最新实施日期：2023年2月20日    版本号：1  修订号：4

1 目的 Purpose

为使认证审核活动科学、公正、有序地进行，指导认证人员按照规定的要求实施管理体系审核，而制定本程序。

To carry out certification activities scientifically, impartially and orderly, and guide auditors to implement management system audit according to specified requirements.

2 范围Applicable scope

适用于对组织管理体系的认证审核活动的管理。

It applies to management of certification audit activity for QMS/EMS

3 职责 Responsibility

3.1市场代表：负责收集和跟进认证申请组织的申请资料附件，并进行申请评审、合同初步评审。市场部经理负责申请和合同评审的审核。

Marketing Representative: responsible for collecting and following the application from the applicants, and conducting the application review and initial contract review. The head of marketing department shall check the application and contract review

3.2技委会：负责合同评审专业确认、负责认证档案材料复查和认证决定。

Technical committee: responsible for confirming the contract review, rechecking the audit reports and making the certification decision.

3.3总经理或管理者代表：负责审定合同评审结果和批准合同。

General manager or management representative: responsible for the approval of the contract review and contract.

3.4项目管理人员（方案管理人员、计划管理人员）：负责根据申请评审、合同评审意见对认证审核方案进行策划，并负责跟进每个审核项目的审核组成员和受审核方之间进行协调调度（含审核现场的变更）。

The audit program planning management personnel（planning management staff or program management staff）in audit department is responsible for organizing and implementing the audit activities according to comments of contract review and supporting documents of application from applicant, and take the responsibility for planning, arrangement and coordination of audit project.

3.5审核部经理：负责根据合同评审、审核方案策划安排，出具审核任务书安排组织实施认证审核的审核人员。并负责批准审核计划，转给项目管理员发企业，同时发审核组长。

Audit department Manager: responsible for Issue audit assignment and arrange auditors to implement certification audit according to contract review and audit plan, and then  provide the audit plan to the auditee and audit team leader.

3.6审核组长：负责根据审核任务书编制审核计划，负责带队管理和领导审核组成员按照审核计划以及公司认证审核的管理制度进行审核，并负责监控、见证审核组成员的能力表现。

Audit team leader: prepare the audit plan based on the audit notification, play a leading role in the audit team, monitor and evaluate other member’s performance.

3.7审核组成员：按照审核任务指派和审核计划的安排，实施审核。并向审核组长做工作汇报。

The member of audit team: conduct the audit based on the audit assignment and audit plan, make the work report to the team leader.

4 程序和要求 Procedure and requirements

4.1认证申请及评审 Certification application and review

4.1.1市场代表收集申请组织各项基本信息、预报价及认证合同中有关内容的沟通，确保申请组织提交的申请内容及相应文件、资质等附件资料完整。

Market representatives collect the basic information about applicant organization, communicate about quotation and certification agreement, the application documents and relevant qualification shall be complete.

4.1.2市场代表将申请组织各项信息录入完整、正确（尤其是认证范围、地址、多现场、规模人数、班别等），正确判断认可标志、专业代码。属转换证书申请组织的，必须在转换接收之前该组织获得CCAA证书转换批准方可受理。

Market representatives input accurately the information about applicant organization (especially the scope, location, multi-sites, the scale and shift information), determine the accreditation logo, code. As for the clients transferred, the application shall be accepted until the approval by CCAA for transfer is granted.

4.1.3合同评审人员负责评审受审核方申请产品/服务的风险等级、认证范围、专业代码、法律法规等信息满足规定的要求。以及任何其它影响认证活动的因素、申请组织及其管理体系的信息充分性、申请组织的风险是否可接受等。

Contract reviewers are responsible for the review of the risk level, scope, IAF code, legislations, ensuring the information meet the requirements. And other aspects affecting the certification activities, adequacy of information about applicant organization and its management system, and risk of applicant organization can be accepted or not.

4.1.4合同评审的作业要求，市场部、审核部按照《合同评审管理办法》的规定实施，审核人日计算和确定按照《审核活动工作人日管理程序》同步实施。并在合同评审过程中指定本项目的项目管理人员（即指审核计划管理员、方案管理员）、认证决定人员，以确保公司具有实施认证管理、认证决定的适宜能力。

As for the requirements for contract review, the marketing department and audit department shall conduct in accordance with the measure for administration of contract review , the calculation and determination of audit duration shall be in line with the audit duration management requirements, in the process of contract review, the project management staff (planning management staff or program management staff) , certification decision maker have been determined to enable to carry out the certification management and certification decision.

4.1.5 针对工程建设施工企业质量管理体系认证评审，除必要的证明法律地位的文件，和行政主管部门的法律许可如资质证明、安全生产许可证等，以及依据GB/T19001 和GB/T50430建立了文件化管理体系文件外，还要求提供：在建项目清单，必要时合同评审人员应对在建项目清单进行核实。

In view of the quality management system certification review of engineering construction enterprises, in addition to the necessary documents to prove the legal status, and the legal license of the administrative department, such as qualification certificate, safety production license, etc., and in accordance with GB / T19001 and GB / T50430 have established a documented management system. In addition to the documents, it is also required to provide a list of projects under construction. If necessary, the contract review personnel shall verify the list of projects under construction.

4.1.6合同评审人员记录形成管理体系《合同评审表》中。每份合同评审需经技委会专业评审人员进行专业确认后，再报总经理/管理者代表批准。

Contract reviewers shall record in contract review form, each contract review shall be confirmed by competent reviewer, then send it to general manager/management representative

4.1.7市场代表根据合同评审的结果和审核、批准的结果与申请组织签订《认证服务合同》。

Market representatives complete certification service contract with the applicant organization based on the result of contract review.

4.2审核任务下达 Notification Assignment

4.2.1审核任务书的下达。

Notification assignment

4.2.1.1项目管理人员根据合同评审的结果和审核方案的策划结果内容，正式任命审核组长、组员或专家（必须满足4.2.2条款规则）下达《审核任务书》。明确审核目的、范围和准则等信息。并同步整理提供审核准备工作文件（见4.3.2）。

According to the contract review and audit programme planning, project management staff shall assign the audit leader, assistant auditor or technical expert(shall satisfy the requirement of clause 4.2.2) and send out the notification to auditors, identify the audit objective, scope and criteria, at the same time prepare the documents for auditing.

4.2.1.2审核部要求审核组根据公司审核要求，检查以下内容：

According to HIC audit requirement, project management staff shall make the following requirements for audit team:

a)检查和验证客户组织与管理体系相关的结构、方针、过程、程序、记录及相关文件；

To examine and verify the structure, policies, processes, procedures, records and related documents of the client organization relevant to the management system.

b）确定上述方面满足与拟认证范围相关的所有要求；

To determine that these meet all the requirement relevant to the intended scope of certification.

c）确定客户组织有效的建立、实施并保持了管理体系过程和程序，以便为建立对客户管理体系的信任提供基础；

To determine that the processes and procedures are established, implemented and maintained effectively, to provide a basis for confidence in the client’s management system.

d）告知客户其方针、目标及指标（与相关管理体系标准或其它规范性文件的期望一致）与结果之间的任何不一致，以使其采取措施。

To communicate to the client, for its action, any inconsistence between the client’s policy, objectives and targets (consistent with the expectations in the relevant management system standard or other normative document) and the results.

4.2.1.3项目管理人员提供“审核行程通知函”，将拟派遣的审核组成员名单、专业等信息提交客户（有要求时，还应提供某个成员的背景材料），以使客户能够对审核组成员的任命表示反对，公司当出现这个情况是要求在现场审核前一周内重组审核组。

Project management staff shall provide the notice of audit schedule with the auditor list, competence to clients((the background information about the appointed auditors can be provided when the client request ). If client submits an objection concerning any audit team member, HIC shall not assign that person to the team if HIC deems the objection well founded.

 

4.2.2审核组的选择及组成 audit team selection and assignment

4.2.2.1决定审核组的规模和组成时，应当根据管理体系覆盖的活动的专业技术领域选择具备相关能力的审核员和技术专家组成审核组。审核组中的审核员应承担审核责任。应考虑下列因素：审核目的、范围、准则和审核时间；是否是结合或联合审核；审核组整体能力；认证要求（包括任何适用的法律、法规或合同要求）；语言和文化；审核组成员的公正性因素等。

When the scale and composition of the audit team is being decided, the auditors and experts who have relevant competence are chosen to make up the audit team, according to activities of the professional technical area covered by management system. The auditor in the audit team shall undertake audit responsibility. The following factors shall be considered: Audit purpose, scope, criteria and audit time; whether it is a combined or joint audit; the overall ability of the audit team; certification requirements (including any applicable laws, regulations or contract requirements); language and culture; impartiality of audit team members, etc

4.2.2.2 审核组中至少要有一名专职审核员，一名专业审核员, 需要时，可以聘用技术专家为审核组提供技术支持。技术专家主要负责提供认证审核的技术支持，不作为审核员实施审核，不计入审核时间，其在审核过程中的活动由审核组中的审核员承担责任。技术专家应在审核员的指导下工作。

In audit team, there must be at least one full time auditor, one professional auditor. If necessary, the technical experts can be recruited to supply technical support to audit team. The technical experts are mainly responsible for supplying technical support of certification audit, not consider as auditor to carry out audit, and will not be counted in the audit duration. And the auditors in the audit team, shall take responsibility of activities of the experts during the audit process. The technical experts shall work under the instruction of the auditor.

4.2.2.3 审核组长应为级别审核员，要考虑其具备一定组织、管理协调和处理审核问题的能力，具有相应的专业能力（具备专业代码）以及对管理体系整体有效性做出判断的能力，审核组长在整个审核过程中起到领导作用。

The audit leader shall be the auditor, take account of the ability to organize and coordinate, solve the problems raised in the auditing, and have expertise and the ability to judge the overall effectiveness of management systems. The audit leader is taken a leading role in the auditing

4.2.2.4 审核组成员应具备所要求的审核能力，包括了解受审核方的行业技术知识，掌握受审核方有关质量/环境/职业健康/信息安全/能源管理体系方面的特殊性，有能力对其管理体系中有专业特点的活动进行控制的有效性做出评价，并依据审核计划的安排开展审核工作。

The member of audit team shall be qualified for the task, including understanding the client’s industrial knowledge, knowing the specific aspects relating to QMS, EMS, have the ability to evaluate the effectiveness of control on the activities with professional features, and conduct the audit based on the audit plan. 

4.2.2.5 审核组中的审核员没有完全具备审核所需的知识和技能，可以通过技术专家予以满足，但技术专家不能独立承担审核任务，应在审核员的指导下进行工作。

Where a team is performing the task, the expertise needs to exist within that team or could be provided by the technical expert, but the technical expert shall not take the audit task independently, which shall be conduct the audit under the guidance by the auditor

4.2.2.6 工程建设施工质量管理体系的审核标准需覆盖ISO9001和GB/T50430双标准。参加GB/T50430审核的所有审核员均需完成CCAA质量管理体系注册和建筑施工领域专业注册。50430审核组内所有专业均需由专业审核员覆盖。需要时，认证机构可以聘用技术专家为审核组提供技术支持。专业审核员/技术专家专业能力要求需符合CNAS-SC15 《工程建设施工企业质量管理体系认证机构认可方案》要求。

The audit criteria for construction quality management system shall cover ISO9001 and GB/T 50430, the auditor for auditing of quality management systems of engineering construction enterprises shall passed the GB/T50430- national training and examination. Competent auditor/technical expert shall meet the requirements of accreditation scheme for certification bodies certifying the quality management systems of engineering construction enterprises. When necessary, the certification body can employ technical experts to provide technical support for the audit team. The professional competence of professional auditors / technical experts shall meet the requirements of cnas-sc15 "accreditation scheme for quality management system certification institutions of engineering construction enterprises". 

4.2.2.7 当审核组不具备与受审核方语言的沟通能力时，可考虑使用翻译人员，翻译人员的选择要避免对审核产生不正当影响，翻译人员应在审核员的指导下工作。

When the audit team has the language communication problem with the organization, the translator can be used, but the selection of translator shall not have the undue influence on the audit, the translator shall work under the guidance by the auditor.

4.2.2.8 审核项目中审核组需要安排观察员任务的。由项目管理员与受审核方沟通，征得到受审核方同意后方可正式派遣。审核组应确保观察员不影响或干预审核过程或审核结果。

If the observer is in the audit team, the project management staff shall communicate with client, the presence of observer shall be agreed to by the client prior to the conduct of the audit. Audit team shall ensure that observers do not influence or interfere in the audit process or outcome of audit.

