宁波大学 质量体系质量手册

6．1 质量方针本节规定了船员教育和培训的质量方针、质量目标。

6．1．1 质量方针6．1．1．1学校船员教育和培训的质量方针为：确保培养出德、智、体全面发展,具有安全、环保和用户意识，符合国家有关法规和国际有关公约要求的高素质航海人才。

6．1．1．2质量方针是学校从事船员教育和培训的质量宗旨。

本校从事船员教育和培训的全体教职员工要树立质量意识，视教育质量为生命，把提高船员教育和培训质量作为进行教学工作的永恒的主题。

6．1．1．3“高素质”意指培养的学生要达到基础理论扎实、实践技能强、英语水平高，心理健康，体魄健全，敬业精神好，用人单位满意。

6．1．1．4学校通过与有关单位保持密切联系，以获得国际、国内船员教育和培训的新要求的信息，开展教学和训练的评估活动，不断提高办学质量。

6．1．2 质量目标6．1．2．1学校船员教育和培训的“质量目标”是贯彻质量方针的奋斗目标。

6．1．2．2学校船员教育与培训主要通过下列途径实现质量目标a.按照《规则》规定的质量要素建立质量体系，并不断改进和完善。

b.加强对教师的培养，为教师的职称晋升及取得必要的海上资历创造条件，采取多种途径提高教师的外语水平。

c.充分利用综合性大学的资源，提高学生的外语、法律和计算机知识水平以及人文素质；经常聘请国内外航海专家来校讲学，提高学生对现代化国际航运业的适应性。

d.在专业课和培训教学中，要逐步采用现代化教学手段；要加强对学生（员）的安全和环保意识教育。

e.对教职员工、学生进行质量体系知识培训，使他们理解并坚持贯彻质量方针，不断提高培养人才的质量，使用人单位满意。

f.加强实验室建设，争取有较多的投入，满足实践教学的要求。

g.对学生进行半军事化管理,对培训学员加强日常管理，培养其具有良好的服从意识和纪律观念。

h.有针对性地对学生进行思想素质教育和心理健康指导，使其具有较好的敬业精神和较高的政治素质。

积极开展体育活动，增强学生的体质。

i.教职工、学生的努力是质量体系获得顺利实施的保证。

...文件类型：质量手册文件名称：附录编号： QM1013版号04修改号 00实施开场日期：2021年 5月 1日共 3页，第 2页质量体系要素对照表附录二质量体系要素要素依据编号题目船员教育和培训质量管理规那么6． 1质量方针第六条6． 2职责和权限第七条6． 3教学方案第八条6． 4学员录取与管理第九条6． 5教学与管理人员第十条6． 6教学和培训设备第十一条6． 7教学和训练的实施第十二条6． 8质量记录控制第十三条6． 9教学和训练的检查和评估第十四条6． 10纠正和预防措施第十五条6． 11文件与资料的控制第十六条6． 12内部审核第十七条文件类型：质量手册文件名称：附录编号： QM1013版号04修改号 00实施开场日期：2021年 5月 1日共 3页，第 3页程序文件与要素依据对应表附录三程序文件编号程序文件要素依据?船员教育和培训质量管理规那么?QP2001专业培养方案和教学实施方案与课第八条教学方案程教学大纲的编制QP2002招生与录取管理第九条学员录取与管理QP2003注册、成绩和学籍管理第九条学员录取与管理QP2004半军事化管理 ( 船员培训日常管理 )第九条学员录取与管理QP2006学(员)生档案管理第九条学员录取与管理QP2007毕(结)业与派遣第九条学员录取与管理QP2021证书管理第九条学员录取与管理QP2021师资管理第十条教学与管理人员QP2021管理人员的任用和考核第十四条教学与管理人员QP2021员工培训第十条教学与管理人员QP2021教学设备管理第十一条教学和培训设备QP2021教材管理第十一条教学和培训设备QP2021图书资料管理第十一条教学和培训设备QP2021 开课方案与课程表的编制第十二条教学和训练的实施QP2021教学日历的编制第十二条教学和训练的实施QP2021课堂教学第十二条教学和训练的实施QP2021实践性教学第十二条教学和训练的实施QP2021课程考试与考务管理第十二条教学和训练的实施QP2005思想素质教育第十二条教学和训练的实施QP2021质量记录控制第十三条质量记录控制QP2021教学和训练的检查和评估第十四条教学和训练的检查和评估QP2022纠正和预防措施第十五条纠正和预防措施QP2023文件与资料的控制第十六条文件与资料的控制QP2024内部审核第十七条内部审核QP2025管理评审第十七条内部审核。

