发行日期：2024年6月20日  版本号：4  修订号：7   

lssue Date:June 20, 2024   Issue Number: 4   Revise No: 7

目录

1. 目的及适用范围 Purpose and scope of application 

2. 管理职责 Management responsibilities 

3. 人员管理程序 Personnel management procedures 

4. 过程管理程序Process management procedure 

目的及适用范围Purpose and scope of application 

为确保BOHAN提供食品安全管理体系（英文缩写FSMS，下同）和危害分析与关键控制点（HACCP）体系认证过程的有效性，本程序规定了开展FSMS和HACCP体系认证的特定要求。

    In order to ensure the effectiveness of the certification process of food safety management system (English abbreviation FSMS, the same below) and hazard analysis and critical control point (HACCP) system provided by BOHAN, this procedure specifies the specific requirements for the certification of FSMS and HACCP system.

本程序适用于FSMS和HACCP体系认证过程管理，仅包括特殊要求，对于ISO17021的通用要求已在G-BOHAN -UD 01~19程序中说明，此处不再详述。

This procedure is applicable to the management of FSMS and HACCP system certification process, and only includes special requirements. The general requirements for ISO17021 have been described in G-BOHAN-UD 01 ~ 19 procedures and will not be detailed here.

管理职责 Management responsibilities 

2.1 审核组负责对现场进行审核

The audit team is responsible for the site audit

2.2 审核部负责认证审核全过程的监视和测量

  The audit department is responsible for monitoring and measuring the whole process of certification audit

2.3 总经理负责对监督扩大/缩小、认证资格的暂定、恢复、撤销、注销处理的审批

The general manager is responsible for the examination and approval of the expansion / reduction of supervision, temporary, restoration, revocation and cancellation of certification qualification

2.4总经理负责签发认证证书。

The general manager is responsible for issuing the certificate.

人员管理程序 Personnel management procedures 

3.1申请评审人员

Application review personnel

3.1.1 FSMS申请评审人员（含确定HACCP项目）FSMS application review personnel (including determining HACCP projects)

3.1.1.1具有大专以上学历，有两年以上工作经验，且应具有相应技术领域的基本理论知识和一定的实践经验。Hold a college degree or above, have at least two years of work experience, and possess basic theoretical knowledge and practical experience in the corresponding technical field.

3.1.1.2应具备应用以下知识和技能的能力：Should have the ability to apply the following knowledge and skills:

特定管理体系标准和（或）规范性文件的知识：熟悉相关的食品安全管理体系标准（如ISO 22000）；Knowledge of specific management system standards and/or normative documents: Familiar with relevant food safety management system standards (such as ISO 22000);

认证机构过程的知识：评价申请组织的产品、过程和操作；Knowledge of the certification body process: evaluating the products, processes, and operations of the applying organization;

客户的业务领域的知识：客户业务领域的通用术语、实践和过程的知识；Knowledge of the customer's business domain: knowledge of common terminology, practices, and processes in the customer's business domain;

客户的产品、过程和组织的知识，足以理解申请组织如何运作，以及组织如何应用标准/方案或其他相关规范性文件的要求；The customer's knowledge of the product, process, and organization is sufficient to understand how the applying organization operates and how the organization applies the requirements of standards/schemes or other relevant normative documents;

划分申请组织在食品链中所属的行业类别和子行业类别的能力；The ability to classify the industry category and sub industry category to which the applying organization belongs in the food chain;

确定申请组织活动的复杂程度的能力；The ability to determine the complexity of applying for organizational activities;

多场所抽样的能力；Ability to sample from multiple locations;

根据食品链行业类别能识别前提方案、食品安全危害、法律要求等要求的能力；The ability to identify prerequisite solutions, food safety hazards, legal requirements, and other requirements based on the category of the food chain industry;

确定任何与组织和其食品行业类别或产品相关的特殊季节性因素的能力；The ability to identify any special seasonal factors related to the organization and its food industry category or product;

确定与行业类别和被评审的地理区域相关的特定文化和社会习俗的能力；The ability to identify specific cultural and social customs related to industry categories and the geographic region being evaluated;

确定审核FSMS、食品产品、过程或服务所需的特殊因素的能力；The ability to identify special factors required for auditing FSMS, food products, processes, or services;

具备依据食品链分类表和机构程序，识别审核组所需的行业类别和子行业类别的能力要求的能力；Ability to identify industry categories and sub industry categories required by the audit team based on the food chain classification table and institutional procedures;

具有有效的沟通和读写能力，以履行认证过程中的职能。Having effective communication and reading/writing skills to fulfill the functions during the certification process.

3.1.2 对于HACCP申请评审人员，除应满足FSMS申请评审决定人员能力准则的要求外，还应成功地完成了以下方面的培训：

 For HACCP Application Review personnel, in addition to meeting the requirements of FSMS application review decision-making personnel ability criteria, they should also successfully complete the following aspects of training:

3.1.2.1 HACCP原理、危害评估和危害分析；

  HACCP principle, hazard assessment and hazard analysis;

3.1.2.2包含良好卫生规范、前提方案、食品防护计划的食品安全管理原则；

Food safety management principles including good health practices, prerequisite programs, and food protection plans;

3.1.2.3 相关的HACCP体系标准（如危害分析与关键控制点(HACCP)体系认证要求（V1.0）等）。

Relevant HACCP system standards (such as HACCP system certification requirements (v1.0).

3.2 审核方案管理人员（选择审核组、计算审核时间Select audit team, calculate audit time）Audit scheme management personnel

3.2.1 FSMS审核方案管理人员

3.2.1 FSMS Audit Scheme Manager

3.2.1.1具有大专以上学历，有两年以上工作经验。

  Have college degree or above and have more than two years working experience.

3.2.1.2 应具备应用以下知识和技能的能力Should have the ability to apply the following knowledge and skills：

1）特定管理体系标准和（或）规范性文件的知识：熟悉相关的食品安全管理体系标

准（如ISO 22000）；Knowledge of specific management system standards and/or normative documents: Familiar with relevant food safety management system standards (such as ISO 22000);

认证机构过程的知识；Knowledge of the certification body process;

客户的业务领域的知识：客户业务领域的通用术语、实践和过程的知识；Knowledge of the customer's business domain: knowledge of common terminology, practices, and processes in the customer's business domain;

客户的产品、过程和组织的知识，足以理解申请组织如何运作，以及组织如何应用标准/方案或其他相关规范性文件的要求；The customer's knowledge of the product, process, and organization is sufficient to understand how the applying organization operates and how the organization applies the requirements of standards/schemes or other relevant normative documents;

确定申请组织活动的复杂程度的能力；The ability to determine the complexity of applying for organizational activities;

多场所抽样的要求及运用的能力；The requirements and ability to apply multi site sampling;

计算审核活动实施时间的能力；The ability to calculate the audit time of audit activities;

根据食品链行业类别能识别前提方案、食品安全危害、法律要求等要求的能力；The ability to identify prerequisite solutions, food safety hazards, legal requirements, and other requirements based on the category of the food chain industry;

确定任何与组织和其食品行业类别或产品相关的特殊季节性因素的能力；The ability to identify any special seasonal factors related to the organization and its food industry category or product;

确定与行业类别和被评审的地理区域相关的特定文化和社会习俗的能力；The ability to identify specific cultural and social customs related to industry categories and the geographic region being evaluated;

确定审核FSMS、食品产品、过程或服务所需的特殊因素的能力；The ability to identify special factors required for auditing FSMS, food products, processes, or services;

具备依据食品链分类表和机构程序，识别审核组所需的行业类别和子行业类别的能力要求的能力；Ability to identify industry categories and sub industry categories required by the audit team based on the food chain classification table and institutional procedures;

具有有效的沟通和读写能力，以履行认证过程中的职能。Having effective communication and reading/writing skills to fulfill the functions during the certification process.

3.2.2 对于HACCP审核方案管理人员，除应满足FSMS申请评审决定人员能力准则的要求外，还宜成功地完成了以下方面的培训：

    For HACCP audit scheme management personnel, in addition to meeting the requirements of FSMS application review decision-making personnel ability criteria, they should also successfully complete the following aspects of training:

3.2.2.1 HACCP原理、危害评估和危害分析；

  HACCP principle, hazard assessment and hazard analysis;

3.2.2.2包含良好卫生规范、前提方案、食品防护计划的食品安全管理原则；

  Food safety management principles including good health practices, prerequisite programs, and food protection plans;

3.2.2.3相关的HACCP体系标准（如GB/T27341-2009、GB14881-2013等）。

Relevant HACCP system standards (such as GB / t27341-2009, gb14881-2013, etc.).

3.2.2.4 HACCP审核时间参见CNCA-N-001:2021《危害分析与关键控制点（HACCP）体系认证实施规则》附件3。

Refer to Appendix 3 of cnca-n-001:2021 implementation rules for HACCP system certification.

3.3 认证决定人员

 Certification decision maker

3.3.1 FSMS认证决定人员应具备与某一行业类别审核员要求同样的教育、食品安全培训、审核培训和工作经历，但不要求具备或保持审核经历。应具备应用以下知识和技能的能力：

  FSMS certification decision-making personnel shall have the same education, food safety training, audit training and work experience as auditors of a certain industry category, but they are not required to have or maintain audit experience.Should have the ability to apply the following knowledge and skills:

1）审核原则、实践和技巧的知识；Knowledge of audit principles, practices, and techniques;

2）特定管理体系标准和（或）规范性文件的知识：熟悉相关的食品安全管理体系标

准（如ISO 22000）；Knowledge of specific management system standards and/or normative documents: Familiar with relevant food safety management system standards (such as ISO 22000);

3）认证机构过程的知识；Knowledge of the certification body process;

4）客户的业务领域的知识：客户业务领域的通用术语、实践和过程的知识，足以理解标准/方案或其他规范性文件中对申请组织所属行业的预期；Knowledge of the client's business domain: knowledge of common terminology, practices, and processes in the client's business domain, sufficient to understand the expectations of the industry to which the applying organization belongs in standards/schemes or other normative documents;

5）根据食品链行业类别识别前提方案、食品安全危害、法律要求等方面的能力；Ability to identify prerequisite plans, food safety hazards, legal requirements, and other aspects based on the category of the food chain industry;

6）确定任何与组织和其食品行业类别或产品相关的特殊季节性因素的能力；The ability to identify any special seasonal factors related to the organization and its food industry category or product;

7）确定与行业类别和被评审的地理区域相关的特定文化和社会习俗的能力；The ability to identify specific cultural and social customs related to industry categories and the geographic region being evaluated;

8）确定审核FSMS、食品产品、过程或服务所需的特殊因素的能力；The ability to identify special factors required for auditing FSMS, food products, processes, or services;

9）具备依据食品链分类表和机构程序，识别审核组所需的行业类别和子行业类别的能力要求的能力；Ability to identify industry categories and sub industry categories required by the audit team based on the food chain classification table and institutional procedures;

10）有能力应用ISO22003-1规定的通用的审核原则、实践、技巧，充分实施认证审核并评估内部审核流程；Capable of applying the general audit principles, practices, and techniques specified in ISO22003-1, fully implementing certification audits, and evaluating internal audit processes;

11）了解通用的组织类型、规模、管理、架构和工作场所的操作规范、信息和数据系统、文档系统和信息技术等知识；Understand common organizational types, sizes, management, architecture, and workplace operating standards, information and data systems, document systems, and information technology knowledge;

12）有能力应用指定的规范性文件实施认证，确定其范围和审核活动实施时间是否恰当，以及方案/标准是否得到有效实施并符合要求；Ability to apply specified normative documents for certification, determine the scope and timing of audit activities, and ensure that plans/standards are effectively implemented and meet requirements;

13）具备识别生物危害、化学危害、物理危害、过敏原、食品安全标签要求、与食品链行业类别相关的食品安全法规及其公认的控制机制的能力，以及有能力评价组织识别和满足适用的（生产国/目的地国）食品安全法规和标签要求的能力；The ability to identify biological hazards, chemical hazards, physical hazards, allergens, food safety labeling requirements, food safety regulations and recognized control mechanisms related to the food chain industry category, as well as the ability to evaluate the organization's ability to identify and meet applicable (production country/destination country) food safety regulations and labeling requirements;

14）具备在食品链（子）行业类别中，应用食品安全、HACCP、危害评估和危害分析原则的能力，以及应用方案要求的能力，包括但不限于：外包过程、食品防护、食品欺诈；Ability to apply principles of food safety, HACCP, hazard assessment, and hazard analysis in sub industry categories of the food chain, as well as the ability to apply program requirements, including but not limited to: outsourcing processes, food protection, and food fraud;

15）具备理解组织及其对外沟通的职责、理解组织结构、文化和沟通方法的能力，以及评估组织是否达到其所需的沟通目标的能力；Ability to understand the responsibilities of the organization and its external communication, comprehend organizational structure, culture, and communication methods, as well as assess whether the organization has achieved its required communication goals;

16）具备评估审核报告、纠正措施文件和做出认证决定所需的其他信息的能力；Ability to evaluate audit reports, corrective action documents, and other information required to make certification decisions;

17）具备有效沟通能力和充分的读写能力,以履行认证过程中的职能。Having effective communication skills and sufficient reading and writing abilities to fulfill the functions in the certification process.