4.2.2.9 审核项目中如有认可机构现场见证的任务需求，认可机构见证评审员需与审核组同组的，由项目管理员与受审核方沟通和协调，如果受审核方不同意的，视为不配合认可机构的现场见证。该认证审核项目应临时取消或终止。

If the audit project will be witnessed on site by accreditation body, the assessors are with the audit team. The presence of accreditation assessors shall be agreed to by the client prior to the conduct of the audit. If client refuses the witness audit, it regard as the client is reluctant to the on-site witness by accreditation body. This audit project shall be cancelled or terminated

4.2.2.10 审核组可以有实习审核员，其要在审核员的指导下参与审核，不计入审核时间，在审核过程中的活动由审核组中的审核员承担责任。审核组中的实习审核员人数不应超出注册及高级审核组成员总数，实习审核员不可独立承担审核任务，审核组长需指派一名注册级别或以上审核员与实习审核员同组，指导实习审核员参与审核，对实习审核员的审核内容和发现最终负责，并向组长汇报实习审核员的工作表现。

There can be provisional auditor in the audit team, who shall be involved in the audit under the guide of auditor, but not counted into audit duration, and the auditor of the audit team shall be responsible for the provisional auditor. The number of provisional auditor shall be less than the total number of registered and senior auditors, the trainee audit shall not undertake the audit on their own.The lead audit shall assign one registered or above level auditor to make up one group with the provisional auditor and guide the provisional auditor to participate the audit, and take final responsibility for the audit content and findings of the provisional auditor and report to the lead audit the performance of the provisional auditor.

4.2.2.11 审核组可以只有一名审核员，但这名审核员应满足以上对审核组的全部要求；

Audit team can be one auditor, but this auditor shall meet all above-mentioned requirements except

4.2.2.12.向导：为审核组配备向导是为了方便审核。审核组长应与受审核方沟通，每位审核员安排一名向导陪同，审核组应确保向导不影响或不干预审核过程或审核结果。向导职责包括：

Guide（s）are assigned to the audit team to facilitate the audit, the audit team leader shall communicate with the client, each auditor shall be accompanied by a guide. The audit team shall ensure that guides do not influence or interfere in the audit process or outcome of the audit. The responsibilities of the guide can include:

1）为面谈建立联系或安排时间；

Establishing contacts an timing for interviews

1. 安排对现场或组织的特定部分的访问；

Arranging visits to specific parts of the site or organization

1. 确保审核组成员知道并遵守关于现场安全和安保程序的规则；

Ensuring that rules concerning site safety and security procedures are known and respected by the audit team members

1. 代表受审核方观察审核；

Witnessing the audit on behalf of the client

1. 应审核员请求提供澄清或信息。

Providing clarification or information as requested by an auditor

4.2.2.13 为保证审核的连续性，尽量安排一阶段审核的组长参与二阶段审核；审核组应当全员完成审核计划的全部工作。除不可预见的特殊情况外，审核过程中不得更换审核计划确定的审核员（技术专家和实习审核员除外）。

To ensure audit continuity, it shall make effort to appoint the stage 1 leader to participate in the stage 2; the whole audit team shall fully participate all the audit work. Except the unexpected special circumstance, the auditors confirmed in the audit plan shall not be changed during the process of audit(except technical experts and internship auditors).

4.2.2.14审核组成员应遵循“公正性与保密声明”，不从事合同以外的工作(包括向受审核方提供质量/环境/职业安全健康管理体系任何形式的咨询)。应当遵守与从业相关的法律法规，对认证活动及作出的认证审核报告和审核结论的真实性承担相应的法律责任。

Members of audit team shall comply with the “impartiality and confidentiality statement”, no employee relationship with the auditee, shall not provide the consultation of QMS/EMS to application organization by any means. The audit team shall conform to the relevant laws and regulations, and undertake the corresponding responsibility for the certification activities and certification audit report and the authenticity of audit conclusion.

4.3审核的实施  the conduct of audit

4.3.1审核的种类： the type of audit

4.3.1.1初审（第一阶段和第二阶段）。Initial audit(stage 1 and stage 2)

管理体系初次认证审核均应分两个阶段（即第一阶段、第二阶段）进行。

The initial certification audit shall be divided into two stages(stage 1, stage 2)

4.3.1.2监督审核。Surveillance audit

4.3.1.3再认证审核（再认证换证审核）。Recertification audit

4.3.1.4特殊审核（扩大、缩小认证范围审核、其他审核）。

Special audit (extensions to scope, verification of major nonconformity, suspended certification recovery, investigation of appeals and complaints). 

4.3.1.5证书转换审核（执行《认证证书转换管理程序》）。

Certificate transfer audit(conduct according to Procedure for Administration of Certificate Transfer)

4.3.2审核计划编制 preparing the audit plan

4.3.2.1 审核组长收到项目管理员提供的经批准的《审核任务书》后，即联系审核组全体成员。 

Audit leader shall contact with other assistant auditor when receiving the approved notification from the project management staff.

4.3.2.2 审核组长应制定书面的审核计划交审核组实施。如果组长不是该专业的专业审核员，应与专业审核员沟通。在审核活动开始前，审核组应将书面审核计划交申请组织确认。遇特殊情况临时变更计划时，应及时将变更情况书面通知受审核的申请组织，并协商一致审核计划应与审核目的和范围相适应，审核计划至少应包括或引用：

Audit leader shall make written audit plan for the audit team to carry out. If leader auditor is not the technical auditor of sector, the lead auditor shall communicate with technical auditor. Before the audit activity, the audit team shall confirm the written audit plan with the applying organization. If there is special situation to change the audit plan, the audit team shall timely inform the auditee of the situation of the changes in written notice, and make agreement that the audit plan shall fit in the audit objectives and scope. The audit plan at least shall include or refer to:

a.审核目的（审核的目的是评价受审核方管理体系：与审核准则的符合性；满足适用法律法规及合同要求的能力；持续实现其规定目标的有效性；适用时，识别管理体系的潜在改进区域。）；

Audit objectives (Audit objectives are to evaluate the management system of organization, the conformity with the audit criteria, satisfy the competence as required by applicable statutory, regulatory and contractual requirements, consistently achieve the effectiveness of specified objectives, to identify the potential improvement of management system.)

b.审核准则（包括管理体系规范性文件、受审核方管理体系文件、法律法规。）；

Audit criteria (including management system normative documents, management system documentations, statutory and regulatory requirements, relevant laws and regulations)

c.审核范围（包括审核的地址、组织单元、部门、活动及过程。）；

Audit scope(including the location, organization unit, department, activities and processes)

d.拟实施现场审核活动（适用时，包括对临时场所的访问和远程审核活动）的日期和场所；

The date and sites where the on –site audit activities are to be conducted, including visits to temporary site, and remote auditing activities, as appropriate)

e. 审核涉及的部门

Related audit department

f.现场审核活动预期的时间和持续时间（注意：每个工作日的有效审核时间不得少于8个小时，其中审核会议、沟通时间不得大于1个小时，午餐时间不得作为有效审核时间。）；

The expected time and duration of on-site audit activities (Note: the audit duration for each workday shall not be less than eight hours, the lunch time shall not be as the audit duration).

g. 审核组成员（其中：审核员应标明注册证书号及专业代码；技术专家应标明专业代码、技术职称或职务，如果在职应注明其服务的单位）及与审核组同行人员的角色和职责；

The role and responsibility for audit member and accompanying persons (the audit shall note the registered certificate number and professional code; the technical experts shall note the professional code, technical title or position, if on job, the company the experts work in shall be noted)

h.在现场审核活动开始前，审核计划应经公司评审和接受，并提交给受审核方。

Before the on-site audit activities, the audit plan shall be reviewed and accepted by the company, and then sent to the auditee.

4.3.2.3 审核目的应说明审核要完成任务，并应包括下列内容：

The audit objective shall state the audit task, and shall include the following content:

1. 确定客户管理体系与审核准则的符合性；

Confirm the compliance of the client’s management system and audit norm;

2. 确认管理体系确保客户组织满足适用的法律法规及合同要求的能力；

Determination of ability of the management system to ensure the client organization meet the applicable laws and regulations and the competence of the contract requirement.

3. 确定管理体系确保客户能合理预期达成规定目标的有效性。

Determination of the effectiveness of the management system to ensure that the client organization can reasonably expect to achieving its objectives.

d) 适用时，识别管理体系的潜在改进区域；

Identify potential improvement area of the management system, where appropriate;

 

4.3.2.4审核范围应说明审核的内容和地址，例如拟审核的地址、组织单元、活动及过程。当初次认证或再认证过程包含一次以上审核（例如覆盖不同位置的审核）时，单次审核的范围可能并不覆盖整个认证范围，但整个审核所覆盖的范围应与认证文件中的范围一致。审核准则应被用作确定符合性的依据，并应包括：

Audit scope shall state the audit content and site, such as the site address, organization unit, activities and process to be audited. When initial certification or recertification includes more than one audit(such as the audit that covers different site), the single audit scope may not cover the whole certification scope, but the whole audit covered scope shall be accordance in the scope of the certification documents. The audit norm shall be used as the basis of confirming compliance, and shall include:

1. 所确定的管理体系规范性文件的要求；

The confirmed requirement of the management system normative documents

2. 所确定的由客户制定的管理体系的过程和文件；

The confirmed process and documents of management system developed by the client.

3. 审核计划可以随着现场审核活动的进展有充分的灵活性，允许更改。

The audit plan shall be flexible according to the progress of on-site audit activities, and it can be modified.

4.3.2.5 通常情况下，初次认证审核、监督审核和再认证审核应在申请组织申请认证的范围涉及到的各个场所现场进行。如果管理体系包含在多个场所进行相同或相近的活动，且这些场所都处于该申请组织授权和控制下，认证机构可以在审核中对这些场所进行抽样，但应制定合理的抽样方案以确保对各场所管理体系的正确审核。如果不同场所的活动存在根本不同、或不同场所存在可能对管理产生显著影响的区域性因素，则不能采用抽样审核的方法，应当逐一到各现场进行审核。

Under normal situation, initial certification, surveillance and certification audit shall be carried out at the on-site place that the scope involved. If management system include carry out the same activities or similar activities at multi-site, and all these sites are under the authorization and control by the applying organization, the certification body shall sample audit, but shall make reasonable sample plan to ensure the correct audit for the management system of each site. If the different site has different activity, or different site has area factor which might has obvious influence on management production, then the sampling audit can’t be adopted, the audit team shall audit each site.

4.3.2.6 为使现场审核活动能够观察到产品生产或服务活动情况，现场审核应安排在认证范围覆盖的产品生产或服务活动正常运行时进行。由于产品生产的季节性原因，在每次监督审核时难以覆盖所有产品的，在认证证书有效期内的监督审核需覆盖认证范围内的所有产品。

To make the on-site audit activities observe the products production or service activities situation, on-site audit shall be arranged when the certification scope coved products or service activities are being carried out normally. Because of seasonal reason of the products production, if each surveillance can’t cover all the products, all the surveillance audit shall cover all the products covered by the certification scope in the validity period of certification.

1. 准备审核工作文件 preparing the audit working document
   1. 项目核项目管理人员为审核组准备必要的工作文件（如：审核记录表单等），用于审核过程的参考和记录；

The audit project management personnel prepare the necessary working documents for audit team (such as: audit record form etc.), used for reference and record in audit process.

4.3.3.2 审核员应结合受审核方的实际情况编制审核计划中的“审核日程安排表”，包括确定的抽样计划，用于实施审核的提示与参照；

Auditor shall combine the auditee actual situation to establish the “audit agenda arrangement form” of audit plan, including confirmed sampling plan, used for reference of implementing audit

4.3.3.3 审核工作文件，包括其使用后形成的记录，应至少保存到审核结束，在审核结束后经审核组长整理提交管理系统。审核组成员在任何时候都应当妥善保管涉及保密或知识产权信息的工作文件。

Audit working documents, including the record，shall be saved at least after the audit.After the audit, the lead auditor shall be submitted to management system. Audit team member shall properly keep working documents which involved confidentiality or intellectual property informaiton.