质量手册编制：________________ 日期：______________ 审核：________________ 日期：______________ 核准：________________ 日期：______________ 受控状况：_________________________________01 发布令................................................................ .6/3502 授权令............................................................... .7/3503 企业概况.............................................................. .8/3504 组织架构............................................................ .10/3505 质量方针和质量目标.................................................. 11/351 适用范围........................................................... ..12/352 引用标准............................................................. 12/353 术语和定义........................................................ ..12/354 质量管理体系...................................................... ..12/35总要求文件要求5 管理职责............................................................. 16/35管理承诺5.2 以客户为中心5.3 质量方针规划1.1.1 质量目标1.1.2 质量管理体系规划职责、权限和沟通1.2.1 职责和权限1.2.2 管理者代表1.2.3 内部沟通管理评审5.6.1总则5.6.2评审输入5.6.3评审输出6资源管理.............................. .................................................. 20/35资源的提供人力资源2.1.1 人员安排2.1.2 培训、意识和能力设施工作环境7 产品实现.................................................................. 22/35实现过程的规划与客户有关的过程4.1.1 与产品有关的要求的确定4.1.2 与产品有关的要求的评审4.1.3 客户沟通设计和开发采购7.4.1采购控制7.4.2采购信息7.4.3采购产品的验证生产和服务的运作7.5.1生产和服务的运作控制7.5.2产品和服务运作过程的确认7.5.3标识与可追溯性7.5.4客户财产7.5.5产品防护测量和监控装置的控制8 测量、分析和改善.......................................................... ..30/35规划测量和监控8.2.1客户满意8.2.2内部审核8.2.3过程的测量和监控8.2.4产品的测量和监控不合格品控制数据分析4.1.1.1 持续改善4.1.1.2 纠正措施4.1.1.3 预防措施01 发布令为了满足市场的需求和客户的要求，适应市场的竞争，不断提高我公司的质量管理水平，依据£09001:2000《质量管理体系一要求》标准，我公司制定了《质量手册》，本《质量手册》符合国家有关政策、法律法规和本公司实际情况，现正式批准发布，从发行之日起开始实施。

质量手册版本： A受控状态：文件编号：XRCD/1受控号:生效日期：2003年月日编制审核批准章节号：内容0．1 目录0．2 前言0．3 术语0．4 手册说明0．5 范围0．6 企业概况0．7 质量方针、质量目标0．8 组织结构与职责0．9 质量职能分配表4. 1管理职责4. 2质量体系4. 3合同评审4. 4设计控制4. 5文件和资料的控制4. 6采购4. 7顾客提供产品的控制4. 8产品标识和可追溯性4. 9过程控制4. 10检验和试验4. 11检验、测量和试验设备的控制4. 12检验和试验状态4. 13不合格品的控制4. 14纠正和预防措施4. 15搬运、贮存、包装、防护和交付4. 16质量记录的控制4. 17内部质量审核4. 18培训4. 19效劳4. 20统计技术附录1：程序文件一览表附录2：质量手册更改一览表1．本质量手册引用QS—9000：1998中的有关定义。

1．目的本质量手册的目的是传达公司的质量方针、质量目标、程序及要求。

描述和实施有效的质量体系，为顾客提供充分的信任。

2．适用范围适用于本公司汽车灯具的设计、开发、生产、安装直到效劳各阶段的质量管理工作以及按QS—9000：1998的标准要求向顾客和第三方提供质量保证。

3．编制和审批3．1本手册由质量管理部质量管理科统一协调负责编制。

3．2管理者代表负责手册的审核、总经理负责批准。

3．3本手册由总经理负责宣布颁发实施令。

4．手册的管理4．1本手册由质量管理部质量管理科归口管理。

4．2本手册分为“受控〞与“非受控〞两种类型。

受控的?质量手册?发给本公司所覆盖的所有职能部门和第三方认证机构，手册加盖“受控〞章并编写受控号；非受控?质量手册?提供给顾客及企业外部人员使用，手册封面不加盖“受控〞章，手册修改时不予跟踪更改。

