4.1、理解组织及其环境

组织应确定与其目标和战略方向相关并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。

组织应对这些内部和外部因素的相关信息进行监视和评审。

注1：这些因素可以包括需要考虑的正面和负面要素或条件；

注2：通过考虑国际、国家、地区或当地的法律法规、技术、竞争、市场、文化、社会和经济因素，有助于理解外部环境。

注3：考虑组织的价值观、文化、知识和绩效等相关因素，有助于理解内部环境。

4.1、Understanding the organization and its context

The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system.

The organization shall monitor and review information about these external and internal issues.

NOTE 1 Issues can include positive and negative factors or conditions for consideration.

NOTE 2 Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, market, cultural, social and economic environments, whether international, national, regional or local.NOTE 3 Understanding the internal context can be facilitated by considering issues related to values, culture, knowledge and performance of the organization.