4.3.4 审核组与受审核方的沟通 the communication between audit team and organization

审核组长负责与受审核方代表建立沟通渠道并与受审核方就审核准备资料、文件、安全、审核组成员信息、审核行程、接送地址等事宜进行密切沟通联系。必要时审核组长应请求项目管理员予以协助联系和沟通。

Audit team leader is responsible for the establishment of communication channel with the client representative about the documents, safety, personnel information of auditor, audit schedule, travel arrangement. if necessary, the audit team leader can ask the project management staff to contact and coordinate

4.3.5 审核组内部的工作沟通 work communication in audit team

4.3.5.1 审核组长向审核组成员分配对特定过程、职能、场所、区域或活动实施审核的职责。所进行的分配应考虑到所需能力、有效并高效地使用审核员、实习审核员和技术专家的不同作用和职责，并指导其编制检查记录表，对审核过程进行有效的控制管理，编制完成审核报告。

Audit team leader shall be responsible for allocation of the process, function, sites, places or activities to the member of audit team for conducting the audit. the competence, effective and efficient use of auditor, the different roles and responsibilities of provisional auditor and technical expert, and guide them to draw up the checklist, have the effective control of audit process, complete the audit report.  

4.3.5.2 审核组中专业审核员或技术专家在审核前应就相关技术专业问题对审核组中其他成员进行交底和培训，以保证审核组全体审核人员都了解如下内容：

The competent auditor or technical expert shall carry out technical disclosure and training about the technical professional issues with other members of audit team prior to the conduct of audit to ensure the audit team understands the following:  

a.相关法律法规及产品标准等。

Legislative and regulatory requirements and product standards

b.质量管理体系中生产工艺关键过程、特殊过程的控制。

The control of the key and special process of the quality management system

c.环境管理体系中减少有害环境影响技术及其实际应用；环境因素及环境影响的控制措施。

The technique and application of reduction of environmental impact in the environmental management system, and the control measures for environmental aspects and environmental impacts

d. 职业健康安全管理体系中减少危害因素影响技术及其实际应用、危害因素分析和控制措施。

The technology of reducing the influence of hazardous factors in occupational health and safety management system and its practical application, analysis and control measures of hazardous factors

4.3.5.3审核实施过程中发生任何的异常情况，如为认证业务范围、规模、特种设备等与申请时的严重差异等。审核组长应填写《审核组现场审核异常处理单》或《管理体系变更申请表》。并与受审核方确认后，及时与项目管理员取得联系，按照公司领导的处理意见进行后续的作业。

If any abnormal cases take place, such as: the serious difference in scope, scale, special equipment when comparing the information provided during the application stage, the audit team leader shall complete the On-site Exception Handling Form or Management System Change Application Form after the confirmation with the organization, get touch with project management staff, and follow the work based on the handling suggestion from HIC office.

4.4 初次认证审核 Initial Audit

4.4.1 第一阶段审核The stage 1 

4.4.1.1第一阶段审核目的是确定受审核方已按标准建立并运作了管理体系，并依此确认受审核方对审核的准备程度，为公司第二阶段审核的顺利实施作充分的准备工作。

The stage 1 is to confirm the organization has established and operated the management system, and the degree of readiness for the auditing, also determine the preparedness for the stage 2.

4.4.1.2第一阶段审核现场和非现场审核的界定。Definition for on-site stage 1 and off-site stage 1.

a. 原则上，以下情况必须进行一阶段现场审核：

In principle , if one of following situations is met, the stage 1 shall be conducted on-site.

—复杂的管理体系，如组织规模、结构及其职能复杂（如集团公司或规模超过200人的组织）。

-complex management system, such as: the scales and structure and complex functions(group company or the company has more than 200 employees)

—组织的运作场所及现场复杂，如具有多个临时场所和/或多场所的组织。

-complex the operational sites, such as the organization has many temporary sites/or additional sites

—体系覆盖了相当数量的产品/服务范围（认证范围超过四个含以上），或为高复杂程度的活动和过程；

-the management system covers amounts of products/services(the scope has more than four products/services), or the activities and process with high complexity

—公司新扩展认可后专业领域的第一个认证审核项目。

-the first project after HIC is accredited in the scope extension

—经确认属于高风险的认证专业；

  It is confirmed to be a high-risk industry;

—工程建设施工企业质量管理体系认证的初次审核；

—当结合审核时，一阶段现场实施审核的必要条件是结合该产品/服务的过程或活动和在QMS、EMS、OHSMS、EnMS、ISMS领域的风险等级来确定，如该专业在任一领域属于非有限风险等级的，应进行一阶段的现场审核。

When it comes to Integration Management System, the necessary condition for stage 1 on-site audit is to combine the process or activity of the product / service with the risk level in QMS, EMS, OHSMS, EnMS and isms. If the specialty belongs to non limited risk level in any field, one-stage on-site audit shall be conducted.

b. 第一阶段为非现场审核的必要条件为审核组有条件可获得第一阶段审核所需的所有受审核方资料，审核组需与受审核方就第二阶段审核准备情况进行充分电话沟通，确保审核组可以以非现场的形式进行第一阶段审核，并能够满足第一阶段审核需达到的所有目的。若审核组实施第一阶段非现场审核后仍无法满足第一阶段审核的所有目的，应立即报告审核部要求实施第一阶段现场审核。在下列情况，第一阶段审核可以不在申请组织现场进行：

Essential condition for stage 1 off site audit is that the audit team has the access to all the information as required for auditing of stage 1. Audit team shall have the telephone communication with the audited party about the preparation of stage 2, ensuring that the audit team conducts the off -site stage 1 and come to the aim of stage 1. If the audit team deems that the off -site auditing of stage 1 cannot meet the aim of stage 1, audit team shall notify audit department and conduct on-site auditing of stage 1.

Under the following situation, the stage 1 audit can be conducted off-site:

—申请组织已获本认证机构颁发的其他认证证书，认证机构已对申请组织管理体系有充分了解。

The applying organization has obtained other certification certificate issued by our certification body, and the certification body has fully understanding of the quality management system of the applying situation.

—认证机构有充足的理由证明申请组织的生产经营或服务的技术特征明显、过程简单，通过对其提交文件和资料的审查可以达到第一阶段审核的目的和要求。

The certification body has fully justification to verify that the production business or service technic of the applying organization has obvious characteristics and the process is simple. Through submitting document and material review, the stage 1 audit objectives and requirements shall be achieved.

—申请组织获得过其他经认可的认证机构颁发的有效的质量管理体系认证证书，通过对其文件和资料的审查可以达到第一阶段审核的目的和要求。

The applying organization has obtained the effective quality management system certification certificate issued by another certification body. Through submitting document and material review, the stage 1 audit objectives and requirements shall be achieved.

除以上情况之外，第一阶段审核应在申请组织的生产经营或服务现场进行。

Except above situation, the stage 1 audit shall be conducted at production business or service site of the applying organization.

4.4.1.3第一阶段审核的内容（现场或非现场） stage 1(on-site or off-site)

a.文件评审

a.Document review

1) 文审通常由审核组长进行，也可由组长委托的审核员进行，并填写《文件审查报告》，以确定文件所述的管理体系与审核准则、审核任务书及企业适用法律法规要求的符合性。

A document review is undertaken to confirm that the auditee’s management system conforms to: applicable requirements, audit objectives and criteria, and applicable laws and regulations. The document review is usually carried out by the lead auditor, or another auditor assigned by the lead auditor. The document review findings will be recorded in the ‘document review report’.

2) 当组长不具备相关专业能力时，组长应与审核员/技术专家参与文审进行沟通。

When lead auditor has no technical competence, the lead auditor shall communicate with auditor/technical experts.

3)  文审的结果应书面通知受审核方，如存在问题，须按要求告知企业做出采取纠正或纠正措施。企业应在规定时间内实施纠正或纠正措施并提供纠正证据，经审核组长验证符合要求后进入现场审核，纠正或纠正措施的证据文件应随审核材料一并交回公司。如企业未能在审核前对文审提出的问题采取有效纠正或纠正措施，审核组长应及时与公司审核部沟通。

The auditee will be informed in writing of the result of the document review. If there are non-conformances that require action prior to proceeding towards stage 2, then the auditee will be advised of the need to complete the corrections or corrective action before the stage 2 and within the timescale decided by the lead auditor. Where applicable, the audit team will verify if correction or corrective action are acceptable before proceeding to arrange the stage 2. Evidence of correction or corrective action received will be sent back with the other audit document to company, as appropriate.  If the auditee fails to provide evidence of correction or corrective evidence where requested, then the lead auditor will communicate this to the audit department to action.

——结合现场情况，确认申请组织实际情况与质量管理体系文件描述的一致性，特别是体系文件中描述的产品或服务、部门设置和负责人、生产或服务过程等是否与申请组织的实际情况相一致,对体系文件补充审核，了解其体系策划的充分性及与审核准则的符合性。主要包括：

Supplementary audit on the system documentation to have a better understanding on the adequacy of system planning and compliance of audit criteria, the content of planning mainly include:

—建立了所需的文件体系；

The necessary system documents have been established.

—阐明了管理体系的实施范围，包括任何的删减及其合理性；

The implementing scope of management system has been clarified including any exclusion and its rationality (QMS)

—建立了适当的质量、环境、职业健康安全管理方针；

Suitable policy for quality, environment has been established.

—制定了相应的质量目标、环境、职业健康安全目标、指标和管理方案；

Relevant objective of quality and environment, target and management program all have been established.

—识别和确定了应控制的过程、重要环境因素和不可接受风险，并制定了相应的控制措施；

Identified and determined the process, significant environmental aspects which should be controlled, and set up the relevant controlling measures.

—识别了应遵守的适用法律法规和其他要求；

Identified applicable law and regulatory and other requirements which should comply with

—对管理体系的运行绩效建立了必要的监控机制；

The necessary monitoring mechanisms are established for the performance of operation of management system.

—规定了管理体系各职能与层次的相应职责、有关的责任机制和信息交流机制，并确定了必要的资源能力；

Relevant responsibilities of each function and level of management system, relevant responsibility mechanism and information exchange mechanism are stipulated, and the necessary resource capacity is confirmed.

—规定了对管理体系进行内审和管理评审并持续改进的要求。

Specifies the requirements for internal audit and management review for management system, and maintain the continuous improvement.

—确认申请组织建立的质量管理体系覆盖的活动内容和范围、申请组织的员工人数、活动过程和场所，遵守相关法律法规及技术标准的情况。审核方的组织机构、职能、产品/服务、活动和过程等方面的特点。主要包括：

Confirm the content and scope of activities covered by the quality management system established by the application organization, the number of employees of the application organization, the activity process and place, and the compliance with relevant laws, regulations and technical standards. The characteristics of the auditor's organization, functions, products / services, activities and processes, etc. It mainly includes:

b.通过对受审核方运作场所和现场的勘察（可以获得受审核方办公室、主要生产车间、检测室、设备、仓库等照片），并与主要管理者和相关人员讨论交流了解受审核方组织机构、职能、产品/服务、活动和过程等方面的特点，特别是管理体系过程的总体策划和实施情况，以确定受审核方第二阶段审核的准备情况。

b.Through the investigation of the auditee's operation site and site (photos of the auditee's office, main production workshop, testing room, equipment and warehouse can be obtained), communication with their main manager and relevant personnel, In order to understand the characteristics of the auditee's organization, functions, products / services, activities and processes, especially the overall planning and implementation of management system process, the purpose is to confirm the preparation situation of the stage 2.   

—c.结合现场情况，审核申请组织有关人员理解和实施标准要求的情况，审查受审核方理解和实施标准要求的情况，特别是对管理体系的关键绩效或重要的因素、过程、目标和运作的识别情况。主要包括：

c.In combination with the site conditions, review the understanding and implementation of the standard requirements by the relevant personnel of the application organization, and review the understanding and implementation of the standard requirements by the auditee, especially the identification situation for the key performance or the operation of significant aspects, process and objective and operation e of management system. It mainly includes:

—了解受审核方对质量管理过程、环境因素和危险源的识别、评价和管理情况，并与受审核方共同确认对关键过程、需确认的过程、重要环境影响和重大危险源的关键控制点、关键限值识别的充分性、适宜性和控制方法的合理性；

Understand the identification, evaluation and administration of quality management process, legal requirements and environmental aspects by auditee, shall confirm with applicants together about key process, the process needs to be verified, control points for the significant environmental impact and hazardous origin, identification’s sufficiency and suitability on the key data, and the rationality of control methods.

