ISO9001:2008质量管理体系现场认证审核记录填写要点
ISO9001: 2008 quality management system certification audit log fill point field
质量管理体系现场审核记录中应描述从4.1到8.5.3的全部条款，当组织对某一条款删减时，在现场审核记录中应标出条款删减的编号并说明原因，不能漏审条款。
Quality management system audit record should describe all terms from 4.1 to 8.5.3, when the organization of a clause exclusions, on site audit records shall be marked with numbered clause exclusions and explain the reasons, can not leak the clause.
现场审核记录所填写的内容包括：现场审核到的符合和不符合质量管理体系要求的客观事实，能够为认证机构评价组织质量体系运行的有效性提供证据，具体要求如下：
On site audit records to fill in the content includes: the audit to meet and do not meet the requirements of quality management system of objective facts, can provide certification evaluation organization of the effective operation of the quality system to provide evidence, specific requirement is as follows:
4.1质量体系总要求
4.1 quality system requirements
简要介绍组织按标准要求建立了文件化的质量体系，体系中所确定的过程及内审、管理评审、持续改进实施的符合性。该条款也可以在各条款审完之后综合描述。
Brief introduction of organization in accordance with the standard requirements to establish a documented quality system, system of the identified process and internal audit, management review, continuous improvement implementation conformance. The terms can also be in the clause after the comprehensive description of the.
4.2.1文件要求总则
General requirements for 4.2.1 file
质量体系文件层次，质量手册，质量程序文件数量，作业文件数量，质量记录数量。
Quality system file level, quality manual, procedure document quality number, document number, quality record number.
4.2.2质量手册
The 4.2.2 quality manual
简要介绍质量手册中对有关条款的删减及其符合性，过程描述的符合性，是否引用程序文件。
Brief introduction of the quality manual for terms related to the exclusions and compliance, process description conformity, whether the reference program file.
4.2.3文件控制
4.2.3 file control
审核到的“文件控制程序”及是否符合“标准”要求；抽查质量体系文件是否经审批，是否有受控标识（抽数量不少于3个）；需要文件的部门和场所是否得到适用文件的有效版本；外来文件是否有识别标识并受到控制，是否发放到需要的部门和场所；文件更改控制的符合性；作废文件控制的符合性。
Audit to" file control program" and with" standards" requirement; check whether the approval of quality system documents, whether there is a controlled marking ( pumping quantity not less than 3); the need to document the departments and places are applicable document valid version; external files are identified and controlled, whether to grant to require departments and places; document change control compliance; obsolete document control compliance.
4.2.4记录的控制
4.2.4 record control
审核到的“质量记录控制程序”及是否符合“标准”要求；抽查到的质量记录名称、保存期限，以及质量记录控制符合与不符合质量体系要求的客观证据。
Audit to the" quality record control procedure" and is in accordance with the" standard " requirement; selective examination to quality record name, expiration date, and the record quality control in accordance with the does not accord with objective evidence of quality system requirements.
5.1管理承诺
5.1 management commitment
最高管理者如何作出管理承诺，包括：顾客要求，适用的法律法规要求、国家、行业标准，方针、目标、管理评审、资源保障。
Top management how to make management commitment, including: customer requirements, applicable statutory and regulatory requirements, national, industry standards, principles, objectives, management review, resources security.
5.2以顾客为关注焦点
5.2 customer focus
最高管理者如何了解到顾客的要求，如何确保满足顾客的要求。
Top management how to understand customer requirements, how to ensure that meet customer requirements.
5.3质量方针
5.3 quality policy
质量方针内容是否包括对满足要求和持续改进的承诺；制订的指导思想；如何贯彻实施；是否对适宜性进行定期评审。
Quality content is included to meet the requirements and the commitment to continual improvement; formulate guiding ideology; to implement; whether the suitability for periodic review.
5.4.1质量目标
5.4.1 Quality Objectives
质量目标是否分解，是否包括产品要求的内容，并可测量。
Quality is the goal decomposition, including whether the product content requirements, and can measure.
5.2.4质量管理体系策划
The 5.2.4 quality management system planning
质量体系策划方案或质量体系建立工作计划；质量体系变更时是否策划，以保持质量体系的完整性。
Quality management system planning program or quality system to establish work plan; quality system change is planning, in order to maintain the integrity of the quality system.
