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TSCA认证:eCFR 770.7 (b) EPA TSCA VI的实验室认证机构 临安科达认证技术咨询服务有限公司   时间:2019-04-19   点击:703 次
EPA TSCA Title VI 实验室ABs(认证机构)。参加EPA TSCA Title VI第三方认证计划,作为EPA TSCA Title VI 实验室AB,实验室AB必须具有本节所述的资格,提交申请并按照本节所述与EPA签订认可协议,并且,在获得EPA的认可后,公正地履行本节所述的责任。
 

§770.7   Third-party certification. 第三方认证

(b) EPA TSCA Title VI Laboratory ABs. To participate in the EPA TSCA Title VI Third-Party Certification Program as an EPA TSCA Title VI Laboratory AB, a Laboratory AB must have the qualifications described in this section, submit an application and enter into a recognition agreement with EPA as described in this section, and, upon recognition from EPA, impartially perform the responsibilities described in this section.

(b) EPA TSCA Title VI 实验室ABs(认证机构)。参加EPA TSCA Title VI第三方认证计划,作为EPA TSCA Title VI 实验室AB,实验室AB必须具有本节所述的资格,提交申请并按照本节所述与EPA签订认可协议,并且,在获得EPA的认可后,公正地履行本节所述的责任。

(1) Qualifications. To qualify for recognition by EPA under the EPA TSCA Title VI Third-Party Certification Program as an EPA TSCA Title VI Laboratory AB, an applicant Laboratory AB must:

1)资格。要获得EPA根据EPA TSCA Title VI第三方认证计划作为EPA TSCA Title VI 实验室 AB的资格,申请人实验室AB必须:

(i) Be a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA), or have membership in one of the ILAC recognized regional accreditation cooperations, or an equivalent organization as determined by EPA;

i)成为国际实验室认可合作组织(ILAC)相互承认协议(MRA)的签字人,或者是ILAC认可的区域认证合作之一,或EPA确定的同等组织的成员

(ii) Be in conformance with ISO/IEC 17011:2004(E) (incorporated by reference, see §770.99);

ii)符合ISO / IEC 170112004E)(通过引用并入,见§770.99

(iii) Be competent to perform accreditation activities for laboratory accreditation according to ISO/IEC 17025:2005(E) (incorporated by reference, see §770.99); and

iii)有权根据ISO / IEC 170252005E)进行实验室认可的认证活动(通过引用并入,见§770.99

(iv) Be competent to ensure EPA TSCA Title VI TPC inspection activities are in conformance with ISO/IEC 17020:2012(E) (incorporated by reference, see §770.99).

iv)有资格确保EPA TSCA Title VI TPC检查活动符合ISO / IEC 170202012E)(通过引用并入,见§770.99)。

(2) Application. To be recognized by EPA under the EPA TSCA Title VI Third-Party Certification Program, a Laboratory AB must submit an application to EPA, which may be submitted in conjunction with a Product AB application. For recognition, a Laboratory AB must submit an application in accordance with §770.8 that contains the following:

2申请。根据EPA TSCA Title VI第三方认证计划获得EPA的认可,实验室AB必须向EPA提交申请,该申请可以与产品AB申请一起提交。为了识别,实验室AB必须按照§770.8提交申请,其中包含以下内容:

(i) Name, address, telephone number, and email address of the organization or primary contact;

i)组织或主要联系人的姓名,地址,电话号码和电子邮件地址

(ii) Documentation of ILAC MRA signatory status, membership in one of the ILAC recognized regional accreditation cooperations, or an equivalent organization as determined by EPA;

iiILAC MRA签字识别的文件,成为ILAC认可的区域认证合作伙伴之一,或由EPA确定的同等组织

(iii) Description of any other qualifications related to the Laboratory AB's experience in performing laboratory accreditation and inspection certification of TPCs including an affirmation that assessors will be technically competent to assess TPCs ability to perform their activities under paragraph (c)(4) of this section; and

iii)描述与实验室AB在进行TPC实验室认可和检验认证方面的经验相关的任何其他资格,包括确认评估员在技术上有权评估TPC根据本条款(c)(4)开展其活动的能力部分

(iv) If not a domestic entity, name and address of an agent for service located in the United States. Service on this agent constitutes service on the AB or any of its officers or employees for any action by EPA or otherwise by the United States related to the requirements of this part. ABs may share an agent for service.

iv)如果不是国内实体,则位于美国的服务代理商的名称和地址。该代理商的服务构成AB上的服务或任何其官员或雇员参与EPA的任何行动美国或其他方面与本部分的要求有关。AB可以共享代理服务。

(3) Recognition agreement. To be recognized by EPA under the EPA TSCA Title VI Third-Party Certification Program, a Laboratory AB must enter into a recognition agreement with EPA that describes the EPA TSCA Title VI Laboratory AB's responsibilities under this subpart.

