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HB90.42000

The Food Processing Industry

Guide to ISO 9001:2000

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THE FOOD PROCESSING INDUSTRY GUIDE TO ISO 9001:2000

COPYRIGHT
Standards Australia International All rights are reserved. No part of this work may be reproduced or copied in any form or by any means, electronic or mechanical, including photocopying, without the written permission of the publisher. Published by Standards Australia International Ltd GPO Box 5420, Sydney, NSW 2001, Australia
ISBN 0 7337 3707 2

HB 90.42000

PREFACE
The objective of this guide is to assist the food processing industry to develop an understanding of quality management systems based on the ISO 9000 series of Standards, and to provide guidance on their implementation. The following terminology is used in this guide: This document, HB 90.42000, is referred to herein as the guide. ISO 9001:2000, Quality management systemsRequirements, is referred to as the standard.

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In this guide, the standard is presented clause-by-clause, in grey-shaded boxes, followed by guidance to that clause explaining how the requirements of the standard may be implemented, using terminology and examples appropriate to the food processing industry. Headings and clause numbers used in this guide parallel those of ISO 9001:2000, and the Bibliography from the standard is included. There are many ways in which the food industry may achieve the intent of the standard. Where examples are given on how the intent may be realized, they should not be taken as prescriptive or exhaustive. Appendix A outlines the major changes between the 1994 and 2000 editions of ISO 9001. Appendix B provides a brief overview of HACCP in an ISO 9001 context, and includes the 7 HACCP Principles and a flowchart showing the logic sequence for application of HACCP. Appendix C is a map of ISO 9001 clauses vs HACCP Principles. Appendix D lists some areas of application where legislative requirements may apply under international, national and state food industry, public health and trade legislation, codes and standards. Appendix E provides additional guidance on documenting your quality management system. Appendix F outlines typical records for a manufacturer in the food processing industry. Appendix G provides additional guidance on controlling design and development. The HACCP Principles in Appendix B are based on Codex Alimentarius ALINORM 95/13 Annex to Appendix III, published by the Codex Alimentarius Commission. Records of a manufacturer in Appendix F is based on Use of ISO 9000 Series in Food Inspection and Certification published by the Food and Agriculture Organization of the United Nations. Appendix G is essentially based on the Food Processing Industry Quality System Guidelines, 1986, published by the American Society for Quality. Further assistance has been taken from this document while preparing this guide.

HB 90.42000

CONTENTS
FOREWORD.............................................................................................................................. 5 INTRODUCTION ...................................................................................................................... 6 0.1 General............................................................................................................................. 6 0.2 Process approach .............................................................................................................. 7 0.3 Relationship with ISO 9004 ............................................................................................. 9 0.4 Compatibility with other management systems .............................................................. 10 1 SCOPE ................................................................................................................................ 11 1.1 General........................................................................................................................... 11 1.2 Application..................................................................................................................... 11 2 NORMATIVE REFERENCE .............................................................................................. 13 3 TERMS AND DEFINITIONS ............................................................................................. 13 4 QUALITY MANAGEMENT SYSTEM .............................................................................. 16 4.1 General requirements ..................................................................................................... 16 4.2 Documentation requirements.......................................................................................... 18 5 MANAGEMENT RESPONSIBILITY................................................................................. 24 5.1 Management commitment .............................................................................................. 24 5.2 Customer focus............................................................................................................... 25 5.3 Quality policy................................................................................................................. 26 5.4 Planning ......................................................................................................................... 27 5.5 Responsibility, authority and communication................................................................. 28 5.6 Management review ....................................................................................................... 31 6 RESOURCE MANAGEMENT ........................................................................................... 34 6.1 Provision of resources .................................................................................................... 34 6.2 Human resources ............................................................................................................ 35 6.3 Infrastructure.................................................................................................................. 37 6.4 Work environment.......................................................................................................... 37 7 PRODUCT REALIZATION................................................................................................ 39 7.1 Planning of product realization....................................................................................... 39 7.2 Customer-related processes ............................................................................................ 41 7.3 Design and development ................................................................................................ 45 7.4 Purchasing...................................................................................................................... 54 7.5 Production and service provision.................................................................................... 60 7.6 Control of monitoring and measuring devices ................................................................ 72 8 MEASUREMENT, ANALYSIS AND IMPROVEMENT ................................................... 75 8.1 General........................................................................................................................... 75 8.2 Monitoring and measurement ......................................................................................... 76 8.3 Control of nonconforming product ................................................................................. 83 8.4 Analysis of data.............................................................................................................. 85 8.5 Improvement .................................................................................................................. 87 BIBLIOGRAPHY..................................................................................................................... 91

