质量手册 Quality Manual QM-01-2013 Rev.A update 0625

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中英语品质手册

品驰电子有限公司 TAA Technologies Ltd

质 量 手 册

Quality manual

文件编号Document No: QM-01

版本Rev.A.0

拟制Prepared by:

审核Review by:

批准Approval by:

日期Date:

受控状态Control Status 分发号Release No 持有人Holder

2013年6月8日发布 2013年6月8日实施 Release Date Take effect Date

品驰电子有限公司 发 布

中英语品质手册

文件名Document Name: 质量手册 文件编号File No: QM-01 版本Rev. A 总页数Total pages: 33页

文 件 控 制 页 Document Control Page

中英语品质手册

文件名Document Name: 质量手册 文件编号File No: QM-01 版本Rev. A 总页数Total pages: 33页

目录 Contents

0.1 质量手册颁布令 Quality Manual publishing direction

0.2 管理者代表任命书Letter of appointment Management Representative 0.3 质量方针、质量目标 Quality Policy and Quality Objectives 0.4 公司质量管理体系架构图 QMS Organization

0.5 部门职责分配表The assignment table of department responsibility 1.0 质量管理体系范围 Scope of QMS 2.0 引用标准 Normative Reference 3.0 术语 Glossary

4.0 质量管理体系 Quality Management System 4.1 总要求 General requirements

4.2 文件要求 Document Requirements 5.0 管理职责 Management responsibility 5.1 管理承诺 Management Commitment 5.2 以顾客为关注焦点 customer focus 5.3 质量方针 Quality Policy 5.4 策划 Planing

5.5 职责、权限和沟通 Responsibility, authority and communication 5.6 管理评审 Management Review 6.0 资源管理 Resource Management 6.1 资源的提供Provision of resources 6.2 人力资源 Human resources 6.3 基础设施 infrastructure 6.4 工作环境 work environment

7.0 产品实现 product realization

7.1 产品实现策划 Planning of product realization 7.2 与顾客有关过程 customer-related processes 7.3 设计与开发控制 design and development 7.4 采购Purchasing

7.5 生产和服务提供production and service provision

7.6 监视和测量设备的控制control of monitoring and measuring equipment 8.0 测量、分析和改进 measurement,analysis and improvement 8.1 总则 General

8.2 监测和测量 monitoring and measurement

8.3 不合格品控制 control of nonconforming product 8.4 数据分析 analysis of data 8.5 改进 improvement

中英语品质手册

文件名Document Name: 质量手册 文件编号File No: QM-01 版本Rev. A 总页数Total pages: 33页

质量手册颁布令

Quality Manual publishing direction

为建立和完善我公司的质量管理体系,提高企业的竞争能力,实现公司的质量方针和目标,依据ISO9001:2008《质量管理体系-要求》标准,结合本公司的实际情况及顾客需求和期望,编制了A版《质量手册》。 《质量手册》是全公司质量工作的法规性、纲领性文件,用于统一、协调全公司的质量管理体系运行的各个过程,是公司开展各项质量活动的行为准则,全公司员工必须严格贯彻执行。

现批准发布A/0版《质量手册》,并于2013年7月1日开始实施。

To establish and perfect our company quality management system, and improve competitive capability, and achieve company policy and objectives, we drow up this quality manual Rev.A , according to ISO9001:2008 Qualtiy Management System-Requirement and integrated our company practice and customer requirement and expectation. Quality Manual is a regulatory and framework document for our company quality work, and integrates and coordinates all process of quality management system. It is a standard of behavior for carrying out all quality activity. Personnel in TAA must execute strictly.

Quatlity Manual Rev.A is approved, released and take effect on July 1,2013.

总经理:

General Manager

Date: Year Month Date

中英语品质手册

文件名Document Name: 质量手册 文件编号File No: QM-01 版本Rev. A 总页数Total pages: 33页

管理者代表任命书

Letter of appointment management representative

为贯彻执行 ISO9001:2008《质量管理体系—要求》,确保质量管理体系的有效性,特任命 先生/小姐为我公司的管理者代表。

管理者代表在质量管理体系方面的职责为: 1.确保公司质量管理体系得到建立和保持;

2.向最高管理者报告质量管理体系的业绩,包括改进的需求; 3.确保在整个组织内提高满足顾客要求的意识; 4.就质量管理体系和质量保证体系有关事宜对外联系。

To implement ISO9001:2008 QMS requirement and ensure its was appoint as our company Management Representative.

