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ISO 22000:2005 Compliance Audit

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The purpose of this audit is for the Auditor to check compliance to the standards of ISO 22000:2005 Food Safety Management; to conduct an assessment of hygienic standards in all aspects of food handling procedures carried out in the operation and to ensure that all relevant corrective actions are carried out and documented.
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ISO 22000:2005 Compliance Audit

Internal Auditing Procedure

Internal Inspection and Auditing Procedure

Who are the person(s) responsible for FSMS

e.g. Food Safety Team Leader

Who is the Approval Authority for FSMS

e.g. COO

Where is information located

e.g. FSMS information is kept in a centralized location on the operations master server

What is the revision timing / frequency

e.g. revision occurs annually or if there is a change to management, a system failure, process change or revision in related scientific or regulatory information.

What is the goal of the audit

e.g. The goal is to ensure that FSMS is working correctly and efficiently. To identify and correct faults that may injure customer or stakeholders to the business, to verify that training and resource is adequate and implemented effectively

Define the Scope of the FSMS

e.g. The audit and inspection is relevant to all food handling operations starting from receiving to sale of goods. The audit may be upgraded to include suppliers of food, chemicals, services or equipment that may impact on the safety of food

Describe the content of the FSMS

e.g. The audit program and audit plan form part of the audit procedure

What is the training requirement / criteria / frequency for FSMS

Internal Auditors and Inspectors shall be trained in food safety customer requirements either by education or through practical hands on experience. As a minimum Internal Auditors should be HACCP trained.

Inspection and Audit Program

Describe the Audit

e.g. The audit is a quantitative measure of the standards being followed based on a scoring system defined in this handbook. A report is emailed to senior management and relevant managers listing corrective actions and target dates for accomplishment. Photographs can be included in the report as supporting evidence. review of completed corrective actions form part of the audit criteria. Full criteria is based on the clauses of international standard ISO 22000:2005 (4: Food Safety Management System, 5: Management Responsibility, 6: Resource Management, 7: Planning & Realization of Safe Products, 8: Validation, verification and improvement of the food safety management system). The results of the audit are used as a verification tool for the food safety training plan.

Inspection and Audit Plan

Auditor contact details

(check name not set)

Auditee contact details

Define the scope of the audit

e.g. Fresh food handling areas including receiving, storage & warehousing, processing (Bakery / Delicatessen / Rotisserie), sale of ready-to-eat and ready-to-cook foods. Operation teams are advised in advance when the audit will be conducted and the scope of what will be checked and who will be required.

Define the scheduled frequency and duration of the audit, include desk audit, site audit and delivery of final report

e.g. Audits are carried out bi-annualy, at six month intervals, and involves an announced audit based on defined criteria. The audit may take 3 full working days: 1 day to complete a site audit, 1 day to complete a desk audit and 1 day to complete the report. The final report shall be issued by email within 5 working days of day 3 being completed. NB: If changes to the audit date is needed this shall be advised to relevant parties by email.

Date for receipt of desk audit documentation and time frame for document review

e.g. Documents shall be reviewed on site as part of the 1 day desk audit, It shall be carried out for each relevant section. Any records can be removed from the section for review. It should be agreed a return date no longer than 3 days.

Define the preliminary agenda for the site audit

e.g. The preliminary agenda for the site audit will be issued 5 working days prior to the audit inspection.

Proposed date for completion

e.g. Proposed follow up dates will be agreed on the last day of the audit and included in the report

Outcome of the audit or inspection

e.g. Non-Conformance Corrective Actions or Corrections are raised verbally or formally by email report

4.0 Food Safety Management System (Desk Audit)

4.1 General Requirements

Is there an established FSMS

does the scope specify the products or product categories, processes and production lines

Is there a system to identify food safety hazards

Are the means to communicate (internally & externally) pertaining to food safety effective

Is the FSMS periodically reviewed

Have any outsourced processes been identified within the documented FSMS

4.2.1 Documentation

Is the policy (5.2) documented

Do objectives support the policy

Has the organization identified the ISO 22000:2005 minimum requirement documents

Has the organization established documented, implemented and maintained other procedures to ensure development, implementation and updating of the FSMS

4.2.2 Control of Documents

Is there a documented procedure for control of documents

Approved prior to use

Review, update and re-approve

Changes are effectively identified and documented

Availability at point of use

Legibility and readability

Control over external documents

Prevent the inadvertent use of obsolete documents and identification of obsolete documents

4.2.3 Control of Records

Is there are document procedure for control of records





Retention time and disposition of records

5.0 Management Responsibility

5.1 Management Commitment

Is the commitment of top management evident to the Auditor

Have top management established business objectives to support food safety

5.2 Food Safety Policy

Is the policy documented and is there a method of communication

Is it appropriate to the role of the organization in the food chain

Does it refer to both statutory and regulatory requirements and with customer food safety requirements

