F103-12-QMS-2015 ISO 9001 2015 Checklist Guidance Doc-encn_看图王.pdf

ISO 9001:2015 Checklist/ Guidance Document ISO 9001:2015 核查表/指南文件 Clause # Requirements Yes No Objective evidence/ Remarks 条款 要求 是 否 客观证据/备注 4 Context of the organization 组织环境 4.1 Understanding the organization and its context 理解组织及其环境  Has the organization identified the external and internal issues Describe the process used by the organization to identify the internal that are relevant to its ‘context’ and that affect its ability to and external issues and monitoring process; achieve the intended result(s) of its quality management 描述组织用于识别内部和外部因素的过程以及监视过程； system? Does the organization continue to monitor and review those issues to establish whether any changes to them will affect its QMS or its purpose? 组织是否已经识别了影响其实现质量管理体系预期结果的各种外 部和内部因素？组织是否持续对这些因素进行监视和评审，并且 确认这些因素的变化对其质量管理体系或其预期结果会有影响？ Notes: 备注：  The context of the organization (also known as its business or organizational environment) refers to the combination of internal and external factors and conditions that can have an effect on an organizations approach to its products, services, investments and intended outcome of its QMS. 组织环境（也称之为其商业的或组织的环境）指的是内部和外部因素的总和，相关信息能影响一个组织产品、服务、投资以及其质量管理体系预期结果的方 法。  An organization’s context may include: 组织环境可包括： - Specific objectives targets of the organization. 组织具体的目标/指标。 - Needs and expectations of its customers and any other relevant ‘interested parties’ e.g. Shareholders, employees, end used, suppliers, regulators etc. 其顾客或是任何相关利益方的需求和期望，例如：股