—了解受审核方的方针、目标、指标与法律法规相关要求的一致性，目标、指标的可测量性。

Be familiar with the conformance of the policy, objective and target with relevant requirements of law and regulatory, and the measurable objective and target

d.收集关于受审核方的管理体系范围的必要信息，以及相关的法律法规要求和遵守情况。主要包括：

d.To collect necessary information about the scope of management for audited party, and compliance of requirements of relevant law and regulatory, It mainly includes:

—受审核方文件描述的管理体系范围与现场运行情况的一致性；

Consistency of the management system scope described in the documents of auditee with the operation on site

—客户的场所

The client site

—使用的过程和设备

Process and equipment used

- 所建立的控制的水平（特别是客户为多场所时）

Levels of controls established (particularly in case of multisite clients)

—产品、服务和活动范围；

Scope of product, service and activity

—组织规模、生产/服务状况、流程、班次安排；

Production/service status, process and shifting arrangement and organization scale

—运作场所及现场的分布、距离及所处区域；

Distribution of operating site and workplace, distance and its area

—动力及上下水管网分布等；

Distribution of power and water pipe networks system

—管理体系运行中对有关法律法规要求的遵守或执行情况，包括相关法律许可类文件及其有效性。如营业执照、生产许可证、CCC/UL/CE等强制性认证证书、QS证书、卫生许可证、安全许可证等资质证书；其它与质量、环境和职业健康安全等任何法定的评价、验收和抽查报告，如环评报告、职业健康安全评价报告、环保/安全验收报告、排污申报和排污许可证、协议等证明文件；所提供的产品是否属于国家明令淘汰的产品，如高能耗、高污染、结构落后、安全性差的产品。

The compliance or implantation status of the requirements of relevant law and regulatory including relevant law license document and its effectiveness, For example: business license, production license, compulsory certification such as CCC/UL/CE, QS certificate, sanitary license, safety production license, qualification certificate; and other regulatory assessment, inspection and sampling examination reports which relate to quality, environment and occupational and health safety such as environment evaluation report, occupational and health safety evaluation report, environmental inspection and acceptance report, pollution discharge reporting, pollution discharge license and agreement; also whether the products provided belong to the eliminating products that required by government, such as products with high energy consumption, high pollution, lag structure, poor safety etc.

—环境、职业健康安全的主动和被动监测情况；

Active and passive monitoring status of environment

—受审核方对适用法律法规的识别及在管理体系中的运用情况，以及合规性评价的实施情况；

Audited party’s identification for applicable law and regulatory and its operation in management system, and the implementation of compliance evaluation

—有关违法和投诉记录。

Relevant records of irregularity and complaint

e. 评价质量管理体系运行过程中是否实施了内部审核与管理评审，确认质量管理体系是否已有效运行并且超过3个月。受审核方是否策划和实施了内部审核与管理评审。主要包括：

Evaluate whether internal audit and management review have been implemented during the operation of the quality management system, and confirm whether the quality management system has been in effective operation for more than 3 months. Whether the audited party planed and implemented the internal audit and management review. It mainly includes:

—审查内审和管理评审是否覆盖了管理体系范围活动及管理体系标准要求，结论是什么？提出了哪些改进要求；

To review whether the internal audit and management review cover the activities within the scope of management system and requirements of management system standard, the conclusion and improving requirements decided.

—评价内审和管理评审的策划及实施情况。

f. 结合管理体系标准或其他规范性文件充分了解客户的管理体系和现场运作，以便为策划第二阶段审核提供关注点；

Provide a focus for planning the stage 2 by gaining a sufficient understanding of the client's management system and site operations in the context of the management system standard or other normative document;

g．二阶段审核组能力及审核人日配置的需求，二阶段审核的时间、路线安排等

To evaluate the planning and implementation of internal audit and management review

4.4.1.4结合质量管理体系覆盖活动的特点识别对质量目标的实现具有重要影响的关键点，并结合其他因素，科学确定重要审核点、第二阶段现场审核时关注点主要包括：Focus of on-site stage 2 mainly includes:

—质量管理体系宜重点关注设计、关键生产/服务、检验、采购过程及生产/服务提供场所；

Quality management system shall focus on the design, key production/service, inspection, purchasing process and production/service provided sites； 

—环境管理体系宜重点关注如动力装置场所、危险化学品仓库、污染物治理设施、固废堆放场所及其作业现场。 

Environment management system shall focus on power plant place, hazardous chemical warehouse, pollutant treatment facilities, solid waste stock places and working site.

—职业健康安全管理体系宜重点关注如：高处作业、铅冶炼、高粉尘作业、机械加工、压力容器操作、有毒化学品车间、危险化学品仓库和储存罐区等高风险作业场所。

The occupational health and safety management system should focus on such high-risk workplaces as high-altitude operation, lead smelting, high dust operation, mechanical processing, pressure vessel operation, toxic chemical workshop, hazardous chemical warehouse and storage tank farm.

一阶段审核重点内容主要审核企业策划的管理体系是否符合要求。

Key point for stage 1 is the auditing to determine if management system established by organization meet the requirements.

一现场巡视要求/Requirements for Site Tour：

一阶段现场巡视应根据现场的平面图和管网图，界定清楚审核的地域范围，对所界定的范围进行全面巡视。

For site inspection at the stage 1, all of site specific conditions related to the organization’s site and boundaries shall be identified by using the site plan and pipe network diagram.

与申请组织讨论确定第二阶段审核安排

Discuss with the application organization to determine the second stage audit arrangement.

4.4.1.5第一阶段审核结束后，审核组应对被审核方的以下内容在《第一阶段审核报告》中进行阐述，并将书面报告发送客户。内容如下：

When the stage 1 is conducted, the management systems initial stage 1 report be written and send to client, the report shall address as follows:

a.文件审核的结论；

Conclusion of document review

b.体系运行基本状况；

Basic status of system operation

c.质量、环境、职业健康安全方针的建立情况；

Establishment of quality, environment, occupational health and safety policy

d.相应的质量目标、环境、职业健康安全目标、指标和管理方案的建立情况；

Establishment of the targets and management programme of quality , environmental objective and occupational health and safety,

e.是否识别和确定了应控制的过程、重要环境因素、危险源及相关风险，并制定了相应的控制措施；

Whether it has identified and confirmed the process that shall be controlled, significant environment aspects, Hazard sources and related risks and also established relevant control actions.

f.应遵守的法律法规和其它要求的识别和遵守情况

Identification and compliance for the law and regulatory that shall be complied and other requirements

g.是否对管理体系的运行绩效建立了必要的监控机制；

Whether it establishes the necessary monitoring mechanisms for operation performance of management system

h.管理体系各个职能与层次的相应职责、有关的责任机制和信息交流机制的建立情况，是否确定了必要的资源能力；

Establishment of each function and level’s responsibilities for management system, and establishment of relevant accountability mechanism and information exchange mechanism, and whether the necessary resource capacity is confirmed

i.管理体系内审和管理评审是否已实施；

Whether the initial audit and management review for management system are implemented

j.目前的主要问题及是否具备第二阶段审核的条件。

The current major problems and the ready conditions of the stage 2

4.4.1.6第一阶段审核的后续工作 Follow-up work of the stage 1

a.审核组应将第一阶段审核情况形成书面文件告知申请组织。对在第二阶段审核中可能被判定为不符合项的重要关键点，要及时提醒申请组织特别关注。第一阶段审核发现不符合项的，应全部纠正完成后（需有相应的证明材料），方可继续进行第二阶段审核；

The audit team shall document the stage 1 audit situation in written form and then inform the applying organiztion. For the important key points might be defined as non-conformities in the stage 2 audit, the audit team shall remind the applying organization of paying special attention. The nonconformity found in the stage 1 audit, shall be corrected (the corresponding material is needed), then the stage 2 audit can be proceeded;

b.第一阶段审核完成后，应对受审核方的管理体系进行评价，审核组长负责完成并提交《第一阶段审核报告》；

After stage 1 audit, the management system of the auditee shall be assessed, and the lead auditor shall take responsibility for finishing and submitting the “audit report of stage 1”;

c.审核组长确认一阶段问题已整改关闭后，应经审核部批准后，由审核项目管理人员下达二阶段的现场审核任务；如被审核方仍然存在不符合（特别是不满足法规要求、监测不达标）情况时，不能进入二阶段现场审核；

After the lead auditor confirms that all the findings of stage 1 have been closed up, through the approval of the audit department, the audit project management personnel shall assign the on-site audit task of stage 2; if there is still nonconformity of the auditee(especially doesn’t meet the laws and regulaitons requirment, monitoring doesn’t reach the standard), the stage 2 audit can’t be proceeded;

d.第一阶段审核和第二阶段审核应安排适宜的间隔时间，使申请组织有充分的时间解决第一阶段中发现的问题.

There shall be proper interval between stage 1 audit and stage 2 audit, to make the applying organizaiton has enough time to resolve the problems found in the stage 1.

f. 如发生影响管理体系的重要变更，如范围变更、企业搬迁或其他重大变化，审核部应策划重新安排一阶段审核。审核组应告知客户一阶段的结果有可能导致推迟或取消二阶段。

If any significant changes which would impact the management system occur, such as scope change, working place moving or other significant changes, the audit department shall plan to repeat all or part of stage 1. The client shall be informed that the results of the stage 1 may lead to postponement or cancellation of the stage 2 by audit team.

4.4.2 第二阶段现场审核 On Site stage 2 

4.4.2.1审核目的：评价受审核方管理体系的实施情况，包括有效性。

The purpose of the stage 2 is to evaluate the implementation, including the effectiveness, of the client’s management system.

4.4.2.2审核要求Requirements for audit

a.第二阶段审核应依据标准的要求并基于第一阶段审核的结果，对受审核方的管理体系进行全面的符合性、适宜性和有效性评价。

stage 2 shall make assessment on the compliance, suitability and effectiveness of audited party’s management system based on the results of stage 1. 

b.第二阶段审核时可采用一阶段收集到的信息，并对管理体系进行深入现场审核。

stage 2 can use the information collected on the stage 1, and conduct profound auditing of management system.

c.为确保审核的有效性，公司要求第二阶段审核是审核员不得有过多时间制作审核检查记录和会议。

In order to ensure the effectiveness of the audit, HIC requires that when conducting the stage 2, too much time shall not allocated to the preparation of audit records and meeting.

4.4.2.3第二阶段审核应在受审核方的现场进行，并至少覆盖以下方面：

Audit on the stage 2 shall be implemented on site, and it covers followings at least:

1. 在第一阶段审核中识别的重要审核点的监视、测量、报告和评审记录的完整性和有效性；

The monitoring, measuring of the important audit points of the stage 1 audit, the completeness and effectiveness of report and review record;

2. 为实现总管理目标而建立的各层级目标是否具体、是否有针对性、是否可测量并且可实现；

Whether the different levels objectives established to achieve the general management objective is make pointed references, measurable, and realizable;

3. 对管理体系覆盖的各过程和活动的管理及控制情况；

The control of all the processes and activities covered by the management system;

4. 企业实际工作记录是否真实；

Whether is real working record of the enterprise is actual;

5. 企业的内部审核和管理评审是否有效；

Whether the internal audit and management review of the enterprise is effective;

6. 基于受审核方的管理职责；

The management function based on the auditee;

7. 企业管理体系和绩效中与遵守法律法规有关的方面。

The content of the enterprise management system and performance which is relevant to complying with laws and regulations.

8. 规范性要求、方针、绩效目标和指标（与适用的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关系.

The norm requirement, policy, performance objective and target(accordance with the applicable management system standard and other norm documents), the relationship among the applicable laws, responsibility, personnel competence, conducting, procedure, performance data, internal audit findings and conclusion

1. 当实施EMS现场审核时，应对以下情况予以特别关注：

When conducting on site audit against EMS, following aspects shall be concerned particularly:

1. 若受审核方有晚班作业时，审核员应策划对夜班的审核，在审核夜班时应针对夜班作业过程中产生的所有环境因素进行审核，特别是针对夜班的环境目标比白班环境目标控制严格的环境因素受审核方的具体控制控制措施的审核。

If the auditee has the night shift work, the auditor shall have the planning for the audit of night shift. when auditing the night shift work, the auditor shall audit all the environmental aspects generated in the night shift work process, especially the audit on the environmental aspects that shall higher control of environmental objective on the night shift than day shift

2. 在实施现场审核过程中，审核员应对应急控制予以充分审核，应对受审核方各班次、各部门、各区域所识别的应急情况进行审核，并需审核各班次、各部门、各区域应急控制的作业人员，审核受审核方应急情况识别的充分性。确认受审核方是否识别了所有可能发生的紧急情况（如夜班生产、临时施工等），对紧急情况是否制定了应急预案，对应急预案是否进行了演习、评审和培训，审核各区域是否配备了相关的应急物资，对应急物资的管理情况是否适当，当应急预案被评审为不满足要求时，审核受审核方是否采取了纠正措施等。

In the process of on-site audit, the auditor shall fully audit the emergency control, the emergency situation identified by each shift, department and area of the auditee, and the operators of emergency control of each shift, department and area, and the adequacy of emergency situation identification of the auditee. Confirm whether the auditee has identified all possible emergency situations (such as night shift production, temporary construction, etc.), whether an emergency plan has been formulated for the emergency situation, whether the emergency plan has been exercised, reviewed and trained, whether relevant emergency materials have been provided in each area, whether the management of emergency materials is appropriate, and when the emergency plan is reviewed as not meeting the requirements Check whether the audited party has taken corrective measures, etc. 

