体系认证实施程序
1.Purpose目的
This procedure is made to make sure that the requirements for the customer management system certification are fully understood, and to carry out application acceptance and audit management in a standardized, consistent, and efficient way, while reducing certification risks.
为确保客户管理体系认证要求能够得到充分理解,规范、一致、高效地开展申请受理与审核管理工作,降低认证风险,特制定本程序。
2.Applicable scope适用范围
This program is used for planning and carrying out the application review, acceptance, initial certification audit, surveillance audit, recertification audit, certificate change audit, and other temporary notification audits for QMS management system certification projects (including certification transfers).
本程序适用于QMS管理体系认证项目(含认证转换)的申请评审、受理和初次认证审核、监督审核、再认证审核、证书变更审核和其他临时通知审核的策划和实施。
3.Terms and Definitions术语和定义
3.1 QMS
A certification project based on GB/T 19001/ISO9001 as the basic audit standard.
以GB/T 19001/ISO9001 为基本审核准则的认证项目。
3.2 Certification Conversion认证转换
TASH recognizes valid management system certifications issued by another recognized certification body in order to grant its own certification.
TASH为了颁发自己的认证,而承认另一个已认可的认证机构颁发的现行有效的管理体系认证。
3.3 Certificate Change证书变更
Reissuing certification certificates for customers to keep the certificate information continuously relevant.
为保持证书信息的持续适宜性而为客户换发认证证书。
3.4 Audit with short advance notice提前较短时间通知的审核
To investigate complaints, respond to changes, or follow up on suspended customers, it may be necessary to carry out audits on certified customers with little prior notice or without notifying them at all.
为调查投诉、对变更做出回应或对被暂停的客户进行追踪,可能需要在提前较短时间通知获证客户或不通知获证客户,就对其进行的审核。
3.5 On-site phase one audit现场一阶段审核
The first phase of the audit carried out at the client's site.
在客户现场实施的第一阶段审核。
3.6 Audit time审核时间
The time needed to plan and complete a full and effective audit of a client organization management system is usually measured in person-days.
策划并完成一次完整有效的客户组织管理体系审核所需要的时间,一般以人天数为单位。
3.7 Technical expert技术专家
Someone who provides specific knowledge or expert advice to the review team.
向审核组提供特定知识或专业意见的人。
3.8 Serious non-compliance严重不符合
Nonconformity that affects the management system's ability to achieve intended results.
影响管理体系实现预期结果的能力的不符合。
3.9 Minor non-compliance轻微不符合
A nonconformity that does not affect the management system's ability to achieve the intended results.
不影响管理体系实现预期结果的能力的不符合。
3.10 Improvement suggestion改进建议
Current evidence shows that the requirement has been effectively implemented, but based on the auditor's experience and knowledge, using some kind of improvement method might be more effective or reliable.
目前的证据显示要求已被有效实施,但是基于审核员的经验和知识,采用某种改进方法可能会更加有效或稳妥。
4.Responsibilities职责
4.1 The audit project manager is in charge of receiving and reviewing applications, creating/updating audit plans, quoting prices and signing contracts, forming the audit team, assigning audit tasks, submitting audit materials, and adjusting audit plans.
审核项目管理人员负责接受和评审申请、建立/修订审核方案、报价和签订合同、组成审核组、下达审核任务、上报审核材料、调整审核方案。
4.2 The lead auditor is responsible for preparing the audit plan, organizing audit preparation, holding the opening meeting, controlling the audit process, communicating with the client, confirming audit findings, organizing the preparation of audit conclusions, holding the closing meeting, drafting and submitting the audit report, organizing the follow-up on nonconformities, archiving audit materials, and participating in adjusting the audit program.
审核组长负责编制审核计划、组织审核准备、召开首次会议、控制审核过程、与客户进行沟通、确认审核发现、组织准备审核结论、召开末次会议、编制和提交审核报告、组织跟踪不符合、归档审核材料,并参与调整审核方案。
4.3 Audit team members are responsible for gathering and verifying information, identifying and recording audit findings, helping prepare audit conclusions, following up on non-conformities, and filing audit materials.
审核组成员负责获取和验证信息、确定和记录审核发现、参与准备审核结论、参与跟踪不符合、归档审核材料。
5.Certification process认证流程
5.1 Certification Customer Information Collection认证客户信息收集
The issuing department should plan and collect information about certified clients through the websites of relevant national and local government authorities as well as mainstream media sites, using this as one way to monitor certified clients. If any negative information about a certified client is found, it should be investigated and verified immediately, and appropriate measures should be taken, including suspending or revoking the certificate. In subsequent certification management and review activities, the risks and impacts of negative information should be clearly considered, with proper arrangements made and implemented.
发证部门应策划并通过国家、地方政府相关主管部门网站及主流媒体网站收集与认证客户相关的信息,作为对认证客户监督的方式之一,如发现获证客户存在不良信息,应在第一时间进行调查核实,然后立即采取相应的应对措施,包括暂停或撤销认证证书。在后续的认证管理和审核活动中应明确考虑不良信息带来的风险和影响,做出适当安排并实施。
Before each audit, the lead auditor should check relevant websites to see if the organization to be audited has any negative information (including administrative penalties), and treat this as one of the key points during the on-site audit. The audit report should provide a detailed description of the analysis of the reasons for any negative information (especially cases involving administrative penalties), corrective actions, and the effectiveness of those actions. This can be documented in the appropriate sections of the audit report based on the type of negative information, such as 'Laws, Regulations, and Other Requirements,' 'Operational Controls,' or 'Nonconformities and Corrective Actions.'
审核组长应当在每次审核前查询相关网址,了解拟实施审核的组织是否存在不良信息(包括行政处罚),并将其作为现场审核的重要关注点之一,组织对不良信息(尤其是被行政处罚的情况)的原因分析、纠正和纠正措施的有效性等情况需要在审核报告中进行详细描述(可根据不良信息的情况描述在审核报告的相应栏目,如“法律法规及其他要求”栏、“运行控制”栏、“不符合和纠正措施”栏等)。
Related information can be checked from the following website:
相关信息可以通过以下网站获得:
a) The "National Enterprise Credit Information Publicity System" can be accessed at http://gsxt.saic.gov.cn/; "Credit China" is available at http://www.creditchina.gov.cn/; the "Unified Inquiry Platform for Certification and Accreditation Business Information" allows you to check information on compulsory product certification (3C), management system certification, certification bodies, and certified personnel, available at http://cx.cnca.cn/;
“国家企业信用信息公示系统”,网址:http://gsxt.saic.gov.cn/;“信用中国”网址:http://www.creditchina.gov.cn/“认证认可业务信息统一查询平台”可查询强制性产品认证(3C)、管理体系认证、认证机构、认证人员等信息,网址:http://cx.cnca.cn/;
b) Information you can check on the "State Administration for Market Regulation" includes administrative licenses (like industrial product production, special equipment, metrology, import and export inspection and quarantine, etc.), company quality credit, corporate standards, national spot checks on product quality, and more. Website: http://www.aqsiq.gov.cn/;
“国家市场监管总局”可查询信息包括行政许可(工业产品生产、特种设备、计量、进出口检验检疫等)、企业质量信用、企业标准、产品质量国家抽查结果等信息,网址:http://www.aqsiq.gov.cn/;
c) The 'State Food and Drug Administration' lets you check information on administrative licenses and quality inspections, spot checks, on-site inspections, recalls, and other info for products like food, medicine, and medical devices. Website: http://www.sda.gov.cn/;
“国家食品药品监督管理局” 可查询信息包括食品、药品、医疗器械等产品的行政许可和质量抽查、飞行检查、召回等信息,网址:http://www.sda.gov.cn/;
d) The 'Ministry of Ecology and Environment' can provide information related to environmental protection administrative permits, supervision and law enforcement, information notifications, and corporate credit. Website: http://www.mee.gov.cn/;
“生态环境保护部”可查询环境保护相关的行政许可、监督执法、信息通报、企业信用等信息,网站:http://www.mee.gov.cn/;
e) The 'Ministry of Emergency Management' allows you to check information related to work safety administrative permits, supervision inspections, safety tips, hazard exposure, and accident investigations, website: http://www.chinasafety.gov.cn/;
“应急管理部” 可查询安全生产相关的行政许可、监管监察、安全提示、隐患曝光、事故查处等信息,网址:http://www.chinasafety.gov.cn/;
f) Websites of the certified customer's local provincial and municipal departments for business, quality, environment, and health safety supervision and management (such as the Market Supervision Bureau, Administration for Industry and Commerce, Quality Supervision Bureau, Food and Drug Administration, and other related government departments);
认证客户属地省市的经营、质量、环境、健康安全监督管理部门网站(市场监管局、工商局、质监局、食药局等相关政府部门);
g) Government website for administrative permits related to certified clients, where you can check the validity and related information of a client's administrative permit, such as: National Construction Market Supervision Public Service Platform, website: http://jzsc.mohurd.gov.cn/;
与认证客户相关的行政许可政府部门网站,查询客户行政许可资质的有效性及相关信息,如:全国建筑市场监管公共服务平台,网址:http://jzsc.mohurd.gov.cn/;
h) Other ways to look up company information, like Tianyancha, Qichacha, and other platforms for checking company risk information.
