ISO9000认证质量体系的建立、实施和改进
ISO9000 quality certification system establishment, implementation and improvement

建立、完善质量体系一般要经历质量体系的策划与设计，质量体系文件的编制、质量体系的试运行，质量体系审核和评审等阶段，每个阶段又可分为若干具体步骤， “六段十二步”工作方法是建立ISO9000质量管理体系程序化和规范化的系统步骤，此方法可结合企业具体情况做相应的调整。
Establishing, perfecting quality system will generally experience quality system planning and designing, compiling documents of quality system, quality system commissioning, quality system audit and evaluation stages, each stage can be divided into several steps," six step twelve" working method is to establish ISO9000 quality management system program and standardization the system steps, this method can be combined with the specific circumstances of enterprises make corresponding adjustment.
一、调查诊断，调整资源  
One, diagnostic investigation, to adjust resources
二、培训起步，系统策划
Two, the training starts, system planning
三、编写文件，发放运行  
Three, prepare documents, issuing operation
四、审核评审，纠偏完善  
Four, rectification and improvement of audit review,
五、整顿改进，正式审核  
Five, consolidate improvements, a formal audit
六、总结提高，持续改进
Six, improve the summary, continuous improvement
一、调查诊断，调整资源：
One, diagnostic investigation, to adjust resources:
（一） 调查了解: 实地调查企业现况、产品现况,填制《调查记录》  
( a ) to investigate: field survey enterprise status, product status, fill in" records"
1.管理层访谈  
1 management interviews
2.现场调查诊断
2 field investigations in the diagnosis of
A.与现场人员交谈，了解情况；       
A and field staff to talk, understand the situation;
B 现场观察
B field observation
C.检查现场文件和记录；
C. Check the scene file and record;
D.如实记录体系运行现状  
D. Truthfully record the system running status
3.整理调查结果,总结确定工作思路
Finishing 3 findings, summarizes the working train of thought
（二）诊断摸底: 了解企业现况与标准的差距,明确工作重点。  
( two) the diagnosis diagnostic: understanding enterprise status and the standard difference, make clear working key.
现状调查和分析的目的是为了合理地选择体系要素，内容包括：
Investigation and Analysis on the current aim is to reasonably select the system elements, including:
1．体系情况分析。即分析本组织的质量体系情况，以便根据所处的质量体系情况选择质量体系要素的要求。
Analysis of 1 system. The analysis of the organization of the quality system, according to the quality system quality system requirements to choose.
2．产品特点分析。即分析产品的技术密集程度、工艺要求、产品安全特性等，以确定要素的采用程度。
2 product characteristic analysis. The analysis of the products of technology intensive degree, technical requirements, product safety features, to identify elements of the degree.
3．组织结构分析。组织的管理机构设置是否适应质量体系的需要。应建立与质量体系运作相适应的组织结构并确立各部门的职责和权限。
3 organizational structure analysis. Organization management organization is to adapt the need of quality system. We should establish and quality system is adapted to the structure and to establish the responsibilities of various departments and authorities.
4．生产设备和检测设备能否适应质量体系的有关要求。
4 production equipment and testing equipment can meet the relevant requirements of quality system.
5．技术、管理和操作人员的组成、结构及水平状况的分析。
5 the technical, management and operations staff composition, structure and level analysis.
6．管理基础工作情况分析。即标准化、计量、质量责任制、质量教育和质量信息等工作的分析。  7.工作环境的适应性
6 basic management work analysis. The standardization, metrology, quality system of job responsibility, quality education and quality of information work analysis. 7 work environment adaptability
对以上内容可采取与标准中规定的质量体系要素要求进行对比性分析。
The above can be taken with the standard quality system requirements for comparative analysis.
（三）调整资源   
( three) adjustment of resource
在一个组织中除质量管理外，还有其他职能管理。组织机构设置由于历史沿革多数并不是按质量形成客观规律来设置相应的职能部门的，所以在完成落实质量体系要素并展开成对应的质量活动以后，必须将质量活动中相应的工作职责和权限分配到各职能部门。
In an organization in quality management, and other management functions. Organization because of historical evolution and most not by quality objective law to set the corresponding functions, so to implement quality system elements and expanded into the corresponding quality activities, must be quality activities in the corresponding responsibilities and privileges assigned to each function branch.
