi PHI (29) l mt u vo
review (see 5.8.2). ca hot ng cp nht h thng (xem 8.5.2)
v xem xt ca lnh o (xem 5.8.2)

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5.6.2. Trao i thng tin ni b


5.6.2 Internal communication

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:

a) products or new products; a. cc sn phm v cc sn phm mi

b) raw materials, ingredients and services; b. cc nguyn liu, thnh phn v cc dch
v

c) production systems and equipment; c. h thng sn xut v cc thit b

d) production premises, location of d. nh xng sn xut, b tr cc thit b v


equipment, surrounding environment; mi trng xung quanh

e) cleaning and sanitation programmes; e. cc chng trnh v sinh v ty trng

f) packaging, storage and distribution f. h thng ng gi, lu kho v phn phi


systems;

g) personnel qualification levels and/or g. trnh nng lc ca nhn vin v/ hoc s


allocation of responsibilities and phn chia cc trch nhim v quyn hn
authorizations;

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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

j) customer, sector and other requirements j. cc yu cu ca khch hng, ca


that the organization observes; ngnh v cc yu cu khc m t chc tun
th

k) relevant enquiries from external interested k. cc yu cu lin quan ca cc bn hu


parties; quan bn ngoi

l) complaints indicating food safety hazards l. cc khiu ni v an ton thc phm c


associated with the product; lin quan n sn phm

m) other conditions that have an impact on m. cc vn khc c tc ng n an ton


food safety. thc phm

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)

5.7 Emergency preparedness and response 5.7. S chun b v ng ph vi tnh


hung khn cp

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Lnh o cao nht PHI (34) thit lp, thc


Top management shall establish, implement
hin v duy tr cc th tc qun l cc
and maintain procedures to manage potential
tnh hung khn cp tim n v cc s c c
emergency situations and accidents that can
kh nng tc ng n an ton thc phm
impact food safety and which are relevant to
v c lin quan n vai tr ca t chc
the role of the organization in the food chain.
trong dy chuyn thc phm

5.8 Management review 5.8. Xem xt ca lnh o

5.8.1 General 5.8.1. Khi qut

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).

5.8.2 Review input 5.8.2. u vo ca vic xem xt

The input to management review shall u vo ca vic xem xt ca lnh o


include, but is not limited to, information on PHI (38) bao gm, nhng khng gii hn,
cc thng tin v

a) follow-up actions from previous a. cc hnh ng tip theo t cc cuc xem


management reviews, xt ca lnh o ln trc

b) analysis of results of verification activities b. phn tch kt qu ca cc hot ng thm


(see 8.4.3), tra (xem 8.4.3)

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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)

e) reviewing results of system-updating e. vic xem xt cc kt qu ca hot ng cp


activities (see 8.5.2), nht h thng qun l an ton thc phm
(xem 8.5.2);

f) review of communication activities, f. vic xem xt cc hot ng trao i thng


including customer feed-back (see 5.6.1), and tin, bao gm phn hi ca khch hng (xem
5.6.1), v

g) external audits or inspections. g. cc cuc nh gi, gim nh ca bn


ngoi

NOTE The term withdrawal includes Ch thch : thut ng withdrawal bao gm


recall. recall

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

5.8.3 Review output 5.8.3. u ra ca vic xem xt

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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b. nng cao tnh hiu lc ca h thng qun


b) improvement of the effectiveness of the
l an ton thc phm (xem 8.5),
food safety management system (see 8.5),

c) resource needs (see 6.1), and c. nhu cu v ngun lc (xem 6.1) v

d) revisions of the organization's food safety d. iu chnh cc chnh sch ca t chc v


policy and related objectives (see 5.2). an ton thc phm v cc mc tiu lin
quan (xem 5.2)

6 Resource management 6. Qun L Ngun Lc

6.1 Provision of resources 6.1. Cung cp ngun lc

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.

6.2 Human resources 6.2. Ngun nhn lc

6.2.1 General 6.2.1. Khi qut

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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quyn hn ca cc chuyn gia bn ngoi

6.2.2 Competence, awareness and training 6.2.2. Nng lc, nhn thc v o to

The organization shall T chc PHI (45)

a) identify the necessary competencies for a. xc nh nng lc cn thit ca nhng


personnel whose activities have an impact on ngi thc hin cc cng vic c tc ng
food safety, n an ton thc phm

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

c) ensure that personnel responsible for c. m bo cc c nhn c trch nhim


monitoring, corrections and corrective actions gim st, thc hin s khc phc v hnh
of the food safety management system are ng khc phc h thng qun l an ton
trained, thc phm c o to

d) evaluate the implementation and the d. nh gi vic thc hin v hiu qu ca


effectiveness of a), b) and c), a,b v c

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

f) ensure that the requirement for effective f. m bo cc yu cu v trao i thng


communication (see 5.6) is understood by all tin hiu qu (xem 5.6) c tt c cc c
personnel whose activities have an impact on nhn thc hin cc cng vic c tc
food safety, and ng n an ton thc phm thu hiu, v

g) maintain appropriate records of training g. Duy tr h s thch hp v o to v cc


and actions described in b) and c). hot ng c m t b v c,

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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

6.4 Work environment 6.4. Mi trng lm vic

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.