Responsibility for management representative on quality management system: 1) Ensuring that processes needed for the quality management system are established, implemented and maintained,

2) Reporting to top management on the performance of the quality management

system and any need for improvement, and

3) Ensuring the promotion of awareness of customer requirements throughout the

organization.

4) Liaison with external parties on matters relating to the quality management

system

总经理:

General Manager

Date: Year Month Date

中英语品质手册

文件名Document Name: 质量手册 文件编号File No: QM-01 版本Rev. A 总页数Total pages: 33页

质量方针及质量目标

Quality policy and objectives

质量方针 Quality policy

公司的质量方针:诚信服务、共谋发展、追求实效、创新领先

质量方针的具体解释为:

诚信服务—真诚为客户提供服务,努力倡导行业环境的和谐诚信; 共谋发展—与和作伙伴共同发展,追求双赢;

追求实效—为客户提供高附加值、高效率的专业服务,注重实效;

创新领先—通过不断的技术创新和规范管理,努力成为国内外同行业的领先者。

Company quality policy Sincerity service, Development together,

Pursuit effect, Lead innovation

Quality policy explains Sincerity service means sincerely serving customer and initiating harmonious and honest business environment, Development together means developing and wining with partner, Pursuit effect means providing customer with high-value and high efficient service. Lead innovation means doing industry leader by continual technical innovation and standardized management.

质量目标Quality objectives

1.产品生产合格率92%以上; First pass yield is more than 92%. 2.出货检验合格率95%以上; Pass rate for outgoing inspection is more than 95%;

3.顾客满意度不低于90%以上; Customer satisfaction is more than 90%;

总经理:

General Manager

Date

中英语品质手册

文件名Document Name: 质量手册 文件编号File No: QM-01 版本Rev. A 总页数Total pages: 33页

品 驰 电 子 有 限 公 司

质量管理体系组织架构图

Quality management system organization

注:财务部不在本体系管理范围内

Note: QMS no contain Finance department

中英语品质手册

文件名Document Name: 质量手册 文件编号File No: QM-01 版本Rev. A 总页数Total pages: 33页

中英语品质手册

文件名Document Name: 质量手册 文件编号File No: QM-01 版本Rev. A 总页数Total pages: 33页

●主要责任部门 〇配合部门

1 质量管理体系范围 Scope of quality management system 1.1 总则 General

依据ISO9001:2008《质量管理体系要求》结合公司实际情况,建立质量管理体系,编制本 《质量手册》。

Quality management system is established to draw up this quality manual according to ISO9001:2008 quality management system-requiremet and integrating practice of company.

本《质量手册》适用于公司内部质量管理以及对质量管理体系的审核、评审和持续改进;适用于公司生产经营全过程的各相关环节;证实公司具有稳定地提供满足顾客和适用法律法规要求的产品的能力,以及持续增强顾客满意的能力,是向社会和相关方的承诺。

This quality manual is applies to internal quality management and to audit, review and continuous improvement for quality management system. It is applies to overall process of company product and service. It is commitment for society and interested party that we have ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and aims to enhance customer satisfaction

1.2 应用 Application

1.2.1 本手册适用于: a) 本公司的生产和服务;

b) 本公司QMS覆盖的所有区域、部门和人员; c)第二方、第三方对本公司QMS的审核; d)本公司与供方/顾客的合同条件;

This quality manual is suitable for a) Our company products and service

b) Scope, department and personnel QMS covers. c) Second party and third party audits

d) Contract with our supplier and customer

1.2.2 应用 application

根据本公司产品的性质及其实现过程的特点,并考虑了顾客要求和适用的法律法规要求,本公司决定采用ISO9001:2008标准规定的全部条款,不作任何删减。

Our company decides to adopt all clauses written in ISO9001:2008, no any exclusion, according to our product and process character and considering customer requirements and applicable statutory and regulatory requirements

中英语品质手册

文件名Document Name: 质量手册 文件编号File No: QM-01 版本Rev. A 总页数Total pages: 33页

2 引用标准Normative references

下列文件中的条款通过本手册的引用而成为本手册的条款。凡是注日期的引用文件,其随后所有的修改单(不包括勘误的内容)或修订版均不适用于本手册,然而,鼓励根据本手册达成协议的各方研究是否可使用这些文件的最新版本。凡是不注日期的引用文件,其最新版本适用于本手册。

