2020下半年直播电商行业投资策略:直播电商站上风口格局重塑-申万宏源-20200630.pdf
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1、y objectives, b) a quality manual, c) documented procedures required by this international Standard, d) documents needed by the organization to ensure the effective planning, operation and control of its processes, and e) records required by this International Standard (see 4.2.4) 4.2 Documentation
2、requirements 4.2.1 总则 质量管理体系文件应包括: a) 形成文件的质量方针和质量目标 b) 质量手册 c) 本标准所要求的形成文件的程序 d) 组织为确保其过程的有效策划,运 行和控制所需的文件 e) 本标准所要求的记录(见4.2.4) 12Title: TS / 16949 ) * 4 Quality management system 4 质量管理体系 NOTE 1: Where the term appears within this International Standard, this means that the procedure is establishe
3、d, documented, implemented and maintained. NOTE 2: The extent of the quality management system documentation can differ from one organization to another due to: a) the size of organization and type of activities, b) the complexity of processes and their interactions, and c) the competence of personn
4、el NOTE 3: The documentation can be in any form or type of medium. 注 1: 本标准出现“形成文件的程序 ”之处,即要求建立该程序,形成文件, 并加以实施和保持. 注 2: 不同组织的质量管理体系文件 的多少于详略程度取决于: a) 组织的规模和活动的类型 , b) 过程及其相互作用的复杂程度, c) 人员的能力. 注 3: 文件可采用任何形式或类型的 媒体. 13Title: TS / 16949 ) * 4 Quality management system 4 质量管理体系 4.2.2 Quality manual The
5、 organization shall establish and maintain a quality manual that includes: a) the scope of the quality management system, including details of and justification for any exclusions (see 1.2). b) the documented procedures established for the quality management system, or reference to them, and c) a de
6、scription of the interaction between the processes of the quality management system. 4.2.2 质量手册 组织应编制和保持质量手册,质量手册 包括: a) 质量管理体系的范围,包括任何删 减的细节与合理性(见1.2) b) 为质量管理体系编制的形成文件的 程序或对其引用 c) 质量管理体系过程之间的相互作用 的表述 . 14Title: TS / 16949 ) * 4 Quality management system 4 质量管理体系 4.2.3 Control of documents Document
7、s required by the quality management system shall be controlled. Quality records are a special type of document and shall be controlled according to the requirements given in 4.2.4. A documented procedure shall be established to define the controls needed a) to approve documents for adequacy prior t
8、o issue, b) to review and update as necessary and re- approve documents, c) to ensure that changes and the current revision status of documents are identified, 4.2.3 文件控制 质量管理体系所要求的文件应予以控 制.记录是一种特殊类型的文件,应按 照4.2.4的要求进行控制. 应编制形成文件的程序,以规定以下方 面所需的控制: a) 文件发布前得到批准,以确保文件 是充分与适宜的, b) 必要时对文件进行评审与更新,并 再次批准,
9、c) 确保文件的更改和现行修订状态得 到识别, 15Title: TS / 16949 ) * 4 Quality management system 4 质量管理体系 d) to ensure that relevant versions of applicable documents are available at points of use. e) to ensure that documents remain legible and readily identifiable. f) to ensure that documents of external origin are ide
10、ntified and their distribution controlled, and g) to prevent the unintended use of obsolete document, and to apply suitable identification to them if they are retained for any purpose. d) 确保在使用处可获得适用文 件的有关版本 e) 确保文件保持清晰,易于识别 , f) 确保外来文件得到识别,并控 制其分发, g) 防止作废文件的非预期使用, 若因任何原因而保留作废文件时 ,对这些文件进行适当的标识. 16T
11、itle: TS / 16949 ) * 4 Quality management system 4 质量管理体系 4.2.3.1 Engineering specifications The organization shall have a process to assure the timely review, distribution and implementation of all customer engineering standards/specifications and changes based on customer required schedule. Timely
12、 review should be as soon as possible, and shall not exceed two working weeks. The organization shall maintain a record of the date on which each change is implemented in production. Implementation shall include updates documents. 4.2.3.1 工程规范 组织应有一过程以确保对所有客户的工 程标准/规范和更改和在客户要求的时 间表的基础上进行及时的评审,发放和 实施
13、。进行及时的评审应该尽早,并且 不应超过2个工作周。 组织应保持在生产中的每一个更改实施 日期的记录。实施应包括更新文件。 17Title: TS / 16949 ) * 4 Quality management system 4 质量管理体系 NOTE: A change in these standards / specifications requires an updated record of customer production part approval when these specifications are referenced on the design record
14、or if they affect documents of production part approval process, such as control plan, FMEAs, etc. 注:当这些规范指向设计记录或他们影 响到生产零件审批过程,诸如控制计划 ,FMEA等时,这些标准/规范中的每一 个更改都要求客户生产零件审批的更新 记录。 18Title: TS / 16949 ) * 4 Quality management system 4 质量管理体系 4.2.4 Control of records Records shall be established and main
15、tained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, pro
16、tection, retrieval, retention time and disposition of records. 4.2.4 记录控制 应建立并保持记录,以提供符合要 求和质量管理体系有效运行的证 据.记录应保持清晰,易于识别和 检索.应编制形成文件的程序,以 规定记录的标识,贮存,保护,检索 ,保存期限和处置所需的控制. 19Title: TS / 16949 ) * 4 Quality management system 4 质量管理体系 NOTE 1: “Disposition” above includes disposal. NOTE 2: “Records” also
17、include customer- specified records. 4.2.4.1 Records retention The control of records shall satisfy regulatory and customer requirement. 注1:上述的“处置”包括处理。 注2:“记录”也包括客户指定的记录 。 4.2.4.1 记录的保持 记录控制应满足法规和客户要求。 20Title: TS / 16949 ) 5 Management responsibility 管理层职责 21Title: TS / 16949 ) * 5 Management resp
18、onsibility 5 管理层职责 5.1 Management commitment Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by: a) communicating to the organization the importance of meeting customer as well
19、as statutory and regulatory requirements, b) establishing the quality policy, c) ensuring that quality objectives are established, d) conducting management reviews, and e) ensuring the availability of resources. 5.1 管理承诺 最高管理者应通过以下活动,对其建立, 实施质量管理体系并持续改进其有效性 的承诺提供证据: a)向组织传达满足顾客和法律法规要求 的重要性, b) 制定质量方
20、针, c) 确保质量目标的制定, d) 进行管理评审, e) 确保资源的获得, 22Title: TS / 16949 ) * 5 Management responsibility 5 管理层职责 5.1.1 Process efficiency Top management shall review the product realization processes and the support processes to assure their effectiveness and efficiency. 5.1.1 过程有效性 最高管理层应评审产品的实现过程和支 持过程以确保它们的有效
21、性和效率。 23Title: TS / 16949 ) * 5 Management responsibility 5 管理层职责 5.2 Customer focus Top management shall ensure that customer requirements are determined and fulfilled with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1). 5.2 以顾客为关注焦点 最高管理者应以增强顾客满意为目 的,确保顾客的要求得到确定并予以 满足(见7.2.1和8.2.
22、1). 24Title: TS / 16949 ) * 5 Management responsibility 5 管理层职责 5.3 Quality policy Top management shall ensure that the quality policy. a) is appropriate to the purpose of the organization, b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality
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