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ISO22000 Certification
System overview
With the continuous improvement of consumers' requirements for food safety, countries have formulated strict food safety laws and regulations. The increase of food safety regulations and the inconsistency of technical standards make it difficult for food manufacturers to cope with. In order to meet the requirements of all aspects, under the initiative of the Danish Standards Association and through the coordination of the international organization for standardization (ISO), the relevant national Standards will be integrated in the international scope, and finally a unified international food safety management system will be formed. At present, this work is in progress.
At the beginning of 2001, the Danish standards association submitted to the ISO/TC34 food production secretariat the proposal of ISO/AW1 22000 -- food management system requirements. The 14 members of TC34 were willing to participate in the development of the new standard of ISO22000 -- food safety management system requirements, and proposed to set up a working group for the draft of the standard (ISO/TC34 / WG). According to the requirements of the first meeting of the working group held in Copenhagen in November 2001, the standard ISO22000 -- food safety management system requirements will be published by the end of 2004.
At present, the draft standard -- ISO/WD 22000 "food safety management system (FSM) requirements" has been published. The draft stipulates the requirements of FSM system operation and puts forward the components of FSM system. The standard includes 8 aspects:
1. The scope of
These requirements apply to operators who wish to design and implement effective food safety management systems throughout the food chain, including organizations related to one or more steps in the food chain and others directly involved in the food chain.
2. Normative reference document
ISO 9000:2000 quality management system -- fundamentals and vocabulary.
3. Terms and definitions
3.1 control measures (actions and activities)
3.2 critical control points
3.3 CLS
3.4 terminal products
3.5 flow chart
3.6 food safety
When preparing and/or consuming food for its intended use, ensure that the consumption of food is not harmful to the consumer.
3.7 food safety management system (FSM system)
To guide and control an organization's food safety management system.
3.8 confirmation of FSM system
Objective evidence to identify food safety management systems, including hazard analysis, critical control point (CCP) programs, and supporting safety measures (SSM) procedures, to ensure food safety.
3.9 verification of FSM system
Through objective evidence, it is determined that the stipulated requirements of the food safety management system are fulfilled and the stipulated implementation criteria are met.
3.10 hazards
3.11 implementation criteria
3.12 potential hazards
3.13 related hazards
3.14 products with questionable safety
3.15 SSM programs
3.16 supporting safety measures (SSM)
4. Policy and principles
4.1 general provisions
The food safety management system is a continuous system, with policies developed by top management that are developable, documented, enforceable and sustainable. In practice, the various elements of the system are interactive and controllable and consistent with external requirements. The entire outcome of the system should be recorded.
4.2 food safety policy
The top management of the organization shall define, document, and make public its policies, and undertake to implement food safety obligations.
4.3 organization
4.3.1 human resources
The upper management of the organization should provide adequate resources for the implementation and control of the SFM system.
4.3.2 food safety team
The upper management of the organization shall appoint a food safety team leader who shall be responsible for organizing the work of the food safety team.
A food safety team shall be formed to establish and maintain the FSM system. The food safety team shall be composed of comprehensive professionals with relevant knowledge and experience to develop and implement the FSM system.
4.3.3 other responsibilities
4.3.4 personnel skills
Personnel engaged in work related to food safety should receive appropriate education, training, skills and experience.
4.4 food safety management system
4.4.1 general provisions
The organization shall ensure that known potential hazards in all areas of application of the system are identified and evaluated, that the related hazards assessed are controlled, and that the products of the organization do not harm consumers.
4.4.2 system elements and requirements
The FSM system is composed of the following elements:
A. Describe all factors and conditions affecting food safety;
B. Identify hazard analysis of related hazards and measures for their adequate control;
C. The related hazard control system consists of a CCP plan and SSM program.
D. Procedures and records in accordance with this standard.
5. Design of food safety management system
5.1 preparation of data and information
5.1.1 description of relevant characteristics
5.1.2 raw materials and ingredients
Each material and ingredient (including additives and processing accessories) shall give information relevant to the hazard assessment.
5.1.3 flow chart
Flowcharts should be used for all FSM applications. The flowchart should clearly and concisely provide/describe possible hazards and control options.