一般地讲，一个质量职能部门可以负责或参与多个质量活动，但不要让一项质量活动由多个职能部门来负责。
Generally speaking, a quality functions can be responsible for or involved in a number of quality activities, but don't let a quality activity consists of multiple functional departments to be responsible for.
目前我国企业现有职能部门对质量管理活动所承担的职责、所起的作用普遍不够理想,总的来说应该加强。在活动展开的过程中，必须涉及相应的硬件、软件和人员配备，根据需要应进行适当的调配和充实。
At present our country enterprise existing departments of quality management activities, responsibilities, the role is generally not ideal, in general should be strengthened. In the event the unfolding process, must be related to the corresponding hardware, software and personnel, according to the need of proper allocation and full.
二、培训起步, 系统策划
Two, the training starts, system planning
（一）全员ISO9000基础知识培训
( a ) the full ISO9000 basic knowledge training
1.培训目的
The 1 objective of the training
A.了解ISO9000的基础知识及企业推行ISO9000意义;
A. ISO9000 to understand the basic knowledge and enterprise to carry out ISO9000 significance;
B.了解ISO9000族标准的内容和基本要求；
B. ISO9000 understanding of the contents and basic requirements of family standards;
C.了解ISO9000体系的建立和实施办法；
C. ISO9000 system establishment and implementation;
2.学习内容：
2 learning content:
A. ISO9000基础知识(2H)
A . ISO9000 knowledge base ( 2H )
B. ISO9000八项原则、十二项原理、四种方法、两个基本目的  (3H)       
B . ISO9000 eight principles, twelve principles, four methods, two basic purposes ( 3H )
C.ISO9000术语(1H)    
C.ISO9000 terminology ( 1H )
D.ISO9001标准理解（9H）    
The D.ISO9001 standard understanding ( 9H )
E.如何编写质量体系文件（2H）     
E. How to compile the quality system documents ( 2H )
F.质量管理体系的建立、实施与改进（2H）   
F. The establishment of quality management system, implementation and improvement ( 2H )
3.说明: 质量体系建立和完善的过程，是始于教育，终于教育的过程，也是提高认识和统一认识的过程，教育培训要分层次，循序渐进地进行。
3: quality system build and perfect process, is in education, finally the process of education, but also to raise awareness and understanding of the process, training level, step by step for.
A.第一层次为决策层领导。
A. The first level is decision-making layer leads.
主要培训：        
The main training:
通过介绍质量管理的发展历程，说明建立、完善质量体系的迫切性和重要性；        
Through the introduction of the history of quality management, build, perfect quality system and the urgency and importance of;
通过ISO9000族标准的总体介绍，提高按国家（国际）标准建立质量体系的认识。        
Through the ISO9000 standards overall presentation, improve according to national ( International ) standards to establish quality system knowledge.
通过质量体系要素讲解（重点应讲解“管理职责”等总体要素），明确决策层领导在质量体系建设中的关键地位和主导作用。
Through the quality system elements on ( focus should be on" management" and other general elements ), clear decision-making leadership in quality system construction in the key position and leading role.
B. 第二层次为管理层，重点是管理、技术和生产部门的负责人，以及与建立质量体系有关的工作人员。这一层次的人员是建设、完善质量体系的骨干力量，起着承上启下的作用，要使他们全面接受ISO9000族标准有关内容的培训，在方法上可采取讲解与研讨结合，理论与实践结合.   
B. Second level of management, focus on management, technology and production departments, and the establishment of quality system related staff. This level of personnel is construction, improve the quality system backbone, played the role of connecting link, to make them fully accepted the ISO9000 standards about the content of the training, the method can be adopted to explain and research combined together, the combination of theory and practice.
