Date of Issue: June 2018
发行日期：2018年7月
Affected Publication: API Specification Q1, Quality Management System Requirements for Manufacturing Organizations for the Petroleum and Natural Gas Industries, Ninth Edition, June 2013
受影响出版物：API Q1 石油天然气行业制造企业质量管理体要求。 第九版 2013年7月
Effective Date: June 1, 2019
生效日期：2019年7月1日
Addendum 2
增补 2
Page 3, the following definition shall be added:
第3页 ，增加下列定义
3.1.22
supply chain
供应链
Suppliers and associated sub-supplier(s) required for product realization.
产品实现需要的供应商或有关联的下级供应商
Page 11, Section 5.4.3, bullet d) shall be replaced with the following:
第11页，5.4.3章节，d)项，被下列取代
d)  include identification of, or reference to, products, components and/or activities deemed critical to the design;
d)  包括识别和引用的产品、部件，或对设计至关重要的活动。
Page 11, Section 5.4.3, the NOTE shall be replaced with the following:
第11页，5.4.3段，注释，被下列取代
NOTE Identification of criticality of products, components, and/or activities can be maintained outside of the design and development process.
注：
在设计和开发过程之外，识别关键产品、部件和活动应该被维持。
Page 12, Section 5.6.1.1 shall be replaced with the following:
第12页，5.6.1.1章节，注释，被下列取代
The organization shall maintain a documented procedure to ensure that purchased products, components or activities conform to specified requirements.
组织应保持一个程序文件来保证采购的产品、部件和活动符合规范要求。
The procedure shall address:
程序应该规定;
a)  identification of critical products, components or activities;
a)  识别关键产品、部件和活动。
b)  initial evaluation and selection of suppliers based on their ability to supply products, components or activities in accordance with the organization‘s requirements (see 5.6.1.2 and
5.6.1.3);
b)  首次评估和选择供应商要基于他们提供产品、部件或活动的能力，应符合组织的要求(见55.6.1.2和5.6..1.3)
c)  type and extent of control applied to the supply chain for critical products, components or activities;
c)  关键产品、部件和活动供应链的控制类型和范围。
NOTE Section 5.6.1.6 contains additional requirements for outsourced activities.
注 5.6.1.6章节包括外部资源活动的附加要求。
d)  criteria, scope, frequency, and methods for reassessment of suppliers; and
d)  供应商再次评估的准则、范围、频率和方法；和
e)  maintaining a list of approved suppliers and scope of approval.
e)  维持一个已批准供应商的清单和批准范围。
Pages 12 and 13, Section 5.6.1.2 shall be replaced with the following:
第12、13页，5.6.1.2章节被下列取代
For purchase of critical products, components or activities, the initial evaluation of suppliers by the organization shall be site-specific for each supplier and shall include the following:
对于关键产品、部件或活动，组织对供应商的首次评估应该在每个供应商特定场地，应该包括以下内容。
a)  verification that the supplier’s quality management system conforms to the quality system requirements specified for suppliers by the organization;
a)  确认供应商的质量管理体系符合，组织对供应商规定的质理体系要求。
b)  verification of the type and extent of control applied by the supplier, internally and to their supply chain, in order to meet the organization’s requirements; and
b)  由供应商，内部或其供应链所控制的类型和范围的确认，为了符合组织要求，和
c)  assessment of the supplier to ensure its capability to meet the organization’s specified requirements by one or more of the following:
c)  评估供应商确保其能力符合组织规定的要求，包括以下一项或多项：
1)  performing an on-site evaluation of relevant activities, or
1)  执行相关活动的现场评估，或
2)  performing first article (see 3.1.11) inspection to ensure conformance to stated requirements, or
2)  执行首件（见3.1.11）检验保证符合现场的需求，或
3)  identifying how the supplied product, component or activity conforms to stated requirements when limited by proprietary, legal, and/or contractual arrangements.
3)  当被业主、法律、和或合约安排限制时，如何识别供给的产品、部件、或活动符合现场要求。
Page 13, Section 5.6.1.3, bullet c) shall be replaced with the following:
第13页，5.6.1.3章节c）项被下列取代
c)  assessment of the product or component upon delivery, or activity upon completion.
c)  对交付后的产品或完成的活动的评估。
Page 13, Section 5.6.1.4, shall be replaced with the following:
第13页，5.6.1.4章节被下列取代
The organization shall determine the supplier reevaluation frequency based on supplier risk and supplier quality performance.
组织应基于供应商的风险和供应商的质量绩效定义供应商的再评估频率。
Fdocumented 翻译or the reevaluation of suppliers of critical products, components or activities, the requirements of
5.6.1.2 shall apply.
对于关键产品、部件或活动的供应商的再评估，5.6.1.2的要求应该被应用。
For the reevaluation of suppliers of noncritical products, components or activities, the requirements of 5.6.1.3 shall apply.
对于关键产品、部件或活动的供应商的再评估，5.6.1.3的要求应该被应用。
Page 13, Section 5.6.1.6, the following note shall be added after the first paragraph: