ISO 22000-2018 食品安全管理体系
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
4.2 Understanding the needs and expectations of interested parties...............................................................9
4.3 Determining the scope of the food safety management system....................................................................9
4.4 Food safety management system.........................................................................................................................................10
5 Leadership...............................................................................................................................................................................................................10
5.1 Leadership and commitment..................................................................................................................................................10
5.2 Policy............................................................................................................................................................................................................10
5.2.1 Establishing the food safety policy.................................................................................................................10
5.2.2 Communicating the food safety policy........................................................................................................10
5.3 Organizational roles, responsibilities and authorities.......................................................................................11
6 Planning......................................................................................................................................................................................................................11
6.1 Actions to address risks and opportunities.................................................................................................................11
6.2 Objectives of the food safety management system and planning to achieve them....................12
6.3 Planning of changes.........................................................................................................................................................................12
7 Support........................................................................................................................................................................................................................13
7.1 Resources..................................................................................................................................................................................................13
7.1.1 General..................................................................................................................................................................................13
7.1.2 People.....................................................................................................................................................................................13
7.1.3 Infrastructure..................................................................................................................................................................13
7.1.4 Work environment......................................................................................................................................................13
7.1.5 Externally developed elements of the food safety management system......................14
7.1.6 Control 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
7.5.1 General..................................................................................................................................................................................16
7.5.2 Creating and updating..............................................................................................................................................16
7.5.3 Control 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
Bibliography.............................................................................................................................................................................................................................37