质量管理体系文件 综述，质量管理体系文件综述
质量管理体系文件？
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7.2 质量管理体系中使用的iso三体系认证类型 在质量管理体系中使用下述几种类型的iso三体系认证： a) 向组织内部和外部提供关于质量管理体系的一致信息的iso三体系认证，这类iso三体系认证称为质量手册； b) 表述质量管理体系如何应用于特定iso三体系认证、项目或合同的iso三体系认证，这类iso三体系认证称为质量计划； c) 阐明要求的iso三体系认证，这类iso三体系认证称为规范； d) 阐明推荐的方法或建议的iso三体系认证，这类iso三体系认证称为指南； e) 提供如何一致地完成活动和过程的信息的iso三体系认证，这类iso三体系认证包括形成iso三体系认证的程序、作业指导书和图样；f) 为完成的活动或达到的结果提供客观证据的iso三体系认证，这类iso三体系认证称为记录。 每个组织确定其所需iso三体系认证的多少和详略程度及使用的媒体。这取决于下列因素，诸如组织的类型和规模、过程的复杂性和相互作用、iso三体系认证的复杂性、顾客要求、适用的法规要求、经证实的人员能力以及满足质量管理体系要求所需证实的程度。质量手册的结构（参考）：--封面--前言（企业简介，手册介绍）--目录
1.0------颁布令
2.0------质量方针和目标
3.0------组织机构
3.1--行政组织机构图
3.2--质量保证组织机构图
3.3--质量职能分配表
4.0------质量体系要求
4.1--管理职责（示例）
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1.--目的
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2.--范围
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3.--职责
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4.--管理要求
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5.--引用程序iso三体系认证
4.2--质量体系
4.20--统计技术
5.0------质量手册管理细则
6.0------附录质量手册内容概述前言：企业简介：简要描述企业iso认证流程建议、企业规模、企业历史沿革；隶属关系；所有制性质；主要iso三体系认证情况（iso三体系认证iso认证流程建议、系列型号、）；采用的标准、主要销售地区；企业地址、通讯方式等内容。目的：说明为什么开展该项活动。范围：说明活动涉及的（iso三体系认证、项目、过程、活动......）范围。职责：说明活动的管理和执行、验证人员的职责。程序内容：详细阐述活动开展的内容及要求。质量记录：列出活动用到或产生的记录。支持性iso三体系认证：列出支持本程序的第三层iso三体系认证。手册介绍：介绍本质量手册所依据的标准及所引用的标准；手册的适用范围；必要时可说明有关术语、符号、缩略语。颁布令：以简练的iso14001环境管理体系认证说明本公司质量手册已按选定的标准编制完毕，并予以批准发布和实施。颁布令必须以公司较高管理者的身份叙述，并予亲笔手签姓名、日期。质量方针和目标（略）组织机构：行政组织机构图、质量保证组织机构图指以图示方式描绘出本组织内人员之间的相互关系。质量职能分配表指以表格方式明确体现各质量体系要素的主要负责部门、若干相关部门。质量体系要求：根据质量体系标准的要求，结合本公司的实际情况，简要阐述对每个质量体系要素实施控制的内容、要求和措施。力求语言简明扼要、精炼准确，必要时可引用相应的程序iso三体系认证。质量手册管理细则：简要阐明质量手册的编制、审核、批准情况；质量手册修改、换版规则；质量手册管理、控制规则等。附录：质量手册涉及之附录均放于此（如必要时，可附体系iso三体系认证目录、质量手册修改控制页等），其编号方式为附录A、附录B，以此顺延。
不知道你是生产企业还是商业企业，不过工商所要求你提供的东西都是表明你对质量是有控制的，也就是你进、销、存、产等一系列的质量相关iso三体系认证。当然如果你企业还不是很壮大的情况下也可以直接提供质管部iso三体系认证的，另外如果你是特殊行业，比如医药企业就不一样了。
应该只要提供质量体现iso三体系认证，和你们iso三体系认证的相关检验报告。再说他们应该给你们一张表的啊！按照他们的要求做就好了啊！
求关于TSO9000质量论证体系的文献综述(包括外文)？
ISO 9000 is a family of standards for quality management systems. ISO 9000 is maintained by ISO, the International Organization for Standardization and is administered by accreditation and certification bodies. The rules are updated, as the requirements motivate changes over time.Some of the requirements in ISO 9001:2008 (which is one of the standards in the ISO 9000 family) includea set of procedures that cover all key processes in the business;monitoring processes to ensure they are effective;keeping adequate records;checking output for defects, with appropriate and corrective action where necessary;regularly reviewing individual processes and the quality system itself for effectiveness; andfacilitating continual improvementA company or organization that has been independently audited and certified to be in conformance with ISO 9001 may publicly state that it is "ISO 9001 certified" or "ISO 9001 registered". Certification to an ISO 9001 standard does not guarantee any quality of end products and services; rather, it certifies that formalized business processes are being applied.Although the standards originated in manufacturing, they are now employed across several types of organizations. A "product", in ISO vocabulary, can mean a physical object, services, or software.Contents of ISO 9001ISO 9001 certification of a fish wholesaler in TsukijiISO 9001:2008 Quality management systems — Requirements is a document of approximately 30 pages which is available from the national standards organization in each country. Outline contents are as follows:Page iv: ForewordPages v to vii: Section 0 IntroductionPages 1 to 14: RequirementsSection 1: ScopeSection 2: Normative ReferenceSection 3: Terms and definitions (specific to ISO 9001, not specified in ISO 9000)Pages 2 to 14Section 4: Quality Management SystemSection 5: Management ResponsibilitySection 6: Resource ManagementSection 7: Product RealizationSection 8: Measurement, analysis and improvementIn effect, users need to address all sections 1 to 8, but only 4 to 8 need implementing within a QMS.Pages 15 to 22: Tables of Correspondence between ISO 9001 and other standardsPage 23: BibliographyThe standard specifies six compulsory documents:Control of Documents (
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2.3)Control of Records (
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2.4)Internal Audits (
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2.2)Control of Nonconforming Product / Service (
8.3)Corrective Action (
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5.2)Preventive Action (
