NSF-ISR Transition Requirements for Revised ISO 17021-1 Programs

NSF-ISR针对修改的ISO17021-1程序的过渡要求

Purpose / Subject:目标/主题:

 

This document describes the process for the NSF-ISR transitions for clients to the ISO 9001: 2015, ISO 14001: 2015, RC 14001:2015and ISO 13485:2016.  The process for transitioning of client registrations for each Standard will be the same unless specifically noted in the document.

该文件就新版ISO9001:2015, ISO14001:2015,RC14001:2015和ISO13485:2016介绍了NSF-ISR为客户提供的过渡指南。如无特别说明,该文件中所有相关认证标准都采用同样的过渡流程。

 

Affected Departments and Personnel:涉及的部门和人员:

This document will serve as a set of requirements and guidance information for all NSF-ISR Departments and Regional Offices, including the shared NSF International resources of Audit Services and Business Development.

该文件为NSF-ISR的所有部门和地方办公室提供了一系列要求和指南,包括共享国际资源的NSF审核服务部和业务拓展部。

 

  1. General:

概要:

 

  1. This document was prepared using information gathered from the requirements in ANAB Accreditation Rules and Heads Up documents on the subject of transitions for ISO 9001: 2015, ISO 14001 2015, and RC-14001; and with the guidance provided in IAF ID (Informative Documents) # 9 and #10, as well as American Chemistry Council (ACC) Transition to RC14001:2015, Technical Specification – December 23, 2015.ISO 13485:2016 was supported using ANAB guidance (ANAB Heads Up #340).

该文件的所有信息都源于ANAB认可的规则, 抬头文件中涉及的过渡至新版ISO9001:2015,                ISO14001  :2015  和RC-14001的课题, IAF第9号及第10号信息文件中提供的过渡指南,以及美化学委员会(ACC)2015 年12月23日发表的过渡至RC14001:2015的技术规范。ISO 13485:2016使用ANAB指导支持(ANAB抬头# 340)

 

  1. This document was prepared as a supplement to the NSF-ISR Audit Procedure (AESOP 7246) and takes precedence where issues related to ISO 9001:2015, ISO 14001:2015, RC 14001:2015and ISO 13485: 2016Transitions are concerned.

该文件作为NSF-ISR审核流程(AESOP 7246)的补充,以ISO9001, ISO14001和RC-14001以及ISO13485:2016过渡的相关事项为首要议题

 

  1.  It is understood that there may be exceptions made for certain circumstances, or specific client needs.  Any deviation from the following procedure shall be communicated to the appropriate BUM, or designee, for review and approval.

众所周知,某些特殊状况或客户的特定需要会产生某些特例。任何违背下述程序的情况都应告知相应的区

              域业务经理或下派人员以获得评审和批准。

 

  1. There is a 3-year transition period allowed for clients upgrading to ISO 9001: 2015, ISO 14001: 2015, RC-14001:2015and ISO 13485:2016 (the Standards), however, it is strongly recommended that most client organizations upgrade well before the end of the transition period.

须升级到新版ISO9001:2015, ISO14001:2015,RC-14001:2015以及ISO13485:2016标准的客户允许有3年过渡期。然而,强烈推荐客户和企业大多宜提前完成升级。

 

  1. Both ISO 9001:2015 and ISO 14001:2015were revised and officially published on September 15, 2015.  RC-14001:2015 was revised and officially published late September 2015.ISO 13485:2016 was published March 1, 2016The official expiration date for all certificates issued for ISO 9001:2008,ISO14001:2004, RC-14001:2015 will be September 14, 2018.  The official expiration for ISO 13485:2003 will be February 28, 2019.

    修订后的ISO 9001:2015 和ISO 14001:2015这两个标准及RC-14001:2015标准都已先后于2015年9月15日和2015年9月底正式公布。ISO13485:2016于2016年3月1日发布。基于这3类标准所分别颁发的证书有效期都正式截止于2018年9月14日。ISO 13485:2003有效期正式截止于2019年2月28号。

  2. The following document is being introduced as a guidance and training tool for all NSF-ISR personnel, and will be introduced to all International Regional Offices issuing NSF-ISR certificates for all of the Standards.

下述文件作为过渡指南和培训工具正被引荐给所有NSF-ISR人员,并即将引荐给所有可以颁发该类标准

              的NSF-ISR证书的国际区域办公室。

  1. The QMS and EMS Business Unit Managers (BUMs) will coordinate with the managers for Operations, Audit Services, Business Development, Client Retention and NSF QA to ensure that all relevant personnel receive training about the transition / upgrade process using this document.

    QMS(质量管理体系)和EMS(环境管理体系)的业务区域经理将和经理在执行,审核服务,业务拓

                  展,客户维护和NSF质量保证方面协同合作,以确保所有相关人员都由该文件受到过渡/升级程序的培训

     

  2. It is expected that the requirements from IAF and ANAB may change somewhat over the transition period, and this document may be revised during that time to keep up with any changes, or as needed to refine and clarify the process.

