BS ISO 22004-2014 Food safety management systems Guidance on the application of ISO 22000《食品安全管理系统 ISO 22000应用指南》.pdf

1、BSI Standards PublicationBS ISO 22004:2014Food safety managementsystems Guidance on theapplication of ISO 22000BS ISO 22004:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 22004:2014.The UK participation in its preparation was entrusted to TechnicalCommitt

2、ee AW/90, Quality systems for the food industry.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Stand

3、ards Institution 2014. Published by BSI StandardsLimited 2014ISBN 978 0 580 80727 5ICS 67.020Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 September 2014.Amen

4、dments issued since publicationDate Text affectedBS ISO 22004:2014 ISO 2014Food safety management systems Guidance on the application of ISO 22000Systmes de management de la scurit des denres alimentaires Recommandations pour lapplication de lISO 22000INTERNATIONAL STANDARDISO22004First edition2014-

5、09-01Reference numberISO 22004:2014(E)BS ISO 22004:2014ISO 22004:2014(E)ii ISO 2014 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2014All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or

6、mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester.ISO copyright officeCase postale 56 CH-1211 Geneva 20Tel. + 41 22 749

7、01 11Fax + 41 22 749 09 47E-mail copyrightiso.orgWeb www.iso.orgPublished in SwitzerlandBS ISO 22004:2014ISO 22004:2014(E) ISO 2014 All rights reserved iiiContents PageForeword iv0 Introduction .v1 Scope . 12 Normative references 13 Terms and definitions . 14 General (Clause 7 of ISO 22000:2005) . 2

8、5 Planning . 55.1 Management responsibility (Clause 5 of ISO 22000:2005) . 55.2 Resource management (Clause 6 of ISO 22000:2005) . 65.3 Emergency preparedness (5.7 of ISO 22000:2005) . 65.4 Control of documents including records (4.2.2 and 4.2.3 of ISO 22000:2005).65.5 PRPs (7.2 of ISO 22000:2005) .

9、 75.6 Preliminary steps to enable hazard analysis (7.3 and 7.7 of ISO 22000:2005) 75.7 Hazard analysis (7.4 of ISO 22000:2005) 85.8 Validation of control measures or combination of control measures (8.2 of ISO 22000:2005) . 95.9 Establishing the HACCP plan (7.6 of ISO 22000:2005) .105.10 Establishin

10、g the OPRPs (7.5 of ISO 22000:2005) 115.11 Verification planning (7.8 of ISO 22000:2005) 115.12 Traceability (7.9 of ISO 22000:2005) . 126 Implementation 136.1 General (7.6.4, 7.8 and 8.2 of ISO 22000:2005).136.2 Monitoring (7.6.4 of ISO 22000:2005) 136.3 Corrections and corrective actions (7.10.1 a

11、nd 7.10.2 of ISO 22000:2005).146.4 Handling of potentially unsafe products (7.10.3 and 7.10.4 of ISO 22000:2005) .146.5 Communication process (5.6 of ISO 22000:2005) 156.6 Documentation (4.2 of ISO 22000:2005) 167 Verification 207.1 General (7.8 and 8.4 of ISO 22000:2005) . 207.2 Verification of spe

12、cifications for incoming materials and contracted services (7.8 of ISO 22000:2005) 217.3 System verification (8.4 of ISO 22000:2005) 218 Improvement .228.1 Management review (5.8 of ISO 22000:2005) . 228.2 Improvement and updating (8.5 of ISO 22000:2005) .229 Use of consultancy and externally develo

13、ped generic guidelines (Clause 1 and 4.1 of ISO 22000:2005) 23Annex A (informative) Correspondence between this International Standard (ISO 22004) and related documents .24Annex B (informative) Improvement through learning .31Annex C (informative) Involvement and motivation through training 32Biblio

14、graphy .33BS ISO 22004:2014ISO 22004:2014(E)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

15、 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 Elect

16、rotechnical Commission (IEC) on all matters 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

