hb 90.5-2000 correlation between iso 9001-2000 and the haccp principles correlation between iso...

7/31/2019 HB 90.5-2000 Correlation Between ISO 9001-2000 and the HACCP Principles Correlation Between ISO 9001-2000 A

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HB90.52000

Correlation between ISO 9001:2000

and the HACCP Principles


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CORRELATION

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 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 3703 X


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HB 90.52000 2

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.

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 Published by CSIRO Publishing.

2 The seven HACCP Principles are given on Page 7.


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HB 90.520003

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.....................................................................................................................................121.1 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 .............................................................................................205.1 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 .......................................................................................................296.3 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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HB 90.52000 4

8 MEASUREMENT, ANALYSIS AND IMPROVEMENT.....................................................................41

8.1 General......................................................................................................................41

8.2 Monitoring and measurement ....................................................................................42

8.3 Control of nonconforming product ............................................................................458.4 Analysis of data .........................................................................................................46

8.5 Improvement .............................................................................................................47

APPENDIX A MAP OF ISO 9001 CLAUSES VS HACCP PRINCIPLES .....................................49


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5

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.

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

developmentare 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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6

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 theorganizations 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

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 similaranalysis, 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


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

Establish record keeping and documentation

Establish critical limits for each CCP

Establish a monitoring system for each CCP

Establish corrective action for deviations that may occur

Establish verification procedure

Construct the flow diagram

Identify the intended use

Describe the product

Assemble the HACCP team

On-site verification of flow diagram

List all identified hazards associated with each stepand

consider preventive measures to control hazards

Identifiedhazard

Step Preventivemeasure

BiologicalChemicalPhysical

Apply HACCP decision tree to each step with identified hazard(s)(answer each question in sequence)

Q1 Do preventive measures exist?

Yes

Modify step, process or product

No

Is control at this step for safety? Yes

No Not a CCP Stop*

(*) Proceed to next identified hazard in described process

Q2 Yes

Q3 Could contamination with identified hazard(s) occur inexcess of acceptable level(s) or could these increaseto unacceptable level(s)?

Not a CCP Stop*

Is the step specifically designed to eliminate or reducethe likely occurrence of a hazard to an acceptable level?

Will a subsequent step eliminate identified hazard(s)or reduce likely occurrence to an acceptable level?

Q4

Yes Not a CCP Stop*

No CriticalControl

Point

No

No

Yes

No


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CORRELATION

INTRODUCTION

0.1 General

The adoption of a quality management system should be a strategic decision of anorganization. The design and implementation of an organizations quality managementsystem is influenced by varying needs, particular objectives, the products provided, theprocesses employed and the size and structure of the organization. It is not the intent of thisInternational Standard to imply uniformity in the structure of quality management systems oruniformity of documentation.

The quality management system requirements specified in this International Standard arecomplementary to requirements for products. Information marked NOTE is for guidance inunderstanding 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 theorganizations own requirements.

The quality management principles stated in ISO 9000 and ISO 9004 have been taken intoconsideration 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 enhancecustomer satisfaction by meeting customer requirements.

For an organization to function effectively, it has to identify and manage numerous linkedactivities. An activity using resources, and managed in order to enable the transformation ofinputs 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 theidentification and interactions of these processes, and their management, can be referred toas the "process approach".

An advantage of the process approach is the ongoing control that it provides over the linkagebetween the individual processes within the system of processes, as well as over theircombination and interaction.

When used within a quality management system, such an approach emphasizes theimportance 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, andd) continual improvement of processes based on objective measurement.

The model of a process-based quality management system shown in Figure 1 illustrates theprocess linkages presented in clauses 4 to 8. This illustration shows that customers play asignificant role in defining requirements as inputs. Monitoring of customer satisfaction requiresthe evaluation of information relating to customer perception as to whether the organizationhas met the customer requirements. The model shown in Figure 1 covers all therequirements of this International Standard, but does not show processes at a detailed 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 results inaccordance with customer requirements and the organizations policies.

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

0.3 Relationship with ISO 9004The present editions of ISO 9001 and ISO 9004 have been developed as a consistent pair ofquality management system standards which have been designed to complement eachother, but can also be used independently. Although the two International Standards havedifferent scopes, they have similar structures in order to assist their application as aconsistent pair.

ISO 9001 specifies requirements for a quality management system that can be used forinternal application by organizations, or for certification, or for contractual purposes. It focuseson 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 systemthan does ISO 9001, particularly for the continual improvement of an organizations overallperformance and efficiency, as well as its effectiveness. ISO 9004 is recommended as aguide for organizations whose top management wishes to move beyond the requirements ofISO 9001, in pursuit of continual improvement of performance. However, it is not intended forcertification 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 thecompatibility of the two standards for the benefit of the user community.

This International Standard does not include requirements specific to other managementsystems, such as those particular to environmental management, occupational health andsafety management, financial management or risk management. However, this InternationalStandard enables an organization to align or integrate its own quality management systemwith 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 thatcomplies with the requirements of this International Standard.


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HACCP PRINCIPLES

CORRELATIONThere 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

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, andprocess 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 organizationa) 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 ofconformity 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

All requirements of this International Standard are generic and are intended to be applicableto all organizations, regardless of type, size and product provided.

Where any requirement(s) of this International Standard cannot be applied due to the natureof an organization and its product, this can be considered for exclusion.

Where exclusions are made, claims of conformity to this International Standard are notacceptable unless these exclusions are limited to requirements within clause 7, and suchexclusions do not affect the organizations ability, or responsibility, to provide product thatmeets customer and applicable regulatory requirements.

HACCP PRINCIPLES

CORRELATION

There are no HACCP Principles that correlate with Clause 1 Scope


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