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ISO 22000:2018 Is Coming!

17 April 2018
ISO 22000:2005, the international food safety standard that specifies the requirements to ensure safe production within the entire food chain, from farm to fork, has now been revised by the Technical Committee ISO/TS 34/SC 17. 

The international standards are to be reviewed every five years in order to ensure whether a new revision is required or not. The objective of this review has been harmonising the scheme with other standards following the ISO high level structure (HSL).

Currently, the revision is on FDIS stage, meaning the final draft is under development and pending for final approval. 


1. In total 45 terms and definitions, of which 31 are new, such as action criterion for the monitoring of an operational prerequisite program, stakeholder and significant food safety hazard among others, and other three are now clearly defined so they do not bring us to confusion when implementing them (monitoring, operational prerequisite programmes, OPRP, and critical control points, CCP).

2. High level structure: therefore we need to consider 7 main clauses instead of 5 as we used to see in the 2005 version:

Context of the organization

The internal and external issues relevant for the strategic direction of the business and the ability to get the intended results are to be determined. In this section, it is also now required to identify the needs and expectations of stakeholders. 


This is a new heading now included in the latest version, although the requirements were already available through section 5, Management Commitment. 


Following the aspects considered by other recently revised standards like ISO 9001:2015 and ISO 14001:2015, the actions to address risk and opportunities must also be defined. We will need to manage the risks at the operational level (through HACCP), as well as the strategic level of the management system, and also evaluate the effectiveness of the actions taken and their impact to clients and other interested parties needs.


There are no substantial changes, but we will need to consider the capability of current resources and also being aware of restrictions; we should also consider also all resources that are required from external sources. It is now clearly described the steps to follow when a business uses externally developed elements in the food safety management system. 


  • For both, traceability system and emergency preparedness and response, further details regarding what needs to be considered are now mentioned within 8.3 and 8.4 clauses respectively. 
  • Processing aids, packaging and utilities are also to be added to the required documented flow diagrams.
  • Within the characteristics of raw materials, ingredients and packaging, the source of each product needs now also to be defined and documented. 
  • When selecting and/or establishing PRPs, the applicable technical specification in the ISO/TS 22002 series is considered.
  • The validation of control measures must be documented and conducted before the implementation of the HACCP plan.
  • The HACCP and OPRP plan are put together in a Hazard Control Plan with action criteria to be defined for the identified OPRPs and critical limits (as usual) for CCPs.

Performance evaluation

  • There are further aspects to be discussed during management review meetings, such as performance of external providers (suppliers), review of risks and opportunities and effectiveness of actions taken to address them, opportunities for continual improvement, the adequacy of resources, etc.
  • There is also a new clause that includes mandatory documented information and evaluation of effectiveness with regard to results from monitoring and measurement verification.


  • No critical changes, but steps to follow when nonconformity occurs are now clearly detailed.

3. The risk-based approach: in the introduction section is now specified that not only the risks identified through HACCP are to be considered, also risks at the organizational level will be evaluated to ensure an effective implementation of the food safety management system and fulfilment of intended goals.

4. Plan-Do-Check-Act (PDCA) cycle: there are two separate cycles that work together, one applies to the overall food safety management system and the other involves the operations specified in section 8 that simultaneously covers the HACCP principles. 

According to plans, the second edition of the standard is expected to be released by June 2018. 

We should not forget either that FSSC 22000 has recently transitioned to version 4.1, but due to the upcoming ISO 22000, all certified organizations against any of these schemes should prepare for the changes that will come into effect shortly.  

Marta Vaquero Food Safety Certification Manager at NQA Global