5.5.1职责和权限
5.5.1 responsibility and authority
组织内各级人员的职责是否有明确规定，各级人员是否清楚这种规定。
Organization responsibilities are clearly defined, all levels of personnel is clear such provisions.
5.5.2管理者代表
5.5.2 management representative
是否指定了管理者代表，管理者代表是否清楚自己的职责。
Whether the designated management representative, representative of the management is aware of their responsibilities.
5.5.3内部沟通
5.5.3 internal communication
为保证质量体系有效运行，组织采取哪些内部沟通方式，如：会议、简报等。
In order to ensure the effective operation of the quality system, organization to which internal communication, such as: conferences, briefings and other.
5.6管理评审
5.6 management review
管理评审的时间间隔是否符合要求，管理评审的时间和主持者；管理评审的内容（评审输入）；管理评审提出的问题（评审输出）；对问题的原因分析，采取、实施的改进、纠正或预防措施及有效性证实（8.5.1、8.5.2、8.5.3）。
Management review time interval for compliance with the requirements of the time, management review and moderator; management review ( review input ); management review questions ( review output ); the analysis of the cause of the problem, take, carry out improvement, corrective or preventive measures and effectiveness of ( 8.5.1, 8.5.2, 8.5.3 confirmed ).
6.1资源的提供
The 6.1 provision of resources
组织为实施、保持和持续改进质量体系确定并提供哪些资源。
The organization to implement, maintain and continual improvement of the quality system to identify and provide what resources.
6.2人力资源（能力、意识和培训）
6.2 human resources ( competence, awareness and training )
是否规定了从事影响产品质量工作人员的“资格、能力要求”；依据所规定的“能力要求”对人员进行了能力评定；对未满足能力要求的人员采取、实施了哪些措施（如培训等）；采取措施有效性评价的证据；抽查了哪些人员的培训记录或资格证书。
Whether the provisions of the personnel performing work affecting product quality personnel " qualifications, competence requirements"; according to the provisions of the " requirements" for personnel to carry out ability evaluation; on unmet abilities required of personnel to take, implementation measures ( such as training ); take measures to evaluate the effectiveness of evidence; examination of what personnel records of training or qualification certificate.
6.3基础设施
6.3 infrastructure
组织为保证产品符合要求，具备哪些设施、设备和支持性服务设施，并对其进行维护的客观证据。
Organization to ensure that products conform to requirements, have the facilities, equipment and supporting services and facilities, and carries on the maintenance of the objective evidence.
6.4工作环境
6.4 work environment
为保证产品质量是否确定了工作环境的要求，对工作环境符合性实施了现场审核的客观证据。
In order to ensure product quality and to determine whether or not the working environment, the working environment with implementation of the audit objective evidence.
7.1产品实现的策划
7.1 planning of product realization
对产品、项目或合同是否进行了策划，策划结果的证据。
The product, project or contract, whether to carry out the planning, planning the evidence.
7.2.1与产品有关的要求的确定
7.2.1 determination of requirements related to the product
组织采取了哪些方式以确定顾客的要求和适用的法律、法规要求，如：市场调研、走访顾客等。
The organization has taken to identify customer requirements and applicable laws, regulatory requirements, such as: Market Research, visit customer.
7.2.2与产品有关的要求的评审
7.2.2 review of requirements related to the product
抽查了哪些顾客合同的评审记录（抽样量不少于3个，少于3个应说明原因），合同评审的日期和合同签订日期，参加评审者，评审内容；口头合同执行情况；合同变更的执行情况。
Checks which customer contract review records ( sample volume of not less than 3, less than 3 months shall explain reasons ), contract review date and the date of the contract, to participate in the assessment, evaluation content; oral contract implementation; contract change implementation.
7.2.3顾客沟通
7.2.3 customer communication
组织采取了哪些与顾客沟通的方式；组织在产品提供之前、提供之中、提供之后与顾客沟通的客观证据；将顾客反馈的质量信息为持续改进提供机会（8.5.1）。
The organization has taken and customer communication way; tissue is provided in the product before, offer, provide objective evidence after communicating with customers; customer feedback quality information for continuous improvement opportunities ( 8.5.1 ).
7.3设计和开发
7.3 design and development
设计和开发策划、设计和开发评审、设计和开发验证、设计和开发确认、设计和开发更改的控制符合和不符合质量体系要求的客观证据。
Design and development planning, design and development review, design and development verification, design and development validation, control of design and development changes consistent with and not in accordance with the requirements of objective evidence.
