AS9120B内审检查表中英文版.docx

1、AS9120B内审检查表中英文版4.1Is there objective evidence that the organization has determined and is monitoring information regarding its context, both internally and externally?是否有客观证据表明组织已经确定并且正在监控内部和外部有关其背景的信息？4.2Has the organization determined its interested parties and their requirements, and is it monit

2、oring and reviewing their needs and expectations? 组织是否确定了其感兴趣的各方及其要求，是否正在监督和审查他们的需求和期望？4.3 Is there a documented scope of the quality management system? Does it address the requirements from 4.1 and 4.2? Does it adequately justify any standard requirements that are deemed not applicable to the compa

3、ny?NOTE: The management system scope document is not the same as the scope of certification.质量管理体系是否有书面记录？它是否满足4.1和4.2的要求？是否足以证明任何被认为不适用于公司的标准要求？注意：管理系统范围文档与认证范围不同。4.4 Do the client-identified processes satisfy all elements of AS 9120:2016? How are risks and opportunities considered, and what plans

4、have been made to address them? Has the organization established and maintained documented information that includes: a general description of relevant interested parties; the scope of the quality management system, including boundaries and applicability; a description of the processes needed for th

5、e quality management system and their application throughout the organization; the sequence and interaction of these processes; assignment of the responsibilities and authorities for these processes. NOTE: The above description of the quality management system can be compiled into a single source of

6、 documented information and referred to as a quality manual.客户识别的流程是否满足AS 9120：2016的所有要素？如何考虑风险和机遇，以及为解决这些问题制定了哪些计划？组织是否建立并维护了包含以下内容的文档信息： - 相关利益方的一般描述; - 质量管理体系的范围，包括边界和适用性; - 描述质量管理体系所需的过程及其在整个组织中的应用; - 这些过程的顺序和相互作用; - 为这些过程分配责任和权限。注意：以上对质量管理体系的描述可以编译成文件信息的单一来源，并称为质量手册。5.1Please list evidence that

7、 Leadership has taken accountability for the effectiveness of the quality system and has integrated the quality management system with the company business processes.请列出领导层对质量体系有效性负责的证据，并将质量管理体系与公司业务流程相结合。5.1How does Leadership assure awareness that the process approach is achieved?领导力如何确保意识到过程方法已经实

8、现？5.1What evidence is there that leadership supports other relevant management roles to demonstrate leadership in their areas of responsibility?有哪些证据表明领导层支持其他相关管理角色，以展示其责任领域的领导力？5.1.2What evidence exists that leadership has ensured that the risks and opportunities that can affect conformity of produ

9、cts and services and the ability to enhance customer satisfaction are determined and addressed?有哪些证据表明领导层已确保能够确定和解决影响产品和服务一致性的风险和机遇以及提高客户满意度的能力？5.1.2dWhat evidence exists that product and service conformity and on-time delivery performance are measured and appropriate action is taken if planned resu

10、lts are not, or will not be, achieved?有哪些证据可以衡量产品和服务的一致性和准时交付绩效，如果没有或不会实现计划的结果，会采取适当的行动？5.3 Has Top Management appointed a specific member of the organizations management, identified as the management representative, who shall have the responsibility and authority for oversight of the requirements b

11、elow? Does the management representative have the organizational freedom and unrestricted access to top management to resolve quality management issues? NOTE: The responsibility of a management representative can include liaison with external parties on matters relating to the quality management sys

12、tem.o ensuring that the quality management system conforms to the requirements of this International Standard;o ensuring that the processes are delivering their intended outputs;o reporting on the performance of the quality management system and on opportunities for improvement (see 10.1), in partic

13、ular to top management;o ensuring the promotion of customer focus throughout the organization;o ensuring that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.最高管理层是否指定了组织管理层的特定成员，该管理层被确定为管理代表，谁有责任和权力监督下面的要求？管理层代表是

14、否具有组织自由和不受限制的高层管理人员访问权限以解决质量管理问题？注：管理者代表的职责可包括与外部各方就质量管理体系相关的事宜进行联络:-确保质量管理体系符合本国际标准的要求;-确保流程实现其预期产出;-报告质量管理体系的绩效和改进机会（见10.1），特别是高层管理人员;-确保在整个组织内促进以客户为中心;-确保在计划和实施质量管理体系变更时保持质量管理体系的完整性。6.1.1What evidence exists that when planning for the quality management system, the organization has considered the

