当前位置：文档库 › 英文版质量手册

英文版质量手册

WINCA

Winca Material Technology (Linyi) Co., Ltd.

QUALITY MANUAL

(English Translation)

June 2004

ISO14001质量手册英文版模板(2008版)

ABC Farms ISO 14001 - Environmental Management System Manual Prepared By: Approved By: Signature: ____________________________ Date: _________ / Revision #: 0 / Revision Date: / Effective Date:

SECTION 0 - TABLE OF CONTENTS MANUAL ISO SECTION SECTION TITLE PAGE SECTION 0TABLE OF CONTENTS x SECTION I INTRODUCTION x SECTION II DISTRIBUTION, REVISION & CONTROL x 4.2 4.2ENVIRONMENTAL POLICY x 4.3 4.3PLANNING x 4.3.1 4.3.1 Environmental Aspects x 4.3.2 4.3.2 Legal and Other Requirements x 4.3.3 4.3.3 Objectives and Targets x 4.3.4 4.3.4 Environmental Management Programs x 4.4 4.4IMPLEMENTATION & OPERATION x 4.4.1 4.4.1 Structure and Responsibility x 4.4.2 4.4.2 Training, Awareness and Competence x 4.4.3 4.4.3 Communication x 4.4.4 4.4.4 Environmental Management System Documentation x 4.4.5 4.4.5 Document Control x 4.4.6 4.4.6 Operational Control x 4.4.7 4.4.7 Emergency Preparedness and Response x 4.5 4.5CHECKING AND CORRECTIVE ACTION x 4.5.1 4.5.1 Monitoring and Measurement x 4.5.2 4.5.2 Non-conformance and Corrective Action x 4.5.3 4.5.3 Records Management x 4.5.4 4.5.4 Environmental Management System Audits x 4.6 4.6MANAGEMENT REVIEW x

吉利供应商质量手册(第1版)

ID 号：33526871 受控文件编制: 汪斌,叶雁飞;文控审核: 赵建岭;会签: 何伟,丁云长,崔载福,陈卫德,胡雄旺,徐华2,徐海波;意见汇总: 汪斌,赵建岭;审核: 徐华2;批准: 刘向阳;发布目标: 赵建岭归档日期：2012-04-20 17:16:38 编码： GL 质量管理体系文件文件名称吉利供应商质量手册版本 1 页码 / 文件编号 GLW000864 生效日期 2012年4月23日

供应商质量手册（第一版）浙江吉利控股集团有限公司

前言《供应商质量手册》是参考吉利公司的质量管理手册、程序文件，并结合当前吉利供应商管理的现状而编制的，以指导供应商在准入、零部件开发、量产初期及批量生产管理等过程中的需要开展哪些工作及提交哪些文件。当前，吉利在不断提升自身竞争能力的同时，努力打造具有“三高一低”（高质量、高技术、高忠诚度和低成本）的、一流竞争力的供应商体系。相信通过相互合作、沟通理解和及时采取措施将有利于吉利和供应商双方事业的发展，最终实现“让世界充满吉利”的美好愿景！本手册版权属于浙江吉利控股集团有限公司及其各子公司。未经吉利的书面许可，本手册的任何内容都不能以任何形式和手段进行复制、储存和传送。供应商不得以任何方式将本手册中提到的吉利品质体系内容提供给第三者。本手册将在运用过程中不断更新完善，各供应商朋友如在应用过程中发现不足，请及时反馈指正。如有任何问题，请与相关SQE联系。吉利集团质量管理部供应商管理室 2012年4月

目录第一章供应商选点 (4) 第二章先期产品质量策划 (6) 第一节第一阶段供应商品熟评价 (6) 第二节第二阶段供应商品熟评价 (25) 第三节第三阶段供应商品熟评价 (34) 第四节第四阶段供应商品熟评价 (53) 第五节第五阶段供应商品熟评价 (59) 第六节生产件批准程序（PPAP） (61) 第三章量产管理 (66) 第一节驻厂检验 (66) 第二节受控发运 (69) 第三节统计技术 (71) 第四节质量改进 (73) 第五节供应商审核管理 (80) 第六节免检管理 (81) 第七节供应商优化管理 (82) 第八节供应商违约管理 (83) 第四章供应商品质五星级评价 (84)

ISO9001：2015全套文件英文版(含质量手册及全套程序文件)

Ningbo XXX Material Technology Co.,Ltd ISO9001:2015 Quality Manual Revision [A/0] - [2018/3/1] (c) [Copyright Year Of 2018] [Ningbo XXX Material Technology Co.,Ltd]; all rights reserved. This document may contain proprietary information and may only be released to third parties with approval of management. Document is uncontrolled unless otherwise marked; uncontrolled documents are not subject to update notification.

Revision [A/0] - [2018/3/1] Page 1 of 19 TABLE OF CONTENTS 0.0 Revision History and Approval ...................................................................................................................... 3 1.0 Welcome to Ningbo XXX Material Technology Co.,Ltd ................................................................................ 4 2.0 XXX Material: Who We Are ........................................................................................................................... 4 2.1 Determining Our Strategic Direction ......................................................................................................... 4 2.2 Scope of the Management System ........................................................................................................... 4 2.2.1 Scope Statement ............................................................................................................................... 4 2.2.2 Facilities Within the Scope ................................................................................................................ 4 2.2.3 Permissible Exclusions ..................................................................................................................... 5 2.2.4 Scope of the ISO9001:2015 Quality Manual ..................................................................................... 5 3.0 Quality Policy................................................................................................................................................. 5 4.0 Management System Structure and Controls ............................................................................................... 5 4.1 Process Approach .................................................................................................................................... 5 4.1.1 Process Identification ........................................................................................................................ 5 4.1.2 Process Controls & Objectives .......................................................................................................... 6 4.1.3 Outsourced Processes ...................................................................................................................... 7 4.2 Documentation & Records ....................................................................................................................... 7 4.2.1 General .............................................................................................................................................. 7 4.2.2 Control of Documents ....................................................................................................................... 7 4.2.3 Control of Records ............................................................................................................................ 7 4.3 Change Management ................................................................................................................................ 8 4.4 Risks and Opportunities ............................................................................................................................ 8 5.0 Management & Leadership ........................................................................................................................... 8 5.1 Management Leadership and Commitment .............................................................................................. 8 5.2 Customer Focus ........................................................................................................................................ 9 5.3 Quality Policy ............................................................................................................................................. 9 5.4 Organizational Roles Responsibilities & Authorities ................................................................................. 9 5.5 Internal Communication ............................................................................................................................ 9 5.6 Management Review .............................................................................................................................. 10 6.0 Resources ................................................................................................................................................... 10 6.1 Provision of Resources ........................................................................................................................... 10 6.2 Human Resources .................................................................................................................................. 10 6.3 Infrastructure ........................................................................................................................................... 11 6.4 Work Environment ................................................................................................................................... 11 6.5 Organizational Knowledge ...................................................................................................................... 11 7.0 Operation ..................................................................................................................................................... 11 7.1 Operational Planning and Control ........................................................................................................... 12 7.2 Customer-Related Activities .................................................................................................................... 12 7.2.1 Capture of Customer Requirements ............................................................................................... 12 7.2.2 Review of Customer Requirements ................................................................................................ 12 7.2.3 Customer Communication ............................................................................................................... 12 7.3 Design and Development ........................................................................................................................ 13 7.4 Purchasing .............................................................................................................................................. 13 7.5 Provision of [Production of adhesive tape] .............................................................................................. 13 7.5.1 Control of Provision of [Production of adhesive tape] ..................................................................... 13 7.5.2 Identification and Traceability .......................................................................................................... 14 7.5.3 Property Belonging to Third Parties ................................................................................................ 14 7.5.4 Preservation .................................................................................................................................... 14 7.5.5 Post-Delivery Activities .................................................................................................................... 14 7.5.6 Process Change Control ................................................................................................................. 15 7.5.7 Measurement and Release of [Production of adhesive tape] ......................................................... 15 7.5.8 Control of Nonconforming Outputs .. (15)