3. 审核过程中应确认审核边界。如客户提出区域内某一场所不在认证范围内，需进行充分取证，如书面的租赁协议等。对于审核边界外的周边，应考虑相关方影响，如固废和能源消耗。

When conducting the on-site audit, the audit boundary shall be confirmed. If the client proposed some regional place is not in the scope of certification, the auditor shall collect sufficient evidence, such as a written lease agreement, etc. The auditor shall take account of the related side effects to the surrounding outside of  the audit border, such as solid waste and energy consumption.

审核过程应充分追踪确认审核证据，不能停留在表面。如企业提出并已见生活垃圾由物业处理，需通过其他方式确认生活垃圾的最终符合环境要求的处理途径，如查看合同约定，物业管理规定等。

During the audit process, the auditor shall fully tracked evidence and confirmed, not only stay on the surface. If the client has put forward and the auditor has seen the life garbage disposed by the property company, it is necessary to confirm the way in dealing with the life garbage whether it meet the environmental requirements through other ways, such as review the contract agreement, property management regulations, etc..

J ) 当实施QMS现场审核时，应对以下情况予以特别关注：

When conducting on site audit against QMS, following aspects shall be concerned particularly:

如受审核方申请删减设计，审核员应策划对设计删减的审核。确认8.3是否删减应根据企业文件范围，依据生产现场实际有无设计职能和责任进行判定。删减不影响组织提供满足顾客要求和适用法律法规要求的产品的能力或责任，否则不能删减。根据客户要求修改已定型产品作为设计过程。

If the client apply for design exclusion, the audit team shall plan the audit of design. Confirm the design exclusion, according to the document of the client, and whether there is design ability or responsibility on actual production. Such exclusions do not affect the organization’s ability, or responsibility, to provide product that meets customer and applicable statuory and regulatory requirements. It shall be defined as design process, to change the finalized products according to customer demand changes

基于风险的思维，关注认证客户使用ERP系统或电子文件管理系统等涉及的IT潜在风险以及解决其潜在风险的应对措施。

Based on the risk thinking, pay attention to the potential IT risks involved in the use of ERP system or electronic document management system by certified customers and the countermeasures to solve their potential risks.

10. 对领导层的审核，应确保最高管理者参与。不能以完全审核管代或其他授权人取代对领导层的审核。当最高领导者不能出席或不能全程参与审核时，可以视频、电话或其他方式沟通参与审核过程。

When audit the top management, it shall be ensured that the GM participate in it. The audit of management representative or other authorized person can not replace the audit of the top management. When the GM can not attend or can not participate in the whole audit, he can participate in the audit process through video, telephone or other means of communication.

4.4.2.4第二阶段现场审核及审核的后续活动的实施：

Implementation of on -site audit of stage 2 and its following activity

a.首次会议Opening meeting

首次会议由审核组长主持召开，与受审核方的管理层、主要职能部门负责召开正式的首次会议，时间一般应控制在0.5小时。首次会议参加人员应在《首次会议签到表》签名。会议目的是简要解释将如何进行审核活动，并应包括下列内容：

Opening meeting, as the formal opening meeting with the client’s management, and those responsible for functions or processes to be audited, which shall be held by audit leader, and the time is controlled within half an hour generally. The “Audit Attendance register for Opening Meeting” shall be filled on the meeting. The purpose of meeting is to provide a short explanation of how the audit activities will be undertaken and shall include the following elements:

1. 介绍参会人员，包括简要介绍其角色。

Introduction of the participants, including an outline of their roles

2. 确认认证范围。

Confirmation of the scope of certification

3. 确认审核计划（包括审核类型、范围、目的和准则）及其变化，以及与受审核方的其他相关安排，例如末次会议日期和时间，审核期间审核组与受审核方管理层会议日期和时间；

Confirmation of audit plan(including types and scope of audit, objectives and criteria), any changes, and other relevant arrangements with the client, such as the data and time for the closing meeting, interim meetings between the audit team and the client’s management.

4. 确认审核组与受审核方之间的正式沟通渠道。

Confirmation of formal communication channels between the audit team and the client.

5. 确认审核组可获得所需的资源和设施。     

Confirmation that the resources and facilities needed by the audit team are available  

6. 确认与保密有关的事宜。

Confirmation of matters relating to confidentiality

7. 确认适用于审核组的相关的工作安全、应急和安保程序。

Confirmation of relevant work safety, emergency and security procedures for the audit team

8. 确认可得到向导和观察员及其角色和身份。

Confirmation of the availability, roles and identifies of any guides and observers.

9. 报告的方法，包括审核发现的任何分级。

The method of reporting, including any grading of audit findings

10. 说明可能提前终止审核的条件。

Information about the conditions under which the audit may be prematurely terminated

11. 确认审核组长和审核组代表公司对审核负责，并应控制审核计划的执行。

Confirmation that the audit team leader and audit team representing HIC is responsible for the audit and shall be in control of executing the audit plan including audit activities and audit trails.

12. 确认以往评审或审核的发现的状态（如对一阶段审核、上次监督审核）。

Confirmation of status of findings of the previous review or audit（such as: stage 1, last surveillance audit）

13. 基于抽样实施审核的方法和程序。

The methods and procedures to be used to conduct the audit based on sampling

14. 确认审核中使用的语言。

The confirmation of language to be used during the audit

15. 确认在审核中将告知受审核方审核进程及任何关注点。

Confirmation that, during the audit, the client will be kept informed of audit progress and any concerns

16. 让受审核方代表提问。

Opportunity for the client to ask question

备注：一二阶段首次会议内容均应覆盖以上内容，不能因为一阶段已说明会议内容，而在二阶段省略。

Note: The content of the first meeting in the first and second stages should cover the above content, and the content of the meeting cannot be omitted in the second stage because the content of the meeting has been explained in the first stage.

b.为审核组配备向导。

b. Guide(s)are assigned to the audit team to facilitate the audit.

c. 现场收集审核证据。审核员可采用以下方法收集证据：

c. collecting the audit evidence, the auditor can use following methods to collect the evidence:

—利用提问和听取谈话收集证据。

-question and interviews

—利用审查文件、资料、记录收集证据。

-review of documentation and records

—利用观察生产、工作活动和情况收集证据。

-observation of the processes and activities

—利用抽取已有的测试结果进行重新测试收集证据。

- Re-test the result of tested products

d) 审核员应采取客观、公正的态度随机抽样，坚决杜绝送样，保证抽样具有代表性。

d. Auditor shall do the random sampling with objectivity and impartiality for ensuring its representativeness of the sample, never allow the auditee to select the audit samples.

—多场所审核的场所抽样要求，依据《多场所认证管理要求》实施审核。

The requirements for sampling of multi-sites, the audit shall be conducted in Management Requirements for Multi-site Certification

—监视测量设备审核抽样要求：按受审核方申请提供的最新监视测量设备清单（有经受审核方盖章签字确认）。属于强制检定目录的监视测量设备和用于最终成品检验的监视测量设备需100%检定；仅用于进料、制程、非强制检定的监视测量设备按照以下表格的抽样方法实施抽样，抽样时需覆盖各种不同类型监视测量设备,不可避重就轻。强检范围为：《中华人民共和国强制检定的工作计量器具检定管理办法》中列出用于贸易结算、安全防护、医疗卫生、环境监测；苏州辖区企业强检的范围，依据《苏州市计量监督管理办法》予以实施。

-the requirements for sampling of monitoring and measuring equipment: the client shall provide the list of monitoring and measuring equipment(with stamp on), the monitoring and measuring equipment under the mandatory verification catalog and monitoring and measuring equipment used for the final inspection need 100% full verification. The monitoring and measuring equipment used for the material purchased, manufacture procedure, or optional verification can be sampled based on below sampling methods, the sampling shall cover the monitoring and measuring equipment with each types, shall not avoid the important and dwell on the trivial. The mandatory inspection scopes are stated in the Measure of People's Republic of China on Administration of Mandatory Inspection of monitoring and measuring Equipment.  

名称/Name	样本总数/ The total number of samples	抽样方法/sampling method
强制检定监视测量设备 monitoring and measuring equipment for mandatory inspection	任何数量/ any number	100%全检/100% full inspection
成品检验监视测量设备/ monitoring and measuring equipment for final inspection	任何数量/ any number	100%全检//100% full inspection
其他监视测量设备/other monitoring and measuring equipment	任何数量/ any number	20%当样本量少于5个时，需至少抽取1个样本。 20%, when the samples are less than 5, the sampling should be one

—特种设备审核抽样方案：按受审核方申请提供的最新特种设备清单（有经受审核方盖章签字确认），受审核方应对所有特种设备按规定实施登记备案和定期检定，审核员现场审核时数量小于等于20件时需50%随机检查符合性，当大于20件时在抽取10件的基础上需另随机抽取超出20件部分的20%。具体见以下表格：

Sampling plan for special equipment: the client shall provide the list of special equipment, the client shall register all the special equipment and have the regular inspection, the auditor shall have 50 % casual inspection when the numbers of special equipment is less than 20, when the numbers is over 20, the sampling size shall be 10+（total number-20）*20%

样本总数// The total number of samples	抽样方法/sampling method
小于等于20件/Less than 20	50% 当样本量少于5个时需全检 Full inspection when the number is less than 5
大于20件/over 20	10+（总数-20）*20% 10+（total number-20）*20%

 

e.审核组长必要时在审核组成员之间重新分配工作，并定期将审核进程及任何关注告知受审核方。当可获得的审核证据显示审核目的无法实现，或显示存在紧急和重大的风险时，审核组长应向受审核方和公司审核部报告这一情况，以确定适当的行动。该行动可以包括重新确认或修改审核计划，改变审核目的或审核范围，或者终止审核。审核组长应向公司审核部报告所采取行动的结果。如果在现场审核活动的进行中发现重要的信息发生改变：如申请人数、被审核方名称、地址、认证范围所覆盖的产品等。审核组长应与受审核方确认并填写《管理体系变更申请表》提交公司项目管理人员对变更内容评审后决定采取的相应的措施并告知审核组长。

Audit team leader shall re-assign the task to other member of auditor, as appropriate, inform on a regular basis the audit progress and any concerns to client. The audit evidence obtained indicates the audit objective can not be achieved, or there is the probability of emergency or risk, the audit team leader shall notify the client and audit department to decide what the appropriate action can be taken. Appropriate actions can include confirmation and modification of audit plan, change of audit objectives or scope of certification, or termination of audit. The results from the action taken shall be informed to audit department by audit team leader. If the changes taken on on-site audit activities include the change of number of personnel，the name, address, and scope of certification. Audit team leader shall confirm with the client and complete the management system change application form to project management staff who will get it back to leader after the review of change.

f.审核员在收集证据过程中，应互相合作，互通信息，正确对待和妥善处理各种情况，保证审核工作顺利进行。

On the process of collecting evidence, auditors shall cooperate with each other, exchange information, and treat various situations rightly and properly to ensure the audit be completed successfully.

g.审核员在审核OHSMS过程中，应面谈以下人员During the audit of the OHSMS, the auditor should interview the following persons：

1）负责 OHS 法律责任的管理者The management with legal responsibility for Occupational Health and Safety；

2）负责 OHS 的员工代表Employees' representative(s) with responsibility for Occupational Health and Safety；

3）负责监视员工健康的人员，如医生和护士。远程面谈的理由应被记录Personnel responsible for monitoring employees' health, for example, doctors and nurses. Justifications in case of interviews conducted remotely shall be recorded；

4）管理人员、长期和临时员工Managers and permanent and temporary employees.

5）亦面谈的其他人员，如Other personnel that should be considered for interview are：

1. 从事与预防 OHS 风险相关活动的管理人员和员工Managers and employees performing activities related to the prevention of Occupational Health and Safety risks；
2. 承包方的管理者和员工Contractors’management and employees.

h.审核组应对审核发现进行分析，确认不符合事实，开具不符合报告，不符合项的性质分强制性不符合项（分一般不符合和严重不符合），推荐性不符合项（即观察不符合）；不符合项应以客观事实为基础，以审核准则为依据，经审核组充分讨论和受审核方确认。

Audit team shall analyze the audit findings and confirm the nonconformities and raise the nonconformity report, the nonconformity can be divided into mandatory nonconformity(minor and major), opportunity for improvement（OFI）. Nonconformity shall be raised according to objective fact and audit criterion, and it shall be discussed sufficiently by audit team and confirmed by audited party.