3.3.2 HACCP认证决定人员应满足FSMS认证决定人员的能力准则要求，并且宜具备与某一行业类别审核员要求同样的教育、HACCP体系培训、审核培训和工作经历。宜确保具备应用（但不限于）以下知识和技能的能力：

The HACCP certification decision-making personnel shall meet the requirements of the FSMS certification decision-making personnel's ability criteria, and shall have the same education, HACCP system training, audit training and work experience as the auditors of a certain industry category.The ability to apply (but not limited to) the following knowledge and skills should be ensured:

3.3.2.1当前的HACCP原理；

Current HACCP principle;

3.3.2.2理解前提计划、良好卫生规范、食品防护计划等的食品安全管理原则

Understand the food safety management principles of premise plan, good health practice, food protection plan, etc

3.3.2.3 识别显著食品安全危害；

Identify significant food safety hazards;

3.3.2.3 相关的HACCP体系标准；

Relevant HACCP system standards;

3.3.2.4 食品安全危害的识别；

Identification of food safety hazards;

3.3.2.5 关键控制点和关键限值的确定；

Determination of key control points and key limits;

3.3.2.6 与食品安全有关的法律法规，以能够对HACCP体系实施有效审核；

 Laws and regulations related to food safety to enable effective auditing of the HACCP system;

3.3.2.7 产品、过程和操作；

  Products, processes, and operations;

3.3.2.8 可操作的控制措施；

  Operational control measures;

3.3.2.9 致敏物质管理的知识；

  Knowledge of allergen management;

3.3.2.10 食品防护的知识；

  Knowledge of food protection;

3.3.2.11 食品欺诈预防的知识。

  Knowledge of food fraud prevention.

3.4 审核员 Auditors

3.4.1教育经历：Education experience:

3.4.1.1 FSMS审核员教育经历：

FSMS auditor education experience:

FSMS申请人应具有大学本科（含）以上高等教育学历（国家教育部门、人事部门及组织部门承认的大学教育经历，包括大学本科及其以上学历或相应的学位）。在任何情况下，申请人都应提供所声明的教育经历的书面证明。

FSMS applicants should have bachelor's degree or above in Higher Education (including university education experience recognized by national education department, personnel department and Organization Department, including bachelor's degree or above or corresponding degree).In any case, the applicant should provide written proof of the stated educational experience.

关于食品或食品相关专业的范围，应为：

The scope of food or food related specialties should be:

食品专业：食品科学与技术、食品科学与工程（制糖工程、发酵工程、粮食油脂以及植物蛋白工程、农产品加工及贮藏工程、水产品加工及贮藏工程）；

Food science and technology, food science and Engineering (sugar making engineering, fermentation engineering, grain oil and vegetable protein engineering, agricultural products processing and storage engineering, aquatic products processing and Storage Engineering);

食品相关专业：农学（作物栽培学与耕作学、作物遗传育种）、园艺（果树学、茶学、蔬菜学）、植物保护（植物病理学、农业昆虫与害虫防治、农药学）、动物科学（动物遗传育种与繁殖、动物营养与饲料科学、草业学、特种经济动物饲养）、动物医学、水产养殖学、海洋渔业科学与技术、植物营养学、土壤学、公共卫生与预防医学（营养与食品卫生学、卫生毒理学）、生物科学（微生物学、生物化学与分子生物学）、生物技术、化学工程与技术；

Food related majors:Agronomy (crop cultivation and cultivation, crop genetics and breeding), horticulture (fruit tree science, tea science, Vegetable Science), plant protection (plant pathology, agricultural insects and pest control, agricultural pharmacy), Animal Science (animal genetics, breeding and reproduction, animal nutrition and feed science, Prataculture, special economic animal feeding), animal medicine, aquaculture, marine fishery scienceAnd technology, plant nutrition, soil science, public health and preventive medicine (nutrition and food hygiene, Health Toxicology), Biological Science (Microbiology, biochemistry and Molecular Biology), biotechnology, chemical engineering and technology;

食品相关专业应具有包含普通微生物学和普通化学的相应高等教育知识，即具备食品相关专业学历的申请人，应能提供普通微生物学和普通化学的高等教育学习证明（成绩单或单科学习证明）；

Food related majors should have corresponding higher education knowledge including general microbiology and general chemistry, that is, applicants with food related professional qualifications should be able to provide higher education study certificates (transcripts or single subject study certificates) of General Microbiology and general chemistry;

食品及相关专业名称如有差异或发生变化，以教育部《普通高等学校本科目录》及国务院学位委员会、教育部《授予博士、硕士和培养研究生的学科、专业目录》中的学科、专业为准。

If there is a difference between the Ministry of general education, the Ministry of food and the Ministry of food, the Ministry of higher education, the Ministry of food science and the Ministry of higher education, the Ministry of food and the Ministry of higher education, the Ministry of higher education, the Ministry of food and the Ministry of higher education, the Ministry of food and the Ministry of higher education, the Ministry of higher education, the Ministry of higher education, the Ministry of food and the Ministry of higher education, the Ministry of food.

   3.4.1.2 HACCP审核员教育经历

3.4.1.2 education experience of HACCP auditor

1）HACCP的注册资格和初始资格要求：

  HACCP registration and initial qualification requirements:

    HACCP体系审核员的注册以FSMS审核员注册资格（含实习）为初始资格。

The registration of HACCP system auditor is based on FSMS auditor registration qualification (including Internship).

2）HACCP申请人的教育经历要求：

  The education experience requirements of HACCP applicants are as follows:

    HACCP申请人的学历、教育经历同FSMS申请人，参见3.4.1.1。

The educational background and educational experience of HACCP applicants are the same as those of FSMS applicants, see 3.4.1.1.

3.4.2 工作经历Work experience

3.4.2.1 FSMS工作经历

  FSMS work experience

审核员申请人的工作经历要求具体为：

The work experience requirements of the auditor applicant are as follows:

1）申请人应在满足上述教育经历的前提下，具有在食品行业至少4年的工作经验，其中至少2年的食品安全工作经历，具有1年以上该技术领域的食品安全相关工作经验。

  The applicant shall have at least 4 years of working experience in the food industry, including at least 2 years of food safety work experience and more than 1 year of food safety related work experience in the technical field on the premise of meeting the above education experience.

2）申请人应具备至少2年的以上食品安全工作经历：

  The applicant shall have at least 2 years of food safety experience:

食品生产、制造、零售组织中的技术、检验、质量管理、质量保证或食品安全工作经历；

Working experience in technology, inspection, quality management, quality assurance or food safety in food production, manufacturing and retail organizations;

食品卫生管理、检验机构中的技术、检验工作经历；

Technical and inspection experience in food hygiene management and inspection institutions;

食品教学、科研机构的教研工作经历；

Teaching and research experience of food teaching and research institutions;

食品卫生执法领域的专业技术、管理工作经历；

Professional technology and management experience in the field of food hygiene law enforcement;

   3.4.2.2 HACCP工作经历Working experience

   HACCP申请人的工作经历基本同FSMS申请人的工作经历要求.

The working experience of HACCP applicants is basically the same as that of FSMS applicants

3.4.3 培训经历Training experience

 3.4.3.1 FSMS审核员培训内容应包括：

3.4.3.1 the training contents of FSMS auditor shall include:

        1）HACCP原理、危害评估和危害分析；

HACCP principle, hazard assessment and hazard analysis;

         2）包括前提方案（PRPs）等的食品安全管理原则；

Food safety management principles including prerequisite programs (PRPs), etc;

         3）基于GB/T 19011-2021的审核方法；

Audit method based on GB / T 19011-2021;

         4）相关的食品安全管理体系标准（如GB/T 22000/ISO 22000）；

Relevant food safety management system standards (such as GB / T 22000 / ISO 22000);

         5）基于ISO 22003-1:2022的审核与认证过程。

Audit and certification process based on GB / T 22003 or ISO 22003-1:2022.

3.4.3.2 HACCP审核员培训内容应包括：

The training contents of HACCP auditors shall include:

         1）HACCP体系标准；

HACCP system standard;

         2）HACCP体系认证实施规则；

HACCP System Certification Implementation Rules;

         3）CCAA HACCP体系审核员注册准则。

CCAA HACCP auditor system.

3.4.4 审核经历Audit experience

3.4.4.1FSMS审核员申请人的审核经历

FSMS auditor applicant's audit experience

以实习审核员的身份，作为审核组成员在审核员以上注册资格人员的指导和帮助下完成至少4 次相应领域完整体系审核，现场审核经历不少于15 天。现场审核应覆盖相应领域认证标准所有条款。当申请人具有CCAA 某一认证领域审核员或强制性产品认证检查员以上注册资格时，可减少1 次完整体系审核和5 天现场审核经历。

As an intern auditor, as a member of the audit team, complete at least 4 times of complete system audit in corresponding field under the guidance and help of registered personnel above auditor, and have on-site audit experience of no less than 15 days.The on-site audit shall cover all provisions of the certification standards in the corresponding field.When the applicant has CCAA certification field auditor or compulsory product certification inspector or above registration qualification, 1 complete system audit and 5 days on-site audit experience can be reduced.

所有审核经历应在申请前3年内获得，并取得晋级见证中的满意结论。

All audit experience should be obtained within 3 years before application, and satisfactory conclusion in promotion witness shall be obtained.

3.4.4.2 HACCP审核员申请人的审核经历

  Review experience of HACCP auditor applicant

具有FSMS注册资格的HACCP申请人在相应体系审核员以上注册资格人员的指导和帮助下完成至少4 次相应领域完整体系审核，现场审核经历不少于15 天。现场审核应覆盖相应领域认证标准所有条款。当申请人具有CCAA 某一认证领域审核员或强制性产品认证检查员以上注册资格时，可减少1 次完整体系审核和5 天现场审核经历。

The HACCP applicant with FSMS registration qualification shall complete at least 4 times of complete system audit in corresponding field under the guidance and assistance of the corresponding system auditor or above registered qualification personnel, and the on-site audit experience shall not be less than 15 days.The on-site audit shall cover all provisions of the certification standards in the corresponding field.When the applicant has CCAA certification field auditor or compulsory product certification inspector or above registration qualification, 1 complete system audit and 5 days on-site audit experience can be reduced.

所有审核经历应当在申请前3年内获得，并完成晋级见证。

All audit experience should be obtained within 3 years before the application, and the promotion witness should be completed.

“涵盖HACCP原理的体系审核”包括HACCP体系审核、FSMS审核、乳制品HACCP体系审核

"System audit covering HACCP principle" includes HACCP system audit, FSMS audit and dairy HACCP system audit

3.4.4.3 FSMS/HACCP审核员的年度确认

  Annual confirmation of FSMS / HACCP auditors

1）在注册证书有效期内，审核员应在每个注册年度提交一次完成下列活动的证明，表明其持续符合本准则的相关要求：

  During the validity period of the registration certificate, the auditor shall submit a certificate for completing the following activities once in each registration year, indicating that the auditor continues to meet the relevant requirements of this Code:

a）至少完成1 次管理体系认证审核；

  Complete at least one management system certification audit;

b) 完成至少16 学时与相应领域相关的继续教育课程，其中至少包括8 学时经CCAA 确认的继续教育课程；

  Complete at least 16 class hours of continuing education courses related to corresponding fields, including at least 8 hours of continuing education courses confirmed by CCAA;

c）持续遵守行为规范要求；

  Continuous compliance with code of conduct requirements;

d）已妥善解决任何针对其审核表现的投诉；

  Any complaints about its audit performance have been properly resolved;

e）当CCAA 有指定的专业发展活动时，已按要求完成。

  When CCAA has designated professional development activities, it has been completed as required.

2）审核员应保留与完成年度确认有关记录和证明，在CCAA 有要求时提交CCAA。

  Auditors shall keep records and certificates related to the completion of annual confirmation and submit them to CCAA when required by CCAA.

3）年度确认从注册次年开始实施，在注册日期的对应月份申报。

  The annual confirmation shall be implemented from the next year of registration and shall be declared in the corresponding month of the registration date.

3.4.4.4  FSMS/HACCP审核员再注册的要求

Requirements for re registration of FSMs / HACCP auditors

1）各级别审核员应每3 年进行一次再注册，以确保持续符合本准则相应级别审核员的各项要求。

  Auditors at all levels should be re registered every three years to ensure continuous compliance with the requirements of the standards for auditors at the corresponding level.

2）实习审核员再注册要求：

  Re registration requirements for trainee Auditor:

a） 注册证书到期前3 个月内，向CCAA 提出再注册申请；

  Apply to CCAA for re registration within 3 months before the expiration of the registration certificate;

b） 注册证书有效期内持续遵守审核员行为规范；

  Continuously abide by the code of conduct of auditors during the validity of the registration certificate;

c） 已妥善解决任何针对其审核表现的投诉；

  Any complaints about its audit performance have been properly resolved;

d） 完成CCAA 指定的专业发展活动（适用时）。

  Complete professional development activities designated by CCAA (when applicable).

