Application of ISO in food processing industry

Safety between food industry and the market and then between the market and the consumer is
one of the most important aspects of the industry as a whole.

In considering industry to market practices, food safety considerations include the origins of food
including the practices relating to food labeling, food hygiene, food additives and pesticide residues, as
well as policies on biotechnology and food and guidelines for the management of governmental import
and export inspection and certification systems for foods.

Food companies all along the supply chain continuum have recognized the need to streamline food safety
activities by implementing food safety management systems (FSMSs) to ensure effective food safety
practices, comply with the necessary regulatory requirements, meet the specifications of food chain
customers downstream, and provide consumers with a high level of confidence in the products they
purchase. ISO 9001 is an internationally recognised quality management system standard
developed by the International Organization of Standardisation (ISO). This standard was developed
to provide a uniform standard for quality management worldwide. ISO 9001 is generic in nature and does
not relate specifically to food manufacture or food safety. It has been used as the basis for other more
specific standards for quality management, for example in the automotive industry, the medical device
industry, and the aerospace industry.

ISO and its member countries developed the quality management system approach, tailoring it to apply to
food safety by incorporating the widely used and proven HACCP (Hazard Analysis and Critical Control
Points) principles into the quality management system. The resulting standard is ISO 22000.

This standard provides an opportunity to minimise system and audit variations (for example based on
geography, sector, product or customer). It also reduces barriers to trade across borders and the supply
chain, through a truly global food safety standard.

ISO 22000 is a standard developed by the International Organization for Standardization dealing
with food safety. The ISO 22000 international standard specifies the requirements for a food safety
management system that involves interactive communication, system management, prerequisite
programs and HACCP principles.
Application of ISO in food processing industry

HACCP is a preventative food safety management system in which every step in the manufacture,
storage and distribution of a food product is analyzed for microbiological, physical and chemical hazards.

The consequences of unsafe food can be serious and ISO’s food safety management standards help
organizations identify and control food safety hazards. As many of today’s food products repeatedly cross
national boundaries, International Standards are needed to ensure the safety of the global food supply
chain.

The ISO 22000 family contains a number of standards each focusing on different aspects of food
safety management.

-ISO 22000:2005 contains the overall guidelines for food safety management
-ISO 22004:2014 provides generic advice on the application of ISO 22000
-ISO 22005:2007 focuses on traceability in the feed and food chain
-ISO/TS 22002-1:2009 contains specific prerequisites for food manufacturing
-ISO/TS 22002-2:2013 contains specific prerequisites for catering
-ISO/TS 22002-3:2011 contains specific prerequisites for farming
-ISO/TS 22002-4:2013 contains specific prerequisites for food packaging manufacturing
-ISO/TS 22003:2013 provides guidelines for audit and certification bodies

HACCP and ISO certifications serve different purposes, but are also complementary. HACCP
focuses on the sanitation of facilities, equipment and products, all of which must meet government and
municipal standards. ISO is a quality control method. Both standards can be implemented either
individually or simultaneously.

Food safety is related to the presence of and levels of food-borne hazards in food at the point of
consumption. As food safety hazards may be introduced at any stage of the food chain, adequate
control throughout the food chain is essential. Thus, food safety is a joint responsibility of all parties
Application of ISO in food processing industry

participating in the food chain. Food safety management systems are intended to provide food safety and
security. Food hygiene is vital throughout the whole food chain – from raw material to transportation of
ready products.

Consumers have a right to expect that the foods they purchase and consume will be safe and of
high quality. They have a right to voice their opinions about the food control procedures, standards and
activities that governments and industry use to ascertain that the food supply has these characteristics.
While consumers, governments and others play an important part in ensuring food safety and quality, in
free-market societies the ultimate responsibility for investing the physical and managerial
resources that are necessary for implementing appropriate controls lies with the food industry

Following are the ISO Standards applicable to food industry:

1. ISO 8086|IDF 121:2004 gives general guidelines for inspection and sampling procedures to be
used to check the effectiveness of cleaning and disinfection methods used in dairy plants and
receiving stations, including milk-collection tankers.

It deals with visual inspection, sampling from plant surfaces (product line, bottle washing
equipment, containers, etc.), re-usable product containers, air, sampling of water and aqueous
solutions other than those added to the product, and sampling of raw materials and products.

ISO 8086|IDF 121:2004 does not cover equipment normally installed in farms (e.g. milking
machinery or refrigerated bulk milk tanks), nor does it deal with the equally important areas of
health and hygiene of personnel, factory environment, internal arrangement of the factory,
methods of cleaning, packaging materials brought in new from outside (paper, cardboard, plastic,
new bottles, etc.), food ingredients and additives, selection of number of units and treatment of
the sample in the laboratory.

2. ISO 14470:2011 specifies requirements for the development, validation and routine control of the
process of irradiation using ionizing radiation for the treatment of food, and establishes guidelines
for meeting the requirements.
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ISO 14470:2011 covers irradiation processes using the radionuclides Co or Cs, electron
beams or X-ray generators.

