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The ISO 22000 Family of Standards – An Overview
SG/KMK/AC/lz/14518141
2007-06-25
www.iso.org
International Organization
for Standardization
2
The ISO 22000 Family of Standards – An Overview
SG/KMK/AC/lz/14518141
2007-06-25
Overview of the ISO 22000
Family of Standards
Kevin McKinley, Deputy-Secretary-General,
ISO Central Secretariat
Albert Chambers, ISO/TC 34 Working Group Expert and Vice-Chair,
Canadian Advisory Committee, ISO/TC 34
Joint UNCTAD/WTO Informal Information
Session on Private Standards
25 June 2007, Geneva
3
The ISO 22000 Family of Standards – An Overview
SG/KMK/AC/lz/14518141
2007-06-25
Increased demand for
voluntary international standards
Globalization of trade in products and services
Outsourcing and foreign investment
Deregulation/privatization of public services
The climate change challenge and energy efficiency
mandates
Public demand for consumer safety, environmental
protection, corporate social responsibility
Need for international solidarity to face global
terrorism, pandemics and natural disasters
Pace of innovation and convergence of new
technologies
4
The ISO 22000 Family of Standards – An Overview
SG/KMK/AC/lz/14518141
2007-06-25
ISO and the international scene
World Trade Organization: observer status and collaboration
UN and UN agencies including: CODEX, ILO (labour), IMO
(maritime), ITC (Intl Trade Centre), UPU (postal), UN/ECE
(Commission for Europe), UNIDO (development), WHO
(health), WMO (meteorology), WtO (tourism) …
Other intergovernmental groups including OECD, medical
device regulators (GHTF) …
600 liaisons with international organizations in technical work
Links with seven regional standardization-related bodies
Economic actors: Accreditation (IAF), Lab accreditation
(ILAC), Consumers International, International Chamber of
Commerce, World Economic Forum, etc…
5
The ISO 22000 Family of Standards – An Overview
SG/KMK/AC/lz/14518141
2007-06-25
World Trade Report 2005
Section II
Trade, Standards and the WTO
Economics of standards and trade
Institutions and policy issues
Standards in the multi-lateral
trading system
6
The ISO 22000 Family of Standards – An Overview
SG/KMK/AC/lz/14518141
2007-06-25
The ISO system
At June 2007
• IT tools
• Standards
development
procedures
• Consensus
building
• Dissemination
156 national members
685 active
Committees
3 000 technical
bodies
50 000 experts
Central
Secretariat
in Geneva
150 staff
Catalogue of more
than 16 000
published standards
Consensus at two levels:
- Amongst global experts
- Amongst countries
through ISO members
7
The ISO 22000 Family of Standards – An Overview
SG/KMK/AC/lz/14518141
2007-06-25
Implementation of the ISO Action Plan
Improving awareness
Developing capacity
Increasing regional
cooperation
Developing electronic
communications
Increasing
participation
Key objectives:
8
The ISO 22000 Family of Standards – An Overview
SG/KMK/AC/lz/14518141
2007-06-25
Disseminating ISO 22000 standards
Cairo, Egypt (ARSO)
Windhoek, Namibia (SADC)
Ouagadougou, Burkina Faso (UEMOA)
Dubai, UAE (GSO)
New Delhi, India (SAARC)
Jakarta, Indonesia (ACCSQ)
Astana, Kazakhstan, Central Asia
Kenya, Tanzania, Uganda (following ToT
seminars)
Croatia, Libya, Mozambique and Yemen
Training delivered in:
English, French, Spanish, Russian and Arabic
ISO 22000 regional seminars held in:
ISO 22000 national seminars held in:
9
The ISO 22000 Family of Standards – An Overview
SG/KMK/AC/lz/14518141
2007-06-25
ISO/TC 34, Food products
Working Groups on: Food Safety Management
Systems, GMOs, Traceability systems, Food
irradiation
Subcommittees (mostly test methods) on: Seeds;
Fruits and vegetables; Cereals; Milk; Meat and
poultry; Spices; Tea; Microbiology; Animal feeding
stuffs; Fats and oils; Sensory analysis; Coffee
711 published standards, 55 participating countries,
49 observer countries
Active liaisons with Codex Alimentarius Commission
10
The ISO 22000 Family of Standards – An Overview
SG/KMK/AC/lz/14518141
2007-06-25
ISO 22000 Family of Standards
New Family – initiated in 2001
Four Standards so far:
ISO 22000:2005 – Food safety management system –
Requirements
ISO 22003:2007 - Requirements for bodies providing
audit and certification of food safety management
systems
ISO TS 22004:2005 - Guidance on the application of
ISO 22000
ISO 22005 – Traceability in the feed and food chain (to
be published in July 2007)
11
The ISO 22000 Family of Standards – An Overview
SG/KMK/AC/lz/14518141
2007-06-25
What food businesses were looking for ?
