ISO 22000 Audit Preparation Checklist

ISO 22000 specifies the requirements to plan, implement, operate, maintain and update a documented food safety management system, where an organization in the food chain industry needs to ensure that food is safe at the time of human consumption.

"The requirements specified in ISO 22000 are generic and intended to be applicable to all organizations in the food chain, regardless of size and complexity, including organizations directly or indirectly involved in one or more of the steps in the food chain." - PECB

To ensure food safety along the food chain, ISO 22000 combined the following generally recognized key elements:

• Interactive communication
• System management
• Prerequisite programmes (PRPs)
• Principles of the Hazard Analysis and Critical Control Point (HACCP)

However, the 2018 version adds the general management principles to the previously isolated food safety principles of an FSMS:

• Customer focus
• Leadership
• Engagement of people
• Process approach
• Improvement
• Evidence-based decision making
• Relationship management

This Process Street checklist prepares the company for meeting ISO 22000 requirements before the actual certification audit.

By going through the checklist, you will identify areas of improvement concerning processes and procedures, as well as verifying if customer’s product requirements are adequately researched, established, and implemented.

This checklist does not cover every aspect of ISO 22000 certification, that is to say, clauses 4-8. Rather, It is designed to take you through all general requirements. We highly recommend seeking out expert assistance to guide you through the entire certification process.

For best results, users are encouraged to edit the checklist and modify the contents to best suit their use cases, as it cannot provide specific guidance on the particular risks and controls applicable to every situation.

A little info about Process Street

Process Street is superpowered checklists. By using our software to document your processes, you are instantly creating an actionable workflow in which tasks can be assigned to team members, automated, and monitored in real-time to ensure they are being executed as intended, each and every time.

The point is to minimize human error, increase accountability, and provide employees with all of the tools and information necessary to complete their tasks as effectively as possible.

To get things started, enter basic details about your company, as well as the project leader in charge of preparing for the ISO 22000 audit.

Provide a clear overview of what your current certification status is and what your goals are for the future concerning ISO 22000 certification.

Also, from the dropdown below, determine if you are looking to obtain multi-site certification or not. Based on your answer, conditional logic will present or not-present relevant tasks.

The importance of defining responsibilities and levels of authority within your company is stated in Clause 5 of ISO 22000 (Leadership).

Provide an overview of the various responsibilities with your organization, including top management. 

All personnel must know what it is expected from them
(responsibilities) and what top management allows them to do (authorities). This can be easily implemented through an organigram and job descriptions of all staff of the organization with their duties and authorities described. - ISO 22000:2018 FSMS Implementation Guide

You can also link to and/or attach the manual containing details of your management system.

Provide a description of how the various functions in your organization are able to communicate (i.e communication channels).

As a minimum, there should be:

In addition to stating the various internal communication channels, you should develop a comprehensive communication plan.

There must be an efficient communication system with providers of services, products or processes, customers, and regulators among other interested parties, and also internally with the food safety team.

An effective way to create a plan is to follow the table template shown in the image below.

As a “rule of thumb,” it is advisable to treat contractors or outsourced operations as if they were “direct” employees and communicate in a manner that is effective and so that the communication is two-way.

Link to and/or attach the manual containing details of your FSMS.

It is much easier and very systematic to have a manual, which can be used as the main document with reference and links to all other documents. - ISO 22000 Resource Center

Documentation must include:

Having a manual to detail all aspects of your FSMS is excellent and will put you in a strong position to obtain ISO 22000 certification. 

However, an extension of that is to have a document management procedure that ensures the manual stays fully up-to-date and new documents are not unknowingly swept under the rug. 

Provide an overview of your document management procedure that demonstrates a clear ability to ensure data integrity moving forward. 

Link to and/or attach the manual containing details of your document management system.

Management reviews are an essential element of the FSMS.

The aim of the review is for top management to assess the performance of the management system to ensure it has been effective, adequate and suitable for the needs of the business, ultimately preventing unsafe food products or services from reaching consumers.

ISO 22000:2018 includes new elements to be considered during management review meetings, apart from the inputs already mentioned in the previous version:

You will need to retain documented information on your management reviews; these would normally be meeting minutes or perhaps call recordings if you carry out conference calls.

The quality objectives you define should be S.M.A.R.T, that is to say:

Examples of quality objectives include:

• Obtain 100% customer on-time delivery
• Reduce production defects by 10%
• Average operational efficiency to be 90% or greater

You can also link to and/or attach relevant documentation below.

Quality objectives should be communicated to each level of the organization with corresponding objectives and plans at each level to help meet the overall planned goal. Using a balanced scorecard is a good method to communicate these objectives.

A specific requirement of ISO 22000 is "to evaluate and assess customer requirements and demonstrate conformity with those mutually agreed customer requirements that relate to food safety, in order to enhance customer satisfaction"

State the requirements of your customers in the form field below. 

You can also link to and/or attach relevant documentation.

Regular communication with customers is essential to understanding their needs, preferences, and ensuring a fruitful relationship in the long-term.

In the form field below, detail your customer communication strategy.

This should include:

You can also link to and/or attach relevant documentation.

The diversity of activities within the organization will determine the level of training required to fulfill competence.

Training gaps are usually identified with the development of new processes, for example, the introduction of new machinery or in achieving compliance with regulatory requirements.

Detail the training needs for your team in the form field below

No matter how big or small the organization is, training records are essential as reference and evidence of the fulfillment of competence.

Having determined your team's training needs (displayed below) in the previous task, it is now time to take the appropriate measures necessary for successful implementation. 

Training needs

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In the form field below, provide an overview of how you will implement your team's training needs. 

You can also link to and/or attach relevant training documentation. 

Continual improvement may not be one of the most important components for ISO 22000 certification. Nevertheless, having a clear plan as well as processes in place will put your organization in a more favourable position to be granted certification. 

A Food Safety Management System is primarily intended to ensure food is safe for consumption. It does this through the application of the processes determined by you as necessary for your operations, as well as the processes determined by the standard as necessary for continual improvement. - ISO 22000:2018
FOOD SAFETY MANAGEMENT SYSTEM IMPLEMENTATION GUIDE

Link to and/or attach your plans/processes for continual improvement. 

In the form field below, provide a detailed comparison of raw material use across your various locations that you are looking to get certified. 

Now, provide a detailed comparison of product processes across your various locations that you are looking to get certified. 

Of course, if you are looking to get multiple locations certified, a full internal audit needs to be conducted at each one of them. 

Link to and/or attach internal audit documentation. 

You're almost at the finish line as far as preparation goes. Great work!

Now is the time to assess your organization's overall level of preparation for the external audit. 

To round things off, list the action items that have been identified as you've progressed through the checklist. 

In other words, identify the gaps and translate them into action items so you and your team can move forward to finalizing preparations for the external audit and maximize your chances of gaining certification. 

• Safety Culture - ISO 22000 Audit 
• Tuv-Nord - Questionnaire to Assist preparation for an ISO 22000 Audit
• PECB - ISO 22000 Food Safety Management System

• GFSI Compliance Checklist
• HACCP Compliance Checklist
• FSSC 22000: ISO/TS 22002-1 Internal Audit Checklist
• FSSC 22000: ISO/TS 22002-3 Internal Audit Checklist
• FSSC 22000: ISO/TS 22002-4 Internal Audit Checklist