The document outlines the requirements and documentation needed for three quality management systems: ISO 9001, ISO 22000, and HACCP. It provides tables comparing the clauses and requirements for documented procedures for each system. It also includes descriptions of key aspects of each system such as mandatory documentation, HACCP principles, food safety hazards, and ISO 22000 requirements. The goal is to establish an integrated management system that meets the documentation needs for all three standards.

2. Customer
Communication
Customers
Customers
Requirements
Satisfaction
Continual Improvement Of The
Quality Management System
Resource
Management
Measurement,
Analysis &
Improvement
Product
Realization
ProductInput Output
4
86
5
7
Management
Responsibility
Key: Value-adding activities. Information flow.
P
A
C
D
Customer
Feedback
Do Plan
Check Act
P D C A - Circle
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3. Quality
Manual
Procedures
&
Process Flow
Charts
Work
Instructions
The Concept
Quality Policy
………………
………………
Signed ______.
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4. Quality
Forms Quality
Records
Filed Data for
Reference/Evidence
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5. Quality Management System Requirements – ISO 9001
Clause
Reference
Description
Documented Procedures
Required
No Yes
1 Scope. 
2 Normative Reference. 
3 Terms and Conditions. 
4 Quality Management System. 
4.2.3 Control of Documents. 
4.2.4 Control of Quality Record. 
5 Management Responsibility. 
6 Resource Management. 
7 Product Realization. 
8 Measurement, Analysis and Improvement. 
8.2.2 Internal Audit. 
8.3 Control of Non-Conforming Product 
8.5.2 Corrective Action. 
8.5.3 Preventive Action. 
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6. Food Safety Management System – ISO 22000
Clause
Reference
Description
Documented Procedures
Required
No Yes
1 Scope. 
2 Normative Reference. 
3 Terms and Conditions. 
4 Food Safety Management System. 
4.2.2 Control of Documents. 
4.2.3 Control of Quality Record. 
5 Management Responsibility. 
6 Resource Management. 
7 Planning and Realization of safe products 
7.2 Program 
7.3.5.1 Flow Diagrams 
7.6 Plan 
7.6.5 Handling of potentially unsafe products 
7.10.1
7.10.2
Corrective Action. 
Preventive Action. 
7.10.4 Control of Non-Conforming Product Withdrawals 
8
Validation, Verification and Improvement of the Food
Safety Management System. 
8.4.1 Internal Audit.  6MMS - 26/08

7. Hazard Analysis Critical Control Point - HACCP
Clause
Reference
Description
Documented Procedures
Required
No Yes
1 Introduction 
2 Scope of Application 
3 Reference Documents 
4 Terms and Definitions 
5 HACCP System Requirements 
5.1.3 Organization Chart and Reporting Structure 
5.3.1 Flow Diagrams 
5.3.2 Layout (Production facilities) 
5.4 Pre-requisite program (PRP) 
5.6 Control Measures & CCP 
5.9 Corrective Actions 
5.11 Internal Audit 
5.12.1 Control of Documents 
5.12.1 Manual 
5.12.2 Control of Records 
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8. 8
Mandatory Documentation Required by IMS
S.No. Description of Document ISO-9001 ISO-22000 HACCP Remarks
1 Policy Statement   
2 Objective   
3 Manual   
4 Mandatory SOPs
4.1 Control of Documents 4.2.3  4.2.2  5.12.1 
4.2 Control of Quality Record 4.2.4  - 5.12.2 
4.3 Handling of potentially unsafe products - 7.6.5  -
4.4 Internal Audit 8.2.2  8.4.1  5.11 
4.5 Control of Non-Conforming Product 8.3  - -
4.6
Control of Non-Conforming Product,
Withdrawals - 7.10.4  -
4.7 Corrective Action 8.5.2 
7.10.1 
7.10.2
5.9 
4.8 Preventive Action 8.5.3  - -
5 Flow Diagrams - 7.3.5.1 5.3.1 
6 Programs - 7.2 5.4 
7 Plans - 7.6 5.6 
8 Layout (Production Facilities) - - 5.3.2 
9 Organization Chart & Reporting Structure - - 5.1.3 
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10. 1) What is HACCP?
2) Origin of HACCP.
3) Why HACCP?
4) Food HAZARDS.
5) Seven principles of HACCP.
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11.  A system of prevention.
 A documented quality assurance system
which can be independently audited.
 HACCP identifies hazard and preventive
measures for their control.
 HACCP is recognized and used
internationally in trade insurance and
regulation.
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12.  Developed by NASA & US Army – 1960’s
 Based on Engineering system
 1960 - 1980
- Quality assurance principles adopted by food industry.
 1980’s – Major international food scares.
 1990’s – HACCP promoted widely;
12
- Food for Astronauts - Zero gravity
- Food poisoning
- Failure modes and effect analysis.
- Airline catering - Fast Food outlets
- Hospital Catering - Food Processors
- FAO
- WHO
- USDA / FDA
- CODEX
- EC DIRECTIVE
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13.  Legislation and Regulatory requirements.
 Customer’s requirement.
 Consumers expect safe food.
 It provides manufacturers with;
 Self confidence
 Assurance
 Brand protection
 It is verifiable and auditable.
 It produces evidence in litigation.
 It is recognized by insurance companies.
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14. 14
5.1
Management
Responsibility
5.2
Products
5.3
Processes
5.4
PRP
5.11 Verification
5.5
Hazard
Analysis
5.6.1 Specific Control Measures
related to CCP’s
5.7
Critical
Limits
5.8
Monitoring
5.9
Corrective
Actions
5.10
Validation
5.6.2 General Control Measures
5.12 Documentation and Registration
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15. 15
Potential Areas
Analysis Of Hazards
Biological Chemical Physical
Raw Materials
Distribution
R.M. Storage
F.G. Storage
Processing
Packaging
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Inspection