Better planning, less post-process verification
More efficient & dynamic hazard control
Systematic management of prerequisite programs
Better documentation
Communication among trade partners
Resource optimization (internally & along food
chains)
12
The ISO 22000 Family of Standards – An Overview
SG/KMK/AC/lz/14518141
2007-06-25
2 Potential of ISO 22000
Seeking international coherence among many GMPs
EFSIS
Nestlé 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
13
The ISO 22000 Family of Standards – An Overview
SG/KMK/AC/lz/14518141
2007-06-25
ISO 22000 - Outline
Section 1 – Scope
Section 2 – Normative Reference
Section 3 – Terms & Definitions
Section 4 – Food Safety Management System
Section 5 – Management Responsibility
Section 6 – Resource Management
Section 7 – Planning & Realization of Safe Products
Section 8 – Verification, Validation & Improvement
14
The ISO 22000 Family of Standards – An Overview
SG/KMK/AC/lz/14518141
2007-06-25
Scope: what is ISO 22000:2005 ?
A management system standard (based on
ISO 9001:2000)
Specific to food safety management (not quality, etc)
Based on Codex HACCP approach with some innovations
Designed for all segments of food chain & all types
of food business (micro to global)
Enables a food business to plan, implement, operate,
maintain and update a system to provide safe end
products and demonstrate conformity with applicable
regulatory requirements
15
The ISO 22000 Family of Standards – An Overview
SG/KMK/AC/lz/14518141
2007-06-25
Section 5 – Management Responsibility
Commitment
Food Safety Policy
Food Safety Management System Planning
Responsibility & authority
Team Leader & Team
Communication (External & Internal) [Innovation]
Emergency preparedness & response
Management Review
16
The ISO 22000 Family of Standards – An Overview
SG/KMK/AC/lz/14518141
2007-06-25
External communication
Establish, implement & maintain effective arrangements
for pro-active communicating with:
Suppliers and contractors
Customers, (product information, enquiries, contracts,
customer feedback, etc.)
Food authorities
Other organizations that have an impact on, or will be
affected by the effectiveness or updating of the food
safety management system
17
The ISO 22000 Family of Standards – An Overview
SG/KMK/AC/lz/14518141
2007-06-25
Section 7 – Planning & Realization
Prerequisite Programs (“Initial” & “Final”)
Preliminary Steps (team, product characteristics, inputs, intended use,
process mapping, etc)
Hazard analysis (hazards, acceptable levels, assessment, control
measures)
Design of Operational PRPs & CCPs
Updating “initial” system
Verification planning
Traceability system
Control of non-conformity (corrections & corrective action, recalls, etc)
18
The ISO 22000 Family of Standards – An Overview
SG/KMK/AC/lz/14518141
2007-06-25
7.3.2 Food Safety Team
7.6 Design and redesign
of the HACCP plan
7.3.5.2 Description of process
steps and control measures
7.5 Design and redesign
of operational PRPs
7.8 Verification planning
7.2
PreRequisite
Programs
(PRP)
7.3.3 Product Characteristics
7.3.4 Intended Use
7.3.5.1 Flow Diagram
7.4.4 Identification and assessment of
control measures
7.4.3 Hazard assessment
7.4.2 Hazard identification and
acceptable levels
8.4 Validation of control measure
combinations
5
2
3
4
6.