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5.3)In addition to these, ISO 9001:2008 requires a Quality Policy and Quality Manual (which may or may not include the above documents).Summary of ISO 9001:2008 in informal languageThe quality policy is a formal statement from management, closely linked to the business and marketing plan and to customer needs. The quality policy is understood and followed at all levels and by all employees. Each employee needs measurable objectives to work towards.Decisions about the quality system are made based on recorded data and the system is regularly audited and evaluated for conformance and effectiveness.Records should show how and where raw materials and products were processed, to allow products and problems to be traced to the source.You need to determine customer requirements and create systems for communicating with customers about product information, inquiries, contracts, orders, feedback and complaints.When developing new products, you need to plan the stages of development, with appropriate testing at each stage. You need to test and document whether the product meets design requirements, regulatory requirements and user needs.You need to regularly review performance through internal audits and meetings. Determine whether the quality system is working and what improvements can be made. Deal with past problems and potential problems. Keep records of these activities and the resulting decisions, and monitor their effectiveness (note: you need a documented procedure for internal audits).You need documented procedures for dealing with actual and potential nonconformances (problems involving suppliers or customers, or internal problems). Make sure no one uses bad product, determine what to do with bad product, deal with the root cause of the problem and keep records to use as a tool to improve the system.1987 version1994 versionISO 9000:1994 emphasized quality assurance via preventive actions, instead of just checking final product, and continued to require evidence of compliance with documented procedures. As with the first edition, the down-side was that companies tended to implement its requirements by creating shelf-loads of procedure manuals, and becoming burdened with an ISO bureaucracy. In some companies, adapting and improving processes could actu中证集团iso认证的王老师 be impeded by the quality system.[citation needed]2000 versionThe Portuguese ISO 9001 certification imageISO 9001:2000 combines the three standards 9001, 9002, and 9003 into one, called 900
1. Design and development procedures are required only if a company does in fact engage in the creation of new products. The 2000 version sought to make a radical change in thinking by actu中证集团iso认证的王老师 placing the concept of process management front and center ("Process management" was the monitoring and optimizing of a company's tasks and activities, instead of just inspecting the final product). The 2000 version also demands involvement by upper executives, in order to integrate quality into the business system and avoid delegation of quality functions to junior administrators. Another goal is to improve effectiveness via process performance metrics — numerical measurement of the effectiveness of tasks and activities. Expectations of continual process improvement and tracking customer satisfaction were made explicit.The ISO 9000 standard is continu中证集团iso认证的王老师 being revised by standing technical committees and advisory groups, who receive feedback from those professionals who are implementing the standard.[1]2008 versionISO 9001:2008 only introduces clarifications to the existing requirements of ISO 9001:2000 and some changes intended to improve consistency with ISO 14001:200
4. There are no new requirements. Explanation of changes in ISO 9001:200
8. A quality management system being upgraded just needs to be checked to see if it is following the clarifications introduced in the amended version.[1] Practical Guide to Implementing ISO 9001:2008CertificationISO does not itself certify organizations. Many countries have formed accreditation bodies to authorize certification bodies, which audit organizations applying for ISO 9001 compliance certification. Although commonly referred to as ISO 9000:2000 certification, the actual standard to which an organization's quality management can be certified is ISO 9001:2000. Both the accreditation bodies and the certification bodies charge fees for their services. The various accreditation bodies have mutual agreements with each other to ensure that certificates issued by one of the Accredited Certification Bodies (CB) are accepted worldwide.The applying organization is assessed based on an extensive sample of its sites, functions, products, services and processes; a list of problems ("action requests" or "non-compliances") is made known to the management. If there are no major problems on this list, or after it receives a satisfactory improvement plan from the management showing how any problems will be resolved, the certification body will issue an ISO 9001 certificate for each geographical site it has visited.An ISO certificate is not a once-and-for-all award, but must be renewed at regular intervals recommended by the certification body, usu中证集团iso认证的王老师 around three years. In contrast to the Capability Maturity Model there are no grades of competence within ISO 900