7 Planning and realization of safe products 7. Hoch nh v to sn phm an ton

7.1 General 7.1. Khi qut

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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7.2.1. T chc PHI (50) xy dng, p


7.2.1 The organization shall establish,
dng v duy tr cc chng trnh tin quyt
implement and maintain PRP(s) to assist in
h tr vic kim sot
controlling

a) the likelihood of introducing food safety a. Kh nng xut hin cc mi nguy i vi


hazards to the product through the work sn phm v mt an ton thc phm t mi
environment, trng lm vic

b) biological, chemical and physical b. S nhim bn sinh hc, ha hc, vt l


contamination of the product(s), including vo (cc) sn phm bao gm nhim cho
cross contamination between products, and gia cc loi sn phm, v

c) food safety hazard levels in the product c. Cc mc ca mi nguy v an ton thc


and product processing environment. phm i vi sn phm v mi trng sn
xut sn phm

7.2.2 The PRP(s) shall 7.2.2. Cc chng trnh tin quyt


PHI

a) be appropriate to the organizational needs a. ph hp vi cc nhu cu ca t chc v


with regard to food safety, an ton thc phm

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

c) be implemented across the entire c. c p dng xuyn sut trong ton b h


production system, either as programmes thng sn xut nh cc chng trnh kim
applicable in general or as programmes sot chung hoc cc chng trnh kim
applicable to a particular product or sot c th cho mt sn phm hoc mt dy
operational line, and chuyn sn xut, v

d) be approved by the food safety team. d. c ph duyt bi nhm an ton thc


phm

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T chc PHI (52) xc nh cc yu cu


The organization shall identify statutory and
php lut v ch nh c lin quan n cc
regulatory requirements related to the above.
vn trn

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)

NOTE Annex C gives a list of relevant Codex Ch Thch: Ph lc C cung cp danh mc


publications. cc n bn ca CODEX c lin quan

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

a) construction and lay-out of buildings and a. cu trc v b tr mt bng nh xng


associated utilities; v cc tin ch i km

b) lay-out of premises, including workspace b. mt bng nh xng, bao gm khng gian


and employee facilities; lm vic v cc tin ch cho cng nhn

c) supplies of air, water, energy and other c. h thng cung cp kh, nc, nng lng
utilities; v cc tin ch khc

d) supporting services, including waste and d. cc dch v h tr bao gm vic x l rc


sewage disposal; thi v nc thi

e) the suitability of equipment and its e. s ph hp ca cc thit b v kh nng v


accessibility for cleaning, maintenance and sinh, bo tr , bo tr tin on cc thit b ny
preventative maintenance;

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f. vic qun l cc nguyn vt liu mua vo


f) management of purchased materials (e.g.
(nguyn liu, cc thnh phn ph liu,
raw materials, ingredients, chemicals and
ha cht v bao b), ngun cung cp (nc,
packaging), supplies (e.g. water, air, steam
kh, hi v ), x l (rc v nc thi) v
and ice), disposals (e.g. waste and sewage)
bo qun sn phm (lu kho v vn chuyn)
and handling of products (e.g. storage and
transportation);

g) measures for the prevention of cross g. cc bin php ngn nga s nhim bn
contamination; cho

h) cleaning and sanitizing; h. v sinh v ty trng

i) pest control; i. kim sot cn trng v ng vt gy hi,

j) personnel hygiene; j. v sinh c nhn

k) other aspects as appropriate. k. v cc kha cnh khc khi cn thit

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

Documents should specify how activities Ti liu cn ch r phng php qun l cc


included in the PRP(s) are managed. hot ng thuc cc chng trnh tin quyt

7.3 Preliminary steps to enable hazard 7.3. Cc bc chun b cho hot ng


analysis phn tch mi nguy

7.3.1 General 7.3.1. Khi qut

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Tt c cc thng tin lin quan cn thit cho


All relevant information needed to conduct
vic phn tch mi nguy PHI (58) c thu
the hazard analysis shall be collected,
thp, duy tr , cp nhp v vn bn ha . H
maintained, updated and documented.
s PHI (59) c duy tr.
Records shall be maintained.

7.3.2 Food safety team 7.3.2. Nhm An ton thc phm

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 Product characteristics 7.3.3. c tnh ca sn phm

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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a) biological, chemical and physical a. cc tnh cht sinh hc, ha hc v vt l


characteristics;

b) composition of formulated ingredients, b. cng thc phi trn ca cc thnh phn ,


including additives and processing aids; bao gm ph gia v cc cht h tr quy trnh
sn xut

c) origin; c. ngun gc , xut x

d) method of production; d. phng php sn xut

e) packaging and delivery methods; e. phng php ng gi v giao hng

f) storage conditions and shelf life; f. iu kin bo qun v hn s dng

g) preparation and/or handling before use or g. phng php chun b v/ hoc x l


processing; trc khi s dng hoc a vo sn xut

h) food safety-related acceptance criteria or h. cc chun mc chp nhn lin quan n


specifications of purchased materials and an ton thc phm hoc cc tiu chun ca
ingredients appropriate to their intended uses. nguyn vt liu, cc thnh phn mua vo
ph hp vi mc ch s dng ca chng

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

The descriptions shall be kept up-to-date Bn m t PHI (65) c cp nht, khi cn


including, when required, in accordance with thit, theo yu cu ca 7.7
7.7.