预计IAF和ANAB的要求在过渡时期可能会有所更改,所以该文件可能会在过渡期作相应修改来完善并明

        确该程序

 

 

  1. Accreditation:

认可

 

  1.  NSF-ISR will not issue any certificates for the Standards until such time as official ANAB approval has been granted per the application process.

根据申请程序给予正式的ANAB批准日后,NSF-ISR方可颁发证书

 

  1. The ANAB application process will be completed by the respective Business Unit Managers for QMS and EMS, with the assistance of NSF Quality Assurance.

ANAB申请程序将由QMS和EMS各自的业务区域经理在NSF品质担当的协同下共同完成。

 

  1. Once official notification of approval for the 2015 versionsand ISO 13485:2016of the Standards is received from ANAB, NSF Quality Assurance will notify the Business Unit Managers who will be responsible for communicating the approval to all interested parties.

一旦收到ANAB发出的2015版以及ISO13485:2016标准认证的正式获批通知,NSF的品质担当会通知相应的业务区域经理,他们会将通过认证的消息传达给有关各方。

 

  1. The Automotive Business Unit Manager and NSF Quality Assurance will be responsible for notifying the IAOB of the updated Standards accreditations, per IATF Rules 4th Edition.

    依据IATF第4版规则,将由汽车业务区域经理和NSF的品质担当通知IAOB已通过标准升级

     

  2. NSF-ISR Clients:

NSF-ISR客户:

 

  1. All NSF-ISR clients registered to ISO 9001: 2008 and/or ISO 14001: 2004 and/or RC-14001:2013 and ISO 13485:2003will be required to “upgrade” their registrations to the 2015 and 2016  versions of the Standards by September 14, 2018.  All NSF-ISR clients registered to ISO 13485:2003 will be required to “upgrade” by February 28, 2019.

所有NSF-ISR的ISO 9001: 2008, ISO 14001: 2004 和/或RC-14001:2013以及ISO13485:2003的认证客户都须将证书升级到2015版以及2016版,且升级完成时间不得迟于2018年9月14号。所有的NSF-ISR认证ISO13485:2003的客户,升级时间必须不得晚于2019年2月28日。

 

  1. he Business Unit Managers (BUMs) for QMS and EMS will be responsible for ensuring that regular email updates, newsletters, and other forms of communication are used on a regular basis to ensure that all registered clients are aware of the transition requirements for their respective standards. 

QMS和EMS的业务区域经理须采用常规通讯方式,如邮件,电子简报等,以确保所有认证客户都能获悉

 其各自认证标准的过渡要求。

 

  1. The BUMs, or designees will be responsible for providing timely responses to internal and external inquiries about the transition process for their respective Standards.

就各自标准过渡程序的内外部来电来函等咨询,区域业务经理或下派人员须及时答复

 

  1.  The QMS and EMS BUMs will coordinate regularly with Operations and Business Development to track the status for client upgrades to the 2015 version of the Standards.

            QMS和EMS的区域业务经理将和运营部及业务拓展部协同合作,定期跟进客户2015版证书升级的情况。

     

  2.  All clients for ISO 9001/14001 should have upgrades scheduled and completed by June 15, 2018in order to allow for corrective actions and CB Reviews to be completed.  All ISO 13485 clients will have untilNovember 30, 2017 to complete their upgrade audit.In extenuating circumstances and with approval by the QMS or EMS BUM respectively, clients may be allowed to go beyond that date, however, under no circumstances will the expiration date of September 14, 2018 (or February 28, 2019 for ISO 13485:2003)be waived or changed.

            所有客户都应将ISO9001/14001升级计划定于2015年6月15号之前完成,从而预留时间给可能出现的纠正措施程序和认证机构评审程序。所有的ISO13485客户必须在2017年11月30日截止完成升级审核。

                  特殊情况,并且分别经QMS或者EMS区域业务经理批准,可以允许客户晚于此日期。然而,在任何情况下,2018年9月14日(ISO13485:2003截止到2019年2月28日)到期后将被放弃或改变。

     

  3. The QMS and EMS BUMs will review the number of clients who have not opted to upgrade by June 15, 2018 to determine actions to be taken before the certificates issued for either ISO 9001:2008, ISO 14001:2004 or RC-14001:2013that expire on September 14, 2018.  The same type of review will be conducted by the Technical Scheme Manager for ISO 13485 for clients who have not upgraded their medical devices certificate by November 30, 2018.