The following document references are indispensable for the application of this quality manual. For date references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 9000:2005 质量管理体系 基础和术语

ISO 9001:2008 质量管理体系 要求

ISO9000:2005, Quality management systems — Fundamentals and vocabulary ISO9001:2008, Quality management systems — Requirement

3 术语和定义 Terms and definition

本手册采用ISO9000:2005 《质量管理体系 基础和术语》标准中的定义。 本手册中所出现的术语“产品”,也可指“服务”

For the purposes of this document, the terms and definitions given in ISO9000, Throughout

the text of this quality manual, wherever the term “product” occurs, it can also mean “service”

4 质量管理体系 Quality management system 4.1 总要求 General requirements

4.1.1本公司按照ISO9001:2008《质量管理体系—要求》标准的要求建立、实施、保持了文件

化的质量管理体系,并将持续改进其有效性。

Our company establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with ISO9001-2008 Quality management system-requirements .

4.1.2在建立质量管理体系的过程中: a.确定公司质量管理体系过程;

b.确定过程的输入、输出以及过程的排列顺序和相互作用;

c.为确保过程有效运行并能达到预期的目标,编制了所需的接收准则、作业指导书、操作 规程或规范等;

d.公司配备了必要的资源和信息,包括经培训的人力资源、资金、生产设施、技术和必要 的信息;

e.为了分析、评价和改进过程的有效性,确定了监视、测量和分析过程的方法和要求。

中英语品质手册

文件名Document Name: 质量手册 文件编号File No: QM-01 版本Rev. A 总页数Total pages: 33页

f.通过对监视、测量结果的分析,找出质量管理体系中的不足和差异,并制定采取措施的 程序,以实现公司的目标和对过程的持续改进。

Processes of quality management system establishing,

a) determine the processes of quality management system for company,

b) determine input and output process, the sequence and interaction of these processes,

c) determine criteria,sop and operation standards to ensure that both the operation and control of these processes are effective.

d) company provides necessary resource and information, included trained human resource, capital, production facility, technology and necessary information.

e) determine monitored, measured and analysised methods and requirements to analyze, evaluate and improve process effectiveness.

f) Find out QMS insufficient and difference by analyzed monitoring and measurement result,

and take action to achieve company objectives and improve continually process

4.1.3 本公司暂无外包过程。

There is no outsourced process on our company.

4.2 文件要求 Documentation requimements

4.2.1 总则General

4.2.1.1本公司建立并维持一个符合ISO9001的质量管理体系。

quality management system should establish and maintain to meet ISO9001:2008

Quality management system-requirement .

4.2.1.2 本公司质量管理体系文件包括:

a.公司的质量方针和质量目标; b.质量手册;

c.ISO9001-2008标准要求形成文件的程序和记录;

d.公司还编制了相关的作业规范,如指导书、操作规范、图纸和质量计划等文件,

包括记录;

Quality management system documentation in our company including a. Quality policy and quality objectives b. Quality manual

c. Procedure and record required in ISO9001-2008. d. Operation standards

4.2.2 质量手册Quality manual

4.2.2.1 本公司编制并保持了质量手册。

a.本公司所建立的质量管理体系覆盖ISO9001-2008标准所有要求。 b.为质量管理体系编制的形成文件的程序或对其应用; c.质量管理体系过程之间的相互作用的表述;

Quality manual establish and maintain

a).Quality management system cover all requirement written in ISO9001-2008.

b).Document procedures or application established for the quality management system c) Description of interaction between the processes of the quality management system.

中英语品质手册

文件名Document Name: 质量手册 文件编号File No: QM-01 版本Rev. A 总页数Total pages: 33页

4.2.2.2《质量手册》的控制规定 Quality manual control

A《质量手册》的编写 Quality manual writes

a.总经理负责《质量手册》编制工作的组织与协调。

General manager is responsible for organized and coordinated the writing work b.管理代表负责《质量手册》的具体编制工作。

Quality management representative is responsible for writing work.

