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Audit Checklist
ISO 22000:2018 Standard
ISO 22000 - 4.1 Understanding The Organization and Its Context
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How the organization determined external and internal issues relevant to its purpose and strategic direction ?
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How the organization monitors and reviews information about these internal and external issues ?
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ISO 22000 - 4.2 Understanding The Needs and Expectations of Interested Parties
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How organization determined relevant interested parties to QMS ?
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How the organization has determined the relevant needs and expectations of interested parties ?
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How the organization monitors and reviews information about interested parties and their relevant requirements ?
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- N/A
ISO 22000 - 4.3 Determining The Scope of The Food Safety Management System
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Verify QMS scope is documented.
- Not in place
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- Fully in place
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Verify scope states what products and services are covered by the FSMS and how it justifies instances where requirements cannot be applied.
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- Fully in place
- N/A
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How the processes for the FSMS were determine ? a. Verify the inputs and outputs to the processes. b. Verify the sequence and interaction of of the processes. c. Verify the criteria, methods, measurement and related performance indicators needed to operate and control the processes. d. Verify how resources are determined and allocated. e. Verify how responsibilities and authorities are determined. f. Verify how risks and opportunities are considered and what actions are taken to address them. g. Verify what methods are used to monitor, measure and evaluate processes. h. Verify changes, if needed, are implemented to achieve intended results. i. Verify how opportunities for improvement for the FSMS and its processes are determined. j. Reviewed documented information created to support the operation of its processes.
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undefined
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ISO 22000 - 4.4 Food Safety management system and its processes
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How the processes have been determined and how they interact ?
- Not in place
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- Quite a lot
- Fully in place
- N/A
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How the processes for the FSMS were determine ?
- Not in place
- Not very much
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- Quite a lot
- Fully in place
- N/A
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Verify the sequence and interaction of the processes.
- Not in place
- Not very much
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- Quite a lot
- Fully in place
- N/A
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Verify the criteria, methods, measurement and related performance indicators needed to operate and control the processes.
- Not in place
- Not very much
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- Quite a lot
- Fully in place
- N/A
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Verify how resources are determined and allocated.
- Not in place
- Not very much
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- Quite a lot
- Fully in place
- N/A
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Verify how responsibilities and authorities are determined.
- Not in place
- Not very much
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- Quite a lot
- Fully in place
- N/A
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Reviewed documented information created to support the operation of its processes.
- Not in place
- Not very much
- Partially
- Quite a lot
- Fully in place
- N/A
ISO 22000 - 5.1 Leadership and commitment
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How is the demontration of leadership and commitment by top management ?
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- Fully in place
- N/A
ISO 22000 - 5.2 Policy
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Has top management defined, documented and communicated its food safety policy?
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- Quite a lot
- Fully in place
- N/A
ISO 22000 - 5.3 Organizational Roles, Responsibilities and Authorities
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Is appropriate to the role of the organization in the food chain?
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Conforms with both statutory and regulatory requirements and with mutually agreed food safety requirements of customers?
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- Not very much
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- Quite a lot
- Fully in place
- N/A
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Is communicated, implemented and maintained at all levels of the organization?
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- Fully in place
- N/A
ISO 22000 - 6.1 Actions to address risks and opportunities
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How risks and opportunities are determined and addressed so the FSMS can achieve its intended results, prevent and reduce undesired effects and achieve continual improvement ?
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How actions are planned to address risks and opportunities ?
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- Fully in place
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How actions are integrated and implemented into the FSMS processes ?
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- Quite a lot
- Fully in place
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How the organization evaluates the effectiveness of the actions ?
- Not in place
- Not very much
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- Fully in place
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How actions are taken to address risks and opportunities determined as being appropriate to the potential impact on the conformity of products and services ?
- Not in place
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- Quite a lot
- Fully in place
- N/A
ISO 22000 - 6.2 Quality Objective and Planning to Achieve Them
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Has the organization identify quality objectives are established at relevant functions, levels and processes ?
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How the organization determines what will be done, with what resources, when completed and how the results will be evaluated for quality objectives?
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ISO 22000 - 6.3 Planning of changes
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How FSMS changes are planned systematically ?
- Not in place
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- Quite a lot
- Fully in place
- N/A
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How the organization demonstrates the purpose and potential consequences of changes ?
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ISO 22000 - 7.1 Resources
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How resources are determined for the organization ?
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How the capabilities and constraints on internal resources are considered ?
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How needs from external providers are considered ?
