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Introducing ISO

220000:2005 – The
Easy Way to
Certification

From 22000foodsafety
Who are ISO ?

The International Organization for


Standardization (ISO) was established in
1947 and is an association of 157
members, which each represent their own
country. ISO employs a system of Technical
Committees and Working Groups to
develop International Standards.

British Standards Institute is the National


Standards Body that represents the United
Kingdom at ISO www.bsigroup.com

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What is ISO 22000:2005?

ISO 22000:2005 is an international standard


that 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.

ISO 22000:2005 is applicable to all


organizations in the food chain, regardless
of size, that want to implement systems
that consistently provide safe products.

ISO published ISO 22000 on September 1,


2005.

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What is ISO 22000:2005?
ISO 22000 is designed for the certification of
established Food Safety Management Systems and
so an organisations FSMS can be certified as
compliant with this standard by an independent
body.

An organisation can be in compliance with ISO


22000:2005 without being formally certified by an
accredited body. An organisation can apply the food
safety management system and state that the FSMS
complies with ISO 22000, however, the system is
likely to have more credibility with customers if it
has been approved by an independent body.

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What is ISO 22000:2005?
In order to comply with ISO 22000 an organisation shall:

Plan, implement, maintain and update a food safety


management system to supply products that are safe
for the consumer
Demonstrate compliance with applicable customer,
statutory and regulatory food safety requirements
Demonstrate compliance with recognised industry
codes of practice
Effectively communicate food safety issues to
suppliers, customers and relevant parties in the food
chain
Conform to the stated food safety policy
Demonstrate such conformity to relevant interested
parties

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What is ISO 22000:2005?
ISO 22000 integrates the principles of the Hazard Analysis
and Critical Control Point (HACCP) system developed by the
Codex Alimentarius Commission with prerequisite
programmes. Hazard analysis is the key to an effective food
safety management system.
ISO 22000 assists in defining the system requirements to
gather the information and knowledge in order to establish an
effective combination of control measures.
ISO 22000 requires that all hazards that may be reasonably
expected to occur in the food chain, including hazards that
may be associated with the process and facilities used, are
identified and assessed.
During hazard analysis, the FSMS ensures hazard control by
combining the prerequisite programmes, operational
prerequisite programmes and HACCP plans.

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What is ISO 22000:2005?
ISO has developed additional standards that are related to
ISO 22000. These standards are known as the ISO 22000
family of standards:
 ISO 22000:2005 - Food safety management systems
requirements for any organization in the food chain.
 ISO TS 22003:2007 - Food safety management systems
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 22000:2005.
 ISO 22005:2007 - Traceability in the feed and food chain
- General principles and basic requirements for system
design and implementation.
ISO 22000 can also be closely incorporated with the quality
management system of ISO 9001.

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ISO 22000:2005 Key Elements
ISO 22000 combines generally recognized key
elements to ensure food safety along the food
chain :

Interactive Communication

HACCP Principles

System Management

Prerequisite programmes

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ISO 22000:2005 Key Elements
Interactive Communication

Clear communication along the food chain is


essential to ensure that all relevant food safety
hazards are identified and adequately controlled at
each step. This implies communication of the needs
of the organization to organizations both upstream
and downstream in the food chain.

Communication with customers and suppliers, based


on the information generated through systematic
hazard analysis, will also assist in establishing
customer and supplier requirements in terms of
feasibility, need and impact on the end product.

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ISO 22000:2005 Key Elements
System Management

The most effective food safety systems are designed,


operated and updated within the framework of a
structured management system and incorporated into
the overall management activities of the organization.

This provides maximum benefit for the organization and


interested parties. ISO 22000 is aligned with the
requirements of ISO 9001:2000 in order to enhance the
compatibility of the two standards and to ease their
joint or integrated implementation.

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ISO 22000:2005 Key Elements
HACCP Principles

ISO 22000 combines the Codex Alimentarius


HACCP (Hazard Analysis and Critical Control
Points) principles and application steps,
developed by Codex
Alimentarius, with prerequisite programmes.

It uses the hazard analysis to determine the


strategy for hazard control.

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ISO 22000:2005 Key Elements
Prerequisite Programmes
The effective production of safe products requires a
detailed HACCP plan and the integration of two
categories of Prerequisite programmes:
Infrastructure and maintenance programmes
Operational prerequisite programmes

Infrastructure and maintenance programmes address


basic hygienic requirements and accepted good
agricultural, manufacturing, storage, transport and
veterinary practices of a permanent nature.