4. 3本手册由质量管理部质量管理科负责质量体系的统一编号，确定发放范围，经管理者代表审核、总经理批准后统一发放，手册持有者需签名领取，并妥善保存。

BRITISH STANDARDBS ISO 10005:2005Quality management systems — Guidelines for quality plansICS 03.120.1012 &23<,1* :,7+287 %6, 3(50,66,21 (;&(37 $6 3(50,77(' %< &23<5,*+7 /$:L i c e n s e d C o p y : I n s t i t u t e O f T e c h n o l o g y T a l l a g h t , I n s t i t u t e o f T e c h n o l o g y , T u e N o v 07 12:26:20 G M T +00:00 2006, U n c o n t r o l l e d C o p y , (c ) B S IBS ISO 10005:2005This British Standard was published under the authority of the Standards Policy and Strategy Committee on 29 July 2005© BSI 29 July 2005ISBN 0 580 46489 XNational forewordThis British Standard reproduces verbatim ISO 10005:2005 and implements it as the UK national standard. It supersedes BS ISO 10005:1995 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee QS/1, Quality management and quality assurance procedures, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary.Cross-referencesThe British Standards which implement international publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard does not of itself confer immunity from legal obligations.—aid enquirers to understand the text;—present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep UK interests informed;—monitor related international and European developments and promulgate them in the UK.Summary of pagesThis document comprises a front cover, an inside front cover, the ISO title page, pages ii to v, a blank page, pages 1 to 23 and a back cover.The BSI copyright notice displayed in this document indicates when the document was last issued.Amendments issued since publicationAmd. No. Date CommentsL i c e n s e d C o p y : I n s t i t u t e O f T e c h n o l o g y T a l l a g h t , I n s t i t u t e o f T e c h n o l o g y , T u e N o v 07 12:26:20 G M T +00:00 2006, U n c o n t r o l l e d C o p y , (c ) B S IINTERNA TIONAL STANDARD ISO 10005Second edition2005-06-01Reference number ISO 10005:2005(E)Quality management systems — Guidelines for quality plansSystèmes de management de la qualité— Lignes directrices pour les plans qualitéBS ISO 10005:2005L i c e n s e d C o p y : I n s t i t u t e O f T e c h n o l o g y T a l l a g h t , I n s t i t u t e o f T e c h n o l o g y , T u e N o v 07 12:26:20 G M T +00:00 2006, U n c o n t r o l l e d C o p y , (c ) B S IiiL i c e n s e d C o p y : I n s t i t u t e O f T e c h n o l o g y T a l l a g h t , I n s t i t u t e o f T e c h n o l o g y , T u e N o v 07 12:26:20 G M T +00:00 2006, U n c o n t r o l l e d C o p y , (c ) B S IBS ISO 10005:2005iiiContentsPage1 Scope .................................................................................................................................................... 12 Normative references .......................................................................................................................... 13 Terms and definitions .. (14)Development of a quality plan (3)4.1 Identifying the need for the quality plan ........................................................................................... 34.2 Inputs to the quality plan .................................................................................................................... 44.3 Scope of the quality plan .................................................................................................................... 44.4 Preparation of the quality plan .. (45)Content of the quality plan ................................................................................................................. 55.1 General ................................................................................................................................................. 55.2 Scope .................................................................................................................................................... 65.3 Quality plan inputs .............................................................................................................................. 65.4 Quality objectives ................................................................................................................................ 65.5 Management responsibilities ............................................................................................................. 65.6 Control of documents and data ......................................................................................................... 65.7 Control of records ............................................................................................................................... 75.8 Resources ............................................................................................................................................ 75.9 Requirements ...................................................................................................................................... 85.10 Customer communication ................................................................................................................ 85.11 Design and development .................................................................................................................. 