1. 强制不符合项的定义：出现下列情况之一者即构成强制性不符合项。

Mandatory nonconformity: any one of following item is met, the mandatory nonconformity shall be raised.

—未能满足管理体系标准的一项或多项要求；或

absence of or failure to implement and maintain one or more requirements for management system

—对受审核方管理体系实现预期结果的能力产生重大怀疑的情况； 

The significant doubt with regard to the competence of the intended results achieving for management system

2. 推荐性不符合项定义：出现下列情况之一者即构成推荐性不符合项。

Opportunity for improvement（OFI）：the following situations found will raise OFI

—潜在的不符合，但在审核时没有客观证据证明其为不符合。

-Potential nonconformity, but no objective evidence shows it is the nonconformity during the audit.

3) 强制性不符合分为严重不符合项和一般不符合项，无论客户纠正时限的长短，均须严格按照以下整改时限进行整改：

Mandatory nonconformity is divided into major nonconformity and minor nonconformity, the time limit for correction and corrective measures taken for mandatory nonconformity(major, minor)( applicable to all audit type) shall be as follows:

严重不符合：受审核方已发生重大的产品质量/环境/职业健康安全/信息安全、能源管理事故或事故的隐患，或发现受审核方存在违反国家法律法规，或受审核方对审核活动不予配合导致审核活动无法进行，或体系存在重大缺陷不符合认证标准要求等情况。审核组应立即通知公司项目管理员，并得到审核部经理批准后终止现场审核活动，审核组向受审核方开具不符合项报告（严重），现场审核不予通过。严重不符合项的整改周期为现场审核结束日起90日内受审核方提交原因分析和纠正/纠正措施向公司申请，待受审核方全部纠正完毕后申请重新实施现场审核。

Major nonconformity: If the client has the major quality /environmental accidents on products/services or accident potential, or find that the organization has violated the state laws and regulations，or have major nonconformity in system(refer to never conduct internal audit, management review, no planning or planning failure), the audit team shall notify the project management staff, and terminate the audit activities after the approval from the head of audit department., audit team leader shall take record in management systems audit detail report. The client shall submit the plan including the root cause, corrections/corrective measures within 90 calendar days from the date when the audit is ended. The audit team shall verify on site. After the verification in writing make by audit team leader, the organization can re-apply for audit after the major nonconformities were closed.  

一般不符合项：除上述严重不符合事实外，均为一般不符合项。审核组向受审核方开具不符合项报告，一般不符合项的整改周期为现场审核结束日起90日内，受审核方提交对原因分析和纠正/纠正措施，经审核组长书面验证通过后方可推荐认证注册，超期或受审核方的整改及措施没有得到审核组书面验证合格的，审核组将不予推荐受审核方认证注册。

For a minor nonconformity, client shall submit a plan with root cause and correction/corrective measure within 90 calendar days from the date the audit is finished. The audit team shall verify on site. After the verification in writing make by audit team leader, the registration of certification shall be proceed, If not, the registration of certification shall not be proceed

推荐性不符合项原则上审核组不要求受审核方予以纠正和反应。但是推荐性不符合项的信息也需要写入审核检查记录中和审核报告中。属于不符合的审核发现不应作为改进机会予以记录。审核员应避免提示客户不符合的原因或解决方法。

For an OFI, there is no requirement to submit a correction or response, but audit team shall record into the audit record and audit report. The NCRs can’t be record as OFI. The auditor however shall refrain from suggesting the cause of nonconformities or their solution.

i.审核组内沟通会：internal communication meeting in audit team

在末次会议前，审核组长按照审核计划安排组织审核组成员进行内部沟通会议，沟通交流审核进展、与受审核方的信息等状况。沟通会议内容主要包括编制《管理体系审核不符合项报告》、收集和核实审核检查记录、综合判断管理体系的有效性、准备审核报告。

Before the closing meeting, audit team leader shall carry out internal communication meeting with other member of auditor about the audit progress, the information with client based on the audit plan, the communication meeting include preparing the management systems audit detail report, collection and verification of audit record, confirmation of the effectiveness of management system, preparation of audit report.

j.准备审核结论preparing the audit conclusion

在末次会议前，审核组长应解决审核组与受审核方之间关于审核证据或审核发现的任何分歧意见，未解决的分歧点应记录。审核组应：

Prior to closing meeting, audit leader shall settle the divergent views between the audit team and client on the audit evidence and audit finding, the divergent views unsettled shall be recorded, the audit team shall：

1. 对照审核目的审查审核发现和审核中收集的任何其他适用的信息。

Review the audit findings, and any other appropriate information collected during the audit, against the audit objectives

2. 考虑审核过程中内在的不确定性，就审核结论达成一致。

Agree upon the audit conclusions, taking into account the uncertainty inherent in the audit process

3. 确定任何必要的跟踪活动。

Identify any necessary follow-up actions

4. 确认审核方案的适宜性，或识别任何所需要的修改（例如范围、审核时间或日期、监督频次、能力）。

Confirm the appropriateness of the audit programme or identify any modification required(e.g. scope, audit time or dates, surveillance frequency, competence, any concern for next audit)

k.与受审核方的交流会Communication with clients

在末次会议前，审核组长代表审核组与受审核方代表（最高管理层、管理者代表）在审核结束后与管理层交流审核情况，审核组应向受审核方管理层报告审核主要发现（包括正面的）、审核结论和提出不符合，提交给客户书面的不符合项报告。同时审核组长应给予受审核方提出问题的机会。以确保证据准确且不符合得到理解，与审核组的任何分歧意见得到解释和澄清。审核组长应记录任何未解决的分歧意见并提交公司。

Prior to closing meeting, audit team leader representing the audit team shall communicate with the client’s management( management representative) about the audit. Audit team shall clarify the audit findings (including the strengths and weakness), audit conclusion and nonconformity. Audit team shall send the client written nonconformity report. And audit team leader shall give me the opportunity to client for raising the questions. Which ensure the evidence is sufficient and the nonconformity has been clarified, the divergent views with the audit team have been explained and clarified, the divergent views unsettled shall be recorded and submit to HIC.

l.末次会议 Close meeting

审核组应与受审核方的管理层、部门的负责人召开一个末次会议。应要求组织代表邀 请负有 OHS 法律责任的管理者，负责监视员工健康的人员、 负责 OHS 的员工代表参加末 次会议。如不能如期参加，应记录缺席的理由。

The audit team shall hold a closing meeting with the auditee's management and department heads.The organization representative shall be requested to invite the management legally responsible for occupational health and safety, personnel responsible for monitoring employees’ health and the employees' representative(s) with responsibility for occupational health and safety to attend the closing meeting. Justification in case of absence shall be recorded.

在末次会中所有参加会议人员须在《末次会议签到表》签到，时间一般控制在0.5小时。末次会议包括下列内容：

1. 向受审核方说明所收集的审核证据基于对信息的抽样，因而会有一定的不确定性；

Advising the client that the audit evidence collected was based on a sample of the information, thereby introducing an element of uncertainty.

2. 进行报告的方法和时间表，包括审核发现的任何分级；

The method and timeframe of reporting, including any grading of audit findings

3. 确认企业已收到书面的不符合项报告；

Confirm the auditee has received the written non- conformity report

4. 审核组、公司处理不符合的过程；

Audit team and HIC’s Process for handing nonconformities

5. 受审核方为审核中发现的任何不符合的纠正和纠正措施提出计划的时间表；

The timeframe for the client to present a plan for correction and corrective action for any nonconformities identified during the audit

6. 认证机构在审核后的活动；

HIC’s post audit activities

7. 说明投诉处理过程和申诉过程。

Information about the complaint handing and appeal processes

备注：一二阶段末次会议内容均应覆盖以上内容，不能因为一阶段已说明会议内容，而在二阶段省略。

Note: The content of the final meeting of the first and second stages should cover the above content, and the content of the meeting cannot be omitted in the second stage because the content of the meeting has been explained in the first stage.

m.审核报告编制 preparing audit report

公司于每次审核结束认证决定完成后向客户邮寄书面审核报告。公司享有对审核报告的所有权。审核组可以识别改进机会，但不应提出具体解决办法的建议。

HIC shall provide written report by post for each the client, after the certification decision finished. Ownership of the audit report is maintained by HIC. The audit team may identify opportunities for improvement but shall not recommend specific solutions.

审核组长负责审核报告编制并对审核报告内容负责。审核报告要求准确、简明和清晰的记录，以便为公司认证决定提供充分的信息，审核报告至少包括或引用下列内容：

Audit team leader shall ensure that the audit report is prepared and shall be responsible for its content. The audit report shall provide an accurate, concise and clear record of the audit to enable an informed certification decision to be made and shall include or refer to the following:

1. 注明认证机构。

Identification of the certification body

1. 受审核方的名称和地址及其管理者代表。

The name and address of the client and the client’s management representative,

1. 审核的类型（例如初次、监督或再认证审核）。

The type of audit(e.g. initial, surveillance or recertification audit)

1. 审核准则。

The audit criteria

1. 审核目的。

Audit objectives

1. 审核范围，特别是标识出所审核的组织或职能单元或过程，以及审核时间；

Audit scope, especially marking the audited organization or function unit or procee, and audit time;

7）任何偏离审核计划的情况及其理由；

Any deviation from the audit plan and their reasons; 

8. 任何影响审核方案的重要事项；

Any significant issues impacting on the audit programme;

9) 注明审核组长、审核组成员及其个人注册信息，以及任何与审核组同行的人员；

Note the lead auditor, audit team member and its personal registration information, and any personnel accompany with the audit team;

10) （现场或非现场）审核活动的实施日期和地点。

(on-site or offsite) audit activities implementation date and site;

11)  应叙述审核工作情况，按与审核类型的要求一致的审核要求逐项就审核证据、审核发现和审核结论进行详细描述；对目标实现情况的评价，应同时叙述测量方法；

To state the audit working situation, according to the audit type, to describe the audit evidence, audit finding and audit conclusion one by one; to assess the situation of the objective achievement, and meanwhile state the way of measuring;

12) 如有时，在上次审核后发生的影响客户管理体系的重要变更；

Significant changes, if any, that affect the management system of the client since the last audit took place;

13) 识别出的不符合项。不符合项的表述，应基于客观证据和审核依据，用写实的方法准确、具体、清晰描述，易于被申请组织理解。不得用概念化的、不确定的、含糊的语言表述不符合项；

To identify the nonconformity. Nonconformance shall be raised according to objective fact and audit criterion, and it shall be described  correctly, concretely, clearly, and easily understood  by the applying organization. And the conceptualized, uncertain, vague expression can’t be used to describe the nonconformity.

14)已识别出的任何未解决的问题；

Any unresolved issues, if identified

15) 适用时，是否为结合、联合或一体化审核；

Where applicable, whether the audit is combined, joint or integrated;

16) 说明审核基于对可获得信息的抽样过程的免责声明；

A disclaimer statement indicating that auditing is based on a sampling process of the available information;

17) 适用时，接受审核的客户对认证文件和标志的使用进行着有效的控制；

The audited client is effectively controlling the use of the certification documents and marks, if applicable;

18) 适用时，对以前不符合采取的纠正措施有效性的验证情况。

Verification of effectiveness of taken corrective actions regarding previously identified non-conformities, if applicable.

19) 审核组对是否通过认证的意见建议

The audit team’s opinion and recommend about whether pass the certification or not.

审核报告还应包含：

The audit report shall also contain:

1) 关于管理体系符合性与有效性的声明以及对下列方面相关证据的总结：

A statement on the conformity and the effectiveness of the management system together with a summary of the evidence relating to:

-- 管理体系满足适用要求和实现预期结果的能力；

The capability of the management system to meet applicable requirements and expected outcomes;

-- 内部审核和管理评审的过程；

The internal audit and management review process;

2)对认证范围适宜性的结论；

A conclusion on the appropriateness of the certification scope;

3) 确认是否达到审核目的。

Confirmation that the audit objectives have been fulfilled;

n) 不符合项关闭 Close of Non-conformance

审核组应在末次会议上要求客户在规定期限内（严重不符合项30天内，再认证证书到期前，一般不符合项90天内）分析原因，并说明为消除不符合已采取或拟采取的纠正和纠正措施。

The audit team shall ask the client for complete the root cause, corrections, corrective actions in deadline (the major shall be closed in 30 days, and before the expiry date of re-certification; the non-conformance shall be closed in 90 days).