Operational prerequisite programmes are implemented


to control identified food safety hazards in the product
or processing environment

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About ISO 22000:2005
ISO 22000 is a food safety management system standard that lays
down the requirements needed to demonstrate the control food
safety hazards in order to ensure that food is safe for consumption.
The requirements of this ISO 22000 are generic and so ISO 22000
is applicable to all organizations that are involved in the food chain,
regardless of size and complexity that want to implement systems
that consistently provide safe products.
Organizations that are directly involved that would benefit from ISO
22000 certification include feed producers, farmers, producers of
ingredients, food manufacturers, retailers, food services, catering
services, organizations providing cleaning and sanitation services,
transportation, storage and distribution services.
Other organizations that are indirectly involved that may benefit
from ISO 22000 certification include suppliers of equipment,
cleaning agents, packaging materials, and other food contact
materials.

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ISO 22000 Definitions
Food Safety
The concept that food will not cause harm to the consumer
when it is eaten according to its intended use. Food safety
is related to the occurrence of food safety hazards.
Food Chain
The sequences in the production, processing, distribution,
storage and handling of a food, including its ingredients,
from primary production to consumer. This includes the
production of feed for food-producing animals and for
animals intended for food production. The scope of this
definition also includes the production of materials
intended to come into contact with food.
Food Safety Policy
A statement of food safety intent formally expressed by
senior management.

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ISO 22000 Definitions
Food Safety Hazard
A biological, chemical or physical agent in food(including
allergens), or condition of food, with the potential to cause an
adverse health effect.
In the context of feed and feed ingredients, relevant food safety
hazards are those that may be present in and/or on feed and
feed ingredients and that may subsequently be transferred to
food through animal consumption of feed and may thus have the
potential to cause an adverse human health effect.
For producers of food chain packaging materials, cleaning agents
and similar products, relevant food safety hazards are those
hazards that can be directly or indirectly transferred to food
because of the intended use of the products and thus have the
potential to cause an adverse human health effect.

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ISO 22000 Definitions
Risk

Risk is defined as the combination of the


probability of occurrence of harm and the severity
of that harm. The term "hazard" is not to be
confused with the term "risk" which, in the context
of food safety, means a function of the probability
of an adverse health effect and the severity of
that effect when exposed to a specified hazard.

Flow Diagram

A flow diagram is a schematic and systematic


presentation of the sequence and interactions of
steps

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ISO 22000 Definitions
End Product

A product that will not undergo any further processing or


transformation by the organization prior to delivery to the
customer/consumer. This may be a raw material to the
next organisation or consumer depending on it’s position
in the food chain.

Control Measure

An action or activity that can be used to prevent or


eliminate a food safety hazard or reduce it to an
acceptable level.

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ISO 22000 Definitions
Critical Control Point (CCP)

A step in the process at which control can be applied and is essential to


prevent or eliminate a food safety hazard or reduce it to an acceptable level.

Critical Limit

A critical limit is the maximum or minimum value to which a physical,


biological, or chemical hazard must be controlled at a critical control point to
prevent, eliminate, or reduce to an acceptable level. Critical limits are
established to determine whether a CCP remains in control and the product is
safe.

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ISO 22000 Definitions
Prerequisite Programme (PRP)

Base conditions and activities that are necessary to


maintain a safe environment for the production, handling
and provision of safe end products. These are
infrastructure and maintenance prerequisites that an
organisation has decided are the minimum pre-conditional
hygienic conditions.

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ISO 22000 Definitions
Operational Prerequisite Programme (Operational PRP)
A prerequisite programme identified by the hazard analysis as essential in
order to control food safety hazards in the product or in the process.

An operational prerequisite programme is a specified procedure(s) or


instruction(s), specific to the nature and size of the operation, that enhances
and/or maintains operational conditions to enable more effective control of food
safety hazards and/or that controls the likelihood of introducing food safety
hazards and their contamination of or proliferation in the product(s) and
product processing environment.

Types of operational prerequisites include:


Physical contamination controls ( e.g. Metal detection)
Chemical contamination controls (e.g. Cleaning controls)
Prevention of cross contamination (e.g. Allergen controls)

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ISO 22000 Definitions
Control Point (CP)
Any point, step or procedure at which control can be applied so that potential
quality deficiencies can be prevented; eliminated or reduced to an acceptable
level. The loss of control may not lead to an unacceptable food safety risk.