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HB 90.42000

APPENDIX AMAJOR CHANGES ...................................................................................... 92 APPENDIX B HACCP PRINCIPLES AND ISO 9001......................................................... 94 APPENDIX CMAP OF ISO 9001 CLAUSES VS HACCP PRINCIPLES............................ 97 APPENDIX D LEGISLATIVE REQUIREMENTS.............................................................. 99 APPENDIX EDOCUMENTING YOUR QUALITY MANAGEMENT SYSTEMS........... 100 APPENDIX FRECORDS OF A MANUFACTURER......................................................... 105 APPENDIX GADDITIONAL GUIDANCE ON CONTROLLING DESIGN AND DEVELOPMENT................................................................................................................... 108
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HB 90.42000

FOREWORD
This guide provides guidance on ISO 9001, Quality management systemsRequirements, in food industry terms, and explains what each clause requires when applied to food processing. The objective is to assist the industry to understand and apply the principles of ISO 9001 in a food industry context. The guidance is applicable to preparation, processing, packaging and storage in the food processing industry, irrespective of the type of food or beverage, the processes and methods used, and the scale of the business. It does not take into consideration on-farm production, distribution, or retailing of finished product. However, it may have an application for food service operations, such as catering services intended for airlines and institutions. ISO 9001 focuses on customer needs and expectations, and the most important of these is food product safety. The internationally-recognized principles and steps of Hazard Analysis Critical Control Point (HACCP) are defined by the Codex Alimentarius Commission in its recommended code of practice on general principles of food hygiene and safety. ISO 9001 and a food safety program incorporating HACCP principles are complementary, and can be successfully integrated. It is not necessary to develop separate systems, and may be more effective to develop both systems concurrently. This guide refers to food safety programs and food safety management tools such as HACCP, and explains how such programs and management tools can be related to quality management systems that conform to ISO 9001. HACCP has been incorporated into Codex Alimentarius publications as a food safety management tool, and is increasingly used internationally as a basis for food safety legislation and for regulatory control. Principles of the HACCP System are given in Appendix B. A mapping of ISO 9001 clauses vs HACCP Principles is given in Appendix C, and further reading on ISO 9001 and HACCP is given in HB 90.52000, Correlation between ISO 9001:2000 and the HACCP Principles. This guide does not cover specific legislative requirements that may apply in the food processing industry. However, it does indicate where such legislative requirements might apply, and some areas of application are listed in Appendix D, for easy reference. The food processing organization/food processor, where it is appropriate, should address relevant legislative requirements in documented procedures, which become an integral part of the quality management system. Standards and codes of practice promulgated by the Codex Alimentarius Commission are available. The users of this guide should give due regard to these Standards and codes when implementing the quality management system. The quality management system can also be extended to include environmental and occupational health and safety issues (see clause 0.4). However, the guidance provided in this document has not been extended to cover these applications.

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HB 90.42000

STANDARD

Introduction
0.1 General
The adoption of a quality management system should be a strategic decision of an organization. The design 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 structure 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.

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This 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 9000 and ISO 9004 have been taken into consideration during the development of this International Standard.

GUIDANCE

ABOUT THE STANDARD ISO 9001 provides a systematic approach to the process of quality management. The standard is not prescriptive, as it allows each organization freedom to find methods and ways of implementation that best suit its business needs. The quality management system should be integrated into an organizations operations, rather than trying to build business or operational procedures around the requirements of the standard. However, the requirements of the standard cannot be discarded as being irrelevant because the food processing organization does not want to apply it, or because it has not been carried out previously. Any requirements applicable to the business operation should not be ignored or omitted. There are eight quality management principles that can lead an organization towards improved performance, listed in ISO 9000 and ISO 9004 under the headings Customer focus, Leadership, Involvement of people, Process approach, System approach to management, Continual improvement, Factual approach to decision making and Mutually beneficial supplier relationships. (See clauses 0.3 and 2 for references to ISO 9004 and ISO 9000 respectively.)

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HB 90.42000

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 requirements. 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 the 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 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) b) c) d) understanding and meeting requirements, the need to consider processes in terms of added value, obtaining results of process performance and effectiveness, and continual improvement of processes based on objective measurement.

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The model of a process-based quality management system shown in Figure 1 illustrates the process linkages presented in clauses 4 to 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 1 covers all the requirements of this International Standard, but does not show processes at a detailed level.
NOTE Plan: In addition, the methodology known as Plan-Do-Check-Act (PDCA) can be applied to all processes. PDCA can be briefly described as follows.

establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organizations policies. implement the processes. monitor and measure processes and product against policies, objectives and requirements for the product and report the results. take actions to continually improve process performance.