85.12 Purchasing ......................................................................................................................................... 95.13 Production and service provision .................................................................................................... 95.14 Identification and traceability ......................................................................................................... 105.15 Customer property .......................................................................................................................... 105.16 Preservation of product .................................................................................................................. 105.17 Control of nonconforming product ................................................................................................ 115.18 Monitoring and measurement ........................................................................................................ 115.19 Audits .. (116)Review, acceptance, implementation and revision of the quality plan ......................................... 126.1 Review and acceptance of the quality plan .................................................................................... 126.2 Implementation of the quality plan .................................................................................................. 126.3 Revision of the quality plan .............................................................................................................. 136.4 Feedback and improvement ............................................................................................................. 13 Annex A (informative) Simplified examples of formats for the presentation of quality plans ............ 14 Annex B (informative) Correspondence between ISO 10005:2005 and ISO 9001:2000 ....................... 22 Bibliography .. (23)L i c e n s e d C o p y : I n s t i t u t e O f T e c h n o l o g y T a l l a g h t , I n s t i t u t e o f T e c h n o l o g y , T u e N o v 07 12:26:20 G M T +00:00 2006, U n c o n t r o l l e d C o p y , (c ) B S IBS ISO 10005:2005ivForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.ISO 10005 was prepared by Technical Committee ISO/TC 176, Quality management and quality assurance , Subcommittee SC 2, Quality systems .This second edition cancels and replaces the first edition (ISO 10005:1995). It constitutes a technical revision of that edition, taking into account ISO 9000:2000, ISO 9001:2000 and ISO 9004:2000.L i c e n s e d C o p y : I n s t i t u t e O f T e c h n o l o g y T a l l a g h t , I n s t i t u t e o f T e c h n o l o g y , T u e N o v 07 12:26:20 G M T +00:00 2006, U n c o n t r o l l e d C o p y , (c ) B S IvIntroductionThis International Standard was prepared to address the need for guidance on quality plans, either in the context of an established quality management system or as an independent management activity. In either case, quality plans provide a means of relating specific requirements of the process, product, project or contract to work methods and practices that support product realization. The quality plan should be compatible with other associated plans that may be prepared.Among the benefits of establishing a quality plan are the increased confidence that requirements will be met,greater assurance that processes are in control and the motivation it can give to those involved. It may also give insight into opportunities for improvement.This International Standard does not replace the guidance given in ISO 9004 or in industry-specific documents.Where quality plans are required for project applications, the guidance provided in this International Standard is intended to be complementary to the guidance provided in ISO 10006.In terms of the process model shown in Figure 1, quality management system planning applies to the whole model. Quality plans, however, apply primarily to the path from customer requirements, through product realization and product, to customer satisfaction.Figure 1—Model of a process-based quality management systemBS ISO 10005:2005L i c e n s e d C o p y : I n s t i t u t e O f T e c h n o l o g y T a l l a g h t , I n s t i t u t e o f T e c h n o l o g y , T u e N o v 07 12:26:20 G M T +00:00 2006, U n c o n t r o l l e d C o p y , (c ) B S IblankL i c e n s e d C o p y : I n s t i t u t e O f T e c h n o l o g y T a l l a g h t , I n s t i t u t e o f T e c h n o l o g y , T u e N o v 07 12:26:20 G M T +00:00 2006, U n c o n t r o l l e d C o p y , (c ) B S I1Quality management systems — Guidelines for quality plans1ScopeThis International Standard provides guidelines for the development, review, acceptance, application and revision of quality plans.It is applicable whether or not the organization has a management system in conformity with ISO 9001.This International Standard is applicable to quality plans for a process, product, project or contract, any product category (hardware, software, processed materials and services) and any industry.It is focused primarily on product