Monitoring
Observations or measurements to assess whether control measures are
operating as intended.

Correction
The action taken to eliminate a detected nonconformity and potentially
unsafe product. A correction can be taken in conjunction with a corrective
action. Examples include reprocessing, disposal, and alternate use.

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ISO 22000 Definitions
Corrective Action

Measures taken to rectify conditions adverse to quality


and safety. It includes action taken to prevent
recurrences of the problem.

Validation

The process obtaining adequate evidence that the


control measures managed by the HACCP plan and by
the operational PRPs are capable of being effective.

Verification

Confirmation through the provision of objective evidence


that specified requirements have been fulfilled.

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ISO 22000 Definitions
Updating

An activity to ensure application of the most recent


information.

Non-Conformance

A deficiency in characteristics, documentation or


process implementation, which means product
requirements have not been achieved.

HACCP

HACCP stands for Hazard Analysis and Critical


Control Point. It was developed by the Codex
Alimentarius Commission. HACCP is a system used to
identify, prevent, and control food safety hazards.

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ISO 22000 - HACCP Principles
A HACCP system is based on 7 principles that identify
specific hazards and implements measures for their
control:

Principle 1
Prepare a flow diagram of the steps in the process.
Conduct a hazard analysis by identifying potential hazards.
Assess likelihood of occurrence of these hazards and
identify control options

Principle 2
Identify the Critical Control Points in the process using the
decision tree

Principle 3
Establish Critical Limits for each CCP

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ISO 22000 – HACCP Principles
Principle 4
Establish a monitoring system to ensure control of
the Critical Control Point by scheduled testing or
observations

Principle 5
Establish the corrective action to be taken when
monitoring indicates that a particular Critical Control
Point is moving out of control

Principle 6
Establish documentation concerning all procedures
and records appropriate to these principles and their
application

Principle 7
Validate and Verify that HACCP is working effectively

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ISO 22000 – HACCP Plan
HACCP Plan

The HACCP system is used to develop a HACCP plan.


An HACCP plan is a document that describes how an
organisation manages and controls its food safety
hazards.

An HACCP plan contains:

i.Criticalcontrol points (CCPs)


ii.Process steps where the CCP applies
iii.Hazards that will be controlled at each CCP
iv.Control measures that will be used at each CCP
v.Critical limits that will be applied at each CCP
vi.Procedures that will be used to monitor CCPs
vii.Corrections that will be taken when critical limits
are exceeded

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ISO 22000:2005 Standard

The ISO 22000:2005 Sections:


Section 1: Scope
Section 2: Normative Reference
Section 3: Terms and definitions
Section 4: Food Safety Management System
Section 5: Management Responsibility
Section 6: Resource Management
Section 7: Planning and Realization of Safe
Products
Section 8: Verification, Validation and
Improvement of the Food Safety
Management System

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ISO 22000:2005 Standard
The next few slides show tables that match
our
ISO 22000 food safety management system
document templates to the clauses of the ISO
22000:2005 Standard:

Section 4: Food Safety Management System


Section 5: Management Responsibility
Section 6: Resource Management
Section 7: Planning and Realization of Safe
Products
Section 8: Verification, Validation and
Improvement of the Food Safety Management
System

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ISO 22000 Standard - Section 4: Food Safety Management
System summary of the ISO 22000 compliance

ISO 22000 Section ISO 22000 Manual ISO 22000 Manual Document
Reference

4. Food Safety Management System

4.1 General Requirements QM001 Quality and Food Safety


Management System

4.2 Documentation QM002 QMS Manual Summary

4.2.2 Document Control QM003 Document Control

4.2.2 Document Control QM004 Customer, Statutory and Regulatory


Conformance

4.2.3 Record Control QM005 Record Control

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ISO 22000 Standard – Section 5: Management Responsibility
ISO 22000 Section ISO 22000 Manual ISO 22000 Manual Document
Reference
5. Management Responsibility

5.1 Management Commitment QM006 Management Commitment

5.2 Food Safety Policy QM007 Quality and Food Safety


Policy/Objectives
5.3 FSQMS Planning QM001 Quality Management System

5.4 Responsibility & Authority QM008 Responsibility, Authority and


Communication
5.5 Food Safety Team Leader

5.6 Communication

5.6.1 External Communication

5.6.2 Internal Communication

5.7 Contingency preparedness and QM025 Control of Nonconforming Product


response QM027 Crisis Management
QM028 Product Recall
5.8 Management Review QM009 Management Review