B《质量手册》的审核、批准和发布 quality manual review, approve and release

a.管理者代表对《质量手册》的正确性、完整性和适宜性进行审核。

Management representative reviews quality manual validity, integrity and suitability. b.审核后的《质量手册》经总经理批准并签署发布令

General manager approve and sign publishing direction after QM reviewed. c.《质量手册》文本应带有批准发放的标识。 Quality manual mark on approved status

C《质量手册》的发放 quality manual release

《质量手册》的发放由质量部负责。发放时填写《文件发放(回收)登记表》,并在

《质量手册》的封面上做“受控”标识,注明分发号和持有人。

Quality department is responsible for issuing, filling out document issue/recall

record and marking information on cover

D《质量手册》持有人的责任 owner of quality manual responsibility

a.受控《质量手册》须妥善保管,不得向无关人员传借。

Safekeeping controlled quality manual and not allow lend to irrelevant personnel b.受控《质量手册》换版时,原持有人有权获得新版本。

Quality manual changes Ver., owner has the right to obtain latest version. c.受控《质量手册》持有人调离公司,应归还手册。

owner should return quality manual when leaving company

E《质量手册》的更改 quality manual changes

a.当需要对《质量手册》的内容进行更改时,责任部门应填写《文件更改通知单》

报管理者代表审核,总经理批准

While quality manual needs change, duty department shall fill out document

change notice and sent to management representative review and general manager approved.

b.批准后,质量部负责将所有《质量手册》收集起来,统一更改,更改后再返回原

持有人。

After approved, quality department is responsible for recalling all quality

manuals and changes together, return owner after finished changing. F《质量手册》的非受控版本 uncontrolled quality manual

a.封面上无“受控”标识、无分发号和持有人的《质量手册》,为非受控《质量手册》。 Quality manual cover marked no information belongs to non-controlled quality manual b.《质量手册》的更改和换版,不对非受控版本进行控制。

Modifying and updating only for controlled quality manual, not for uncontrolled version.

4.2.3文件控制Control of documents

4.2.3.1本公司编制“文件控制程序”来保证本公司及外来文件的控制。

Document control procedure establishes to control internal and external document.

a.文件发布前得到批准,以确保文件是充分与适宜的;

中英语品质手册

文件名Document Name: 质量手册 文件编号File No: QM-01 版本Rev. A 总页数Total pages: 33页

approve documents for adequacy prior to issue,

b.需要评审或修订文件时,必须执行“文件控制程序”并再次得到核准;

To review and update as necessary and must implement document control

procedure to re-approve documents

c.质量部在文件封面或里页对文件的修改和现行状态进行标识;

Quality department marks change and the current revision status of documents cover

or inside page to identify..

d.确保各场所都使用相应文件的有效版本.

ensure that relevant versions of applicable documents are available at points of use .文件持有者应确认文件清晰,便于识别和检索;

owner ensure that documents remain legible and readily identifiable,

f. 由质量部对公司所确定的策划和运行质量管理体系所需的外来文件进行识别、保管并控制其分发;

Quality department ensure that documents of external origin determined by company to be necessary for the planning and operation of the quality management system are identified and their distribution controlled.

g.文件的更换、回收和作废由质量部负责,防止各部门非预期使用作废文件,作废文件正文盖上“此面作废”印章。

To prevent the unintended use of obsolete documents,quality department is responsible for documents exchange,recall and scrap and this side invalid print 4.2.4记录控制 Control of records 公司建立《记录管制程序》,规定质量记录的标识、贮存、保护、检索和保存期限和处

理办法,对所产生记录的予以管制。

records control procedure establishes to define the controls needed for the

identification, storage, protection, retrieval, retention and disposition of records. a.质量记录填写要及时、真实可靠、内容完整、字迹清查,不得随意涂改; Writing record need be prompt, real and legible.

b.记录应保存在适宜的环境,以防止损坏、变质和丢失,保管方式便于取存和检索; Records should store on adapt circumstance to prevent damage, moisture and loss and been readily identifiable and retrievable. c.记录应予保存,并按规定期限保存记录;

Records should be keep by due time defined on records list . 4.3 相关文件 Relevant Document 《文件管制程序》 QAD-QP01

Document control procedure QAD-QP01 《记录管制程序》 QAD-QP02

Records control procedure QAD-QP02

5.管理职责 Management responsibility 5.1 管理承诺 management commitment

总经理通过以下活动,对本公司建立和改进质量管理体系的承诺提供证据:

General Manager shall provide evidence of his commitment to the development and implementation of the quality management system and continually improving its effectiveness