5.1.4 production and processing steps
Each process included in the product flow chart may affect food safety. The relevant process parameters and/or application scope should be stated when describing the steps. This information can appear in the flowchart.
5.1.5 other measures prior to hazard analysis
The probability and extent to which all relevant measures (procedures, activities and measurements) that take precedence over the process hazard analysis will affect the introduction of hazards shall be clearly described.
5.1.6 final product features
Information for each final product shall be described, including product name or similar confirmation; Chemical, biological and physical characteristics; Shelf life and storage conditions.
5.1.7 transportation
The mode of transportation, label or other identification tool used to describe the product for each final product shall be described.
5.1.8 intended use
Potential users of each product, storage, preparation conditions related to intended use, etc., shall be identified.
5.2 hazard analysis
5.2.1 general provisions
The food safety team shall conduct hazard analysis for each product and ensure that hazard analysis is carried out when changes occur (see 7.1.3) or other requirements arise.
5.2.2 identify potential hazards
All potential hazards should be identified. Hazards are determined based on the initial description, specific experience and external information in 5.1, as well as epidemiological and other historical data on foods, raw materials and ingredients discussed, and other materials that may be introduced during processing and transportation.
5.2.3 identify related hazards
Each potential hazard should be assessed and rated according to its severity and probability of occurrence. The steps through which hazards may intervene or arise from raw materials, processing to transportation should be identified. Frequent or severe hazards should be identified as related hazards and controlled by the FSM system.
5.2.4 determine an acceptable level of related hazards
The acceptable level is used as a parameter to verify the FSM system and as one of the parameters for implementing safety measures standards and CLS.
5.2.5 construct the control system
All related hazards shall be prevented, eliminated or reduced to established acceptable levels through control measures. For each hazard, control measures affecting its level should be determined (see 5.1.3 and 5.1.4).
5.3 design of CCP system
5.3.1 CCP planning requirements
The food safety group shall develop a CCP plan which shall be agreed upon and documented by the relevant members of the food safety group. For further needs, CCP programs should be regulated.
5.3.2 determine CCPs
When the processing step has a significant impact on the hazard, the measures required to reach the acceptable level should be considered, and a CCP including control measures should be established.
For each CCP, relevant control parameters should be selected to determine whether the control measures are effective.
5.3.3 determine the CLS of CCPs
CLS for selected monitoring parameters should be determined for each CCP.
5.3.4 design monitoring system
Monitoring systems should be established for each CCP. Monitoring methods and frequency should determine whether products deviating from CLS exist and should be withdrawn before their consumption. The monitoring results shall be assessed and recorded by the personnel performing corrective actions.
5.3.5 rectification actions by the CCP
For each CCP, when the monitoring results show that the CCP deviates from the CLS, the corresponding corrective measures shall be established and documented.
5.4 design SSM programs
The food safety team shall establish a control document to determine all SSM procedures related to food safety.
5.5 traceability
The organization shall establish a traceability system to determine the relationship between product batches, raw material batches, and process records.
6. Implement FSM system
6.1 description of the implementers
The organization shall demonstrate that all employees are adequately trained and aware of their roles and responsibilities for food safety.
6.2 traceability
6.2.1 verification of CCPs and SSM programs
Validation should be planned and implemented for all critical control points (CCPs).
6.2.2 control products with safety risks
The organization shall demonstrate procedures to ensure that safe products are supplied to or used by consumers. In order to properly control products with potential safety risks, the organization shall establish documented procedures.
6.2.3 preparation and response in an emergency
The organization shall review and maintain procedures to identify and respond to potential emergencies and possible accidents that may affect food safety.
6.2.4 recall
Some procedures should be identified to facilitate recall.
6.3 monitoring
The organization shall establish and maintain procedures for routine monitoring of key characteristics of operations that significantly affect food safety. Includes records of traceability, related operational controls, and compliance with the organization's food safety objectives.
Monitoring equipment shall be calibrated and maintained. Records of this process are maintained in accordance with the organization's procedures.
6.4 control of documents and records
6.4.1 general principles
6.4.2 file control
The documents required by the FSM system shall be controlled. Records are a special type of file and should be controlled in accordance with 6.6.3.