其他企业信息查询途径,如天眼查、企查查等企业风险信息查询平台。
5.2 Initial Certification / Recertification / Certification Transfer / Certificate Change初次认证/再认证/认证转换/证书变更
5.2.1 Initial certification初次认证
The project management personnel handling the review should ask the client to submit the 'Certification Application Form' (including the required documents and materials).
审核项目管理人员应请客户提交《认证申请表》(包括其要求的文件和资料)。
Applications from organizations that have been ordered to suspend operations by regulatory authorities or are listed as 'seriously illegal enterprises' in the National Enterprise Credit Information Publicity System should not be accepted.
对被执法监管部门责令停业整顿或在全国企业信用信息公示系统中被列入“严重违法企业名单”的申请组织,不应受理其认证申请。
5.2.2 Recertification再认证
The audit project manager should inform the client about the re-certification audit before the certificate expires and ask them to submit the 'Certification Application Form' (including the required documents and materials). The advance notice should take into full account the time needed to complete the re-certification audit and decision, to ensure that the certification decision is made before the certificate expires.
审核项目管理人员应在证书到期前通知客户有关再认证审核事宜并请其提交《认证申请表》(包括其要求的文件和资料)和。提前的时间应充分考虑到完成再认证审核及再认证决定所需的时间,以确保在证书到期前完成本次审核的认证决定。
If the recertification activities are completed before the expiration date of the current certificate and a decision to reissue the certificate is made, the expiration date of the new certificate will be based on the expiration date of the current certificate. The issue date on the new certificate should not be earlier than the date the recertification decision was made.
如果在当前认证证书的终止日期前完成了再认证活动并决定换发证证书,新认证证书的终止日期则基于当前认证证书的终止日期。新认证证书上的颁证日期应不早于再认证决定日期。
For situations where the recertification decision is not made before the certificate expires, certification can be restored if the following conditions are met at the same time:
对于未能在证书到期前完成再认证决定的情况,当同时满足下列条件时,就可以恢复认证:
(1) The recertification review is completed before the certificate expires;
再认证审核在证书到期前完成;
(2) Serious non-conformities have been corrected before the certificate expiration and verified as effective;
严重不符合已经在证书到期前得到纠正,并验证有效;
(3) Able to complete any unfinished recertification activities within six months after the certificate expires.
能够在证书到期后的6 个月内完成未尽的再认证活动。
For those who meet conditions (1) and (2) but not condition (3), at least one more second-stage review should be carried out before the certification can be restored. The effective date of the restored certification should not be earlier than the re-certification decision date, and the termination date should be based on the previous certification cycle.
对于满足条件(1)、(2),但不满足条件(3)的,则应至少再进行一次第二阶段审核才能恢复认证。恢复认证证书的生效日期应不早于再认证决定日期,终止日期应基于上一个认证周期。
If the recertification audit isn't completed before the current certificate expires, or if the corrective actions for major nonconformities haven't been verified, then the certificate shouldn't be renewed, and the original certificate's validity shouldn't be extended either.
如果在当前认证证书终止日期前,未能完成再认证审核或对严重不符合项实施的纠正和纠正措施未能进行验证,则不应予以再认证,也不应延长原认证证书的有效期。
5.2.3 Certification Transfer认证转换
Customers applying for certification conversion need to fill out the 'Certification Application Form' and provide the relevant materials. The audit project manager should determine whether they meet the conditions for conversion and obtain and keep sufficient evidence, such as certificates, reports, and documents of corrective actions taken for non-compliance.
申请认证转换的客户,需要填写《认证申请表》并提供相应资料,审核项目管理人员应判断其是否符合转换的条件,并获取并保留充足的证据,例如证书、报告、对不符合采取的纠正措施的文件。
5.2.4 Certificate Change证书变更
For clients who intend to apply for changes, the project management reviewer should ask the client to submit the 'Certificate Change Application Form' (if combined with recertification for certificate changes, the 'Certification Application Form' also needs to be filled out) along with the relevant documents and materials.
对于有变更申请意向的客户,审核项目管理人员应请客户提交《证书变更申请表》(结合再认证实施证书变更的,还需填写《认证申请表》)及相关的文件和资料。
The types of certificate change are:
证书变更类型有:
1) Client name change客户名称变更。
2) Address change地址变更。
3) Certification scope change认证范围变更。
4) Certification standard change认证标准变更。
5) Other changes其他变更。
5.3 Application Review申请评审
5.3.1 The audit project manager first checks the completeness and accuracy of the 'Certification Application Form' or the 'Certificate Change Application Form' along with the attached documents and materials. If they don't meet the requirements, the client should be asked to provide supplements or make corrections as soon as possible.
审核项目管理人员首先核实《认证申请表》或《证书变更申请表》及其所附文件和资料的完整性和准确性,如不符合要求,应要求客户尽快给予补充或修改。
5.3.2 The audit project manager should review the application materials submitted by the applicant organization and, based on the scope and location of the certification activities, the number of employees, the time needed to complete the audit, and other factors affecting the certification, decide whether they have the ability to handle the certification application.
审核项目管理人员应对申请组织提交的申请资料进行评审,根据申请认证的活动范围及场所、员工人数、完成审核所需时间和其他影响认证活动的因素,综合确定是否有能力受理认证申请。
The application review should be completed within 5 working days after receiving the application form and all the required documents from the client. Professionals should take part in the review and preliminarily determine the number of auditor days needed for each audit during the certification cycle. The review results are recorded in the 'Certification Application Review Form'.
申请评审应在接到客户提交的申请表及完整资料后5 个工作日内完成,应有专业人员参与评审并初步确定认证周期内各次审核所需的审核人天数,评审结果记录到《认证申请评审表》中。
5.3.3 If an application is not accepted, the reason for rejecting it should be recorded in the "Certification Application Review Form," the client should be notified immediately of why it won't be processed, and all materials provided by the client should be returned.