17、 ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directivesAttention 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 respon

18、sible for identifying any or all 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. www.iso.org/patentsAny trade name used in this document is information given for the

19、 convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: For

20、eword - Supplementary informationThe committee responsible for this document is ISO/TC 34, Foods products, Subcommittee SC 17, Management systems for food safety.This first edition of ISO 22004 cancels and replaces ISO/TS 22004:2005, which has been technically revised.iv ISO 2014 All rights reserved

21、BS ISO 22004:2014ISO 22004:2014(E)0 Introduction0.1 GeneralThis International Standard provides guidance on the use of ISO 22000 in four parts: planning, implementation, verification and improvement (Plan, Do, Check, Act). The clauses of ISO 22000 link together to form a food safety management syste

22、m (FSMS).Correspondence with the relevant clauses of ISO 22000 is given in the headings as well as in Annex A (see Tables A.1 and A.2).0.2 Food chain approachEstablishing an FSMS is a tool used to mitigate the risk to public health associated with the organizations products; it is also useful for en

23、suring compliance with statutory/regulatory requirements and/or those specified by customers.ISO 22000 promotes the adoption of a systematic approach for developing, documenting, implementing and maintaining an FSMS. Integral to this approach are supply chain management (supplier evaluation and appr

24、oval) and ensuring the safety of products during distribution.0.3 Process approachISO 22000 also follows the “process approach” (i.e. management of a system of interrelated processes with identified interactions).An advantage of the process approach is the ongoing control it provides between the ind

25、ividual processes within the system.When used within an FSMS, the process approach emphasizes the importance of:a) understanding and fulfilling the ISO 22000 requirements;b) considering food safety as a process;c) considering traceability as a process;d) monitoring of process performance and effecti

26、veness;e) continual improvement of processes based on objective measurement(s).Any and all parties, as defined by internal and external communication, can play a role in defining process requirements. Evaluating the satisfaction of these entities requires the collection and analysis of information t

27、o determine whether or not the organization has been able to meet these demands.0.4 The ISO 22000-related documentsThe ISO 22000 family of documents comprises of a number of individual International Standards and Technical Specifications, which are interrelated and supplementary to each other (see F

28、igure 1). ISO 22000 is the primary International Standard, which defines the requirements and to which the other International Standards and Technical Specifications within the family are linked.ISO/TS 22002 (all parts)6provides guidance to meet the requirements for prerequisite programmes (PRPs). I

29、t is intended to be used in support of the requirements for PRPs specified by ISO 22000. PRP documents of the ISO/TS 22002 series address food chain categories according to ISO/TS 22003:2013, Clause A.1, and potentially related categories.7ISO/TS 22003 provides guidance for the accreditation of cert

30、ification bodies, that is, those groups which can audit organizations in the food chain under ISO 22000. It also defines the basic requirements for companies applying for ISO 22000 certification, the rules applicable to audit and certification, and provides for customers the necessary information an

31、d confidence in the certification process regarding suppliers. ISO 2014 All rights reserved vBS ISO 22004:2014ISO 22004:2014(E)ISO 22005 provides guidance on the establishment and operation of traceability systems including traceability for food safety purposes. Some of this guidance is also include

32、d in this International Standard (see 5.12 and Reference 8).Reference 10 on ISO 22000, also referred to as the “fitness checker”, is a handbook first published in 2006, which specifically targets small businesses that are not familiar with ISO and its standards.10It provides these organizations with

33、 guidance for future certification.Reference 11 on how to use ISO 22000 is a handbook providing generic guidance to assist organizations, in particular small- and medium-sized organizations, on how to develop, document, implement and maintain an FSMS in accordance with ISO 22000.11Bodies providing a

34、udit and certig976icationGuidance on theapplication of ISO 22000:2005Traceability in thefeed and food chainRequirements for bodies providing audit andcertig976ication of food safetymanagement systemsFood SafetyManagementCodex AlimentariusConceptOther supportive standards/documentsISO 22000Are you re