3）审核员再注册要求

  Auditor re registration requirements

a） 注册证书到期前3 个月内，向CCAA 提出再注册申请；

  Apply to CCAA for re registration within 3 months before the expiration of the registration certificate;

b） 注册证书有效期内持续遵守审核员行为规范；

  Continuously abide by the code of conduct of auditors during the validity of the registration certificate;

c） 已妥善解决任何针对其审核表现的投诉；

  Any complaints about its audit performance have been properly resolved;

d） 完成CCAA 指定专业发展活动（适用时）；

  Complete CCAA designated professional development activities (when applicable);

e） 完成历年的年度确认；

  Complete the annual confirmation of previous years;

f） 注册证书有效期内，完成至少4 次完整体系审核或等效的部分体系审核，其中至少包括2 次相应领域完整体系审核或等效的部分体系审核；

  Within the validity period of the registration certificate, complete at least 4 times of complete system audit or equivalent partial system audit, including at least 2 times of complete system audit or equivalent partial system audit in corresponding field;

g） 当不能满足再注册审核经历要求时，申请人应通过相应的考试。

  If the applicant fails to meet the re registration examination experience requirements, the applicant shall pass the corresponding examination.

注：3 次部分体系审核可视为1 次完整体系审核。本注释仅适用于再注册时审核经历的计算。

Note: three partial system audits can be regarded as one complete system audit.This note is only applicable to the calculation of audit experience during re registration.

3.4.5 专业能力评价Professional ability evaluation

3.4.5.1 FSMS审核人员专业能力评价要求

  Requirements for professional competence evaluation of FSMS auditors

FSMS审核员、技术专家进行专业能力评价的基础准则如下表：

The basic criteria for FSMS auditors and technical experts to evaluate their professional competence are as follows:

说明explain:

食品安全管理体系中适宜的高等教育学科专业包括：食品科学与技术、食品工程与生物技术、食品安全、农产品加工、水产品加工、制糖工程、粮油加工、生物科学、发酵工程、农学与植保、畜牧与兽医、水产养殖、渔业科学与技术、医学与营养学、化学工程与制药等。

Suitable higher education disciplines in the food safety management system include: Food Science and technology, food engineering and biotechnology, food safety, agricultural product processing, aquatic product processing, sugar engineering, grain and oil processing, bioscience, fermentation engineering, agronomy and plant protection, animal husbandry and veterinary, aquaculture, fishery science and technology, medicine and nutrition, chemical engineering and pharmacy.

2）适宜的食品安全管理专业工作经历包括：

2) Suitable working experience of food safety management includes:

----食品生产、加工的工艺管理、质量管理、或食品安全管理工作经历；

----Working experience in process management, quality management or food safety management in food production and processing;

----食品卫生管理、食品检验工作经历；

----Food hygiene management, food inspection work experience;

----食品安全教学、科研与开发工作经历；

----Food safety teaching, research and development experience;

----食品安全、卫生执法领域的专业技术、管理工作经历；

----Professional technology and management experience in the field of food safety and health law enforcement;

----食品安全管理相关标准制修订工作经历。

----Working experience of food safety management standards.

3） 非学科专业本科学历的申请人，应具有至少 15 年专业工作经历及相应专业中级（含）以上技术职称。

  Applicants with bachelor's degree in non discipline major shall have at least 15 years of professional work experience and intermediate (including) or above technical title of corresponding specialty.

3.4.5.2  FSMS审核人员能力要求

  Competency requirements for FSMS auditors

确保审核员证实其具备应用以下方面知识和技能的能力：

    Ensure that the auditor has demonstrated the ability to apply the following knowledge and skills:

3.4.5.2.1 通用知识和技能的能力：Ability to acquire general knowledge and skills:

1）业务管理实践的知识；Knowledge of business management practices;

2）审核原则、实践和技巧的知识；Knowledge of audit principles, practices, and techniques;

3）特定管理体系标准和（或）规范性文件的知识：掌握相关的食品安全管理体系标准（如ISO 22000）；Knowledge of specific management system standards and/or normative documents: mastery of relevant food safety management system standards (such as ISO 22000);

4）认证机构过程的知识；Knowledge of the certification body process;

      5）客户的业务领域的知识；Knowledge of the client's business domain;

      6）客户的产品、过程和组织的知识；Knowledge of the customer's products, processes, and organization;

      7）与客户组织中的各个层级相适应的语言技能；Language skills that are compatible with various levels within the client organization;

      8）作记录和撰写报告的技能；Skills in recording and writing reports;

      9）表达、面谈、审核管理技能。Skills in expression, interview, and review management.

      3.4.5.2.2 食品安全管理体系相关的特定的知识和技能：Specific knowledge and skills related to food safety management system:

1）识别并确定与食品链行业类别和申请组织相关因素的能力，包括：前提方案、

食品安全危害、法律法规要求、任何与该组织及其食品行业类别或产品相关的特定季节性因素、与被评估的行业类别和地理区域相关的特定文化和社会习俗、审核食品安全管理体系、产品、过程或服务所需的特定因素；The ability to identify and determine factors related to the food chain industry category and applying organization, including: prerequisite solutions

Food safety hazards, legal and regulatory requirements, any specific seasonal factors related to the organization and its food industry category or products, specific cultural and social customs related to the evaluated industry category and geographical region, specific factors required for auditing food safety management systems, products, processes or services;

2）具备依据食品链分类表和机构程序，识别审核组所需的行业类别和子行业

类别的能力要求的能力；Ability to identify industry categories and sub industry categories required by the audit team based on the food chain classification table and institutional procedures;

3）有能力应用ISO22003-1：2022规定的通用的审核原则、实践、技巧，充分

实施认证审核并评估内部审核流程；Capable of applying the general audit principles, practices, and techniques specified in ISO22003-1:2022, fully implementing certification audits, and evaluating internal audit processes;

4）有能力实施和管理审核，在商定的时间范围内实现审核目标。审核组组长要有

能力组织会议，有效的交流信息，并在必要时分配或重新分配任务；Capable of implementing and managing audits, achieving audit objectives within the agreed time frame. The leader of the audit team should have the ability to organize meetings, effectively exchange information, and allocate or reassign tasks when necessary;

      5）了解申请组织所在行业通用的术语、实践和过程，足以理解标准/方案或其他规范性文件中对该行业的预期；Understand the common terminology, practices, and processes of the industry in which the applying organization operates, and be able to comprehend the expectations of the industry in standards/schemes or other normative documents;

6）了解通用的组织类型、规模、管理、架构和工作场所的操作规范、信息和数据系统、文档系统和信息技术等知识；Understand common organizational types, sizes, management, architecture, and workplace operating standards, information and data systems, document systems, and information technology knowledge;

7）了解组织领导层作用和影响，并有能力评估受审核组织最高管理层是否做出 FSMS的承诺，是否提供足够的资源并实现其预期结果；Understand the role and influence of organizational leadership, and have the ability to evaluate whether the top management of the audited organization has made FSMS commitments, provided sufficient resources, and achieved its expected results;

8）有能力应用指定的规范性文件实施认证，确定其范围和审核活动实施时间是否恰当，以及方案/标准是否得到有效实施并符合要求；Ability to apply specified normative documents for certification, determine the scope and timing of audit activities, and ensure that plans/standards are effectively implemented and meet requirements;

9）具备与客户产品类型或过程相关的知识，足以理解申请组织如何运作，以及组织如何应用标准/方案或其他相关规范性文件的要求；Having knowledge related to the customer's product type or process, sufficient to understand how the applying organization operates and how the organization applies the requirements of standards/schemes or other relevant normative documents;

10）具备识别生物危害、化学危害、物理危害、过敏原、食品安全标签要求、与食品链行业类别相关的食品安全法规及其公认的控制机制的能力，以及有能力评价组织识别和满足适用的（生产国/目的地国）食品安全法规和标签要求的能力；The ability to identify biological hazards, chemical hazards, physical hazards, allergens, food safety labeling requirements, food safety regulations and recognized control mechanisms related to the food chain industry category, as well as the ability to evaluate the organization's ability to identify and meet applicable (production country/destination country) food safety regulations and labeling requirements;

11）具备在食品链（子）行业类别中，应用食品安全、HACCP、危害评估和危害分析原则的能力，以及应用方案要求的能力，包括但不限于：外包过程、食品防护、食品欺诈；Ability to apply principles of food safety, HACCP, hazard assessment, and hazard analysis in sub industry categories of the food chain, as well as the ability to apply program requirements, including but not limited to: outsourcing processes, food protection, and food fraud;

12）具备应用食品链（子）行业类别相关的实践和词汇的能力，包括：食品链的关系、关于前提方案（PRPs）和控制措施的最佳实践、常见的食品链过程、生产技术和加工条件、常用设备、设施的设计、包装类型和属性、微生物术语和名称、化学品术语和名称、良好实验室规范、地方性术语等；Ability to apply practices and vocabulary related to food chain (sub) industry categories, including: relationships in the food chain, best practices regarding prerequisite programs (PRPs) and control measures, common food chain processes, production technology and processing conditions, design of commonly used equipment and facilities, packaging types and attributes, microbiological terminology and names, chemical terminology and names, good laboratory practices, local terminology, etc;

13）具备理解组织及其对外沟通的职责、理解组织结构、文化和沟通方法的能力，以及评估组织是否达到其所需的沟通目标的能力；Ability to understand the responsibilities of the organization and its external communication, comprehend organizational structure, culture, and communication methods, as well as assess whether the organization has achieved its required communication goals;

14）具备有效沟通能力，以履行认证过程中的职能，能够使用恰当的术语、表达方式和语言，与组织任何级别的人员（包括最高管理层）进行有效沟通；Having effective communication skills to perform the functions in the certification process, able to use appropriate terminology, expressions, and language to effectively communicate with personnel at any level of the organization (including top management);

15）具备充分的读写能力，以履行认证过程中的职能，能够快速地进行读写，准确和易于理解地记录和标注，并且能够有效地沟通审核发现和结论；Having sufficient reading and writing abilities to perform the functions in the certification process, able to quickly read and write, accurately and easily understand record and annotate, and effectively communicate audit findings and conclusions;

16）有能力通过易于理解的方式表达审核发现和审核结论。以便在公开场合（如末次会议）向听众恰当地介绍审核发现、审核结论和改进建议；Ability to express audit findings and conclusions in an easily understandable manner. In order to appropriately introduce the audit findings, audit conclusions, and improvement suggestions to the audience in public occasions (such as the final meeting);

17）有能力通过面谈获得与其在认证过 程中的职能相关的信息。能在面谈时通过开放式问题、预先设计好的问题和倾听的审查方式，理解和评估对方的答复内容。Ability to obtain information related to their functions during the certification process through face-to-face interviews. Be able to understand and evaluate the other party's response during face-to-face interviews through open-ended questions, pre designed questions, and listening review methods.

3.4.5.3 HACCP审核人员专业能力评价要求

  Evaluation requirements for professional competence of HACCP auditors

1）HACCP审核员进行专业能力评价的基础准则如下表：

1) The basic criteria for HACCP auditors to evaluate their professional competence are as follows:

2）HACCP技术专家专业能力准则

 Professional competence criteria for HACCP technical experts

对HACCP技术专家的某一种类的专业能力，要求具备与HACCP审核员相同的教育、培训经历，不强制要求工作经历。

For a certain kind of professional ability of HACCP technical experts, it is required to have the same education and training experience as HACCP auditors, and no work experience is required.

说明Explain:

①对于HACCP审核人员专业能力评价中所描述的适宜的高等教育学科专业包括：食品科学与技术、食品工程与生物技术、食品安全、农产品加工、水产品加工、制糖工程、粮油加工、生物科学、发酵工程、农学与植保、畜牧与兽医、水产养殖、渔业科学与技术、医学与营养学、化学工程与制药等。食品科学与工程类：食品科学与工程类、食品质量与安全、粮食工程、乳品工程、酿酒工程。

The appropriate disciplines of Higher Education described in the professional competence evaluation of HACCP auditors include:Food science and technology, food engineering and biotechnology, food safety, agricultural products processing, aquatic products processing, sugar making engineering, grain and oil processing, biological science, fermentation engineering, agronomy and plant protection, animal husbandry and veterinary, aquaculture, fishery science and technology, medicine and nutrition, chemical engineering and pharmacy, etc.Food science and Engineering:Food science and engineering, food quality and safety, food engineering, dairy engineering, brewing engineering.

  ②适宜的危害分析与关键控制点（HACCP）体系管理专业工作经历包括：

Appropriate work experience of hazard analysis and critical control point (HACCP) system management includes:

----食品生产、加工的工艺管理、质量管理、或食品安全管理工作经历；

----Working experience in process management, quality management or food safety management in food production and processing;

----食品卫生管理、食品检验工作经历；

----Food hygiene management, food inspection work experience;

----食品安全教学、科研与开发工作经历；

----Food safety teaching, research and development experience;

----食品安全、卫生执法领域的专业技术、管理工作经历；

----Professional technology and management experience in the field of food safety and health law enforcement;

----食品安全管理相关标准制修订工作经历。

----Working experience of food safety management standards.

③非学科专业本科学历的申请人，应具有至少 15 年专业工作经历及相应专业中级（含）以上技术职称。

Applicants with bachelor's degree in non discipline major shall have at least 15 years of professional work experience and intermediate (including) or above technical title of corresponding specialty.