不接受申请的,应在《认证申请评审表》中记录拒绝申请的原因,并即时通知客户不予受理的理由,并将所有客户提供的资料退回。
5.4 Establish/Revise certification scheme建立/修订审核方案
5.4.1 For initial certification and recertification projects, after accepting the application, the audit project manager should plan a preliminary audit scheme for the next recertification audit and previous audits (including this audit) to clearly identify the audit activities needed throughout the entire certification cycle. The initial certification audit plan should include the two-stage initial audit, the first and second year surveillance audits, and the recertification audit before the third year when the certification expires.
初次认证、再认证项目,接受申请后,审核项目管理人员应对下一次再认证审核及之前的各次审核(包括本次审核)进行初步审核方案策划,以清晰地识别在整个认证周期内所需的审核活动。初次认证审核方案应包括两阶段初次审核、第一年与第二年的监督审核和第三年在认证到期前进行的再认证审核。
5.4.2 After the audit plan is developed and implemented, if there’s a need to increase the number of audits based on the original planned audits (like additional audits, extra supervision audits, or special audits), the project managers need to adjust the audit plan accordingly.
审核方案制订、实施后,对于需要在原有策划的审核的基础上增加审核的次数的情况(如补充审核、增加监督审核、特殊审核),需要项目管理人员重新调整审核方案。
5.4.3 When setting the audit frequency, keep in mind that the first stage audit for initial certification should take place after the customer's management system has been running for at least 3 months. The first surveillance audit after the initial certification should ideally be conducted within 12 months after the stage two audit, and not later than 12 months from the date the certification is issued. After that, surveillance audits should be done every 12 months.
确定审核频次时应注意,初次认证的第一阶段审核应在客户管理体系运行至少3个月后进行,初次认证后的第一次监督审核宜在二阶段审核后的12个月内进行,并不得超出认证证书签发日起的12个月,此后,监督审核应每12个月进行一次。
5.4.4 If the client's scope of certification includes functions or processes provided externally (outsourced), the number of people involved in those functions or processes should be included in the organization's effective headcount. This should be confirmed during the initial audit (Stage 1), as well as before surveillance and recertification audits (through the certified organization questionnaire and certification application), including the externally provided functions, processes, and the number of people from the outsourced party involved. When creating the audit program and audit plan, audits of externally provided functions or processes within the certification scope should be taken into account.
如果客户的认证范围内有外部提供的职能或过程(外包),则上述职能或过程中的人员数量宜纳入组织的有效人数中,并在初审(一阶段)期间、监督审核和再认证审核前(获证组织调查表、认证申请)应确认客户外部提供的职能、过程及涉及的外包方的人员数量。在建立审核方案和编制审核计划时,应考虑对认证范围内外部提供职能或过程的审核。
5.5 Quoting and signing contracts报价和合同签订
5.5.1 For initial certification, recertification projects, and certification transfer projects, the audit project manager submits a quotation to the client based on the review and audit plan. After both parties confirm, they sign a certification agreement with the client's representative.
初次认证、再认证项目和认证转换项目,审核项目管理人员根据评审和审核方案的策划结果,向客户提交报价单,经双方确认后,和客户代表签署认证协议。
5.5.2 For certificate change projects, if the change causes any terms in the original certification contract (including certification fees) to change, a new contract should be signed with the client (and a new quote and confirmation if necessary).
证书变更项目,若变更导致原认证合同的约定事项(包括认证费用)发生变化,应和客户重新签署合同(必要时重新报价和确认)。
5.6 Audit started审核启动
5.6.1 Initial Certification / Recertification / Certificate Change Audit初次认证/再认证/证书变更审核
The audit project manager formally agrees on the audit time with the client, informs them of the audit plan arrangements, and provides the audit schedule.
审核项目管理人员与客户正式商定审核时间并告知其审核方案的安排,提供审核计划。
The Stage Two audit is planned based on the output from Stage One. When deciding the time gap between Stage One and Stage Two, you should consider how long the client might need to address any issues identified in Stage One. Depending on Stage One’s results, the Stage Two schedule may need to be adjusted (for example, postponed or canceled). If that happens, the Stage One audit lead should communicate with the key site project managers in a timely manner and inform the auditee.
二阶段审核是在一阶段审核输出的基础上进行策划,在确定第一阶段和第二阶段的时间间隔时,应考虑客户解决第一阶段识别的任何需要关注问题所需的时间。根据一阶段的结果,可能需要调整第二阶段的安排(如推迟或取消),如果发生这种情况,一阶段审核组长应及时与关键场所项目管理人员沟通并告知受审核方。
The planning for the second-stage audit is carried out based on the results of the first-stage audit. Therefore, the time gap between the first and second stages should be no less than 5 days. The interval between the two stages should not exceed 6 months; otherwise, the first-stage audit should be redone. Before the second-stage audit, if the auditee undergoes any significant changes affecting the management system that make the information obtained meaningless or put the audit conclusions at risk, the first-stage audit should be redone.
二阶段审核的策划是在一阶段审核结果的基础上进行,因此一、二阶段的时间间隔不应少于5天;一、二阶段的间隔不应超过6 个月,否则应重新实施第一阶段审核;二阶段审核前,受审核方如果发生任何影响管理体系的重要变更,而导致所获取的信息失去意义或已做出的审核结论面临风险时,应重新实施第一阶段审核。
5.6.2 Surveillance audit监督审核
5.6.2.1 The audit project manager arranges the audits according to the audit plan frequency and notifies the client about the upcoming surveillance audit at least 2 months in advance, asking them to submit the 'Certificate Holder Information Survey'.
审核项目管理人员按审核方案的审核频次安排,在拟实施审核前至少2 个月通知客户有关监督审核事宜并请其提交《获证方情况调查表》。
If changes in the certified client make the number of auditor days determined during the application review inappropriate, the audit project manager should recalculate the days based on the latest situation of the certified client and the 'Guidelines for Determining Auditor Days,' and record the reason for the adjustment in the 'Certified Client Situation Survey Form.'
如获证客户的变化导致申请评审时确定的审核人天数不适宜,审核项目管理人员应根据获证客户最新的状况和《审核人天数确定指南》重新确定人天数,连同调整理由记录到《获证方情况调查表》。
If the changes reported by the client make the current certificate information unsuitable, the client should also be asked to submit a 'Certificate Change Application Form'.
如获证客户的变化导致现认证证书信息不适宜,则还应请客户提交《证书变更申请表》。
When a client can't undergo a supervision audit within the set timeframe, or notifies that they no longer want to maintain certification, carry out the requirements to suspend, restore, revoke, or reduce the scope of their certification in this document.
当客户不能在规定的期限内接受监督审核,或客户通知不再继续保持认证时,执行本文件认证资格的暂停、恢复、撤销或缩小认证范围的内容。
When a certified customer's product is found to be unqualified in the national product quality spot check, it should be subject to a supervisory review within 30 days from the date the regulatory department issues the notice.
当获证客户的产品在产品质量国家监督抽查中被查出不合格时,自监管部门发出通报起30日内,应对其实施监督审核。
5.6.3 Temporary Notice Review临时通知审核
If it is learned that the customer has experienced (but is not limited to) the following situations, the audit project manager should notify the customer to carry out a temporary audit according to the contract:
如获知客户发生(但不限于)以下情况,审核项目管理人员应依据合同通知客户实施临时审核:
a) The government department imposes penalties on it;
政府部门对其实施处罚;
b) The client's operations have undergone significant changes or other changes that could affect their certification eligibility (including situations with frequent staff turnover, etc.);
客户的运作发生了重大变动或发生了其他可能影响认证资格的变更(包括人员变动较频繁的情况等);
c) Major complaints from customers (especially if exposed by the media);
对客户有重大投诉(特别是被媒体披露);
d) A major accident that affects product quality;
发生影响产品质量的重大事故;
e) Was found to be non-compliant in the national product quality supervision sampling, and it’s been less than 6 months since the last inspection.
