Clause #条款Requirements要求Yes是No否Objective evidence/ Remarks客观证据/备注4Context of the organization组织环境4.1Understanding the organization and its context理解组织及其环境Has the organization identified the external and internal issues that are relevant to its context and that affect its ability to achieve the intended result(s) of its quality management 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?组织是否识别了影响其实现QMS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以确认这些因素的任何变化对其QMS或其预期结果会有影响？Describe the process used by client to identify internal and external issues. Reference objective evidence, including examples of these issues.描述被审核方公司确定内部和外部的因素的过程。参考的客观证据，包括这些因素的例子。被审核方公司（以下指）有制定质量的管理手册，并提供了2016年内外部SWOT分析总表及SWOT交叉分析策略表给审核组进行审核。被审核方公司按程序要求每年按SWOT分析方法对公司的内外部经营环境进行一次全面的评估，并持续对对公司的内外部环境因素进行监视和评审，以确认对公司QMS及其预期结果有无明显影响。审核组认为被审核公司目前对内外部经营环境因素的识别基本充分，对公司组织及其环境的理解基本充分有效。外部环境： 1.目前正处于全球范围的经济危机，整体经济的复苏还存在着多方面的不确定性。2.低价竞争问题成为公司必须面对的实际困难.内部环境：1经过公司不断的现场改善，车间管理水平有所提高，并开始大力推行ISO9001:2015系统和5S，对于完善内部管理水平及及提升效率及绩效起到一定的促进作用。2被审核方公司在近期有增加部分自动化程度高的生产设备来替代老生产设备，能较高的提升生产效率，降低人员方面的风险及成本。 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（也称之为其业务的或组织的环境）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QMS预期结果的方法。 An organizations 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：股东、员工、最终用户、供应商、监管机构等。- Products and services it provides;其提供的产品和服务；- Complexity of organizational processes and their interaction.组织过程及其相互作用的复杂程度。- Competence of personnel working within or on behalf of the organization.代表组织或组织内部的工作人员的能力。- The size and structure of the organization.组织的规模和架构。 Auditors will need to understand the internal and external issues typically experienced in type of organisations and must be prepared and able to challenge an organisation if they believe the organisations interpretation of their context is having deficiency or incorrect. 根据组织的类型，审核员需要了解组织内有代表性的内部和外部因素，尤其是当确信组织对其环境的解释不准确或不正确时，审核员应做好准备并能够向组织提出质疑。 The standard does not ask for any specific requirement that these internal and external issues, or their monitoring and review, have to be documented by an organization, so auditors cannot simply ask for a list of issues or records of reviews. However, the information may be obtained from different sources (refer examples below). The auditors will also need a change in the audit approach and will have to more likely interview the senior management in relation to the organizations context and its strategic direction and related issues.标准并未针对内部和外部因素提出任何具体要求，也未要求组织对这些因素的监视和评审必须形成文件信息。因此，审核员不能直接要求提供一份清单或是评审记录，实际上这些信息可以从不同的来源获得（参考如下示例）。同时，审核员也需要改变自己的审核方法，应该更多的与组织的高层管理人员就其组织环境、战略方向以及相关因素进行讨论。 An evidence of conformity needs to be obtained to assure that organisations are reviewing internal and external issues periodically.需要获取符合性证据，保证组织定期对其内部和外部因素进行评审。Examples 示例： External context can include issues arising from legal, technological, competitive, market, cultural, social and economic environments, whether international, national, regional or local.外部环境可包括来自国际、国内、地区或当地的各种法律法规、技术、竞争、市场、文化、社会和经济环境等因素。 Internal context can include issues related to values, culture, knowledge and performance of the organization.内部环境可包括组织的价值观、文化、知识和绩效等相关因素。 Auditors can obtain information from sources including; Business plan or strategy, Information provided on the organizations website, Annual reports, Management meeting minutes having these issues addressed etc.审核员可获取各种信息的来源包括：业务计划或战略、组织网站上提供的信息、年度报告、有关这些问题的各种管理会议纪要等。 Use of Process approach by organization to identify relevant internal and external issues right from sources of input to receiver of output covering both internal & external context issues as above. Figure-01 Schematic representation of the elements of single process (ISO 9001:2015)组织使用过程方法来识别相关内部和外部因素，从“输入来源”到“输出接收者”，覆盖上述所有内部和外部环境因素。Figure-01 图示单一过程基本要素示意图（ISO 9001:2015）。4.2Understanding the needs and expectations of interested parties理解相关方的需求和期望a) Has the organization determined the interested parties that are relevant to its QMS, who can effect or potentially effect on the organisations ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements and which requirements are relevant to its QMS?组织是否确定了与其QMS有关的相关方，谁会对组织稳定提供符合顾客要求和适用法律法规要求的产品和服务的能力产生影响或具有潜在的影响？被审核方公司在管理手册中描述了相关方