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ISO Align and Enhance ISO 22000

ISO 22000: 2018

The long awaited second edition of International ISO Standard 22000 Food safety management systems — Requirements for any organization in the food chain has just been published (June 2018). Not surprisingly, there are a number of changes, there is much closer alignment with other ISO management standards, additional strategic requirements to address organizational risks and opportunities and more detailed food safety requirements.

As per ISO 22000:2005, ISO 22000:2018 specifies the requirements for a FSMS that combines the key elements of interactive communication, system management, prerequisite programmes and HACCP principles. However, the new ISO 22000 standard advocates using a process approach to developing and implementing a Food Safety Management System and that management of the processes and the system as a whole can be achieved using a Plan-Do-Check-Act (PDCA) cycle, with an overall focus on risk-based thinking.

 

The standard prescribes two Plan-Do-Check-Act Cycles. The first at Organizational Risk Management level covering the framework of all clauses with the exception of Clause 8 Operation:

 

4 Context of the organization
5 Leadership
6 Planning
7 Support
9 Performance evaluation
10 Improvement

 

Posted Image

 

* Plus control of external processes, products & services
** See Operational PDCA Cycle in Appendix

 

The second at Operational level covering Clause 8 Operation based on HACCP Principles but also including ISO 22000’s unique requirement for Operational Prerequisite Programmes: 8 Operation

 

Posted Image

 

ISO 22000:2018 has been developed within the ISO high level structure (HLS). The objective of the HLS is to improve alignment between ISO management system standards so ISO 22000:2018 includes other key elements that are common to ISO management system standards; customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making and relationship management. This permits easier integration with other management standards requirements. For example, excluding Section 8 Operation, if we look at the sections and clauses of International ISO Standard 9001:2015 Quality management systems — Requirements and compare with the sections and clauses of International ISO Standard 22000: 2018 Food safety management systems — Requirements for any organization in the food chain you will see the similarity:

International ISO Standard 9001:2015 Quality management systems — Requirements vs. International ISO Standard 22000: 2018 Food safety management systems — Requirements for any organization in the food chain

 

ISO 9001:2015

 

ISO 22000:2018

 

4 Context of the organization
4 Context of the organization
4.1 Understanding the organization and its context
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of interested parties
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the quality management
4.3 Determining the scope of the food safety management system
4.4 Quality management system and its processes
4.4 Food safety management system
5 Leadership
5 Leadership
5.1 Leadership and commitment
5.1 Leadership and commitment
5.1.1 General

 

5.1.2 Customer focus

 

5.2 Policy
5.2 Policy
5.2.1 Establishing the quality policy
5.2.1 Establishing the food safety policy
5.2.2 Communicating the quality policy
5.2.2 Communicating the food safety policy
5.3 Organizational roles, responsibilities and authorities
5.3 Organizational roles, responsibilities and authorities
6 Planning
6 Planning
6.1 Actions to address risks and opportunities
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.2 Objectives of the food safety management system and planning to achieve them
6.3 Planning of changes
6.3 Planning of changes
7 Support
7 Support
7.1 Resources
7.1 Resources
7.1.1 General
7.1.1 General
7.1.2 People
7.1.2 People
7.1.3 Infrastructure
7.1.3 Infrastructure
7.1.4 Environment for the operation of processes
7.1.4 Work environment
7.1.5 Monitoring and measuring resources
7.1.5 Externally developed elements of the food safety management system
7.1.6 Organizational knowledge
7.1.6 Control of externally provided processes, products or services
7.2 Competence
7.2 Competence
7.3 Awareness
7.3 Awareness
7.4 Communication
7.4 Communication

 

7.4.1 General
(8.2.1 Customer communication)
7.4.2 External communication

 