QMS和EMS的区域业务经理将评审哪些客户到2018年6月15号还没有完成证书升级,以便在发放即

        将于2018年9月14号失效的ISO 9001:2008, ISO 14001:2004或RC-14001:2013证书前采取相应措施

对于没有在2018年11月30日前完成升级医疗设备证书的13485客户,同一类型的审查将由技术方案经理进行指导。

 

  1. Any clients for ISO 9001/ISO 14001 who have not upgraded by September 14, 2018 will be dropped in the IQ system on September 15, 2018.

           任何于2018年9月14号还未完成升级的客户都将从IQ系统中删除。

     

  2. Clients for ISO 13485:2003 will be dropped on the IQ system on March 1, 2019, if they have failed to upgrade their certification by that date.

    2019年3月1号还未完成升级的13485:2003客户都将从IQ系统中删除。

     

  3. Business Development Group and Account Management :

业务拓展团队和财务管理部:

 

  1.  Business Development Group and Account Management personnel may begin to provide quotes to registered clients requesting an upgrade to the 2015 versions of ISO 9001/ISO 14001,and for ISO 13485:2016 effective immediately.

    业务拓展团队和财务管理部人员可开始提供报价给要求升级到2015版ISO9001/ISO14001证书或者ISO13485:2016证书的认证客户,该报价可即刻生效

     

     

  2.  When gathering application information from new or transferring clients for registration to either of the Standards, Business Development Managers (BDMs) must determine and record which version of the Standard(s) they are to provide a quote for.  This must be clearly recorded on the quotation and application records.

                 向新客户或是转机构客户采集申请这三类标准的认证信息时,业务拓展部经理须确定所申请的标准版本号

                 并将其明确记录在报价单和申请表中。

     

  3. Quoting for new clients seeking registration for the 2015 versions of the Standards shall be quoted according to the established audit day tables in the NSF-ISR Quote Guide (AESOP 10923), as the audit duration tables have been verified as being consistent with the latest version of IAF MD 5 and IAF MD 9 as applicable.

    应新客户要求按2015版认证标准报价时,须依据NSF-ISR报价指南(AESOP10923)中建立的审核人

            天表,因审核周期表经验证与最新版IAF中的第5号和第9号强制性文件一致

     

  4. Allupgrade audit durations for clients registered to ISO 9001: 2008 and / or ISO 14001: 2004 and/or RC-14001:2013 shall be calculated using the one of the following three options:

    所有的认证ISO9001;2008和/或ISO14001:2004和/或RC-14001:2013客户的升级审核人天应按照以下三种选择适用的一种进行计算:

  5. Performing an audit equal to the duration of Recertification Audit time, according to the appropriate table in the NSF-ISR Quote Guide (AESOP 10923).

根据NSF-ISR报价指南(AESOP 10923)适用表,实施一次审核与再认证审核时间相同。

  1. Performing the upgrade/transition audit during the normal surveillance audit of the client, PLUS the number of days specified inTABLE 1(for ISO 9001:2015 & ISO 14001:2015) and TABLE 2 (For RC-14001:2015)  located in Annex A of this procedure to determine the appropriate number of days required.

在一般的监督审核中实施升级/过渡审核,要加上本程序的附录A中的表1(ISO9001:2015&ISO14001:2015),以及表2(RC-14001:2015)指定的人天,来决定适当的人天要求。

  1. Performing the upgrade/transition audit during a Special audit of the client, and using the table located in Annex A of this procedure to determine the appropriate number of days required.

在一次特殊审核中实施升级/过渡审核,使用本程序附录A的表格,来决定适当的人天要求。

 

  1. An upgrade auditto any standard may occur at anytime during the current 3-year certification cycle.

    任何标准的一个升级的审核,可能发生在3年认证周期内的任何时候。

  2. All upgrade audits will require a certification decision.  Only those audits performed using Option #1 in section 4.4 of this procedure will be treated as an early recertification, as per applicable standard and result in the start of a new 3-year cycle of certification.

    所有的升级审核都要有认证决定。只有那些使用本程序的4.4部分选项1进行的审核,将升级审核当

            作前期的复评来处理,按照适用标准,开启新一轮3年认证周期

     

  3. ISO 13485:2016 upgrades shall start at the original certification time and if applicable 15% reduction for no design. i.e. NOT THE RECERTIFICATION TIME and justify any reduction from that point. The justification is that the majority of each element of ISO 13485:2016 has an additional clarification point that will have to be verified.

    ISO13485:2016升级应在初始认证时间即非换证时间启动,无设计要减掉15%的人天,以此基数调整。

                   理由是,ISO 13485:2016每个条款的大多数有一个额外的澄清点,必须验证。

     

  4. Combined 9001 and 13485 recertification audits - Where 9001 and 13485 recertifications are being calculated at the same time the ISO 13485 certification time shall be used, (Minus 15% no design if applicable) also ensuring the customer has completed both of the applicable standard check lists. Ensure that both standards are considered as required by MD9 issue 2 section 9.1.4.1.