中英语品质手册

文件名Document Name: 质量手册 文件编号File No: QM-01 版本Rev. A 总页数Total pages: 33页

a.通过培训或其他方式,向公司的全体员工传达满足顾客要求和遵守法律法规的重要性; Communicating to all company personnel that the importance of meeting customer as

well as statutory and regulatory requirements by training or other methods. b.制定和批准公司的质量方针和质量目标;

Establishing and approving company quality policy and objectives c.按照《管理评审程序》的要求进行管理评审;

Performing management review according to requirement of management review procedure d.提供资源,确保质量管理体系有效运行。

Providing resource to ensure quality management system effective operation

5.2 以顾客为关注焦点 Customer focus

5.2.1 公司的成功与发展依存于顾客。因此,总经理的工作应以增强顾客满意为目的。

Company success and development depends on customer, so the work of general

manager is met with the aim of enhancing customer satisfaction 5.2.2 识别并评审顾客当前的需求和未来的期望;

Determine and review customer current requirement and future expectation. 5.2.3 按照《生产过程控制程序》制造产品,实现顾客的要求;

Achieving customer requirement by following process control procedure to produced

product

5.2.4 按照《顾客满意度调查程序》,测量、分析顾客的满意度,找出差距,采取纠正措施,

更好满足顾客的要求和期望。

Measuring and analysing customer satisfaction on the basis of customer satisfaction

survey procedure to find out different, then taking corrective action to satisfy customer requirement and expect.

5.3 质量方针 Quality policy

5.3.1 本公司的质量方针由总经理制定并批准发布,所制订的质量方针

General Manager establishes and approves to release quality policy.The quality policy a.与本公司总的管理宗旨相一致;

is appropriate to the purpose of the company.

b.在满足顾客的要求和持续改进质量管理体系有效性方面做出了承诺;

Includes a commitment to comply with customer requirements and continually

improve the effectiveness of the quality management system

c.为质量目标的制定与评审提供了框架。

Provides a framework for establishing and reviewing quality objectives,

5.3.2 为确保质量方针在公司内部得到沟通和理解,总经理和各级管理人员通过各种方式宣

传质量方针,统一对质量方针的理解。

To communicate and understand within the company, general manager and all staffs

let personnel understand quality policy by kinds of declaring and training.

5.3.3通过管理评审对质量方针的适宜性进行评审,以适应公司内、外部环境和条件的变化。 Adapting changes for internal/external environment and condition, quality policy is

reviewed for continuing suitability on management review. 5.3.4方针的内容:见P6.

Content of quality policy views page 6.

5.4策划 Plan

5.4.1质量目标 quality objectives

每年制定本公司的年度质量目标,它是可测量的,并与质量方针保持一致。各部门分别制定部门质量目标,经总经理批准后实施。要求各部门对本部门的员工进行培训和教育,以确保本部门目标的实现。

中英语品质手册

文件名Document Name: 质量手册 文件编号File No: QM-01 版本Rev. A 总页数Total pages: 33页

Establishing quality objectives each year, it shall be measurable and consistent with

the quality policy. All departments shall establish theirs quality objectives and implement after general manager approved. To ensure quality objectives achieve, personnel shall be trained and educated on each department.

5.4.2 质量管理体系策划 quality management system planning

在公司改制、人事变动、机构变更或体系标准换版时,可能引起质量管理体系的变更,在对质量管理体系的变更进行策划和实施时,应保持质量管理体系的完整性。

Quality management system is likely to change when changes of company, changes

of personnel, changes of organization or changes of standard Rev. The integrity of the quality management system is maintained when change to the quality management system are planned and implemented.

5.5 职责、权限和沟通 Responsibility, authority and communication

5.5.1 职责和权限Responsibility and authority

总经理根据质量管理体系运行的需要,建立相适应的质量管理组织架构,见第7页,及各部门的质量职能和相互关系,见第8页 “部门职责分配表”。

General manager shall establish quality management organization,view page7, and quality function and mutual relation of each department , view page 8, according to requirement of running quality management system.

