ISO 9001-2015 内审查检表.docxVIP

Q#ISO 9001:2015 ClauseAudit QuestionAudit Evidence4 Context of the Organization4.1 Understanding the organization and its context4.1q1The 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.How has the organization determined external and internal issues relevant to its purpose and strategic direction?How do these affect the ability to achieve the intended result of the QMS?4.1q2The organization shall monitor and review the information about these external and internal issues.How do you monitor and review information about these internal and external issues?NOTE 1 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 2 Understanding the internal context can be facilitated by considering issues related to values, culture knowledge and performance of the organization.4.2 Understanding the needs and expectations of interested parties4.2q1Due to their impact or potential impact on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine:the interested parties that are relevant to the quality management system;the requirements of these interested parties that are relevant to the quality management system.How have you determined what interested parties are relevant to the QMS?How have you determined what requirements those parties have that are relevant to the QMS?How has impact or potential impact been determined?4.2q2The organization shall monitor and review the information about these interested parties and their relevant requirements.How do you monitor and review the information about interested parties and their