ISO 22000:2018 Food safety management systems — Requirements for any organization in the food chain

Foreword................................................................................................................ v
Introduction.......................................................................................................... vi

  1. Scope............................................................................................................. 1
  2. Normative references..................................................................................... 1
  3. Terms and definitions......................................................................... 1
  4. Context of the organization............................................................................ 9
    4.1 Understanding the organization and its context...................................... 9
    4.2Understanding the needs and expectations of interested parties..................... 9
    4.3Determining the scope of the food safety management system....................... 9
    4.4Food safety management system...................................................... 10
  5. Leadership................................................................................................... 10
    5.1Leadership and commitment.......................................................... 10
    5.2Policy................................................................................... 10
         5.2.1Establishing the food safety policy........................................... 10
         5.2.2Communicating the food safety policy....................................... 10
    5.3Organizational roles, responsibilities and authorities................................ 11
  6. Planning........................................................................................................ 11
    6.1Actions to address risks and opportunities............................................. 11
    6.2Objectives of the food safety management system and planning to achieve them... 12
    6.3Planning of changes.................................................................... 12
  7. Support........................................................................................................ 13
    7.1     Resources............................................................................... 13
                  7.1.1General........................................................................ 13
                  7.1.2People.......................................................................... 13
                  7.1.3Infrastructure.................................................................. 13
                  7.1.4Work environment............................................................ 13
                  7.1.5Externally developed elements of the food safety management system..0... 14
                  7.1.6Control of externally provided processes, products or services.............. 14
    7.2         Competence............................................................................ 14
    7.3         Awareness.............................................................................. 14
    7.4         Communication........................................................................ 15
                  7.4.1   General......................................................................... 15
                  7.4.2   External communication...................................................... 15
                  7.4.3   Internal communication....................................................... 15
    7.5         Documented information.............................................................. 16
                  7.5.1General........................................................................ 16
                  7.5.2Creating and updating........................................................ 16
                  7.5.3Control of documented information.......................................... 17
  8. Operation..................................................................................................... 17
    8.1     Operational planning and control..................................................... 17
    8.2     Prerequisite programmes (PRPs)...................................................... 17
    8.3     Traceability system.................................................................... 18
    8.4     Emergency preparedness and response............................................... 19
              8.4.1     General........................................................................ 19
              8.4.2     Handling of emergencies and incidents...................................... 19
    8.5     Hazard control......................................................................... 19
              8.5.1    Preliminary steps to enable hazard analysis................................. 19
              8.5.2    Hazard analysis................................................................ 21
              8.5.3    Validation of control measure(s) and combinations of control measures... 23
              8.5.4    Hazard control plan (HACCP/OPRP plan)..................................... 24
    8.6     Updating the information specifying the PRPs and the hazard control plan.......... 25
    8.7     Control of monitoring and measuring................................................. 25
    8.8     Verification related to PRPs and the hazard control plan............................ 26
              8.8.1   Verification.................................................................... 26
              8.8.2   Analysis of results of verification activities.................................. 26
    8.9     Control of product and process nonconformities..................................... 27
              8.9.1    General........................................................................ 27
              8.9.2    Corrections.................................................................... 27
              8.9.3    Corrective actions............................................................. 27
              8.9.4    Handling of potentially unsafe products...................................... 28
              8.9.5    Withdrawal/recall............................................................. 29
  9. Performance evaluation............................................................................... 29
    9.1   Monitoring, measurement, analysis and evaluation................................. 29
            9.1.1      General........................................................................ 29
            9.1.2      Analysis and evaluation....................................................... 29
    9.2   Internal audit........................................................................... 30
    9.3   Management review................................................................... 31
            9.3.1     General........................................................................ 31
            9.3.2     Management review input.................................................... 31
            9.3.3     Management review output................................................... 31
  10. Improvement............................................................................................... 32
    10.1  Nonconformity and corrective action................................................. 32
    10.2  Continual improvement................................................................ 32
    10.3  Update of the food safety management system  32

Annex A (informative) Cross references between the CODEX HACCP and this document....... 33
Annex B (informative) Cross references between this document and ISO 22000:2005 34