15、 issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed to:a) give assurance that the quality management system can achieve its intended result(s);b) enhance desirable effects;c) prevent, or reduce, undesired effects;d) a

16、chieve improvement?(Clarification from section A-4: Although -6.1. specifies that the organization shall plan actions to address risks, there is no requirement for formal methods for risk management or a documented risk management process. Organizations can decide whether or not to develop a more ex

17、tensive risk management methodology than is required by this International Standard, e.g. through the application of other guidance or standards.Not all the processes of a quality management system represent the same level of risk in terms of the organizations ability to meet its objectives, and the

18、 effects of uncertainty are not the same for all organizations. Under the requirements of .6.1, the organization is responsible for its application of risk based thinking and the actions it takes to address risk, including whether or not to retain documented information as evidence of its determinat

19、ion of risks.)有哪些证据表明，在规划质量管理体系时，组织已经考虑了4.1中提到的问题和4.2中提到的要求，并确定了需要解决的风险和机遇：a）保证质量管理体系能够实现其预期的结果;b）增强理想效果;c）预防或减少不良后果;d）实现改善？（A-4节澄清：尽管-6.1。规定组织应制定应对风险的行动，但不要求采用正式的风险管理方法或书面风险管理流程。组织可以决定是否开发更多风险比本国际标准要求的广泛的风险管理方法，例如通过应用其他指南或标准。并非所有质量管理体系的流程在组织实现目标的能力方面都具有相同的风险水平，并且不确定性的影响对所有组织而言都不尽相同。根据.6.1的要求，组织负责应用

20、基于风险的思维和应对风险所采取的措施，包括是否保留记录的信息作为其确定风险的证据。）7.1.4What evidence exists that the organization determines, provides and maintains the environment necessary for the operation of its processes and to achieve conformity of products and services?(NOTE A suitable environment can be a combination of human and

21、physical factors, such as:a) social (e.g. non-discriminatory, calm, non-confrontational);b) psychological (e.g. stress-reducing, burnout prevention, emotionally protective);c) physical (e.g. temperature, heat, humidity, light, airflow, hygiene, noise).These factors can differ substantially depending

22、 on the products and services provided.)有哪些证据表明组织确定，提供和维护其流程运作所必需的环境，并实现产品和服务的一致性？（注意合适的环境可以是人和物理因素的组合，例如：a）社交（例如非歧视性，冷静，非对抗性）;b）心理（例如减压，预防倦怠，情绪保护）;c）物理（例如温度，热量，湿度，光线，气流，卫生，噪音）。根据所提供的产品和服务，这些因素可能会有很大差异。）7.1.6What evidence shows that the organization identifies, maintains and adjusts / acquires new k

23、nowledge as necessary for the operation of its processes and to achieve conformity of products and services?有哪些证据表明，组织确定，维护和调整/获取新知识，这些知识是其流程运作所必需的，并实现产品和服务的一致性？7.3Awareness:What evidence shows that persons doing work are aware of: Their contribution to the effectiveness of the quality management sy

24、stem, including the benefits of improved performance; The implications of not conforming with the quality management system requirements. Their contribution to product safety The importance of ethical behavior意识：有什么证据表明从事工作的人都知道：他们对质量管理体系有效性的贡献，包括提高绩效的好处;不符合质量管理体系要求的影响。他们对产品安全的贡献道德行为的重要性7.5.2What ev

25、idence exists that the organization has considered the format and media for its documented information?有哪些证据表明该组织已经考虑了其记录信息的格式和媒体？7.5.3.2 When documented information is managed electronically, are data protection processes defined (e.g., protection from loss, unauthorized changes, unintended alterat

26、ion, corruption, physical damage)? Is documented information that provides evidence of product origin, conformity and shipment retained? 当以电子方式管理文档化信息时，是否定义了数据保护流程（例如，防止丢失，XX的更改，意外更改，损坏，物理损坏）？ 是否保留了提供产品来源，合规性和装运证据的文件化信息？8.1Have resources been determined to meet on time delivery of products or servic

27、es?是否确定了资源以按时交付产品或服务？8.1What controls prevent the delivery of nonconforming products and services to the customer?哪些控制措施可以防止向客户提供不合格的产品和服务？8.1How is the delivery of nonconforming products and services to the customer prevented?如何防止向客户交付不合格产品和服务？8.1What process is implemented with how work is transfered so that impacts and risks are managed?如何转移工作以实现影响和风险，实施哪些流程？