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ISO 22000 Standard – Section 7: Planning and Realisation of Safe
Products

ISO 22000 Section ISO 22000 Manual ISO 22000 Manual Document
Reference

7. Planning and Realisation of Safe Products

7.1 General Planning and QM012 Planning Product Realization and


Realisation of Safe Products Contract Review

QM020 HACCP System

7.2 Prerequisite Programmes QM011 Infrastructure and Work


Environment

QM015 Prerequisite programmes

7.3 Preliminary steps to enable QM020 HACCP System


Hazard analysis

7.4 Hazard Analysis QM020 HACCP System

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ISO 22000 Standard – Section 7: Planning and Realisation of Safe
Products
ISO 22000 Section ISO 22000 Manual ISO 22000 Manual Document
Reference
7.5 Operational Control
7.5 Establishing the Operational PRPs QM020 HACCP System
7.5 Establishing the Operational Pre- PRP 001 Management of Hygiene and Housekeeping
requisites PRP 002 Management of Pest Control
PRP 003 Control of Visitors and Contractors
PRP 004 Management of Cleaning
PRP 005 Despatch and Distribution
PRP 006 Maintenance
PRP 007 Waste Management
PRP 008 Hygiene Policy
PRP 009 Glass Policy
PRP 010 Ingredients Foreign Body Control Policy
PRP 011 Metal Detection
PRP 012 Nut Handling Procedure
PRP 013 Control of Knives
PRP 014 Control of Brittle Materials
PRP 015 Glass & Brittle Material Breakage Procedure
PRP 016 Types of Allergen
PRP 017 Storage
PRP 018 Allergen Control Procedures
PRP 019 Food Defence System
PRP 020 Control of First Aid Dressings
PRP 021 HACCP Prerequisites

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ISO 22000 Standard – Section 7: Planning and Realisation of Safe
Products
ISO 22000 Section ISO 22000 Manual ISO 22000 Manual Document
Reference
7. Planning and Realisation of Safe Products (ISO 22000)

7.6 Establishing the HACCP plan QM020 HACCP System

7.7 Updating of preliminary QM020 HACCP System


information and documents
specifying the PRP(s) and HACCP
plan
7.8 Verification Planning QM021 Verification, Validation and Improvement

7.9 Traceability System QM016 Identification and Traceability

7.10.1 Corrections QM025 Control of Non Conforming Product


QM026 Corrective Action and Preventive Action
7.10.2 Corrective Actions

7.10.3 Handling of Potentially QM025 Control of Non Conforming Product


unsafe products
7.10.4 Withdrawals QM025 Control of Non-Conforming Product
QM027 Crisis Management
QM028 Product Recall

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ISO 22000 Standard – Section 8: Validation, Verification and
Improvement of the FSQMS
ISO 22000 Section ISO 22000 Manual ISO 22000 Manual Document
Reference
8. Validation, Verification and Improvement of the FSQMS
8.1 General QM020 Hazard Analysis and Critical Control Points

8.2 Validation of Control Measure QM021 Verification, Validation and Improvement


Combinations QM027 Calibration
8.3 Control of Monitoring and QM019 Calibration
Measuring
8.4 FSQMS Verification QM021 Verification, Validation and Improvement
8.4.1 Internal audits QM023 Internal Audit
8.4.2 Evaluation of Individual QM021 Verification, Validation and Improvement
Verification results
8.4.3 Analysis of results of QM021 Verification, Validation and Improvement
Verification activities
8.5 Improvement QM021 Verification, Validation and Improvement
8.5.1 Continual Improvement QM021 Verification, Validation and Improvement
8.5.2 FSQMS updating QM021 Verification, Validation and Improvement

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ISO 22000 Standard
ISO 22000: uses a similar structure to the ISO 9001:2008
quality management system standard. This should make it a
bit easier for ISO 9001 certified organizations to achieve ISO
22000 certification.
Our document QM 002 Food Safety Quality Manual Summary
shows the connections between ISO 9001 and ISO 22000 and
how the ISO 22000 manual is compliant with both.
ISO 22000 has a structured approach to combining the HACCP
plan with prerequisite programmes and operational
prerequisite programmes into a single integrated food safety
management system.
Prerequisite programmes (PRPs) are activities and practices
that must be performed in order to establish and maintain a
hygienic environment and are often referred to with terms such
as “Good Manufacturing Practice”.

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ISO 22000 Implementation

The process of implementing ISO 22000 must


start with Senior Management as defined in
section 5 management responsibility.