realization and is not a guide to organizational quality management system planning.This International Standard is a guidance document and is not intended to be used for certification or registration purposes.NOTE To avoid undue repetition of “process, product, project or contract ”, this International Standard uses the term “specific case ” (see 3.10).2Normative referencesThe following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 9000:2000, Quality management systems — Fundamentals and vocabulary3Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 9000 and the following apply. Some of the definitions below are quoted directly from ISO 9000, but notes are in some cases omitted or supplemented.3.1objective evidencedata supporting the existence or verity of somethingNOTE Objective evidence may be obtained through observation, measurement, test, or other means.[ISO 9000:2000, definition 3.8.1]3.2procedurespecified way to carry out an activity or a process (3.3)NOTE 1Procedures can be documented or not.NOTE 2When a procedure is documented, the term “written procedure ” or “documented procedure ” is frequently used.The document that contains a procedure can be called a “procedure document ”.[ISO 9000:2000, definition 3.4.5]BS ISO 10005:2005L i c e n s e d C o p y : I n s t i t u t e O f T e c h n o l o g y T a l l a g h t , I n s t i t u t e o f T e c h n o l o g y , T u e N o v 07 12:26:20 G M T +00:00 2006, U n c o n t r o l l e d C o p y , (c ) B S I23.3processset of interrelated or interacting activities which transforms inputs into outputsNOTE Adapted from ISO 9000:2000, definition 3.4.1 (the Notes have not been included).3.4productresult of a process (3.3)NOTE 1There are four generic product categories, as follows:—services (e.g. transport);—software (e.g. computer program, dictionary);—hardware (e.g. engine mechanical part);—processed materials (e.g. lubricant).Many products comprise elements belonging to different generic product categories. Whether the product is then called service, software, hardware or processed material depends on the dominant element. For example the offered product “automobile ” consists of hardware (e.g. tyres), processed materials (e.g. fuel, cooling liquid), software (e.g. engine control software, driver's manual), and service (e.g. operating explanations given by the salesman).NOTE 2Service is the result of at least one activity necessarily performed at the interface between the supplier and customer and is generally intangible. Provision of a service can involve, for example, the following:—an activity performed on a customer-supplied tangible product (e.g. automobile to be repaired);—an activity performed on a customer-supplied intangible product (e.g. the income statement needed to prepare a taxreturn);—the delivery of an intangible product (e.g. the delivery of information in the context of knowledge transmission);—the creation of ambience for the customer (e.g. in hotels and restaurants).Software consists of information and is generally intangible and can be in the form of approaches, transactions or procedures (3.2)Hardware is generally tangible and its amount is a countable characteristic. Processed materials are generally tangible and their amount is a continuous characteristic. Hardware and processed materials often are referred to as goods.[ISO 9000:2000, definition 3.4.2]3.5 projectunique process (3.3) consisting of a set of coordinated and controlled activities with start and finish dates,undertaken to achieve an objective conforming to specific requirements, including the constraints of time, cost and resourcesNOTE 1An individual project can form part of a larger project structure.NOTE 2In some projects, the objectives are refined and the product characteristics defined progressively as the project proceeds.NOTE 3The outcome of a project may be one or several units of product (3.4).[ISO 9000:2000, definition 3.4.3]3.6quality management systemmanagement system to direct and control an organization with regard to quality [ISO 9000:2000, definition 3.2.3]BS ISO 10005:2005L i c e n s e d C o p y : I n s t i t u t e O f T e c h n o l o g y T a l l a g h t , I n s t i t u t e o f T e c h n o l o g y , T u e N o v 07 12:26:20 G M T +00:00 2006, U n c o n t r o l l e d C o p y , (c ) B S I3.7 quality objective something sought, or aimed for, related to quality NOTE 1Quality objectives are generally based on the organization's quality policy.NOTE 2Quality objectives are generally specified for relevant functions and levels in the organization.