QMS 差异分析.doc

精品Clause #条款Requirements要求Yes是No否Objective evidence/ Remarks客观证据/备注4Context of the organization组织环境4.1Understanding the organization and its context理解组织及其环境Has the organization identified the external and internal issues that are relevant to its context and that affect its ability to achieve the intended result(s) of its quality management system? Does the organization continue to monitor and review those issues to establish whether any changes to them will affect its QMS or its purpose?组织是否识别了影响其实现QMS预期结果的各种外部和内部因素？组织是否持续对这些因素进行监视和评审以确认这些因素的任何变化对其QMS或其预期结果会有影响？Describe the process used by client to identify internal and external issues. Reference objective evidence, including examples of these issues.描述被审核方公司确定内部和外部的因素的过程。参考的客观证据，包括这些因素的例子。被审核方公司（以下指）有制定质量的管理手册，并提供了2016年内外部SWOT分析总表及SWOT交叉分析策略表给审核组进行审核。被审核方公司按程序要求每年按SWOT分析方法对公司的内外部经营环境进行一次全面的评估，并持续对对公司的内外部环境因素进行监视和评审，以确认对公司QMS及其预期结果有无明显影响。审核组认为被审核公司目前对内外部经营环境因素的识别基本充分，对公司组织及其环境的理解基本充分有效。外部环境： 1.目前正处于全球范围的经济危机，整体经济的复苏还存在着多方面的不确定性。2.低价竞争问题成为公司必须面对的实际困难.内部环境：1经过公司不断的现场改善，车间管理水平有所提高，并开始大力推行ISO9001:2015系统和5S，对于完善内部管理水平及及提升效率及绩效起到一定的促进作用。2被审核方公司在近期有增加部分自动化程度高的生产设备来替代老生产设备，能较高的提升生产效率，降低人员方面的风险及成本。 Notes 备注： The context of the organization (also known as its business or organizational environment) refers to the combination of internal and external factors and conditions that can have an effect on an organizations approach to its products, services, investments and intended outcome of its QMS.组织环境（也称之为其业务的或组织的环境）指的是内部和外部因素的总和，相关信息能影响一个组织产品、服务、投资以及其QMS预期结果的方法。 An organizations context may include:组织环境可包括：- Specific objectives & targets of the organization.组织具体的目标/指标。- Needs and expectations of its customers and any other relevant interested parties e.g. Shareholders, employees, end used, suppliers, regulators etc.其顾客或是任何相关“利益方”的需求和期望，例如：股东、员工、最终用户、供应商、监管机构等。- Products and services it provides;其提供的产品和服务；- Complexity of organizational processes and their interaction.组织过程及其相互作用的复杂程度。- Competence of personnel working within or on behalf of the organization.代表组织或组织内部的工作人员的能力。- The size and structure of the organization.组织的规模和架构。 Auditors will need to understand the internal and external issues typically experienced in type of organisations and must be prepared and able to challenge an organisation if they believe the organisations interpretation of their context is having deficiency or incorrect. 根据组织的类型，审核员需要了解组织内有代表性的内部和外部因素，尤其是当确信组织对其环境的解释不准确或不正确时，审核员应做好准备并能够向组织提出质疑。 The standard does not ask for any specific requirement that these internal and external issues, or their monitoring and review, have to be documented by an organization, so auditors cannot simply ask for a list of issues or records of reviews. However, the information may be obtained from different sources (refer examples below). The auditors will also need a change in the audit approach and will have to more likely interview the senior management in relation to the organizations context and its strategic direction and related issues.标准并未针对内部和外部因素提出任何具体要求，也未要求组织对这些因素的监视和评审必须形成文件信息。因此，审核员不能直接要求提供一份清单或是评审记录，实际上这些信息可以从不同的来源获得（参考如下示例）。同时，审核员也需要改变自己的审核方法，应该更多的与组织的高层管理人员就其组织环境、战略方向以及相关因素进行讨论。 An evidence of conformity needs to be obtained to assure that organisations are reviewing internal and external issues periodically.需要获取符合性证据，保证组织定期对其内部和外部因素进行评审。Examples 示例： External context can include issues arising from legal, technological, competitive, market, cultural, social and economic environments, whether international, national, regional or local.