b
6.c-7
8-9-10
1
1
6.
a
1
Steps added to Codex Alimentarius
Steps according to Codex Alimentarius
Food Safety Management System
Improvement loop
19
The ISO 22000 Family of Standards – An Overview
SG/KMK/AC/lz/14518141
2007-06-25
ISO 22000 & SMEs, Farms, etc
Standard recognizes that the capacities of food
businesses differ (micro to very large)
ISO 22000 permits two options
Site specific development
Externally-developed combination of control measures
(HACCP-based programs) to specifically address
SMEs, farms, etc.
Consistent with national/regional approaches (e.g.
Canadian on-farm programs, national GAPs, EU industry/
”branch” programs)
Industry program must demonstrate conformity with
Section 7
20
The ISO 22000 Family of Standards – An Overview
SG/KMK/AC/lz/14518141
2007-06-25
Example of ISO 22000 along the supply chain
Grain Farm Feed Mill Hatchery
Hatching
Egg Farm
Broiler
Farm
Processor
Further
Processor
Distribution
Centre
Retailer
Consumer
Trucker
Caterer
- Potentially using organization-specific ISO 22000 control measures (red)
- Potentially using externally-developed ISO 22000 control measures (green)
21
The ISO 22000 Family of Standards – An Overview
SG/KMK/AC/lz/14518141
2007-06-25
ISO/TS 22003:2007 – Audit & Certification
Technical Specification – Food Safety Specific - covers
Requirements for accreditation of Certification Bodies
(based on new ISO 17021:2006 which replaced ISO
Guides 62 & 66)
Qualifications & Competencies of auditors, certification
officers, technical experts, etc
Certification Process (2 stage audit, etc)
Food Business Classifications
Minimum Audit Times
Multi-site Audits
22
The ISO 22000 Family of Standards – An Overview
SG/KMK/AC/lz/14518141
2007-06-25
ISO 22005:2007 – Traceability
Sets out the “general principles and basic requirements for system
design and implementation” of traceability system
Uses Codex definition of traceability
Requires food/feed business to:
Set food safety, quality & other objectives
Design a system that meets regulatory & customer requirements
Specify the information to be obtained from its suppliers,
collected within itself & provided to its customers
Establish procedures, documentation, etc
Implement the system (training, etc)
Monitor the system
Review it regularly & Update
23
The ISO 22000 Family of Standards – An Overview
SG/KMK/AC/lz/14518141
2007-06-25
Updating the ISO 22000 Family
ISO standards are managed & updated systematically
Technical Committee (TC 34) has on-going
responsibility
ISO 22000 Family
Working Groups committed to review & update
Additional mechanisms are being considered (e.g. for
interpretation & to provide advice on audit practices
similar to ISO 9001 groups)
24
The ISO 22000 Family of Standards – An Overview
SG/KMK/AC/lz/14518141
2007-06-25
ISO 22000 – New publication
A new publication, in
collaboration with ITC:
ISO 22000, Food safety
management systems - An
easy-to-use checklist for small
business - Are you ready?
