1 ISO Workshop on Conformity Assessment, Johannesburg 2007-05-10

www.iso.org
International Organization
for Standardization
2 ISO Workshop on Conformity Assessment, Johannesburg 2007-05-10

ISO 22000 series

by Pauline Jones

Former Technical Programme Manager of ISO/TC 34


ISO Regional Workshop on Conformity Assessment
9 and 10 May 2007


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Contents
Introduction to food safety problems
ISO 22000 series and TC 34
Codex and HACCP
ISO 22000
ISO/TS 22003
ISO/TS 22004
ISO 22005



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Food safety
Failures in food supply chain can be
dangerous and costly.
Some 65% of ISOs food standards
(700 to date) deal with analysis and
test methods.
ISO standards on food safety
management systems aim to
complement regulatory
requirements and assist in reducing
weak links in the food supply chain.

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Examples of food incidents
glass/razor blades in baby food (depressed market
ca. 100 million)
cross-contamination of Salmonella from raw milk
(76 illnesses, one death)
contaminated chocolate (245 people ill; 500 000
cost)
benzene in bottled mineral water (160 million
bottles destroyed: US$ 79 million cost)
$
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ISO 22000 series
on food safety management
ISO 22000:2005, Food safety management systems --
Requirements for any organization in the food chain
ISO/TS 22003:2007, Food safety management systems --
Requirements for bodies providing audit and certification of
food safety management systems
ISO/TS 22004:2005, Food safety management systems --
Guidance on the application of ISO 22000
ISO 22005:2007, Traceability in the feed and food chain --
General principles and guidance for system design and
development
ISO/TC 34 has prepared a series of international
standards on food safety management systems:
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ISO Technical Committee TC 34,
Food products
Standardization in the fields of
human and animal foodstuffs
animal and vegetable propagation materials
terminology, sampling, methods of test and
analysis
product specifications and requirements for
packaging, storage and transport
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Participation in ISO/TC 34


Participating members: 45, Observer members: 47
10 A-liaisons (e.g. CODEX, AOAC, UN/ECE, IH&RA)
5 B-liaisons (e.g. OIV, WHO) with international and
regional organizations
Experts from more than 20 countries and from six
other international organizations took part in the
Working Group with 3 new liaisons (e.g. CIES, WFSO)

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ISO/TC 34 Liaisons
One of TC 34s most important liaisons is the
FAO/WHO Codex Alimentarius Commission

When developing a new ISO standard,
special care is taken of the relevant Codex
documents,
each comment of any Codex Committee is taken into
consideration during the ISO procedure.
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Codex and ISO activities are complementary
Codex, as an inter-governmental organization (WHO & FAO)
prepares documents to assist governments in their statutory
and regulatory work to protect their citizens from health
hazards caused by food consumption.

ISO, as a non-governmental organization,
prepares consensus-based standards on test methods and
management systems to assist stakeholders along the whole
food chain to fulfil the relevant statutory and regulatory
requirements, as well as customer to supplier requirements
relating to food an feed products.
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HACCP system
Hazard analysis and critical control point (HACCP
system) was developed in the 1980s by Codex.
HACCP plans incorporate issues such as cleaning and
general sanitation which are hard to monitor and even
harder to validate, e.g. hand-washing.
There are often over 20 Critical Control Points (CCPs) per
plan.
HACCP systems in place with differing requirements and
implementations in different countries and for different
foodstuffs

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Advantages of ISO 22000
ISO 22000, Food safety management systems --
Requirements for any organization in the food chain
Constitutes an internationally recognized food safety
management system standard
Incorporates HACCP and goes beyond it
Specifies PreRequisite Programmes (PRPs) in lieu of CCPs
Identifies Operational PRPs as those PRPs which are essential


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Reasons for ISO 22000

Increasing number of national regulations and controls relating to
food safety
Food producers have to comply with different requirements
depending on the country and customer
Retailers are certifying and inspecting food producers and have
set a variety of specific criteria (BRC, IFS,)
ISO 22000 simplifies the process
Requirements of ISO 22000 are generic and are intended to be
applicable to all organizations in the food chain regardless of size
and complexity




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Food Chain Interactions
Essential: Ensure that the Relevant Food Safety Hazards
are identified and adequately controlled
at each step within the food chain.




Inside the
organization

With customers
With organizations upstream in the food chain
With organizations downstream in the food chain
With suppliers
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Food chain
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What does ISO 22000 do?
ISO 22000 specifies the characteristics of a management
system designed to
carry out the hazard analysis,
design the HACCP plan,
identify the prerequisite programmes (PRP), and
select the operational prerequisite programmes
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Definition of PRP
PRP - prerequisite programme
basic conditions and activities that are necessary to
maintain a hygienic environment throughout the
food chain suitable for the production, handling and
provision of safe end products and safe food for
human consumption
The PRPs needed depend on the segment of the food
chain in which the organization operates and the type
of organization.
Documents should specify how activities included in
the PRPs are managed.