外部环境可包括来自国际、国内、地区或当地的各种法律法规、技术、竞争、市场、文化、社会和经济环境等因素。 Internal context can include issues related to values, culture, knowledge and performance of the organization.内部环境可包括组织的价值观、文化、知识和绩效等相关因素。 Auditors can obtain information from sources including; Business plan or strategy, Information provided on the organizations website, Annual reports, Management meeting minutes having these issues addressed etc.审核员可获取各种信息的来源包括：业务计划或战略、组织网站上提供的信息、年度报告、有关这些问题的各种管理会议纪要等。 Use of Process approach by organization to identify relevant internal and external issues right from sources of input to receiver of output covering both internal & external context issues as above. Figure-01 Schematic representation of the elements of single process (ISO 9001:2015)组织使用过程方法来识别相关内部和外部因素，从“输入来源”到“输出接收者”，覆盖上述所有内部和外部环境因素。Figure-01 图示单一过程基本要素示意图（ISO 9001:2015）。4.2Understanding the needs and expectations of interested parties理解相关方的需求和期望a) Has the organization determined the interested parties that are relevant to its QMS, who can effect or potentially effect on the organisations ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements and which requirements are relevant to its QMS?组织是否确定了与其QMS有关的相关方，谁会对组织稳定提供符合顾客要求和适用法律法规要求的产品和服务的能力产生影响或具有潜在的影响？被审核方公司在管理手册中描述了相关方的需求和期望，并有根据实际情况来全面识别与本公司QMS有关的相关方（如下），及对组织稳定提供符合顾客要求和适用法律法规要求的产品和服务的能力产生影响或具有潜在的影响。被审核方公司根据各相关方的具体情况有制定并提供了相关方需求和期望表，同时公司规定每年对不同类型相关方的需求进行监视及评审，必要时进行更新。具体相关方需求如下：1、立法及政府机构：守法及诚信经营，符合法律法规及行业标准要求。成为当地的纳税大户、当地政府检查问题及时整改、配合机关的检查；2、第三方认证机构：管理体系每年要持续改进；3、员工队伍：良好的工作与住宿环境、质量信息明确，少返工，较多的培训学习机会、合理的工作时间；4、投资者：提升企业知名度，业务订单稳定，有效控制成本，实现利润最大化；小轮子大世界的追求，争创轮业的华为。5、客户：订单及时交付、产品合格、配合终端客户的审查、投诉得到及时满意的处理、沟通渠道畅通；6、供应商：采购信息描述清楚完整、价格合理、沟通渠道畅通等。b) Has the organization determined the requirements of these interested parties that are relevant to the QMS?组织是否确定了这些相关方与质量管理体系相关的要求？Does the organization monitor and review the information about these interested parties and their relevant requirements?组织是否对这些相关方的信息和它们的要求进行监视和评审？Notes 备注： An interested party is any person or organization that can affect, be affected by, or perceive themselves to be affected by the decisions or activities of the organization implementing the QMS. “相关方”是能够对组织QMS实施产生影响，或认为自己能够决定或影响组织QMS活动实施的人或组织。 In order to determine whether an interested party, or its requirements, are relevant to their QMS, the organization must consider whether or not they have an effect on the organizations ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements or to enhance customer satisfaction.为了确定与QMS有关的相关方，或及其要求，组织必须考虑他们是否会对组织持续提供产品和服务以满足顾客和适用的法律法规要求或提升顾客满意的能力产生影响。 Each organisation will have its own set of relevant interested parties and these may change over time. Similarly, each interested party may also have its own set of requirements, but all of these may not be relevant to an organizations QMS. For any difference in opinion with client organization regarding the relevant interest of the interested parties, the Auditors should be well prepared to challenge it. 每个组织都有它自己一系列的相关方，而这些相关方可能随着时间而发生变化。同样，每个相关方也可以有它自己一系列的要求，但所有这些要求可能和组织的QMS并没有关系。当审核员与客户组织就其相关方的有关利益观点方面存在不同意见时，审核员应做好充分准备并对其提出质疑。 Auditors will have to ensure that the organisation has been through a process of initially identifying these interested parties/ groups and then to identify their requirements that are relevant to the organisations QMS.审核员必须确保组织已经通过过程初步识别了这些相关方/组织，以及识别了与组织QMS相关的要求。 