[ISO 9000:2000, definition 3.2.5]3.8 quality plan document specifying which processes (3.3), procedures (3.2) and associated resources will be applied by whom and when, to meet the requirements of a specific project (3.5), product (3.4), process or contract NOTE 1These procedures generally include those referring to quality management processes and to product realization processes.NOTE 2 A quality plan often makes reference to parts of the quality manual or to procedure documents.NOTE 3 A quality plan is generally one of the results of quality planning.3.9 record document stating results achieved or providing evidence of activities performed NOTE Adapted from ISO 9000:2000, definition 3.7.6 (the Notes have not been included).3.10 specific case subject of the quality plan (3.8)NOTE This term is used to avoid repetition of “process, product, project or contract ” within this International Standard.4Development of a quality plan4.1Identifying the need for the quality plan The organization should identify what need there may be for quality plans. There are a number of situations where quality plans may be useful or necessary, for example:a)to show how the organization's quality management system applies to a specific case;b)to meet statutory, regulatory or customer requirements;c)in developing and validating new products or processes;d)to demonstrate, internally and/or externally, how quality requirements will be met;e)to organize and manage activities to meet quality requirements and quality objectives;f)to optimize the use of resources in meeting quality objectives;g)to minimize the risk of not meeting quality requirements;h)to use as a basis for monitoring and assessing compliance with the requirements for quality;i)in the absence of a documented quality management system.NOTE There may or may not be a need to prepare a quality plan for a specific case. An organization with an established quality management system may be able to fulfil all of its needs for quality plans under its existing system; the organization may then decide that there is no need to prepare separate quality plans.BS ISO 10005:2005L i c e n s e d C o p y : I n s t i t u t e O f T e c h n o l o g y T a l l a g h t , I n s t i t u t e o f T e c h n o l o g y , T u e N o v 07 12:26:20 G M T +00:00 2006, U n c o n t r o l l e d C o p y , (c ) B S I4.2Inputs to the quality plan Once the organization has decided to develop a quality plan, the organization should identify the inputs for preparation of the quality plan, for example:a)the requirements of the specific case;b)the requirements for the quality plan, including those in customer, statutory, regulatory and industry specifications;c)the quality management system requirements of the organization;d)risk assessments on the specific case;e)the requirement for and availability of resources;f)information on the needs of those engaged in carrying out activities covered by the quality plan;g)information on the needs of other interested parties who will use the quality plan;h)other relevant quality plans;i)other relevant plans, such as other project plans, environmental, health and safety, security and information management plans.4.3Scope of the quality plan The organization should determine what is to be covered by the quality plan and what is covered or to be covered by other documents. Unnecessary duplication should be avoided.The scope of the quality plan will depend on several factors, including the following:a)the processes and quality characteristics that are particular to the specific case, and will therefore need to be included;b)the requirements of customers or other interested parties (internal or external) for inclusion of processes not particular to the specific case, but necessary for them to have confidence that their requirements will be met;c)the extent to which the quality plan is supported by a documented quality management system.Where quality management procedures have not been established, they may need to be developed to support the quality plan.There may be benefits from reviewing the scope of the quality plan with the customer or other interested parties,for example in order to facilitate their use of the quality plan for monitoring and measurement.4.4Preparation of the quality plan 4.4.1Initiation The person responsible for preparing the quality plan should be clearly identified. The quality plan should be prepared with the participation of people who are involved in the specific case, both within the organization and,where appropriate, external parties.When preparing a quality plan, quality management activities applicable to the specific case should be defined and, where necessary, documented.4.4.2Documenting the quality plan The quality plan should indicate how the required activities will be carried out, either directly or by reference to appropriate documented procedures or other documents (e.g. project plan, work instruction, checklist,BS ISO 10005:2005L i c e n s e d C o p y : I n s t i t u t e O f T e c h n o l o g y T a l l a g h t , I n s t i t u t e o f T e c h n o l o g y , T u e N o v 07 12:26:20 G M T +00:00 2006, U n c o n t r o l l e d C o p y , (c ) B S Icomputer application). Where a requirement results in a deviation from the organization's management systems, this deviation should be justified and authorized.Much of the generic documentation needed may already be contained in the organization's quality management system documentation, including its quality manual and documented procedures. This documentation may need to be selected, adapted and/or supplemented. The quality plan should show how the organization's generic documented procedures are applied, or alternatively modified or overridden by procedures in the quality plan.A quality