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Operational PRPs
ISO 22000 reorganizes the traditional concept by
dividing control measures into two groups (PRPs
and CCPs) and introduces the third group, which is
the operational PRPs:
operational prerequisite programme
PRP identified by the hazard analysis as essential in
order to control the likelihood of introducing food
safety hazards, or contamination, or proliferation of
food safety hazards in the products or in the
processing environment

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PRPs and operational PRPs

What are the main differences between PRPs and operational PRPs?
Purpose of the control measure PRP OPRP
Maintenance the basic hygienic
conditions and activities
Yes No
Controlling hazards identified by hazard
analysis and need to be controlled
No Yes
Validation is required No Yes
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Categorization of Control Measures
Control measures
Prerequisite
programmes
Operational
prerequisite
programmes
HACCP plan and
its critical control
points
Basic conditions and
activities.
PRPs do not need validation
but their effectiveness shall
be verified periodically.
Control measures identified by the hazard analysis.
Both shall be validated and verified.
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Validation of control measure combination
Validation includes such activities as:
reference to validations carried out by others,
experimental trials to simulate process conditions;
biological, chemical and physical hazard data collected
during normal operating conditions;
statistically designed surveys or mathematical modelling
use of a guide approved by competent authorities.
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Literature
Our plans
Are we doing things right?
Verification
Are we doing the right things?
Validation
Our plans Our activities
Verification and validation
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ISO 22000 Overview
ISO 22000 allows an organization (even small or less
developed ones ) to implement an externally
developed combination of control measures.
ISO 22000 can be applied independently of other
management system standards.
However, it can easily be integrated with existing
related management systems.
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ISO 22000 and ISO 9001

The structure of ISO 22000 is aligned with ISO 9001:2000
in order to enhance the compatibility of the two standards
for the benefit of the users.

Cross-references between ISO 22000 and ISO 9001 are
provided in Annex A.

An organization already certified to ISO 9001 will find it
easier to obtain certification to ISO 22000.

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ISO 22000 flowchart
Design and Maintenance of Control System






Communication













Customer
requirements
Operation of the control system
Validation
of control
system
Management
Design of control
system
Production
Legislation
Science &
experience
Orders
Monitoring of
control system
Improvement
of control
system
Verification
of control
system
Suppliers and
contractors
Safe end
product



Customer
satisfaction




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Main concepts of ISO 22000

Individual organizations are free to choose the necessary
methods and approaches to fulfil the requirements of ISO
22000.
ISO 22000 is particularly intended for organizations that
seek a more coherent and integrated food safety
management system than is normally required by law.
It is important to note that certification of an ISO 22000
FSMS is a management system certification
and not a product certification.

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Main advantages of ISO 22000
Internationally recognized.
Auditable.
Applicable in varied contexts.
Flexible.
Easily combinable with other management systems
and/or with the HACCP method.
Supported by other ISO deliverables (ISO/TS 22003;
ISO/TS 22004 and ISO 22005).

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ISO 22000 is widely implemented
Although ISO 22000 was published only a year
ago, it has already been implemented by more
than 50 countries, and at least 350 companies
have been certified to it.


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2
Potential of ISO 22000
International coherence among many GMPs
EFSIS
Nestl NQS
FAMI-QS
GMO
ISO 9001
GMP standard for Corrugated &
Solid Board
IFS
GFSI
Guide
SQF
AG 9000
ISO 14001
McDonalds system
Kraft food system
Eurepgap
Friesland Coberco FSS
DS 3027
BRC-IoP
BRC-Food
Dutch HACCP
Irish HACCP
M&S system
Aldi system
Waiterose
system
GMP
GTP
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ISO/TS 22003
ISO/TS 22003, Food safety management systems --
Requirements for bodies providing audit and
certification of food safety management systems
TC 34 needed the assistance of and its liaison
organizations, particularly ISO/CASCO and the
International Accreditation Forum (IAF).
Therefore, a joint working group with ISO/CASCO was
established for the elaboration of ISO/TS 22003.


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Reasons for ISO/TS 22003
Certification of a Food Safety Management System (FSMS)
provides independent demonstration that the FSMS of the
organization
conforms to specified requirements,
is capable of consistently achieving its stated policy
and objectives, and
is effectively implemented.
ISO/TS 22003 gives generic requirements for the
certification bodies.
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ISO 22000 and Conformity Assessment
The ISO 22000 requirements can be used as the basis of
a food safety management system and assessed under
Suppliers Declaration of Conformity, 2
nd
party
inspection or 3rd party certification
ISO/TS 22003 adds specific guidance related to assessing
compliance with ISO 22000 to the requirements for the
certification of management systems according to
ISO/IEC 17021
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Qualifications of FSMS auditors according to
product/service category