    9001与13485结合再认证审核—当9001和13485再认证同时计算人天时,使用13485认证时间,(如果没有设计减少15%),并且确认客户已经完成了两个适用标准检查表。确认两个标准都按照MD9问题2的9.1.4.1部分要求考虑。

     

  5. There may be a need for additional time (i.e. more than the calculated recertification time) for the upgrade audit, depending on the size and complexity of the organization.  Should there be a concern about the upgrade audit time, the BDM or Account Manager should consult with the assigned Lead Auditor prior to preparing the quote.

升级审核可能会因企业规模和架构复杂性而需更长时间完成(比如复评周期长于预期)。客户如果对升级

              审核时间有任何疑虑,区域业务经理或财务经理应于报价前,向指定的审核组长咨询。

 

 

 

 

 

 

 

 

  1. Any previous audit day reductions related to auditor knowledge of the client’s system and/or maturity of the system will not be allowed, as this is a new version of the Standard(s) and will be new to both the client and the auditor.

    审核员以客户体系和/或体系成熟度来判断审核人天折扣的过往经验都不可沿用,因为新公布的标准

              对于客户和审核员来说都还陌生。

 

  1.  Any justified reductions (other than those already mentioned in 4.7 of this document), or additions shall be recorded on the NSF-ISR Quote Reduction and Addition Justification Sheet (AESOP 11616).

         任何被验证合理或是新增的折扣(除该文件4.7中已被提及的人天折扣外)都应被记录在NSF-ISR报价折扣合理性表单中(AESOP 11616)

 

  1. ISO 9001, ISO 14001 and RC-14001 All quoted audit time shall be considered as on-site audit time.  There will be no reductions for off-site planning or report writing.

      ISO 9001, ISO 14001 和RC-14001所有报价中提及的审核时间都应视为现场审核时间。非现场策划或报告编写时间都无任何折扣。

     

  2.  In the case of ISO 13485:2016 the AESOP 10923 quote guide and MD9 issue 2 does specify that off-site time can be allocated for preparation and report writing. The allowance is detailed in the AESOP Quote guidelines.

    针对ISO13485:2016,AESOP10923报价指南和MD9问题2指定非现场时间可以分配给策划和报告编写。

    数据详见AESOP报价指南。

     

  3. Auditors and Audit Services Team:

           审核员和审核服务小组:

     

    1.  The QMS and EMS BUMs, in conjunction with the Audit Services Team are responsible for ensuring that the auditors for their respective standards upgrade their certifications to meet the 2015 version or 2016 versions requirements as applicable.

      QMS和EMS的业务区域经理与审核服务小组协同合作,如适用,负责确保审核员针对各自的标准,升级他们的证书以满足2015版本或者2016版本要求。

       

    2.  NSF-ISR has procured user licenses for all auditors for ISO 9001:2015, ISO 14001:2015, ISO 13485 and communicated the availability of the training to its full-time and independent contract auditors.  Additionally, the American Chemistry Council has provided training materials for transition to RC-14001:2015 to NSF-ISR, who in turn have shared with current RC-14001 auditors. This training and examination is recognized by Exemplar Global, and is available to all auditors free of charge.

              NSF-ISR已取得ISO 9001:2015 和ISO 14001:2015标准审核员的使用许可证,并向其全职独立的签约审

                    核员开放有关新标准的过渡培训项目,并且也将美国化学委员会提供的RC-14001:2015过渡培训资料分

                    享给了现有的RC-14001审核员。此项培训和考核获得了ExemplarGlobal 的认可,且免费向所有审核员

                    开放。

       

    3. All auditors for the Standards are required to take the Auditor Transition Training Course for all of the Standards they are currently certified to audit to.  It is expected that all ISO 9001 Auditors complete the examination by October 31, 2015; all ISO 14001 Auditors complete the examination by December 31, 2015; all RC-14001 Auditors complete the examination by March 15, 2016and all ISO 13485 auditors complete the examination by December 30,2016.

所有具有审核相关标准资格的审核员都须参加标准过渡培训课程。所有ISO9001,ISO14001和RC-

             14001审核员的考核预计分别于2015年10月31日,2015年12月31日和2016年3月15日之前完

               成,ISO13485审核员的考核在2016年12月30日完成。

 

  1.  Upon successful completion of the Transition Exam for ISO 9001:2015, auditors are required to email a copy of their new certificate to the Audit Services Team for NSF-ISR records.

一旦顺利完成ISO9001:2015过渡考核,审核员须将新证书用电子邮件发给审核服务小组以便NSF-ISR记录在案。

 

  1. Satisfactory completion of the ISO 13485:2016 NSF-ISR transition class

    使NSF-ISR的ISO13485:2016过渡班符合要求的完成。

     

  2. The Audit Services Team is responsible for tracking completion of the auditor credentials transition, maintain the certificates of completion, and updating the NSF databases for the auditors’ credentials.

