EN ISO 22000-2018 en Food safety management systems - Requirements for any organization in the food chain.pdf

1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Food safety management systems Requirements for any organization in the food chain (ISO 22000:2018)BS EN ISO 22000:2018EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 22000 June 2018 ICS 03.100.70; 67.020 Super

2、sedes EN ISO 22000:2005English Version Food safety management systems - Requirements for any organization in the food chain (ISO 22000:2018) Systmes de management de la scurit des denres alimentaires - Exigences pour tout organisme appartenant la chane alimentaire (ISO 22000:2018)Managementsysteme f

3、r die Lebensmittelsicherheit - Anforderungen an Organisationen in der Lebensmittelkette (ISO 22000:2018) This European Standard was approved by CEN on 26 May 2018. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standa

4、rd the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English,

5、 French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulg

6、aria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzer

7、land, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2018 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN natio

8、nal Members. Ref. No. EN ISO 22000:2018 ENational forewordThis British Standard is the UK implementation of EN ISO 22000:2018. It is identical to ISO 22000:2018. It supersedes BS EN ISO 22000:2005, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee AW/90,

9、 Quality systems for the food industry.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards I

10、nstitution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 89719 1ICS 03.120.10; 67.020; 03.100.70Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30

11、June 2018.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 22000:2018EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 22000 June 2018 ICS 03.100.70; 67.020 Supersedes EN ISO 22000:2005English Version Food safety management systems - Requirements for a

12、ny organization in the food chain (ISO 22000:2018) Systmes de management de la scurit des denres alimentaires - Exigences pour tout organisme appartenant la chane alimentaire (ISO 22000:2018)Managementsysteme fr die Lebensmittelsicherheit - Anforderungen an Organisationen in der Lebensmittelkette (I

13、SO 22000:2018) This European Standard was approved by CEN on 26 May 2018. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliogr

14、aphical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibi

15、lity of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic

16、 of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE N

17、ORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2018 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 22000:2018 EBS EN ISO 22000:2018BS EN ISO 22000:2018EN ISO 22

18、000:2018 (E) 3 European foreword This document (EN ISO 22000:2018) has been prepared by Technical Committee ISO/TC 34 “Food products“. 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 December 2018

19、, and conflicting national standards shall be withdrawn at the latest by December 2018. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights. This document

20、 supersedes EN ISO 22000:2005. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Rep

21、ublic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 22000:2018 ha

22、s been approved by CEN as EN ISO 22000:2018 without any modification. BS EN ISO 22000:2018BS EN ISO 22000:2018ISO 22000:2018(E)Foreword vIntroduction vi1 Scope . 12 Normative references 13 Terms and definitions . 14 Context of the organization . 94.1 Understanding the organization and its context .

23、94.2 Understanding the needs and expectations of interested parties 94.3 Determining the scope of the food safety management system . 94.4 Food safety management system . 105 Leadership .105.1 Leadership and commitment 105.2 Policy 105.2.1 Establishing the food safety policy 105.2.2 Communicating th

24、e food safety policy .105.3 Organizational roles, responsibilities and authorities.116 Planning 116.1 Actions to address risks and opportunities 116.2 Objectives of the food safety management system and planning to achieve them .126.3 Planning of changes . 127 Support 137.1 Resources 137.1.1 General

25、.137.1.2 People .137.1.3 Infrastructure 137.1.4 Work environment 137.1.5 Externally developed elements of the food safety management system147.1.6 Control of externally provided processes, products or services .147.2 Competence 147.3 Awareness 147.4 Communication . 157.4.1 General. 157.4.2 External

26、communication 157.4.3 Internal communication . 157.5 Documented information 167.5.1 General. 167.5.2 Creating and updating 167.5.3 Control of documented information 178 Operation 178.1 Operational planning and control .178.2 Prerequisite programmes (PRPs) 178.3 Traceability system 188.4 Emergency pr

27、eparedness and response 198.4.1 General.198.4.2 Handling of emergencies and incidents 198.5 Hazard control 198.5.1 Preliminary steps to enable hazard analysis 198.5.2 Hazard analysis 218.5.3 Validation of control measure(s) and combinations of control measures 238.5.4 Hazard control plan (HACCP/OPRP

28、 plan) 248.6 Updating the information specifying the PRPs and the hazard control plan .25 ISO 2018 All rights reserved iiiContents PageBS EN ISO 22000:2018ISO 22000:2018(E)8.7 Control of monitoring and measuring . 258.8 Verification related to PRPs and the hazard control plan .268.8.1 Verification .