Enables small businesses to
assess their readiness to
implement the new ISO 22000
standard
English and French, Spanish
under finalization
25
The ISO 22000 Family of Standards – An Overview
SG/KMK/AC/lz/14518141
2007-06-25
ISO 22000 Family Key Points
Strong management system requirements (ISO 9000
approach)
Innovates on Codex HACCP foundation
Useable by full supply chain (input suppliers, farms,
processors, transporters, final marketers) & all sizes
(micro to global)
Integrates Food Safety & Traceability
Emphasizes Regulatory compliance
Audit & Certification
Managed for the Future

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iso_e.ppt

  • 1. 1 The ISO 22000 Family of Standards – An Overview SG/KMK/AC/lz/14518141 2007-06-25 www.iso.org International Organization for Standardization
  • 2. 2 The ISO 22000 Family of Standards – An Overview SG/KMK/AC/lz/14518141 2007-06-25 Overview of the ISO 22000 Family of Standards Kevin McKinley, Deputy-Secretary-General, ISO Central Secretariat Albert Chambers, ISO/TC 34 Working Group Expert and Vice-Chair, Canadian Advisory Committee, ISO/TC 34 Joint UNCTAD/WTO Informal Information Session on Private Standards 25 June 2007, Geneva
  • 3. 3 The ISO 22000 Family of Standards – An Overview SG/KMK/AC/lz/14518141 2007-06-25 Increased demand for voluntary international standards Globalization of trade in products and services Outsourcing and foreign investment Deregulation/privatization of public services The climate change challenge and energy efficiency mandates Public demand for consumer safety, environmental protection, corporate social responsibility Need for international solidarity to face global terrorism, pandemics and natural disasters Pace of innovation and convergence of new technologies
  • 4. 4 The ISO 22000 Family of Standards – An Overview SG/KMK/AC/lz/14518141 2007-06-25 ISO and the international scene World Trade Organization: observer status and collaboration UN and UN agencies including: CODEX, ILO (labour), IMO (maritime), ITC (Intl Trade Centre), UPU (postal), UN/ECE (Commission for Europe), UNIDO (development), WHO (health), WMO (meteorology), WtO (tourism) … Other intergovernmental groups including OECD, medical device regulators (GHTF) … 600 liaisons with international organizations in technical work Links with seven regional standardization-related bodies Economic actors: Accreditation (IAF), Lab accreditation (ILAC), Consumers International, International Chamber of Commerce, World Economic Forum, etc…
  • 5. 5 The ISO 22000 Family of Standards – An Overview SG/KMK/AC/lz/14518141 2007-06-25 World Trade Report 2005 Section II Trade, Standards and the WTO Economics of standards and trade Institutions and policy issues Standards in the multi-lateral trading system
  • 6. 6 The ISO 22000 Family of Standards – An Overview SG/KMK/AC/lz/14518141 2007-06-25 The ISO system At June 2007 • IT tools • Standards development procedures • Consensus building • Dissemination 156 national members 685 active Committees 3 000 technical bodies 50 000 experts Central Secretariat in Geneva 150 staff Catalogue of more than 16 000 published standards Consensus at two levels: - Amongst global experts - Amongst countries through ISO members
  • 7. 7 The ISO 22000 Family of Standards – An Overview SG/KMK/AC/lz/14518141 2007-06-25 Implementation of the ISO Action Plan Improving awareness Developing capacity Increasing regional cooperation Developing electronic communications Increasing participation Key objectives:
  • 8. 8 The ISO 22000 Family of Standards – An Overview SG/KMK/AC/lz/14518141 2007-06-25 Disseminating ISO 22000 standards Cairo, Egypt (ARSO) Windhoek, Namibia (SADC) Ouagadougou, Burkina Faso (UEMOA) Dubai, UAE (GSO) New Delhi, India (SAARC) Jakarta, Indonesia (ACCSQ) Astana, Kazakhstan, Central Asia Kenya, Tanzania, Uganda (following ToT seminars) Croatia, Libya, Mozambique and Yemen Training delivered in: English, French, Spanish, Russian and Arabic ISO 22000 regional seminars held in: ISO 22000 national seminars held in:
