The purpose of this study was to compare the difference of the methodologies between ISO 22000:2005 and ISO 22000:2018. Compared to the methodology of food safety management system ISO 22000:2005, the methodology of ISO 22000:2018 has not been seen yet. The methodology established in this study was based on the differences of ISO 22000:2018 and ISO 22000:2005 and the abundant experiences of author toward the counseling of verification. The high-level structural management of ISO 22000:2018 can be integrated with other management systems. The risk which was assessed through the severity and possibilities could be converted into an opportunity according to the new method of risk evaluation of ISO 22000:2018 based on the CODEX HACCP. Relatedly, through the implementation of the HACCP system, the key regulatory terms relevant for adherence to ISO 22000:2018 have been added and revised. In particular, the new regulations state that the members of food safety management committees must either possess the expertise required to determine hazards or seek the assistance of outside experts when necessary. This regulation must be effectively implemented in the FSMS of small- and medium-sized enterprises throughout the world. In addition, the key terms and definitions of ISO 22000:2018 such as critical control points, prerequisite programs, and operation prerequisite programs are more clearly defined and consistent with the standard operating procedures of effective food safety management systems. ISO 22000:2018 also pays greater attention to the two “plan, do, check, action” (PDCA) cycles including food safety management system and food safety level. These two PDCA cycles emphasize the need for independent operation but should also be implemented such that they have close synergy and harmony with each other. This methodology was used for the verification of ISO 22000:2018 of seven factories.

中文翻译：

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基于 ISO 22000:2018 危害分析方法的食品安全管理体系与 ISO 22000:2005 相比

本研究的目的是比较 ISO 22000:2005 和 ISO 22000:2018 之间方法的差异。与食品安全管理体系ISO 22000:2005的方法论相比，ISO 22000:2018的方法论还没有出现。本研究建立的方法论是基于 ISO 22000:2018 和 ISO 22000:2005 的差异以及作者对验证咨询的丰富经验。ISO 22000:2018 的高层结构管理可以与其他管理系统集成。根据基于 CODEX HACCP 的 ISO 22000:2018 风险评估新方法，通过严重性和可能性评估的风险可以转换为机会。相关地，通过实施HACCP体系，添加和修订了与遵守 ISO 22000:2018 相关的关键监管条款。特别是，新法规规定食品安全管理委员会的成员必须具备确定危害所需的专业知识，或者在必要时寻求外部专家的帮助。该法规必须在全世界中小企业的 FSMS 中得到有效实施。此外，ISO 22000:2018 的关键术语和定义，如关键控制点、前提方案和操作前提方案，定义更加明确，与有效食品安全管理体系的标准操作程序一致。ISO 22000:2018 也更加关注“计划、执行、检查、行动”（PDCA）循环，包括食品安全管理体系和食品安全水平。这两个 PDCA 循环强调独立运作的必要性，但也应实施，使它们相互之间具有密切的协同和和谐。该方法用于七家工厂的 ISO 22000:2018 验证。