各部门职责和权限如下:

Responsibility and authority of each department 5.5.1.1总经理 General Manamer

a.向公司传达满足顾客和法律法规要求的重要性;

Communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements b.制定质量方针和质量目标;

Establishing the quality policy and quality objectives c.主持管理评审;

Conducting management reviews

d.为确保质量管理体系有效运行配备必要的资源; Ensuring the availability of resources

e.任命管理者代表及与质量有关的工作人员,并予以授权;

Appoint and authorize management representative and relevant quality person

5.5.1.2 管理者代表 Management representative

a.确保质量管理体系的过程得到建立和保持;

Ensuring that processes needed for the quality management system are established, implemented and maintained,

b.向最高管理者报告质量管理体系的业绩,包括改进的需求;

Reporting to top management on the performance of the quality management system and any need for improvement

c.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 throughout the organization

d.就质量管理体系有关事宜对外联系。

Liaison with external parties on matters relating to the quality management system

中英语品质手册

文件名Document Name: 质量手册 文件编号File No: QM-01 版本Rev. A 总页数Total pages: 33页

e.公司分配的其他工作。 Other assigns work.

5.5.1.3 质量部 quality department

a.负责制订公司有关检验和试验所依据的标准文件(检验规程)。 Establishing inspection and test normative document b.组织参与对供方的资格审查。

Organizing and presenting to audit supplier. c.负责对文件和记录实施管理和控制。

Managing and controlling documents and records.

d.负责内审工作的组织工作,对体系运行过程中的不合格组织采取纠正、预防措施 Organizing internal review and taking preventive and corrective action for non-conforming on process of quality management system.

e.按程序文件规定,组织进货检验、过程检验和最终检验;负责监视和测量设备的控制

Organzing incoming material inspection, process inspection and final inspection

and taking charge control of monitoring and measuring equipment according to procedure.

f.组织质量信息的收集、传递、分析和处理工作,建立质量信息系统。

Collect, transfer, analyze and deal with quality information and establish quality information system. 5.5.1.4生产部 manufacture

a.负责按合同/订单要求,合理安排生产进度,按期履约交付合格产品;

Aranging production plan and turning over good products on time according to contract/ order requirement.

b.负责做好设备管理和维护保养工作,确保安全生产和工作环境的清洁文明;

Doing well equipment management and maintaining to ensure production safe and cleaning of work environment.

c.切实做好半成品、成品产品停放、防护和标识工作,防止不合格品转序或使用; Do well work for placing, protesting and marking semi-product and finished-goods to

prevent using and transfering non-conforming product.

d.负责公司的仓库管理;

management warehourse

5.5.1.6销售部 Sale

a.负责产品的销售工作

taking charge product sale.

b.组织合同评审工作,对合同评审进行管理和协调; organizing contract review.

c.做好与顾客的沟通,并收集顾客的意见和建议

do well communication with customer and collecting customer suggestion and advise.

d.负责顾客满意度的调查

taking charge customer satisfaction survey. 5.5.1.7采购部 Purchasing

a. 负责产品采购,确保采购产品质量;

purchasing product and ensuring product quality b. 负责对供方进行管理,对供方进行评价。

Managing and assessing supplier. c. 负责在合格供方中采购产品;

中英语品质手册

文件名Document Name: 质量手册 文件编号File No: QM-01 版本Rev. A 总页数Total pages: 33页

purchasing product from approval vendor list. d. 负责保存合格供方的档案资料;

keeping all record about approval vendor.

5.5.1.8 技术开发部 technical development department

a.负责生产所需作业性文件的编制及实施指导; preparing SOP and instruct operator. b.负责产品设计工作;

taking charge new product design and development c.负责产品工艺的制定与改进;

preparing and improving production technique. e.负责解决生产过程中出现的技术问题;

taking charge technical problem solving on process. f.负责组织对特殊过程进行确认。

Organizing relevant department to Validate special process 5.5.1.9 人力资源部 HR Department

a.负责公司人员招聘管理。

Taking charge people recruit and manage.

b.对新进员工的培训和教育。

Training and educating new employee c.负责所需要具有技能人员安排组织培训。

Arranging training for the necessary competence of personnel d.对所有培训资料的保管和储存。

Keeping and managing all training records.

5.5.2 管理者代表 management representative

相关内容见管理者代表任命书 5.5.3内部沟通 internal communication

通过各种方式进行不同层次和有关职能部门之间内部沟通,确保质量管理体系有效沟通。同时,公司还通过各种会议、布告栏、文件等方式进行内部沟通,以促进公司内各职能和各层次间交流信息,增进理解,协调行动。

Ensuring communication takes place regarding the effectiveness of the quality management

system, company establishes internal communication by meeting, bulletin board and document to promote exchange of information on defferent department.

