理化检测实验室质量管理研究-以A公司为例(硕士)(论文38000字)
摘 要
随着经济的快速发展和国际和国内检测市场的开放，第三方检测机构的检测水平及能力也得到了长足发展。越来越多的检测机构意识到质量管理对于企业在检测市场发展中的重要性。检测实验室作为检测机构的主体，其重点在于专业性、公正性以及独立性，其质量管理水平在一定程度上决定着检测机构自身在行业中的地位、公信力以及市场竞争力。
质量大师约瑟夫•朱兰（Joseph Juran）博士在《朱兰质量手册》中说：质量是指那些能满足顾客需求，从而使顾客感到满意的“产品特性”。质量发展大致经历了三大阶段，分别是质量检验阶段、统计质量控制阶段和全面质量管理阶段，戴明奖、马尔科姆•鲍德里奇国家质量奖和ISO 9000质量管理体系认证在先进的全面质量管理的推动方面有着极其重要的意义，它们建立了准则框架，使得任何组织都可以通过这个准则框架来实践全面质量管理理论，有效提升质量管理水平。
实验室推行实验室认可的发展最早是从十九世纪英国开始的。目前，在国际上有一个专门的组织对实验室认可进行管理——“国际实验室认可合作组织（ILAC）”；在中国，对实验室认可进行管理的组织是“中国合格评定国家认可委员会（CNAS）”，它是ILAC认可多边互认的协议方之一。实验室认可的依据就是ISO系列标准中的ISO/IEC 17025。理化检测实验室质量管理体系持续有效的运行能够保证最终数据结果的准确可靠，达到客户满意。通过ISO/IEC 17025标准要求能够帮助实验室进行全面质量管理，从而使检测工作持续有效的进行，帮助提高检测人员的技术水平，加强实验室人员的管理素质，同时也是获得检测数据准确性的根本保证。2017年底，ISO/IEC 17025：2017发布，对新版17025的学习和了解以及建立在实验室质量管理中的应用模型可以帮助我们进一步了解实验室质量管理的发展趋势和方向。
A公司是中国专业的第三方检验认证服务机构，其检测领域主要涵盖有色金属领域的理化检验，是国内有色金属理化检测方面的权威机构，但是与世界范围内顶尖的检测机构相比，不论在检测领域、市场规模，还是在人员素质、管理水平等方面都还存在很大的差距。近年来，由于市场和检测技术的升级需求，A公司在逐步扩大检测领域和规模的条件下，还应防止质量管理出现“两层皮”的表面形式化现象，将质量管理水平持续保持并持续提升。
综上所述，对A公司理化检测实验室质量管理体系的研究不但有基于新版17025准则要求和过程管理的质量管理体系流程分析的理论意义，还能够通过提出推动全面质量管理实践的有效方法，提高实验室质量检测技术能力和服务水平，从而提升组织的全面质量管理水平，最终达到顾客满意，使第三方检测实验室在市场竞争中发挥作用的重要实践意义。
ISO/IEC 17025：2017准则全文除前言之外有八大部分：范围、规范性引用文件、术语和定义、通用要求、结构要求、资源要求、过程要求和管理体系要求。其中，通用要求包括公正性和保密性；结构要求对实验室法律责任、实验室管理层、实验室活动文件化、实验室活动范围、实验室在确定与其相关的关系、确定结果不受影响、管理层在于客户沟通、体系变更保持其完整性等方面提出要求；资源要求中包括总则、人员、设施和环境条件、设备、计量溯源性、外部提供的产品和服务等六方面；过程要求包括要求/标书和合同的评审、方法的选择/验证和确认、抽样、检测和校准物品的处置、技术记录、测量不确定度的评定、确保结果的有效性、报告结果、投诉、不符合工作、数据控制和信息管理等十一方面；管理体系要求包括方式、管理体系文件、管理体系文件的控制、记录控制、应对风险和机遇的措施、改进、纠正措施、内部审核、管理评审等九方面。实验室通过对资源输入，经过流程转化，以及质量保证的管理手段，得到报告结果的输出。实验室通过内部审核、管理评审和外部评审等手段检查管理体系运行的有效性，提升质量管理水平，使质量管理体系持续有效运行。通过对准则的理顺，结合管理理论知识，运用过程管理方法对A公司理化检测实验室质量管理体系分析，并利用流程图和PDCA图构建模型，从而有效提升理化检测实验室质量管理水平，推动增加公司在检测行业的市场竞争力。
A公司理化检测实验室质量管理体系运行过程中，会面临来自实验室内部、外部不同的问题和挑战，比如来自竞争对手和国家政策变动的挑战、不断提升的市场需求和技术要求提升的挑战，个别人员全面质量管理意识淡薄、缺乏有效的质量绩效考核机制等一类的问题。面对这些问题和挑战，A公司从以下几点入手：
一、加强人员、设备管理。A公司在不断扩大检测领域、拓展检测市场范围的同时，加强人员队伍建设，合理选人，仔细育人，同时提升设备管理水平，使体系运行的情况既能适应不断壮大的检测队伍，提高技术水平，同时又能保证质量安全。
二、提高人员质量意识。质量意识对质量管理行为起着非常重要的影响和制约作用，需要从最高管理者到基层每一位员工的认识和理解，是提高质量水平的根本因素。从加强员工培训入手，促进全员参与，发挥领导的作用，共同实践质量管理体系，提高质量管理水平。
三、改进绩效测评。绩效考核的目的是通过提高实验室的质量管理水平进而提高市场竞争力和经济效益，通过将质量的考核与绩效挂钩，监督和促进质量管理体系运行，激发员工对于质量管理的积极性和主动性，有效降低质量管理风险，为公司的发展提供保障。
对A公司理化检测实验室质量管理体系研究尚有不足之处，例如ISO 17025准则发布不久，基于新版准则和过程管理所提出的模型和改进方案尚有不足之处，有待于在日后的工作中进一步地进行深入分析和不断完善。
总之，希望通过对A公司质量管理体系运行的深入分析及其问题和改进方案的提出，能够有效提高A公司的质量管理水平，进而提升其在同行业里的竞争优势，达到建成具有国际先进水平的检测实验室的质量战略目标。
关键词：理化检测实验室、质量管理、ISO/IEC 17025：2017准则、流程图
Abstract