7.3.3.2 Characteristics of end products 7.3.3.2. c tnh ca thnh phm

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c tnh ca thnh phm PHI (66) c


The characteristics of end products shall be
m t bng vn bn, mc cn thit cho
described in documents to the extent needed
hat ng phn tch mi nguy v khi c th ,
to conduct the hazard analysis (see 7.4),
bao gm cc thng tin sau
including information on the following, as
appropriate:

a) product name or similar identification; a. tn sn phm, hoc cc nhn dng tng


ng

b) composition; b. thnh phn

c) biological, chemical and physical c. cc c tnh sinh hc, ha hc, vt l lin


characteristics relevant for food safety; quan n an ton thc phm

d) intended shelf life and storage conditions; d. hn s dng v iu kin bo qun d


kin;

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;

g) method(s) of distribution. g. (cc) phng php phn phi

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

The descriptions shall be kept up-to-date Bn m t PHI (68) c cp nht , khi


including, when required, in accordance with cn thit , theo yu cu ca 7.7
7.7.

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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

The descriptions shall be kept up-to-date Bn m t PHI (72) c cp nht , khi


including, when required, in accordance with cn thit, theo yu cu ca 7.7
7.7.

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

7.3.5.1 Flow diagrams 7.3.5.1 S quy trnh sn xut

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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S quy trnh sn xut PHI (75) r rng ,


Flow diagrams shall be clear, accurate and
chnh xc v chi tit. Khi thch hp , s
sufficiently detailed. Flow diagrams shall, as
quy trnh sn xut PHI (76) bao gm
appropriate, include the following:
cc thng tin sau

a) the sequence and interaction of all steps in a. trnh t v tng tc ca cc cng on


the operation; trong quy trnh vn hnh

b) any outsourced processes and b. cc cng on gia cng ngoi v cc


subcontracted work; cng vic do thu ph thc hin

c) where raw materials, ingredients and c. v tr m nguyn liu , cc thnh phn,


intermediate products enter the flow; bn thnh phm bt u tham gia vo quy
trnh sn xut

d) where reworking and recycling take place; d. v tr/ cng on m sn phm c lm


li, ti ch;

e) where end products, intermediate products, e. V tr m thnh phm, bn thnh phm,


by-products and waste are released or ph phm v rc thi c c xut
removed. xng hoc thu gom v x l

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

7.3.5.2 Description of process steps and 7.3.5.2. M t cc cng on v cc bin


control measures php kim sot

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Cc bin php kim sot, cc thng s qu


The existing control measures, process
trnh v /hoc cc dung sai cho php hin
parameters and/or the rigorousness with
c hoc cc quy trnh c nh hng n an
which they are applied, or procedures that
ton thc phm PHI (79) c m t
may influence food safety, shall be described
mc cn thit cho hot ng phn tch
to the extent needed to conduct the hazard
mi nguy.(xem 7.4).
analysis (see 7.4).

External requirements (e.g. from regulatory Cc yu cu bn ngoi (nh yu cu ca c


authorities or customers) that may impact the quan nh nc c thm quyn hoc yu cu
choice and the rigorousness of the control ca khch hng) c kh nng nh hng n
measures shall also be described. s chn la v mc nghim ngt ca cc
bin php kim sot cng PHI (80) c
m t

The descriptions shall be updated in Bn m t PHI (81) c cp nhp ph


accordance with 7.7. hp vi yu cu ca 7.7

7.4 Hazard analysis 7.4. Phn tch mi nguy

7.4.1 General 7.4.1. Khi qut

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

7.4.2 Hazard identification and 7.4.2. Nhn dng cc mi nguy v xc


determination of acceptable levels nh mc chp nhn

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7.4.2.1 Tt c cc mi nguy v an ton thc


7.4.2.1 All food safety hazards that are
phm c th xy ra vi sn phm , quy trnh
reasonably expected to occur in relation to
v cc phng tin sn xut hin c PHI
the type of product, type of process and
(83) c nhn dng v lu h s. Vic
actual processing facilities shall be identified
nhn dng PHI (84) da trn
and recorded. The identification shall be
based on

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

b) experience, b. kinh nghim

c) external information including, to the c. cc thng tin bn ngoi, trong phm vi c


extent possible, epidemiological and other th, bao gm cc thng tin v dch bnh v
historical data, and cc d liu ca qu kh, v

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

b) the process equipment, utilities/services b. Thit b sn xut, cc tin ch /dch v v


and surroundings, and iu kin xung quanh, v

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c. cc mt xch trc v sau trong dy


c) the preceding and following links in the
chuyn thc phm.
food chain.