审核服务小组负责跟进审核员证书过渡的完成情况,维护证书的完整性,更新NSF数据库中审核员

        资质。

 

  1.  Upon the Audit Services Team updating the NSF databases, the auditor will be able to be scheduled in IQ to conduct audits to the 9001:2015 version of the Standard(s) and 13485:2016

    一旦审核服务小组更新了NSF数据库,相关获得新证书的审核员就可以在IQ上安排2015版标准的审核了。

     

  2.  Auditors who fail to complete the Auditor Transition Course will not be allowed to participate in audits for the 2015 and 13485:2016 versions of the standards.

    如果过渡考核没有达标,审核员将不得参加2015版以及13485:2016版的审核。

     

  3.  Auditors who elect to take training for the 2015 and 13485:2016 version of the Standard(s) from a source other than that provided by NSF-ISR shall do so at their own cost.  Auditors taking this approach are responsible for ensuring that the training and examination will be acceptable to NSF-ISR, and their Auditor Authentication Body (e.g. Exemplar Global, IRCA, etc.).

            审核员如果不选择NSF-ISR而选择其它机构的2015和13485:2016版新标准的过渡课程培训,所有费用须自理,且应确保该培训和考核结果可获得NSF-ISR及审核员认证机构的认可(如ExemplarGlobal,IRCA等)

     

  4. Certification Decisions:

          认证决定:

     

    1.  Certification decisions for either ISO 9001: 2015, ISO 14001: 2015, RC-14001:2015or ISO 13485:2016cannot be made until the following actions are completed:

直到完成下列所有步骤,才可做出ISO 9001: 2015 ,ISO 14001: 2015,RC-14001:2015或者ISO13485:2016的认证决定。

 

  1.  ANAB has granted its approval, and updated the NSF-ISR accreditations for ISO 9001, ISO 14001 or RC 14001 to the 2015 versions, and ISO 13485:2016.

    ANAB已批准并更新了NSF-ISR 的ISO9001,ISO14001或RC 14001过渡至2015版以及ISO13485:2016 的认证情况

     

  2.  The NSF QA Department in conjunction with the QMS and EMS BUMs will communicate ANAB’s approval to NSF-ISR staff, Regional Offices, Auditors and clients upon approval for the Standards, once received.

    NSF的QA部门和QMS及EMS的业务区域经理一旦收到ANAB的批准,就应将获批结果告知 

                          NSF-ISR的成员,地方办公室,审核员和客户。

     

  3.  All Certification Body (CB) Reviewers who make certification decisions are required to take the sanctioned Auditor Transition Training and examination for the 2015/2016version of the Standard(s) they are currently approved for.  This will include any supplemental training developed by the QMS and EMS BUMs for their respective Standards. 

    所有认证机构中做认证决定的评审员都须参加审核员2015/2016版新标准的过渡培训和考核,该培训还包括QMS和EMS业务区域经理策划的基于各自标准的辅助培训

     

  4.  CB Reviewers will be expected to be fully conversant with this document, and once approved, only render positive certification decisions if the upgrade / transition audit has satisfied all of the criteria established in this document (i.e. Auditor qualifications, audit duration, records, etc.).
     

    认证机构的评审员应透彻了解并熟练掌握该文件内容。一旦获批,如果升级/过渡审核满足了该文件

                       中规定的所有标准(如审核员资质,审核时间跨度,审核记录等),只要给出正面积极的认证决定即

                       可。

     

  5. Registration Certificates:

注册证书

 

  1. All new ISO 9001: 2008, ISO 14001: 2004, and RC 14001:2013 certificates issued from September 15, 2015 onward must have an expiration date of September 14, 2018. All ISO 13485:2002 issued after February 28, 2016 will have an expiration date of February 28, 2019. This has been (will be for RC-14401:2015) implemented as an automated change in the IQ system, but should be verified by the CRM during the Certificate Review job.

    所有自2015年9月15号起发放的ISO9001: 2008, ISO 14001: 2004和RC 14001:2013新证书的到期日

        均为2018年9月14号。所有自2016年2月28日发放的ISO13485:2002新证书的到期日为2019年2月28日。这一措施已在IQ系统里自动实行,但仍应由客户经理在证书评审工作中与客户明确说明

 

 

  1. New client organizations may become registered to ISO 9001: 2008 and/or ISO 14001: 2004 and/or RC 14001:2013 until September 15, 2017for ISO 13485:2003 February 28, 2018.The Certification Decision job in IQ must be performed by that date.  The QMS or EMS BUM approval will be required for certification decisions beyond that date, under extenuating circumstances.

