XXX有限公司质量管理体系程序文件
组织环境分析及相关方控制程序(中英文版)
Organization environment analysis and related party control procedure
批准Approval
管理者代表
审核Review
编写Written
发布日期issue date 
受控状态
controlled device
文件编号NO.
版本号 version number
组织环境分析及相关方控制程序
Organization environment analysis and related party control procedure
1、 目的purpose 
   为保证公司质量管理体系的策划能实现预期的结果,识别、监视并评审与公司的宗旨、战略方向相关的内外部环境;识别、监视并评审与公司质量管理体系有关的相关方期望或要求;根据内外部因素与相关方期望或要求,结合本公司已有的优势和劣势,识别出风险和机会; 针对识别的风险和机会,策划应对措施。 
To ensure that the company's quality management system planning can achieve the desired results, identify, monitor and review the company's purpose, strategic direction related to the internal and external environment; Identify, monitor and review the expectations or requirements of relevant parties related to the quality management system of the company; Identify risks and opportunities according to internal and external factors and expectations or requirements of relevant parties, combined with the company's existing
strengths and weaknesses; Plan countermeasures against identified risks and opportunities.
2、 范围scope 
适用质量管理体系所有相关的部门与过程。Apply quality management system to all relevant departments and processes. 
3、 职责Responsibility 
3.1 企管部:确定内外部环境因素和相关方期望或要求。
enterprise management department:Identify internal and external environmental factors and expectations or requirements of relevant parties 
3.2总经理:批准风险和机会的应对措施。 
GM:Response measures to approve risks and opportunities
3.3 管理者代表:组织各部门进行内外部环境因素和相关方期望或要求的识别评价、并拟定应对措施,对结果进行审核整理。
management representative:Organize the departments to identify and evaluate the internal and external environmental factors and the expectations or requirements of the parties concerned, and draw up measures to review the results
3.4 各部门:配合进行内外部环境因素和相关方期望或要求的识别评价、并拟定应对措施。
Departments:Cooperate with internal and external environmental factors and related party expectations or requirements to identify and evaluate, and formulate countermeasures. 
4、 程序 procedure
4.1组织环境管理 Organizational environmental management
4.1.1在建立与持续改进质量管理体系时,公司将充分识别理解并考虑那些与公司的宗旨、战
略方向相关,并影响公司实现质量管理体系预期结果能力的内部和外部环境。In establishing and continuously improving the quality management system, the company will fully identify, understand and consider those related to the purpose and strategic direction of the company. And influence the internal and external environment of the company's ability to achieve the expected results of the quality management system. 
4.1.2内外部环境要素识别与评估:在每年的管理评审前,由相关部门负责人进行识别并评估其适用性,具体部门及识别项目如下:Identification and evaluation of internal and external environmental elements: prior to the annual management review, the responsible person of the relevant department identifies and assesses their applicability. The specific departments and identifying items are as follows: 
1)企管部:内部(公司价值观、企业文化、人员能力、体系运行、过程能力等),外部(地理位置、现存污染、法律、竞争、市场、文化、社会和经济环境等)。enterprise management department:Internal (corporate values, corporate culture, personnel capabilities, system operation, process capabilities, etc.), external (geographical location, e
xisting pollution, law, competition, market, culture, social and economic environment, etc.)         
2)工程部:内部(产品、人员能力、知识、业绩表现等),外部(法律、技术、竞争、社会和经济环境等)。 
engineering department:Internal (product, human capacity, knowledge, performance, etc.), external (law, technology, competition, social and economic environment, etc.)
3) 营销中心:内部(产品、活动、服务、业绩表现等),外部(法律、技术、竞争、市场、文化、社会和经济环境等)
marketing center:Internal (product, human capacity, knowledge, performance, etc.), external (law, technology, competition, social and economic environment, etc.)
4) 采购部:内部(产品、活动、服务、业绩表现等),外部(法律、技术、竞争、市场、文化、社会和经济环境等)。
purchase department :Internal (product, human capacity, knowledge, performance, etc.), external (law, technology, competition, social and economic environment, etc.)
5) 管理者代表:内部(战略、知识、人员能力、业绩表现等),外部(社会和经济环境等)。
management representative:Internal (strategy, knowledge, personnel ability, performance, etc.), external (social and economic environment, etc.).
4.1.3各部门将识别结果登记在《组织内外部环境要素识别表》上,提交管理者代表 进行汇总整理。Each department registers the identification result on the "identifying form of the internal and external environment elements of the organization", and submits it to the management representative for summary and collation. 
4.1.4 内外部环境要素监测与更新: Monitoring and updating of internal and external environmental factors:
管理者代表每年在管理评审前组织一次全面的内外部内外部环境要素识别与评审。另外各部
门在获得内外内外部环境要素信息变化时,应及时告知管理者代表,由管理者代表对《组织内外部环境要素识别表》进行修订。