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HB90.52000

Correlation between ISO 9001:2000 and the HACCP Principles

CORRELATION
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BETWEEN ISO 9001:2000 AND THE HACCP PRINCIPLES

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 3703 X

HB 90.52000

HOW TO USE THIS HANDBOOK


This Handbook was written to assist those who need to combine their implementation of ISO 9001 and HACCP Principles. The main purpose is to show where the correlations between the two systems occur and where, in relation to each, the opportunity for integration exists. This Handbook does not provide guidance on the application of either ISO 9001 or HACCP Principles to food processing. If such guidance is sought, reference could be made to HB 90.4, The Food Processing IndustryGuide to ISO 9001 or SCARM Report 601, A guide to the implementation and auditing of HACCP. For the purposes of this Handbook, ISO 9001:2000, Quality management systemsRequirements, (referred to hereafter as ISO 9001 or the Standard) is used for the comparison.
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For each Clause of ISO 9001, the HACCP Principle(s)2 having a correlation to the requirements of the ISO 9001 Clause, are listed. The layout used is shown below.

CLAUSE X MAIN CLAUSE


X.X Sub-clause
Clause of the Standard

HACCP PRINCIPLES
List of relevant HACCP Principles that correlate with the above clause

CORRELATION
Discussion of correlation Comment (optional) Discussion of any related issues.

1 2

Published by CSIRO Publishing. The seven HACCP Principles are given on Page 7.

HB 90.52000

TABLE OF CONTENTS
OVERVIEW ..................................................................................................................................5 THE HACCP PRINCIPLES ............................................................................................................7 CORRELATION .............................................................................................................................9 INTRODUCTION ............................................................................................................................9 0.1 General........................................................................................................................9 0.2 Process approach .........................................................................................................9 0.3 Relationship with ISO 9004.......................................................................................10 0.4 Compatibility with other management systems .........................................................10 1 SCOPE .....................................................................................................................................12 1.1 General......................................................................................................................12 1.2 Application................................................................................................................12 2 NORMATIVE REFERENCE ........................................................................................................13 3 TERMS AND DEFINITIONS........................................................................................................14 4 QUALITY MANAGEMENT SYSTEM ...........................................................................................15 4.1 General requirements.................................................................................................15 4.2 Documentation requirements.....................................................................................17 5 MANAGEMENT RESPONSIBILITY .............................................................................................20 5.1 Management commitment .........................................................................................20 5.2 Customer focus..........................................................................................................21 5.3 Quality policy............................................................................................................22 5.4 Planning ....................................................................................................................23 5.5 Responsibility, authority and communication............................................................24 5.6 Management review ..................................................................................................27 6 RESOURCE MANAGEMENT ......................................................................................................28 6.1 Provision of resources ...............................................................................................28 6.2 Human resources .......................................................................................................29 6.3 Infrastructure .............................................................................................................30 6.4 Work environment.....................................................................................................30 7 PRODUCT REALIZATION ..........................................................................................................31 7.1 Planning of product realization..................................................................................31 7.2 Customer-related processes .......................................................................................32 7.3 Design and development ...........................................................................................33 7.4 Purchasing.................................................................................................................35 7.5 Production and service provision...............................................................................36 7.6 Control of monitoring and measuring devices ...........................................................40

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8 MEASUREMENT, ANALYSIS AND IMPROVEMENT .....................................................................41 8.1 General......................................................................................................................41 8.2 Monitoring and measurement ....................................................................................42 8.3 Control of nonconforming product ............................................................................45 8.4 Analysis of data.........................................................................................................46 8.5 Improvement .............................................................................................................47 APPENDIX A MAP OF ISO 9001 CLAUSES VS HACCP PRINCIPLES .....................................49