                 初次申请ISO 9001: 2008, ISO 14001: 2004或RC14001:2013认证的客户或企业机构,其认证完成时间

                 不得迟于2017年9月15号,ISO13485:2003不得迟于2018年2月28日。IQ系统须最迟在这天完成认证决定工作。在情有可原情况下,须经QMS或EMS业务区域经理批准方可推迟该认证决定的时间底线

     

  2. Current clients will be allowed to re-certify to ISO 9001: 2008.r ISO 14001: 2004, and/or RC 14001:2013 until September 15, 2017and ISO 13485:2003 until February28,2018. The Certification Decision job in IQ must be performed by that date.  The QMS or EMS BUM approval will be required for certification decisions beyond that date, under extenuating circumstances.

    现有客户于2017年9月15号前仍可再次申请ISO 9001: 2008, ISO 14001: 2004和/或RC 14001:2013的认证,ISO13485:2003的认证于2018年2月28号前仍可再次申请。IQ系统须最迟在这天完成认证决定工作。在情有可原情况下,须经QMS或EMS业务区域经理批准方可推迟该认证决定的时间底线。

     

     

     

  3. In order to avoid certificates being issued with 1 year (or less) validity, auditors, BDMs, CRMs and the BUMs for QMS and EMS should make every effort to persuade clients to upgrade as soon as possible during the 3-year transition period.

QMS和EMS的审核员,业务拓展部经理,客户关系部经理和业务区域经理应全力说服客户在3年过渡期

        内完成证书升级,以免所发证书只有1年或不到1年有效期。

 

  1.  All certificates issued as a result of an upgrade audit using recertification time will be granted a new certificate to the Standard(s) with a new 3-year cycle.

    与复评所需相同,经升级审核所发放的所有新证书的证书周期都为3年。

     

  2. Client Readiness and Audits:

客户准备和审核

 

  1.  All clients upgrading to either ISO 9001:2015 or ISO 14001:2015 standard should complete the online Readiness Tool for the desired Standard(s) as a starting point.  The Readiness Tool’s for ISO 9001:2015 and ISO 14001:2015 were posted on-line in November 2015.  The Readiness Tool for ISO13485:2016 will be posted by December 15, 2016.The online Readiness Tool will require the client to identify their organization and some specific details (i.e. headcount, number of sites, etc.), and will provide them with a number of pertinent questions related to the “Deltas” for the Standard they select.

            所有需要升级到ISO 9001:2015 或ISO 14001:2015的客户,首先应在线填好准备工具。针对ISO

            9001:2015 和ISO 14001:2015的准备工具已于2015年11月投入使用。13485:2016的准备工具将于2016年12月15日投入使用。线上准备工具要求客户验证其企业身份和某些特殊细节(如人数,场所数量等),并会提出与所选标准的“Deltas”相关的一些问题

     

  2.  Once the client has completed the online questionnaire, the system will grade their answers and provide suggestions on how to proceed.  Suggestions may include scheduling their upgrade audit, if they are deemed ready based upon their answers.  Others may include having a Gap Analysis audit, or point to areas of their system that need to be improved prior to proceeding to the upgrade audit.

              一旦客户填好线上调查问卷,系统就会评估其答案,并给出后续如何进行的建议。如果系统基于客户的答案判定其已准备就绪,系统会给出后续的一些建议,以供客户在正式升级审核前参考,如升级审核的计划安排,差异分析审核的计划安排,或是指出其体系中需要改进的地方。     

     

  3. Gap Analysis:

                   差异分析:

     

    1.  Clients may request Gap Analysis which will be quoted by the appropriate BDM.

                             客户如果要求做差异分析,那么相应的业务拓展部经理会将其费用含在报价单里

       

    2.  The Gap Analysis duration of the audit should be 1 or 2 days.  Additional time for these audits may be required, depending on the size and complexity of the organization.

      差异分析审核需1到2天。根据企业的规模和架构的负责性,该审核可能还要求一些额外审核时间

       

    3.  Once quoted the CRM will schedule a Gap Analysis audit with the client and assigned Lead Auditor.  Gap Analysis audits should be set up as a Special Audit job in IQ, and the.  The auditor assigned to perform Gap Analysis audits shall be qualified to perform audits to the 2015 version of the Standard(s) (refer to section 5 of this document).

                     报价以后,客户关系经理就会和客户商议安排一次差异分析审核并指定审核组长。差异分析审核应在                 IQ中设立为特殊审核…(内容缺失)。指定进行差异分析审核的审核员应具备审核2015版相关新标准

                      的审核资格(详情参见本文第5部分)

       

    4.  The results of a Gap Analysis are not to be consider all-inclusive, as the Deltas between old and new versions of the Standards are the primary focus of the audit.  The findings of the audit should only indicate that requirements of the Standard(s) are effectively implement, or need improvement.

           

      由于审核主要侧重于新旧标准间的Deltas,所以差异分析审核的结果并不是涵盖一切的。该审核发现

                      应仅仅显示标准所提出的要求是否都被有效执行,或仍需改进。

       

    5.  CARs are NOT to be issued during a Gap Analysis audit.

                              差异分析审核期间是不会有纠正措施这方面要求的

       

    6.  The assigned auditor(s) shall use the appropriate Delta Checklist for EMS or QMS (under development) to perform the Gap Analysis, along with the normal NSF-ISR iAudit template.  Sections that are not covered may be marked N/A accordingly.