7.4.1采购过程
7.4.1 purchasing process
是否制定了选择、评价和重新评价供方的准则，抽查了哪些供方的什么评价记录（抽样量不少于3个，少于3个应说明原因）
Whether the development of the selection, evaluation and re-evaluation of the guidelines, selectived examination which supplier evaluation of what records ( sample volume of not less than 3, less than 3 months shall explain reasons )
7.4.2采购信息
7.4.2 procurement information
采购文件是否规定了产品的规格、型号、执行标准、质量要求等内容，组织如何保证采购文件所规定的要求是充分与适宜的。
Procurement documents stipulated product specifications, models, performance standards, quality requirements and other content, organization how to ensure that the procurement requirements of the document is sufficient and appropriate.
7.4.3采购产品的验证
7.4.3 verification of purchased product
采购产品验证的执行情况。
Verification of purchased product implementation.
7.5.1生产和服务提供
7.5.1 production and service provision
组织质量体系所覆盖产品生产过程所需的控制文件和实施过程控制的证据；使用的生产设备和设备的维护情况；现场使用的测量设备；关键过程控制情况；放行和内、外部交付活动实施的符合性及售后服务的实施情况。对28F类和有现场安装过程的企业审核时，审核施工（安装）过程的记录应清楚地描述：施工现场的过程控制符合或不符合质量体系要求的客观证据，从审核记录中能清楚地看出审核员审核了施工（安装）现场。
The organization of quality system covering the production process required control file and implementation of process control of evidence; the use of production equipment and equipment maintenance; the scene measurement equipment; key process control; release and internal, external delivery activities implementation conformance and after sale service implementation. For class 28F and installation process of the enterprise audit, audit construction ( installation ) process records should be clearly described: the construction site of the process control in line with or not in accordance with the requirements of objective evidence from audit records, can clearly see the auditor to audit the construction ( installation ) scene.
7.5.2生产和服务提供过程的确认（特殊过程）
7.5.2 production and service delivery confirmation (special process )
组织确认了哪些过程为特殊过程；特殊过程能力评定准则和进行了评价的客观证据（包括工艺、设备和操作者资格）；实施过程监控的客观证据。
Histological confirmation which process for special process; special process capability evaluation criteria and were evaluated by objective evidence ( including the process, equipment and operator qualification ); process monitoring objective evidence.
7.5.3标识和可追溯性
7.5.3 identification and traceability
在生产现场和库房审核该条款时，应记录审核到的产品名称、标识方法、标识内容等；以及采取了哪些可追溯性标识方法。
In situ production and warehouse audit this provision, shall record the audit to the product name, identification method, identification content; and what traceability identification method.
7.5.4顾客财产
7.5.4 customer property
如果组织没有顾客提供产品时，审核记录中在相关部门对该要素要有说明，如：“无顾客提供产品”，并在审核计划和审核报告矩阵表中有相应的安排和标识，不能漏审条款。
If the organization does not provide products, audit records in the related departments of the elements should have, such as:" no customers with products", and in the audit plan and audit report matrix table has corresponding arrangement and marking, cannot leak trial clause.
7.5.5产品防护
7.5.5 product protection
产品搬运、包装、贮存和交付过程中实施防护的客观证据。
Product handling, packaging, storage and delivery process to implement the protection objective evidence.
7.6监视和测量装置的控制
In 7.6 control of monitoring and measuring devices
检验、测量和试验设备控制符合与不符合质量体系要求的客观证据。
Inspection, measuring and test equipment control with and not in accordance with the requirements of objective evidence.
8.1测量、分析和改进-总则
8.1 measurement, analysis and improvement - General principles
为保证产品和质量体系符合性及持续改进的有效性进行策划的证实材料；采用了哪些统计技术。
In order to ensure the quality of products and system conformity and continually improve the effectiveness of planning the proof material; by which statistical technology.
8.2.1顾客满意
8.2.1 customer satisfaction
顾客反馈的质量信息或顾客满意调查表或市场调研证实材料等及对顾客满意度分析评价的证据和分析评价的频次和方法。利用分析结果为持续改进和采取预防措施提供机会（8.4、8.5.1、8.5.3）。
Customer feedback quality information or customer satisfaction survey or market research confirmed that the material and on the analysis of customer satisfaction evaluation of the evidence and analysis evaluation of the frequency and methods. Using the results of the analysis for continuous improvement and preventive measures provide opportunities ( 8.4, 8.5.1, 8.5.3 ).