6.4.3 control of records
All records shall have legal effect and shall be retained for a specified period of time according to the shelf life of the product, statutory requirements and consumer requirements.
6.5 communication
The organization shall establish channels of communication to ensure the exchange of information relating to food safety.
7. Maintenance of FSM system
7.1 general provisions
The organization shall maintain documented procedures to ensure the continuity and timely updating of the FSM system to ensure food safety.
7.2 assessment of systems and changes
7.2.1 system audit
The organization shall plan and conduct audits to verify the FSM system.
7.2.2 evaluation, complaints and audit reports of products with questionable safety
7.2.3 confirmation of the system
The overall performance of the system is usually evaluated through system validation.
7.3 system update
7.3.1 general principles
The FSM system shall be constantly updated to ensure that the system reflects the latest information on the organization's activities and planned hazard control.
7.3.2 communicate with the food safety team
7.3.3 evaluation of external and internal new information and requirements
The FSM system should be updated based on communication with the food safety team and any changes in the organization's food safety policy. The food safety panel should evaluate this information.
8. Management review
The senior management of the organization shall regularly review the food safety management system to ensure its continued adaptability, adequacy and effectiveness. The management review process should ensure that necessary information is collected to facilitate the assessment by senior management. Management review shall be documented.
Input to the management review shall include the results of the food safety management review, the changing situation, the original management review and subsequent actions. The outputs of the management review include decisions and actions related to possible policy changes, objectives and other elements of the food safety management system, and commitments consistent with continuous improvement.
ISO22000 food safety management system requirements is a voluntary international standard. The standard provides a unified standard for the global food safety management system, and the implementation of the standard can avoid many embarrassments caused by different requirements of different countries. China's food production enterprises should prepare for a rainy day, as soon as possible familiar with and master the standard, according to the standard to establish and improve the food safety management system. Relevant departments should also put forward corresponding requirements to the producers of imported food according to the standards.
Service process
Quick process: contract signing -- details understanding -- data establishment -- on-site audit -- evidence collection.
Management project process: status diagnosis -- basic training -- process planning -- process preparation -- process discussion and review -- system trial operation -- system implementation -- certification.
With the continuous improvement of consumers' requirements for food safety, countries have formulated strict food safety laws and regulations. The increase of food safety regulations and the inconsistency of technical standards make it difficult for food manufacturers to cope with. In order to meet the requirements of all aspects, under the initiative of the Danish Standards Association and through the coordination of the international organization for standardization (ISO), the relevant national Standards will be integrated in the international scope, and finally a unified international food safety management system will be formed. At present, this work is in progress.
At the beginning of 2001, the Danish standards association submitted to the ISO/TC34 food production secretariat the proposal of ISO/AW1 22000 -- food management system requirements. The 14 members of TC34 were willing to participate in the development of the new standard of ISO22000 -- food safety management system requirements, and proposed to set up a working group for the draft of the standard (ISO/TC34 / WG). According to the requirements of the first meeting of the working group held in Copenhagen in November 2001, the standard ISO22000 -- food safety management system requirements will be published by the end of 2004.
At present, the draft standard -- ISO/WD 22000 "food safety management system (FSM) requirements" has been published. The draft stipulates the requirements of FSM system operation and puts forward the components of FSM system. The standard includes 8 aspects:
1. The scope of
These requirements apply to operators who wish to design and implement effective food safety management systems throughout the food chain, including organizations related to one or more steps in the food chain and others directly involved in the food chain.
2. Normative reference document
ISO 9000:2000 quality management system -- fundamentals and vocabulary.
3. Terms and definitions
3.1 control measures (actions and activities)
3.2 critical control points
3.3 CLS
3.4 terminal products
3.5 flow chart
3.6 food safety
When preparing and/or consuming food for its intended use, ensure that the consumption of food is not harmful to the consumer.
3.7 food safety management system (FSM system)
To guide and control an organization's food safety management system.
3.8 confirmation of FSM system
Objective evidence to identify food safety management systems, including hazard analysis, critical control point (CCP) programs, and supporting safety measures (SSM) procedures, to ensure food safety.
3.9 verification of FSM system
Through objective evidence, it is determined that the stipulated requirements of the food safety management system are fulfilled and the stipulated implementation criteria are met.