3)认可协议。根据EPA TSCA Title VI第三方认证计划获得EPA的认可,实验室AB必须与EPA签订一份认可协议,该协议描述了EPA TSCA Title VI 实验室AB在该子部分下的责任。

(i) Each recognition agreement will be valid for three years.

i)每份认可协议有效期为三年。

(ii) Each recognition agreement will identify an EPA Recognition Agreement Implementation Officer and an EPA TSCA Title VI Laboratory AB Implementation Officer that will serve as the point of contact for the EPA TSCA Title VI Third-Party Certification Program.

ii)每份认可协议将确定EPA认可协议执行官和EPA TSCA Title VI Laboratory AB实施官员,该官员将作为EPA TSCA Title VI第三方认证计划的联系人。

(iii) To renew a recognition agreement for an additional three-year period, the EPA TSCA Title VI Laboratory AB must submit an application for renewal in accordance with §770.8 before the three-year period of the recognition agreement lapses. The application must indicate any changes from the EPA TSCA Title VI Laboratory AB's initial application or most recent renewal application.

iii)为了续签三年的认可协议,EPA TSCA Title VI 实验室 AB必须在认可协议的三年期限过后按照§770.8提交续展申请。申请必须表明EPA TSCA Title VI 实验室AB的初始申请或最新续签申请的任何变更。

(iv) If an EPA TSCA Title VI Laboratory AB fails to submit an application for renewal prior to the expiration of the previous recognition agreement, its recognition will lapse and the EPA TSCA Title VI Laboratory AB may not provide accreditation services under TSCA Title VI.

iv)如果EPA TSCA Title VI 实验室 AB在之前的认可协议到期之前未能提交续展申请,其认可将失效,EPA TSCA Title VI 实验室AB可能不会根据TSCA Title VI提供认证服务。

(v) If an EPA TSCA Title VI Laboratory AB does submit an application for renewal prior to the expiration of the previous recognition agreement, it may continue to provide TSCA Title VI accreditation services under the terms of its previous recognition agreement until EPA has taken action on its application for renewal of the recognition agreement.

v)如果EPA TSCA Title VI 实验室 AB在之前的认可协议到期之前确实提交了续展申请,它可以继续根据其先前的认可协议条款提供TSCA Title VI认证服务,直到EPA关于续签认可协议的申请采取行动为止。

(4) Impartiality. EPA TSCA Title VI Laboratory ABs must act impartially when performing activities under the EPA TSCA Title VI Third-Party Certification Program. To demonstrate impartiality, Laboratory ABs must:

4)公正。EPA TSCA Title VI实验室AB在根据EPA TSCA Title VI第三方认证计划开展活动时必须公正行事。为了证明公正性,实验室AB必须:

(i) Ensure that an accreditation decision regarding a TPC is made by persons different from those who conducted the assessment of the TPC; and

i)确保关于TPC的认可决定由与进行TPC评估不同的人做出

(ii) Ensure that the AB's personnel who assess TPCs or make decisions regarding accreditation do not receive financial benefit from the outcome of an accreditation decision.

ii)确保评估TPC或做出有关认证决策的AB人员不会从认可决定的结果中获得经济利益。

(5) Responsibilities. Each EPA TSCA Title VI Laboratory AB has the following responsibilities under the EPA TSCA Title VI Third-Party Certification Program:

5)职责。每个EPA TSCA Title VI 实验室 ABEPA TSCA Title VI第三方认证计划下承担以下责任:

(i) Accreditation. EPA TSCA Title VI Laboratory ABs must determine the accreditation eligibility, and accredit if appropriate, each TPC seeking recognition under the EPA TSCA Title VI Third-Party Certification Program by performing an assessment of each TPC. The assessment must include an on-site assessment by the EPA TSCA Title VI Laboratory AB to determine whether the laboratory meets the requirements of ISO/IEC 17025:2005(E) (incorporated by reference, see §770.99), is in conformance with ISO/IEC 17020:2012(E) (incorporated by reference, see §770.99) and the EPA TSCA Title VI TPC requirements under this part including the formaldehyde test methods ASTM E1333-14 and ASTM D6007-14 (incorporated by reference, see §770.99), if used. In performing the on-site assessment, the EPA TSCA Title VI Laboratory AB must:

i)认可。EPA TSCA Title VI实验室AB必须通过对每个TPC进行评估,确定每个TPC根据EPA TSCA Title VI第三方认证计划获得认可的认证资格,并在适当情况下进行认证。评估必须包括EPA TSCA Title VI 实验室 AB的现场评估,以确定实验室是否符合ISO / IEC 170252005E)的要求(通过引用并入,参见§770.99),符合ISO / IEC 170202012E)(通过引用并入,参见§770.99)和本部分的EPA TSCA Title VI TPC要求,包括甲醛测试方法ASTM E1333-14ASTM D6007-14(通过引用并入,参见§770.99 ),如果使用的话。在进行现场评估时,EPA TSCA Title VI 实验室 AB必须:

(A) Develop a checklist of the TPC requirements under paragraph (c)(4) of this section and the key conformity elements of ISO/IEC 17025:2005(E) (incorporated by reference, see §770.99); and

A)根据本节(c)(4)制定TPC要求清单和ISO / IEC 170252005E)的关键符合要素(通过引用纳入,见§770.99

(B) Use the checklist for each on-site assessment.