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.

7.4.3 Hazard assessment 7.4.3. nh gi mi nguy

A hazard assessment shall be conducted to Vi mi mi nguy c nhn dng (xem


determine, for each food safety hazard 7.4.2), PHI (90) thc hin vic nh gi
identified (see 7.4.2), whether its elimination mi nguy xc nh vic loi b hoc
or reduction to acceptable levels is essential gim thiu mi nguy ti mc chp nhn
to the production of a safe food, and whether c cn thit cho vic sn xut thc phm
its control is needed to enable the defined an ton hay khng, v vic kim sot mi
acceptable levels to be met. nguy c cn thit cho vic m bo t c
mc chp nhn xc nh

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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mi nguy PHI (93) c lu h s

7.4.4 Selection and assessment of control 7.4.4. Chn la v nh gi cc bin php


measures kim sot

Based on the hazard assessment of 7.4.3, an Da trn kt qu nh gi cc mi nguy


appropriate combination of control measures 7.4.3 , PHI (94) la chn mt t hp cc
shall be selected which is capable of bin php kim sot thch hp nhm ngn
preventing, eliminating or reducing these nga , loi b hoc gim thiu cc mi nguy
food safety hazards to defined acceptable v an ton thc phm ti mc chp nhn
levels. xc nh

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

e) the severity of the consequence(s) in the e. mc nghim trng ca (cc) hu qu


case of failure in its functioning; khi cc bin php kim sot b sai lch

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

g) synergistic effects (i.e. interaction that g. cc tc ng tng hp (v d s tng tc


occurs between two or more measures xut hin gia hai hay nhiu bin php lm
resulting in their combined effect being hiu qu tng hp cao hn tng hiu qu ca
higher than the sum of their individual cc bin php n l.)
effects).

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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7.5. Xy dng cc chng trnh


7.5 Establishing the operational
vn hnh tin quyt (PRPs)
prerequisite programmes (PRPs)

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

a) food safety hazard(s) to be controlled by a. cc mi nguy v an ton thc phm c


the programme (see 7.4.4); kim sot bi chng trnh (xem 7.4.4);

b) control measure(s) (see 7.4.4); b. cc bin php kim sot (7.4.4);

c) monitoring procedures that demonstrate c. th tc gim st chng minh chng


that the operational PRPs are implemented; trnh tin quyt c thc hin

d) corrections and corrective actions to be d. s khc phc v hnh ng khc phc


taken if monitoring shows that the operational c thc hin nu kt qu gim st cho
PRPs are not in control (see 7.10.1 and thy cc chng trnh vn hnh tin quyt b
7.10.2, respectively); mt kim sot(xem 7.10.1 v 7.10.2);

e) responsibilities and authorities; e. cc trch nhim v quyn hn

f) record(s) of monitoring. f. Cc h s ca vic gim st

7.6 Establishing the HACCP plan 7.6. Xy dng k hoch HACCP

7.6.1 HACCP plan 7.6.1. K hoch HACCP

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

a) food safety hazard(s) to be controlled at the a. mi nguy v an ton thc phm c


CCP (see 7.4.4); kim sot ti CCP (xem 7.4.4);

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b. cc bin php kim sot (xem 7.4.4)


b) control measure(s) (see 7.4.4)

c) critical limit(s) (see 7.6.3); c. cc gii hn ti hn ( xem 7.6.3);

d) monitoring procedure(s) (see 7.6.4); d. cc th tc gim st ( xem 7.6.4);

e) corrections and corrective action(s) to be e. s khc phc v cc hnh ng khc


taken if critical limits are exceeded (see phc c thc hin khi thng s vt gii
7.6.5); hn ti hn (xem 7.6.5);

f) responsibilities and authorities; f. cc trch nhim v quyn hn;

g) record(s) of monitoring. g. cc h s gim st

7.6.2 Identification of critical control 7.6.2. Nhn dng cc im kim sot ti


points (CCPs) hn (CCPs)

For each hazard that is to be controlled by the ng vi mi mi nguy c kim sot


HACCP plan, CCP(s) shall be identified for bng k hoch HACCP, (cc) im kim
the control measures identified (see 7.4.4). sot ti hn (CCP) PHI (106) c nhn
dng cho cc bin php kim sot c xc
nh (xem 7.4.4).

7.6.3 Determination of critical limits for 7.6.3. Xc nh gii hn ti hn cho cc


critical control points (CCPs) im kim sot ti hn (CCPs)

Critical limits shall be determined for the Cc gii hn ti hn PHI (107) c xc


monitoring established for each CCP. nh cho vic gim st c thit lp ti
mi CCP.

Critical limits shall be established to ensure Gii hn ti hn PHI (108) c thit lp


that the identified acceptable level of the food nhm m bo cc mi nguy thnh phm
safety hazard in the end product (see 7.4.2) is khng vt mc chp nhn v n an ton
not exceeded. thc phm (xem 7.4.2) xc nh

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Gii hn ti hn PHI (109) o lng c


Critical limits shall be measurable.