The FSMS auditors shall
have general knowledge
of microbiology and
chemistry
They shall be educated in
the food industry category
in which they will
conduct FSMS audits
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Qualifications of FSMS auditors (cont)
They shall have successfully
completed training in audit
techniques based on ISO 19011 and
in food safety issues relating to
FSMS (e.g. ISO 22000)
For a first qualification, they shall
have performed within the last
three years at least 12 FSMS audit
days in at least four organizations,
under the leadership of a qualified
auditor.
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Annex A: Food chain categories (1)
Category
codes
Categories Examples of sectors
A Farming 1 (Animals)
animals; fish; egg production; milk production;
fishing; hunting; trapping
B Farming 2 (Plants)
fruits; vegetables; grains; spices; horticulture
products
C
Processing 1 (perishable
animal products)
meat; poultry; eggs; dairy and fish products
D
Processing 2 (products with
long shelf life at ambient
temperature)
fresh fruits and fruit juices; preserved fruits;
fresh vegetables; preserved vegetables;
E
Processing 3 (perishable
vegetal products)
canned products; biscuits; snacks; oils;
drinking water; beverages; pasta; flour;
sugar; salt
F Feed production animal feed; fish feed;
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Annex A: Food chain categories (2)
Category
codes

Categories Examples of sectors
G Catering hotels; restaurants
H Distribution retail outlets; shops; wholesalers
I Services
water supply; cleaning; sewage; waste
disposal; development of product, process
and equipment; veterinary services
J Transport and storage transport and storage
K Equipment manufacturing process equipment; vending machines;
L (Bio)chemical manufacturer
additives; vitamins; pesticides; drugs;
fertilizers; cleaning agents; biocultures;
M
Packaging material
manufacturing
packaging material;
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Annex B: Audit time

Guidance is given on the minimum audit time needed,
depending on the food chain category involved, number of
employees, number of sites, etc.
Minimum audit time for single site, Ts:
Ts = D + H + MS + FTE
where D is the basic on-site audit time
H is the audit days for additional HACCP studies
MS is the audit days for absence of relevant
management system
FTE is audit days per number of employees.







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ISO/TS 22004
ISO/TS 22004, Food safety
management systems Guidance
on the application of ISO 22000
ISO/TS 22004 was published in 2005.


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What is the aim of ISO/TS 22004?
It provides users with explanations that will help
in the application of the standard
It provides additional information for small
and/or less developed organizations on how to
implement certain requirements
ISO/TS 22004 deals with those parts of ISO 22000
which need special attention.
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Guidance in ISO/TS 22004
The guidance helps:
to avoid misinterpretation of ISO 22000;
to clarify the meanings of its terms; and
to eliminate confusion.

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Introduction to ISO/TS 22004
The design and implementation of the system
are influenced by many varying factors:
the type of food safety hazard;
the products provided;
the processes employed;
the size and structure of the organization.
Therefore, only generic guidance can be
given.

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Guidance for small and/or less developed
organizations
In an organization with only one or two people in the management
structure, an internal audit may be carried out as follows:
The manager steps back from direct involvement in the business
operations and tries to be objective about the audit.
Cooperation of another small business allows each to provide the
internal audit for the other.
External parties (e.g. chamber of commerce, consultant,
inspection agencies) could provide independent auditors.


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Assessment and combination of control
measures

The guidance in ISO/TS 22004 lists the information
required to assess the effect of a control measure.
More than one control measure is often required to
control specific food hazards
More than one food safety hazard may be controlled
by the same control measure (but not necessarily to
the same extent).
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ISO 22000 Checklist
ISO and the ITC have recently prepared a checklist to facilitate the use
of ISO 22000, namely
ISO 22000 Are you ready?

This comprehensive document:
Quotes a part from ISO 22000.
Raises a question relating to the quoted part.
If the reply is "Yes" it says Go to the next question
If the reply is "No" it says See guidance below
Detailed explanation is then given to assist in answering the question.

The ISO 22000 Checklist comprises a paper version and a CD Rom. It is
available in English, French and Spanish.




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Traceability
ISO 22005, Traceability system in the feed and food chain -
General principles and basic requirements for system design and
implementation, will be published in 2007

The traceability of food products "from the farm to the fork"
is an important requirement of ISO 22000.
ISO 22005 will help food producers and manufacturers to
comply with the relevant statutory and regulatory
requirements,
It will also be an important tool to prove the origin of food.


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Use of ISO 22005

Choice of traceability system is influenced by regulations,
product, its characteristics and customer expectations
Implementation by an organization of a traceability
system depends on:
technical limits inherent to the organization and
products
cost/benefits of applying such a system.
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ISO 22005 and Codex
ISO 22005 complements CCFICS (Codex) Principles for
Traceability/Product Tracing as a tool within a Food
Import and Export Inspection and Certification System
ISO 22005 does not specify how or when regulators
require or apply traceability/product tracing
This is the work of Codex
CCFICS participated in the ISO Working Group (via
nominated expert(s) from Codex)

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Thank you for your kind attention!

Thank you
for your
kind
attention!