8.2.2内部审核
8.2.2 internal audit
审核到的“内部审核控制程序”及是否符合“标准”要求；内审计划和实施内审记录，内审不合格报告，审核报告是否对质量体系运行的有效性进行了综合评价；审核员的独立性、公正性。对发现的不合格是否进行了原因分析，采取、实施了纠正和预防措施，并验证其实施效果。（8.5.2）。
Audit to "internal audit control procedure" and is in accordance with the" standard" requirement; internal audit plan and carry out internal audit records, audit nonconformity reports, audit reports on the effectiveness of the quality system to carry out a comprehensive evaluation; auditor independence, impartiality. The detected nonconformities are analyzed, taking, the implementation of corrective and preventive measures, and verify the effectiveness of its implementation. ( 8.5.2 ).
8.2.3过程的监视和测量
8.2.3 monitoring and measurement of process
对关键过程进行控制的客观证据，或主管（负责）部门对执行部门进行定期检查的客观证据，或实施工序审核的客观证据。
Key process control objective evidence, or director (responsible ) Department of the executive departments regularly check the objective evidence, or implement the process audit objective evidence.
8.2.4产品的监视和测量
8.2.4 monitoring and measurement of product
进货检验、过程检验、最终检验符合与不符合质量体系要求的客观证据包括：检验规范及编制依据、检验记录及对“规范”的符合性、检验员资格等。
Incoming inspection, process inspection, final inspection in accordance with the do not conform to the quality system requirements include: objective evidence inspection specification and basis, inspection records and on the "norms" conformity, inspector qualifications.
8.3不合格品控制
In 8.3 control of nonconforming product
审核到的“不合格品控制程序”及是否符合“标准”要求；不合格品控制符合与不符合要求的客观证据。
Review of" nonconforming product control procedure" and is in accordance with the" standard" requirement; control of nonconforming product conformity and does not meet the requirements of the objective evidence.
8.4数据分析
8.4 data analysis
对顾客满意度、产品实现过程（包括进货检验、产品加工、过程检验、最终检验）所产生数据进行分析的客观证据，并利用数据分析结果为持续改进和采取预防措施提供机会（8.5.1、8.5.3）。
On customer satisfaction, product realization process ( including incoming inspection, product processing, process inspection, final inspection) generated data for analysis of objective evidence, and using the results of data analysis for continuous improvement and preventive measures provide opportunities for ( 8.5.1, 8.5.3 ).
8.5.1持续改进
8.5.1 continuous improvement
组织通过管理评审和数据分析等活动进行持续改进和有效性评价的客观证据；是否开展了质量改进活动及实施证据。
Tissue through the management review and data analysis and other activities for continuous improvement and effective evaluation of objective evidence; whether to carry out the quality improvement activities and implementation of evidence.
8.5.2纠正措施
8.5.2 corrective actions
审核到的“纠正措施控制程序”及是否符合“标准”要求；组织通过对不合格进行原因分析，采取、实施纠正措施并验证其有效行的客观证据。
Audit to "correct measure control program" and with" standard " requirement; tissue through the unqualified cause analysis, adopt, implement the corrective measures and verify its effective line of objective evidence.
8.5.3预防措施
8.5.3 prevention measures
审核到的“预防措施控制程序”及是否符合“标准”要求；组织通过管理评审或过程监控或数据分析等活动对潜在的不合格进行原因分析，采取、实施预防措施并验证其有效行的客观证据。
Review of" preventive measures to control program" and whether it conforms to the "standard" requirement; tissue through the management review or monitoring and data analysis of potential failure cause analysis, adopt, the implementation of preventive measures and verify its validity of objective evidence.
上述现场审核记录的填写要点，不是审查“记录”的唯一标准，编写的目的仅为参加质量管理体系审核的审核员提供参考，随着对ISO9001：2000标准的深入理解和质量管理体系总部对现场审核记录的进一步要求，对现场审核记录应填写内容的要求将逐步完善。
The field audit records in points, not only standard review" record", written solely for the purpose to quality management system auditors to provide reference, with the ISO9001 2000 standard and the in-depth understanding of the quality management system based on the on-site audit records are further requirements, on-site audit records shall fill in the content request will gradually improve.