ISO stands for the International Organization for Standardization.

This standard-setting body

was created in the 1940s in London and promotes standards across a wide range of industries.

ISO standards could pertain to “making a product, managing a process, delivering a service,
or supplying materials.” They apply to manufacturers, sellers, buyers, users, regulators,
customers, and trade associations. Thus, they are not exclusive to the food industry, and can
indeed benefit manufacturing of many types, including consumer packaged goods (CPG).

There are several types of ISO standards, including those for environmental and energy
management, health and safety, IT security, and quality management. Additionally, ISO has
specific food safety standards to minimize the risk of food contamination.

Why Are ISO Standards Important?

Manufacturers of all sizes have a responsibility to produce safe goods that support the
wellbeing of consumers. For instance, in the food industry, unsafe products can have
devastating consequences, which is why the overarching goal of ISO standards for food
safety is controlling hazards across the global supply chain.

What Are ISO Standards for Food Safety?

ISO standards help Food & Beverage companies promote brand security by keeping their
customers safe and satisfied with products that can be trusted. They give consumers added
confidence, which is especially important in a time when foodborne outbreaks, recalls, and
illness from contaminated foods are among the public’s top food-related concerns. There are
also ISO standards to help promote the safety of other products. ISO 10377:2013, for
instance, offers guidelines for suppliers to achieve consumer product safety.

Oftentimes, ISO certification can also help companies become more efficient by enhancing
systems and procedures. Becoming certified can help companies understand the preventive
quality and safety measures that should be put in place, but it can also aid in the
establishment of streamlined documentation, techniques, and procedures. ISO standards call
for a clear plan, which can result in a positive impact across the entire facility.

General Requirements of ISO Standards

Requirements for ISO standards vary from one type to the next. In general, however, the
standards call for companies to implement policies, processes, and procedures to support
safe, high-quality products and services. ISO formalizes these activities with the goal of
improving customer satisfaction. ISO also aims for continuous improvement, so certified
companies must stay up-to-date with the latest versions of standards as they’re released.

ISO standards such as ISO 9001 have both mandatory and non-mandatory requirements.
While companies must comply with mandatory requirements, non-mandatory requirements
can be submitted for documentation. For example, while a company would need to show
documents outlining their equipment calibration processes, a non-mandatory requirement
would be documents that describe their sales procedures. There is much more paperwork
typically required for ISO standards, including:

 Records for employee training

  Records for the review of products or service requirements

 Records for inputs, outputs, and controls for design and development

 Records for conformity of products and services with acceptable standards

 Records for nonconformances

 Results for monitoring

 Results for internal audits, management reviews, and corrective actions

Types of ISO Standards

ISO reports that they have published more than 23,000 individual standards that cover nearly
all aspects of manufacturing and technology. Some are more popular than others, with the
following being among the most common across manufacturing.

INTRODUCTION TO FOOD SAFETY MANAGEMENT SYSTEM (FSMS) –ISO:

22000

9.1 Introduction

Food safety is a global concern, not only because of the importance for public health but also
because of its impact on international trade. Globalisation of food production and
procurement makes food chains longer and more complex and increases the risk of food
safety incidents. Effective and harmonized food safety systems shall manage and ensure the
safety and suitability of food in each link of the supply chain. For this reason ISO developed
the standard for food safety management systems ISO 22000 which applies to all
organizations in the food chain and thus ensures integrity of the chain. ISO 22000 is a generic
food safety management system standard. It defines a set of general food safety requirements
that apply to all organizations in the food chain. If an organization is part of the food chain,
ISO 22000 wants it to establish a food safety management system (FSMS). It then wants it to
use this system to ensure that food products do not cause adverse human health effects. Since
ISO 22000 is a generic food safety management standard, it can be used by any organization
directly or indirectly involved in the food chain. It applies to all organizations in the food
chain. It doesn’t matter how complex the organization is or what size it is, ISO 22000 can
help ensure the safety of its food products.

9.2 Definition and Terminology

9.2.1 Control (noun)

To state wherein correct procedures are being followed and criteria are being met.

9.2.2 Control (verb)

To take all necessary actions to ensure and maintain compliance with criteria established in
the HACCP plan.
9.2.3 Control measure

Any action and activity that can be used to prevent or eliminate a food safety hazard or
reduce it to an acceptable level.

9.2.4 Corrective action

Any action to be taken when the results of monitoring at the CCP indicate a loss of control.

9.2.5 Critical control point (CCP)

A step at which control can be applied and is essential to prevent or eliminate a food safety
hazard or reduce it to an acceptable level.

9.2.6 Critical limit

A criterion which separates acceptability from unacceptability.

9.2.7 Deviation

Failure to meet a critical limit.

9.2.8 End products

Product that will undergo no further processing or transformation by the organization.

9.2.9 Flow diagram

A systematic representation of the sequence of steps or operations used in the production or

manufacture of a particular food item.

9.2.10 Food safety hazard

Biological, chemical or physical agents in food, or condition of food, with potential to cause
an adverse health effect.