35、ady ?How to useISO 22000 ?ISO22004ISO22000Requirements for any organization in thefood chainISO22005ISO/TS22002-seriesISO/TS22003Prerequisite programmeson food safetyby categoriesFigure 1 Overview of ISO 22000-related documents0.5 Relationship with ISO 9001ISO 22000 has been designed to work in harm

36、ony with ISO 90011and its supporting standards.ISO 9001 provides requirements for a quality management system, which can be used internally by organizations, for certification or for contractual purposes. It focuses on the effectiveness of the quality management system in meeting customers requireme

37、nts.ISO 22000 provides the essential elements of an FSMS for similar purposes.vi ISO 2014 All rights reservedBS ISO 22004:2014ISO 22004:2014(E)0.6 Compatibility with other management systemsAn FSMS is most effective when developed, documented, implemented and maintained within the framework of a str

38、uctured management system, which is incorporated into the overall management activities of the organization.ISO 22000 enables an organization to align or integrate its own FSMS with other related ISO management systems (e.g. ISO 9001,1ISO 14001,4ISO 280009).It is possible for an organization to adap

39、t the management part of its existing ISO 22000 system(s) so as to facilitate the implementation of other ISO management system Standards. For example, the following system elements might be common to any other ISO management system, however, managed differently and/or independently, when needed: po

40、licy; management responsibilities (commitment, resources and objectives); competencies (training); management review; monitoring and measurement; document control; audit of the system; corrective actions; continual improvement; traceability; communication. ISO 2014 All rights reserved viiBS ISO 2200

41、4:2014BS ISO 22004:2014Food safety management systems Guidance on the application of ISO 220001 ScopeThis International Standard provides generic advice on the application of ISO 22000.This International Standard does not create, alter or replace any of the requirements in ISO 22000. As individual o

42、rganizations are free to choose the necessary methods and approaches to fulfil the requirements of ISO 22000, the guidance provided by this International Standard, are under no circumstances, to be considered a requirement.This International Standard has been drafted to enhance acceptance and use of

43、 ISO 22000-based food safety management systems (FSMS), as well as to improve understanding, communication and coordination between organizations in the food chain.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable to

44、 its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 22000:2005, Food safety management systems Requirements for any organization in the food chain3 Terms and definitionsFo

45、r the purposes of this document, the terms and definitions given in ISO 22000 and the following apply.NOTE In the context of food safety, the terms “hazard” and “risk” are still translated into and/or used for the single word: “risk”, thus leading to the use of the incorrect expression “risk analysi

46、s” instead of the correct expression “hazard analysis” (see 3.3 of ISO 22000:2005).3.1significant hazardbiological, chemical or physical hazard, identified through the hazard analysis process, which needs to be controlled at critical control point(s) CCP(s), or by operational PRP(s) and/or by combin

47、ations thereofNote 1 to entry: Lack of control will lead to a potentially unsafe product. Identified hazards, not assessed as significant, need not be controlled at CCP(s) and/or by operational PRP(s).Note 2 to entry: Operational prerequisite programme is abbreviated as OPRP.3.2deviationfailure to m

48、eet an expected outcomeINTERNATIONAL STANDARD ISO 22004:2014(E) ISO 2014 All rights reserved 1BS ISO 22004:2014ISO 22004:2014(E)3.3action limitaction criterionmeasurable or observable criterion established for the monitoring of a control measure applied as an OPRPNote 1 to entry: An action limit or

49、criterion expresses whether or not the control measure is under control, and distinguishes between what is acceptable (limit met or achieved means the control measure is operating as intended) and unacceptable (limit not met nor achieved means the control measure is not operating as intended).4 General (Clause 7 of ISO 22000:2005)ISO 22000 requires the application of a dynamic and systematic process approach to the development, documentation, implementation and maintenance of an FSMS. This is achieved throug