在产品质量国家监督抽查中被查出不合格,且距上一次审核未超过6 个月。
5.7 Choose and assign a audit team选择和指派审核组
5.7.1 When the audit project manager determines the audit team members and decides on the size and composition of the audit team, the following factors should be considered:
审核项目管理人员确定审核组成员,决定审核组的规模和组成时,应考虑下列因素:
(1)The purpose, scope, criteria, and expected audit time;
审核目的、范围、准则和预计的审核时间;
(2)The overall capability of the audit team required to achieve the audit objectives;
实现审核目的所需的审核组整体能力;
(3)Certification requirements (including any applicable laws, regulations, or contractual requirements);
认证要求(包括任何适用的法律、法规或合同要求);
(4)Language and culture.
语言和文化。
5.7.2 The establishment of the review team should also take the following aspects into account:
审核组的确立还应考虑以下方面:
a) The working hours of technical experts, translators, observers, and trainee auditors don’t count toward auditor days; technical experts shouldn’t act as auditors in the audit team and should be accompanied by an auditor.
技术专家、翻译人员、观察员和实习审核员的工作时间不计入审核人天数;技术专家不应担任审核组中的审核员,并应由审核员陪同。
b) Except for translators and observers, all members should be qualified personnel hired by TASH, and the audit team leader should be a registered auditor in the relevant field;
除翻译人员、观察员外,所有成员应为TASH聘用的具有相应资格的人员,审核组长应为对应领域的注册审核员;
c) Except for the observers, none of the audit team members have any threats that could affect the fairness of the audit, especially since they have not been involved in consulting or other activities related to the client's management system in the past two years that could affect fairness. The selected translators and participating observers do not improperly influence or interfere with the audit process or results.
除观察员外,所有审核组成员不存在可能影响审核公正性的威胁,特别是在最近两年内未参与过客户相关管理体系的咨询或其他可能影响公正性的活动。所选择的翻译人员和参与的观察员,不对审核过程或审核结果造成不当影响或干预;
d) At least one professional auditor or technical expert certified in the relevant field should be available.
至少应配备一名相关认证领域的专业审核员或技术专家;
e) The number of trainee auditors should not exceed the total number of auditors at the same level in the audit team. When the team includes trainee auditors, an experienced auditor should be assigned as a reviewer. The reviewer should be capable of taking over the trainee auditor’s tasks and is ultimately responsible for the trainee auditor’s activities and audit findings. Trainee auditors cannot issue audit records or non-conformance reports on their own.
实习审核员的数量不得超过同一审核组级别审核员的总数;审核组中包含实习审核员时,应指派一名审核员作为评价人员。评价人员应有能力接管实习审核员的任务,并对实习审核员的活动和审核发现最终负责;实习审核员不可单独出具核查记录、不符合报告等审核文件。
f) In principle, the lead auditor for the second stage should be the same as the lead auditor for the first stage, and the professionals from the first stage should generally also participate in the second stage audit.
第二阶段审核组长原则上应与第一阶段的审核组长相同,第一阶段的专业人员原则上也应参加第二阶段审核。
5.7.3 Temporary notification for the audit/no notification for the audit: since clients lack the opportunity to oppose the appointment of audit team members, audit project managers should pay more attention when assigning the audit team.
临时通知审核/不通知审核,由于客户缺乏对审核组成员的任命表示反对的机会,审核项目管理人员在指派审核组时应给予更多的关注。
5.8 Assign a audit task下达审核任务
5.8.1 The audit team's tasks include:
审核组的任务包括:
a)Check and verify the structures, policies, processes, procedures, records, and related documented information of the client in relation to the management system standards.
检查和验证客户与管理体系标准相关的结构、方针、过程、程序、记录及相关成文信息;
b)Ensure that the above aspects meet all the requirements related to the intended certification scope;
确定上述方面满足与拟认证范围相关的所有要求;
c)Ensure that the client effectively establishes, implements, and maintains management system processes and procedures, in order to provide a foundation for building trust in the auditee's management system.
确定客户有效地建立、实施并保持了管理体系过程和程序,以便为建立对受审核方管理体系的信任提供基础;
d)Inform the customer of any inconsistencies between their policies, goals, and indicators (consistent with the expectations of relevant management system standards or other normative documents) and the results, so that they can take action.
告知客户其方针、目标及指标(与相关管理体系标准或其他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。
5.8.2 After getting approval, the audit project manager should give the audit team leader the 'Audit Task Sheet' and other necessary materials (like past audit reports, non-conformance reports, audit plans, customer management system documents, and the certificate holder information sheet) at least 7 working days before the audit starts.
经批准后,审核项目管理人员应至少在审核开始前7个工作日向审核组长发放《审核任务单》和其他必要的资料(如以往的审核报告、不符合项报告、审核方案、客户管理体系文件、获证方情况调查表等)。
5.8.3 The total auditor days should be clearly specified in the 'Audit Task Sheet' based on the man-days determined from the application review (including any adjustments after follow-up supervision audits of the certified party, if applicable) and the relevant provisions in the 'Guide to Determining Auditor Days'.
应在《审核任务单》中根据申请评审(适用时包括后续监督审核获证方调查后的调整)确定的人天数以及《审核人天数确定指南》中的相关规定明确总的审核人天。
5.9 Audit Plan审核计划
After receiving the audit assignment, the lead auditor should prepare the audit plan.
审核组长接到审核任务书后,应编制审核计划。
5.10 On-site audit prep现场审核准备
5.10.1 After the lead auditor receives the audit task, they should carry out a document review (specialist auditors for high-risk projects should also participate in the document review). For the first-stage audit, the document review findings are reflected in the 'First-Stage Audit Report.' For surveillance audits, recertification audits, or certificate change audits, if there are changes in the client's documented information, a document review should also be conducted and a 'Document Review Report' issued. Additionally, according to the preliminary planning of the audit program, the products, departments, processes, and locations to be audited should be scheduled, and an 'Audit Plan' should be prepared.
审核组长接到审核任务后,应进行文件评审(高风险项目专业审核员也应参与文件评审)。第一阶段审核,文件评审意见体现在《第一阶段审核报告》中,监督审核、再认证审核、证书变更审核,若客户文件化的信息有变更,也应进行文件评审并出具《文件评审报告》,并按照审核方案的前期策划,安排拟审核的产品、部门、过程、场所,编制《审核计划》。
5.10.2 The audit project manager should review the 'Audit Plan' and sign off on it. High-risk projects should also be reviewed by professionals within the audit team (with their signatures in the audit project manager section of the 'Audit Plan'). The audit team leader should submit the 'Audit Plan' to the client for confirmation before the on-site audit starts. If the client has different opinions with valid reasons, the team leader should adjust the plan, and if necessary, the audit project manager should adjust the composition of the audit team.
审核项目管理人员应对《审核计划》进行评审并签字确认,高风险项目还应经审核组中的专业人员审核(同时在《审核计划》的审核项目管理人员处签字)。审核组长应于现场审核开始前将《审核计划》提交给客户确认。如客户有不同意见及合理理由,审核组长应对计划予以调整,必要时审核项目管理人员对审核组组成进行调整。
5.10.3 The finalized 'Audit Plan' information should be uploaded to the 'Unified Reporting Platform for Certification and Accreditation Business Information' at http://report.cnca.cn/ at least 3 days before the on-site audit starts.
