EN ISO 22000-2005 en Food safety management systems - Requirements for any organization in the food chain《食品安全管理系统 食品链上任一组织的要求 ISO 22000-2005》.pdf

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1、BRITISH STANDARDBS EN ISO 22000:2005Food safety management systems Requirements for any organization in the food chain The European Standard EN ISO 22000:2005 has the status of a British StandardICS 67.020g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49

2、g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN ISO 22000:2005This British Standard was published under the authority of the Standards Policy and Strategy Committee on 16 September 2005 BSI 16 September 2005ISBN 0 580 46684 1National for

3、ewordThis British Standard is the official English language version of EN ISO 22000:2005. It is identical with ISO 22000:2005.The UK participation in its preparation was entrusted to Technical Committee AW/90, Quality systems for the food industry, which has the responsibility to: A list of organiza

4、tions represented on this committee can be obtained on request to its secretary.Cross-referencesThe British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Corresponden

5、ce Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itsel

6、f confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep UK interests informed; monitor related international and European developments and promul

7、gate them in the UK.Summary of pagesThis document comprises a front cover, an inside front cover, the EN ISO title page, the EN ISO foreword page, the ISO title page, pages ii to vii, a blank page, pages 1 to 32, an inside back cover and a back cover.The BSI copyright notice displayed in this docume

8、nt indicates when the document was last issued.Amendments issued since publicationAmd. No. Date CommentsEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 22000September 2005ICS 67.020English VersionFood safety management systems - Requirements for anyorganization in the food chain (ISO 22000:200

9、5)Systmes de management de la scurit des denresalimentaires - Exigences pour tout organisme appartenant la chane alimentaire (ISO 22000:2005)Managementsysteme fr die Lebensmittelsicherheit -Anforderungen an Organisationen in der gesamtenLebensmittelkette (ISO 22000:2005)This European Standard was ap

10、proved by CEN on 18 August 2005.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national

11、standards may be obtained on application to the Central Secretariat or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified

12、to the Central Secretariat has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, No

13、rway, Poland, Portugal, Slovakia,Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2005 CEN All rights of exploitation in any form and by any

14、 means reservedworldwide for CEN national Members.Ref. No. EN ISO 22000:2005: EForeword This document (EN ISO 22000:2005) has been prepared by Technical Committee ISO/TC 34 “Agricultural food products“ in collaboration with Technical Committee CEN/SS C01 “Food Products“, the secretariat of which is

15、held by CMC. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by March 2006, and conflicting national standards shall be withdrawn at the latest by March 2006. According to the CEN/CENELEC Internal Re

16、gulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands,

17、 Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 22000:2005 has been approved by CEN as EN ISO 22000:2005 without any modifications. EN ISO 22000:2005INTERNATIONALSTANDARDISO22000First edition2005-09-01Reference numberIS

18、O 22000:2005(E)Food safety management systems Requirements for any organization in the food chainSystmes de management de la scurit des denres alimentaires Exigences pour tout organisme appartenant la chane alimentaireEN ISO 22000:2005iiiiiContents Page1 Scope 12 Normative references 13 Terms and de

19、finitions 24 Food safety management system 44.1 General requirements . 44.2 Documentation requirements 55 Management responsibility 55.1 Management commitment 55.2 Food safety policy . 65.3 Food safety management system planning 65.4 Responsibility and authority 65.5 Food safety team leader . 65.6 C

20、ommunication . 75.7 Emergency preparedness and response 85.8 Management review 86 Resource management . 86.1 Provision of resources 86.2 Human resources 96.3 Infrastructure . 96.4 Work environment . 97 Planning and realization of safe products . 97.1 General . 97.2 Prerequisite programmes (PRPs) 107

21、.3 Preliminary steps to enable hazard analysis 117.4 Hazard analysis . 137.5 Establishing the operational prerequisite programmes (PRPs) . 147.6 Establishing the HACCP plan . 147.7 Updating of preliminary information and documents specifying the PRPsand the HACCP plan 157.8 Verification planning . 1

22、67.9 Traceability system . 167.10 Control of nonconformity . 168 Validation, verification and improvement of the food safety management system 188.1 General . 188.2 Validation of control measure combinations 198.3 Control of monitoring and measuring . 198.4 Food safety management system verification

23、 . 198.5 Improvement 20EN ISO 22000:2005ivAnnex A (informative) Cross references between ISO 22000:2005 and ISO 9001:2000 . 22Annex B (informative) Cross references between HACCP and ISO 22000:2005 . 27Annex C (informative) Codex references providing examples of control measures, including prerequis

24、ite programmes and guidance for their selection and use 28Bibliography . 32EN ISO 22000:2005vForewordISO (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 o

25、ut through ISOtechnical committees. Each member body interested in a subject for which a technical committee has beenestablished has the right to be represented on that committee. International organizations, governmental andnon-governmental, in liaison with ISO, also take part in the work. ISO coll

26、aborates closely with the InternationalElectrotechnical 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 Stand

27、ards. Draft International Standardsadopted by the technical committees are circulated to the member bodies for voting. Publication as anInternational 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 thi

28、s document may be the subject of patentrights. 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.EN ISO 22000:2005viIntroductionFood safety is related to the presence of food-borne hazards in food at

29、 the point of consumption (intake by theconsumer). As the introduction of food safety hazards can occur at any stage of the food chain, adequatecontrol throughout the food chain is essential. Thus, food safety is ensured through the combined efforts of allthe parties participating in the food chain.