1.AuditingTwo types of auditing are required to become registered to the standard: auditing by an external certification body (external audit) and audits by internal staff trained for this process (internal audits). The aim is a continual process of review and assessment, to verify that the system is working as it's supposed to, find out where it can improve and to correct or prevent problems identified. It is considered healthier for internal auditors to audit outside their usual management line, so as to bring a degree of independence to their judgments.Under the 1994 standard, the auditing process could be adequately addressed by performing "compliance auditing":Tell me what you do (describe the business process)Show me where it says that (reference the procedure manuals)Prove that this is what happened (exhibit evidence in documented records)How this led to preventive actions was not clear.The 2000 standard uses the process approach. While auditors perform similar functions, they are expected to go beyond mere auditing for rote "compliance" by focusing on risk, status and importance. This means they are expected to make more judgments on what is effective, rather than merely adhering to what is form中证集团iso认证的王老师 prescribed. The difference from the previous standard can be explained thus:Under the 1994 version, the question was broadly "Are you doing what the manual says you should be doing?", whereas under the 2000 version, the question is more "Will this process help you achieve your stated objectives? Is it a good process or is there a way to do it better?".The ISO 19011 standard for auditing applies to ISO 9001 besides other management systems like EMS ( ISO 14001), FSMS (ISO 22000) etc.Industry-specific interpretationsThe ISO 9001 standard is generalized and abstract. Its parts must be carefully interpreted, to make sense within a particular organization. Developing software is not like making cheese or offering counseling services; yet the ISO 9001 guidelines, because they are business management guidelines, can be applied to each of these. Diverse organizations—police departments (US), professional soccer teams (Mexico) and city councils (UK)—have successfully implemented ISO 9001:2000 systems.Over time, various industry sectors have wanted to standardize their interpretations of the guidelines within their own marketplace. This is partly to ensure that their versions of ISO 9000 have their specific requirements, but also to try and ensure that more appropriately trained and experienced auditors are sent to assess them.The TickIT guidelines are an interpretation of ISO 9000 produced by the UK Board of Trade to suit the processes of the information technology industry, especi中证集团iso认证的王老师 software development.AS9000 is the Aerospace Basic Quality System Standard, an interpretation developed by major aerospace manufacturers. Those major manufacturers include AlliedSignal, Allison Engine, Boeing, General Electric Aircraft Engines, Lockheed-Martin, McDonnell Douglas, Northrop Grumman, Pratt & Whitney, Rockwell-Collins, Sikorsky Aircraft, and Sundstrand. The current version is AS9100.PS 9000 is an application of the standard for Pharmaceutical Packaging Materials. The Pharmaceutical Quality Group (PQG) of the Institute of Quality Assurance (IQA) has developed PS 9000:200
1. It aims to provide a widely accepted baseline GMP framework of best practice within the pharmaceutical packaging supply industry. It applies ISO 9001: 2000 to pharmaceutical printed and contact packaging materials.QS 9000 is an interpretation agreed upon by major automotive manufacturers (GM, Ford, Chrysler). It includes techniques such as FMEA and APQP. QS 9000 is now replaced by ISO/TS 1694
9.ISO/TS 16949:2002 is an interpretation agreed upon by major automotive manufacturers (American and European manufacturers); the latest version is based on ISO 9001:2000. The emphasis on a process approach is stronger than in ISO 9001:2000. ISO/TS 16949:2002 contains the full text of ISO 9001:2000 and automotive industry-specific requirements.TL 9000 is the Telecom Quality Management and Measurement System Standard, an interpretation developed by the telecom consortium, QuEST Forum. The current version is
4.0 and unlike ISO 9001 or the above sector standards, TL 9000 includes standardized product measurements that can be benchmarked. In 1998 QuEST Forum developed the TL 9000 Quality Management System to meet the supply chain quality requirements of the worldwide telecommunications industry.ISO 13485:2003 is the medical industry's equivalent of ISO 9001:2000. Whereas the standards it replaces were interpretations of how to apply ISO 9001 and ISO 9002 to medical devices, ISO 13485:2003 is a stand-alone standard. Compliance with ISO 13485 does not necessarily mean compliance with ISO 9001:2000.ISO/TS 29001 is quality management system requirements for the design, development, production, installation and service of products for the petroleum, petrochemical and natural gas industries. It is equivalent to API Spec Q1 without the Monogram annex.