确定后的《审核计划》信息应至少在现场审核开始日期3 天前上传至“认证认可业务信息统一上报平台” http://report.cnca.cn/。
5.10.4 The audit team leader thinks that when necessary, we should hold an audit preparation meeting.
审核组长认为必要时,应召开审核准备会。
5.10.5 The content for the audit prep meeting should include:
审核准备会的内容应包括:
a) The audit team leader reports on the audit plan and other information related to the certification scope (such as administrative license qualifications, quality inspections, administrative penalties, quality, environmental, and safety incidents) and assigns tasks for the audit activities.
审核组长通报审核计划以及与认证范围相关的其他信息(行政许可资质、质量抽查、行政处罚、质量、环境及安全事故等情况),对审核活动进行分工;
b) The audit team leader assigns key audit points to the team members and hands out the necessary materials.
审核组长向审核组成员布置审核重点,分发必要的资料;
c) Introduction of necessary knowledge by a professional auditor or technical expert.
专业审核员或技术专家介绍必要的知识。
5.10.6 Audit team members should get other audit preparations done according to the audit tasks assigned in the audit plan, and if needed, fill out the inspection contents in the 'Verification Record Form'.
审核组成员应按审核计划分配的审核任务做好其他审核准备工作,必要时编制《核查记录表》中的检查内容。
5.11 Opening meeting召开首次会议
At the start of the on-site audit, the lead auditor should host the opening meeting. The top management of the applying organization and the responsible personnel from departments related to the quality management system should attend. Everyone attending should sign the 'Opening and Closing Meeting Attendance Sheet'.
在现场审核开始时,审核组长应主持召开首次会议,申请组织的最高管理者及与质量管理体系相关的职能部门负责人员应该参加会议。参加会议的人员应在《首末次会议签到表》上签字。
5.12 Collect and verify information获取和验证信息
5.12.1 According to the arrangements in the 'Audit Plan' (if temporary situations require changes to the audit plan, the consent of the audit team leader should be obtained), audit team members, when applicable, refer to the pre-prepared 'Verification Record Sheet' and gather information related to the audit objectives, scope, and criteria through interviews, observation, document and record review (if needed, with the client's consent, records can be copied, photographed, or recorded). This information is sampled, verified, and used to form audit evidence.
审核组成员按照《审核计划》的安排(遇有临时情况需要改变审核计划的,应征得审核组长的同意),适用时参照预先拟定的《核查记录表》通过面谈、观察、查阅文件和记录等方式(需要时,经客户同意可以复印记录、摄影、录像),抽样获取并验证与审核目的、范围、准则有关的信息,从而形成审核证据。
5.12.2 Each auditor should record their own audit results in their own 'Inspection Record Form'.
每位审核员应将各自的审核情况记录在各自的《核查记录表》中。
5.12.3 During the audit process, the audit team should follow the plan to communicate internally and with the client. Depending on how the communication goes, the lead auditor can reassign team members' tasks if necessary and inform the client.
审核过程中审核组应按计划进行内部沟通和与客户沟通。根据沟通情况,必要时审核组长可重新分派审核组成员的工作并通报客户。
5.12.4 When the available audit evidence shows that the audit objectives cannot be achieved, or indicates urgent and significant risks (like safety risks), the lead auditor should report to the client and project managers, figure out a solution (such as re-confirming or modifying the audit plan, changing the audit objective or scope, or even stopping the audit), and carry it out. The lead auditor should also report the results to the project managers.
当可获得的审核证据已表明审核目的无法实现,或显示存在紧急和重大的风险(例如安全风险)时,审核组长应向客户和项目管理人员报告,确定解决方案(如重新确认或修改审核计划、改变审核目的或审核范围,或终止审核等)并执行。审核组长应向项目管理人员报告执行结果。
5.12.5 When any of the following situations occur, the audit team should report to the certification body and stop the audit after getting their approval.
发生以下情况时,审核组应向认证机构报告,经认证机构同意后终止审核。
a)The applicant organization didn't cooperate with the audit, so the audit couldn't proceed.
申请组织对审核活动不予配合,审核活动无法进行。
b)The management system of the applying organization has major flaws and doesn't meet the relevant certification standards.
申请组织的管理体系有重大缺陷,不符合认证标准的相关要求。
c)There’s a big mismatch between the applicant's actual situation and the submitted materials.
受审核方实际情况与申请材料有重大不一致。
d)Found that the applying organization has major issues with quality, environment, or safety, or other serious legal violations.
发现申请组织存在重大质量环境安全等问题或有其他严重违法违规行为。
e)Other situations that prevent the review process from being completed.
其他导致审核程序无法完成的情况。
5.13 Identify and record audit findings确定和记录审核发现
5.13.1 During the audit process, the auditor should make a preliminary determination of the audit findings and note it in the 'Verification Record Form' (for anything that might be non-compliant, the related information should be recorded in detail). The final determination, especially for non-compliance, should be confirmed by the audit team leader with the team during the internal meeting.
审核过程中审核员应初步确定审核发现并在《核查记录表》中做出判定(对可能构成不符合的,应对相关信息详细记录)。最终的判定,特别是不符合,应由审核组长领导审核组在内部沟通会上确认。
5.13.2 The issues found in the first-stage audit include 'problems that need to be rectified before proceeding to the second-stage audit' and 'other issues that should be noted (anything that needs attention and might be judged as non-compliant in the second-stage audit)'. The audit team should compile them into a Issue List and communicate the follow-up requirements (usually done in writing). Once the audit team leader confirms with the client that the rectifications meet the requirements, the second-stage audit can proceed. For 'other issues that should be noted', the team should continue to pay attention during the second-stage on-site audit. If the problem still exists, a written non-compliance report should be issued. Specifically, the following situations should be clearly listed as 'issues that must be rectified before entering the second-stage audit':
第一阶段审核发现的问题,包括“需要整改后方可进入二阶段审核的问题”和“其他应关注的问题(任何应引起关注的、在第二阶段审核中可能被判定为不符合的问题)”,审核组应汇总形成问题清单并告知其跟踪要求(通常采用书面跟踪)。审核组长与客户沟通确认整改符合要求后,即可进入第二阶段审核;对于“其他应关注的问题”,审核组在第二阶段现场审核中应继续关注,如果发现问题仍然存在,则应出具书面不符合。其中,以下情形应明确列为“需完成整改后方可进入第二阶段审核的问题”:
a) The documented information required by the management system standard has not been established yet;
管理体系标准要求的文件化的信息尚未建立;
b) Qualifications, personnel, premises, facilities, equipment, and other basic conditions do not meet legal and regulatory requirements;
资质、人员、场所、设施、设备等基本条件与法律法规要求不符;
c) Many processes in the quality management system, including outsourced ones, haven't been defined.
质量管理体系的很多过程(包括外包过程)都未确定;
d) The cuts to the ISO 19001 standard are clearly unreasonable;
对ISO 19001 标准的删减明显不合理;
e) Guidelines and objectives haven't been established.
方针和目标未建立;
f) The planning for monitoring, measuring, analyzing, and improving mechanisms is either very inadequate or inappropriate.
监视、测量、分析、改进机制的策划很不充分或很不适宜;
g) Internal audits or management reviews were not carried out;
内部审核或管理评审未实施;
h) The major complaint hasn't been dealt with yet;
重大投诉尚未得到处理;
i) Problems that other review team leaders think must be corrected.
其他审核组长认为必须整改的问题。
5.13.3 If any nonconformities are found during the audit, the corresponding auditor should issue a 'Nonconformity Report.' Nonconformities are divided into major and minor. The determination of major nonconformities follows the following principles:
审核中如发现有不符合,相应的审核员应出具《不符合项报告》。不符合分为严重不符合和轻微不符合。严重不符合的判定遵循以下原则:
a) The management system's outcomes didn't achieve the expected results.