They will also need to ensure that this process is revisited periodically because the relevant requirements of the interested parties may change over time.他们必须确保定期评估这些过程，因为相关方的相关要求可能随时间而改变。 Again, as there are no specific requirements for documented information in the standard, the auditor need to use the same approach, as in clause 4.1, to obtain information through several sources/ documents and interviews with senior management to obtain the objective evidences when there is no direct documentation provided by the client for this purpose. Where the organization has determined that any interested party and/or its requirements are not relevant to QMS, then it does not have to take any action to address them.同时，标准中没有这些信息必须记录下来的具体要求，审核员需要使用相同的方法，在4.1条款中提到的一样，通过多种来源/文件以及当客户不能提供直接的文件信息时，以与组织高级管理人员进行面谈来当获得客观证据，从而获取信息。组织已确定任何相关方及/或其要求和QMS不相关时，,那么不能针对此情形要求采取任何措施。Examples 示例： Interested parties could include the organizations shareholders, employees, customers, end users, suppliers, regulators etc.相关方可包括组织的股东、员工、最终用户、供应商、监管机构等等。 Requirement of Interested parties may include; Specs from raw materials manufacturers/ suppliers, Concerns on employee feedback forms, Contractual requirements from Customers, Corporate policies & procedures, Legal requirements etc. 相关方的要求可包括：从原材料制造商/供应商规范、员工反馈关注点、客户的合同要求、公司政策和程序、法律规定等等。4.3Determining the scope of the quality management system确定质量管理体系的范围The scope of the Quality management system sets its boundaries, identifying what the requirements of the Quality management system are applicable to, and to what they are not. 组织应明确质量管理体系的边界和适用性，以确定其范围。When defining the scope of QMS, has the organization considered 当确定质量管理体系范围时，组织是否考虑下述事项：a) its context (e.g. the internal and external issues it faces)组织环境（如：组织面对的内部和外部因素）b) the requirements of relevant interested parties相关方的要求c) products and/ or services it intends to deliver?组织的产品和/或服务？被审核方确定质量管理体系范围时有左项目中a-c)的内容，确定的范围是适用的。质量管理体系范围有形成文件的信息予以保持，如在管理手册中已明确界定了QMS的范围及边界，本公司质量管理体系范围是PU轮的设计开发和生产制造。质量管理体系无作删减。,Is the scope made available and maintained as documented information?确定的范围是否适用？质量管理体系范围是否作为形成文件的信息予以保持？Does the scope include any justification or instances where specific elements of the standard cannot be applied?当质量管理体系的应用范围不适用于本标准的某些要求时，组织是否说明了理由？Notes 备注： The scope of a management system may include the whole of the organization or specific functions, section of the organization, or one or more functions across a group of organizations. Boundaries for the scope may even include specific geographic location(s), Processes, activities etc. Outsourced functions or processes are considered within the organizations scope of Quality management system.管理体系范围可包括整个组织或具体职能，部分的组织，或组织集团一个或多个职能。边界范围甚至可包括具体的地理位置，过程，活动等等。外包职能或过程是在组织的质量管理体系的范围内。 Although there is no longer any requirement that the scope of an organizations QMS must be documented in a Quality Manual (which is no longer required), it need be available and maintained as documented information (ISO 9001:2015clause 7.5). The scope must include reference to the products and services covered by the QMS.虽然对组织的质量管理体系范围必须以文件化形式在质量手册体现不再有任何要求，但其必须可获得，并作为形成文件的信息保持（ISO 9001:2015 7.5条款）。范围必须包括质量管理体系所覆盖的产品和服务。 Where a requirement cannot be applied (e.g. the organization does not perform any design activity), the organization can determine that the requirement is not applicable. However, this should not result in failure to achieve conformity of products and services or to meet the organizations aim to enhance customer satisfaction (Annex-A. A5)当要求不能应用时（例如：组织不执行任何设计活动），组织可确定该要求不适用。