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1、BRITISH STANDARD BS ISO 15161:2001 Guidelines on the application of ISO 9001:2000 for the food and drink industry ICS 03.120.10; 67 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 25 14:43:56 GMT+00:00 2006, Uncontrolled Copy
2、, (c) BSI BS ISO 15161:2001 This British Standard, having been prepared under the direction of the Consumer Products and Services Sector Policy and Strategy Committee, was published under the authority of the Standards Policy and Strategy Committee on 19 December 2001 BSI 19 December 2001 ISBN 0 580
3、 38777 1 National foreword This British Standard reproduces verbatim ISO 15161:2001 and implements it as the UK national standard. 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 org
4、anizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Stand
5、ards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standa
6、rd does not of itself 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 the UK interests informed; monitor related international and European
7、 developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the ISO title page, pages ii to viii, pages 1 to 35 and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments
8、issued since publication Amd. No. DateComments Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 25 14:43:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO 15161:2001(E) INTERNATIONAL STANDARD ISO 15161 First edition 2001-11-15 Guidelines on the application of ISO 9001:2000 for th
9、e food and drink industry Lignes directrices relatives lapplication de lISO 9001:2000 aux industries de lalimentaire et des boissons Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 25 14:43:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO 15161:2001(E) ii Licensed Copy: sheffieldun sheffieldun,
10、 na, Sat Nov 25 14:43:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO 15161:2001(E) iii Contents Page Foreword.iv Introduction.v 1 Scope1 2 Normative reference1 3 Terms and definitions .1 4 Quality management system3 4.1 General requirements3 4.2 Documentation requirements.4 5 Management responsib
11、ility 7 5.1 Management commitment 7 5.2 Customer focus .7 5.3 Quality policy .8 5.4 Planning8 5.5 Responsibility, authority and communication .9 5.6 Management review.10 6 Resource management.11 6.1 Provision of resources11 6.2 Human resources 11 6.3 Infrastructure .12 6.4 Work environment.12 7 Prod
12、uct realization 13 7.1 Planning of product realization13 7.2 Customer-related processes15 7.3 Design and development17 7.4 Purchasing .20 7.5 Production and service provision22 7.6 Control of monitoring and measuring devices.25 8 Measurement, analysis and improvement26 8.1 General26 8.2 Monitoring a
13、nd measurement 27 8.3 Control of nonconforming product29 8.4 Analysis of data .30 8.5 Improvement 30 Annex A (informative) Interrelationship between the HACCP and ISO 9001:2000 systems .33 Bibliography35 Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 25 14:43:56 GMT+00:00 2006, Uncontrolled Cop
14、y, (c) BSI ISO 15161:2001(E) iv 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 inter
15、ested 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
16、 Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publicatio
17、n 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
18、 patent rights. International Standard ISO 15161 was prepared by Technical Committee ISO/TC 34, Food products. Annex A of this International Standard is for information only. A list of standards and other publications related to this International Standard is given in the Bibliography. Licensed Copy
19、: sheffieldun sheffieldun, na, Sat Nov 25 14:43:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO 15161:2001(E) v Introduction ISO 9001:2000, Quality management systems Requirements 0.1 General The adoption of a quality management system should be a strategic decision of an organization. The design
20、and implementation of an organizations quality management system is influenced by varying needs, particular objectives, the products provided, the processes employed and the size and structure of the organization. It is not the intent of this International Standard to imply uniformity in the structu
21、re of quality management systems or uniformity of documentation. The quality management system requirements specified in this International Standard are complementary to requirements for products. Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement. Th
22、is International Standard can be used by internal and external parties, including certification bodies, to assess the organizations ability to meet customer, regulatory and the organizations own requirements. The quality management principles stated in ISO 9004:2000 have been taken into consideratio
23、n during the development of this International Standard. 0.2 Process approach This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer req
24、uirements. For an organization to function effectively, it has to identify and manage numerous linked activities. An activity using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process. Often the output from one process directly forms th
25、e input to the next. The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management, can be referred to as the “process approach”. An advantage of the process approach is the ongoing control that it provides
26、 over the linkage between the individual processes within the system of processes, as well as over their combination and interaction. When used within a quality management system, such an approach emphasizes the importance of a) understanding and fulfilling requirements, b) the need to consider proc
27、esses in terms of added value, c) obtaining results of process performance and effectiveness, and d) continual improvement of processes based on objective measurement. The model of a process-based quality management system shown in Figure 1 illustrates the process linkages presented in clauses 4 to
28、8. This illustration shows that customers play a significant role in defining requirements as inputs. Monitoring of customer satisfaction requires the evaluation of information relating to customer perception as to whether the organization has met the customer requirements. The model shown in Figure