The rationale for the chosen critical limits L do chn Gii hn ti hn PHI (110)
shall be documented. c vn bn ho

Critical limits based on subjective data (such Gii hn ti hn da trn cc d liu ch


as visual inspection of product, process, quan (nh kim tra ngoi quan sn phm,
handling, etc.) shall be supported by quy trnh, qu trnh x l ...) PHI (111) i
instructions or specifications and/or education km vi cc hng dn hoc chun mc
and training. v/hoc quy trnh o to hay hun luyn

7.6.4 System for the monitoring of critical 7.6.4. H thng gim st cc im kim
control points sot ti hn

A monitoring system shall be established for Mt h thng gim st PHI (112) c


each CCP to demonstrate that the CCP is in thit lp cho tng CCP chng t CCP
control. The system shall include all c kim sot. H thng PHI (113) bao
scheduled measurements or observations gm tt c cc hot ng o lng theo k
relative to the critical limit(s). hoch hoc cc quan st lin quan n gii
hn 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

b) monitoring devices used; b. cc phng tin gim st c s dng

c) applicable calibration methods (see 8.3); c. cc phng php hiu chun c p


dng (xem 8.3)

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d. tn xut gim st
d) monitoring frequency;

e) responsibility and authority related to e. trch nhim v quyn hn lin quan n


monitoring and evaluation of monitoring vic gim st v nh gi cc kt qu gim
results; st

f) record requirements and methods. f. cc yu cu v ghi h s v phng


php

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

7.6.5 Actions when monitoring results 7.6.5. Cc hnh ng khi kt qu gim st


exceed critical limits vt gii hn ti hn

Planned corrections and corrective actions to PHI (116) nu c th trong k hoch


be taken when critical limits are exceeded HACCP cc s khc phc v hnh ng
shall be specified in the HACCP plan. The khc phc c hoch nh thc hin khi
actions shall ensure that the cause of thng s vt gii hn ti hn. Cc hnh
nonconformity is identified, that the ng PHI (117) m bo nguyn nhn ca
parameter(s) controlled at the CCP is (are) s khng ph hp c xc nh, cc
brought back under control, and that thng s kim sot ti CCP c kim sot
recurrence is prevented (see 7.10.2). tr li v ngn nga s ti din (xem
7.10.2)

Documented procedures shall be established PHI (118) lp v duy tr th tc dng vn


and maintained for the appropriate handling bn cho vic x l cc sn phm c nguy c
of potentially unsafe products to ensure that khng an ton mt cch thch hp nhm m
they are not released until they have been bo cc sn phm ny khng c thng qua
evaluated (see 7.10.3). cho n khi chng c nh gi

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(xem7.10.3)

7.7 Updating of preliminary information 7.7. Cp nht cc thng tin ban u v cc


and documents specifying the PRPs and ti liu m t cc chng trnh tin quyt
the HACCP plan v k hoch HACCP

Following the establishment of operational Sau khi thit lp cc chng trnh vn


PRP(s) (see 7.5) and/or the HACCP plan (see hnh tin quyt (operational PRPs)
7.6), the organization shall update the (xem7.5.5) v /hoc K hoch HACCP (xem
following information, if necessary: 7.6), khi cn thit, t chc PHI (119) cp
nht cc thng tin sau y

a) product characteristics (see 7.3.3); a. cc c tnh ca sn phm (xem 7.3.3)

b) intended use (see 7.3.4); b. mc ch s dng (xem 7.3.4)

c) flow diagrams (see 7.3.5.1); c. s quy trnh sn xut (xem 7.3.5.1)

d) process steps (see 7.3.5.2); d. cc cng on sn xut (xem 7.3.5.2)

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

7.8 Verification planning 7.8. Hoch nh vic thm tra

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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a. cc chng trnh tin quyt PRPs c


a) the PRP(s) are implemented (see 7.2),
thc hin (xem 7.2);

b) input to the hazard analysis (see 7.3) is b. u vo ca hot ng phn tch mi


continually updated, nguy (xem 7.3) c cp nht lin tc

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

d) hazard levels are within identified d. mc ca mi nguy nm trong mc


acceptable levels (see 7.4.2), and chp nhn xc nh (xem 7.4.2), v

e) other procedures required by the e. cc th tc khc do t chc t xc nh


organization are implemented and effective. 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).

If system verification is based on testing of Trong trng hp thm tra da trn kt qu


end product samples, and where such test kim tra mu thnh phm v cc mu kim
samples show nonconformity with the tra cho kt qu khng ph hp vi mc chp
acceptable level of the food safety hazard nhn v an ton thc phm (xem 7.4.2) , cc
(see 7.4.2), the affected lots of product shall l sn phm b nh hng PHI (127) c
be handled as potentially unsafe in x l nh cc Sn phm c nguy c khng

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accordance with 7.10.3. an ton nh yu cu ca 7.10.3

7.9 Traceability system 7.9. H thng truy tm ngun gc

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

Traceability records shall be maintained for a H s truy tm ngun gc PHI (130) c


defined period for system assessment to duy tr trong mt thi gian xc nh h tr
enable the handling of potentially unsafe vic x l cc sn phm c nguy c khng
products and in the event of product an ton v trong trng hp thu hi sn
withdrawal phm.