Does it communicate effectively to staff and any on-site suppliers or contractors

Is there evidence of reviews

is it supported by measurable objectives (list the objectives, measures and current status)

5.3 Food Safety Management System Planning

Is there documented evidence that the FSMS is planned implemented, monitored and maintained

5.4 Responsibility & Authority

Are responsibilities and authorities clearly defined and documented

5.5 Food Safety Team Leader

Has top management designated a food safety leader (name)

5.6 Communication

Are methods of communication evident and clear

How are top management communicating effectively, what tools or methods do they use

5.6.1 External Communication

Verify how communication takes place between suppliers and contractors on issues regarding food safety

Communication with statutory and regulatory bodies

Are food safety requirements from statutory and regulatory authorities available

5.6.2 Internal Communication

Verify how communication takes place within the organisation on issues regarding food safety

5.7 Emergency Preparedness & Response

Is there a documented procedure / process for planning and responding to emergency situations and accidents

Has there been any need to use this process

5.8 Management Review

Has management reviewed the FSMS

Are reviews carried out at planned intervals

Do reviews focus on the organisations policy objectives and improvements

Does it include the outcome if the other reviews

Does it include analysis from verification results

Changes affecting the FSMS

Results of corrective actions, emergencies, accidents, recalls and other similar

Review of results from system up-dates

Evaluation of communications whether consumer, customer, regulatory bodies

Evaluation on the results of internal and external audits, inspections relating to products and processes

6.0 Resource Management

6.1 Provision of Resource

Selection and training criteria documented for food safety team members

Where applicable criteria for selection and use of external experts, defined roles and responsibilities

There is a process for identifying necessary competencies for personnel who impact food safety

6.2 Human Resource

What training has been provided and / or competency been decided

What process is in place to evaluate effectiveness of selection and training process

How are personnel made aware of the relevance and importance of their individual activities to food safety and what is the communication process

What records are maintained to demonstrate successful training and communication of FSMS

6.3 Infrastructure

How has the organization provided adequate resources for the establishment and maintenance of the infrastructure needed to meet FSMS requirements (ISO22000:2005)

Work Environment

7.0 Planning & Realization of Safe Products

7.1 General Requirements

The organization shall plan and develop the processes needed for the realization of safe products. The organisation shall implement, operate and ensure the effectiveness of the planned activities and any changes to those activities. this includes PRP / OPRP and HACCP

7.2 Prerequisite Programs (PRPs)

7.2.1 Has the organization identified PRPs

7.2.1 List all the PRPs identified by the organization

7.2.2 Do the PRPs relate to statutory and regulatory requirements

7.2.2 Are PRPs approved by the food safety team

7.2.3 Information based on CODEX (or any other)

Are documents available specifying how activities included in PRPs are managed

Verify that PRPs are being controlled in accordance with documentation

Has consideration been given to construction of infrastructure

Has consideration been given to the criticality of activities and personnel

Has consideration been given to the supply of water, air, energy and other needs

Has consideration been given to supporting services including waste management and sewage disposal

Has consideration been given to the availability of equipment relating to cleaning, maintenance and preventative maintenance

Has consideration been given to measures to prevent cross contamination

Has consideration been given to cleaning, hygiene and sanitation

Has consideration been given to the control of insects and pests

Is there evidence of verification records for the control of all the above

7.3 Preliminary Steps to enable Hazard Analysis

7.3.1 Preliminary steps to enable hazard analysis

Is the information needed for analysis recorded

What information is used

Is it updated frequently and as necessary

7.3.2 food Safety Team

Is there a food safety team

List the people in the team

Is the team competent (6.2.2) and are there records to verify competence Product characteristics, raw materials, ingredients and product contact materials

Are utensils, ingredients, packaging and other contact materials described in documents which include detailed information appropriate

Chemical, physical and biological characteristics for above are documented

Composition for products is defined

Point of origin is defined

Method of production is defined

Methods for packaging and delivery are defined

Storage conditions are defined

Preparation and / or handling specifications before use or processing are defined

Food safety acceptance criteria is defined

Are legal, regulatory and any other food safety requirements met Finished Product Characteristics

The hazard analysis has documented the characteristics of the finished product

The composition of the product is considered, and includes allergens

The name of how the product is identified is documented

Biological, chemical and physical characteristics relevant to the product are defined

Concerns relating to the intent of product and storage requirements have been addressed / defined

Packaging requirements have been identified and defined

Labeling relating to safe product handling, preparation and use (including any warnings) have been identified and defined)

Distribution methods have been defined

Legal and regulatory requirements have been identified and defined

Information is descriptive, detailed, updated and maintained inclusive to changes to the HACCP plan or PRPs