9.2.11 Food safety policy

Overall intentions and direction of an organization related to food safety as formally

expressed by top management.

9.2.12 HACCP plan

A document prepared in accordance with the principles of HACCP to ensure control of

hazards which are significant for food safety in the segment of the food chain under
consideration.

9.2.13 HACCP

A system which identifies, evaluates and controls hazards which are significant for food
safety.

9.2.14 Hazard analysis

The process of collecting and evaluating information on hazards and conditions loading to
their presence to decide which are significant for food safety and therefore should be
addressed in the HACCP plan.

9.2.15 Hazard

A biological, chemical or physical agent in, or condition of, food with the potential to cause
an adverse health effect. It is the potential to cause harm; risk on the other hand is the
likelihood of harm (in defined circumstances, and usually qualified by some statement of the
severity of the harm).

9.2.16 Monitor

The act of conducting a planned sequence of observations or measurements of control

parameters to assess whether a CCP is under control.

9.2.17 Operating limits

Criteria more stringent than critical limits that are used by an operator to reduce that risk of
contamination, eg., if a certain chemical concentration is required to control a hazard, the
operating limit is generally set above the minimum concentration needed to ensure effective
treatment.

9.2.18 Operational prerequisite programme (OPRP)

Identified by the hazard analysis as essential in order to control the likelihood of introducing
food safety hazards (and/ or the contamination or proliferation or food safety hazards in the
product (s) or in the processing environment.

9.2.19 Prerequisite programme (PRP)

Basic condition and activities that is necessary to maintain a hygienic environment

throughout the food chain suitable for production, handling and provision of safe end
products and safe food for human consumption.

9.2.20 Risk

An estimate of the likely occurrence of a hazard.

9.2.21 Severity

The seriousness of a hazard (if not properly controlled)

9.2.22 Step

A point, procedure, operation or stage in the food chain including raw materials, from
primary production to final consumption.

9.2.23 Validation

Verification focused on collecting and evaluating scientific and technical information to

determine if the HACCP plan, when properly implemented, will effectively control the
hazards.

9.2.24 Verification

The use of methods, procedures or test, in addition to those used in monitoring, those
determine if the HACCP system complies with the HACCP plan and/ or whether the plan
needs modification.

9.3 ISO 22000, Food Safety Management Systems – Requirements

ISO 22000, Food safety management systems – Requirements for any organization in the
food chain, was first published in 2005. The standard provides international harmonization in
the field of food safety standards, offering a tool to implement HACCP (Hazard Analysis and
Critical Control Point) throughout the food supply chain. The process module of ISO
22000:2005 has been shown in Fig. 9.1.

Fig. 9.1 Process module of the standard ISO 22000:2005

9.4 Goal of ISO 22000

The goal of ISO 22000 is to control and reduce to an acceptable level, any safety hazards
identified for the end products delivered to the next step of the food chain. An end product is
defined as a product that will not undergo any further processing or transformation by the
organization. The standard combines the following generally-recognized key elements to
ensure food safety at all points of the food chain:

 Requirements for good manufacturing practices or prerequisite programs

  Requirements for HACCP according to the principles of the Codex
Alimentarius (an international commission established to develop food safety
standards and guidelines)
 Requirements for a management system
 Interactive communication between suppliers, customers and regulatory
authorities.
ISO 22000:2005 specifies requirements for a food safety management system where an
organization in the food chain needs to demonstrate its ability to control food safety hazards
in order to ensure that food is safe at the time of human consumption. It is applicable to all
organizations, regardless of size, which are involved in any aspect of the food chain and want
to implement systems that consistently provide safe products. The means of meeting any
requirements of ISO 22000:2005 can be accomplished through the use of internal and/ or
external resources. ISO 22000: 2005 specifies requirements to enable an organization

 To plan, implement, operate, maintain and update a food safety management

system aimed at providing products those, according to their intended use, are
safe for the consumer,
 To demonstrate compliance with applicable statutory and regulatory food
safety requirements,
 To evaluate and assess customer requirements and demonstrate conformity
with those mutually agreed customer requirements that relate to food safety in
order to enhance customer satisfaction,
 To effectively communicate food safety issues to their suppliers, customers
and relevant interested parties in the food chain,
 To ensure that the organization conforms to its stated food safety policy,
 To demonstrate such conformity to relevant interested parties and
 To seek certification or registration of its food safety management system by
an external organization, or make a self-assessment or self-declaration of
conformity to ISO 22000:2005.
ISO 22000:2005 is fully compatible with ISO 9001:2000, so it is suitable for the development
of a fully integrated, risk-based management system. This also means that organizations with
an existing management system should find it fairly easy to expand its scope to include ISO
22000. ISO 22000 was the first in a new family of standards related to food safety namely:

 ISO/ TS 22004:2005 provides guidance on the application of ISO 22000:2005.