质量手册翻译中英文对照解析

质量手册翻译中英文术语表 3.1.1 质量 quality 3.1.2 要求 requirement 3.1.3 等级 grade 3.1.4 顾客满意 customer satisfaction 3.1.5 能力 capability 3.2.1 体系(系统) system 3.2.2 管理体系 management system 3.2.3 质量管理体系 quality management syste m 3.2.4 质量方针 quality policy 3.2.5 质量目标 quality objective 3.2.6 管理 management 3.2.7 最高管理者 top management 3.2.8 质量管理 quality management 3.2.9 质量策划 quality planning 3.2.10 质量控制 quality control 3.2.11 质量保证 quality assurance 3.2.12 质量改进 quality improvement 3.2.13 持续改进 continual improvement 3.2.14 有效性 effectiveness 3.2.15 效率 efficiency 3.3.1 组织 organization 3.3.2 组织结构 organizational structure 3.3.3 基础设施 infrastructure 3.3.4 工作环境 '77ork environment 3.3.5 顾客 customer 3.3.6 供方 supplier 3.3.7 相关方 interested party 3.4.1 过程 process 3.4.2 产品 product 3.4.3 项目 project 3.4.4 设计和开发 design and development 3.4.5 程序 procedure

(2016版ISO13485)质量手册-生产企业

核准人：审核人：制修订人：

文件编号：XXX-QM -2017 编制：年月日审核：年月日批准：年月日受控状态：发放号： 2017年01月04日发布 2017年01月04日实施密级：版本号：B/0

目录 0.2、前言及简述 (5) 0.3、管理者代表任命书 (6) 0.4、质量手册发布令 (7) 质量手册发布令 ............................................................................................................................................... 错误！未定义书签。 1. 范围 (8) 1.1 总则 (8) 1.2 应用 (8) 2. 引用标准 (8) 3. 术语 (8) 4 .质量管理体系 (8) 4.1 总要求 (8) 5.管理职责 (11) 5.1 管理者承诺 (11) 5.2 以顾客为关注焦点 (11) 5.3 质量方针 (11) 5.4 策划 (12) 5.5 职责、权限和沟通 (12) 5.6 管理评审 (15) 6 .资源管理 (16) 6.1 资源提供 (16) 6.2 人力资源 (16) 6.3 基础设施 (16) 6.4 工作环境和污染控制 (16) 7 .产品实现 (17) 7.1 产品实现的策划 (17) 7.2.2 与产品有关的要求的评审 (18) 7.3 设计和开发 (18)

(21) 7.5 生产和服务提供 (22) 7.6 监视和测量设备的控制 (24) 8 .测量、分析和改进 (25) 8.1 总则 (25) 8.2 监视和测量 (25) 8.3 不合格品控制 (27) 8.4 数据分析 (28) 8.5 改进 (28) 9 .MDD要求 (29) 9.1 总则 (29) 9.2 适用范围 (29) 9.3 职责 (29) 9.4 程序要求 (29) 附录A 公司质量目标 (31) 附录B 各部门目标分解 (32) 附录C 职责分配表： (33) 附录D 程序文件清单 (34) 附录E 组织架构图 (35) 附录F YY/T 0287-2017 和GB/T19001-2016 对应关系表 (36)