3.4.5.4 HACCP审核人员能力要求

Competency requirements for HACCP auditors

在满足FSMS审核人员能力要求的前提下，还应对所涉及的相关食 品行业活动具有适宜的HACCP体系知识，包括（但不限于）下述的内容：

On the premise of meeting the competency requirements of FSMS auditors, appropriate HACCP system knowledge should also be possessed for the relevant food industry activities involved, including (but not limited to) the following:

相关的HACCP体系标准；Relevant HACCP system standards;

食品安全危害的识别；Identification of food safety hazards;

关键控制点和关键限值的确定；Determination of key control points and key limits;

可操作的控制措施；Operational control measures;

致敏物质管理；Management of allergenic substances;

食品防护；Food protection;

食品欺诈预防。Prevention of food fraud.

过程管理程序Process management procedure

4.1 申请评审Application review

本机构根据ISO 22003-1:2022附录A确定组织申请认证的相关范围。不应将能够影响认证范围内终产品食品安全的活动、过程、产品或服务排除在认证范围之外。

The organization determines the relevant scope of the organization's application for certification according to Appendix A of ISO 22003-1:2022 . Activities, processes, products or services that could affect the food safety of end products within the scope of certification should not be excluded from the scope of certification.

注：1、要求确定每个或多个场所的认证范围中的类别或子类别；2、简要描述由认证机构审核的产品和/或服务的主要活动/过程类型。Note: 1. It is required to determine the categories or subcategories within the certification scope of each or more locations; 2. Provide a brief description of the main activities/process types of products and/or services reviewed by the certification body.

4.1.1 FSMS申请组织应具备以下条件：

The FSMS application organization shall meet the following requirements:

4.1.1.1 取得国家、地方市场监督管理部门或有关机构注册登记的法人资格（或其组成部分）；

  Obtain the legal person qualification (or its components) registered by the national and local market supervision and administration departments or relevant institutions;

4.1.1.2 已取得相关法规规定的行政许可（适用时）；

The administrative license stipulated by relevant laws and regulations has been obtained (when applicable);

4.1.1.3 未列入严重违法失信名单；

It is not included in the list of serious violations of law and dishonesty;

4.1.1.4 生产、加工及经营的产品或提供的服务符合相关法律、法规、标准和规范的要求；

The products produced, processed and operated or the services provided meet the requirements of relevant laws, regulations, standards and specifications;

4.1.1.5 按照食品安全管理体系认证实施规则规定的认证依据，建立和实施食品安全管理体系，且有效运行3个月以上；

Establish and implement the food safety management system according to the certification basis specified in the implementation rules of food safety management system certification, and operate effectively for more than 3 months;

4.1.1.6 一年内未发生违反相关法律、法规的食品安全事故；

There is no food safety accident in violation of relevant laws and regulations within one year;

4.1.1.7 三年内未因食品安全事故、违反国家食品安全管理相关法规或虚报、瞒报获证所需信息，而被认证机构撤销认证证书。

The certification certificate has not been revoked by the certification authority due to food safety accidents, violation of relevant national food safety management regulations or false or concealed information required for obtaining the certificate within three years.

4.1.2 FSMS评审需提交的资料

Information to be submitted for FSMS review

4.1.2.1 认证申请；

Certification application;

4.1.2.2法律地位证明文件。当食品安全管理体系覆盖多个法律实体时，应提供每个法律实体的法律地位证明文件；

  Legal status documents.When the food safety management system covers multiple legal entities, the legal status certification documents of each legal entity shall be provided;

4.1.2.3申请认证范围所涉及的法律法规要求的行政许可证明文件（适用时）；

  Administrative license documents required by laws and regulations involved in the scope of application for certification (when applicable);

4.1.2.4食品安全管理体系文件化信息（包括产品描述、流程图和过程描述、操作性前提方案计划、危害分析和关键控制点（以下简称 HACCP）计划等）；

  Documented information of food safety management system (including product description, flow chart and process description, operational prerequisite scheme plan, hazard analysis and critical control point (HACCP) plan, etc.);

4.1.2.5组织机构与职责说明；

  Description of organization responsibilities;

4.1.2.6加工生产线、季节性生产、HACCP 项目和班次的详细信息；

  Detailed information of processing production line, seasonal production, HACCP project and shift;

4.1.2.7多场所清单、外包（含委托加工）情况说明（适用时）；

  List of multi sites and description of outsourcing (including entrusted processing) (if applicable);

4.1.2.8产品符合安全要求的相关证据和自我声明；

  Relevant evidence and self declaration of product compliance with safety requirements;

4.1.2.9承诺遵守相关法律法规、认证机构要求及提供材料真实有效的自我声明；

  Promise to comply with relevant laws and regulations, certification body requirements and provide authentic and effective self declaration of materials;

4.1.2.10产品检验报告或送检回执单等。

  Product inspection report or inspection receipt.

4.1.3 HACCP申请组织应具备以下条件：

  The organization applying for HACCP shall meet the following requirements:

  4.1.3.1 取得国家工商行政管理部门或有关机构注册登记的法人资格（或其组成部分）；

  Obtain the legal person qualification (or its components) registered by the State Administration for Industry and commerce or relevant institutions;

  4.1.3.2 取得相关法规规定的行政许可文件（适用时）；

  Obtain the administrative license documents stipulated by relevant laws and regulations (when applicable);

  4.1.3.3 生产经营的产品符合适用的我国和进口国（地区）相关法律、法规、标准和规范的要求；

The products produced and operated shall meet the requirements of applicable laws, regulations, standards and specifications of China and the importing country (region);

  4.1.3.4 按照危害分析与关键控制点（HACCP）体系认证实施规则规定的认证依据，建立和实施了文件化的HACCP 体系，且体系有效运行 3 个月以上；

 Documented HACCP system has been established and implemented according to the certification basis specified in the implementation rules of hazard analysis and critical control point (HACCP) system certification, and the system has been effectively operated for more than 3 months;

  4.1.3.5 一年内未发生违反我国和进口国（地区）相关法律、法规的食品安全卫生事故；

  There is no food safety and health accident in violation of the relevant laws and regulations of China and the importing country (region) within one year;

   4.1.3.6 三年内未因违反本规则4.2.2（4）或（5）条款而被认证机构撤销HACCP认证证书。

  The certification authority has not revoked the HACCP certification certificate due to violation of clause 4.2.2 (4) or (5) of the rules within three years.

4.1.4  HACCP评审需提交的附加资料

  Additional data to be submitted for HACCP review

4.1.4.1 认证申请Certification application;

      4.1.4.2 法律地位证明文件复印件；

       Copies of legal status certificates;

4.1.4.3 有关法规规定的行政许可文件和备案证明复印件（适用时）；

  Copies of administrative license documents and filing certificates stipulated by relevant laws and regulations (when applicable);

4.1.4.4 HACCP 手册（包括范围、程序文件及对其的引用、前提计划、良好卫生规范等）；

HACCP manual (including scope, procedure document and its reference, prerequisite plan, good health practice, etc.);

4.1.4.5 组织机构图与职责说明；

  Organization chart and responsibility description;

4.1.4.6 厂区位置图、平面图；加工车间平面图；产品描述、工艺流程图、工艺描述；危害分析单、HACCP 计划表；加工生产线、实施HACCP 项目和班次的说明；

  Location and plan of the plant area; Plan of processing workshop; Product description, process flow chart and process description; HACCP, hazard analysis plan; Description of processing production line, HACCP project and shift;

4.1.4.7 食品添加剂使用情况说明，包括使用的添加剂名称、用量、适用产品及限量标准等；

  Description of the use of food additives, including the name, dosage, applicable products and limit standards of additives used;

4.1.4.8 生产、加工或服务过程中遵守适用的我国和进口国（地区）相关法律、法规、标准和规范清单；产品执行企业标准时，提供加盖当地政府标准化行政主管部门备案印章的产品标准文本复印件；

  The list of applicable laws, regulations, standards and specifications of China and the importing country (region) shall be complied with in the process of production, processing or service; When the product is in accordance with the enterprise standard, the copy of the product standard with the filing seal of the local government standardization administrative department shall be provided;

4.1.4.9 生产、加工主要设备清单和检验设备清单；

  List of main production and processing equipment and inspection equipment;

4.1.4.10 多场所清单及委托加工情况说明（适用时）；

  List of multi sites and description of entrusted processing (when applicable);

4.1.4.11 产品符合卫生安全要求的相关证据；适用时，提供由具备资质的检验机构出具的接触食品的水、冰、汽符合卫生安全要求的证据；

Relevant evidence that the product meets the health and safety requirements; If applicable, provide the evidence issued by qualified inspection institutions that the water, ice and steam in contact with food meet the health and safety requirements;

4.1.4.12 承诺遵守相关法律、法规、认证机构要求及提供材料真实性的自我声明；

Promise to comply with relevant laws, regulations, certification body requirements and provide self declaration of material authenticity;

4.1.4.12 产品检验报告或送检回执单等。

Product inspection report or inspection receipt.

4.1.4.13 限制要求Restriction requirements

HACCP申请人一年内未发生违反我国和进口国（地区）相关法律、法规的食品安全卫生事故；且五年内未因以下原因而被认证机构撤销认证证书的：

HACCP applicant has no food safety and health accident in violation of relevant laws and regulations of China and import country (region) within one year; And the certification certificate has not been revoked by the certification authority within five years due to the following reasons:

1）出现严重食品安全卫生事故或对相关方重大投诉未能采取有效处理措施的；

  Serious food safety and health accidents or failure to take effective measures to deal with major complaints from relevant parties;

2）虚报、瞒报获证所需信息的。

False information obtained.

4.1.5 申请评审Application Review

4.1.5.1 当申请组织的申请资料提交齐全后，合同评审人员应对提交的申请文件和资料进行评审并保留评审记录，以确保：After the application materials submitted by the applying organization are complete, the contract review personnel shall review the submitted application documents and materials and keep the review records to ensure:

认证要求规定明确、形成文件并得到理解；The certification requirements are clearly defined, documented, and understood;

机构和申请组织之间在理解上的差异得到解决；The differences in understanding between institutions and applying organizations have been resolved;

对于申请的认证范围、申请组织的工作场所和任何特殊要求，机构均有能力开展认证服务；The institution has the ability to provide certification services for the scope of certification application, the workplace of the applying organization, and any special requirements;

合同评审人员应依据食品链行业类别确定组织申请认证的相关范围，范围的描述应：The contract review personnel shall determine the relevant scope of the organization's certification application based on Food chain industry category, and the description of the scope shall:

——识别认证范围内每个场所的行业类别或子行业类别；Identify the industry category or sub industry category of each location within the scope of certification;

——简要描述认证机构审核的产品和/或服务的主要活动或过程的类型。Briefly describe the main activities or processes of the products and/or services audited by the certification body.

确定的认证范围不应：The determined scope of certification should not:

——有歧义；There is ambiguity;

——将根据组织活动的法律责任确定的影响终产品食品安全的活动、过程、产品或服务 排除在认证范围之外； Exclude activities, processes, products, or services that affect the food safety of the final product, as determined by the legal responsibility of the organization's activities, from the scope of certification;

——包括任何促销陈述，品牌或宣称。Including any promotional statements, brand or claims.

4.1.5.2 评审结果处理Handling of Review Results

1）申请材料齐全、符合要求的，予以受理认证申请；If the application materials are complete and meet the requirements, the certification application will be accepted;

2）未通过申请评审的，应书面通知申请组织在规定时间内补充、完善，不同意受理认证申请应明示理由。Those who have not passed the application review shall be notified in writing to the applying organization to supplement and improve within the prescribed time. Reasons for not agreeing to accept the certification application shall be clearly stated.

4.1.5.3 签订认证合同Signing of Certification Contract

机构应与认证委托人签订具有法律效力的书面认证合同或等效文件。认证合同或等效文件应明确体系覆盖的范围以及机构和认证委托人各自应当承担的责任、权利和义务。The CB should sign a legally binding written certification contract or equivalent document with the certification client. The certification contract or equivalent document should clearly define the scope of the system coverage, as well as the responsibilities, rights, and obligations that institutions and certification clients should each undertake.

4.2 审核方案管理Audit scheme management

4.2.1 FSMS/HACCP现场审核应安排在审核范围覆盖产品种类的生产期进行；

FSMS / HACCP on-site audit shall be conducted in the production period covering the product types covered by the audit scope;

4.2.2 FSMS/HACCP审核组成员的要求为: 初审的审核组至少由两名审核员组成，其中至少一名为相应行业类别的审核员。第一、二阶段审核组组长宜为同一人，第二阶段审核组中至少应包含一名第一阶段审核员。同一审核员不能连续两次在同一生产现场审核时担任审核组组长，不能连续三次对同一生产现场实施认证审核；

The requirements for FSMS / HACCP audit team members are as follows: the initial audit team shall be composed of at least two auditors, at least one of whom shall be the auditor of the corresponding industry category.The first and second stage audit team leader should be the same person, and Stage 2 audit team should include at least one stage I auditor.The same auditor cannot act as the leader of the audit team for two consecutive audits at the same production site, and can not implement certification audit on the same production site for three consecutive times;

4.2.3 FSMS/HACCP审核组成员在进入生产现场前应主动出示本人健康证明，并遵守组织对人员的卫生要求；

FSMS / HACCP audit team members should show their own health certificate before entering the production site, and comply with the health requirements of the organization for personnel;

4.2.4 机构应具有选择审核时机和季节的过程，以使审核组有机会针对认证范围内组织有代表性数量的生产线和（或）服务的运行情况进行审核。

The CB should have a process for selecting audit timing and seasons, so that the audit team has the opportunity to conduct audits on the operation of a representative number of production lines and/or services within the certification scope.