3.10 hazards
3.11 implementation criteria
3.12 potential hazards
3.13 related hazards
3.14 products with questionable safety
3.15 SSM programs
3.16 supporting safety measures (SSM)
4. Policy and principles
4.1 general provisions
The food safety management system is a continuous system, with policies developed by top management that are developable, documented, enforceable and sustainable. In practice, the various elements of the system are interactive and controllable and consistent with external requirements. The entire outcome of the system should be recorded.
4.2 food safety policy
The top management of the organization shall define, document, and make public its policies, and undertake to implement food safety obligations.
4.3 organization
4.3.1 human resources
The upper management of the organization should provide adequate resources for the implementation and control of the SFM system.
4.3.2 food safety team
The upper management of the organization shall appoint a food safety team leader who shall be responsible for organizing the work of the food safety team.
A food safety team shall be formed to establish and maintain the FSM system. The food safety team shall be composed of comprehensive professionals with relevant knowledge and experience to develop and implement the FSM system.
4.3.3 other responsibilities
4.3.4 personnel skills
Personnel engaged in work related to food safety should receive appropriate education, training, skills and experience.
4.4 food safety management system
4.4.1 general provisions
The organization shall ensure that known potential hazards in all areas of application of the system are identified and evaluated, that the related hazards assessed are controlled, and that the products of the organization do not harm consumers.
4.4.2 system elements and requirements
The FSM system is composed of the following elements:
A. Describe all factors and conditions affecting food safety;
B. Identify hazard analysis of related hazards and measures for their adequate control;
C. The related hazard control system consists of a CCP plan and SSM program.
D. Procedures and records in accordance with this standard.
5. Design of food safety management system
5.1 preparation of data and information
5.1.1 description of relevant characteristics
5.1.2 raw materials and ingredients
Each material and ingredient (including additives and processing accessories) shall give information relevant to the hazard assessment.
5.1.3 flow chart
Flowcharts should be used for all FSM applications. The flowchart should clearly and concisely provide/describe possible hazards and control options.
5.1.4 production and processing steps
Each process included in the product flow chart may affect food safety. The relevant process parameters and/or application scope should be stated when describing the steps. This information can appear in the flowchart.
5.1.5 other measures prior to hazard analysis
The probability and extent to which all relevant measures (procedures, activities and measurements) that take precedence over the process hazard analysis will affect the introduction of hazards shall be clearly described.
5.1.6 final product features
Information for each final product shall be described, including product name or similar confirmation; Chemical, biological and physical characteristics; Shelf life and storage conditions.
5.1.7 transportation
The mode of transportation, label or other identification tool used to describe the product for each final product shall be described.
5.1.8 intended use
Potential users of each product, storage, preparation conditions related to intended use, etc., shall be identified.
5.2 hazard analysis
5.2.1 general provisions
The food safety team shall conduct hazard analysis for each product and ensure that hazard analysis is carried out when changes occur (see 7.1.3) or other requirements arise.
5.2.2 identify potential hazards
All potential hazards should be identified. Hazards are determined based on the initial description, specific experience and external information in 5.1, as well as epidemiological and other historical data on foods, raw materials and ingredients discussed, and other materials that may be introduced during processing and transportation.
5.2.3 identify related hazards
Each potential hazard should be assessed and rated according to its severity and probability of occurrence. The steps through which hazards may intervene or arise from raw materials, processing to transportation should be identified. Frequent or severe hazards should be identified as related hazards and controlled by the FSM system.
5.2.4 determine an acceptable level of related hazards
The acceptable level is used as a parameter to verify the FSM system and as one of the parameters for implementing safety measures standards and CLS.
5.2.5 construct the control system
All related hazards shall be prevented, eliminated or reduced to established acceptable levels through control measures. For each hazard, control measures affecting its level should be determined (see 5.1.3 and 5.1.4).
5.3 design of CCP system
5.3.1 CCP planning requirements
The food safety group shall develop a CCP plan which shall be agreed upon and documented by the relevant members of the food safety group. For further needs, CCP programs should be regulated.
5.3.2 determine CCPs
When the processing step has a significant impact on the hazard, the measures required to reach the acceptable level should be considered, and a CCP including control measures should be established.