C.第三层次为执行层，即与产品质量形成全过程有关的作业人员。对这一层次人员主要培训与本岗位质量活动有关的内容，包括在质量活动中应承担的任务，完成任务应赋予的权限，以及造成质量过失应承担的责任等内容。
C. Third levels as executive layer, namely the product quality and the whole process of the formation of the workers. On the level of personnel training and the post quality activities regarding content, including the quality activities should undertake the duty, to complete the task should be given permission, as well as the cause of quality fault should assume responsibilities.
（二） 建立推行组织
( two) to establish the implementation of organizational
1.最高管理层重视    
1 Top Management Emphasis
A.带头学习ISO9000基础知识；   
Take the lead in learning basic knowledge of ISO9000 A;
B.积极推动公司贯标工作；    
B. Actively promoting the company standards;
C.组织人力和物力支持；2.成立ISO9000推行委员会
The C. The organization of the human and material support; 2 to set up ISO9000 Implementation Committee
A.成立领导小组，主要领导都应当参与；    
A. Set up a leading group, main leader should participate in the;
B.任命管理代表，负责标准中规定的职责:       
B. The appointment of management representative, responsible for the standard duty:
确保质量管理体系所需的过程得到建立、实施和保持；        
Ensuring that processes needed for the quality management system are established, implemented and maintained;
向最高管理者报告质量管理体系的业绩和任何改进的需求;        
Reporting to top management on the performance of the quality management system and any need for improvement;
确保在整个组织内提高满足顾客要求的意识;        
Ensuring the promotion of awareness of customer requirements;
还可包括就质量体系方面事宜与外部机构的联络。    
Also may include a quality system issues with the external body contact.
C.制定《ISO9000推行委员会及管理者代表任命书》
C. Make" ISO 9000 Committee and appointment of management representative"
（三）系统策划,职能分工  
( three) the system planning, functional division
1. 确定《组织结构图》  
1 determine the" structure"
2. 确定《各部门职责和权限》    
2 identified" departmental responsibilities and authority"
A.各部门职责应覆盖标准要求。
A. The duties of each department should cover the standard requirements.
B.各部门有清楚的职责。
B. All departments have clear responsibilities.
C.各部门工作之间有合理的衔接。
C. The work of various departments have reasonable cohesion.
D.职能分工形成书面文件，并经充分讨论。
D functions form a written document, and after full discussion.
E.应把有关质量的策划、控制、协调、检查、改进工作都反映出来。  
E. Should be concerned the quality planning, control, coordination, check, improved work reflected.
3.确定工作计划,制定《工作总计划》及《月度计划》  
3 determine the work plan, work plan and develop"""" monthly plan
4.确定体系文件清单,制定《体系文件一览表》    
4 determine the system file list file list, making" system"
A.列出原有的文件和记录清单    
A. A list of original documents and records list
B.明确哪些旧文件作废、哪些保留    
B. Clear which the old file invalid, which retained
C.确定体系运行所必须的文件清单    
C. Determine system must file list
5.确定分工负责编写体系文件的部门和人员,制定《职责分配表》   
5 determine the division responsible for the writing system documentation departments and personnel, establish" responsibility assignment table"
至此前期的工作基本完成。 
So far the work completed.
三、编写文件,发放运行
Three, prepare documents, issuing operation
（一）编写文件
( a ) to write file
1.按文件清单和落实的编写职责起草文件
1 according to the list of documents and implement the writing duties to draft a document
A.质量手册：
A quality manual:
简明扼要说明组织如何实施ISO9000的各个要素;     
Be concise and to the point that an organization how to implement ISO9000 elements;
B.程序文件:
B program file:
职责清晰, 清楚描述各个活动流程的过程、涉及的部门/人员,相关的文件记录.      
Clear responsibilities, a clear description of each activity process, involving the departments / personnel, related records.
C.作业性的文件:清楚说明操作步骤,控制要点,注意事项等.      
C. Operation file: clear operational steps, control points, the matters needing attention.
D.质量记录表格: 设计科学合理,提供的数据有明确的作用。    
D. Quality record form : a scientific and rational design, provide data with a clear role.
2. 为了使所编制的质量体系文件做到协调、统一，在编制前应将现行的质量手册（如果已编制）、企业标准、规章制度、管理办法以及记录表各等收集在一起,与策划的《质量体系文件一览表》进行比较，从而确定新编、增编或修订质量体系文件项目。    
2 in order to make the quality system file to achieve coordination, unity, in the preparation before the quality manual ( if have compiled ), enterprise standards, rules and regulations, management and record all collected together, and planning of the" quality system documents list" for comparison, thereby defining new, add knitting or revision of quality system documentation project.