Records shall be in accordance with statutory H s PHI (131) ph hp vi yu cu lut


and regulatory requirements and customer php v ch nh v cc yu cu ca khch
requirements and may, for example, be based hng v, v d nh, da trn vic nhn dng
on the end product lot identification. l thnh phm

7.10 Control of nonconformity 7.10. Kim sot s khng ph hp

7.10.1 Corrections 7.10.1. S khc phc

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T chc PHI (132) m bo khi gii hn


The organization shall ensure that when
ti hn ti CCP vt chun (xem 7.6.5) hoc
critical limits for CCP(s) are exceeded (see
khi c s mt kim sot i vi cc chng
7.6.5), or there is a loss of control of
trnh vn hnh tin quyt, thnh phm b
operational PRP(s), the products affected are
nh hng c nhn dng v vic s dng
identified and controlled with regard to their
v xut xng sn phm ny c kim sot
use and release.

A documented procedure shall be established Mt th tc dng vn bn PHI (133) c


and maintained defining thit lp v duy tr xc nh

a) the identification and assessment of a. vic nhn dng v nh gi cc thnh


affected end products to determine their phm b nh hng xc nh cch x
proper handling (see 7.10.3), and l thch hp (xem 7.10.3), v

b) a review of the corrections carried out. b. vic xem xt s khc phc c thc
hin

Products manufactured under conditions Sn phm c sn xut trong iu kin


where critical limits have been exceeded are (thi im) gii hn ti hn vt chun l
potentially unsafe products and shall be cc sn phm c nguy c khng an ton v
handled in accordance with 7.10.3. Products PHI (134) c x l theo yu cu ca
manufactured under conditions where 7.10.3. Sn phm c sn xut trong iu
operational PRP(s) have not been conformed kin (thi im) cc chng trnh vn hnh
with shall be evaluated with respect to the tin quyt khng ph hp PHI (135) c
cause(s) of the nonconformity and to the nh gi, c xem xt n nguyn nhn ca
consequences thereof in terms of food safety s khng ph hp v hu qu ko theo trong
and shall, where necessary, be handled in phm vi v an ton thc phm, v khi cn
accordance with 7.10.3. The evaluation shall thit PHI (136) c x l theo yu cu
be recorded. ca 7.10.3. Kt qu nh gi PHI (137)
c lu h s

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All corrections shall be approved by the Tt c cc s khc phc PHI(138) c


responsible person(s), and shall be recorded ph duyt bi (cc) c nhn c trch nhim,
together with information on the nature of the v PHI (139) c lu h s bao gm
nonconformity, its cause(s) and thng tin v bn cht ca s khng ph hp,
consequence(s), including information cc nguyn nhn v cc hu qu, bao gm
needed for traceability purposes related to the thng tin cn thit cho mc ch truy tm
nonconforming lots. ngun gc cc l sn phm khng ph hp

7.10.2 Corrective actions 7.10.2. Hnh ng khc phc

Data derived from the monitoring of Cc d liu thu c t vic gim st cc


operational PRPs and CCPs shall be chng trnh vn hnh tin quyt v cc
evaluated by designated person(s) with CCP PHI (140) c nh gi bi (cc)
sufficient knowledge (see 6.2) and authority c nhn c phn cng c kin thc
(see 5.4) to initiate corrective actions. (xem 6.2) v thm quyn (xem 5.4) a
ra cc hnh ng khc phc

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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a. vic xem xt cc s khng ph hp (bao


a) reviewing nonconformities (including
gm cc khiu ni ca khch hang)
customer complaints),

b) reviewing trends in monitoring results that b. vic xem xt xu hng ca cc kt qu


may indicate development towards loss of gim st c khuynh hng pht trin theo
control, hng mt kim sot

c) determining the cause(s) of c. vic xc nh cc nguyn nhn ca cc s


nonconformities, khng ph hp

d) evaluating the need for action to ensure d. vic nh gi s cn thit c hnh ng


that nonconformities do not recur, m bo s khng ph hp khng
ti din

e) determining and implementing the actions e. vic xc nh v thc hin cc hnh ng


needed, cn thit

f) recording the results of corrective actions f. vic lu h s kt qu ca hnh ng


taken, and khc phc c thc hin, v

g) reviewing corrective actions taken to g. vic xem xt cc hnh ng khc phc


ensure that they are effective. c thc hin m bo chng c hiu
qu .