30、Organizations within the food chain range from feed producers and primary producers through foodmanufacturers, transport and storage operators and subcontractors to retail and food service outlets (togetherwith inter-related organizations such as producers of equipment, packaging material, cleaning

31、agents, additivesand ingredients). Service providers are also included.This International Standard specifies the requirements for a food safety management system that combines thefollowing generally recognized key elements to ensure food safety along the food chain, up to the point of finalconsumpti

32、on: interactive communication; system management; prerequisite programmes; HACCP principles.Communication along the food chain is essential to ensure that all relevant food safety hazards are identifiedand adequately controlled at each step within the food chain. This implies communication betweenor

33、ganizations both upstream and downstream in the food chain. Communication with customers and suppliersabout identified hazards and control measures will assist in clarifying customer and supplier requirements (e.g.with regard to the feasibility and need for these requirements and their impact on the

34、 end product).Recognition of the organizations role and position within the food chain is essential to ensure effectiveinteractive communication throughout the chain in order to deliver safe food products to the final consumer. Anexample of the communication channels among interested parties of the

35、food chain is shown in Figure 1.The most effective food safety systems are established, operated and updated within the framework of astructured management system and incorporated into the overall management activities of the organization.This provides maximum benefit for the organization and intere

36、sted parties. This International Standard hasbeen aligned with ISO 9001 in order to enhance the compatibility of the two standards. Cross-referencesbetween this International Standard and ISO 9001 are provided in Annex A.This International Standard can be applied independently of other management sy

37、stem standards. Itsimplementation can be aligned or integrated with existing related management system requirements, whileorganizations may utilize existing management system(s) to establish a food safety management system thatcomplies with the requirements of this International Standard.This Intern

38、ational Standard integrates the principles of the Hazard Analysis and Critical Control Point (HACCP)system and application steps developed by the Codex Alimentarius Commission. By means of auditablerequirements, it combines the HACCP plan with prerequisite programmes (PRPs). Hazard analysis is the k

39、ey toan effective food safety management system, since conducting a hazard analysis assists in organizing theknowledge required to establish an effective combination of control measures. This International Standardrequires that all hazards that may be reasonably expected to occur in the food chain,

40、including hazards that maybe associated with the type of process and facilities used, are identified and assessed. Thus it provides themeans to determine and document why certain identified hazards need to be controlled by a particularorganization and why others need not.During hazard analysis, the

41、organization determines the strategy to be used to ensure hazard control bycombining the PRP(s), operational PRP(s) and the HACCP plan.EN ISO 22000:2005viiCross-references between the Codex Alimentarius Commission HACCP principles and application steps (seeReference 11) and this International Standa

42、rd are provided in Annex B.To facilitate the application of this International Standard, it has been developed as an auditable standard.However, individual organizations are free to choose the necessary methods and approaches to fulfil therequirements of this International Standard. To assist indivi

43、dual organizations with the implementation of thisInternational Standard, guidance on its use is provided in ISO/TS 22004.This International Standard is intended to address aspects of food safety concerns only. The same approach asprovided by this International Standard can be used to organize and r

44、espond to other food specific aspects (e.g.ethical issues and consumer awareness).This International Standard allows an organization (such as a small and/or less developed organization) toimplement an externally developed combination of control measures.The aim of this International Standard is to h

45、armonize on a global level the requirements for food safetymanagement for businesses within the food chain. It is particularly intended for application by organizations thatseek a more focused, coherent and integrated food safety management system than is normally required bylaw. It requires an orga

46、nization to meet any applicable food safety related statutory and regulatory requirementsthrough its food safety management system.NOTE The figure does not show the type of interactive communications along and across the food chain that by-passimmediate suppliers and customers.Figure 1 Example of co

47、mmunication within the food chainEN ISO 22000:2005blank1Food safety management systems Requirements for any organization in the food chain1ScopeThis International Standard specifies requirements for a food safety management system where anorganization in the food chain needs to demonstrate its abili

48、ty to control food safety hazards in order to ensurethat food is safe at the time of human consumption.It is applicable to all organizations, regardless of size, which are involved in any aspect of the food chain andwant to implement systems that consistently provide safe products. The means of meet

49、ing any requirements ofthis International Standard can be accomplished through the use of internal and/or external resources.This International Standard specifies requirements to enable an organizationa) to plan, implement, operate, maintain and update a food safety management system aimed at providingproducts that, according to their intended use, are safe for the consumer,b) to demonstrate compliance with applicable statutory and regulatory food safety requirements,c) to evaluate and assess customer requirements and demonstrate con