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HB 90.52000

OVERVIEW
GENERAL
Many organizations have adopted, or are familiar with, the disciplines outlined in the ISO 9000 series of quality management system Standards. Similarly many organizations have adopted a food safety system based on the HACCP Principles (Hazard Analysis Critical Control Points, see page 7). However these two approaches may be used to complement each other and, in combination, provide a very powerful tool for the control of both management and production operations. For example, the application of the ISO 9000 quality management system Standards are considered to be confined to quality and HACCP to be confined to hazard and safety issues. However the definition of what comprises quality can be very broad and often includes safety issues.
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In the food industry, one of the quality expectations of a customer is that food will not cause food poisoning or contain harmful objects. Here food safety is included in the overall aspects of food quality. Since HACCP is concerned with food safety, there is a very close alignment between quality and safety. In a hospital, HACCP principles may be applied to a range of activities and applications. For example, it may be identified that the selection of the appropriate medicines and drugs, combined with the administration of the correct dosage is an area of potential hazard and that appropriate steps are needed to avoid any possible harm coming to the patient. The patients expectation of this activity may well be that this activity is associated with the quality of care, resulting in the patient recovering from the condition which put the patient in hospital in the first place.

ISO 9000 SERIES STANDARDS


The ISO 9000 series of Standards deals with quality management systems. These Standards set out the responsibilities, processes and resources needed to achieve the organizations aims with respect to quality and relate to how activities which have a bearing on product quality are managed. For the purposes of this Handbook, the correlation between ISO 9001 and the HACCP Principles is described. In general, HACCP Principles are applied to an established food processing system, which appropriately dealt with under ISO 9001 with a permissible exclusion of Clause 7.3 Design and development. (See clause 1.2 of ISO 9001 for interpretation of permissible exclusion.) In Appendix A, the basic correlations are listed. However, if a food processing system is being designed, the inclusion of the HACCP Principles at the design stage can be very effective. For this reason, the correlations with Clause 7.3 Design and development are included. The organization needs to decide what quality means in the context of its activities and operations. The structure of the quality system will then be governed to a very large extent by this organizational definition of quality. It needs to be understood that each organization will view its activities and operations and understanding of quality in the way that suits that organization. The Clauses list requirements, often in considerable detail, but do not indicate how the requirements are to be met or achieved. It is up to the individual organization to determine how the Standard applies to their practices and operations. It follows that rather than applying a rigid set of conditions to an organization, ISO 9001 actually provides a broad framework of requirements, while allowing an extremely flexible approach as to how they are actually implemented. A common mistake is to assume that everything needs to be changed, whereas, more commonly, existing practices may need upgrading to a varying extent to meet ISO 9001 system requirements.

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ISO 9001 does not directly address legislation, regulations, codes of practice or similar decrees. However, where these play a role in the organizations activities, they need to be addressed in the appropriate procedures and thus indirectly become part of the organizations quality management system. ISO 9001s great strength, when properly implemented, is that it sets out requirements to involve the organizations top management and to make management accountable for the operation of the quality management system. It thus provides a management infrastructure to support the organizations activities. An ISO 9001 quality management system can also provide an infrastructure to support HACCP, and as such is a good guide for the practices and procedures implied but not specified in the HACCP Principles.

HAZARD ANALYSIS CRITICAL CONTROL POINTS HACCP


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The seven HACCP Principles shown on page 7 are very broad statements of requirements and, to be implemented effectively, demand considerable understanding of the organizations process(es) and all the associated supporting activities. Because of their very broad and generic nature, the Principles themselves give no guidance on how to go about implementing them. Like ISO 9001, the manner in which the Principles are implemented is up to each individual organization, providing a very flexible approach to implementation. Again, like ISO 9001, the Principles do not address legislation, regulation, codes of practice or similar decrees; where these play a role in the organizations activities, they need to be addressed in the appropriate procedures and thus indirectly become part of the organizations HACCP system. Unlike ISO 9001, there is no stated requirement for support by top management for a HACCP system, although obviously this will be necessary for successful implementation. One potential use of the HACCP Principles that is not often considered is their application to aspects other than hazard. For example, by substituting palatability for hazard and conducting a similar analysis, the critical control points in a process that relate to palatability can be identified and controlled. In other words, the Critical Control Point analysis can be used for virtually any property (including quality).

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HB 90.52000

THE HACCP PRINCIPLES


The HACCP Principles are as set out in Codex Alimentarius ALINORM 95/13 Annex to Appendix III, viz.: HACCP is a system which identifies specific hazard(s) and preventive measures for their control. The system consists of the following seven principles:

Principle No. 1
Identify the potential hazard(s) associated with food production at all stages, from growth, processing, manufacture and distribution, until the point of consumption. Assess the likelihood of occurrence of the hazard(s) and identify the preventive measures for their control.