The requirements given in ISO 14470:2011 are the minimum necessary to control the food
irradiation process.

ISO 14470:2011 does not specify requirements for the primary production and/or harvesting,
post-harvest treatment, storage and shipment, and packaging for foods that are to be irradiated.
Only those aspects of the food production directly related to the irradiation process that may
affect the safety or quality of the irradiated food are addressed.

ISO 14470:2011 does not specify requirements for occupational safety associated with the design
and operation of irradiation facilities.

ISO 14470:2011 does not cover measuring or inspection devices that utilize ionizing radiation.

The application of ISO 14470:2011 does not exempt the user from compliance with current and
applicable legislation.
Application of ISO in food processing industry

3. ISO 21469:2006 specifies hygiene requirements for the formulation, manufacture, use and
handling of lubricants which, during manufacture and processing, can come into incidental
contact (e.g. through heat transfer, load transmission, lubrication or the corrosion protection of
machinery) with products and packaging used in the food, food-processing, cosmetics,
pharmaceutical, tobacco or animal-feeding-stuffs industries. It is not applicable to substances
used as product additives or to those in direct product contact, but confines itself to hygiene
without addressing occupational health and safety matters.

4. ISO 22000: 2018: This document specifies requirements for a food safety management system
(FSMS) to enable an organization that is directly or indirectly involved in the food chain:

a) to plan, implement, operate, maintain and update a FSMS providing products and services that
are safe, in accordance with their intended use;

b) to demonstrate compliance with applicable statutory and regulatory food safety requirements;

c) to evaluate and assess mutually agreed customer food safety requirements and to
demonstrate conformity with them;

d) to effectively communicate food safety issues to interested parties within the food chain;

e) to ensure that the organization conforms to its stated food safety policy;

f) to demonstrate conformity to relevant interested parties;

g) to seek certification or registration of its FSMS by an external organization, or make a self-

assessment or self-declaration of conformity to this document.

All requirements of this document are generic and are intended to be applicable to all
organizations in the food chain, regardless of size and complexity. Organizations that are directly
or indirectly involved include, but are not limited to, feed producers, animal food producers,
harvesters of wild plants and animals, farmers, producers of ingredients, food manufacturers,
retailers, and organizations providing food services, catering services, cleaning and sanitation
services, transportation, storage and distribution services, suppliers of equipment, cleaning and
disinfectants, packaging materials and other food contact materials.

This document allows any organization, including small and/or less developed organizations (e.g.
a small farm, a small packer-distributor, a small retail or food service outlet) to implement
externally-developed elements in their FSMS.

Internal and/or external resources can be used to meet the requirements of this document.

5. ISO/TS 22002-1:2009 specifies requirements for establishing, implementing and maintaining

prerequisite programmes (PRP) to assist in controlling food safety hazards.

ISO/TS 22002-1:2009 is applicable to all organizations, regardless of size or complexity, which

are involved in the manufacturing step of the food chain and wish to implement PRP in such a
way as to address the requirements specified in ISO 22000:2005, Clause 7.

ISO/TS 22002-1:2009 is neither designed nor intended for use in other parts of the food supply
chain.

Food manufacturing operations are diverse in nature and not all of the requirements specified in
ISO/TS 22002-1:2009 apply to an individual establishment or process.
Application of ISO in food processing industry

Where exclusions are made or alternative measures implemented, these need to be justified and
documented by a hazard analysis, as described in ISO 22000:2005, 7.4. Any exclusions or
alternative measures adopted should not affect the ability of the organization to comply with these
requirements. Examples of such exclusions include the additional aspects relevant to
manufacturing operations listed under 1), 2), 3), 4), and 5) below.

ISO/TS 22002-1:2009 specifies detailed requirements to be specifically considered in relation to

ISO 22000:2005, 7.2.3: a) construction and layout of buildings and associated utilities; b) layout
of premises, including workspace and employee facilities; c) supplies of air, water, energy, and
other utilities; d) supporting services, including waste and sewage disposal; e) suitability of
equipment and its accessibility for cleaning, maintenance and preventive maintenance; f)
management of purchased materials; g) measures for the prevention of cross-contamination; h)
cleaning and sanitizing; i) pest control; j) personnel hygiene.

In addition, ISO/TS 22002-1:2009 adds other aspects which are considered relevant to
manufacturing operations: 1) rework; 2) product recall procedures; 3) warehousing; 4) product
information and consumer awareness; 5) food defence, biovigilance, and bioterrorism.

6. ISO/TS 22002-5: 2019: This document specifies requirements for establishing, implementing and
maintaining prerequisite programmes (PRPs) for transport and storage in the food chain to assist
in controlling food safety hazards.

This document is applicable to all organizations, regardless of size or complexity, that are
involved in transport and storage activities across the food supply chain and that wish to
implement PRPs in such a way as to address the requirements specified in ISO 22000.