                      指定的审核员应采用EMS或QMS相应的Deltas检查表(设计中)和NSF-ISR常规的电子审核模

                      板来进行差异分析审核。其中企业不涉及的部分可相应标为“N/A”

       

  4. Regularly Scheduled Audits:

    定期安排的审核

    1.  During the registered clients’ regularly scheduled audits during the transition period, the assigned Lead Auditor shall request that the client give them an estimate of when they would like to have their upgrade audit.

过渡期间,在对认证客户定期安排审核时,指定的审核组长应要求客户提供升级审核的预计时间

 

  1.  The clients’ response to the timing plan for the upgrade audit for the Standard(s) shall be recorded by the Lead Auditor in the FRS Changes section of the audit report.

审核组长应将客户对升级审核的时间计划所作的回复一一记录在审核报告的合同变更部分。

 

  1.  CRMs shall review client record for FRS Changes noted on all audit reports for the Standards during the transition period.  If the Lead Auditor has neglected to record the planned upgrade timing in the FRS Changes, the CRM shall contact the Lead Auditor and request that they provide the information via email.

    客户关系经理应评审所有标准过渡期的审核报告中注明合同变更的客户记录。如果审核组长出于疏

               忽,没有将计划升级时间记录在合同变更中,客户关系经理应联系审核组长并要求其发邮件告知相关

               信息。

 

  1.  Being aware of the clients’ upgrade intentions will allow NSF-ISR to better anticipate auditor resource needs, and assist in tracking the completion of the transition for all clients registered to the Standard(s).

对客户升级需求的意识有利于NSF-ISR预估审核员资源需求,更好地协助和跟进认证相关标准的所

                有客户的证书升级完成情况。

 

  1. The Delta Checklist:

    数据检查表

    1.  Prior to scheduling an upgrade audit to the 2015 and/or 2016 version of the Standard(s), the client should be sent a “Delta Checklist” for review and self-assessment of readiness.  The checklist should be sent to the client by the CRM, Retention Team, Lead Auditor or BDM.

      计划2015版和/或2016版新标准升级审核之前,客户应提交填写好的Deltas检查表以供准备情况的评审和自我评估。该检查表应由客户关系经理,维持小组,审核组长或业务区域经理提供给客户填写。

       

    2.  For ISO 9001: 2015, the client may use the ISO 9001-2015 Upgrade Planner and Delta Checklist (AESOP 15604).

      申请ISO9001: 2015认证的客户可以采用ISO 9001-2015升级计划工具和Deltas检查表(AESOP 15604)

       

    3.  For ISO 14001: 2015, the client may use the ISO 14001:2015 Upgrade Planner and Delta Checklist (AESOP 15688.).

               申请ISO14001: 2015认证的客户可以采用ISO 14001:2015升级计划工具和Deltas检查表(AESOP

                15688.)

       

    4. For RC 14001:2015, the client may use the RC 14001:2015 Upgrade Planner and Delta Checklist.

申请RC 14001:2015认证的客户可以采用RC 14001:2015升级计划工具和Deltas检查表

 

  1. The client should provide information for the Standard(s) per the appropriate “Delta Checklist“, for each question and requirement via internal documents and records, as completely as possible. This information shall be made available to the auditor (s) during the onsite upgrade audit.

    客户应基于相应Deltas检查表针对每个问题和内部文件及记录中的要求提供相关信息,越完整越好。该信息应在现场升级审核中对审核员开放。

     

  2. If the client decides to use the Delta Checklist, the client’s representative may forward the Delta Checklist to the assigned Lead Auditor. The Lead Auditor will review the information provided in the checklist and verify that it is complete, and the client is ready for the upgrade audit.

            一旦填写完成,客户代表可以将Deltas检查表提交给指定的审核组长。审核组长将评审检查表中提

            供的信息并确认其完整性。如果没有任何问题,客户就可以准备升级审核了。

     

  3.  The Delta Checklist and any associated records provided by the client may be reviewed by the assigned Lead Auditor as pre-planning information, and prepare the upgrade audit plan according to the processes defined by the client.  The Lead Auditor may request supporting information from the client, as needed.

Deltas检查表和任何由客户提供的相关记录可以由指定的审核组长作为预先策划信息来评审,然后由客

       户确定的程序来准备升级审核方案。如有需要,审核组长可能会要求客户提供支持信息。

 

  1. Once client readiness has been established(either by the Delta Checklist review, or by client request for an upgrade audit), the Account Manager may confirm the schedule for the upgrade audit with the client and NSF-ISR Lead Auditor.