plan may be included as part of another document or documents, for example project quality plans are often included in project management plans (see ISO 10006).4.4.3Responsibilities In preparing the quality plan, the organization should agree and define the respective roles, responsibilities and obligations both within the organization and with the customer, regulatory authorities or other interested parties.Those administering the quality plan should ensure that the persons it refers to are aware of the quality objectives and any specific quality issues or controls required by the quality plan.4.4.4Consistency and compatibility The contents and format of the quality plan should be consistent with the scope of the quality plan, the inputs to the plan and the needs of the intended users. The level of detail in the quality plan should be consistent with any agreed customer requirement, the organization's method of operation and the complexity of the activities to be performed. The need for compatibility with other plans should also be considered.4.4.5Presentation and structure The presentation of the quality plan may have any of several forms, for example a simple textual description, a table, a document matrix, a process map, a work flow chart or a manual. Any or all of these may be presented in electronic or hard-copy formats.NOTE Examples of quality plans are provided in Annex A.The quality plan may be broken up into several documents, each of which represents a plan for a distinct aspect. Control of the interfaces between the different documents needs to be clearly defined. Examples of these aspects include design, purchasing, production, process control or particular activities (such as acceptance testing).An organization may wish to prepare a quality plan that conforms to applicable requirements of ISO 9001.A cross-reference matrix is provided in Annex B for guidance.5Content of the quality plan 5.1General The examples and lists provided in this clause should not be considered comprehensive or limiting in any way.The quality plan for a specific case should cover the topics examined below as appropriate. Some topics in this guidance may not be applicable, for example where design and development are not involved.BS ISO 10005:2005L i c e n s e d C o p y : I n s t i t u t e O f T e c h n o l o g y T a l l a g h t , I n s t i t u t e o f T e c h n o l o g y , T u e N o v 07 12:26:20 G M T +00:00 2006, U n c o n t r o l l e d C o p y , (c ) B S I5.2Scope The scope should be clearly stated in the quality plan. This should include:a) a simple statement of the purpose and expected outcome of the specific case;b)the aspects of the specific case to which it will be applied, including particular limitations to its applicability;c)the conditions of its validity (e.g. dimensions, temperature range, market conditions, resource availability or quality management systems certification status).5.3Quality plan inputs It may be necessary to list or describe the inputs to the quality plan (see 4.2), to facilitate, for example,—reference to input documents by users of the quality plan,—checking consistency with input documents during maintenance of the quality plan, and —identification of changes to input documents that may necessitate a review of the quality plan.5.4Quality objectives The quality plan should state the quality objectives for the specific case and how they will be achieved. Quality objectives may be established, for example, in relation to —quality characteristics for the specific case,—important issues for satisfaction of the customer or other interested parties, and —opportunities for improvement of work practices.These quality objectives should be expressed in measurable terms.5.5Management responsibilities The quality plan should identify individuals within the organization who are responsible, in the specific case, for the following:a)ensuring that the activities required for the quality management system or contract are planned,implemented and controlled, and their progress monitored;b)determining the sequence and interaction of the processes applicable to the specific case;c)communicating requirements to all affected departments and functions, subcontractors and customers, and resolving problems that arise at the interfaces between such groups;d)reviewing the results of any audits conducted;e)authorizing requests for exemption from the organization's quality management system requirements;f)controlling corrective and preventive actions;g)reviewing and authorizing changes to, or deviations from, the quality plan.Reporting lines of those involved in implementing the quality plan may be presented in the form of a flow chart.5.6Control of documents and data For documents and data applicable to the specific case, the quality plan should state:a)how the documents and data will be identified;b)by whom the documents and data will be reviewed and approved;BS ISO 10005:2005L i c e n s e d C o p y : I n s t i t u t e O f T e c h n o l o g y T a l l a g h t , I n s t i t u t e o f T e c h n o l o g y , T u e N o v 07 12:26:20 G M T +00:00 2006, U n c o n t r o l l e d C o p y , (c ) B S I。

