IATF16949认证要求修订认可解释SI10-11

自2016年10月1日IATF发布了IATF16949:2016新版标准以来，收到了大量的反馈和意见。一段的时间后，IATF终于在其官网发布了新标准及更新官方批准解释。

SI 1-9 于2017年10月发布生效，详见本栏目其它文章细解，本处不再重复；

SI 10-11于2018年4月发布，2018年6月生效；

SI 8 & 10于2018年6月修订后再次发布，于2018年7月生效；

SI 12-13于2018年6月发布，并于2018年7月生效。

IATF16949认证要求修订认可解释SI11-7.1.5.3.2.External laboratory外部实验室

External/commercial/independent laboratory facilities used for inspection, test, or calibration services by the organization shall have a defined laboratory scope that includes the capability to perform the required inspection, test, or calibration, and either:
— the laboratory shall be accredited to ISO/IEC 17025 or its national equivalent (e.g., CNAS-CL01 in China) by an accreditation body (Signatory) of the ILAC MRA (International Laboratory Accreditation Forum Mutual Recognition Arrangement – www.ilac.org) or national equivalent and include the relevant inspection, test, or calibration service in the scope of the accreditation (certificate); the certificate of calibration or test report shall include the mark of a national accreditation body; or
— there shall be evidence that the external laboratory is acceptable to the customer.

组织用于检验、测试或校准服务的外部/商业/独立实验室设施应具有确定的实验室范围，包括执行所需的检查、测试或校准的能力，或：
— 该实验室应通过ILAC MRA (国际实验室认证论坛互认协议 – www.ilac.org)的认证机构(签约方) 或国家同等效力机构的 ISO/IEC 17025或国家同等标准的认证(如中国的CNAS-CL01)，并包括认证（证书）范围内的相关检查、测试或校准服务；校准证书或测试报告应包括国家认证机构的标志；或
— 应有证据表明外部实验室对于顾客是可接受的。
Rationale for change:改变的理由
Some organizations found the lab accreditation requirements for external/commercial/independent laboratory facilities used for inspection, test, or calibration services confusing and needed clarification. Clarified lab accreditation requirements and expectations.

一些组织发现，用于检查、测试或校准服务的外部/商业/独立实验室设施的实验室认证要求令人困惑而需要解释清楚。阐明实验室认证要求和期望。

IATF16949认证要求修订认可解释SI11-8.5.6.1 Temporary change of process controls过程控制的临时变更

SANCTIONED INTERPRETATION:The organiation shall identify,document,and maintain a list of the process controls,including inspection ,measuring,test,and error-froofing devices,that includes the primary process control and  the approved back-up or alternate methods,The list of process controls shall include the primary process controls and the approved back-up or alternate methods, if back-up or alternate methods exist.

组织应识别、记录和维护过程控制的列表，包括检查、测量、测试和错误检测设备。 这包括主要的过程控制和批准的备份或替代方法。 过程控制的列表应包括主要过程控制和已批准的备份或替代方法，如果存在备份或替代方法。
Rationale for change改变理由：

Clarified that not every primary process control has a back-up or alternate method ,Clarified that if a back-up or alternate method exists ,that those back-up or alternate methods are included on a list maintained by the organization.it is not a requirement to have an alternative process control for every primary control.

阐明并不是每个主要过程控制都有备份或替代方法。阐明如果存在备份或替代方法，则将这些备份或替代方法包含在组织维护的列表中。并不要求每个主要控制都要有一个替代过程控制。