急求 一些关于iso9000簇标准的综述？
你要干嘛用，如果只是想了解的话，建议你搜一下认证咨询咨询公司的网站
物业质量管理体系文件？
质量管理体系iso三体系认证版本/修改号：HFWY/QH－A(2010)/01发放号：受控状态：编制：审核：批准：共一册，第一册：质量管理手册XXXX物业有限责任公司0.1目录章节号｜iso三体系认证编号｜iso三体系认证iso认证流程建议｜页码｜0.1｜QH/0.1｜1｜0.2｜QH/0.2｜公司概况｜4｜0.3｜QH/0.3｜管理者代表任命书｜6｜0.4｜QH/0.4｜质量方针、质量目标批准令｜7｜0.5｜QH/0.5｜《质量手册》颁布令｜9｜0.6｜QH/0.6｜公司组织结构｜12｜0.7｜QH/0.7｜质量职能分配表｜15｜1｜QH/1｜范围｜16｜2｜QH/2｜引用标准｜17｜3｜QH/3｜术语和定义｜18｜4｜QH/4｜质量管理体系｜19｜
4.1｜QH/
4.1｜总要求｜20｜
4.2｜QH/
4.2｜iso三体系认证要求｜24｜
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2.1｜QH/
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2.1｜总则｜24｜
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2.2｜QH/
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2.2｜质量手册｜27｜
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2.3｜QP/
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2.3-01｜iso三体系认证控制程序｜28｜
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2.4｜QP/
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2.4-02｜记录控制程序｜33｜5｜QH/5｜管理职责｜36｜
5.1｜QH/
5.1｜管理承诺｜37｜
5.2｜QH/
5.2｜以业主为关注焦点｜38｜
5.3｜QH/
5.3｜质量方针｜39｜
5.4｜QP/
5.4-03｜管理体系策划控制程序｜40｜
5.5｜QH/
5.5｜职责、权限和沟通｜45｜
5.6｜QP/
5.6-04｜管理评审控制程序｜46｜6｜QH/6｜资源管理｜51｜
6.1｜QH/
6.1｜资源提供｜52｜
6.2｜QP/
6.2-05｜人力资源控制程序｜53｜
6.3｜QP/
6.3-06｜基础设施控制程序｜58｜
6.4｜QP/
6.4-07｜工作环境控制
质量管理体系文件管理制度？
质量管理体系iso三体系认证管理制度iso三体系认证iso认证流程建议:质量管理体系iso三体系认证管理制度｜编号:晓李药房-QM-01-2019｜起 草 人:门iso认证公司质量负责人｜审 核 人:公司质量负责人｜批 准 人:公司法定代表人｜起草日期:201
9.0
4.06-10｜审核日期:201
9.0
4.11-13｜批准日期:201
9.0
4.14｜执行日期：201
9.0
4.15｜起草原因:根据《药品经营质量管理规范》（单位食药监管总局令第13号)要求｜版 本 号:N0.3｜
1、目的：规范门iso认证公司质量管理体系iso三体系认证的管理。
2、依据：《药品管理法》及其实施条例、新《药品经营质量管理规范》及现场检查指导原则的规定制定本制度。
3、适用范围：本制度规定了质量管理体系iso三体系认证的起草/修订、审核、批准、印制、发布、指导、监督、执行、保管、废除、收回和销毁等，适用于质量管理体系iso三体系认证管理全过程。
4、责任：门iso认证公司企业、质量负责人，公司质量负责人、法定代表人、行政部对本制度的实施负责。
5、内容：
5.1质量管理体系iso三体系认证主要包括质量管理制度、岗位职责、操作规程、档案、记录和凭证等。
5.2质量管理体系iso三体系认证的起草/修订、指导、监督、执行、保管由门iso认证公司质量负责人负责；审核由公司质量负责人负责；批准由公司法定代表人负责；印刷、发布、废除、收回和销毁由公司行政部负责。iso三体系认证的起草和修订必须符合下列要求：
5.4