29、 1 covers all the requirements of this International Standard, but does not show processes at a detailed level. Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 25 14:43:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO 15161:2001(E) vi NOTE In addition, the methodology known as “Plan-Do-Check-Ac
30、t” (PDCA) can be applied to all processes. PDCA can be briefly described as follows: Plan: establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organizations policies. Do: implement the processes. Check: monitor and measure processes an
31、d product against policies, objectives and requirements for the product and report the results. Act: take actions to continually improve process performance. Figure 1 Model of a process-based quality management system 0.3 Relationship with ISO 9004 The present editions of ISO 9001 and ISO 9004 have
32、been developed as a consistent pair of quality management system standards which have been designed to complement each other, but can also be used independently. Although the two International Standards have different scopes, they have similar structures in order to assist their application as a con
33、sistent pair. ISO 9001 specifies requirements for a quality management system that can be used for internal application by organizations, or for certification, or for contractual purposes. It focuses on the effectiveness of the quality management system in meeting customer requirements. Licensed Cop
34、y: sheffieldun sheffieldun, na, Sat Nov 25 14:43:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO 15161:2001(E) vii ISO 9004 gives guidance on a wider range of objectives of a quality management system than does ISO 9001, particularly for the continual improvement of an organizations overall perfor
35、mance and efficiency, as well as its effectiveness. ISO 9004 is recommended as a guide for organizations whose top management wishes to move beyond the requirements of ISO 9001, in pursuit of continual improvement of performance. However, it is not intended for certification or for contractual purpo
36、ses. 0.4 Compatibility with other management systems This International Standard has been aligned with ISO 14001:1996 in order to enhance the compatibility of the two standards for the benefit of the user community. This International Standard does not include requirements specific to other manageme
37、nt systems, such as those particular to environmental management, occupational health and safety management, financial management or risk management. However, this International Standard enables an organization to align or integrate its own quality management system with related management system re
38、quirements. It is possible for an organization to adapt its existing management system(s) in order to establish a quality management system that complies with the requirements of this International Standard. There is a need for guidance on implementing the requirements of ISO 9001 for organizations
39、involved in all aspects of the food and drink industry. This includes organizations involved in sourcing, processing and packaging food and drink products. This International Standard aims to encourage the use of the ISO 9000 series of standards within the food and drink industry the use of these st
40、andards alongside other common systems in use in this sector may assist an organization to better address customer satisfaction and organizational effectiveness by the effective implementation of a quality management system. ISO 9001 also requires organizations to seek to continually improve their q
41、uality management systems, an aspect often missing from other models of food safety management commonly used in the food and drink industry. The adoption of a quality management system needs to be a strategic decision of the organization. The design and the implementation of an organizations quality
42、 management system is influenced by varying needs: the particular objectives, the products provided, the processes employed and the size and structure of the organization. It is not the purpose of ISO 9001 to imply uniformity in the structure of quality management systems or uniformity of the docume
43、ntation. The process-oriented base of ISO 9001 makes it easier to envisage how different systems within a business link together; often it is at the interfaces between internal customers and suppliers or between different systems that problems occur. Any model which clarifies these critical areas fo
44、r an organization will assist in the smooth running of its business. ISO 9001 focuses on customers needs and expectations. One of the most important customer expectations (and often one which is implicit rather than stated directly) is to have safe food products. ISO 9001 allows an organization to i
45、ntegrate its quality management system with the implementation of food safety systems such as HACCP (hazard analysis and critical control point). The internationally recognized principles and steps of HACCP are defined by the Codex Alimentarius Commission in its recommended international code of pra
46、ctice on general principles of food hygiene. Any other accepted food safety system can, of course, also be integrated into the quality management system. However, considering the fact that HACCP is widely used comprehensively, this system was chosen to demonstrate how integration may be achieved. Th
47、e application of HACCP within a quality management system conforming to ISO 9001 can result in a food safety system that is more effective than the application of either ISO 9001 or HACCP alone, leading to enhanced customer satisfaction and improved organizational effectiveness. As an example, the a
48、pplication of HACCP for the identification of hazards and control of risks is related to quality planning and preventive actions required by ISO 9001. Once the critical points have been identified, the principles of ISO 9001 can be used for control and monitoring. Procedures for conducting an HACCP
49、study can easily be documented within the quality system. To assist the user, the requirements of ISO 9001 are given in boxed text in this International Standard, followed by relevant guidance. Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 25 14:43:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO 15161:2001(E) viii Linkages between the basic HACCP principles and specific clauses of ISO 9001 are shown in annex A. This International Standard represents an attempt to identify the specific issues to be considered when establishing a quality management system in the f