5.6管理评审 management review

5.6.1 总则 genaral

公司建立《内审和管理评审程序》确保内审和管理评审的有效实施。确保在内外环境和质量体系变化后体系能及时改进和完善,保证质量方针和目标的实现,由总经理主持管理评审会议,每年一次且两次间隔不超过12个月,特殊情况可以增加次数。

Ensuring internal review and management review implement effectiveness, company establish internal and management review procedure. Ensuring quality management system improvement and perfection, and quality policy and quality objectives achivement, general manager shall conduct management review on every year. It doesn t allow more than 12 Month between year and year, adding management review times if special situation or general manager requirement.

5.6.2 评审输入 Review input

中英语品质手册

文件名Document Name: 质量手册 文件编号File No: QM-01 版本Rev. A 总页数Total pages: 33页

a.本公司的质量方针、目标的实施情况;

Status of quality policy and quality objectives. b.内部和外部质量审核的结果;

Result of internal and external audit c.顾客反馈;

Customer feedback

d.过程的业绩和产品的符合性;

Process performance and product conformity, e.纠正和预防措施的状况;

Status of preventive and corrective actions f.以往管理评审的跟踪措施;

Follow-up actions from previous management reviews g.可能影响质量管理体系的变更;

Changes that could affect the quality management system h.改进的建议。

Recommendations for improvement 5.6.3 评审输出 Review output

本公司各级管理者在管理评审中应提出以下方面有关的任何决定和措施:

The output from the management review shall include any decisions and actions related to

a.质量管理体系及其过程有效性的改进,包括对质量方针、质量目标、组织机构、过程控制等评价

improvement of the effectiveness of the quality management system and its processes,including assessment of quality policy,quality objectives, organization and process control.

b.与顾客要求有关的产品的改进,对现有产品符合性的评价包括是否需要进行产品、过程审核等与评审内容相关的要求。

improvement of product related to customer requirements, assessment of current

product conformity, including whether product and process need audit. c.为质量管理体系各项活动配备的资源是否适宜。

Resource of providing is adequate for action of quality management system d.对质量管理体系的持续适宜性、充分性和有效性的评价。

Assessming continuing suitability, adequacy and effectiveness of quality management system

e. 对上述评价结果所需采取的跟踪措施。

Corrective action is taking for result of management review. 5.7 相关文件 relevant document

《内审和管理评审程序》 QAD-QP-05

Internal review and management review procedure QAD-QP-O5

6资源管理 resource mangement

6.1 资源提供Provision of resources

为满足建立、保持和改进质量管理体系的需要及使顾客满意,本公司确保并提供如下方面所需的资源

Our company provides below resource to meet establishing, maintaining and improving requirement of QMS and make customer satisfaction.

中英语品质手册

文件名Document Name: 质量手册 文件编号File No: QM-01 版本Rev. A 总页数Total pages: 33页

a.实施、保持质量管理体系并持续改进其有效性;

to implement and maintain the quality management system and continually improve

its effectiveness

b.通过满足顾客要求,增强顾客的满意

to enhance customer satisfaction by meeting customer requirements

任何资源不足而影响顾客期望的情况应提交管理评审并采取应对措施。

Situation should submit management review and take action for resource insufficient to

affect customer expectation. 6.2人力资源 human resources

本公司建立并实施《人力资源培训程序》,对培训教育活动进行控制,以满足相关要求。 Human resource train procedure established and implemented to control training and

educating action to meet relevant requirement.

6.2.1 本公司应委派具有能力的人员承担质量管理体系中各岗位的工作,这些人员应经过适

当的教育、培训,并具备相应的技能和经历,才能胜任其所担任的工作。

personnel appoints to take over the work for quality management system, and

performs work affecting conformity to product requirements shall be competent on the basis of appropriate education, training, skills and experience.

6.2.2 能力、意识和培训Competence, training and awareness

6.2.2.1公司应识别并确定从事影响产品和要求的符合性工作的活动人员能力需求; determine the necessary competence for personnel performing work

affecting conformity to product requirements

6.2.2.2 公司提供培训或采取其他措施以满足这些需求,达成必须的能力; Provide training or take other actions to achieve the necessary competence 6.2.2.3 评价所采取措施的有效性;

evaluate the effectiveness of the actions taken

6.2.2.4 确保员工能清楚地了解他们从事工作与其他过程的相关性和接口,以及此项

工作的重要性和承担的责任,同时应让他们认识到这职位工作对本公司质量管理体系的影响和意义,从而积极有效地工作,为实现质量目标作出贡献。

ensure personnel are aware of the relevance and importance of their activities and

how they contribute to the achievement of the quality objectives

6.2.2.5 公司人力资源部保存教育、培训、技能和经历的适当记录。

HR maintain appropriate records of education, training, skills and experience

6.3 基础设施 Infrastructure

6.3.1公司应识别、提供并维护为实现产品、服务符合性要求所需要的基础设施,包括:

Company shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes

a) 建筑物、工作场所和相应的设施,如办公场所、生产场所及配套设施水、电、气的供应等; Buildings, workspace and associated utilities, like office, production place and supporting

facility , like water, electricity and air etc.

中英语品质手册

文件名Document Name: 质量手册 文件编号File No: QM-01 版本Rev. A 总页数Total pages: 33页

b) 过程设备,包括硬件和软件,如生产设备、开发用电脑、检测设备、应用软件等; process equipment (both hardware and software), like facility, computer, inspection

equipment and utility software.

c) 支持性服务,如运输、通讯、信息系统等等。

supporting services (such as transport, communication or information systems) 6.3.2 各部门主管应确认在任何设施不足的问题并报告适当的人员采取纠正预防措施,任何

增加设备所需费用要由总经理批准。

Department leader should determine problem of insufficient facility and report and take

preventive and corrective action. Any adding facility, it should be approve by general manager.

6.4 工作环境 work environment

公司应识别实现生产和服务符合性所需的环境中人和物的因素,并对其实施有效控制,包括:

Company shall determine and manage the work environment needed to achieve conformity to product requirement

a.卫生和安全条件;health and safe condition b.工作方法 ;work method c.职业道德;work ethic

d.周围的工作条件(温度、湿度、灰尘、噪音、照明、或天气等)。

Work environment (such as noise, temperature, humidity, lighting or weather).

6.5 相关文件 Relevant document

《人力资源培训程序》 HR-QP04

Human resource train procedure

7 产品实现 product realization

7.1 产品实现的策划 Planning of product realization

公司应策划和开发产品实现所需的过程。产品实现的策划应与质量管理体系其他过程的要求相一致,

Company shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system 在产品实现过程的策划中,应确定以下方面的适用内容: In planning product realization, we shall determine the following, a) 产品的质量目标和要求;

Quality objectives and requirements of product

中英语品质手册

文件名Document Name: 质量手册 文件编号File No: QM-01 版本Rev. A 总页数Total pages: 33页

b) 针对相应产品确定的过程和文件,以及所需提供的资源;

the need to establish processes and documents, and to provide resources specific to the

product

c) 针对产品所需要的验证、确认、监视、测量、检验和试验活动,以及产品的验收准则; Required verification, validation, monitoring, measurement, inspection and test

activities specific to the product and the criteria for product acceptance d) 为实现过程及其产品满足要求提供证据所需的记录。

records needed to provide evidence that the realization processes and resulting

product meet requirements

策划形成的文件可包括:产品加工图纸、产品工艺文件、产品工艺流程图、产品验收规范及记录等。

document planning includes product drawing, technical document, process flow diagram, inspection criteria and records.

7.2 与顾客有关的过程Customer-related processes 本公司建立实施《合同评审程序》,对合同评审活动进行控制,以满足相关要求。 contract review procedure established and implement to control review action 7.2.1与产品有关的要求的确定Determination of requirements related to the product

销售部负责识别客户的需求与期望,组织有关部门对产品需求进行评审,并负责与客户沟

通,公司应确认以下内容:

Sale department is responsible for determining customer requirement and expectation

and organizing relevant department to review product requirement, and communicating with customer.

a.顾客明示的产品要求,包括产品质量要求及涉及可用性、交付、支持服务、价格等方面的要求;

requirements specified by the customer, including the requirements for delivery and post delivery activities.

b.顾客没有明确要求,但预期或规定的用途所必要的产品要求。

requirements not stated by the customer but necessary for specified or intended use, where known

c.产品适用的法律法规要求。

statutory and regulatory requirements applicable to the product d.公司确定的任何附加要求

any additional requirements considered necessary by the company

7.2.2 与产品有关的要求评审Review of requirements related to the product

评审应达到下列目的:(包括口头定单等) Review should reach blow purpose

a.合同符合国家有关法令; contract meet nation laws b.合同符合本公司营销策略;

contract meet company marketing strategy

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