Corrective actions shall be recorded. Cc hnh ng khc phc PHI(143) c


lu h s

7.10.3 Handling of potentially unsafe 7.10.3. X l cc sn phm c nguy


products c khng an ton

7.10.3.1 General 7.10.3.1. Khi qut

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T chc PHI (144) x l cc sn phm


The organization shall handle nonconforming
khng ph hp bng cch thc hin cc
products by taking action(s) to prevent the
hnh ng ngn nga sn phm khng
nonconforming product from entering the
ph hp tham gia vo dy chuyn thc
food chain unless it is possible to ensure that
phm, tr khi c th m bo rng

a) the food safety hazard(s) of concern a. cc mi nguy v an ton thc phm cn


has(ve) been reduced to the defined quan tm c gim thiu n mc chp
acceptable levels, nhn xc nh

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

c) the product still meets the defined c. mc d c s khng ph hp xy ra, sn


acceptable level(s) of the food safety phm vn p ng cc mc chp nhn
hazard(s) of concern despite the c xc nh cho cc mi nguy v an
nonconformity. ton thc phm cn quan tm

All lots of product that may have been Tt c cc l sn phm c kh nng b nh


affected by a nonconforming situation shall hng bi tnh hung khng ph hp PHI
be held under control of the organization until (145) c t chc lu gi c kim sot cho
they have been evaluated. n khi chng c nh gi

If products that have left the control of the Nu sn phm c xc nh l khng an


organization are subsequently determined to ton sau khi chng ri khi phm vi kim
be unsafe, the organization shall notify sot ca t chc, t chc PHI (146) thng
relevant interested parties and initiate a bo cho cc bn lin quan v khi xng
withdrawal (see 7.10.4). qu trnh thu hi (xem 7.10.4)

NOTE The term withdrawal includes Ch thch: Thut ng withdrawal bao gm


recall. recall

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Vic kim sot v cc gii php ng ph v


The controls and related responses and
cc thm quyn x l cc Sn phm c nguy
authorization for dealing with potentially
c khng an ton PHI (147) c vn bn
unsafe products shall bedocumented.
ho

7.10.3.2 Evaluation for release 7.10.3.2. nh gi vic xut xng

Each lot of product affected by the Mi l sn phm b nh hng bi s khng


nonconformity shall only be released as safe ph hp CH C PHP xut xng nh
when any of the following conditions apply: sn phm an ton khi v ch khi mt trong
cc iu kin sau y xy ra

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)

c) the results of sampling, analysis and/or c. cc kt qu ly mu, phn tch v/hoc


other verification activities demonstrate that cc hot ng thm tra chng t l l sn
the affected lot of product complies with the phm b nh hng ph hp vi mc chp
identified acceptable levels for the food nhn c xc nh cho cc mi nguy
safety hazard(s) concerned. cn quan tm

7.10.3.3 Disposition of nonconforming 7.10.3.3. X l cc sn phm khng


products ph hp

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

a) reprocessing or further processing within a. ti ch hoc tip tc ch bin bn


or outside the organization to ensure that the trong hoc bn ngoi t chc nhm m
food safety hazard is eliminated or reduced to bo mi nguy v an ton thc phm c loi
acceptable levels; tr hoc gim thiu n mc chp nhn

b) destruction and/or disposal as waste. b. hu b v/hoc x l nh cht thi

7.10.4 Withdrawals 7.10.4. Thu hi

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

1) notification to relevant interested parties 1. thng bo n cc bn hu quan (nh, c


(e.g. statutory and regulatory authorities, quan c thm quyn/ chc nng, khch hng
customers and/or consumers), v/hoc ngi tiu dung)

2) handling of withdrawn products as well as 2. x l cc sn phm c thu hi cng


affected lots of the products still in stock, and nh cc l sn phm b nh hng cn trong
kho, v

3) the sequence of actions to be taken. 3. trnh t cc hnh ng cn thc hin

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Sn phm c thu hi PHI (151) c


Withdrawn products shall be secured or held
bo v hoc lu gi c kim sot cho n
under supervision until they are destroyed,
khi chng c hu b, s dng cho mc
used for purposes other than originally
ch khc mc ch s dng ban u, c
intended, determined to be safe for the same
xc nh l an ton cho mc ch s dng
(or other) intended use, or reprocessed in a
ban u hoc mc ch s dng khc, hoc
manner to ensure they become safe.
c ti ch sao cho chng tr nn an ton

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.)

8 Validation, verification and 8. Thm nh, thm tra v ci tin h


improvement of the food safety thng qun l an ton thc phm
management system

8.1 General 8.1. Khi qut

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.

8.2 Validation of control measure 8.2. Thm nh t hp cc bin php


combinations kim sot

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Trc khi p dng cc bin php kim sot


Prior to implementation of control measures
c nu trong cc chng trnh vn hnh
to be included in operational PRP(s) and the
tin quyt PRPs v k hoch HACCP, v
HACCP plan and after any change therein
sau khi c thay i cc ni dung ny (xem
(see 8.5.2), the organization shall validate
8.5.2), t chc PHI (155) thm nh (xem
(see 3.15) that
5.15) rng

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)

Modifications may include changes in control Vic iu chnh c th bao gm s thay i


measures (i.e. process parameters, cc bin php kim sot (nh thng s qu
rigorousness and/or their combination) and/or trnh, chnh xc yu cu v/hoc kt hp
change(s) in the raw materials, manufacturing c hai) v/hoc thay i v nguyn liu,
technologies, end product characteristics, cng ngh sn xut, c tnh ca thnh
methods of distribution and/or intended use phm, phng php phn phi v/ mc ch
of the end product. s dng ca thnh phm

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8.3. Kim sot theo di v o lng


8.3 Control of monitoring and measuring

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.

