質量管理體系文件？

2.
7.2 質量管理體系中使用的iso三體系認證類型 在質量管理體系中使用下述幾種類型的iso三體系認證： a) 向組織內部和外部提供關于質量管理體系的一致信息的iso三體系認證，這類iso三體系認證稱為質量手冊； b) 表述質量管理體系如何應用于特定iso三體系認證、項目或合同的iso三體系認證，這類iso三體系認證稱為質量計劃； c) 闡明要求的iso三體系認證，這類iso三體系認證稱為規范； d) 闡明推薦的方法或建議的iso三體系認證，這類iso三體系認證稱為指南； e) 提供如何一致地完成活動和過程的信息的iso三體系認證，這類iso三體系認證包括形成iso三體系認證的程序、作業指導書和圖樣；f) 為完成的活動或達到的結果提供客觀證據的iso三體系認證，這類iso三體系認證稱為記錄。 每個組織確定其所需iso三體系認證的多少和詳略程度及使用的媒體。這取決于下列因素，諸如組織的類型和規模、過程的復雜性和相互作用、iso三體系認證的復雜性、顧客要求、適用的法規要求、經證實的人員能力以及滿足質量管理體系要求所需證實的程度。質量手冊的結構（參考）：--封面--前言（企業簡介，手冊介紹）--目錄
1.0------頒布令
2.0------質量方針和目標
3.0------組織機構
3.1--行政組織機構圖
3.2--質量保證組織機構圖
3.3--質量職能分配表
4.0------質量體系要求
4.1--管理職責（示例）
4.
1.
1.--目的
4.
1.
2.--范圍
4.
1.
3.--職責
4.
1.
4.--管理要求
4.
1.
5.--引用程序iso三體系認證
4.2--質量體系
4.20--統計技術
5.0------質量手冊管理細則
6.0------附錄質量手冊內容概述前言：企業簡介：簡要描述企業iso認證流程建議、企業規模、企業歷史沿革；隸屬關系；所有制性質；主要iso三體系認證情況（iso三體系認證iso認證流程建議、系列型號、）；采用的標準、主要銷售地區；企業地址、通訊方式等內容。目的：說明為什么開展該項活動。范圍：說明活動涉及的（iso三體系認證、項目、過程、活動......）范圍。職責：說明活動的管理和執行、驗證人員的職責。程序內容：詳細闡述活動開展的內容及要求。質量記錄：列出活動用到或產生的記錄。支持性iso三體系認證：列出支持本程序的第三層iso三體系認證。手冊介紹：介紹本質量手冊所依據的標準及所引用的標準；手冊的適用范圍；必要時可說明有關術語、符號、縮略語。頒布令：以簡練的iso14001環境管理體系認證說明本公司質量手冊已按選定的標準編制完畢，并予以批準發布和實施。頒布令必須以公司較高管理者的身份敘述，并予親筆手簽姓名、日期。質量方針和目標（略）組織機構：行政組織機構圖、質量保證組織機構圖指以圖示方式描繪出本組織內人員之間的相互關系。質量職能分配表指以表格方式明確體現各質量體系要素的主要負責部門、若干相關部門。質量體系要求：根據質量體系標準的要求，結合本公司的實際情況，簡要闡述對每個質量體系要素實施控制的內容、要求和措施。力求語言簡明扼要、精煉準確，必要時可引用相應的程序iso三體系認證。質量手冊管理細則：簡要闡明質量手冊的編制、審核、批準情況；質量手冊修改、換版規則；質量手冊管理、控制規則等。附錄：質量手冊涉及之附錄均放于此（如必要時，可附體系iso三體系認證目錄、質量手冊修改控制頁等），其編號方式為附錄A、附錄B，以此順延。

不知道你是生產企業還是商業企業，不過工商所要求你提供的東西都是表明你對質量是有控制的，也就是你進、銷、存、產等一系列的質量相關iso三體系認證。當然如果你企業還不是很壯大的情況下也可以直接提供質管部iso三體系認證的，另外如果你是特殊行業，比如醫藥企業就不一樣了。