审核组应于客户在规定期限内完成原因分析、纠正和纠正措施并提交符合要求的证据后关闭不符合项。

The audit team shall close the non-conformance after verify the root cause, corrections, corrective actions and evidence submitted by client in deadline

原因分析是不符合发生的分析，不能就事论事，需从人员执行的有效性、文件规定、操作流程、外部规定等角度进行分析。纠正是针对发生的问题遏制结果。纠正措施是系统性长期的措施，以防止不符合项的再次发生，需根据原因分析，从人员执行的有效性、文件规定、操作流程等角度采取措施避免问题再次发生。

Root cause is the analysis of non-conformance raised, shall be analysised from the personnel implementation, documents requirement, operation process, external regulation. Correction is to stop the result of nonconformance. Corrective action is long-term and system measures, in order to prevent from nonconformance occur again, to be evaluated from the root cause.

未满足以上要求的不符合项不能关闭。审核组长应告知客户纠正、纠正措施的有效性审核和验证结果。

If the root cause, corrections, corrective actions doesn’t meet those requirements, the nonconformance can’t be closed. The lead auditor shall inform the client of the result of the review and verification for correction and corrective actions.

如果为了验证纠正和纠正措施的有效性，将需要补充一次全面的或有限的审核，或者需要文件化的证据（需要在未来的审核中确认），则公司应通过市场部或客服部告知客户。

The client shall be informed by the marketing department or client service department if an additional full audit, an additional limited audit, or documented evidence (to be confirmed during future audits) will be needed to verify effective correction and corrective actions.

o)审核结束后，审核组长按照审核清单上报资料，将有关审核文件提交审核部确认无材料遗漏后提交认证决定人员进行资料审定并做出认证决定。

After the completion of audit, the audit team shall gather, organize and pack the audit records and lists, and submits relevant audit material to audit department for confirmation. If complete, audit department will submit to certification decision maker for them to make the certification decision.

p) 对终止审核的项目，审核组应将已开展的工作情况形成报告，认证机构应将此报告及终止审核的原因提交给申请组织，并保留签收或提交的证据。

For the project which is terminated, the audit team shall form the report about the implemented working situation, the certification body shall submit this report and the reason for terminating the audit to the applying organization, and the evidence of sining for receiving or submitting evidence shall be kept.

4.4.2.5初次认证的审核结论 The audit conclusion of initial certification

审核组应对第一、二阶段审核中收集的所有信息和证据进行分析，评价，以评审审核发现并得出一致的审核结论。

Audit team shall analyze and evaluate all the information and evidence collected in the audits of stage 1 and stage 2, review audit findings and reach a consistent audit conclusion.

4.5保持认证Maintaining Certification

4.5.1 如果本机构发现获证组织发生了与 OHS 有关的严重事件，如严重事故或严重违法，有必要实施独立于监管机构的特殊审核，以便调查管理体系是否存在严重问题以及是否有效发挥作用。审核组应记录调查的结果。

If the agency finds that a serious incident related to OHS has occurred in a certified organization, such as a serious accident or serious violation of law, it is necessary to conduct a special audit independent of the regulatory body in order to investigate whether there are serious problems with the management system and whether it is functioning effectively. The audit team shall document the results of the investigation.  

4.5.2 由获证客户提供的或在特殊审核期间，审核组直接收集的有关导致监管机构参与（调查）的事件信息，如严重事故或严重违法（行为），应为本机构提供决定采取措施的理由，如果，一旦证明体系严重地不能满足 OHSMS 认证要求，应采取暂停或撤销认证的措施。这些要求应在认证机构和组织签署的合同协议中明确。

Information provided by certified clients or directly collected by the audit team during a special audit about events leading to the involvement of the regulator (investigation), such as a serious accident or serious violation of law (act), shall provide the agency with reasons for deciding to take action, If, once it is proved that the system is seriously unable to meet the OHSMS certification requirements, measures should be taken to suspend or withdraw the certification. These requirements should be specified in the contractual agreement signed by the certification body and the organization.

4.5.3 监督审核Surveillance

4.5.3.1 监督审核的目的：Purpose

在获证组织的证书有效期（三年）应定期实施监督审核，以验证其管理体系是否持续满足认证要求，保持认证资格。

Surveillance shall be implemented regularly within the valid period (three years) of certificate for certified organization to verify that whether the management system can continually meets the certification requirements and keep the registration.

4.5.3.2 监督审核的频次 Frequency of surveillance

在认证证书有效期内，审核部需按照认证合同的要求对获证组织进行例行的监督审核。

During the validity period of the certification, the audit department shall carry out routine surveillance audit on the certificated organization in accordance with the requirements of the certification contract.

4.5.3.3 监督审核的内容及要求Surveillance Contents and Requirements

监督审核应在获证组织现场进行。由于产品生产的季节性原因，在每次监督审核时难以覆盖所有产品的，在认证证书有效期内的监督审核需覆盖认证范围内的所有产品。应按照初次审核方案策划和审核组长策划的条款和区域的实施监督审核，主要要求如下：

The surveillance audit shall be conducted on the site of the certified organization. Due to the seasonal reasons of product production, it is difficult to cover all products in each surveillance audit, and the surveillance audit within the validity period of certification certificate shall cover all products within the scope of certification. The surveillance audit shall be carried out in accordance with the terms and areas planned by the initial audit plan and the audit team leader. The main requirements are as follows:

4.5.3.3.1 针对不同的受审核方的实际情况，监督审核的抽样要抽有代表性的区域和职能；

Sampling of surveillance should be conducted on the representative and function area according to the facts of situation of different audited party

4.5.3.3.2 监督审核前受审核方应按规定的时间间隔实施了内审和管评；

Audited party shall implement internal audit and management review within the specified interval before surveillance on site audit.

4.5.3.3.3 应包括以下方面的审核It includes following aspects:

——上次审核以来管理体系覆盖的活动及运行体系的资源是否有变更；

Whether the activities covered by the management system and system resources have been changed since last audit;

——已识别的重要关键点是否按管理体系的要求在正常和有效运行；

Whether the identifies important key points have conducted normally and effectively according to the requirement of management system;

——对上次审核中确定的不符合项采取的纠正和纠正措施是否继续有效；

Whether the correction and corrective action for nonconformity of last audit is continuously effective;

——管理体系覆盖的活动涉及法律法规规定的，是否持续符合相关规定；

Whether the laws and regulations involved in the activities covered by the management system continuously conforms to the relevant stipulation;

——总目标及各层级目标是否实现。目标没有实现的，获证组织在内部管理评审时是否及时调查并采取了改进措施；

Whether the general objective and all the grading objectives have been achieved. If the objective has been achieved, whether the certified organization has investigated timely and taken improving measures in the internal management review;

——获证组织对认证标志的使用或对认证资格的引用是否符合相关的规定；

Whether the use of the certification mark or the reference for the certification qualification conforms to the relevant stipulations;

——内部审核和管理评审是否规范和有效；

Whether the internal audit and management review is normative and effective;

——是否及时接受和处理投诉；

Whether the complaint can be accepted and treated timely;

——针对内审发现的问题或投诉的问题，及时制定并实施了有效的持续改进；

For the internal audit findings or complaints, the continuously effective improvement was developed and carried out;

——管理体系在实现获证客户目标方面的有效性；

Effectiveness of management system on achieving the objective of certified client;

——持续的运作控制 Continual operation control

——为持续改进而策划的活动的进展。

Development of the activity planed for continual improvement

ISO9001:2015必审条款：6.2、9.3、7.1.3（指特种设备）、8.3、8.5.1、7.1.5、9.2、8.6、10.3. 涉及GB/T50430的同时需覆盖条款：3.2、5.2(人员资质)、6.3（施工机具）、7.3、8.3、8.4、10.2、10.3、10.4、10.5、10.6、11.2、11.3、11.4、12、13（改进）。

Necessary clauses for ISO9001:2015: 6.2、9.3、7.1.3（special equipment）、8.3、8.5.1、7.1.5、9.2、8.6、10.3. When involved in GB/T50430 at the same time, the following clause shall be covered：3.2、5.2(personnel qualification)、6.3（construction equipment）、7.3、8.3、8.4、10.2、10.3、10.4、10.5、10.6、11.2、11.3、11.4、12、13（improvement）.

ISO14001:2015必审条款: 6.1.2、 6.1.3、 6.2.1、 6.2.2、 8.1、9.1、 9.1.1、9.1.2、 9.2.1、 9.2.2、 9.3、10，当管理体系发生变化时应审核：4.4、 6.1.3、7.1、7.5、7.5.1、 7.5.2。

Necessary clauses for ISO14001:2015: 6.1.2、6.1.3、6.2.1、6.2.2、8.1、9.1、9.1.1、9.1.2、9.2.1、9.2.2、9.3 、10，when the management system has change, the following shall be audited：4.4、 6.1.3、7.1、7.5、7.5.1、7.5.2.

OHSMS必审条款:  5.4、6.1.2、 6.1.3、 6.2.1、 6.2.2、 8.1、9.1、 9.1.1、9.1.2、 9.2.1、 9.2.2、 9.3、10。

Necessary clauses for OHSMS:  5.4、6.1.2、 6.1.3、 6.2.1、 6.2.2、 8.1、9.1、 9.1.1、9.1.2、 9.2.1、 9.2.2、 9.3、10。

4.5.3.3.4监督审核的准备与实施要求同初审。Preparation of surveillance and its implementation requirements equal to initial audit .

4.5.3.3.5监督审核/再认证报告除应包括初审审核报告要求的全部内容外还应包括对前次审核发现的不符合的纠正情况，审核组应提出是否继续保持认证证书的意见建议。

In addition to all contents required in initial audit report, surveillance/recertification report shall also contain the correction for the nonconformity of last audit. The audit team shall come up with the opinion and suggestions whether the certification certificate will be kept or not.

4.5.4 特殊审核 Special audit

4.5.4.1 特殊审核的目的：为确认获证组织的管理体系因非常规的变更是否持续有效；

Purpose: To ensure that management system of certified organization is continual effective due to unconventional changes.

4.5.4.2获证组织在认证证书有效期内出现以下情况时，应进行特殊审核：

Certified organization shall carry out special audit when following situations happened within the valid period of certificate

a.获证组织出现重大变更可能影响组织的活动与运行（例如：管理层人员发生改变、组织地址变迁、所有权变更、设备重大改变、组织机构发生重大变化等）；

Certified organization has major changes may affect the activity and operation of organization (such as ownership of organization, changes of personnel and equipment etc)

b.获证组织发生了重大质量/环境/安全事故；

Major quality/environment accident

c.相关方严重投诉、抱怨，或其他来自相关方的信息的分析，表明已获证的组织不再满足认证机构的要求；

Relevant parties’ major complaints or the analysis of information from other relevant parties proves that certified organization will no longer meet the requirements of certification body

d.距上次现场审核时间超过合同规定时间，且办理过暂停或撤销手续后再次恢复的监督审核。

This audit date to last audit exceeds the time limits as stated in the agreement and suspended client be reinstated.

e.扩大认证范围的审核。（一般的，这类审核活动可和监督审核同时进行）。

Audit for scope extension(in general, the audit can be conducted together with surveillance audit)

4.5.4.3特殊审核的实施 Implementation of special audit 

a.现场审核人日数、审核目的、审核内容、审核范围等应按审核方案策划实施；

On-site audit duration, audit purpose, contents and scope shall be implemented according to audit program.

b.对已获证组织申请扩大认证范围，组织需填写《管理体系变更申请表》及相关的证明性文件，经评审合格后，由审核项目管理人员策划审核方案，确定审核时间，审核项目管理人员应根据新的审核范围所涉及活动/产品的复杂性、可能的风险等级、组织新增规模等因素确定增加的审核人日。

If certified organization applies for increasing certification scope, it need to fill in the “Management System Change Application From”. The audit program management personnel responsible for planning audit after changed reviewed. When determine the audit duration, the audit program management personnel shall consider the increased scope relevant activity/product complexity, possible risk level and organization scale.

c.制定审核计划应考虑审核组的专业能力，尽可能安排一名上次审核组成员参与本次审核，如不能安排时，应向审核组提供上次审核相关背景资料和信息，使其做好充足的审核前的准备工作。

It shall consider the technical competence when the audit plan is established and makes effort to arrange a member of last audit team to attend this audit, if not, it shall provide the relevant background documents and information about last audit to audit team for making a sufficient preparation before audit.

d.特殊审核的条款应由项目管理人员根据4.6.2条款描述的具体情况进行策划。

Clauses of special audit shall be planned by project management personnel according to the specific contents described in clause 4.6.2.

4.5.5 再认证审核 Recertification

4.5.5.1再认证的目的Purpose

再认证审核为现场审核。再认证的目的是确认获证组织的管理体系作为一个整体的持续符合性与有效性，以及与认证范围的持续相关性和适宜性。

The recertification audit shall be carried out on site. The purpose is to verify whether the management system of certified organization fully meets requirements of management system standards continually and whether it keeps the continual effectiveness on the whole, which is to confirm whether the certification registration be maintained.