Principle No. 2
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Determine the points/procedures/operational steps that can be controlled to eliminate the hazard(s) or minimize its likelihood of occurrence.

Principle No. 3
Establish critical limit(s) which must be met to ensure that the Critical Control Point is under control.

Principle No. 4
Establish a system to monitor control of the Critical Control Point by scheduled testing or observations.

Principle No. 5
Establish the corrective action to be taken when monitoring indicates that a particular Critical Control Point is not under control.

Principle No. 6
Establish procedures for verification which include supplementary tests and procedures to confirm that the HACCP system is working effectively.

Principle No. 7
Establish documentation concerning all procedures and records appropriate to these principles and their application. Codex Alimentarius ALINORM 95/13 Annex to Appendix III also includes a logic diagram on the application of HACCP Principles, and this is reproduced as a flowsheet on page 8. This flowsheet shows that, before the principles can be applied, a significant amount of preparatory work has to be done. It should be noted that HACCP Principle 2 is basically a decision process. As such it does not actually correlate well with any of the ISO 9001 Clauses. However, it is of major significance since the application of the remaining HACCP Principles is dependent on the decisions made.

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HB 90.52000

Assemble the HACCP team Describe the product Identify the intended use
Construct the flow diagram

On-site verification of flow diagram

List all identified hazards associated with each step and consider preventive measures to control hazards Identified hazard Biological Chemical Physical Step Preventive measure

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Apply HACCP decision tree to each step with identified hazard(s) (answer each question in sequence) Q1 Do preventive measures exist? Yes No Is control at this step for safety? No Q2 Not a CCP Yes Stop* Yes Modify step, process or product

Is the step specifically designed to eliminate or reduce the likely occurrence of a hazard to an acceptable level? No

Q3

Could contamination with identified hazard(s) occur in excess of acceptable level(s) or could these increase to unacceptable level(s)? Yes No Not a CCP Stop* No Critical Control Point

Q4

Will a subsequent step eliminate identified hazard(s) or reduce likely occurrence to an acceptable level? No Yes Not a CCP Stop*

(*) Proceed to next identified hazard in described process

Establish critical limits for each CCP

Establish a monitoring system for each CCP Establish corrective action for deviations that may occur

Establish verification procedure

Establish record keeping and documentation

FLOWSHEET LOGIC SEQUENCE FOR APPLICATION OF HACCP (Ref. Codex Alimentarius ALINORM 95/13 Annex to Appendix III)

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HB 90.52000

CORRELATION
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. 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.

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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) 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 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: Do: Check: Act:
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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.
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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 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.

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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HB 90.52000

HACCP PRINCIPLES

CORRELATION
There are no HACCP Principles that correlate with Clause 0 Introduction Comment Clause 0.2 Process approach of the Introduction provides the basis on which the Standard has been developed. Figure 1 presents the overview of the Standard in pictorial form as a process approach which involves a number of Plan-Do-Check-Act (PCDA) cycles. In a sense the HACCP Principles follow a similar PCDA pattern in that
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Principles 1 and 2 cover the planning activities (plan); Principle 3 sets out the control parameters (do); Principle 4 provides for the measurement (check); and Principle 5 provides the feedback loop for action (act). Principles 6 and 7 cover the necessary documentation of the system and the provision of the necessary records. The Standard provides a comprehensive quality management system, with involvement of all levels of the organization and covering the all the activities within the organization. The HACCP Principles apply at a lower level in that they directly address the organizations processes on a process by process basis without considering the organizational structure and management processes necessary to support them. If they are considered at a somewhat higher level they can be interpreted as covering planning, and process control on an overall basis. Thus the HACCP Principles can be applied within the quality management system which can be used to deliver the system support needed for the activities not addressed by the HACCP Principles but necessary for their successful implementation.

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CLAUSE 1 SCOPE
1.1 General
This International Standard specifies requirements for a quality management system where an organization a) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and b) 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.

1.2 Application
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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.

HACCP PRINCIPLES

CORRELATION
There are no HACCP Principles that correlate with Clause 1 Scope

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HB 90.5-2000, Correlation between ISO 9001:2000 and the HACCP Principles Correlation between ISO 9001:2000 and the HACCP Principles

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