管理体系运行结果未能实现预期的结果;
b) The establishment, implementation, and maintenance of key or core processes of the management system have serious flaws, seriously affecting the management system's ability to achieve its intended results.
管理体系关键过程或核心过程的建立、实施和保持存在严重缺陷,对管理体系实现管理体系预期结果的能力造成严重影响的;
c) Unable to effectively or falsely provide monitoring and measurement results of the management system's operation, seriously affecting the audit team's judgment of the audit conclusions.
无法有效或虚假提供管理体系运行监视和测量结果,严重影响审核组审核结论的判定;
d) If there are major accidents, complaints, or regulatory penalties in the operation of the management system, and there is no evidence of effective corrective measures being taken.
管理体系运行出现重大事故、投诉、监管部门处罚,且未能提供采取有效纠正措施证据的。
5.13.4 If the audit team thinks it's necessary to point out improvements to the client, they can fill them in under the 'Improvement Suggestions/Opportunities' section of the Audit Report.
审核组认为有必要向客户指出的改进事项,可将其填写在《审核报告》中的“改进建议/机会”中
5.14 Prepare for the audit conclusion准备审核结论
5.14.1 Before the final meeting, the audit team leader should organize an internal audit team meeting, covering:
审核组长在末次会议前,应组织审核组内部沟通会,内容包括:
a) Review the audit findings and any other relevant information obtained during the audit against the audit objectives, and, considering any inherent uncertainties in the audit process, reach an agreement on the audit conclusion (including the recommendation for certification);
对照审核目的审查审核发现和审核中获取的任何其他适用的信息,并考虑审核过程中内在的不确定性,对审核结论(包括对认证的推荐建议)达成一致;
b) When applicable, determine how to track nonconformities. Tracking methods are divided into written and on-site. If no serious nonconformities are found and corrective actions and their implementation can be verified through witness materials, you can choose written tracking; in other cases, on-site tracking is usually preferred.
适用时,确定不符合项的跟踪方式。跟踪方式分为书面和现场两种,没有发现严重不符合项,且可以通过见证材料证实纠正和纠正措施计划或其实施情况时,可选择书面跟踪;其他情况下,通常应选择现场跟踪;
c) Confirm the suitability of the audit plan, or identify any necessary changes (such as scope, audit time or date, frequency of supervision, capabilities);
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);
5.14.2 The audit team suggests the following types of recommendations for various audits:
审核组在各类审核中对认证的建议类型如下:
5.14.2.1 Stage 1 audit:
第一阶段审核:
a) The client is ready for the second stage of the review (no issues found) and can move on to it.
客户已为第二阶段审核做好准备(未发现问题),可进入第二阶段审核;
b) The client isn't fully prepared yet (issues were found). Once the issues listed in the Issue List that need to be resolved before moving to Phase 2 are addressed and confirmed acceptable by the audit team, they can move on to the Phase 2 audit. During the on-site audit, we'll continue to keep an eye on the problems identified in Phase 1.
客户准备尚不够充分(发现问题),待问题清单中“需完成整改后方可进入第二阶段审核的问题”得到整改并经审核组确认接受后,可进入第二阶段审核,现场审核中将继续关注第一阶段审核中发现的问题;
c) The client is not well-prepared (many issues were found) and is not ready to move on to the second-stage review in the short term. If they want to continue with the certification, the first-stage review should be carried out again after system improvements.
客户准备很不充分(发现问题很多),短期内不具备进入第二阶段审核的条件。若继续申请认证,应在系统改进后重新实施第一阶段审核;
5.14.2.2 Initial certification review, re-certification review:
初次认证审核、再认证审核:
a) No non-conformities were found, certification/recertification is recommended;
未发现不符合项,推荐认证/再认证;
b) If non-conformities are found, such as the client analyzing the reasons for the non-conformance within the specified time and taking corrective and corrective actions that have been reviewed by the audit team, accepted, and confirmed to be effective (for minor non-conformities, a corrective and corrective action plan that has been reviewed and accepted by the audit team is also acceptable), certification/re-certification is recommended.
发现有不符合,如客户在规定的时间内,对不符合分析原因并采取了经审核组评审、接受并证实有效的纠正和纠正措施(对轻微不符合能够提出经审核组评审并接受的纠正和纠正措施计划也可),推荐认证/再认证;
c) The following situations will not be recommended for certification/recertification:
发现以下情形,不予推荐认证/再认证:
—The client had a major quality incident within a year.客户在一年内发生了重大质量事故;
—There are major flaws in the system's operation, and it doesn’t meet certification requirements.体系运行存在重大缺陷,不能满足认证要求;
—Complaints and analyses about it, or any other information, indicate that the customer does not meet the certification requirements;对其投诉和分析或任何其他信息表明客户不符合认证要求;
—Nonconformities and corrective actions were not accepted/verified as effective within the specified time.不符合的纠正和纠正措施未能在规定的时间内被接受/验证有效;
—Found that the customer has major issues (quality, environment, safety) or other serious legal violations related to products and services发现客户存在重大问题(质量、环境、安全)或有其他与产品和服务相关严重违法违规行为。
5.14.2.3 Surveillance audit, certificate change audit, temporary notice audit:
监督审核、证书变更审核、临时通知审核:
a) No non-conformities were found, recommended to maintain certification.
未发现不符合项,推荐保持认证;
b) If nonconformities are found, such as the customer analyzing the causes within the specified time and taking corrective and corrective actions that have been reviewed by the audit team, accepted, and confirmed effective (for minor nonconformities, a corrective and corrective action plan that can be reviewed and accepted by the audit team is also acceptable), it is recommended to maintain the certification;
发现有不符合,如客户在规定的时间内,对不符合分析原因并采取了经审核组评审、接受并证实有效的纠正和纠正措施(对轻微不符合能够提出经审核组评审并接受的纠正和纠正措施计划也可),推荐保持认证;
c) If any of the following situations are found during the review, the certification will be paused (or the recommended change will not be made):
若审核中发现以下情形,暂停(或不予推荐变更)认证:
—A major quality accident affecting the management system happened发生影响管理体系的重大质量事故;
—The system has serious flaws and can't meet the certification requirements.体系运行存在严重缺陷,不能满足认证要求;
—Indicating through complaints, analysis, or any other information that the certified party no longer meets the certification requirements;对其投诉和分析或任何其他信息标明获证方不再符合认证要求;
—Nonconformities and corrective actions were not accepted/verified as effective within the specified time.不符合的纠正和纠正措施未能规定的时间内被接受/验证有效;
5.14.3 Before the final meeting is officially held, the lead auditor should also communicate with the client, including the audit conclusions, agreeing on follow-up actions for non-conformities, seeking the client's input and asking for their confirmation (if necessary, explaining unresolved issues and their possible impact on the audit conclusions). Any unresolved disagreements should be recorded in future audit reports.
在正式召开末次会议前,审核组长还宜与客户沟通,包括审核结论、商定对不符合的后续措施的安排、征求客户意见并请其确认(必要时,说明未解决的问题及可能对审核结论的影响),未解决的分歧点应在未来的审核报告中加以记录。
5.15 Close meeting召开末次会议
5.15.1 The lead of the audit team is responsible for hosting the final meeting with the client's management, relevant departments, or process owners. The meeting content follows the opening and closing meeting procedures (which can be adjusted based on the client's familiarity with the audit process). Those attending the meeting should sign the 'Opening and Closing Meeting Attendance Sheet'.