4.3 多场所抽样Multi site sampling

多场所组织是指组织有一个确定的中心职能机构策划、控制或管理某些食品安全管理体系活动，并且有一个由场所组成的网络来全部或部分实施这些活动。

A multi-site organization is an organization having an identified central function at whichcertain FSMS activities are planned, controlled or managed, and a network of sites at which suchactivities are fully or partially carried out.

可能的多场所组织的示例：Examples of possible multi-site organizations are:

——以特许经营方式开展业务的组织；organizations operating with franchises;

——生产者团体（对于行业类别 A 和 B）；producer groups (for categories A and B)

——有一个或多个生产场所及销售网点的加工企业；a manufacturing company with one or more production sites and a network ofsales offices;

——服务组织有多个场所，各场所提供相似的服务；service organizations with multiple sites offering a similar service;

——有多个分支的组织。 organizations with multiple branches.

多场所组织的抽样应覆盖所有活动。Sampling of multi-site organizations shall cover all activities

4.3.1 机构应证明多场所抽样不会降低审核有效性。当进行多场所抽样时，认证机构 应基于以下条件证明合理性并记录理由：The certification body shall demonstrate that the sampling of sites does not undermine effective auditing. When multi-site sampling is undertaken, the certification body shall justify anddocument the rationale based on the following conditions:

a）所有场所在一个统一控制和管理的食品安全管理体系下运行；sites are operating under one centrally controlled and administered FSMS

b）接受抽样的场所是相似的（如：食品链子行业类别、地理位置、过程和技术、规模 和复杂程度、法律法规要求、顾客要求、食品安全危害和控制措施）；sites subject to sampling are similar (food chain subcategory, geographical location, processes and) technologies, size and complexity, regulatory and statutory requirements, customer requirementsfood safety hazards and control measures);

c）中心职能是组织的一部分，得到清晰识别且未分包给外部的组织；the central function is part of the organization, clearly identified and not subcontracted to anexternalorganization;

d）所有场所与中心职能有法律或合同关系；all sites have a legal or contractual link with the central function;

e）中心职能应获得组织的授权，以界定、建立并保持食品安全管理体系；the central function has organizational authority to define, establish and maintain the FSMS;

f）所有场所都应服从组织的内部审核方案且已完成审核；all sites are subject to the organization's internal audit programme and have been audited,

g）将单一场所的审核发现视为整个食品安全管理体系的情况，并实施相应的纠正措施；audit findings at a site are considered indicative of the entire FSMS and corrective actions areimplemented accordingly;

h）中心职能负责确保收集和分析所有场所的绩效评价和顾客投诉的结果； the central function is responsible for ensuring that outcomes of performance evaluation andcustomer complaints from all sites are collected and analysed;

i）组织的食品安全管理体系应服从集中的管理评审；the organization's FSMS is subject to central management review;

j）中心职能有权启动食品安全管理体系的持续改进。the central function has authority to initiate continual improvement ofthe FSMS

注：中心职能是实施控制并得到最高管理者授权的，是对每个场所产生影响的。没有要求中心职能仅处于某个单一场所。

NO'TE:The central function is where operational control and authority from the top management of theorganization is exerted over every site. There is no requirement for the central function to be located in asingle site.

4.3.2 本机构进行多场所抽样采用《多场所认证管理要求》的通用要求外，还需满足以下条件，以确保对食品安全管理体系进行有效的审核：

In addition to the general requirements of the "Multi-site Certification Management Requirements" for multi-site sampling, the agency also needs to meet the following conditions to ensure an effective audit of the food safety management system:

4.3.2.1 多场所抽样适用于行业类别A和B。抽样可应用于多场所组织，最小抽样量是场所总数的平方根√(x)，向上进位取整数。应基于场所的生产复杂程度（例如露地生产、多年生植物生产、室内生产、户外畜牧生产、室内畜牧生产），对每个风险行业类别抽取平方根样本。The use of multi-site sampling is permitted for categories A and B. Sampling may be appliedto multi-site organizations, with the minimum sample size being the square root of the total numberof sites: √(x), rounded up to the next whole number, The square root sample shall be taken per riskcategory based on production complexity of the sites (e.g. open field plant production, perennial plantproduction, indoor production, open field livestock production, indoor livestock production).

4.3.2.2 多场所抽样适用于行业类别F和G，以及仅适用于行业类别E的再次加热类型的场所（如 活动餐饮、咖啡店、酒吧）和有限的制备和烹饪（如复热、油炸）场所。对于20个和不足20个场所的组织，所有场所都应进行审核。对于超过20个场所的组织，场所 的最小抽样量应为20加上其他场所总量的平方根：y=20 √（x − 20），向上进位取整数。适用于初次认证、监督和再认证审核。The use of multi-site sampling is permitted for categories F and G, and only for re-heating-type facilities(e.g. event catering, coffee shops, pubs) for category E and only for facilities with limited preparation orcooking (e.g. re-heating, frying) . For organizations with 20 sites or fewer, all sites shallbe audited. For organizations with more than 20 sites, the minimum number of sites to be sampled shallbe 20 plus the square root of the total number of other sites: y= 20 √(x- 20), rounded up to the next whole number. This applies to the initial certification, to surveillance and to recertification audits.

4.3.2.3 多场所抽样不允许应用于食品链行业类别中任何其他行业类别。Multi site sampling is not allowed to be applied to any other industry category in Food chain industry category.

4.3.2.4 对于符合多场所抽样条件的组织，机构应确保（如通过合同约定）组织在认证前一年内对每个场所进行了内部审核，适用时，应提供纠正措施的有效性。获证后，多场所组织每年的内部审核应覆盖组织认证范围内的所有场所，并应证实纠正措施的持续有效。Where multi-site sampling is permitted, the certification body shall ensure (e.g. via contractual arrangements) that the organization has conducted an internal audit for each site within one year prior to certification and when applicable the effectiveness of corrective actions shall beavailable, Following certification, the annual internal audit shall cover all sites of the organization included in the certification scope of the multi-site organization and ongoing effectiveness of correctiveactions shall be demonstrated.

4.3.2.5 当允许多场所抽样时，机构应规定并使用抽样方案，同时满足以下条件，以确保对食品安全管理体系进行有效的审核：Where multi-site sampling is permitted, the certification body shall define and utilize asampling programme to ensure an effective audit of the FSMS where the following conditions apply.

a）在抽样场所审核之前，机构至少每年应对食品安全管理体系的中心职能进行一次审核；At least annually, an audit ofthe central function for the FSMS shall be performed by the certificationbody prior to the sampled site audits.

b）机构至少每年应对规定数量的抽样场所进行审核；At least annually, audits shall be performed by the certification body on the required number ofsampled sites.

c）应对抽样场所的审核发现进行评估，以确定这些结果是否表明食品安全管理体系存在系统不足，因此可能适用于某些或所有其他场所；Audit findings of the sampled sites shall be assessed to ascertain if these indicate an overall FSMSdeficiency and therefore can be applicable to some or all other sites.

d）应将抽样场所的审核发现视为整个食品安全管理体系的情况，并应实施相应的纠正措施；Where audit findings of the sampled sites are considered indicative of the entire FSMS, correctiveactions shall be implemented accordingly.

e）对于20个和不足20个场所的组织，所有场所都应进行审核。 For organizations with 20 sites or fewer, all sites shall be audited.

当接受认证的食品安全管理体系无法表明有能力达到预期结果时，机构应增加抽样量或终止场所抽样。The certification body shall increase the size of sample or terminate the site sampling where the FSMSsubject to certification does not indicate the ability to achieve the intended results.

4.3.2.6 样本应具有部分选择性和部分随机性，并应选择具有代表性的不同场所，确保审核覆盖认证范围内的所有过程。The sample shall be partly selective and partly random and shall result in a represent ativerange of different sites being selected, ensuring all processes covered by the scope of certification willbe audited.

至少25％的样本应随机抽取。其余部分的选择应使证书有效期内所选场所之间的差异尽可能大。 At least 25 % of the sample shall be selected at random, The remainder shall be selected so that thedifferences among the sites selected over the period of validity of the certification are as large aspossible.

场所选取应考虑，但不限于以下方面：The site selection shall consider, among others, the following aspects:

内部审核，管理评审或以往审核的结果；results ofinternal audits, management reviews or previous audits;

投诉，产品撤回或召回，以及其他关于纠正措施方面的记录；records of complaints, product withdrawals/recalls, and other relevant aspects of correctiveaction;

场所特征的变化；variations in the site characteristics;

自上次审核以来的其他相关变化。other relevant changes since the last audit.

4.3.2.7 如果任一场所存在严重不合格且未能在商定的时间范围内实施令人满意的纠

正措施，则不应授予或保持整个多场所组织的认证，直到采取满意的纠正措施。lf any site has a major nonconformity and satisfactory corrective action have not beenimplemented in the agreed time frame, certification shall not be granted or maintained for the wholemulti-site organization pending satisfactory corrective action.

4.3.2.8 机构应确定在每个抽样场所实施的食品安全管理体系过程并将其包含在认证范围内。The certification body shall identify and include in the scope of certification the processes ofthe FSMS implemented at each sampled site.

4.4 审核时间的确定Determination of audit time

4.4.1 审核结果要求Audit outcome requirements

应证实审核活动实施时间可以实现以下审核结果：Audit duration shall be justified to accomplish the following audit outcomes:

评估方案规定的食品安全危害[包括危害分析和关键控制点（HACCP）和PRPs]管理的有效实施（如果允许，进行识别和选择）；assesses effective implementation (identification and selection if allowed) of the management offood safety hazards [this includes hazard analysis and critical control points (HACCP) and PRPsl asdefined by the scheme;

评估FSMS相互关联过程的有效管理；assesses effective management of the interrelated processes ofthe FSMS

评估体系满足适用法律法规要求的能力；assesses system ability to meet applicable statutory and regulatory requirements;

评估组织对产品、过程和变更管理使用有效的基于风险的方法的情况；assesses the organization's use of an effective risk-based approach to products and processes and management of change;

评估是否满足方案和组织的要求（如果有）；assesses whether the requirements ofthe scheme and ofthe organization, ifany, are met;

验证认证范围与组织的活动相适宜，且审核抽样具有代表性。verifies that the certification scope is appropriate to the activities of the organization and auditsamplingis representative.

4.4.2 确定审核活动实施时间Determining audit duration

在确定审核活动实施时间时，机构应考虑，但不限于以下方面：In determining the audit duration, the certification body shall consider, among other things, thefollowing aspects:

a）相关标准或方案中的要求，可包含在审核活动实施时间计算考虑之内，也可另

行计算；the requirements of the relevant standards or schemes that may be included in, or in addition to,audit duration;

b）食品链分类表列出的行业类别和子行业类别（如果组织的范围覆盖了不止一个行业类别，则审核活动实施时间的计算应由最高推荐基础审核活动实施时间算起）；the categories and subcategories given in Food Chain Classification Table (if the scope of the organization covers morethan one category, the audit duration calculation shall be taken from the highest recommendedbasic audit duration);

c）客户活动的复杂程度（如产品和过程类型的数量、生产线的数量、影响食品安全的人数或工作类型和种类的数量、产品开发、内部实验室检测、卫生）及其FSMS；the complexity of the client activities (e.g. number of product and process types, number of productlines, number of people or type and variety of tasks affecting food safety, product development, in.house laboratory testing, sanitation) and its FSMS;

d）与组织的产品、过程、服务相关联的危害；the hazards associated with the products, processes and services ofthe organization;

e）法律法规环境；the statutory and regulatory context;

f）认证范围内活动的外包情况；any outsourcing of any activities included in the scope of certification;

g）食品安全管理体系的成熟度和有效性，审核类型（如初次、监督、不通知、跟踪） 以及任何以往审核的结果；the maturity and effectiveness of the FSMS, type of audit (e.g. initial, surveillance, unannounced, follow-up) and the results of any prior audits;

h）场所的规模、基础设施、场所数量，其地理位置和季节性；the site size, infrastructure and number of sites, their geographical locations and seasonality;

i）多场所的考虑；the multi-site considerations;

j）是否是结合审核、联合审核或一体化审核；whether audits are combined, joint or integrated;

k）审核实现方法（如 ICT 及其使用范围）；the audit delivery method (e.g. ICT and the extent used);

l）食品安全管理体系集中控制的程度；the level of centralized control ofthe FSMS;

m）自动化水平、封闭式生产系统、技术使用、机械化和劳动密集程度；the level of automation, closed production systems, use of technology, mechanization and labourintensiveness;

n）语言和翻译的需要。any language or interpretation needs.

4.4.3 FSMS审核时间的确定 Determination of FSMS Audit Time

4.4.3.1 总则General

FSMS 审核应按照食品链行业类别分类和最少审核活动实施时间的要求，满足最少审核活动实施时间计算。FSMS方案可以设计自己的行业类别且审核活动实施时间计算超过最少审核活动实施时间。机构应遵循参考ISO 22003-1附录A和附录B要求的行业类别和审核活动实施时间计算。最少审核活动实施时间包括初次认证的一阶段和二阶段。

FSMS audits should be conducted according to the classification of food chain industry categories and the minimum implementation time of audit activities, meeting the calculation of the minimum implementation time of audit activities. FSMS schemes can design their own industry categories and calculate audit activity implementation time beyond the minimum audit activity implementation time. Institutions should follow the industry category and audit activity implementation time calculation requirements specified in Appendix A and Appendix B of ISO 22003-1. The minimum implementation time for audit activities includes the first and second stages of initial certification.