校准实验室质量管理体系质量手册第一章：引言1.1手册目的本手册是校准实验室质量管理体系的基本文件，旨在提供校准实验室质量管理体系的指南和规范，以确保校准结果的可靠性和准确性。

1.2适用范围本手册适用于校准实验室的所有工作人员，包括校准工程师、校准技术员、质量管理员等。

所有人员都应严格按照本手册的要求执行工作。

1.3质量管理体系概述校准实验室质量管理体系是为了确保校准实验室的准确性、可靠性和可追溯性而建立的一系列管理活动，旨在提升校准实验室的绩效，满足客户需求。

1.4质量管理体系文件质量管理体系文件包括：质量手册、程序文件和记录文件。

其中，质量手册是对整个质量管理体系的概述，程序文件则是具体实施过程的规范。

第二章：质量政策和目标2.1质量政策校准实验室的质量政策是校准实验室质量管理体系的基础，以保证校准实验室的可靠性和准确性。

质量政策应符合国家和行业相关法律法规的要求，并根据实验室的特点和需求进行制定。

2.2质量目标校准实验室应设立明确的质量目标，并制定相应的措施，以实现这些目标。

质量目标应与实验室的业务需求和质量政策相一致，并定期进行评估和修订。

第三章：组织结构和职责3.1组织结构校准实验室的组织结构应包括管理层、技术部门、质量管理部门和支持部门。

各部门之间应建立协作和协调机制，确保校准工作的顺利进行。

3.2职责分工不同部门和岗位应明确工作职责和权限，并进行适当的培训和考核，以确保各项工作的质量有保障。

第四章：质量管理体系要求4.1文件控制校准实验室应建立合理的文件控制体系，保证质量管理体系文件的正确性和实时性，包括文件编制、发布、修订、废止等程序和记录。

4.2质量记录管理校准实验室应建立有效的质量记录管理体系，包括标识、保存、查询和保密等方面的要求，并定期进行审核和归档。

4.3设备管理校准实验室应建立设备管理体系，包括设备校准、维护和故障处理等方面的要求，并定期进行设备的检查和维修，确保设备的正常运行和准确性。

质量手册——目录
章节号：内容
0目录
0.1目录
0.2前言
0.3术语
0.4手册说明
0.5范围
1企业概况
2质量方针、目标
3组织机构与职责
4质量职能分配表
4.1管理职责
4.2质量体系
4.3合同评审
4.4设计控制
4.5文件和资料的控制
4.6采购
4.7顾客提供产品的控制
4.8产品标识和可追溯性
4.9过程控制
4.10检验和试验
4.11检验、测量和试验设备的控制
4.12检验和试验状态
4.13不合格品的控制
4.14纠正和预防措施
4.15搬运、贮存、包装、防护和交付
4.16质量记录的控制
4.17内部质量审核
4.18培训
4.19服务
4.20统计技术
附录1：体系文件一览表
附录2：质量手册更改一览表
质量体系文件一览表
注：作√标注的为已获取原版复印件。

质量手册范本1. 引言质量手册是一种组织内部使用的文件，描述了该组织的质量管理体系和质量政策。

本质量手册范本旨在为组织提供一个参考指南，帮助其编写适用于自身的质量手册。

以下是一个质量手册的范本。

2. 质量管理体系2.1 建立与实施质量管理体系本组织致力于建立和实施一个有效的质量管理体系，以确保产品和服务的质量符合客户的要求和期望，并满足相关法规法律的要求。

2.2 质量政策本组织的质量政策是确保客户满意度的提高，并不断追求卓越和持续改善。

我们承诺提供高质量的产品和服务，提高客户满意度，并遵守质量管理体系的要求。

2.3 质量目标本组织设定了一系列质量目标，并通过制定相关措施和监控机制来实现这些目标。

我们的目标包括提高产品质量、降低不良率、提升客户满意度等。

3. 组织结构与职责3.1 组织结构本组织的质量管理体系由各级管理层、部门和员工共同组成。

每个层级和部门在质量管理方面承担着特定的职责和义务。

3.2 质量管理职责- 高级管理层：负责制定质量政策和目标，并为质量管理体系提供资源和支持。

- 部门经理：负责质量管理体系的实施和监督，确保部门内各项工作符合相关质量标准和要求。

- 员工：负责遵守质量管理体系的标准和规定，参与质量管理活动，并提供持续改进的建议。

4. 质量管理过程4.1 客户需求确认本组织通过与客户进行沟通和确认，了解客户的需求和期望，并将其转化为明确的质量要求。

4.2 设计控制在产品或服务的设计阶段，本组织采用有效的设计控制措施，确保产品或服务能够满足相关质量标准和客户的要求。

4.3 供应商管理本组织与供应商建立合作关系，并对其进行评估和审核，确保他们能够提供符合质量要求的产品和服务。

4.4 生产控制在产品或服务的生产过程中，本组织采用各种控制措施，包括质量检查、关键过程控制等，以确保产品或服务的质量符合要求。

4.5 测量和改进本组织通过制定测量指标和持续改进计划，对产品和服务的质量进行监控和改进，以满足客户的需求和提高竞争力。