然而，这不应该导致未实现产品和服务符合性要求，或未达成以提升顾客满意为目的的组织目标(附录A. A5)。 If the organization has excluded any requirement, this must be clearly recorded and the organization must be able to justify the exclusion.当组织有删减要求时，必须清楚记录删减内容以及删减的正当理由。 Auditors will need to verify that the organisations scope is documented, and evidence that it has been produced in consideration of organizations context and products and services. If exclusions have been applied by the organisation, auditors must ensure that they are recorded and that the rationale for the exclusion is stated and justified.审核员必须核实组织所确定的范围是文件化的，并且证明该范围是在考虑了组织环境及产品和服务的基础上确定的。当组织有删减时，审核员必须确保删减内容已被记录，并且提供了删减的正当理由。4.4Quality management system and its processes质量管理体系及其过程4.4.1Has the organization adopted the process approach while establishing, implementing, maintaining and continually improving the effectiveness of its quality management system?组织是否已采用了过程方法用来建立、实施、保持和持续改进其质量管理体系有效性？被审核方公司已采用了过程方法用来建立、实施、保持和持续改进其质量管理体系有效性，如已建立管理手册及附件、程序文件及作业标准等。Has the organization determined the processes needed for the quality management system and their application throughout the organization including; 组织是否已确定质量管理体系所需的过程及其在整个组织内的应用，包括：a) inputs required and the outputs expected 所要求的输入和期望的过程输出b) sequence and interaction of processes,过程的顺序和相互作用c) Measurements and related performance indicators, 监视和测量的准则和方法、相关的绩效指标d) availability of resources needed, 获得所需的资源，e) Responsibilities and authorities assigned, 针对各个过程所分配的职责和权限，f) Risks and opportunities associated, and planned and implemented appropriate actions to address them,与过程相关的风险和机遇，以及应对措施的策划和实施，g) Evaluation of processes, and 对过程的评价，以及h) improvement opportunities for the established processes and QMS.针对过程及质量管理体系的改进机会被审核方公司已确定质量管理体系所需的过程及其在整个组织内的应用，如所要求的输入和期望的过程输出、过程的顺序和相互作用、监视和测量的准则和方法、相关的绩效指标、获得所需的资源，针对各个过程所分配的职责和权限，与过程相关的风险和机遇，以及应对措施的策划和实施，对过程的评价管理手册及附件中已识别了QM所需的过程，明确了各过程之间的关系。被审核方公司根据产品的特点对产品实现的各过程进行了策划，主要过程包括：业务接订单/市场需求样品制作-合同评审-计划排期-按照策划及相应工艺要求实施生产和服务活动（外发加工过程无）-对生产和服务之产品质量实施监控(进料检验、巡检、成品检验、相关测试)-交付-顾客反馈-持续改进。被审核方公司质量管理体系策划并运行了以下主要过程：体系策划过程（应对风险和机遇的措施、管理目标及其实现的策划、体系变更的策划）、资源的提供过程(人员、基础设施、过程运行环境、监视测量资源、知识)、行成文件的信息管理过程、产品和服务的要求控制过程(顾客沟通、要求的确定/评审/更改)、外部提供的过程（外部供方评估、控制类型和程度、提供给外部供方的信息）、生产和服务提供的控制（生产制造控制）过程、产品和服务的放行/不合格输出的控制过程、监视、测量、分析和评价过程、改进等过程等. 对与顾客有关的过程/采购/生产和服务的提供/监视和测量装置等过程的控制要求都进行了明确规定，对其过程有关的职责、过程目标均进行了明确规定。同时，被审核方公司编制及发行了各适用过程的流程图、产品的QC工程图、作业指导书/规范、过程记录。相关过程的人员、生产设备、计量设备、工作环境等资源配置较充分有效，各相关过程文件的编制和运作有效。4.4.2,a) Does the organisation maintain the documented information necessary to support the operation of its processes? 组织是否保持形成文件的信息以支持过程运行？b) Do they also retain documented information that evidences that processes are being carried out as planned?组织是否也保留了确认其过程按策划进行的形成文件的信息？被审核方公司有保持形成文件的信息以支持过程运行，也保留了确认其过程按策划进行的形成文件的信息。被审核方已制定及颁布2015版质量管理手册及相关过程管理程序或规定，并保留对以上相应的文件化信息。Notes 备注： ISO 9001:2015 includes specific requirements necessary for the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system. This requires an organization to systematically define and manage processes and their interactions so as to achieve the intended results in accordance with both the quality policy and strategic direction of the organization. ISO 9001:2015包括采用过程方法进行开发、实施和改进质量管理体系有效性时所需的具体要求。这要求一个组织系统地定义和管理过程及其相互作用，以实现预期的结果符合质量方针和组织的战略方向。 