4.5.5.2 再认证的受理要求Acceptance requirements of recertification

认证证书期满前，若获证组织申请继续持有认证证书，认证机构应当实施再认证审核决定是否延续认证证书。客服部在获证组织注册证书有效期满前三个月向受审核方发出《再认证通知函》。

Before the expiry date of the certification certificate, if the certified organization applies for continuously keep the certification certificate, the certification body shall carry out recertification audit to decide whether the certificate shall be maintained. Customer service department shall issue the “Recertification Notification Letter” to certified organization client at the three months before the expiration date.

4.5.5.3 再认证的内容及要求Contents and requirements of recertification

4.5.5.3.1在上一周期的证书到期前，应关闭再认证审核的严重不符合；

It shall close the major nonconformity raised by recertification before last date of expiration period;

4.5.5.3.2当管理体系及组织或管理体系的运作环境发生重大变更时，如认证范围变更，场所增加，组织结构变化，法规要求变化等，再认证可能需要一阶段审核，具体由审核项目管理人员策划审核方案；

When the management system, the organization, or internal and external environment of the organization has major changed, such as the certification scope changed, added places, structure changed or relevant laws changed, the recertification might need stage 1 audit, and the audit projects management personnel shall plan the audit scheme;

4.5.5.3.3如无重大变化，可以不进行第一阶段现场审核，但至少包括文件审核和现场审核，再认证的内容与初审相同，此外还应审核组织投诉、申诉记录以及前此审核发现的不符合项所采取的纠正措施；

If there is no major change, the stage 1 cannot be conducted, but it shall include document review and on-site audit at least. The content of recertification audit is same as the initial audit stage 2. In addition, the audit shall be conducted for complaints of organization, appeals record and the corrective actions of nonconformity in previous audits;

4.5.5.3.4再认证所需的人日数执行《审核活动工作人日管理程序》的规定。

The audit duration o recertification shall be executed as the specifications of the “Audit Duration Management Requirements”.

4.5.5.3.5再认证前还需对组织管理体系在上一个认证周期的实施与绩效的的考核进行一次评审；审核组应根据获证组织上一周期内每次审核的审核报告和不符合项报告，综合多方信息,包括：以往审核报告对体系运行绩效的评价、针对不符合项采取纠正措施的有效性、体系持续运行情况等。对上一认证周期运行绩效进行评价,评价内容应涵盖：管理体系是否持续有效运行、以往针对不符合项采取的纠正措施是否持续有效、受审核方管理体系自我纠正自我改进的机制是否持续有效等方面，从而对管理体系持续的适宜性、充分性和有效性作出评价。

The recertification audit will include a recertification review of the previous two surveillance audits and the certificated organization’s performance over the certification period. The review will also cover the non-conformity report of the previous audits of the certified client, as well as the evaluation of the system operation performance in the previous audit report, the effectiveness of correction measures for the findings, the system operation status, etc. For the evaluation of the operation performance of the previous certification period, the following shall be taken into consideration: whether the management system is operated continuously and effectively, whether the correction measures for the previous findings are effective, whether the self-correction and self-improvement system of the auditee is effective, etc. In this way, the suitability, sufficiency and effectiveness of the management system shall be evaluated.

4.5.5.3.6再认证的准备与实施要求同初审。

The preparation and implementation requirements are same as the initial audit.

4.5.5.3.7再认证报告除应包括初审审核报告要求的全部内容外还应包括对前次审核发现的不符合的纠正情况。

In addition to all contents required in initial audit report, recertification report shall also contain the correction for the nonconformity of last audit.

4.5.5.3.8 再认证现场审核包括以下方面内容：

Recertification on site audit shall include the following reviews at least:

a) 结合内外部的变更情况判断整个管理体系的有效性,认证范围的持续相关性和适宜性；

To judge the effectiveness of the management system according to the internal and external changes The continuous relevance and appropriateness of certification scope

b) 对管理体系改进及提高整体绩效的承诺的实现情况；

Achievement for the commitment of improving management system and the whole performance

c) 管理体系在实现获证客户的目标和管理体系的预期结果方面的有效性

the effectiveness of the management system with regard to achieving the certified client’s objectives and the intended results of the respective management system (s).

4. 对上一认证周期年管理体系运行绩效、是否持续满足管理体系运要求等进行审核，并证实体系的有效性得到保持；

Audit for the last certification cycle management system performance, whether meet the demands of the management system operation continuous, and verify the effectiveness of the system is maintained;

5. 持续改进目标和指标是否顺利实现；

Whether realize the continuous improvement objective and indicator

6. 验证上次不符合项纠正措施的有效性，并在审核记录及审核报告中记录关注结果。

Verify the validity of the CARs of last audit, and record the review results in audit record and audit repors.

4.5.5.4 再认证推荐及证书有效期 Re-certification recommend and certificate valid date

4.5.5.4.1 再认证审核在证书到期前完成，且在证书到期前完成对严重不符合项实施的纠正和纠正措施，可推荐再认证。再认证证书有效期为上一周期证书延续三年，本次注册日期不早于再认证决定日期。

If the re-certification audit conducted before the expiry date of the existing certification, and verify the implementation of corrections and corrective actions for any major nonconformity, the client can be recommended and the validity of the certification. The valid date of the re-certification can be based on the expiry date of the existing certification. The issue date on a new certificate shall be on or after the recertification decision

4.5.5.4.2 证书到期前未实施再认证审核，不能推荐再认证或延长认证有效期。

If the re-certification audit has not be completed before the expiry date of the existing certification,, it can’t be recommended, and the validity of the certification shall not be extended.

4.5.5.4.3 证书到期前实施了再认证审核，但未能在证书到期前完成对严重不符合项实施的纠正和纠正措施，不能推荐再认证或延长认证有效期。

If the re-certification audit conducted before the expiry date of the existing certification, but the verify the implementation of corrections and corrective actions for any major nonconformity is not completed before the expiry date, it can’t be recommended, and the validity of the certification shall not be extended.

4.5.5.4.4 证书到期前实施了再认证审核，证书到期前完成对严重不符合项实施的纠正和纠正措施，如能在证书到期后6个月内完成所有不符合项实施的纠正和纠正措施或认证决定，则可推荐再认证并延长认证有效期，证书有效期为上一周期证书延续三年，本次注册日期不早于再认证决定日期。如不能在证书到期后6个月内完成所有不符合项实施的纠正和纠正措施或认证决定，则需至少进行一次二阶段审核才能重新认证。且证书有效期为上一周期证书延续三年，本次注册日期不早于再认证决定日期。

If the re-certification audit conducted before the expiry date of the existing certification, and verify the implementation of corrections and corrective actions for any major nonconformity, when verify the implementation of corrections and corrective actions for all the nonconformity, and HIC make the certification decision within 6 months after the expiry date, the client can be recommended and the validity of the certification. The valid date of the re-certification can be based on the expiry date of the existing certification. The issue date on a new certificate shall be on or after the recertification decision.

If verify the implementation of corrections and corrective actions for all the nonconformity, or HIC certification decision can’t be finished within 6 months after the expiry date, at least a stage 2 shall be conducted to restore certification. The effective date on the certificate shall be on or after the recertification decision and the expiry date shall be based on prior certification cycle.

4.5.5.4.5 客服部应将以上要求告知客户说明后果。

Customer service department shall inform certified clients for those results.

4.5.5.4.6 技委会根据以上再认证审核的结果，以及审核组提供的认证周期内体系评价结果和认证使用方的投诉，执行《认证决定管理程序》，作出是否更新认证的决定。

Certification decision maker of technological department make the decision that whether the certification shall be renewal in accordance with the results of recertification audit and the evaluation results on the system of last certification period and the complaints from relevant parties, according to ‘Certification Decision Management Procedure’.

5保密 Confidentiality

5.1审核组成员对每次审核均签署保密承诺，并经客户确认。

To every audit, the audit team sign for confidentiality commitment letter. The confidentiality commitment letter will be confirmed by the auditee.

5.2 审核组长在首末次会议上告知客户HIC的审核信息保密性要求。

The lead auditor informed the auditee of HIC audit information confidentiality requirement during the opening meeting and closing meeting.

5.3 审核中收集的审核表单之外的过程证据，包括纸质和电子版，应在审核结束后归还受审核方或销毁。

The paper or electronic process evidence collected during audit, excluding audit form, shall be return to the auditee or destructed.

5.4公司应配置确保保密信息（如文件、记录）的安全处理的设备和设施，认证资料由专人保管，确因工作需要查阅时，应办理借阅手续，并做好记录；公司数据库中的客户信息要设置阅览和修改的权限，要有防病毒控制，要定期备份。

HIC shall set the equipment and facility that can ensure the safe processing of the confidential information (such as the documents and records), and the certification documents are kept by specially-assigned person, the lending procedures should be complied and make a record If they are needed in work. The customer information on the company’s database shall be set the privilege to view and modify, and must have the anti-virus control with backup in regular time.

 

6 引用文件和记录表单 References and records

6.1 ISO/IEC 17021《合格评定 管理体系审核认证机构的要求》

ISO/IEC 17021:2015 Conformity assessment -- Requirements for bodies providing audit and certification of management system

6.2 ISO/IEC TS 17021-2《合格评定 管理体系审核与认证机构要求 第2 部分：实施环境管理体系审核及认证的能力要求》

ISO/IEC TS 17021-2, “ Conformity assessment – Requirements for bodies providing audit and certification of management systems – Part 2: Competence requirements for auditing and certification of environmental management systems ”(CNAS-CC121:2013)

6.3 ISO/IEC TS 17021-3《合格评定 管理体系审核认证机构的要求—第3 部分：质量管理体系审核与认证的能力要求》

ISO/IEC TS 17021-3 “ Conformity assessment -- Requirements for bodies providing audit and certification of management systems -- Part 3: Competence requirements for auditing and certification of quality management systems”

6.4 HIC-QC/UD-20《审核活动工作人日管理程序》  

HIC-QC/WI-I14 “ Audit Duration Management Procedure ”

6.5 HIC-QC OD-05 《多场所认证管理要求》  

HIC-QC OD-05  “ Management Requirements for Multi-site Certification”

6.6 HIC-101《认证申请表》  （初审适用） 

HIC-101 “ Certification Application Form ”(Applicable to initial audit)

6.7 《合同评审表》（初审、再认证适用）

“Management System Contract Review Form”(Applicable to Initial audit, Recertification)

6.8 HIC-102《认证服务合同书》（初审、再认证适用）  

HIC-102 “ Management System Certification Agreement” (Applicable to initial audit, recertification)

6.9 《审核任务书》（初审、监督、再认证适用）

 “Audit Notification”

6.10 HIC-208《管理体系审核不符合项报告》（初审、监督、再认证适用）

HIC-208 “Management Systems Audit Detail Report”

6.11 HIC-201《文件审核报告》 （初审、再认证适用）   

HIC-201 “Document Review Report”

6.12 HIC-205 《审核计划》（初审、监督、再认证适用）       

HIC-205  “Audit Plan”

6.13 HIC-210-1 《首次会议签到表》（初审、监督、再认证适用）

HIC-210-1  “Audit Attendance register for Opening Meeting”

6.14 HIC-210-2《末次会议签到表》（初审、监督、再认证适用）   

HIC-210-2 “Audit Attendance register for Closing Meeting”

6.15 HIC-207《审核记录表》（初审、监督、再认证适用）

HIC-207“Checklist” 

6.16 HIC-217 《管理体系变更申请表》（初审、监督、再认证适用）  

HIC-217  “Management System Change Application Form”

6.17 HIC-203《第一阶段审核报告》（初审一阶段审核适用）

6.18 《认证证书确认单》（初审、监督、再认证适用）

 “Certificate Confirmation Form”

6.19 HIC-211《认证人员现场表现见证评价表》（初审、监督、再认证适用）

HIC-211 “Auditor Performance Evaluation Form”

6.20 HIC-213《监视测量设备清单》（初审、监督、再认证适用）

HIC-213 “List of Monitoring and Measuring Equipment”

6.21 HIC-214 《特种设备清单》（初审、监督、再认证适用）

HIC-214 “List of Special Equipment”

6.22 HIC-215 《3年审核方案》（初审、监督、再认证适用）

HIC-215 “Management System Audit Record – 3 Year Plan”

6.23 HIC-218 《审核组现场审核异常处理单》（初审、监督、再认证适用）

HIC-218 “On-site Exception Handling Form”