7.3.4 Intended use

What documents are available that address hazards relating to the products intended use

Have these included factors raised in hazard analysis

Has the organization included the concerns of any special groups i.e. children, pregnant women, elderly

Is this information updated when there are changes to FSMS, scientific research or regulations Flow diagrams, process flow and control measure

Has the organization implemented flow diagrams as common practice

Have the flow diagrams been approved by the food safety team description of process flow and measure control

Is the method used for identifying hazards effective

Are external requirements considered when analyzing hazards

Does the organization update HACCP and PRP plans

7.4 Hazard Analysis

Are hazards and control methods determined by the food safety team Hazard identification and determining level of acceptability Are all hazards identified acceptably Are the level of control determined acceptably

7.4.3 Hazard Analysis

Has the organization demonstrated that hazard analysis focuses on eliminating and reducing hazards and is their determination acceptable

Has the organization identified hazards to the satisfaction of legal and regulatory expectations

Has the severity of the risk been determined

Is the methodology for determining severity of risk based on sound and acceptable scientific and technological methods or studies

7.4.4 Control methods, section and evaluation

Do the selected measures prevent, eliminate or minimize the hazard to an acceptable level

Hazard analysis is effective for HACCP and PRPs through the scope of the FSMS

Hazard analysis refers to the hazard and the magnitude of the severity

There are documented methods to measure, monitor and control all identified hazards

The control point and measure for controlling is accurate and adequate, it considered other control points in combination

It addresses the possibility of failure preventing the inclusion of the hazard affecting the process or the food

Are all the above adequate and effective

Has the synergy of other control measure points been considered

Are the above addressed in the HACCP / PRP

Are the above expressed through documents, records, procedures, instructions, manuals, handbooks or other wise

7.5 Establishing the Operational Prerequisite Programs (OPRPs)

Have OPRPs documented and implemented

OPRPs address (please list)

OPRP hazards are identified as Biological, Chemical and Physical and are controlled

OPRP documents reference the control measures to be applied

OPRP control methods are effectively implemented

OPRPs are adequate and effective to trigger corrections

Responsibilities and authorities are determined for actions or corrections

Supported by records

7.6 Establishing the HACCP Plan

7.6.1 HACCP Plan

Is the HACCP Plan documented

How many HACCP plans are there

Does the plan address the hazard point of control

Does the plan address the reaction or action needed to be taken in the event of a deviation or fault

The CCPs and respective Critical Limits are identified

Procedures for controlling CCPs are documented

Record for monitoring CCPs are available for checking

7.6.2 Identifying critical control points

Is the identification of CCPs effective

7.6.3 Determining Critical Limits

Is there a CL for each CCP

Is each CL measurable

The scientific means to justify each CL is adequate and effective

7.6.4 Monitoring systems

Is there a monitoring system in place (briefly describe)

7.6.5 Are there any actions or any monitoring non-conformance resulting from monitoring CL

7.7 Updating of preliminary information and documents specifying the PRPs and the HACCP Plan

Is there documented evidence to support and necessary update with reference to product characteristics, intended use, flow diagrams, process steps or control methods

7.8 Verification Planning

Does verification planning define and document activity & purpose, method, frequency and responsibilities

What other procedures have been developed and implemented as a result of verification planning

Relating to verification, are the preparation methods and planning activities compatible

7.9 Traceability System

Is there a documented system for traceability

Have there been any internal traceability audits or mock exercises

7.10 Control of Non-Conformity

7.10.2 Is there a documented procedure to address corrective actions Handling potentially unsafe products: Are the controls and responses for handling potentially unsafe products documented There is a documented procedure and defined criteria of evaluation for the release of non-conforming product There is a documented procedure for the disposition of non-conforming products

7.10.4 There is a documented procedure for product withdrawal or recall that addresses all relevant points

8.0 Validation, Verification and Improvement of the Food Safety Management System

8.1 General Requirements

Is there documented evidence of validations, verification and continual improvements

8.2 Validation of control measure combinations

Is there any documented or observed evidence of validation of control method combinations

8.3 Control of monitoring and measuring

Do records for monitoring and measuring demonstrate good practice i.e. all CCPs are within the defined CL, and any CAs are documented

8.4 Food Safety Management System verification

Is there a documented procedure addressing internal audits

Is there any audit program auditing within the scope of the FSMS

Do audits focus on adequacy, effectiveness and providing evidence of sustaining improvements in relation to the organizations food safety objectives

Are auditors competent

After identifying the need for action are they promptly taken by the process owner

8.4.3 How are the results of verification activities analysed

8.5 Improvement

8.5.1 Is there any evidence that improvements to the FSMS are directed to top management

8.5.2 Is there any evidence that the FSMS is updated as part of continual improvements