應該只要提供質量體現iso三體系認證，和你們iso三體系認證的相關檢驗報告。再說他們應該給你們一張表的啊！按照他們的要求做就好了啊！

求關于TSO9000質量論證體系的文獻綜述(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 (
4.
2.3)Control of Records (
4.
2.4)Internal Audits (
8.
2.2)Control of Nonconforming Product / Service (
8.3)Corrective Action (
8.
5.2)Preventive Action (
8.
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中證集團iso認證的王老師 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中證集團iso認證的王老師 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中證集團iso認證的王老師 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中證集團iso認證的王老師 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中證集團iso認證的王老師 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中證集團iso認證的王老師 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 一些關于iso9000簇標準的綜述？

你要干嘛用，如果只是想了解的話，建議你搜一下認證咨詢咨詢公司的網站

物業質量管理體系文件？

質量管理體系iso三體系認證版本/修改號：HFWY/QH－A(2010)/01發放號：受控狀態：編制：審核：批準：共一冊，第一冊：質量管理手冊XXXX物業有限責任公司0.1目錄章節號｜iso三體系認證編號｜iso三體系認證iso認證流程建議｜頁碼｜0.1｜QH/0.1｜1｜0.2｜QH/0.2｜公司概況｜4｜0.3｜QH/0.3｜管理者代表任命書｜6｜0.4｜QH/0.4｜質量方針、質量目標批準令｜7｜0.5｜QH/0.5｜《質量手冊》頒布令｜9｜0.6｜QH/0.6｜公司組織結構｜12｜0.7｜QH/0.7｜質量職能分配表｜15｜1｜QH/1｜范圍｜16｜2｜QH/2｜引用標準｜17｜3｜QH/3｜術語和定義｜18｜4｜QH/4｜質量管理體系｜19｜
4.1｜QH/
4.1｜總要求｜20｜
4.2｜QH/
4.2｜iso三體系認證要求｜24｜
4.
2.1｜QH/
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2.1｜總則｜24｜
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2.2｜QH/
4.
2.2｜質量手冊｜27｜
4.
2.3｜QP/
4.
2.3-01｜iso三體系認證控制程序｜28｜
4.
2.4｜QP/
4.
2.4-02｜記錄控制程序｜33｜5｜QH/5｜管理職責｜36｜
5.1｜QH/
5.1｜管理承諾｜37｜
5.2｜QH/
5.2｜以業主為關注焦點｜38｜
5.3｜QH/
5.3｜質量方針｜39｜
5.4｜QP/
5.4-03｜管理體系策劃控制程序｜40｜
5.5｜QH/
5.5｜職責、權限和溝通｜45｜
5.6｜QP/
5.6-04｜管理評審控制程序｜46｜6｜QH/6｜資源管理｜51｜
6.1｜QH/
6.1｜資源提供｜52｜
6.2｜QP/
6.2-05｜人力資源控制程序｜53｜
6.3｜QP/
6.3-06｜基礎設施控制程序｜58｜
6.4｜QP/
6.4-07｜工作環境控制

質量管理體系文件管理制度？

質量管理體系iso三體系認證管理制度iso三體系認證iso認證流程建議:質量管理體系iso三體系認證管理制度｜編號:曉李藥房-QM-01-2019｜起 草 人:門iso認證公司質量負責人｜審 核 人:公司質量負責人｜批 準 人:公司法定代表人｜起草日期:201
9.0
4.06-10｜審核日期:201
9.0
4.11-13｜批準日期:201
9.0
4.14｜執行日期：201
9.0
4.15｜起草原因:根據《藥品經營質量管理規范》（單位食藥監管總局令第13號)要求｜版 本 號:N0.3｜
1、目的：規范門iso認證公司質量管理體系iso三體系認證的管理。?
2、依據：《藥品管理法》及其實施條例、新《藥品經營質量管理規范》及現場檢查指導原則的規定制定本制度。?????
3、適用范圍：本制度規定了質量管理體系iso三體系認證的起草/修訂、審核、批準、印制、發布、指導、監督、執行、保管、廢除、收回和銷毀等，適用于質量管理體系iso三體系認證管理全過程。??
4、責任：門iso認證公司企業、質量負責人，公司質量負責人、法定代表人、行政部對本制度的實施負責。?????
5、內容：?
5.1質量管理體系iso三體系認證主要包括質量管理制度、崗位職責、操作規程、檔案、記錄和憑證等。
5.2質量管理體系iso三體系認證的起草/修訂、指導、監督、執行、保管由門iso認證公司質量負責人負責；審核由公司質量負責人負責；批準由公司法定代表人負責；印刷、發布、廢除、收回和銷毀由公司行政部負責。iso三體系認證的起草和修訂必須符合下列要求：
5.4