Do: Check:

Act:

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HB 90.42000

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Figure 1 Model of a process-based quality management system

The process approach forms one of the basic tenets of the revised edition. The boxes in Figure 1 correspond to the main clauses 5 to 8 of the standard. (Clause 4 gives an overview or executive summary of what is required to implement a quality management system.) The standard now encourages you to understand and adopt this approach to managing an organization and working to achieve customer satisfaction. The process approach is based on the concepts that any work gets done by a process, i.e. a system of activities that transforms inputs and resources into outputs; a product is the result of a process, or series of related processes, that can be identified, planned, controlled and improved.

This systematic approach provides a tool for breaking down big processes or tasks into a series of inputs, processes and sub-processes, very similar to doing a process flowchart. Each sub-process can then be monitored, measured and passed on as outputs to the next stage, and the information gathered can be used as feedback to improve the system. What is important is to identify each step, unit or organization in the supply chain, and to understand and control its functions, responsibilities, inputs, processes, and outputs. The process approach provides a basis for analysis, planning, resource allocation and controls within the quality management system, and for understanding and improving your processes.

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HB 90.42000

STANDARD

0.3 Relationship with ISO 9004


The present editions of ISO 9001 and ISO 9004 have 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 consistent 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. 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 performance 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 purposes.

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GUIDANCE

ISO 9004 AND AN ORGANIZATIONS STAKEHOLDERS ISO 9001 and ISO 9004 have been developed to complement each other, and users of this guide are encouraged to read ISO 9004, Quality management systemsGuidelines for performance improvements, to gain a broader understanding of how a quality management system can be used in their business. The difference between the objectives of ISO 9001 and the wider range of objectives covered by ISO 9004 can be summed up in the difference between the process model diagrams in the two standards. ISO 9001 looks at customer requirements and satisfaction, and ISO 9004 looks further to all the stakeholders, i.e. to the overall performance of the organization. In addition to customers, stakeholders draws in shareholders in the business, employees, regulators, neighbourhood and community interests, and so forth. The terms stakeholder and interested party are commonly used interchangeably and in a very sweeping way to refer to the broad range of individuals and groups that may be affected by an organizations activities. This broad approach to quality management may suit many organizations in the food processing industry, who are used to working to satisfy a range of customers that includes consumers and the general public.

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HB 90.42000

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STANDARD

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 management 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 requirements. 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.

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GUIDANCE

ENVIRONMENTAL MANAGEMENT HEALTH AND SAFETY

AND

OCCUPATIONAL

Care has been taken to ensure that ISO 9001 is compatible with the international standard for environmental management systems (EMS)*, ISO 14001, Environmental management systemsSpecification with guidance for use. These Standards recognise that organizations have a broad range of responsibilities, and these may include environmental responsibilities and the health and safety of employees and the public. A broad common approach can allow more flexibility for integrating quality, environmental, hygiene and safety aspects into management systems, and may suit many organizations in the food processing industry.

* Organizations in Australia and New Zealand also have available AS 4801 and NZS 4801, Occupational health and safety management systemsSpecification with guidance for use, which they can use as a basis for their occupational health and safety (OHS) management systems. Further guidance on management system integration is provided in AS/NZS 4581, Management system integration Guidance to business, government and community organizations, and HB 139, Step by step guidance on integrating management systemsHealth and safety, environment, quality, and should be helpful for food processing organizations. This broad common approach to management systems may suit many organizations in the food processing industry. For more information, or to download these publications, visit the Standards Australia web site: www.standards.com.au
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HB 90.42000

STANDARD

1 Scope
1.1 General
This International Standard specifies requirements for a quality management system where an organization a) b) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements.

NOTE: In this International Standard, the term product applies only to the product
intended for, or required by, a customer.
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GUIDANCE

This general clause explains the scope of ISO 9001 and the reasons you may choose to apply it to your business. The quality management system is a means of showing that you can meet your customers requirements, by providing services and products of the quality and standard that they require and expect. Conducting your business in this way can provide confidence to prospective customers, and being able to show that you have met your customers requirements is usually a commercial advantage.

STANDARD

1.2 Application
All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided. Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion. Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organizations ability, or responsibility, to provide product that meets customer and applicable regulatory requirements.

GUIDANCE

This clause introduces the concept that some requirements of clause 7, Product realization, may not be relevant to your processes or products, and therefore may be excluded from the scope of your quality management system. The intent of ISO 9001 is that organizations should consider all the requirements, and must comply with all those that are applicable. This possibility of exclusions applies only within clause 7. Clauses 4, 5, 6 and 8 are mandatory requirements. (This provision for exclusions replaces the tailoring referred to in ISO 9001:1994.)
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HB 90.4-2000, The Food Processing Industry Guide to ISO 9001:2000 The Food Processing Industry - Guide to ISO 9001:2000

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