7.4.3 Internal communication
7.5 Documented information
7.5 Documented information
7.5.1 General
7.5.1 General
7.5.2 Creating and updating
7.5.2 Creating and updating
7.5.3 Control of documented information
7.5.3 Control of documented information
8 Operation *
8 Operation *
9 Performance evaluation
9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
9.1.1 General
9.1.2 Customer satisfaction

 

9.1.3 Analysis and evaluation
9.1.2 Analysis and evaluation
9.2 Internal audit
9.2 Internal audit
9.3 Management review
9.3 Management review
9.3.1 General
9.3.1 General
9.3.2 Management review inputs
9.3.2 Management review input
9.3.3 Management review outputs
9.3.3 Management review output
10 Improvement
10 Improvement
10.1 General

 

10.2 Nonconformity and corrective action
10.1 Nonconformity and corrective action
10.3 Continual Improvement
10.2 Continual improvement

 

10.3 Update of the food safety management system

 

* There is a comparison of Clause 8 in the appendix

 

This similarity will make integrating the Quality requirements of ISO 9001 into an ISO 22000 Complaint Food Safety Management System far easier, and vice versa.

 

Key Changes in ISO 22000:2018 (Sections 4 to 10) requirements for a Food Safety Management System

 

4.1 Understanding the organization and its context
A new requirement to determine external and internal issues (positive and negative) that affect the organization’s ability to achieve the intended result(s) of its Food Safety Management System.
Examples of issues given are legal, technological, competitive, market, cultural, social and economic environments, cybersecurity and food fraud, food defence and intentional contamination, knowledge and performance of the organization.

 

4.2 Understanding the needs and expectations of interested parties
A new requirement to determine relevant interested parties and the relevant requirements of the interested parties.

 

5.1 Leadership and commitment
A greater emphasis on Top Management to demonstrate leadership and commitment

 

6.1 Actions to address risks and opportunities
A new requirement to plan address the issues referred to in 4.1 and the requirements referred to in 4.2 and 4.3 and determine the risks and opportunities that need to be addressed.

 

6.2 Objectives of the food safety management system and planning to achieve them
A greater emphasis on specifying objectives for the FSMS and a need to prescribe:
a) what will be done;
b) what resources will be required;
c) who will be responsible;
d) when it will be completed;
e) how the results will be evaluated.

 

7.1.6 Control of externally provided processes, products or services
A new requirement to establish and apply criteria for the evaluation, selection, monitoring of performance and re- evaluation of external providers of processes, products and/or services and ensure adequate communication of requirements.

 

7.4 Communication
A greater emphasis on specifying internal and external communications relevant to the FSMS and a need to prescribe:
a) on what it will communicate;
b) when to communicate;
c) with whom to communicate;
d) how to communicate;
e) who communicates.

 

8.2.3 A new requirement to consider the applicable part of the ISO/TS 22002 series when selecting and/or establishing PRP(s).

 

8.4.2 New requirements Handling of emergencies and incidents
There is a need to respond to actual emergency situations and incidents and take action to reduce the consequences of the emergency situation.

 

8.5.4 Hazard control plan (HACCP/OPRP Plan)
A change where there is now a requirement to document CCPs and OPRPS in a Hazard Control Plan.
A new definition of action criteria for OPRPs: action criterion - measurable or observable specification for the monitoring (3.27) of an OPRP (3.30)
Note: An action criterion is established to determine whether an OPRP remains in control, and distinguishes between what is acceptable (criterion met or achieved means the OPRP is operating as intended) and unacceptable (criterion not met nor achieved means the OPRP is not operating as intended).

 

9.1 Monitoring, measurement, analysis and evaluation
A greater emphasis on specifying monitoring, measurement, analysis and evaluation and a need to prescribe:
a) what needs to be monitored and measured;
b) the methods for monitoring, measurement, analysis and evaluation, as applicable, to ensure valid results;
c) when the monitoring and measuring shall be performed;
d) when the results from monitoring and measurement shall be analysed and evaluated;
e) who shall analyse and evaluate the results from monitoring and measurement.