当确定涉及任何食品安全方面的员工人数时，应折算为全日制员工的人数（FTE）。如果一个组织实行轮班工作制，并且产品和（或）过程相似，那么FTE数量可以根据主要班次员工（包括季节性工人）加上对食品安全有影响的非生产员工。When determining the number of employees involved in any aspect of food safety, it shall be expressedas the number of full-time equivalent (FTE) employees. When an organization deploys workers in shiftsand the products and/or processes are similar, the F'TE number will be calculated based on employeeson the main shift (including seasonal workers) plus non-production staff having an impact on foodsafety.

当存在极其高度重复的班次或过程时，可在认证范围内根据各自企业的实际情况进行合理和连贯的减少。机构应记录决定及其理由。In cases of unusually high repetitive shifts or process, a coherent and consistent reduction can beapplied on a company-to-company basis within the scope of certification. The determination and itsjustification by the certification body shall be recorded.

审核活动实施时间不包括用于审核策划、审核准备、往返现场、若开具不符合项实施审核后续活动或未指定为审核员的组员（即技术专家、笔译员、口译员、观察员和实习审核员、报告撰写人员）的时间。Audit duration does not include time for audit planning, audit preparation, travel to and from site, auditfollow-up activities if there are nonconformities, or team member(s) not assigned as an auditor (i.e.technical experts, translators, interpreters, observers and auditors-in-training, and report writers).

当方案所有者已经建立了其确定审核活动实施时间的规则时，如果该方案的规则不低于作为共同基础的最少审核活动实施时间的要求，则该方案的规则适用。

Where a scheme owner has established their own rules for determination for audit duration, theoutcome of the scheme rules shall apply provided that the scheme rules are not less than those requiredin this annex as a common minimum.

4.4.3.2 FSMS 认证审核的最小初始认证审核时间应给定为Ds，以天数表示，The minimum initial certification audit duration for FSMS certification audits shall be given as Ds expressed in days, which is calculated:

Ds=TD TH TFTE

Ds：总审核时间Is the total audit duration;

TD ：（子）类别和认证范围（包括一个HACCP）的基本现场审核时间，以天为单位；Is the basic site audit duration for (sub) category and scope of certification (includes one HACCP study),in days;

TH ：每增加一个HACCP项目需要增加的审核天数；Is the number of audit days for additional HACCP studies;

TFTE：全职员工数量的审核天数Is the number of audit days per number of FTE employees.

表1.1 计算最短审计持续时间的变量

Variables for calculation of minimum audit duration

Note:

1、如果覆盖了不止一个行业类别或子行业类别，则使用行业类别或子行业类别最高TD值去确定Ds。在计算审核活动实施时间时，应使用所有行业类别或子行业类别的组合参数（HACCP 项目，FTE）；

If there are multiple categories or subcategories, use the category or subcategory with the highest TD value to determine Ds. The combined parameters (HACCP study, FTE) for all the categoriessubcategories shall be used when calculating the audit duration.

2、当方案要求包含其他相互关联的要素[如良好农业规范（GAP），农业的]与食品安全管理体系共同审核时，这些应包括在最少审核活动实施时间内。

When the scheme requirements encompass other interrelated elements e.g. good agricultural practice(GAP), agronomic audited in conjunction with the FSMS,these shall be included in the minimum auditduration.

3、使用4.4.1条款中的因素和表1.1而产生的审计持续时间 应被证明并形成文件。

The resulting audit duration using the factors in Clause B.2 and Table B.1 shall be justified and documented.

4、至少总审计时间的50 %应用于审核食品安全计划的实施以及预防计划和控制措施的实施。A minimum 50 % of total audit duration shall be spent on auditing the operational food safety planning and the implementation of PRPs and control measures.

注1：食品安全计划的实施不包括与FSMS开发、培训、内部审计、管理审查和改进相关的活动。

NOTE 1 Operational food safety planning does not include activities related to FSMS development, traininginternalaudit,management review and improvement.

在FSMS与另一个相关管理体系或食品安全体系FSS结合的情况下），可以缩短审计持续时间。结合审核的时间应确定并记录如下In cases ofa FSMS which is integrated with another relevant management system or food safety system FSS), a reduction in audit duration is possible. The combined audit duration shall be determined andrecorded as follows：

---分别计算各方案的审计时间（包括方案限制和允许的删减）Calculate the audit duration for each scheme separately (including scheme restrictions and allowedreductions);

----将审核持续时间加在一起；Add the audit durations together;

---考虑到在结合的持续时间上最多可以删减20%，确定减少的程度。基于结合的删减幅度为0%至20%，由整体业务战略、管理评审、政策方法、目标、流程、内部审核和防止再次发生的有效纠正措施的结合水平决定。Determine the degree of reduction considering a maximum of 20 % reduction can be made on thecombined duration. The reduction range based on integration is 0 % to 20 % determined by theevel ofintegration ofoverall business strategy, management reviews, approach to policy, objectivessystems, processes, internal audits and effective corrective action to prevent reoccurrence.

注2“相关管理体系”是指涵盖相同过程、产品和服务的质量或食品安全体系。

NOTE 2"Relevant management system means a quality or food safety system which covers the sameprocesses,products and services.

与表1.1的偏差应理由充分并记录决定的因素，如管理体系的成熟度、客户流程和体系的先验知识（例如，已由同一认证机构依据不同方案认证了该客户）、客户的准备情况（例如已获得相关的第三方方案的认证），高度自动化。

Deviations from Table B.1 can be justified and shall be recorded, determined by factors such as maturityof the management system, prior knowledge of client processes and systems (eg. already certified bysame certification body to different scheme), client preparedness (e.g. already certified by a relevantthird-party scheme) and a high level of automation.

4.4.3.3 多场所认证Multi-site certification

中心职能部门的现场审核持续时间应等于或大于Ds。The site audit duration of the central function shall be equal to or greater than Ds.

每个被审核现场的现场审计时间应等于或大于该现场Ds的一半。The site audit duration for each site audited shall be equal to or greater than half of Ds for that site.

4.4.3.4 FSMS监督和再认证最少审核时间的计算

  Calculation of minimum FSMS surveillance and recertification audit time.

  监督审核的最少时间应是初次认证审核时间的三分之一，审核时间至少为1天 （行业类别A和B至少为0.5天）；再认证的最少时间应是初次认证审核时间的三分 之二，审核时间至少为1天（行业类别A和B至少为0.5天）。当形成适当的文件且理由充分时，对于根据员工数量、组织规模和/或产品数量判断为不太复杂或初次最少 审核时间低于1.5天的行业类别的组织可以减少最少审核时间。

The minimum surveillance audit time shall be one-third of the initial certification audit time, with a minimum of 1 audit day (0,5 audit day for categories A and B). The minimum recertification audit time shall be two-thirds of the initial certification audit time, with a minimum of 1 audit day (0,5 audit day for categories A and B). When properly documented and justified, a reduction to the minimum can be made in a less complex organization measured by number of employees, size of the organization and/or product volume or within categories having an initial minimum audit time of less than 1,5 audit days.

4.4.3.5 HACCP 审核时间的确定Determination of HACCP audit time

HACCP 审核时间的确定应考虑上述 4.4.1、4.4.2 相关要求。

The determination of HACCP audit time should take into account the relevant requirements of 4.4.1 and 4.4.2 mentioned above.

初次审核活动实施时间的计算参照 4.4.3（说明：HACCP 仅适用 C/D/E/F/G/I/K 等行 业类别涉及的最少审核活动实施时间的变量），但审核时间也应满足《危害分析与关键控 制点（HACCP）体系认证实施规则》的要求，当通过两者计算的审核时间不一致时，则 最终以计算的较长的审核时间为准。

The calculation of the implementation time for the initial audit activity is based on 4.4.3 (note: HACCP only applies to variables with the minimum audit activity implementation time involved in industry categories such as C/D/E/F/G/I/K), but the audit time should also meet the requirements of the "Hazard Analysis and Critical Control Point (HACCP) System Certification Implementation Rules". When the audit time calculated by the two methods is inconsistent, the longer calculated audit time shall prevail.

4.4.3.5.1 HACCP初次认证最少审核时间

  Minimum audit time for HACCP initial certification

单一场所的最少审核时间为TS TA：

  The minimum audit time for a single site is Ts TA:

基础审核时间Ts =（TD TH TMS TFTE），式中各项的时间根据下表计算。

The basic audit time Ts = (TD TH TMS TFTE), in which the time of each item is calculated according to the table below.

表1

TA为HACCP认证的附加审核时间。根据企业人员规模增加对应的审核时间。

TA is the additional audit time of HACCP certification.According to the size of enterprise personnel, increase the corresponding audit time in table .

表2  HACCP附加审核时间

Additional audit time of HACCP

最少审核时间包括初次认证的第一阶段和第二阶段的审核时间，但不包括审核准备和编制审核报告的时间。

The minimum audit time includes the audit time of the first stage and Stage 2 of the initial certification, but does not include the time for audit preparation and preparation of audit report.

4.4.3.5.2主要场所之外增加场所的基础审核时间根据表1计算，对规模小、风险和复杂程度低、体系成熟度高、自动化程度高以及其中心职能的集中化程度高的组织，可考虑减少增加场所的审核时间，但减少时间不能超过该场所基础审核时间的50%。每个场所应分别增加相应的附加审核时间TA。

  The basic audit time of additional sites outside the main sites is calculated according to Table 3.1. For organizations with small scale, low risk and complexity, high system maturity, high degree of automation and high degree of centralization of their central functions, the audit time of additional sites can be reduced, but the reduction time shall not exceed 50% of the basic audit time of the site.Each site should increase the corresponding additional audit time tA.

4.4.3.5.3 监督和再认证最少审核时间

Minimum audit time for supervision and recertification

1）监督审核的最少时间为TS的三分之一 TA，且审核时间不应少于2天。

The minimum time for supervision and audit is one third of TS TA, and the audit time shall not be less than 2 days.

2）再认证的最少时间为TS的三分之二 TA，且审核时间不应少于2天。

The minimum time for re certification is two thirds of TSand tA, and the audit time shall not be less than 2 days.

4.4.4 一些要求增加最少审核时间的因素Some factors that require an increase in minimum audit time：

1）组织未经相关的管理体系的认证，宜增加审核时间。注：认证的管理体系宜覆盖与食品安全相关的产品和/或服务的范围，才认为是相关的；If the organization has not been certified by the relevant management system, it is advisable to increase the audit time. Note: The certification management system should cover the scope of products and/or services related to food safety in order to be considered relevant;

2）产品类型的数量；The quantity of product types;

3）生产线的数量；The number of production lines;

4）产品开发；Product development;

5）关键控制点（CCPs）的数量；The number of critical control points (CCPs);

6）操作性前提方案（OPRPs）的数量；The number of Operational Prerequisite Plans (OPRPs);

7）建筑面积；Building area;

8）基础设施；Infrastructure;

9）使用组织内部实验室检测；Use internal laboratory testing within the organization;

10）审核中使用翻译；Translation is used during the review process;

11）组织的规模和复杂程度；The size and complexity of the organization;

12）组织所在行业的风险较高，或组织的风险较高；The risk of the industry in which the organization operates is relatively high, or the risk of the organization is relatively high;

13）相关食品安全管理体系标准的要求；Requirements for relevant food safety management system standards;

14）技术和法规的关联内容；The correlation between technology and regulations;

15）食品安全管理体系范围内的生产活动的外包；Outsourcing of production activities within the scope of the food safety management system;

16）以往审核的结果（初审不适用）；Previous audit results (preliminary review not applicable);

17）场所的数量及多场所的情况；The number of places and the situation of multiple places;

18）存在委托加工，且被委托加工组织未通过HACCP/FSMS认证；There is commissioned processing, and the commissioned processing organization has not passed HACCP/FSMS certification;

19）其他应增加审核人日的因素（如当有必要召开额外会议时（如评审会、协调会、 审核组沟通会））。Other factors that should increase the number of audit person days (such as when it is necessary to hold additional meetings (such as review meetings, coordination meetings, audit team communication meetings)).

4.4.5当HACCP认证与其他相关认证结合审核时，认证机构宜考虑下列因素，根据企业的具体情况对结合审核的时间进行调整：

When HACCP certification is combined with other relevant certification, the certification body should consider the following factors and adjust the time of combined audit according to the specific situation of the enterprise:

a）HACCP体系与相关认证的整合程度；

  The integration degree of HACCP system and relevant certification;

b）HACCP体系与其他相关认证整合后的复杂程度；

  The complexity of HACCP system after integration with other relevant certification;

c）有能力实施多项认证的审核员资源情况。

  The resources of auditors with the ability to implement multiple certifications.