With the rapid economic development and the opening up of international and domestic testing markets, the testing level and capability of third-party testing institutes have also made great strides. More and more testing organizations are aware of the importance of quality management in testing the market. Testing laboratories as the main body of the testing organization, its emphasis is on professionalism, impartiality and independence, and its quality management to a certain extent determines the status of the testing agency in the industry, credibility and market competitiveness.
Dr. Joseph Juran, the quality guru, states in the Juran Quality Handbook: Quality refers to the "product attributes" that satisfy the customer and satisfy the customer. Quality development has gone through roughly three stages, namely quality inspection phase, statistical quality control phase and total quality management phase, Deming Prize, Malcolm Baldrige National Quality Award and ISO 9000 Quality Management System Certification in the advanced comprehensive The promotion of quality management is extremely important. They set up the framework of guidelines so that any organization can adopt the guideline framework to practice total quality management theory and effectively improve the quality management level.
Laboratory development of laboratory accreditation was first started in the 19th century in the UK. At present, there is a special international organization that manages laboratory accreditation - "International Laboratory Accreditation Cooperation (ILAC)"; in China, the organization that manages accreditation of laboratories is "China National Accreditation Board for Conformity Assessment CNAS) ", which is one of the parties to ILAC's recognition of multilateral mutual recognition. Laboratory accreditation is based on the ISO series of standards ISO / IEC 17025. Physical and chemical testing laboratory quality management system continuous and effective operation of the final data to ensure the accuracy and reliability of results to achieve customer satisfaction. Through the ISO / IEC 17025 standard requirements can help the laboratory total quality management, so that testing continues to be effective, to help improve the technical level of inspectors, laboratory personnel to enhance the management of quality, but also to obtain the accuracy of the test data Guarantee. The end of 2017, ISO / IEC 17025: 2017 release, the new 17025 learning and understanding, as well as the application of the model established in laboratory quality management can help us to further understand the development trend of laboratory quality management and direction.