审核组长负责主持召开与客户管理层、相关部门或过程负责人的末次会议。会议内容见首末次会议流程(可根据客户对审核过程的熟悉程度调整)。参加会议的人员应在《首末次会议签到表》上签字。
5.15.2 At the last meeting, the lead auditor should focus on reporting the audit findings (especially those that help the client understand any nonconformities) and the audit conclusions, and seek the client's input. Any differences of opinion between the client and the audit team on the findings or conclusions should be discussed and resolved as much as possible. If there are still unresolved differences, they should be documented in future audit reports.
审核组长在末次会议上重点应报告审核发现(特别是使客户理解不符合项)和审核结论并征求客户意见。客户与审核组对审核发现或结论的任何分歧意见应得到讨论并尽可能获得解决,若仍存在不能解决的分歧,应在未来的审核报告中记录。
5.15.3 If any uncertainties or obstacles that could affect the audit conclusion or reliability are encountered during the review, they should also be mentioned in the final meeting and recorded in the future audit report. This may include (but is not limited to):
若审核中遇到有可能影响审核结论、可靠性的不确定因素和(或)障碍,也应在末次会议上说明,并记录在未来的审核报告中。这可能包括(但不限于):
a) During the review process, the reviewer felt unwell, which led to an insufficient review.
审核过程中审核人员身体不适,导致的审核不充分;
b) Some audit evidence couldn't be fully obtained due to relevant personnel being unavailable or certain locations being closed.
因相关人员不在、相关场所关闭等原因,某些审核证据未能充分获取;
c) Poor coordination between the two sides affects the efficiency and thoroughness of the review.
双方配合不好,影响到审核的效率和充分性;
d) Some units, locations, or processes weren't fully reviewed due to confidentiality, force majeure, or other reasons.
由于保密、不可抗力或其他原因,某个(些)单元、场所、过程未能充分审核。
5.16 Prepare and submit the review report编制和提交审核报告
After each audit, an audit report should be prepared and submitted to the auditee. The audit team leader should make sure the audit report is prepared and is responsible for its content. The audit report should describe the main points of the audit accurately, concisely, and clearly, so there’s enough information for certification decisions.
每次审核完毕后都应编制审核报告,并提交给受审核方。审核组长应确保审核报告的编制,并对审核报告的内容负责。审核报告应准确、简明和清晰地描述审核活动的主要内容,以便为认证决定提供充分的信息。
5.17 Tracking non-compliance跟踪不符合
5.17.1 For any nonconformities found during the audit, the audit team should ask the client to analyze the reasons and propose corrective and corrective actions. After the client submits the relevant corrective and corrective actions (or a plan) within the specified time, the audit team leader or an auditor who participated in this audit (hereinafter referred to as the 'follow-up personnel') will review it to determine if it is acceptable (especially whether sufficient corrective actions have been taken for the root cause, not just the correction) and inform the client. If acceptable, for serious nonconformities, on-site verification of the effectiveness of the corrective and corrective actions is still needed, and the client is informed. For on-site follow-up, the audit team leader should agree on a specific date with the client and arrange implementation to collect evidence.
对审核中发现的不符合项,审核组应要求客户分析原因,并提出纠正和纠正措施。客户在规定的时间内提交有关纠正和纠正措施(或纠正和纠正措施计划)后,审核组长或其指派参加过本次审核的审核员(以下简称“跟踪人员”)评审以确定其是否可以接受(特别是是否针对不符合的原因制定了充分的纠正措施而不是仅仅是纠正)并告知客户。如可以接受,对严重不符合项还需要现场验证相应纠正和纠正措施的有效性并告知客户。现场跟踪,审核组长应与客户商定具体日期并安排实施,以便收集证据。
(1)During the initial certification, the verification of corrective and corrective actions taken for major non-conformities should be completed within 6 months after the second stage ends; otherwise, certification will not be granted, or a second stage audit will need to be conducted again before certification registration can be recommended. For minor non-conformities, the client should submit a root cause analysis and corrective actions within 3 months after the second stage ends.
初次认证时,针对严重不符合所采取的纠正和纠正措施的验证,应在第二阶段结束后6个月内完成,否则,不予通过认证,或需要再实施一次二阶段审核,才能推荐认证注册。针对轻微不符合,客户应在第二阶段结束后3个月内提交原因分析和整改措施。
(2)Serious non-conformities found during the recertification audit should be corrected and corrective actions taken within three months after the on-site audit, and the corrective actions should be verified before the original certificate expires. For minor non-conformities found during the recertification audit, the client should submit a root cause analysis and corrective measures within one month.
再认证审核中发现的严重不符合项,应在现场审核结束后3个月完成纠正与纠正措施,并在原认证证书到期前完成对纠正与纠正措施的验证。再认证审核中发现的轻微不符合,客户应在一个月内提交原因分析和整改措施。
(3)For serious non-conformities found during the supervisory audit, the client should complete corrections and corrective actions within 3 months after the on-site audit ends; for minor non-conformities, the client should submit a cause analysis and corrective measures within a month.
监督审核中发现的严重不符合,客户应在现场审核结束后3个月内容完成纠正和纠正措施;监督审核中发现的轻微不符合,客户应在一个月内提交原因分析和整改措施。
If the client can't complete the corrections as required within the time specified above, the certification/re-certification won't be approved, or the client's certification could be suspended.
如果客户不能在上述规定的时间内按要求完成整改,则不予通过认证/再认证,或暂停客户认证。
5.17.2 The corrections, identified causes, and corrective actions submitted by the customer should be reviewed to determine if they are acceptable. If the customer's proposed corrections and corrective actions are not acceptable, the follow-up person should ask the customer to revise them and review them again.
应审查客户提交的纠正、所确定的原因和纠正措施,以确定其是否可被接受。如客户提出的纠正和纠正措施不能接受,跟踪人员应要求客户重新制定,并再次加以评审。
5.17.3 The effectiveness of any corrective and corrective actions taken should be verified, and evidence of the closure of non-conformities should be recorded. If the corrective and corrective actions for serious non-conformities are found to be ineffective, the follow-up personnel should ask the client to implement them effectively and then track and verify them again.
应验证所采取的任何纠正和纠正措施的有效性。并记录不符合已关闭的证据。若严重不符合的纠正和纠正措施经验证表明未能有效实施,跟踪人员应要求客户有效实施,并再次加以跟踪验证。
5.17.4 If a full or limited follow-up audit is needed to verify the effectiveness of corrections and corrective actions (for major nonconformities), or documented evidence is required (effectiveness will be confirmed at the next audit, for minor nonconformities), the client should be informed.
如果为了验证纠正和纠正措施的有效性(适用于严重不符合),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(有效性在下次的审核中确认,适用于轻微不符合),应告知客户。
5.17.5 If the corrections and corrective actions for non-conformities are not accepted within the specified time frame (and for major non-conformities, the corrective actions should also be verified as effective), the lead auditor should not recommend registration, re-registration, or maintaining the certificate, and should inform the client and explain the consequences.