16. The major causes of Food Borne Incidence;
 Poor quality raw materials,
 Miss-handling raw materials.
 Change in formulation of product,
 Change in the process of product,
 Cross-contamination,
 Inadequate cleaning,
 Inadequate maintenance,
 Addition of the wrong ingredients.
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17. 17
 Bacteria
 Fungi.
 Viruses.
 Parasites.
 Algae.
 Glass.
 Metal.
 Stones, Twinges, Leaves
 Wood.
 Pest.
 Jewelry.
 Biological  Chemical
 Cleaning Chemicals.
 Pesticides.
 Allergens
 Toxic Metals.
 Nitrites & N-nitrites
Compound.
 Plasticizers &
Packaging Migration.
 Veterinary, Residues –
antibiotics.
 Chemical additives.
 Physical;
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18. 1) Systematic approach to food safety.
2) Proactive preventative management
system.
3) Complements and strengthens Quality
Management System (QMS).
4) Can be integrated with QMS.
5) Helps to demonstrate Due Diligence.
6) Internationally recognized approach.
7) Fewer rejects.
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19. 8) Cost effectiveness.
9) Increased confidence/customer
satisfaction.
10) Improves teamwork understanding and
motivation.
11) Risk Management Tool.
12) Brand Protection.
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20. 20MMS - 26/08

21. 21
Assemble the HACCP Team
Describe Product
Identify Intended Use
Construct Flow Diagram
1)
2)
3)
4)
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22. 22
List of all Potential Hazards, Conduct
Hazard Analysis, Determine Control
Measures.
Determine CCPs
Establish Critical Limit for Each CCP
On-Site Verification of Flow Diagram
5)
6)
7)
8)
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23. 23
Establish Corrective Action for
Deviations that may Occur.
Establish Verification Procedures
Establish Record Keeping and
Documentation
Establish a Monitoring System for
Each CCP
9)
10)
11)
12)
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24. Hazard Analysis Check Sheet
Step/
Input
Hazard
Cause/Hazard
Justification
Significance
Control/
Preventive
Measures
Q1 Q2 Q3 Q4 Q5
CCP
/CP
Reason for
Decision
Lik
(H)(L)
(M)
Sev
(H)(L)
(M)
Biological
Chemical
Physical
Quality
Biological
Chemical
Physical
Quality
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25. 25MMS - 26/08

26. It is a Food Safety Management System (FSMS)
that uses a management systems approach as
well as a HACCP process.
The goal of ISO 22000 is to provide one
internationally recognized standard for a food
safety management system that can be
applied to any organization in the food chain.
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27. The organization must develop an effective
system that meets the requirements of the
Standard and document, implement and
maintain the system.
The system must be evaluated and updated
to stay current
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28. Establish and document a system for:
Collecting preliminary information for hazard analysis
Conducting hazard analysis
Establishing and maintaining the HACCP plan
Conducting verification activities
Tracing product, materials and distribution
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29. Establish and document a system for
controlling all nonconforming product
When a critical control point is exceeded, potentially
unsafe product must be identified, assessed, controlled
and dispositioned appropriately.
An established withdrawal process is necessary so
quick action can be taken if needed.
Identify corrections and corrective actions to be taken
to eliminate the nonconformity and the cause of the
nonconformity.
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30. Establish and document a process to validate
control measures before they are
implemented.
Plan for revalidation when changes are made.
Ensure that all measuring and monitoring
devices and methods are capable of providing
the accuracy needed.
30MMS - 26/08

31. Continually improve the FSMS through the
use of:
Management review
Internal audits
Corrective actions
Verification results
Validation Results
Update the FSMS
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