3．为了提高质量体系文件的编制效率，减少返工，在文件编制过程中要加强文件的层次间、文件与文件间的协调。尽管如此，一套质量好的质量体系文件也要经过自上而下和自下而上的多次反复。   
3 in order to improve the quality system document preparation efficiency, reducing rework, the documentation process to strengthen the file hierarchy, the coordination between documents. Despite this, a set of quality good quality system documents are subject to top-down and bottom-up repeatedly.
4．编制质量体系文件的关键是讲求实效，不走形式。既要从总体上和原则上满足 ISO9000族标准，又要在方法上和具体做法上符合本单位的实际，满足符合性、适用性、有效性和充分性等要求。
4 the preparation of quality system documentation is the key to effective, do not take a form. Not only from the general principles and meet ISO9000 standard, and on the methods and specific practices consistent with this unit actual, meet compliance, applicability, effectiveness and sufficiency requirements.
（二）文件讨论    
( two) documents discuss
1. 在顾问的配合下,进行标准符合性及内容适用性和充分性讨论和检讨；    
In cooperation with the 1 consultants, for conformity to the standard and content of applicability and full discussion and review;
2. 管理层对文件系统进行评审确认
2 the management of the file system on the review to confirm
（三）文件管制部门进行文件登录和发放管理工作,包括: 审核、批准\复印、装订、受控、登记、发效、签收等
( three) document control department for document log and release management work, including: audit, approval \ copy, binding, controlled, registration, effect, such as receiving
（四）发放运行
( four) extend operation
1.体系文件培训、宣传工作     
1 system file training, propaganda work
2.实施并检验体系的控制有效性,完善管理     
2 implementation and inspection system control effectiveness, improve the management
3.在质量体系试运行过程中，要重点抓好以下工作：
3 in the quality system running process, should have caught mainly the following work:
A．有针对性地宣贯质量体系文件。使全体职工认识到新建立或完善的 质量体系是对过去质量体系的变革，是为了向国际标准接轨，要适应这种变革就必须认真学习、贯彻质量体系文件。
A targeted promotion of quality system documents. Make all worker to recognize the new build or improve the quality system quality system change to the past, to international standards, to adapt to this change must learn seriously, carry out the quality system documents.
B．实践是检验真理的唯一标准。体系文件通过试运行必然会出现一些问题，全体职工立将从实践中出现的问题和改进意见如实反映给有关部门，以便采取纠正措施。
B. Practice is the sole criterion for testing truth. System file through the trial operation will appear a few problems, all employees, from the practical problems and improving opinion reflect to the relevant departments, so that corrective measures.
C．将体系试运行中暴露出的问题，如体系设计不周、项目不全等进行协调、改进。
C. The system in trial operation exposed the problem, such as system design week, not congruent coordinate, improvement project.
D．强信息管理，不仅是体系试运行本身的需要，也是保证试运行成功的关键。所有与质量活动有关的人员都应按体系文件要求，做好质量信息的收集、分析、传递、反馈、处理和归档等工作。 
D. Strong information management system, is not only a test run to their own needs, but also guarantee the successful trial run key. All quality activities related to personnel should according to the system documentation requirements, good quality information collection, analysis, transmission, feedback, processing and archiving.
四、审核评审,纠偏完善
Four, rectification and improvement of audit review,
（一）培训内审员:培训并考核,合格发证  
( a ) training auditors: training and assessment, qualified certification
（二）组织内部质量审核活动    
( two) the organization of internal quality audit
1. 步骤:       
1 steps:
A.策划内审活动,任命内审组长,组成审核小组       
A. Planning the internal audit activity, the appointment of the internal audit team leader, an audit group
B.编制内审计划       
B. The preparation of audit programs
C.文件审核       
C document review
D..现场审核       
D on-site audit.