- Not in place
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- Quite a lot
- Fully in place
- N/A
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How the organization provides persons necessary to consistently meet customer, applicable statutory and regulatory requirements for the FSMS including the necessary processes ?
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- Quite a lot
- Fully in place
- N/A
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How the organization determines, provides and maintains the infrastructure for the operation of processes to achieve products and services conformity ?
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- Quite a lot
- Fully in place
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How the organization determines, provides and maintains the environment for the operation of processes to achieve products and service conformity ?
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- Quite a lot
- Fully in place
- N/A
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How resources are determined to ensure valid and reliable monitoring and measuring results ?
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- Fully in place
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How the organization ensures that the resources provided are suitable for the specific type of monitoring and measurement activities being undertaken and that they are maintained to ensure continued fitness of purpose ?
- Not in place
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- Fully in place
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How measurement instruments are verified or calibrated at specific intervals against national or international standards ?
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How measurement instruments are identified ?
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How measurement instruments are safeguarded from adjustments, damage and deterioration ?
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How the organization determines the validity of previous measurements if you find an instrument to be defective during verification or calibration ?
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- Quite a lot
- Fully in place
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How the organization determines the necessary knowledge for the operation of processes and achieves conformity of products and services ?
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- Quite a lot
- Fully in place
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How knowledge is maintained and made available to the extent necessary ?
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How the organization determines current knowledge and how its acquires additional knowledge when addressing changing needs and trends ?
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ISO 22000 - 7.2 Competence
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How you determine the necessary competence of people doing work under your control that affects quality performance ?
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How you determine competence on the basis of appropriate education, training or experience ?
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How you take actions to acquire necessary competence where applicable and how do you evaluate the effectiveness of those actions ?
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ISO 22000 - 7.3 Awareness
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Verify people doing work under the organization's control are aware of : a. Food safety policy b. Objectives FSMS relevant to their task c. Individual contribution to the effectiveness of the FSMS d. The implications of not conforming with the FSMS requirements
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- Quite a lot
- Fully in place
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undefined
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- Quite a lot
- Fully in place
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ISO 22000 - 7.4 Communication
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Verify internal and external communication process (what, when, with whom and how to communicate).
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- Quite a lot
- Fully in place
- N/A
ISO 22000 - 7.5 Documented Information
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Has the documented information required by the standard and necessary for the effective implementation and operation of the FSMS been established?
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- Quite a lot
- Fully in place
- N/A
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Verify documented information that shows the effectiveness of the FSMS.
- Not in place
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- Quite a lot
- Fully in place
- N/A
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Show me how you control documented information and make it available and suitable for use. Tell me how you protect your documented information.
- Not in place
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- Quite a lot
- Fully in place
- N/A
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Verify how the organization controls the distribution, access, retrieval, use, storage, preservation, legibility, control of changes, retention and disposition of documented information.
- Not in place
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- Quite a lot
- Fully in place
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Verify documented information of external origin is identified, as appropriate, and controlled.
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- Fully in place
- N/A
ISO 22000 - 8.1 Operational planning and control
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How the organization has planned, implemented and controlled processes needed to meet the requirements of products and services ?
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How requirements for products and services are determined ?
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- Quite a lot
- Fully in place
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How resources are determined ?
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- Quite a lot
- Fully in place
- N/A
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How process control is implemented ?
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- Quite a lot
- Fully in place
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Determine how output from the planning process is suitable for operations.
- Not in place
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- Quite a lot
- Fully in place
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Verify how unintended changes are reviewed and what actions are taken to mitigate any adverse effects, as necessary.
- Not in place
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- Fully in place
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Verify how outsourced processes are controlled.
- Not in place
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- Quite a lot
- Fully in place
- N/A
ISO 22000 - 8.2. Prerequisite Programmes (PRPs)
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Has the organization establish, implement, maintain and update PRP(s) to facilitate the prevention and/or reduction of contaminants (including food hazards) in the products, product processing and work environment ?
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- Quite a lot
- Fully in place
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Has the organization identify the applicable statutory, regulatory and mutually agreed customer requirements ?
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- Fully in place
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Does the documented information specify the selection, establishment, applicable monitoring and verification of the PRP(s) ?
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- Fully in place
- N/A
ISO 22000 - 8.3 Traceability System
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How do you trace and identify incoming material from the suppliers and the first stage of the distribution route of the end product?
- Not in place
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- Quite a lot
- Fully in place
- N/A
ISO 22000 - 8.4 Emergency Preparedness and Response
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Does top management ensure procedures are in place to respond to potential emergency situations or incidents that can have an impact on food safety which are relevant to the role of the organization in the food chain ?