The standard requires senior management to


demonstrate commitment to the food safety
management system (FSMS). This needs to be
supported by food safety policy and objectives.
These should lead to the planning and
development of the FSMS.

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ISO 22000 Implementation

The following slides show the typical steps


in developing a FSMS compliant with ISO
22000:2005.

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ISO 22000 Implementation – Senior
Management Responsibilities
i. Demonstrate a commitment to food safety
ii. Issue a food safety policy
iii. Establish food safety objectives
iv. Define the scope and boundaries of the FSMS.
v. Plan the establishment of the FSMS.
vi. Provide adequate support to establish the FSMS.
vii. Ensure there is adequate infrastructure and work
environment.
viii. Appoint a food safety team leader
ix. Appoint the food safety team
x. FSMS responsibilities and authorities are documented and
communicated
xi. Establish food safety communication systems
xii. Provide the resources required to establish, document,
implement, maintain and update the FSMS.

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ISO 22000 Implementation –
Management Responsibilities
xiii. Implement training and awareness programs.
xiv. Ensure personnel are competent particularly in terms of
food safety
xv. Ensure that systems are in place to manage potential
emergency situations and accidents.
xvi. Establish, implement and maintain infrastructure and
maintenance prerequisite programs (PRPs) to control food
safety hazards
xvii. Establish , implement and maintain operational
prerequisite programs (PRPs) to control food safety
hazards
xviii. The food safety team describe product characteristics are
described for raw materials, ingredients and product
contact materials (such as packaging). Key information
should be documented usually in specifications and legal
food safety requirements identified.

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ISO 22000 Implementation – Food
Safety Team Role
xix. The characteristics of end products are described and
documented
xx. The intended use of the end product is described including
vulnerable groups
xxi. Flow diagrams are prepared for all products and processes
including all the steps in the process
xxii. Food safety control measures are identified
xxiii. Perform a food safety hazard analysis
xxiv. Identify and document food safety hazards
xxv. Specify acceptable levels for each hazard
xxvi. Assess the food safety hazards
xxvii. Select and assess control measures for each food safety
hazard
xxviii. Decide if control measures are to be part of operational
prerequisite programs or the HACCP plan. HACCP 004 HACCP
Calculator aids this process.

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ISO 22000 Implementation – Food Safety
Team Role
xxix. Establish the operational PRPs
xxx. Prepare the HACCP plan
xxxi. Identify critical control points (CCP)s for each food
safety hazard
xxxii. Determine the critical limit for each CCP
xxxiii. Determine and establish monitoring procedures and
records for each CCP
xxxiv. Determine the corrections and corrective actions to be
taken when monitoring results exceed critical limits
xxxv. Allocate responsibility and authority for monitoring and
recording, corrections and corrective actions
xxxvi. Document the HACCP plan
xxxvii.Validate that the control measures and combination of
control measures are capable of achieving the intended
level of control of the food safety hazards.

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ISO 22000 Implementation
xxxviii.The management team ensure all staff are
competent and adequately trained in the
requirements of the prerequisite
programmes, operational prerequisite
programmes and the HACCP Plan
xxxix. The food safety team update the
preliminary information based on the
HACCP plan and prerequisites programmes
and amend the operational PRP’s and
HACCP plan if necessary
xl. The management establish a product
traceability system
xli. The system is used to identify and correct
nonconforming products. Evaluate data and
take corrective actions.

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ISO 22000 Implementation
xlii. A system is put in place to control products
that are potentially unsafe including
withdrawal procedures
xliii. A system is put in place to control monitoring
and measuring methods and monitoring
devices
xliv. Systems are put in place to control FSMS
documents and records
xlv. Systems are put in place to verify that the
FSMS is implemented effectively including
internal audits
xlvi. The food safety team evaluate the results of
verification activities
xlvii. The senior management team carry out food
safety management reviews

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ISO 22000 Implementation
xlviii. The senior management team implement actions to
continually improve the FSMS
xlix. The food safety team update the FSMS as necessary
by reviewing data collected and information including
customer feedback, audit reports, results of
verification activities and management review output
and decide if the hazard analysis, design of
operational PRPs and the HACCP plan need review.

The ISO 22000 Internal Audit /Gap analysis Checklists


supplied as part of the ISO 22000 manual package will
assist in implementing a FSMS or integrating ISO
22000 into an existing management system.

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That’s the end of this
presentation
Thank you for attending.

www.22000foodsafety.com