E..总结会,报告审核结果       
E. Summary, report the audit results
F.相关部门有针对性实施纠正和预防措施       
F. Relevant departments to implement corrective and preventive action
G.跟踪验证实施的效果       
G. Follow up and verify the implementation effect
H.完成审核报告   
H. The completion of the audit report
2. 质量体系审核在体系建立的初始阶段往往更加重要。
2 quality system audit in the system to establish the initial stage are often more important.
在这一阶段，质量体系审核的重点，主要是验证和确认体系文件的适用性和有效性。
At this stage, quality system audit is the main focus, verification and validation system documents the applicability and effectiveness.
A.审核与评审的主要内容一般包括：　　             
A audits and reviews the main content includes:
规定的质量方针和质量目标是否可行          
Provision of a quality policy and quality objectives is feasible
体系文件是否覆盖了所有主要质量活动，各文件之间的接口是否清楚；          
System file covers all the major quality activities, various files between interface is clear;
组织结构能否满足质量体系运行的需要，各部门、各岗位的质量职责是否明确；          
Organization structure can meet the need of quality system operation, departmental door, each post quality responsibility is clear;
质量体系要素的选择是否合理；          
Quality system element selection is reasonable;
规定的质量记录是否能起到见证作用          
Specified quality record whether it can play a role of witness
所有职工是否养成了按体系文件操作或工作的习惯，执行情况如何。       
All staff is developed according to the system of file operations or work habits, executive circumstance how.
B．该阶段体系审核的特点是：          
B. The phase of system audit is characteristic:
体系正常运行时的体系审核，重点在符合性，在试运行阶段，通常是将符合性与适用性结合起来进行；          
System during normal operation of the system, focus on the conformity, in the trial operation stage, usually will meet and applicability of combine;
为使问题尽可能地在试运行阶段暴露无遗，除组织审核组进行正式审核外，还应有广大职工的参与，鼓励他们通过试运行的实践，发现和提出问题；          
In order to make the problem as much as possible in the trial operation stage completely unmasked, in addition to the organization's audit team to conduct a formal audit, also have the participation of broad worker, encourage them through the trial operation of the practice, and put forward that the problem;
在试运行的每一阶段结束后，一般应正式安排一次审核，以便及时对发现的问题进行纠正，对一些重大问题也可根据需要，适时地组织审核；          
In the test run of each phase, should generally be formal arrangements for an audit, so that timely find problems were corrected, to some major issue can also be based on need, timely organization review;
在试运行中要对所有要素审核覆盖一遍；          
During the trial run of all elements of audit coverage;
充分考虑对产品的保证作用；          
Give full consideration to the product guarantee;
在内部审核的基础上，由最高管理者组织一次体系评审。      
In the internal audit basis, from top management to organize a system review.
C.应当强调，质量体系是在不断改进中行以完善的，质量体系进入正常运行后，仍然要采取内部审核，管理评审等各种手段以使质量体系能够保持和不断完善。
The C. It should be stressed, in the continuous improvement of the quality system is to improve, the quality system in normal operation, still need to adopt the internal audits, management reviews and other means to make quality system to maintain and continue to improve.
（三）组织管理评审活动 ,以评价体系的有效性适用性和充分性。
( three) the organization of management review activities, in order to evaluate the validity of system suitability and adequacy.
（四）针对文件和体系运作进行再完善。
(four ) according to the file and the system operation to improve.
五、整顿改进,正式审核
Five, consolidate improvements, a formal audit
（一）各部门对工作进行自纠自查,现场整理整顿（二）迎审前准备工作
( a ) the various departments of the work of self-examination and self-correction, on-site reorganizes the (two ) face of pretrial preparation work
（三）配合审核,通过认证,获得证书六、总结提高,持续改进
( three) audits, through certification, certificate six, summary rises, continuous improvement
（一）系统回顾,总结提高意识和管理手段
( a ) a systematic review, summarize and improve awareness and management means
（二）制度化运行,持续的教育训练
( two) the system operation, continuing education and training
（三）形成自我完善和持续改进的体系
( three) formation of self-improvement and continuous improvement system