4.4.6 多场所审核时间的确定

  Determination of multi site audit time

若受审核方HACCP覆盖多个场所，应对每一生产场所实施现场审核，若受审核方将影响食品安全的重要生产过程采用委托加工等方式进行时，除非被委托加工组织的被委托加工活动已获得相应的危害分析与关键控制点（HACCP）体系或食品安全管理体系认证，否则应对委托加工过程实施现场审核，并按照HACCP的要求策划审核时间。

If the auditee's HACCP covers more than one place, on-site audit shall be carried out for each production site. If the auditee uses the method of entrusted processing to carry out important production processes affecting food safety, unless the entrusted processing activities of the entrusted processing organization have obtained the corresponding HACCP system or food safety management system certification,Otherwise, the on-site audit shall be carried out for the entrusted processing process, and the audit time shall be planned according to the requirements of HACCP.

4.5 第一阶段审核Stage 1 audit

4.5.1 FSMS审核FSMS audit

对于FSMS，通过了解组织的食品安全危害识别、分析、HACCP 计划和前提方案（PRPs）、方针和目标，了解组织的食品安全管理体系，以确认组织的二阶段审核准备状态。第一阶段审核应审查但不限于以下方面的内容：

For FSMS, through understanding the organization's food safety hazard identification, analysis, HACCP plan and prerequisite program (PRPs), policies and objectives, understand the food safety management system of the organization, so as to confirm the organization's Stage 2 audit readiness.The first stage audit shall review but not be limited to the following aspects:

4.5.1.1 组织的前提方案（PRPs）与组织业务活动的适宜性（例如：法律、法规、顾客和认证方案的要求）；

  The suitability of PRPs and business activities of the organization (e.g. requirements of laws, regulations, customers and certification schemes);

4.5.1.2食品安全管理体系包括相应的过程和方法，以识别和评估组织的食品安全危害，以及后续对控制措施（组合）的选择和分类；

  The food safety management system includes corresponding processes and methods to identify and evaluate the food safety hazards of the organization, as well as the subsequent selection and classification of control measures (combinations);

4.5.1.3实施了食品安全相关的法律、法规；

  Laws and regulations related to food safety have been implemented;

4.5.1.4食品安全管理体系的设计是为了实现组织的食品安全方针；

  The design of food safety management system is to realize the food safety policy of the organization;

4.5.1.5食品安全管理体系实施程度证明可以进行第二阶段的审核；

  The implementation degree of food safety management system can be verified in Stage 2;

4.5.1.6控制措施的确认、活动的验证和改进的方案符合食品安全管理体系标准要求；

  The confirmation of control measures, verification of activities and improvement scheme meet the requirements of food safety management system standards;

4.5.1.7食品安全管理体系的文件和安排适合内部沟通和与相关供应商、顾客、 利益相关方的沟通；

  The documents and arrangements of food safety management system are suitable for internal communication and communication with relevant suppliers, customers and stakeholders;

4.5.1.8需要评审的其他文件和（或）需要提前获取的知识。

  Other documents to be reviewed and / or knowledge to be acquired in advance.

当组织采用由外部开发的控制措施组合时，第一阶段应评审食品安全管理体系文件，确定控制措施组合是否：

In the first stage, whether the combined control measures should be adopted in the development of food safety management system is determined by the organization

— 适合于该组织；

- suitable for the organization;

— 满足ISO 22000的要求；

- meet the requirements of GB / T 22000 / ISO 22000;

— 保持及时更新。

- keep up to date.

在收集遵守法规的信息时，应对相关资质证明的有效性进行检查。

When collecting information on compliance with regulations, the validity of relevant qualification certificates shall be checked.

4.5.2 食品安全管理体系第一阶段应在客户的场所实施，以达到上述的目标。

For FSMS, the stage 1 shall be carried out at the client’s premises in order to achieve the objectives stated above.

特殊情况下，当有充分理由时，部分第一阶段可以不在现场，但应提供证据证明第一阶段的目标全部实现。特殊情况可包括组织地处偏远地区，或产品为短暂季节性生产。

In exceptional circumstances, part of stage 1 can take place off-site and shall be fully justified. The evidence demonstrating that stage 1 objectives are fully achieved shall be provided. Exceptional circumstances can include very remote location, short seasonal production.

对于第一阶段审核过的食品安全管理体系的相应部分，被确定为实施充分、有效并符合要求的，第二阶段可以不再对其审核。然而，应确信食品安全管理体系已审核的部分持续符合认证要求。在这种情况下，第二阶段的审核报告应包含第一阶段审核中的审核发现，并且应清楚地表述第一阶段审核已经确立的符合性。

For the corresponding part of the food safety management system that has been audited in the first stage, and is determined to be fully, effectively and in line with the requirements, Stage 2 can not be audited.However, it should be assured that the audited parts of the food safety management system continue to meet the certification requirements.under these circumstances,The audit report of Stage 2 shall contain the audit findings in the first stage audit, and shall clearly state the conformity established in the first stage audit.

第一阶段审核提出的影响实施第二阶段审核的问题应在第二阶段审核前得到解决。第一阶段审核和第二阶段审核的时间间隔不应超过6个月。如果需要更长的时间间隔，应重新实施第一阶段。

The problems that affect the implementation of Stage 2 audit raised by the first stage audit should be solved before Stage 2 audit.The time interval between the first stage audit and Stage 2 audit shall not exceed 6 months.If a longer time interval is required, the first phase should be re implemented.

4.5.2 HACCP审核HACCP audit

对于HACCP，除需满足FSMS第一阶段审核要求外，还应至少关注以下方面：

For HACCP, in addition to meeting the requirements of FSMS Stage 1 audit, at least the following aspects should be paid attention to:

4.5.2.1收集关于受审核方的HACCP体系范围、过程和场所的必要信息，以及相关的法律、法规、标准要求的遵守情况；

Collect necessary information about the scope, process and place of the auditee's HACCP system, and the compliance with relevant laws, regulations and standards;

4.5.2.2 充分识别委托加工等生产活动对食品安全的影响程度；

  Fully identify the influence degree of entrusted processing and other production activities on food safety;

4.5.2.3 初步评价受审核方厂区环境、厂房及设施、设备、人员、卫生管理等是否符合相对应的良好生产规范（GMP）的要求；

  Preliminarily evaluate whether the environment, plant and facilities, equipment, personnel and health management of the auditee meet the requirements of corresponding good manufacturing practice (GMP);

4.5.2.4 了解受审核方对认证标准要求的理解，评审受审核方的HACCP体系文件；重点评审受审核方各体系文件的符合性、适应性和充分性，特别关注关键控制点、关键限值的确定及其支持性证据；

  Understand the auditee's understanding of certification standard requirements, and review the auditee's HACCP system documents; Focus on the conformity, adaptability and sufficiency of each system document of the auditee, and pay special attention to the determination of critical control points, critical limits and supporting evidence;

4.5.2.5 充分了解受审核方的HACCP体系和现场运作，评价受审核方的运作场所和现场的具体情况及体系的实施程度，确认受审核方是否已为第二阶段审核做好准备，并与受审核方商定第二阶段审核的细节，明确审核范围，为策划第二阶段审核提供关注点。

 Fully understand the auditee's HACCP system and on-site operation, evaluate the auditee's operation site and site conditions and the implementation degree of the system, confirm whether the auditee is ready for Stage 2 audit, and negotiate with the auditee the details of Stage 2 audit, clarify the audit scope, and provide focus for planning Stage 2 audit.

对于第一阶段审核过的HACCP体系的相应部分，被确定为实施充分有效并符合要求的，第二阶段可以不再对其审核，但应确保HACCP体系已审核的部分持续符合认证要求。第二阶段的审核报告应包含对第一阶段审核中的审核发现，并且应清楚地表述第一阶段已经确认的符合性。审核记录应能体现审核人员对HACCP计划中CCP技术参数的判断。

For the corresponding parts of the HACCP system that have been audited in the first stage, if it is determined that the implementation is fully effective and meets the requirements, it can not be audited in Stage 2, but it is necessary to ensure that the part of the HACCP system that has been audited continuously meets the certification requirements.The audit report of Stage 2 shall include the audit findings in the first stage audit,It should be clearly stated in the first stage.The audit record shall reflect the auditor's judgment on the CCP technical parameters in the HACCP plan.

4.5.3 FSMS和HACCP体系第一阶段和第二阶段审核的间隔应不超过6个月；如超过6个月，应重新实施第一阶段审核。

 The interval between the first stage and Stage 2 of FSMS and HACCP system shall not exceed 6 months; If more than 6 months, the first stage of audit should be re implemented.

4.5.4 FSMS和HACCP体系第一阶段审核应在受审核方的生产或加工场所实施。

The first stage audit of FSMS and HACCP system shall be carried out in the auditee's production or processing site.

4.6 第二阶段Stage 2

4.6.1 FSMS审核FSMS audit

第二阶段审核的目的是评价认证委托人食品安全管理体系的实施情况及其有效性。第二阶段审核应在认证委托人的现场实施，并应确保对认证范围内有代表性的生产线、行业类别与子行业类别的典型产品/服务进行审核。第二阶段审核应至少覆盖以下方面：

The purpose of Stage 2 audit is to evaluate the implementation and effectiveness of the certification client's food safety management system.Stage 2 audit shall be carried out at the site of the certification client, and shall ensure that the representative production line, industry category and sub industry category within the scope of certification are reviewed.Stage 2 audit should cover at least the following aspects:

4.6.1.1与食品安全管理体系标准或其他规范性文件的所有要求的符合情况及证据；

Compliance with all requirements of food safety management system standards or other normative documents and evidence;

4.6.1.2 依据据食品安全管理体系关键绩效目标和指标（与食品安全管理体系标准或其他规范性文件的期望一致），对绩效进行的监视、测量、报告和评审；

Monitor, measure, report and review the performance according to the key performance objectives and indicators of food safety management system (consistent with the expectation of food safety management system standards or other normative documents);

4.6.1.3 客户的食品安全管理体系的能力以及在符合适用法律法规要求和合同要求方面的绩效；

The ability of the customer's food safety management system and its performance in compliance with applicable laws and regulations and contract requirements;

4.6.1.4 客户过程的运作控制；

Operation control of customer process;

4.6.1.5 内部审核和管理评审；

Internal audit and management review;

4.6.1.6 针对客户方针的管理职责；

Management responsibilities for customer policies;

4.6.1.7 规范性要求、方针、绩效目标和指标（与食品安全管理体系标准或其他规范性文件的期望一致）、适用的法律要求、职责、人员能力、运作、程序、绩效数据和内部审核发现及结论之间的联系；

The relationship between normative requirements, policies, performance objectives and indicators (consistent with the expectations of food safety management system standards or other normative documents), applicable legal requirements, responsibilities, personnel capabilities, operations, procedures, performance data and internal audit findings and conclusions;

4.6.2 HACCP审核HACCP audit

对于HACCP，除需满足FSMS第二阶段审核要求外，至少还应关注以下内容：

For HACCP, in addition to meeting the requirements of FSMS Stage 1I audit, at least the following contents should be paid attention to:

4.6.2.1 与我国和进口国（地区）适用法律、法规及标准的符合性，以及出口食品生产企业安全卫生要求的符合性（适用时）；

Compliance with applicable laws, regulations and standards of China and importing countries (regions), and compliance with safety and health requirements of export food production enterprises (when applicable);

4.6.2.2 HACCP体系实施的有效性，包括HACCP计划、前提计划及防护计划的实施，对产品安全危害的控制能力；

The effectiveness of HACCP system implementation, including the implementation of HACCP plan, premise plan and protection plan, and the control ability of product safety hazards;

4.6.2.3 原辅料及与食品接触材料的食品安全危害识别的充分性和控制的有效性；

Adequacy of food safety hazard identification and control effectiveness of raw and auxiliary materials and materials in contact with food;

4.6.2.4 生产加工过程中的良好卫生规范执行的有效性；

Effectiveness of implementation of good hygiene practices in production and processing;

4.6.2.5生产过程中对食品安全危害控制的有效性；

Effectiveness of food safety hazard control in the production process;

4.6.2.6产品可追溯性体系的建立及不合格产品的控制；

Establishment of product traceability system and control of unqualified products;

4.6.2.7食品安全验证活动安排的有效性及食品安全状况；

Effectiveness of food safety verification activities and food safety status;

4.6.2.8 受审核方对投诉的处理。

Handling of complaints by auditee.

4.6.3 对于FSMS和HACCP，都应进行产品安全性验证。

  For FSMS and HACCP, product safety verification shall be conducted.

  4.6.3.1 FSMS认证的产品安全性验证

Product safety verification of FSMS certification

  为验证危害性分析的输入持续更新、危害水平在确定的可接受水平之内、HACCP计划和（FSMS）操作性前提方案计划得以实施且有效，特别是产品的安全状况等情况，

In order to verify that the input of hazard analysis is continuously updated, the hazard level is within the determined acceptable level, the HACCP plan and (FSMS) operational prerequisite scheme plan are implemented and effective, especially the safety status of products,

适用时，在现场审核或相关过程中需要对认证范围内覆盖的产品进行抽样验证，以验证产品的安全性。

When applicable, the products covered in the scope of certification need to be sampled and verified in the on-site audit or related process to verify the safety of the products.