29、268.8.2 Analysis of results of verification activities .268.9 Control of product and process nonconformities 278.9.1 General.278.9.2 Corrections .278.9.3 Corrective actions 278.9.4 Handling of potentially unsafe products 288.9.5 Withdrawal/recall .299 Performance evaluation 299.1 Monitoring, measure

30、ment, analysis and evaluation 299.1.1 General.299.1.2 Analysis and evaluation 299.2 Internal audit .309.3 Management review 319.3.1 General.319.3.2 Management review input .319.3.3 Management review output 3110 Improvement .3210.1 Nonconformity and corrective action 3210.2 Continual improvement .321

31、0.3 Update of the food safety management system .32Annex A (informative) Cross references between the CODEX HACCP and this document .33Annex B (informative) Cross references between this document and ISO 22000:2005 34Bibliography .37iv ISO 2018 All rights reservedBS EN ISO 22000:2018ISO 22000:2018(E

32、)ForewordISO (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 t

33、echnical 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

34、 of electrotechnical standardization. The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of ISO documents should be noted. This docu

35、ment was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all

36、such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www .iso .org/patents).Any trade name used in this document is information given for the convenience of users and

37、 does not constitute an endorsement. For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to

38、Trade (TBT) see www .iso .org/iso/foreword .html.This document was prepared by Technical Committee ISO/TC 34, Food products, Subcommittee SC 17, Management systems for food safety.Any feedback or questions on this document should be directed to the users national standards body. A complete listing o

39、f these bodies can be found at www .iso .org/members .html.This second edition cancels and replaces the first edition (ISO 22000:2005), which has been technically revised through the adoption of a revised clause sequence. It also incorporates the Technical Corrigendum ISO 22000:2005/Cor.1:2006. The

40、following annexes are included to provide the users of this document with further information: Annex A: cross references between the CODEX HACCP principles and this document; Annex B: cross reference between this document and ISO 22000:2005. ISO 2018 All rights reserved vBS EN ISO 22000:2018ISO 2200

41、0:2018(E)Introduction0.1 GeneralThe adoption of a food safety management system (FSMS) is a strategic decision for an organization that can help to improve its overall performance in food safety. The potential benefits to an organization of implementing a FSMS based on this document are:a) the abili

42、ty to consistently provide safe foods and products and services that meet customer and applicable statutory and regulatory requirements;b) addressing risks associated with its objectives;c) the ability to demonstrate conformity to specified FSMS requirements.This document employs the process approac

43、h (see 0.3), which incorporates the Plan-Do-Check-Act (PDCA) cycle (see 0.3.2) and risk-based thinking (see 0.3.3).This process approach enables an organization to plan its processes and their interactions.The PDCA cycle enables an organization to ensure that its processes are adequately resourced a

44、nd managed, and that opportunities for improvement are determined and acted on.Risk-based thinking enables an organization to determine the factors that could cause its processes and its FSMS to deviate from the planned results, and to put in place controls to prevent or minimize adverse effects.In

45、this document, the following verbal forms are used: “shall” indicates a requirement; “should” indicates a recommendation; “may” indicates a permission; “can” indicates a possibility or a capability.“NOTES” provide guidance in understanding or clarifying the requirements in this document.0.2 FSMS pri

46、nciplesFood safety is related to the presence of food safety hazards at the time of consumption (intake by the consumer). Food safety hazards can occur at any stage of the food chain. Therefore, adequate control throughout the food chain is essential. Food safety is ensured through the combined effo

47、rts of all the parties in the food chain. This document specifies the requirements for a FSMS that combines the following generally recognized key elements: interactive communication; system management; prerequisite programmes; hazard analysis and critical control point (HACCP) principles.In additio

48、n, this document is based on the principles that are common to ISO management system standards. The management principles are: customer focus; leadership; engagement of people;vi ISO 2018 All rights reservedBS EN ISO 22000:2018ISO 22000:2018(E) process approach; improvement; evidence-based decision

49、making; relationship management.0.3 Process approach0.3.1 GeneralThis document adopts a process approach when developing and implementing a FSMS and improving its effectiveness to enhance production of safe products and services while meeting applicable requirements. Understanding and managing interrelated processes as a system contributes to the organizations effectiveness and efficiency in achieving its intended results. The process approach involves the systematic definition and management of processes, and their interac