HB 90.4-2000 the Food Processing Industry - Guide to ISO 9001-2000 the Food Processing Industry - Guide to Is

7/31/2019 HB 90.4-2000 the Food Processing Industry - Guide to ISO 9001-2000 the Food Processing Industry - Guide to Is

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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 anymeans, electronic or mechanical, including photocopying, without the written permission of the

publisher.

Published by Standards Australia International LtdGPO Box 5420, Sydney, NSW 2001, Australia

ISBN 0 7337 3707 2


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HB 90.42000 2

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 guidanceon 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.

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.


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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....................................................................................... 397.2 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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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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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 foodindustry 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 givenin 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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Standards Australia www.standards.com.au

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STANDARD Introduction

0.1 General

The adoption of a quality management system should be a strategic decision ofan organization. The design and implementation of an organizations qualitymanagement system is influenced by varying needs, particular objectives, theproducts provided, the processes employed and the size and structure of theorganization. It is not the intent of this International Standard to implyuniformity in the structure of quality management systems or uniformity ofdocumentation.

The quality management system requirements specified in this InternationalStandard are complementary to requirements for products. Information markedNOTE is for guidance in understanding or clarifying the associatedrequirement.

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 havebeen taken into consideration during the development of this InternationalStandard.

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, Processapproach, 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.)
http://www.standards.com.au/http://www.standards.com.au/


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www.standards.com.au Standards Australia

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STANDARD 0.2 Process approach

This International Standard promotes the adoption of a process approach whendeveloping, implementing and improving the effectiveness of a qualitymanagement system, to enhance customer satisfaction by meeting customer

requirements.For an organization to function effectively, it has to identify and managenumerous linked activities. An activity using resources, and managed in orderto enable the transformation of inputs into outputs, can be considered as aprocess. Often the output from one process directly forms the input to the next.

The application of a system of processes within an organization, together withthe 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 providesover the linkage between the individual processes within the system ofprocesses, as well as over their combination and interaction.

When used within a quality management system, such an approachemphasizes the importance of

a) understanding and meeting requirements,

b) the need to consider processes 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 1illustrates the process linkages presented in clauses 4 to 8. This illustrationshows that customers play a significant role in defining requirements as inputs.Monitoring of customer satisfaction requires the evaluation of informationrelating to customer perception as to whether the organization has met thecustomer requirements. The model shown in Figure 1 covers all therequirements of this International Standard, but does not show processes at adetailed level.

NOTE In addition, the methodology known as Plan-Do-Check-Act (PDCA) can be

applied to all processes. PDCA can be briefly described as follows.

Plan: establish the objectives and processes necessary to deliver resultsin accordance with customer requirements and the organizationspolicies.

Do: implement the processes.

Check: monitor and measure processes and product against policies,

objectives and requirements for the product and report the results.

Act: take actions to continually improve process performance.


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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

processapproach is based on the concepts that

any work gets done by a process, i.e. a system of activities thattransforms inputs and resources into outputs;

a product is the result of a process, or series of related processes, thatcan 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 allocationand controls within the quality management system, and for understanding and

improving your processes.


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STANDARD 0.3 Relationship with ISO 9004

The present editions of ISO 9001 and ISO 9004 have been developed as aconsistent pair of quality management system standards which have beendesigned to complement each other, but can also be used independently.

Although the two International Standards have different scopes, they havesimilar structures in order to assist their application as a consistent pair.

ISO 9001 specifies requirements for a quality management system that can beused for internal application by organizations, or for certification, or forcontractual purposes. It focuses on the effectiveness of the qualitymanagement system in meeting customer requirements.

ISO 9004 gives guidance on a wider range of objectives of a qualitymanagement system than does ISO 9001, particularly for the continualimprovement of an organizations overall performance and efficiency, as wellas its effectiveness. ISO 9004 is recommended as a guide for organizationswhose 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.

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 betweenthe 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 ofcustomers that includes consumers and the general public.


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STANDARD 0.4 Compatibility with other management systems

This International Standard has been aligned with ISO 14001:1996 in order toenhance the compatibility of the two standards for the benefit of the usercommunity.

This International Standard does not include requirements specific to othermanagement systems, such as those particular to environmental management,occupational health and safety management, financial management or riskmanagement. However, this International Standard enables an organization toalign or integrate its own quality management system with related managementsystem requirements. It is possible for an organization to adapt its existingmanagement system(s) in order to establish a quality management system thatcomplies with the requirements of this International Standard.

GUIDANCE ENVIRONMENTAL MANAGEMENT AND OCCUPATIONAL

HEALTH AND SAFETY

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
http://www.standards.com.au/http://www.standards.com.au/http://www.standards.com.au/http://www.standards.com.au/


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STANDARD 1 Scope

1.1 General

This International Standard specifies requirements for a quality managementsystem where an organization

a) needs to demonstrate its ability to consistently provide product that meetscustomer and applicable regulatory requirements, and

b) aims to enhance customer satisfaction through the effective application ofthe system, including processes for continual improvement of the systemand the assurance of conformity to customer and applicable regulatoryrequirements.

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

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 tobe applicable to all organizations, regardless of type, size and productprovided.

Where any requirement(s) of this International Standard cannot be applied dueto the nature of an organization and its product, this can be considered forexclusion.

Where exclusions are made, claims of conformity to this International Standardare not acceptable unless these exclusions are limited to requirements withinclause 7, and such exclusions do not affect the organizations ability, orresponsibility, to provide product that meets customer and applicable regulatoryrequirements.

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 and8 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 Is