Company A is a professional third-party inspection and certification service organization in China. Its testing area mainly covers the physical and chemical testing of non-ferrous metals. It is the authoritative agency for the physical and chemical testing of non-ferrous metals in China. However, compared with the top testing organizations in the world, Testing areas, the size of the market, or in the quality of personnel, management and so there is still a big gap. In recent years, due to the upgrading of market and testing technology, Company A should prevent the appearance of "two skins" in quality management under the condition of gradually expanding the scope and scale of testing and keep the quality management level continuously and continuously Enhance.
In summary, the A company physical and chemical testing laboratory quality management system research not only based on the new version of the 17025 standard requirements and process management quality management system process analysis of the theoretical significance, but also through the promotion of total quality management practices to promote effective methods, Improve the quality and service level of laboratory quality testing technology, so as to enhance the overall quality management level of the organization and finally achieve customer satisfaction and make the third-party testing laboratories play an important role in the market competition.
In addition to the preamble, the full text of the ISO / IEC 17025: 2017 guidelines includes eight sections: Scope, Normative References, Terms and Definitions, General Requirements, Structural Requirements, Resource Requirements, Process Requirements, and Management System Requirements. Among them, the general requirements include fairness and confidentiality; the structural requirements of the laboratory legal responsibility, laboratory management, laboratory activities documentation, scope of laboratory activities, laboratories to determine the relationship with the relevant, to determine the results are not affected, Management is in the customer communication, system changes to maintain its integrity and other aspects of the request; The resource requirements include the general principles, personnel, facilities and environmental conditions, equipment, measurement traceability, externally provided products and services, etc. The process requirements include requirements / proposals and contract review, method selection / validation and validation, sampling, Detection and calibration of the disposal of goods, technical records, the measurement of measurement uncertainty, to ensure the validity of the results, the report results, complaints, non-compliance with work, data control and information management, etc. 11 aspects; management system requirements include the way management system Documents, management system document control, record control, measures to deal with risks and opportunities, improvement, corrective measures, internal audit, management review and other aspects. Laboratory through the input of resources, through the process of conversion, and quality assurance management tools to get the output of the report. The laboratory checks the effectiveness of the management system through internal audits, management reviews and external reviews to improve the quality management level so that the quality management system can operate continuously and effectively. Through the straightening out of the guidelines, combined with the management theory knowledge, using process management method to analyze the A company's physical and chemical testing laboratory quality management system, and using the flow chart and PDCA graph to build the model, so as to effectively improve the physical and chemical testing laboratory quality management level, and promote Increase the company in the testing industry's market competitiveness.
A company physical and chemical testing laboratory quality management system operation process, will face different problems and challenges from inside and outside the laboratory, such as from competitors and national policy challenges, rising market demand and technical requirements to enhance the challenge, Individual staff total quality management awareness is weak, the lack of effective quality performance appraisal mechanism and other issues. In the face of these problems and challenges, Company A starts with the following points:
First, strengthen personnel, equipment management. While expanding the testing field and expanding the scope of the testing market, Company A strengthens the building of the contingent of personnel, reasonably selecting and carefully educating people and at the same time improves the level of equipment management so that the operation of the system can both adapt to the ever-growing testing team and improve the technology Level, while ensuring quality and safety.
Second, improve staff quality awareness. Quality awareness plays a very important role in the quality management. It requires understanding and understanding from the top management to every employee at the grassroots level. It is a fundamental factor to improve the quality level. Start with strengthening staff training, promote full participation, give play to the role of leadership, jointly practice the quality management system and improve the quality management level.