ISO13485-2016-YYT0287-2017质量手册

质量手册（YY/T 0287-2017/ISO 13485-2016）目录

1.0范围 1.1总则本质量手册是依据YY/T 0287-2017/ISO 13485：2016《医疗器械质量管理体系用于法规的要求》和GB/T 19001-2016/ISO9001:2015《质量管理体系要求》标准制定。公司生产医疗器械产品的设计和开发、生产、贮存和流通、安装或服务，以及相关活动（如技术支持）的设计和开发或提供应当遵守本手册的要求。本质量手册适用于本公司生产产品生命周期内全过程的控制与管理，适用于向本公司提供产品（包括与质量管理体系相关的服务）的供方或外部方，也适用于证实本公司有能力提供持续满足顾客要求和适用的法规要求的医疗器械和相

关服务。对于本手册要求的适用于公司但不是由公司组织实施的过程，公司应在质量管理体系中通过监视、维护和控制这些过程并对其负有责任。本质量手册是公司执行质量管理体系的纲领性文件，其它质量文件若与手册不符之处，以本手册为准。质量手册由质管部负责编写，管理者代表审核，总经理批准，发放到公司各部门，文件领用人在“文件发放登记表”上签名后领取封面有“受控”印章、发放日期、分发号的有效文件。未经管理者代表同意，任何人员不得将本手册提供给本公司以外的人员。具体规定按《文件控制程序》执行。 1.2删减和不适用说明 1.2.1 YY/T0287-2017/ISO13485：2016不适用条款说明 1.2.2医疗器械生产质量管理规范不适用条款说明公司生产的医疗器械产品体积较大、价值较高，不适宜留样，因此《医疗器械生产质量管理规范》中第六十一条“企业应当根据产品和工艺特点制定留样管理规定，按规定进行留样，并保持留样观察记录。”不适用本公司质量体系。 2.0规范性引用文件

ISO13485：2016质量手册英文版(修改公司名及程序名就可直接套用)

Table of Contents 1. Purpose & Scope (2) 2. Applicable Standards (2) 3. Business Profile (2) 4. Authority & Responsibility (2) 5. Terms & Definitions (2) 6. Policy & Objectives (3) 7. Application (4) 8. Quality Management System (4) 9. Management Responsibility (6) 10. Resource Management (8) 11. Product Realization (8) 12. Purchasing (11) 13. Production Control / Product Identification & Traceability (12) 14. Control of Inspection, Measuring, and Test Equipment (13) 15. Measurement, Analysis, Improvement (14)

1. Purpose & Scope This manual describes the Quality Management System (QMS) established by and for Dongguan XXX Appliances Limited. The principles and policies on which this manual is based; along with operating procedures, work instruc-tions, and other supporting documents; govern all processes that affect quality throughout the organiza-tion. 2. Applicable Standards 2.1 The QMS is structured and intended to be in compliance with the following standards. ISO 13485:2016 Medical Devices Quality Management Systems Requirements for Regulatory Purposes 21 CFR Part 820 Quality System Regulation (Exclusions and Exceptions noted below.) 2.2 Normative References ISO 9000:2015 Quality Management Systems · Fundamentals and Vocabulary ISO 13485:2016 Medical devices · Quality Management Systems · Guidance on the Application of ISO 13485:2016 3. Business Profile 3.1 Mission Statement To deliver zero defects to our internal and external suppliers and customers. 3.2 XXX, with one facility located at xxx, Dongguan City, Guangdong Province, China. 3.3 The organizational structure is described by Dongguan XXX Appliances Limited Organization Chart. 4. Authority & Responsibility 4.1 This manual is issued under the authority of the President. 4.2 It is the responsibility of the Director of Quality, who is the designated Management Representative, to ensure that the principles of this manual, the Quality Policy, quality objectives, customer requirements, applicable regulatory requirements, and quality management system requirements are promoted, com-municated to and understood by all XXX employees. 5. Terms & Definitions 5.1 Corrective Action A process improvement methodology aimed at identifying and eliminating the causes of known non-conformities to prevent their recurrence. A problem solving process.