Where necessary to ensure valid results, the Khi cn thit m bo kt qu ng thit


measuring equipment and methods used b v phng php o lng

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,

b) shall be adjusted or re-adjusted as b. PHI (160) c hiu chnh hoc hiu


necessary, chnh li khi cn thit

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

d) shall be safeguarded from adjustments that d. PHI (162) c gi gn trnh b hiu


would invalidate the measurement results, chnh lm mt tnh ng n ca cc kt qu
and o

e) shall be protected from damage and e. PHI (163) c bo v trnh h


deterioration. hng hoc suy gim cht lng

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PHI (164) duy tr h s cc kt qu hiu


Records of the results of calibration and
chun hoc kim tra xc nhn
verification shall be maintained.

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

8.4.1 Internal audit 8.4.1. nh gi ni b

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

b) is effectively implemented and updated. b. c c p dng mt cch hiu lc v


c cp nht

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

The responsibilities and requirements for Trch nhim v cc yu cu v vic hoch


planning and conducting audits, and for nh v thc hin nh gi, v vic bo
reporting results and maintaining records, co kt qu v duy tr h s PHI (175)
shall be defined in a documented procedure. c quy nh trong mt th tc dng vn
bn

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Lnh o chu trch nhim v khu vc c


The management responsible for the area
nh gi PHI (176) m bo tin hnh
being audited shall ensure that actions are
khng chm tr cc hot ng loi b s
taken without undue delay to eliminate
khng ph hp c pht hin trong khi
detected nonconformities and their causes.
nh gi v nguyn nhn ca chng. Cc
Follow-up activities shall include the
hot ng sau nh gi PHI (177) bao
verification of the actions taken and the
gm vic thm tra cc hnh ng c
reporting of the verification results.
tin hnh v bo co kt qu thm tra

8.4.2 Evaluation of individual verification 8.4.2. nh gi cc kt qu thm tra n


results l

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).

If verification does not demonstrate Nu vic thm tra chng t c s khng


conformity with the planned arrangements, ph hp vi cc b tr sp xp hoch
the organization shall take action to achieve nh, t chc PHI (179) tin hnh cc
the required conformity. Such action shall hnh ng t c s ph hp theo yu
include, but is not limited to, review of cu. Cc hnh ng ny PHI (180) bao
gm, nhng khng gii hn trong, vic xem
xt v

a) existing procedures and communication a. cc th tc hin hnh v cc knh thng


channels (see 5.6 and 7.7), tin (xem 5.6 v 7.7),

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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c. cc chng trnh tin quyt (xem 7.2), v


c) the PRP(s) (see 7.2), and

d) the effectiveness of human resource d. hiu qu ca hot ng qun l ngun


management and of training activities (see nhn lc v hot ng o to (xem 6.2)
6.2).

8.4.3 Analysis of results of verification 8.4.3. Phn tch cc kt qu ca cc hot


activities ng thm tra

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

a) to confirm that the overall performance of a. xc nhn kt qu chung ca c h thng


the system meets the planned arrangements tho mn cc b tr sp xp hoch nh
and the food safety management system v cc yu cu ca h thng qun l an ton
requirements established by the organization, thc phm do t chc thit lp

b) to identify the need for updating or b. nhn ra nhu cu cp nht v ci tin h


improving the food safety management thng qun l an ton thc phm
system,

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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e. cung cp bng chng l cc s khc phc


e) to provide evidence that any corrections
v cc hnh ng khc phc thc hin c
and corrective actions that have been taken
hiu qu
are effective.

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).

8.5 Improvement 8.5. Ci tin

8.5.1 Continual improvement 8.5.1. Ci tin thng xuyn

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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Ch thch : ISO 9001 trnh by vic ci tin


NOTE ISO 9001 addresses continual
thng xuyn tnh hiu lc ca h thng
improvement of the effectiveness of quality
qun l cht lng. ISO 9004 cung cp
management systems. ISO 9004 provides
hng dn v ci tin thng xuyn hiu
guidance on continual improvement of the
lc v hiu qu ca h thng qun l cht
effectiveness and efficiency of quality
lng cho cc vn bn ngoi cc vn
management systems beyond what is
nu ISO 9001
addressed in ISO 9001.

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

a) input from communication, external as a. u vo ca hot ng trao i thng tin


well as internal, as stated in 5.6, vi bn ngoi v ni b, nh trnh by 5.6

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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c. u ra ca vic phn tch cc kt qu ca


c) output from the analysis of results of
cc hot ng thm tra (xem 8.4.3), v
verification activities (see 8.4.3), and

d) output from management review (see d. u ra ca xem xt ca lnh o (xem


5.8.3). 5.8.3)

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)

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