  • 9. 9 The ISO 22000 Family of Standards – An Overview SG/KMK/AC/lz/14518141 2007-06-25 ISO/TC 34, Food products Working Groups on: Food Safety Management Systems, GMOs, Traceability systems, Food irradiation Subcommittees (mostly test methods) on: Seeds; Fruits and vegetables; Cereals; Milk; Meat and poultry; Spices; Tea; Microbiology; Animal feeding stuffs; Fats and oils; Sensory analysis; Coffee 711 published standards, 55 participating countries, 49 observer countries Active liaisons with Codex Alimentarius Commission
  • 10. 10 The ISO 22000 Family of Standards – An Overview SG/KMK/AC/lz/14518141 2007-06-25 ISO 22000 Family of Standards New Family – initiated in 2001 Four Standards so far: ISO 22000:2005 – Food safety management system – Requirements ISO 22003:2007 - Requirements for bodies providing audit and certification of food safety management systems ISO TS 22004:2005 - Guidance on the application of ISO 22000 ISO 22005 – Traceability in the feed and food chain (to be published in July 2007)
  • 11. 11 The ISO 22000 Family of Standards – An Overview SG/KMK/AC/lz/14518141 2007-06-25 What food businesses were looking for ? Better planning, less post-process verification More efficient & dynamic hazard control Systematic management of prerequisite programs Better documentation Communication among trade partners Resource optimization (internally & along food chains)
  • 12. 12 The ISO 22000 Family of Standards – An Overview SG/KMK/AC/lz/14518141 2007-06-25 2 Potential of ISO 22000 Seeking international coherence among many GMPs EFSIS Nestlé 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
  • 13. 13 The ISO 22000 Family of Standards – An Overview SG/KMK/AC/lz/14518141 2007-06-25 ISO 22000 - Outline Section 1 – Scope Section 2 – Normative Reference Section 3 – Terms & Definitions Section 4 – Food Safety Management System Section 5 – Management Responsibility Section 6 – Resource Management Section 7 – Planning & Realization of Safe Products Section 8 – Verification, Validation & Improvement
  • 14. 14 The ISO 22000 Family of Standards – An Overview SG/KMK/AC/lz/14518141 2007-06-25 Scope: what is ISO 22000:2005 ? A management system standard (based on ISO 9001:2000) Specific to food safety management (not quality, etc) Based on Codex HACCP approach with some innovations Designed for all segments of food chain & all types of food business (micro to global) Enables a food business to plan, implement, operate, maintain and update a system to provide safe end products and demonstrate conformity with applicable regulatory requirements
  • 15. 15 The ISO 22000 Family of Standards – An Overview SG/KMK/AC/lz/14518141 2007-06-25 Section 5 – Management Responsibility Commitment Food Safety Policy Food Safety Management System Planning Responsibility & authority Team Leader & Team Communication (External & Internal) [Innovation] Emergency preparedness & response Management Review
  • 16. 16 The ISO 22000 Family of Standards – An Overview SG/KMK/AC/lz/14518141 2007-06-25 External communication Establish, implement & maintain effective arrangements for pro-active communicating with: Suppliers and contractors Customers, (product information, enquiries, contracts, customer feedback, etc.) Food authorities Other organizations that have an impact on, or will be affected by the effectiveness or updating of the food safety management system
  • 17. 17 The ISO 22000 Family of Standards – An Overview SG/KMK/AC/lz/14518141 2007-06-25 Section 7 – Planning & Realization Prerequisite Programs (“Initial” & “Final”) Preliminary Steps (team, product characteristics, inputs, intended use, process mapping, etc) Hazard analysis (hazards, acceptable levels, assessment, control measures) Design of Operational PRPs & CCPs Updating “initial” system Verification planning Traceability system Control of non-conformity (corrections & corrective action, recalls, etc)