ISO9001质量手册英文版(ISO9001QualityManual)

ISO 9001:2000 QUALITY MANUAL WOLSTENHOLME INTERNATIONAL LIMITED CONTENTS 1.0 Scope of the Quality Management System at Wolstenholme International Limited 1.1 Statement of Quality Policy 2.0 Quality Management System Documented Procedures 2.1 Document Control 2.2 Control of Quality Records 2.3 Internal Quality Audits 2.4 Control of Nonconforming Product 2.5 Corrective Action 2.6 Preventative Action 3.0 Quality Management System Processes and Interrelations 3.1 Organisation Charts 3.2 Responsibilities 3.3 Interrelation of Processes 3.4 Processes 1.0 Scope of the Quality Management System at Wolstenholme International Limited

Wolstenholme International Limited is a Company with a long-standing successful history of supplying metal powders, pastes, pellets, varnish, offset ink, flexography ink and other related products for use in a large range of applications, on a worldwide basis. The scope of the Quality Management System encompasses all activities on the Darwen Site. The Metallic Powders Operation at Darwen is responsible for the manufacture and supply of metal powders and pigments mainly in aluminium, copper and brass (bronze) based alloys, for use in printing, inks, plastics and other industrial and engineering applications. The Ink Operation at Darwen is responsible for the manufacture of a wide range and type of printing ink, 'one-pack' gold ink, varnish and related printing products. All production processes at Darwen are validated before leaving the site and as such sub-clause 7.5.2 is excluded. The overall operation at Darwen is controlled by the Ink & Print business unit and the Industrial business unit. Technical Service and Research and Development are vital to the future development of the Company, together with understanding and developing new products and applications for our customers. The manufacturing, technical and administration functions of the Company are based in Darwen, Lancashire, England and employ some 210 staff at that location. Through the application of Quality Management Systems and Company wide training programmes, Wolstenholme International Ltd. is committed to ensuring continuous improvements to both its processes and product technology.

ISO9001：2015质量手册-英文版

Quality Management System Policy Manual ISO 9001:2015 11-8-17 Date Printed: _______________

1. Quality Management System Scope COMPANY NAME establishes this quality policy manual to implement and maintain a quality management system meeting the requirements of ISO 9001:2015, to ensure customer satisfaction in the manufacturing of stamped, formed, machined and fabricated metal parts, weldments, subassemblies and painting of metal parts to customer and COMPANY NAME specifications 1.1. Non-applicable Clauses of ISO 9001: 1.1.1. 8.3 Product Design & Development of Products & Services – COMPANY NAME is a custom manufacturer and designs are provided by our customers. 2. Quality Policy Statement COMPANY NAME is committed to continually improving all products and services to achieve our customer’s expectations. We do this by: 1) Living our values, 2) Providing opportunities for employee involvement, motivation and training, 3) Developing, documenting and following processes. 3. Quality Objectives COMPANY NAME’s quality management system objectives are to enable COMPANY NAME to be our customers’ first choice by: 1) Achieving satisfactory ratings on quality, delivery and other key metrics tracked and reported by our customers through their formal supplier evaluation and performance systems, 2) Achieving a level of 700 ppm as tracked through COMPANY NAME’s RA system for customers without a formal supplier evaluation system for quality, 3) Achieving a 95% on-time delivery to the COMPANY NAME warehouse for customers without a formal supplier evaluation system for delivery. Policy Manual Revisions Log Date 3/22/17 8/7/17 Summary of Revisions Rewrite of Quality Policy Manual to meet ISO 9001:2015. 1. Revised 4.2 to include “employees”, “owners” and “regulators”. Made By JGV JGV 2. Added Figure 2 to support to support the COMPANY NAME QMS Process Flow 11-8-17 Updated to clarify risk, inputs, out puts and KPI’s for Support and Management Process in QMS Process Reference page (page 6) JGV Management Approval Name: Title: Signature: Date: Paul Gintner President