若不符合项的纠正和纠正措施未能在规定的期限内被接受(严重不符合项的纠正和纠正措施还应被验证有效),审核组长不应推荐注册、再注册或保持证书,并应告知客户并解释后果。
6.Suspension, reinstatement, revocation, or narrowing of certification scope for certified organizations获证组织认证资格的暂停、恢复、撤销或缩小认证范围
6.1 Suspension of certification认证资格的暂停
Certification of the organization should be suspended if any of the following situations occur:
发生以下情况之一时,应暂停获证组织的认证资格:
a) The management system of the certified organization continuously or seriously fails to meet certification requirements, including the requirements for the effectiveness of the system's operation;
获证组织的管理体系持续地或严重地不满足认证要求,包括对管理体系运行 有效性要求;
b) Non-conformities issued during the audit (especially major non-conformities), where the certified organization fails to take the agreed corrective and corrective actions within the set timeframe, or the corrective actions taken within the agreed timeframe are not accepted by the audit team or the certification body (or are not proven effective);
审核中开具的不符合项(尤其是严重不符合项),获证组织未能在约定的时 间内采取相应纠正和纠正措施,或在约定的时间内所采取的纠正和纠正措施 未被审核组或认证机构接受(或未被证实有效);
c) The certified organization cannot undergo audits according to the planned time intervals and frequency requirements, including but not limited to:
获证组织不能按策划的时间间隔和频次要求接受审核,包括但不限于:
The first certification cannot complete the first surveillance audit within 12 months from the certification decision date;初次认证不能在认证决定日期起12个月内完成第1次监督审核;
From the date of the initial certification decision, each subsequent audit should be completed within its audit cycle (one audit cycle every 12 months). Suspending the certification does not affect the scheduling of future audits for that certificate.从初次认证的认证决定日期起,后续的每一次审核应在其审核周期(每 12 个月为一个审核周期)内完成,认证证书暂停不影响该证书后续的审 核周期安排;
The planning for surveillance audits should at least ensure that an audit is conducted once every calendar year, and the time interval between the end dates of two surveillance audits should not exceed 12 months.监督审核周期策划应至少满足在每个日历年进行一次,且两次监督审核 结束日期的时间间隔不应大于12个月;
Re-certification refers to not signing the certification contract for the next cycle two months before the current certification's validity period expires.再认证在本周期认证证书有效期到期前2个月未签订下一认证周期的认证合同。
d) The certification certificates and marks of the certified organization are used in ways that don't comply with the Regulations on the Use of Certificates and Marks; relevant proof of non-compliance should be submitted (such as photos, videos, screenshots, and written descriptions).
获证组织的认证证书和认证标志使用不符合证书和标志使用管理规定的要求;应提交相应不符合的证据材料(如照片、视频、截图及文字描述等);
e) The certified organization or the scope and boundaries of its management system have undergone significant changes, and TASH was not promptly notified to handle them properly;
获证组织或其管理体系的范围和边界发生重大变更,且未及时通知TASH妥善处理;
f) A certified organization has a major accident, or is reported negatively by media from government regulatory departments at various levels;
获证组织发生重大事故,或被各级政府监管部门媒体报道不良信息;
h) If the administrative license, qualification certificate, or mandatory certification held by the certified organization has expired and the corresponding renewal application has been submitted and officially accepted, a proof of the official acceptance of the renewal application should be submitted.
获证组织持有的行政许可证明、资质证书、强制性认证证书等过期失效,且相应的换发申请已提交,并被正式受理的;应提交换发申请正式受理的证明;
i) The certified organization didn’t pay the relevant certification fees on time as agreed in the contract.
获证组织未按合同约定及时交纳有关认证费用;
j) The certified organization does not assume, or has not fulfilled, the responsibilities and obligations stipulated in the certification contract; a detailed explanation should be provided.
获证组织不承担、或未履行认证合同约定的责任和义务;应提交具体情况说明;
k) If a certified organization proactively requests a pause, it should submit a written suspension request along with a detailed explanation;
获证组织主动请求暂停,应提交书面暂停申请和详细说明;
l) The certification standard expires when its validity period ends;
认证标准有效期到期失效;
m) Other situations that affect the validity of certification for certified organizations; relevant explanations and supporting materials should be submitted.
其他影响获证组织认证资格有效性的情况;应提交相应的情况说明和证据材料。
6.2 Management During Certification Suspension认证资格暂停期间的管理
6.2.1 A certified organization can apply to have its suspended certification reinstated once it has resolved the issues that caused the suspension within the specified suspension period, and the corresponding evidence has been reviewed and can prove that the issues have been effectively resolved.
获证组织针对造成暂停的问题在规定的暂停期限内已解决,且相应的证据经 评审可以证明问题已得到有效解决后,可申请恢复被暂停的认证资格。
6.2.2 If a certified organization fails to resolve the issues that caused the suspension within the specified suspension period, a decision can be made to revoke the certification or reduce its certification scope based on the collected information and evidence.
如果获证组织未能在规定的暂停期限内解决造成暂停的问题,可根据收集到信息和证据作出撤销认证资格,或缩小其认证范围的决定。
6.3 Revocation of Certification认证资格的撤销
There is evidence that the management system of a certified organization may fail to continue meeting certification requirements after certification, and if any of the following situations occur, their certification should be revoked:
有证据表明,获证组织的管理体系在获证后不能持续满足认证的要求,存在以下情况之一时,应撤销其相应认证资格:
a) The audit did not pass. There is no operational management system, or the conditions to operate are no longer met, so it cannot continuously provide products or services that meet the requirements. Supporting documents must include the 'Audit Report'.
审核未通过,没有运行管理体系或者已不具备运行条件,无法持续提供符合 要求的产品或服务。证明材料须附《审核报告》;
b) The legal status certificate of the certified organization has been canceled or revoked; or it has been ordered to suspend operations for rectification by the administrative regulatory authorities; or it has been listed on the 'serious illegal and untrustworthy list' by the market supervision department;
获证组织的法律地位证明文件被注销或撤销;或被行政监管部门通报责令停 业整顿;或被市场监督管理部门列入“严重违法失信名单”;
c) If a certified organization has a major accident, and the investigation (audit) shows that the cause of the accident proves there are serious flaws in its management system, or the organization fails to investigate the cause of the major accident and take effective corrective actions during the suspension period;
获证组织发生重大事故,经调查(审核)造成事故的原因证明其管理体系存 在严重缺陷,或组织未能在暂停期内就造成重大事故的原因进行调查并采取 有效的纠正措施;
d) If a certified organization experiences major public opinion incidents and the certified client cannot be reached within 24 hours after the incident; or for cases reported by national government departments or exposed by central media, if the certified client cannot be reached within 2 hours; TASH has the right to revoke their certification first and then decide on the follow-up actions based on the investigation results after the relevant case or situation is handled.
获证组织发生重大舆情,且舆情发生后,24小时内无法联系上获证客户的; 对于国家级政府部门通报的或中央媒体曝光的,如2小时内无法联系上获证客户的;TASH有权先撤销其认证资格,待相关案件或情况处理后再根据调查 结果确定后续处理方式;
e) Certification bodies refuse to cooperate with supervision and inspections carried out by administrative regulatory authorities at all levels, or they hide or provide false materials and information during inquiries and investigations on relevant matters.
获证组织拒绝配合各级行政监管部门实施的监督检查,或者对有关事项的询问和调查隐瞒或提供虚假材料和信息;
f) The suspension period for the certification has expired, but the issues that caused the suspension haven't been effectively resolved (including held administrative permits, qualification certificates, or mandatory certification certificates related to the system scope that have expired and for which renewal applications haven't been approved, or no renewal application has been submitted).
暂停认证证书的期限已满但导致暂停的问题未得到有效解决(包括持有的与 体系范围有关的行政许可证明、资质证书、强制性认证证书等已经过期失效 且换发申请未获批准,或未提出换发申请);
g) The certified organization actively applies to cancel the certificate.
获证组织主动申请撤销证书;
h) The certified organization didn’t pay the relevant certification fees on time as agreed in the contract.
获证组织未按合同约定及时交纳有关认证费用;
i) The certified organization failed to correctly reference and promote the certification information according to the relevant regulations, causing serious impact or consequences, or failed to complete corrections within 2 months as required by the institution;
获证组织未按相关规定正确引用和宣传获得的认证信息,造成严重影响或后果,或者未按机构要求在2个月内完成纠正;
j) Other situations that affect the effectiveness of the management system or where it can't operate properly.
其他影响管理体系运行有效性或不具备运行条件的情况。