There needs to be evidence that these process requirements are included e.g. in the design, operation and on-going update of the organizations QMS. The organizations will have to pay attention to use the performance indicators to control and monitor processes, and the risks and opportunities associated with them. 需要有证据表明这些过程要求，包括例如在设计、运行和持续更新组织的质量管理体系。组织必须注意使用绩效指标控制和监控过程，以及与它们相关的风险和机遇。 Although there is no longer any reference to Records (ISO 9001: 2008 clause 4.2.4), there is still a requirement to demonstrate evidence of compliance with QMS requirements and processes (ISO 9001:2015 clause 7.5).虽然不再提及任何“记录”（ISO 9001: 2008 4.2.4条款），但在质量管理体系要求及过程符合性的客观证据方面仍有要求（ISO 9001: 2015 7.5条款）。 Auditor must note that there are explicit requirement for a process-based quality management system now. They should also note the additional new requirements regarding use of performance indicators to control and monitor processes, and the requirement for processes to be assessed from a risk and opportunity perspective. In effect, auditors will need to review how the organisation has designed its process-based management system.审核员必须注意，现在基于过程的质量管理体系有明确的要求。他们还应该注意对使用绩效指标控制和监控过程的额外的新要求，以及从风险和机遇的角度进行过程评估的要求。实际上，审核员需要评审组织如何设计了基于过程的管理体系。Examples 示例： Existing operational procedures, work instructions and flow charts are valid examples of documented information and can be used to evidence that the requirement for documented information to support the operation of processes is being met. If these are working well for the organisation then there is no need to replace them.现有的运作程序、工作指南和流程图是形成文件的信息的有效例证，同时可用来证明支持过程运行的形成文件的信息要求已得到满足。如果这些运行良好，组织不需要替换它们。 Use of Turtle diagram by the organization for identifying the Process related Inputs, Outputs, Resources used (Human & Infrastructure), Monitoring and measuring processes and documentation.组织使用乌龟图来识别过程相关的输入、输出、使用的资源（人力和基础设施），监视和测量过程和文件信息。 Use of Process approach by organization to identify sources of input, input, activities, output, receiver of output, performance indicators to control and monitor processes, and the risks and opportunities associated with them. Figure-01 Schematic representation of the elements of single process (ISO 9001:2015)为控制及监控过程以及与之相关的风险和机遇，组织使用过程方法来识别输入资源、输入、活动、输出、输出接收者、绩效指标Figure-01 图示单一过程的基本要素(ISO 9001:2015)。5Leadership领导作用5.1Leadership and commitment领导作用和承诺5.1.1General总则Has top management exhibited their leadership and commitment towards its Quality Management system by:最高管理者是否能证实其对质量管理体系的领导作用和承诺？通过：Objective evidence must include an interview with Top management covering the elements of points a) to j) to ensure thorough understanding and leadership at the highest level. If the Top management is not involved, a non-conformance needs to be raised.客观证据必须包括和最高管理层的面谈，覆盖a)-j)内容已确保在最高管理层对于领导作用的充分了解。若最高管理层未参与，需要提出不符合项。a) Taking accountability of QMS effectiveness?对质量管理体系的有效性承担责任？管理手册中已明确了最高管理者在QMS中的领导作用和承诺。包括了标准所规定了内容，如对质量管理体系的有效性承担责任。最高管理者参与制定了质量方针和质量目标（与组织环境和战略方向相一致），通过建立质量管理体系将公司的业务融入到体系中，通过对组织和环境和相关方的需求的识别评价，采用基于风险和PDCA过程方法对体系进行控制。公司已配备了满足客户需求所需的资源（人员、设备等）。并定期通过内审和管理评审对体系的有效性进行评审。并明确了公司各部门的职责和权限。同时，管理手册中有明确最高管理具有对质量管理体系的有效性承担责任、沟通有效的质量管理和符合质量管理体系要求的重要性、确保质量管理体系实现其预期结果、促进、指导和支持人员为质量管理体系的有效性做出贡献、推动改进、支持其他相关管理者在其职责范围内发挥领导作用等职责。b) Ensuring Quality policy and Quality objectives are established and, are consistent with its overall strategic direction and the context in which the organization operates?确保制定质量管理体系的质量方针和质量目标，并与组织环境和战略方向相一致？c) ensuring that quality management system requirements are integral to the organi