一旦客户准备就绪(通过Delta检查表检查或者通过客户要求一个升级审核),财务经理可与客户及NSF-ISR审核组长一起确定升级审核的时间计划

      

  1.  The upgrade audit will proceed in accordance with the NSF-ISR Audit Procedure (AESOP 7246).  The Audit Team, as applicable, will verify conformance for each requirement of the audit standard during the onsite upgrade audit.

            升级审核将根据NSF-ISR审核步骤(AESOP 7246)来执行。如可行,审核小组将在现场升级审核期

            间验证审核标准中每个要求的符合度

     

  2. The NSF-ISR Lead Auditor shall use the Deltas Checklist in conjunction with the established template for the audit Standard to record the results of the audit.

              NSF-ISR的审核组长将结合Deltas检查表和模板来记录标准审核的结果。

     

  3. For upgrades using Recertification audit time (Option #1, in section 4.4), NSF-ISR Auditors shall use the time to audit all processes, with a focus on ensuring that the Delta requirements have been effectively implemented by the client organization.

    对于使用再认证审核时间的升级(4.4部分的选项1),NSF-ISR审核员必须在此时间内审核所有的过程,重点确认“Delta”要求已经被客户组织有效的执行了。

     

  4. For upgrades during Surveillance (Option #2, in section 4.4), NSF-ISR Auditors shall use the additional time calculated by the BDM, or Account Manager to verify that the Deltas requirements have been effectively implemented, and sample the client organization’s audit, per normal surveillance audit requirements (refer to AESOP 7246).

    对于监督期间的升级(4.4部分的选项2),NSF-ISR审核员必须使用业务区域经理或者财务经理计算的额外的时间,以确认“Delta”要求已经被有效的执行,并按照一般的监督审核要求(参考AESOP 7246)对客户组织的审核进行抽样。

     

  5. For upgrades during Special Audits (Option #3, in section 4.4), NSF-ISR Auditors shall use the calculated audit time to verify the that the Delta requirements have been effectively implemented, and review the mandatory items audited during every on-site audit activity (i.e. Management Review, Internal Audits, Corrective Action and Customer Complaints).

    对于特殊审核期间的升级(4.4部分选项3),NSF-ISR审核员必须使用计算的审核时间来确认Delta要求被有效的执行,并检查每个现场审核活动审核的强制性项目(例如:管审、内审、纠正措施和顾客反馈)

     

  6. At the conclusion of the audit activity, the NSF-ISR Auditors will complete their audit reports per the normal process (i.e. Word template or iAudit), and submit the final, completed Delta Checklist as part of the audit evidence, along with all other required attachments.

              审核结束后,NSF-ISR审核员将根据常规程序(比如用word模板或电子审核模板)填写审核报告,

               然后将最终完整的数据检查表及其他所有要求的附件作为审核证据提交上去。

     

     

     

     

     

    Annex A  附录A

     

    TABLE 1  表格1

     

    Audit Duration Table for ISO 9001:2015 and ISO 14001:2015

    ISO9001:2015ISO14001:2015审核人天表

     

    IMPORTANT:ONLY for use with Options #2 or #3 in Section 4.4 of this procedure.

    注:只适用于本程序4.4部分的选项#2或者#3

     

Number of personnel人数

Option #2 (Surveillance)选项#2(监督审核)

Option #3 (Special Audit)

选项#3(特殊审核)

1 – 249

0.5

1.0

250 – 499

1.0

1.0

500 – 749

1.5

1.5

750 – 999

2.0

1.5

For larger organizations, please follow the above progression.

对于大型企业,请参照以上进度

 

 

 

TABLE 22

 

Audit Duration Table for RC-14001:2015

RC-14001:2015审核人天表

 

IMPORTANT:ONLY for use with Options #2 or #3 in Section 4.4 of this procedure.

注:只适用于本程序4.4部分的选项#2或者#3

 

 

Number of personnel人数

Option #2 (Surveillance)选项#2(监督审核)

Option #3 (Special Audit)选项#3(特殊审核)

1 – 249

1.0

1.5

250 – 499

1.5

1.5

500 – 749

2.0

2.0

750 – 999

2.5

2.0

For larger organizations, please follow the above progression.
对于大型企业,请参照以上进度

 

 

 

 

 

Amendment Record

 

Version #

版本号

 

Submitted Date

提交日期

 

Summary of Changes

变更概要

1

10/2015

Initial issue首次发布

2

10/2015

Accepting tracked changes      接受的跟踪更改

3

2/2016

Adding RC 14001:2015, Updating Actual (vs projected dates) for ISO 14001:2015

增加RC 14001:2015,更新ISO14001:2015实际日期(对比预计日期)

4

11/2016

Added ISO 13485:2016 revision, updated to include options for transition audit duration and method.

增加ISO 13485:2016版本,更新包括升级审核人天和方法的选择