  • 18. 18 The ISO 22000 Family of Standards – An Overview SG/KMK/AC/lz/14518141 2007-06-25 7.3.2 Food Safety Team 7.6 Design and redesign of the HACCP plan 7.3.5.2 Description of process steps and control measures 7.5 Design and redesign of operational PRPs 7.8 Verification planning 7.2 PreRequisite Programs (PRP) 7.3.3 Product Characteristics 7.3.4 Intended Use 7.3.5.1 Flow Diagram 7.4.4 Identification and assessment of control measures 7.4.3 Hazard assessment 7.4.2 Hazard identification and acceptable levels 8.4 Validation of control measure combinations 5 2 3 4 6. b 6.c-7 8-9-10 1 1 6. a 1 Steps added to Codex Alimentarius Steps according to Codex Alimentarius Food Safety Management System Improvement loop
  • 19. 19 The ISO 22000 Family of Standards – An Overview SG/KMK/AC/lz/14518141 2007-06-25 ISO 22000 & SMEs, Farms, etc Standard recognizes that the capacities of food businesses differ (micro to very large) ISO 22000 permits two options Site specific development Externally-developed combination of control measures (HACCP-based programs) to specifically address SMEs, farms, etc. Consistent with national/regional approaches (e.g. Canadian on-farm programs, national GAPs, EU industry/ ”branch” programs) Industry program must demonstrate conformity with Section 7
  • 20. 20 The ISO 22000 Family of Standards – An Overview SG/KMK/AC/lz/14518141 2007-06-25 Example of ISO 22000 along the supply chain Grain Farm Feed Mill Hatchery Hatching Egg Farm Broiler Farm Processor Further Processor Distribution Centre Retailer Consumer Trucker Caterer - Potentially using organization-specific ISO 22000 control measures (red) - Potentially using externally-developed ISO 22000 control measures (green)
  • 21. 21 The ISO 22000 Family of Standards – An Overview SG/KMK/AC/lz/14518141 2007-06-25 ISO/TS 22003:2007 – Audit & Certification Technical Specification – Food Safety Specific - covers Requirements for accreditation of Certification Bodies (based on new ISO 17021:2006 which replaced ISO Guides 62 & 66) Qualifications & Competencies of auditors, certification officers, technical experts, etc Certification Process (2 stage audit, etc) Food Business Classifications Minimum Audit Times Multi-site Audits
  • 22. 22 The ISO 22000 Family of Standards – An Overview SG/KMK/AC/lz/14518141 2007-06-25 ISO 22005:2007 – Traceability Sets out the “general principles and basic requirements for system design and implementation” of traceability system Uses Codex definition of traceability Requires food/feed business to: Set food safety, quality & other objectives Design a system that meets regulatory & customer requirements Specify the information to be obtained from its suppliers, collected within itself & provided to its customers Establish procedures, documentation, etc Implement the system (training, etc) Monitor the system Review it regularly & Update
  • 23. 23 The ISO 22000 Family of Standards – An Overview SG/KMK/AC/lz/14518141 2007-06-25 Updating the ISO 22000 Family ISO standards are managed & updated systematically Technical Committee (TC 34) has on-going responsibility ISO 22000 Family Working Groups committed to review & update Additional mechanisms are being considered (e.g. for interpretation & to provide advice on audit practices similar to ISO 9001 groups)
  • 24. 24 The ISO 22000 Family of Standards – An Overview SG/KMK/AC/lz/14518141 2007-06-25 ISO 22000 – New publication A new publication, in collaboration with ITC: ISO 22000, Food safety management systems - An easy-to-use checklist for small business - Are you ready? Enables small businesses to assess their readiness to implement the new ISO 22000 standard English and French, Spanish under finalization
  • 25. 25 The ISO 22000 Family of Standards – An Overview SG/KMK/AC/lz/14518141 2007-06-25 ISO 22000 Family Key Points Strong management system requirements (ISO 9000 approach) Innovates on Codex HACCP foundation Useable by full supply chain (input suppliers, farms, processors, transporters, final marketers) & all sizes (micro to global) Integrates Food Safety & Traceability Emphasizes Regulatory compliance Audit & Certification Managed for the Future