 

Click here to view the New IFSQN ISO 22000 2018 Implementation Package

 

Appendix

International ISO Standard 9001:2015 Quality management systems — Requirements vs. International ISO Standard 22000: 2018 Food safety management systems — Requirements for any organization in the food chain

 

8 Operation
8 Operation
8.1 Operational planning and control
8.1 Operational planning and control
8.2 Requirements for products and services
8.2 Prerequisite programmes (PRPs)
8.2.1 Customer communication

 

8.3 Design and development of products and services

 

(8.5.2 Identification and traceability)
8.3 Traceability system
8.4 Control of externally provided processes, products and services

 

8.4 Emergency preparedness and response

 

8.4.1 General

 

8.4.2 Handling of emergencies and incidents
8.5 Production and service provision

 

8.5.1 Control of production and service provision

 

8.5.2 Identification and traceability

 

8.5.3 Property belonging to customers or external providers

 

8.5.4 Preservation

 

8.5.5 Post-delivery activities

 

8.5.6 Control of changes

 

8.5 Hazard control

 

8.5.1 Preliminary steps to enable hazard analysis

 

8.5.1.1 General

 

8.5.1.2 Characteristics of raw materials, ingredients and product contact materials

 

8.5.1.3 Characteristics of end products

 

8.5.1.4 Intended use

 

8.5.1.5 Flow diagrams and description of processes

 

8.5.1.5.1 Preparation of the flow diagrams

 

8.5.1.5.2 On-site confirmation of flow diagrams

 

8.5.1.5.3 Description of processes and process environment

 

8.5.2 Hazard analysis

 

8.5.2.1 General

 

8.5.2.2 Hazard identification and determination of acceptable levels

 

8.5.2.3 Hazard assessment

 

8.5.2.4 Selection and categorization of control measure(s)

 

8.5.3 Validation of control measure(s) and combinations of control measures

 

8.5.4 Hazard control plan (HACCP/OPRP plan)

 

8.5.4.1 General

 

8.5.4.2 Determination of critical limits and action criteria

 

8.5.4.3 Monitoring systems at CCPs and for OPRPs

 

8.5.4.4 Actions when critical limits or action criteria are not met

 

8.5.4.5 Implementation of the hazard control plan

 

8.6 Updating the information specifying the PRPs and the hazard control plan

 

8.7 Control of monitoring and measuring
8.6 Release of products and services
8.8 Verification related to PRPs and the hazard control plan

 

8.8.1 Verification

 

8.8.2 Analysis of results of verification activities
8.7 Control of nonconforming outputs
8.9 Control of product and process nonconformities

 

8.9.1 General

 

8.9.2 Corrections

 

8.9.3 Corrective actions

 

8.9.4 Handling of potentially unsafe products

 

8.9.4.1 General

 

8.9.4.2 Evaluation for release

 

8.9.4.3 Disposition of nonconforming products

 

8.9.5 Withdrawal/recall

 

Author Biography

 

Tony Connor, Chief Technical Advisor, IFSQN

 

Tony received an honors degree in Molecular Biology and Biochemistry from Durham University before embarking on a successful 20-year career in the UK food industry in a variety of roles including Laboratory Manager, Production Manager, Quality Assurance Manager, Technical Manager, Technical Development Manager and Group Technical Manager. Tony qualified as a Lead Audit Assessor in 1994. Since 2009 Tony has been Chief Technical Advisor to the International Food Safety & Quality Network.

 

 

ISO 22000 Food Safety Management System - Food Manufacturers Edition

 

This is an ideal package for Food Manufacturers looking to meet International Food Safety Standards. This manual meets the requirements of International Standard ISO 22000: 2018 for Food Safety Management Systems. This 2018 version of the package is an upgrade including extensive ISO 22000 HACCP Implementation Guidance, Additional Training and a New Implementation Workbook.

 

Find Out More >>




1 Comments

excellent.
 
keep it up good work.

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