 ISO 22005:2007 provides requirements for the design and implementation of a
feed and food traceability system.
 ISO/ TS 22003:2007 set requirements for bodies providing audit and
certification of ISO 22000.
9.5 Use of FSMS (ISO 22000)

 Primary producers: Dairy Farms, Ranches, Fisheries, Dairies

 Processors: Dairy, Fish, Meat, Poultry, Feed
 Manufacturers of Soups, Snacks, Breads, Cereals, Dressings, Beverages,
Seasonings, Packaging, Frozen food, Canned food, Confectionery, Dietary
supplements
 Food service providers: Grocery stores, Restaurants, Cafeterias, Hospitals,
Hotels, Resorts, Airlines, Cruise ships, Seniors lodges, Nursing homes
  Other service providers for Storage service providers, Catering service
providers, Logistics service providers, Transportation, Distribution, Sanitation,
Cleaning
 Product suppliers: Suppliers of tools, utensils, equipment, additives,
ingredients, raw materials, cleaning agents, sanitizing agents, packaging
materials, other food contact materials
9.6 Methodology for Developing an ISO 22000 and HACCP

ISO 22000 uses HACCP. It was developed by the CAC. HACCP is a methodology and a
management system. It is used to identify, prevent and control food safety hazards. HACCP
management systems apply the following methodology:

1. Conducting a food safety hazard analysis.

2. Identifying your critical control points (CCP’s).
3. Establishing critical limits for each critical control point.
4. Developing procedures to monitor critical control points.
5. Designing corrective actions to handle critical limit violations.
6. Creating a food safety record keeping system.
7. Validating and verifying the system.
An HACCP plan is a document that describes how an organization plans to manage and
control its food safety hazards. An HACCP plan contains at least the following information:

1. Critical control points (CCP’s)

2. Hazards that will be controlled at each CCP
3. Control measures that will be used at each CCP
4. Critical limits that will be applied at each CCP
5. Procedures that will be used to monitor CCPs
6. Actions that will be taken when limits are violated
ISO 22000 shows organizations how to combine the HACCP plan with pre-requisite
programs (or programmes) and operational pre-requisite programs into a single integrated
food safety management strategy.

9.6.1 Prerequisite programs (PRPs)

There are the conditions that must be established throughout the food chain and the activities
and practices that must be performed in order to establish and maintain a hygienic
environment. PRPs must be suitable and be capable of providing food that is safe for human
consumption. PRPs are also referred to as good hygienic practices, good agricultural
practices, good production practices, good manufacturing practices, good distribution
practices and good trading practices.

9.6.2 Operational pre-requisite programs (OPRPs)

These are pre-requisite programs (PRPs) that are essential. They are essential because a
hazard analysis has shown that they are necessary in order to control specific food safety
hazards. OPRPs are used to reduce the likelihood that products will be exposed to hazards,
that they will be contaminated and that hazards will proliferate. PRPs are also used to reduce
the likelihood that the processing environment will be exposed to hazards.

9.7 Comparison of ISO 22000 with HACCP and ISO 9000:2000

Developed with the participation of food sector experts, ISO 22000 incorporates the
principles of HACCP and covers the requirements of key standards developed by various
global food retailer syndicates, in a single document. The prerequisite programmes (PRPs)
are the main difference between ISO 22000 and HACCP. The incorporation of PRPs in the
ISO 22000 made the system more flexible as a smaller number of CCPs was introduced. ISO
22000 strengthens the HACCP system in several ways. It is a management standard,
therefore, it shares the following common elements with other management system standards

 Policy
 Planning
 Implementation and operation
 Performance assessment
 Improvement
 Management review
The main changes of ISO 22000 compared with HACCP are the following:

1. Extension of the scope to include all the food businesses from feed and
primary production as well as the organizations indirectly involved in the food
chain.
2. The hazards that require control are those managed not only by CCPs but also
through prerequisite programmes (PRPs).
3. There is provision of crisis management procedures in the case that external
dangers turn up.
4. Exist additional requirements for external communication between the food
organizations and the relevant authorities involved in food safety beyond the
internal communication requirements.
5. ISO 22000 uses a systems approach to prevent new hazards from occurring in
the food products and recognize the new technologies to control food safety
hazards. On the other side, HACCP is inherently a system to prevent food
safety hazards.
6. ISO 22000 strengthens HACCP by linking the plan to PRPs and defining
management’s responsibilities.
7. ISO 22000 is implemented through the whole supply chain and not only in this
final stage. The ISO 22000 standard is fully compatible with other ISO
management system standards such as ISO 9001. However, there are
differences between the two standards.
8. The focus of ISO 9001 is quality while the focus of ISO 22000 is food safety.
9. ISO 22000 extends the successful management system approach of the ISO
9001:2000 quality management system standard which is widely implemented
in all sectors but does not itself specifically address food safety.
10. The standard ISO 22000 can be applied on its own, or in combination with
other management system standards such as ISO 9001:2000 with or without
independent (third party) certification of conformity. Companies already
certified to ISO 9001 will find it easy to extend this to certification to ISO
22000.