- Not in place
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- Quite a lot
- Fully in place
- N/A
ISO 22000 - 8.5 Hazard control
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Does the organization collect and maintain the hazard analysis and preliminary documented information with point : a. Applicable statutory, regulatory and customer requirements b. The organization’s products, processes and equipment c. Food safety hazards relevant to the FSMS
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Has the organization conduct a hazard analysis, based on the preliminary information ?
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Has the organization identify and document all food safety hazards that are reasonably expected to occur in relation to the type of product, type of process and process environment ?
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- Fully in place
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Based on the hazard assessment, has the organization determine an appropriate control measure or combination of control measures that capable of preventing or reducing the identified significant food safety hazards to defined acceptable levels ?
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Has the organization establish, implement and maintain a hazard control plan ?
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- Fully in place
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Has the organization maintain documented information which following information for each control measure at each CCP or OPRP ?
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- Quite a lot
- Fully in place
- N/A
ISO 22000 - 8.6 Updating The Information Specifying The PRPs and The Hazard Control Plan
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Does organization establish and update the following of the hazard control plan ?
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- Quite a lot
- Fully in place
- N/A
ISO 22000 - 8.7 Control of Monitoring and Measuring
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Is there evidence that the specified monitoring and measuring methods and equipment are adequate to ensure the performance of the monitoring and measuring procedures?
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- Quite a lot
- Fully in place
- N/A
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Does the organization take action appropriate for the equipment and any product affected, If the measuring equipment is non-conforming?
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- Quite a lot
- Fully in place
- N/A
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Are records of such assessment and resulting actions maintained?
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- Quite a lot
- Fully in place
- N/A
ISO 22000 - 8.8 Verification related to PRPs and the hazard control plan
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Does the food safety team systematically evaluate the individual results of planned verification ?
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- Quite a lot
- Fully in place
- N/A
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Does the organization take action to achieve the required conformity, when verification does not demonstrate conformity with the planned arrangements?
- Not in place
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- Fully in place
- N/A
ISO 22000 - 8.9 Control of product and process nonconformities
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Has the organization ensure the data has been evaluated from the monitoring of OPRPs and at CCPs by designated persons who are competent and have the authority to initiate corrections and corrective actions ?
- Not in place
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- Quite a lot
- Fully in place
- N/A
ISO 22000 - 9.1 Monitoring, measurement, analysis and evaluation
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Has the organisation determined what needs to be monitored and measured and the methods for monitoring, measurement, analysis and evaluation, to ensure valid results?
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- Quite a lot
- Fully in place
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Has it established when the results from monitoring and measurement shall be analyzed and evaluated?
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- Quite a lot
- Fully in place
- N/A
ISO 22000 - 9.2 Internal Audit
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Verify audits are conducted at planned intervals.
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- Quite a lot
- Fully in place
- N/A
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Verify organization has established, implemented, and maintains an internal audit program.
- Not in place
- Not very much
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- Quite a lot
- Fully in place
- N/A
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Verify appropriate correction and corrective actions are taken without delay
- Not in place
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- Quite a lot
- Fully in place
- N/A
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Review retained documented information.
- Not in place
- Not very much
- Partially
- Quite a lot
- Fully in place
- N/A
ISO 22000 - 9.3 Management Review
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Verify management reviews FSMS at planned intervals.
- Not in place
- Not very much
- Partially
- Quite a lot
- Fully in place
- N/A
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Verify inputs to management review includes.
- Not in place
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- Quite a lot
- Fully in place
- N/A
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Verify outputs to management review includes.
- Not in place
- Not very much
- Partially
- Quite a lot
- Fully in place
- N/A
ISO 22000 - 10.2 Nonconformity and Corrective Action
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Does the organisation operate appropriate processes for managing nonconformities and the related corrective actions?
- Not in place
- Not very much
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- Quite a lot
- Fully in place
- N/A
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How organization reacts to nonconformity, including complaints, by evaluating how its takes action to control and correct it and how it deals with the consequences?
- Not in place
- Not very much
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- Quite a lot
- Fully in place
- N/A
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How the organization evaluates the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere?
- Not in place
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- Quite a lot
- Fully in place
- N/A
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How organization implements necessary actions?
- Not in place
- Not very much
- Partially
- Quite a lot
- Fully in place
- N/A
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How organization evaluates the effectiveness of actions taken?
- Not in place
- Not very much
- Partially
- Quite a lot
- Fully in place
- N/A