1.范围1。1概述1。1.1本标准规定了供应商质量保证计划（第4类）的最低要求。供应商负责规划和开发一个程序，该程序提供客观证据，证明合同要求得到满足，并检测和处置不合格产品或服务。1.1.2本标准可适用于为库存生产的产品（即，未来出售给身份不明的客户），在这种情况下，工作开始前向客户提交的资料不适用。但是，应提供客观证据证明符合本标准，但要求在开工前提交数据的要求除外。购买前应与客户协商解决。1.1.3（a）本标准的要求应适用于设计分析和工艺、生产、检验和试验设备操作中使用的计算机软件的控制。 （b） 构成产品或服务一部分或纳入产品或服务的计算机软件应根据本标准进行最终验收检查和测试。注:本标准不适用于计算机软件的设计、开发、编码和配置管理。如果需要，建议使用CSA Q396系列软件质量保证计划标准。1.2客户的责任客户的责任是（a）根据供应商在工作开始时满足规定要求的能力评估和选择供应商；注:应考虑由认可机构提供证据或进行注册，以履行这一责任。（b） 在标书和合同中规定（i）工程范围和要求；（ii）要求供应商满足的质量保证计划标准； （iii）适用于客户提供的产品或服务的质量保证计划标准；（iv）适用于产品或服务的监管要求；（c） 必要时进行监督和审核，以确保供应商符合标准；（d） 证明客户提供的产品或服务符合规定的要求，且符合最终产品或服务的质量要求，或建议供应商对不符合项进行了适当处理；以及（e）评估供应商的质量保证计划，因为其与库存（库存）产品相关，并在初始评估时与供应商解决在工程开始前需要提交文件的标准要求。 注:当一个公认的权威机构已经为库存产品注册了质量保证计划时，在工作开始前向客户提交的要求可能不包括在注册中。客户应与供应商解决此问题。1.3供应商的责任供应商的责任是（a）满足合同规定的要求；（b） 制定、实施和维护本文规定的质量保证计划；（c） 提供产品和服务符合合同要求的客观证据；（d） 为客户提供进入适用场所或工作区域的通道，以便进行质量监督和审核；以及（e）在授予合同之前，为客户确定哪些产品将从库存中供应，并证明产品在生产时已实施质量保证计划。 1.4监管机构要求应满足适用于产品或服务的所有联邦、省、地区和市政法案、法规、细则及其参考规范的要求。

1. Scope1.1General1.1.1This Standard specifies minimum requirements for a supplier's quality assurance program - Category 4. The supplier is responsible for planning and developing a program which provides objective evidence that contract requirements are met and which detects and dispositions nonconforming products or services.1.1.2This Standard may be applied to products produced for inventory (ie, for future sale to unidentified customers), in which case submittals to customers before the work starts do not apply. However, objective evidence shall be available to show compliance with this Standard, except for those requirements where submittal of data is required before start of the work. This shall be resolved with the customer before purchase.1.1.3 (a) The requirements of this Standard shall apply to the control of the use of computer software employed in design analysis and in the operation of process, production, inspection, and test equipment. (b) Computer software that forms part of or is incorporated into products or services shall be subject to final acceptance inspection and testing according to this Standard. Note: This Standard does not apply, however, to the design, development, coding, and configuration management of computer software. Where this is required, the CSA Q396 Series of Standards on Software Quality Assurance Programs is recommended.1.2Customer's ResponsibilitiesThe customer's responsibilities are(a) to evaluate and select suppliers based on their ability to meet specified requirements by the time the work starts; Note: Evidence or registration by a recognized authority should be considered to fulfill this responsibility.(b) to specify in the tender and contract (i) the scope of and requirements for the work; (ii) the quality assurance program standards the supplier is required to meet; (iii) the quality assurance program standards applied to customer-supplied products or services; (iv) the regulatory requirements that apply to the products or services;(c) to carry out surveillance and audits as and when required to ensure that the supplier is conforming to the Standard;(d) to certify that customer-supplied products or services comply with specified requirements and that they are consistent with the quality requirements of the final products or services or to advise the supplier that nonconformances have been suitably dispositioned; and(e) to evaluate the supplier's quality assurance program as it relates to products produced for inventory (stock) and to resolve with the supplier at the time of the initial evaluation those standard requirements where document submittal is required before start of the work.Note: When a recognized authority has registered a quality assurance program for products produced to inventory, submittal requirements to customers before the work starts may not be included in the registration. The customer should resolve this with the supplier.1.3Supplier's ResponsibilitiesThe supplier's responsibilities are(a) to satisfy the requirements specified in the contract;(b) to develop, implement, and maintain the quality assurance program specified herein;(c) to produce objective evidence that products and services meet contract requirements;(d) to provide customer access to the applicable premises or working area for the purpose of quality surveillance and audit; and(e) to identify for the customer before the award of the contract which products will be supplied from inventory and to demonstrate that the quality assurance program was implemented for the products at the time they were produced.1.4Regulatory Authority Requirements The requirements of all Federal, Provincial, Territorial, and Municipal Acts, Regulations, Bylaws, and their referenced Codes that apply to the product or service shall be met.