This document is neither designed nor intended for use in other parts of the food supply chain or
in isolation.

In this document, transport and storage is aligned with ISO/TS 22003:2013, Annex A, Category
G. This document includes all food and feed products and food packaging and packaging
materials.

Live animals are excluded from the scope of this document except when intended for direct
consumption, e.g. molluscs, crustaceans and live fish.

7. ISO/CD 22003-1: Food safety management systems — Requirements for bodies providing audit and
certification of food safety management systems — Part 1: Requirements for bodies providing audit and
certification of food safety management systems
8. ISO/AWI 22003-2: Food safety management systems — Requirements for bodies providing audit and
certification of food safety management systems — Part 2: Requirements for bodies providing audits of food
safety management system elements in conjunction with safe food product/process certification
9. ISO/TS 22003:2013:. ISO/TS 22003:2013 defines the rules applicable for the audit and certification
of a food safety management system (FSMS) complying with the requirements given in ISO
22000 (or other sets of specified FSMS requirements). It also provides the necessary information
and confidence to customers about the way certification of their suppliers has been granted.
10. ISO 22006:2009 gives guidelines to assist crop producers in the adoption of ISO 9001:2008 for
crop production processes. The term "crop" includes seasonal crops (such as grains, pulses,
oilseeds, spices, fruit and vegetables), row-planted crops that are cultivated, perennial crops that
are managed over a period of time, and wild crops that are not formally planted or managed.
Horticultural crops provide an even broader range of types from annual and perennial fruits,
vegetables, and ornamental flowering plants to perennial shrubs and trees, and root crops. These
Application of ISO in food processing industry

diverse crops require a broad range of planting, cultivating, pest control, and harvesting methods
and practices. Decisions regarding planting, growing, and harvesting activities can be similar,
although specific steps can be quite different when considering the range of crops.

ISO 22006:2009 gives guidelines on the use and application of ISO 9001:2008 to the
establishment and management of a quality management system (QMS) by an organization
involved in crop production.

ISO 22006:2009 is not intended to change, add or reduce the requirements of ISO 9001:2008,
nor is it intended for certification.

Further down the supply chain, in manufacturing processes, the language of ISO 9001:2008, ISO
15161 or ISO 22000 is considered more appropriate. The need for an ISO 9001:2008-based
system containing agricultural terminology became apparent due to difficulties in the
interpretation of the language of ISO 9001:2008 for crop production applications.

11. ISO/TS 34700:2016 provides requirements and guidance for the implementation of the animal
welfare principles as described in the introduction to the recommendations for animal welfare of
the OIE TAHC (Chapter 7.1).

12. ISO/TS 34700:2016 applies to terrestrial animals bred or kept for the production of food or feed.
The following areas are excluded: animals used for research and educational activities, animals
in animal shelters and zoos, companion animals, stray and wild animals, aquatic animals, killing
for public or animal health purposes under the direction of the competent authority, humane killing
traps for nuisance and fur species.

Application of this document is limited to aspects for which process or species-specific chapters
are available in the OIE TAHC. At the time of publication of this document, they are:

- Chapter 7.2: Transport of animals by sea;

- Chapter 7.3: Transport of animals by land;

- Chapter 7.4: Transport of animals by air;

- Chapter 7.5: Slaughter of animals;

- Chapter 7.9: Animal welfare and beef cattle production systems;

- Chapter 7.10: Animal welfare and broiler chicken production systems; and

- Chapter 7.11: Animal welfare and dairy cattle production systems.

This document is designed to guide users in conducting a gap analysis and developing an animal
welfare plan that is aligned with the OIE TAHC. It can also be used to facilitate the
implementation of any public or private sector animal welfare standards that meet at least the OIE
TAHC.

The scope of this document is intended to be revised as the animal welfare provisions of the OIE
TAHC are supplemented or amended.

13. ISO 51900:2009 applies to the minimum requirements for dosimetry needed to conduct research
on the effect of radiation on food and agricultural products. Such research includes establishment
of the quantitative relationship between absorbed dose and the relevant effects in these products.
ISO 51900:2009 also describes the overall requirement for dosimetry in such research, and in
Application of ISO in food processing industry

reporting of the results. It is necessary that dosimetry be considered as an integral part of the
experiment.

ISO 51900:2009 applies to research conducted using the following types of ionizing radiation:
gamma radiation, X-ray (bremsstrahlung), and electron beams. The purpose of ISO 51900:2009
is to ensure that the radiation source and experimental methodology are chosen such that the
results of the experiment will be useful and understandable to other scientists and regulatory
agencies.

ISO 51900:2009 describes dosimetry requirements for establishing the experimental method and
for routine experiments; however, ISO 51900:2009 is not intended to limit the flexibility of the
experimenter in the determination of the experimental methodology. ISO 51900:2009 includes
tutorial information in the form of notes.

ISO 51900:2009 does not include dosimetry requirements for installation qualification or
operational qualification of the irradiation facility.
Application of ISO in food processing industry