B)使用每个现场评估的清单。

(ii) Reassessment. Each EPA TSCA Title VI Laboratory AB must, in accordance with ISO/IEC 17011:2004(E) section 7.11 (incorporated by reference, see §770.99), conduct a follow-up reassessment or surveillance on-site assessment of each TPC laboratory that the AB has accredited.

)再评估。每个EPA TSCA Title VI 实验室 AB必须符合ISO / IEC 170112004E)第7.11节(通过引用并入,见§770.99),对AB认可的每个TPC实验室进行后续重新评估或监督现场评估。

(iii) Proficiency. Each EPA TSCA Title VI Laboratory AB must verify the accuracy of the formaldehyde emissions tests conducted by the TPC laboratory by ensuring the TPC laboratory participates in the CARB interlaboratory comparison for formaldehyde emissions when offered. In lieu of participation in the CARB interlaboratory comparison ensure that the TPC laboratory participates in an EPA-recognized proficiency testing program, if available.

iii)能力。每个EPA TSCA Title VI 实验室 AB必须通过确保TPC实验室参与CARB实验室间甲醛排放比较来验证TPC实验室进行的甲醛排放测试的准确性。代替参与CARB实验室间比对,确保TPC实验室参与EPA认可的能力验证计划(如果有)。

(iv) Suspension, reduction, withdrawal. Each EPA TSCA Title VI Laboratory AB must suspend, reduce, or withdraw the accreditation of a TPC laboratory that the AB has accredited when circumstances warrant.

iv)暂停,减少,撤回。在环境允许时每个EPA TSCA Title VI 实验室AB必须暂停,减少或撤销AB认可的TPC实验室的认证。

(v) Notifications. Each EPA TSCA Title VI Laboratory AB must provide, in accordance with §770.8, the following notifications to EPA as applicable:

v)通知。每个EPA TSCA Title VI 实验室 AB必须根据§770.8EPA提供以下通知(如适用):

(A) Notification of the loss of its status as a signatory to the ILAC MRA, or loss of membership in one of the ILAC recognized regional accreditation cooperations, or an equivalent organization as determined by EPA, within five calendar days of the date that the body receives notice of the loss of its signatory or membership status.

A)通知失去其作为ILAC MRA签字人的身份,或失去ILAC认可的区域认证合作的成员资格,或由EPA确定的同等组织,在机构收到失去其签字人或会员身份通知之日起的五个日历日内。

(B) Notification that a TPC laboratory has failed to comply with any provision of this part within 72 hours of the time the Laboratory AB identifies the deficiency. The notice must include a description of the steps taken to address the deficiency.

B)在实验室AB确定缺陷的72小时内,通知TPC实验室未能遵守本部分的任何规定。通知必须包括解决缺陷所采取步骤的说明。

(C) Notification of suspension, reduction or withdrawal of a TPC laboratory's accreditation within 72 hours of the time that the suspension, reduction or withdrawal takes effect.

C)在暂停,减少或退出生效后72小时内通知暂停,减少或撤销TPC实验室的认可。

(D) Notification of a change in a non-domestic Laboratory AB's agent for service within five calendar days.

D)在五个日历日内通知非国内实验室AB的服务代理人的变更。

(vi) Records. Each EPA TSCA Title VI Laboratory AB must maintain, in electronic form, the checklists and other records documenting compliance with the requirements for assessment, reassessment, and surveillance on-site assessments of TPC laboratories for three years.

(六)记录。每个EPA TSCA Title VI 实验室AB必须以电子形式保存清单和其他记录三年,记录符合TPC实验室评估,重新评估和监督现场评估要求。

(vii) Annual report. Each EPA TSCA Title VI Laboratory AB must provide, in accordance with §770.8, an annual report to EPA on or before March 1st of each year for AB services performed during the previous calendar year including the number and locations of assessment, reassessment, and surveillance on-site assessments performed for each TPC laboratory.

vii)年度报告。每个EPA TSCA Title VI实验室AB必须根据§770.8,在每年31日或之前向EPA提供上一日历年AB服务的年度报告,包括评估,重新评估和监督的数量和地点为每个TPC实验室进行现场评估。

(viii) EPA meetings. Each EPA TSCA Title VI Laboratory AB must meet with EPA at least once every two years in person, via teleconference, or through other virtual methods to discuss the implementation of the EPA TSCA Title VI Third-Party Certification Program.

viiiEPA会议。 每个EPA TSCA Title VI 实验室AB必须至少每两年与EPA会面一次,通过电话会议,或通过其他虚拟方法讨论EPA TSCA Title VI第三方认证计划的实施。

(ix) Inspections. Each EPA TSCA Title VI Laboratory AB must allow inspections of the AB's facilities by EPA, at reasonable times, within reasonable limits, and in a reasonable manner, upon the presentation of appropriate credentials and a written notification to the AB.

ix)检查。每个EPA TSCA Title VI 实验室AB必须允许EPA在合理的时间内,在合理的限度内,以合理的方式,在向AB提交适当的证书和书面通知后检查AB的设施。

 

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