For each CCP, relevant control parameters should be selected to determine whether the control measures are effective.
5.3.3 determine the CLS of CCPs
CLS for selected monitoring parameters should be determined for each CCP.
5.3.4 design monitoring system
Monitoring systems should be established for each CCP. Monitoring methods and frequency should determine whether products deviating from CLS exist and should be withdrawn before their consumption. The monitoring results shall be assessed and recorded by the personnel performing corrective actions.
5.3.5 rectification actions by the CCP
For each CCP, when the monitoring results show that the CCP deviates from the CLS, the corresponding corrective measures shall be established and documented.
5.4 design SSM programs
The food safety team shall establish a control document to determine all SSM procedures related to food safety.
5.5 traceability
The organization shall establish a traceability system to determine the relationship between product batches, raw material batches, and process records.
6. Implement FSM system
6.1 description of the implementers
The organization shall demonstrate that all employees are adequately trained and aware of their roles and responsibilities for food safety.
6.2 traceability
6.2.1 verification of CCPs and SSM programs
Validation should be planned and implemented for all critical control points (CCPs).
6.2.2 control products with safety risks
The organization shall demonstrate procedures to ensure that safe products are supplied to or used by consumers. In order to properly control products with potential safety risks, the organization shall establish documented procedures.
6.2.3 preparation and response in an emergency
The organization shall review and maintain procedures to identify and respond to potential emergencies and possible accidents that may affect food safety.
6.2.4 recall
Some procedures should be identified to facilitate recall.
6.3 monitoring
The organization shall establish and maintain procedures for routine monitoring of key characteristics of operations that significantly affect food safety. Includes records of traceability, related operational controls, and compliance with the organization's food safety objectives.
Monitoring equipment shall be calibrated and maintained. Records of this process are maintained in accordance with the organization's procedures.
6.4 control of documents and records
6.4.1 general principles
6.4.2 file control
The documents required by the FSM system shall be controlled. Records are a special type of file and should be controlled in accordance with 6.6.3.
6.4.3 control of records
All records shall have legal effect and shall be retained for a specified period of time according to the shelf life of the product, statutory requirements and consumer requirements.
6.5 communication
The organization shall establish channels of communication to ensure the exchange of information relating to food safety.
7. Maintenance of FSM system
7.1 general provisions
The organization shall maintain documented procedures to ensure the continuity and timely updating of the FSM system to ensure food safety.
7.2 assessment of systems and changes
7.2.1 system audit
The organization shall plan and conduct audits to verify the FSM system.
7.2.2 evaluation, complaints and audit reports of products with questionable safety
7.2.3 confirmation of the system
The overall performance of the system is usually evaluated through system validation.
7.3 system update
7.3.1 general principles
The FSM system shall be constantly updated to ensure that the system reflects the latest information on the organization's activities and planned hazard control.
7.3.2 communicate with the food safety team
7.3.3 evaluation of external and internal new information and requirements
The FSM system should be updated based on communication with the food safety team and any changes in the organization's food safety policy. The food safety panel should evaluate this information.
8. Management review
The senior management of the organization shall regularly review the food safety management system to ensure its continued adaptability, adequacy and effectiveness. The management review process should ensure that necessary information is collected to facilitate the assessment by senior management. Management review shall be documented.
Input to the management review shall include the results of the food safety management review, the changing situation, the original management review and subsequent actions. The outputs of the management review include decisions and actions related to possible policy changes, objectives and other elements of the food safety management system, and commitments consistent with continuous improvement.
ISO22000 food safety management system requirements is a voluntary international standard. The standard provides a unified standard for the global food safety management system, and the implementation of the standard can avoid many embarrassments caused by different requirements of different countries. China's food production enterprises should prepare for a rainy day, as soon as possible familiar with and master the standard, according to the standard to establish and improve the food safety management system. Relevant departments should also put forward corresponding requirements to the producers of imported food according to the standards.
Service process
Quick process: contract signing -- details understanding -- data establishment -- on-site audit -- evidence collection.
Management project process: status diagnosis -- basic training -- process planning -- process preparation -- process discussion and review -- system trial operation -- system implementation -- certification.
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