 BOHAN审核组根据我国和进口国（地区）有关指南、标准、规范或相关要求策划安全性验证活动。安全性验证可采用以下三种方式：

BOHAN audit team plans safety verification activities according to relevant guidelines, standards, specifications or relevant requirements of China and import countries (regions).There are three ways to verify security:

 1）委托具备相应资质能力的检测机构完成；或

  Entrust the testing agency with corresponding qualification to complete the work; or

 2）由现场审核人员进行风险评估，现场见证认证委托人实施的产品安全性检验；或

  The on-site auditors shall conduct risk assessment and witness the product safety inspection implemented by the certification client; or

 3）由现场审核人员确认并收集 12 个月内由具备资质的第三方检验检测机构出具的检验报告。当审核组认为检验项目不足以验证产品的安全性时，应采取相应的处理措施。

The on-site auditors shall confirm and collect the inspection reports issued by qualified third-party inspection and testing institutions within 12 months.When the audit team considers that the inspection items are not enough to verify the safety of the product, corresponding treatment measures shall be taken.

 4.6.3.2 HACCP认证的产品安全性验证

Product safety verification of HACCP certification

  为验证危害分析的输入持续更新、危害水平在确定的可接受水平之内、HACCP 计划和前提计划得以实施且有效，特别是产品的安全状况等情况，在现场审核或相关过程中应采取对申请认证产品进行抽样检验的方法验证产品的安全性。

In order to verify that the input of hazard analysis is continuously updated, the hazard level is within the determined acceptable level, the HACCP plan and prerequisite plan are implemented and effective, especially the safety status of the product, the method of sampling inspection of the product applied for certification shall be adopted in the on-site audit or related process to verify the safety of the product.

  BOHAN审核组应根据我国和进口国（地区）有关指南、标准、规范或相关要求策划抽样检验活动，确定检验方法和检验项目。抽样检验可采用以下三种方式：

BOHAN audit team shall plan sampling inspection activities and determine inspection methods and items according to relevant guidelines, standards, specifications or relevant requirements of China and import countries (regions).Sampling inspection can be carried out in the following three ways:

  1）委托具备相应能力的检测机构完成，检验机构应满足 GB/T 27025 的要求；或

The inspection organization shall meet the requirements of GB / T 27025; or

  2）由现场审核人员利用申请人的检验设施完成；或

It is completed by on-site auditors using the applicant's inspection facilities; or

  3）由现场审核人员确认由其他检验机构出具的检验结果的方式完成。

The on-site auditors shall confirm the inspection results issued by other inspection institutions.

 当采用利用申请人的检验设施完成检验时，认证机构应提出对所用检验设施的控制要求；

The inspection facilities to be used by the applicant when completing the inspection;

  当采用确认由其他检验机构出具检验结果的方式完成检验时，出具检验结果的检验机构应具备资质和能力，并依据《检测和校准实验室能力的通用要求》（GB/T 27025）获得实验室认可。同时，审核组应提出以下相应的控制要求：

When the inspection is completed by confirming the inspection results issued by other inspection institutions, the inspection institutions issuing the inspection results shall be qualified and capable, and shall be recognized by the laboratory according to the general requirements for the competence of testing and calibration laboratories (GB / T 27025).Meanwhile, the audit team shall put forward the following corresponding control requirements:

   1）检验结果时效性的合理界定；

    Reasonable definition of timeliness of test results;

   2）检验结果中的检验项目不全时的处理方式。

How to deal with the incomplete inspection items in the inspection results.

4.7 审核报告Audit report

4.7.1 FSMS的审核报告应包括组织的前提方案、使用的HACCP方法、对HACCP小组的评定意见，以及产品安全性验证等与食品安全管理体系相关的其他问题。

The FSMS audit report should include the premise scheme of the organization, the HACCP method used, the evaluation opinions on the HACCP team, and other issues related to the food safety management system such as product safety verification.

4.7.2 HACCP审核报告应包括组织的前提计划、使用的HACCP方法以及对HACCP小组的评价意见，还包括组织的产品安全性验证结果。

The HACCP audit report shall include the organization's premise plan,the HACCP method used and the evaluation opinions on the HACCP team, as well as the organization's product safety verification results.

4.8 认证决定Certification decisions

认证决定人员应根据审核过程中收集的信息和其他有关信息，对审核结果进行综合评价，以及对产品的实际安全状况进行评价。必要时，认证机构应对认证委托人满足所有认证依据的情况进行风险评估，以做出认证委托人所建立的食品安全管理体系能否获得认证的决定。

According to the information collected during the audit and other relevant information, the certification decision-making personnel shall comprehensively evaluate the audit results and evaluate the actual safety status of the products.If necessary, the certification authority shall conduct risk assessment on the situation that the certification client meets all the certification bases,In order to make the decision whether the food safety management system established by the certification client can obtain the certification.

审核组成员不得参与认证决定。认证决定人员应对产品安全性验证结果进行评价。

Members of the audit team shall not participate in the certification decision.The certification decision-making personnel shall evaluate the product safety verification results.

4.9 保持认证Maintain Certification

若认证机构实施不提前通知审核作为监督活动的一部分，认证机构应提前说明并告知获证客户组织和实施此类审核的条件。If the certification body conducts an audit without prior notice as part of its supervisory activities, the certification body shall explain and inform the certified client in advance of the conditions for organizing and conducting such audits.

4.9.1 监督审核Supervision audit

应根据策划要求，确保对获证管理体系在认证周期内进行有效的跟踪监督，发生重大变化或发生食品安全事故时，应增加监督审核的频次。

According to the planning requirements, it is necessary to ensure effective tracking and supervision of the certified management system in the certification cycle. In case of major changes or food safety accidents, the frequency of supervision and audit should be increased.

每次监督审核应尽可能覆盖认证范围内的有代表性的生产线、行业类别与子行业类别的典型产品/服务，如因产品/服务的季节性或客户需求等原因，监督审核难以覆盖认证范围内所有代表性的生产线、行业类别与子行业类别的典型产品/服务的，应保证在认证证书有效期内的监督审核覆盖认证范围内的所有代表性的生产线、行业类别与子行业类别的典型产品/服务。

Each supervision and audit shall cover the representative production lines, typical products / services of industry category and sub industry category within the scope of certification as far as possible. For example, due to the seasonality of products / services or customer demand, the supervision audit cannot cover all representative production lines, typical products / services of industry category and sub industry category within the scope of certification,The supervision and audit within the validity period of the certificate shall cover all representative production lines, typical products / services of industry category and sub industry category within the scope of certification.

4.9.1.1 对于FSMS和HACCP体系监督审核至少应包括：

  For FSMS and HACCP system, the supervision and audit shall at least include:

   1）体系变化和保持情况；

    Changes and maintenance of the system;

   2）内部审核和管理评审；

Internal audit and management review;

   3）重要原、辅料供方及委托加工的变化情况；

Changes of suppliers of important raw and auxiliary materials and entrusted processing;

   4）对上次审核中确定的不符合采取的措施；

The measures taken for the non conformity identified in the last audit;

   5）投诉的处理；

Handling of complaints;

   6）食品安全管理体系在实现获证组织目标和食品安全管理体系的预期结果方面的有效性；（FSMS适用）

The effectiveness of the food safety management system in achieving the objectives of the certified organization and the expected results of the food safety management system; (applicable to FSMS)

   7）组织的前提计划、良好卫生规范、关键控制点、关键限值的保持和变化情况及其有效性；（HACCP适用）

The organization's premise plan, good health practice, critical control points, and the maintenance and change of key limits and their effectiveness; (applicable to HACCP)

   8）持续符合我国和进口国（地区）相关法律法规标准的情况；

Continuous compliance with relevant laws and regulations in China;

   9）为持续改进而策划的活动的进展；（FSMS适用）

Progress of activities planned for continuous improvement; (applicable to FSMS)

   10）持续的运作控制；

Continuous operational control;

   11）任何变更；（如：范围的变更）

Any change; (e.g. change of scope)

   12）认证证书和标识和（或）任何其他对认证资格的使用；

Certification certificate and identification and / or any other use of certification qualifications;

   13）质量监督或行业主管部门抽查的结果等。

The results of quality supervision or spot check by the competent department of the industry.

   必要时，监督审核应对产品的安全性进行验证。

If necessary, the supervision and audit shall verify the safety of products.

4.10 再认证Recertification

   再认证审核应在认证证书到期前完成。再认证审核应确保对认证范围内有代表性的生产线、行业类别与子行业类别的典型产品/服务进行审核。原则上，再认证程序与初次认证程序一致，但可不进行第一阶段现场审核。但必要时，如FSMS、HACCP体系或运作环境（如区域、法律法规、食品安全标准等）有重大变更且经评价需要时，再认证审核应按照审核方案策划的要求进行第一阶段审核。

The re certification audit shall be completed before the expiration of the certification certificate.The re certification audit shall ensure that the representative production lines, industry categories and sub industry categories within the scope of certification are reviewed.In principle, the re certification procedure is consistent with the initial certification procedure, but the first stage on-site audit may not be conducted.But when necessary,If there are significant changes in FSMS, HACCP system or operating environment (such as region, laws and regulations, food safety standards, etc.) and need to be evaluated, the first stage audit shall be carried out in accordance with the requirements of audit scheme planning.

4.10.1 FSMS、HACCP应关注产品的安全性验证；

  FSMS and HACCP should pay attention to product safety verification;

4.10.2 再认证审核应包括针对下列方面的现场审核：

  Recertification audit shall include on-site audit for the following aspects:

   1）根据内部和外部变化，食品安全管理体系在保持认证范围相关性和适宜性方面的整体有效性；

   According to the internal and external changes, the overall effectiveness of the food safety management system in maintaining the relevance and suitability of the certification scope;

   2）经证实的对保持食品安全管理体系有效性并改进食品安全管理管理体系，以提高整体绩效的承诺；

   Proven commitment to maintaining the effectiveness of the food safety management system and improving the food safety management system to improve overall performance;

   3）食品安全管理体系在实现获证组织目标和管理体系预期结果方面的有效性。    

   The effectiveness of the food safety management system in achieving the objectives of the certified organization and the expected results of the management system.

4.11 不通知审核Audit without prior notice

4.11.1 在初次认证审核后，每三年策划实施一次不通知审核。不通知审核可结合监督审核或再认证审核进行，并在审核报告中注明审核类型为不通知审核。After the initial certification audit, plan and implement a non notified audit every three years. Non notification audit can be combined with supervision audit or re certification audit, and the audit type should be indicated as non notification audit in the audit report.

4.11.2 客服部应提前与获证组织确定无法实施不通知审核的时间段，以避免审核时获证组织因季节性生产、维修等原因没有生产现场的情形。The customer service department should determine in advance with the certified organization the time period during which the audit cannot be conducted without notice, in order to avoid situations where the certified organization does not have a production site due to seasonal production, maintenance, and other reasons during the audit.

4.11.3 不通知审核可在审核前48小时内向获证组织提供审核计划，获证组织无正当理由不得拒绝审核。Without notifying the audit, the audit plan may be provided to the certified organization within 48 hours before the audit, and the certified organization shall not refuse the audit without justifiable reasons.

4.11.4 如因安全或签证问题不能按计划实施不通知审核时，审核部和技委会应进行风险评估并对评估结果进行记录。If the planned audit cannot be carried out without notification due to security or visa issues, the audit department and technical committee should conduct a risk assessment and record the assessment results.

4.12 跟踪调查Follow up investigation

4.12.1 跟踪调查方式Tracking and Investigation Methods

审核部在风险分析的基础上，策划采用不通知现场审核、生产现场产品抽样检验、市场抽样检验、问卷调查、宣传材料审查等方式对获证组织HACCP体系的部分或全部内容实施跟踪调查。Tracking and Investigation Methods

On the basis of risk analysis, the audit department plans to conduct follow-up investigations on some or all of the content of the certified organization's HACCP system through methods such as on-site audits without notification, product sampling inspections at production sites, market sampling inspections, questionnaire surveys, and review of promotional materials.

4.12.2 跟踪调查实施及结果处理Follow up investigation implementation and result processing

机构应跟踪调查活动的程序、实施要求及跟踪调查结果处理办法。当跟踪调查结果表明获证组织已不再符合认证要求时，应暂停或撤销认证证书。The CB should track the procedures, implementation requirements, and methods for handling the results of investigation activities. When the tracking investigation results indicate that the certified organization no longer meets the certification requirements, the certification certificate should be suspended or revoked.

4.13 不符合项整改Rectification of non conformity items

4.13.1 初审/监督审核的不符合项整改

Rectification of non conformity items in preliminary review / supervision audit

FSMS和HACCP体系认证的受审核方对不符合采取纠正和纠正措施的时间不得超过3个月。

The period of review and corrective actions for non conformance to the FSMS and HACCP system shall not exceed 3 months.

4.13.2 再认证审核的不符合项整改

  Rectification of non conformity items in recertification audit

 1）再认证审核中发现的严重不符合项，认证机构应要求获证组织在规定时限内实施纠正与纠正措施，并在原认证证书到期前完成对纠正与纠正措施的验证。  

  For the serious non conformity found in the re certification audit, the certification body shall require the certificated organization to implement the corrective and corrective measures within the specified time limit, and complete the verification of the correction and corrective measures before the expiration of the original certification certificate.

 2）如果在当前认证证书到期前，认证机构未能完成再认证审核或未能对严重不符合项实施的纠正和纠正措施进行验证，则不应批准再认证。

  If the certification body fails to complete the recertification audit or verify the correction and corrective measures for serious non conformance items before the expiration of the current certification certificate, the recertification shall not be approved.