Third, improve performance evaluation. The purpose of the performance appraisal is to improve the market competitiveness and economic benefits by improving the quality management level in the laboratory, to monitor and promote the operation of the quality management system by linking the quality assessment and performance, to motivate employees' enthusiasm and initiative in quality management, Effectively reduce the risk of quality management for the company's development to provide protection.
A company physical and chemical testing laboratory quality management system research there are still inadequacies, such as ISO 17025 guidelines released shortly after, based on the new version of the guidelines and process management model and improvement programs have shortcomings, to be in the future work Further in-depth analysis and continuous improvement.
In short, I hope through the A company quality management system in-depth analysis of the operation and the proposed improvement programs, A company can effectively improve the quality management level, thereby enhancing its competitive advantage in the industry to achieve the international advanced level The quality of strategic objectives of the testing laboratory.
目录
第1章绪论 12
1.1 研究背景 12
1.2 国内外检测行业现状 13
1.2.1 国外检测行业现状 13
1.2.2 国内检测行业现状 14
1.3 研究目的和意义 15
1.3.1 研究目的 15
1.3.2 研究意义 16
1.4 研究方法 17
1.5研究内容与论文框架设计 18
1.5.1 主要研究内容 18
1.5.2 论文框架 19
第2章理化检测实验室质量管理理论基础 19
2.1 质量管理概述 19
2.1.1 质量的基本概念 19
2.1.2 质量管理的发展概述 20
2.1.3 质量管理奖与质量管理认证概述 21
2.2 实验室认可概述 25
2.2.1 实验室认可的概念 25
2.2.2 实验室认可的发展概述 26
2.2.3 实验室认可的管理组织和依据标准概述 27
2.2.4 实验室认可流程概述 28
2.2.5 全面质量管理、ISO 9000与ISO/IEC 17025 28
2.3 检测实验室管理概述 30
2.3.1 检测实验室质量管理概述 30
2.3.2 检测实验室质量管理体系内容概述 31
2.3.3 理化检测实验室质量管理的一些要求 34
第3章 A公司的质量管理现状 36
3.1 公司概况 36
3.2 公司质量管理体系架构 37
3.2.1 质量方针和质量目标 37
3.2.2 质量管理体系文件架构 38
3.2.3 质量管理体系组织结构图 39
第4章基于ISO 17025：2017要求和过程管理的质量管理体系流程分析 41
4.1 资源要求 41
4.1.1 人员 41
4.1.2 设施和环境条件 42
4.1.3 设备 43
4.1.4 外部提供的产品和服务 45
4.2 过程要求 46
4.2.1 要求、标书和合同的评审 46
4.2.2 方法的选择、验证和确认 46
4.2.3 检测物品的处置 48
4.2.4 技术记录 49
4.2.5 确保结果的有效性 50
4.2.6 报告结果 50
4.2.7 投诉 52
4.2.8 不符合工作 53
4.2.9 数据控制和信息管理 54
4.3 管理体系要求 55
4.3.1 文件管理 55
4.3.2 风险和机遇 56
4.3.3 改进 56
4.3.4 纠正措施 56
4.3.5 内部审核 57
4.3.6 管理评审 58
4.3.7 质量保证体系框架图 58
第5章 A公司的理化检测实验室质量管理问题及挑战 59
5.1 面临的挑战 59
5.1.1 来自竞争对手和国家政策变动的挑战 59
5.1.2 不断提升的市场需求和技术要求提升的挑战 59
5.2 问题分析 60
5.2.1 个别人员全面质量管理意识淡薄 60
5.2.2 缺乏有效的质量绩效考核机制 60
第6章改进建议 61
6.1 加强人员队伍建设，提升设备管理能力，提高技术水平 61
6.2 提高人员全面质量意识 62
6.2.1 加强员工培训 62
6.2.2 全员参与 62
6.2.3 领导的作用 62
6.3 改进绩效测评，加强质量管理 62
第7章结论与展望 63
7.1 主要研究结论 63
7.2 研究的不足与展望 64 |
