ISO14001质量手册英文版模板(2008版)

合集下载

ISO9001质量手册-中英文版

2. 引用标准………………………………………………………………………………….7 Normative reference
3. 术语和定义……………………………………………………………………………….7-8 Terms
4. 质量管理体系 Quality management system 4.1 总要求……………………………………………………………………………….8-9 General requirements 4.2 文件要求…………………………………………………………………………….9-11 Documentation requirements
开发部
Date
D&D Dept
日期
品质部
Date
QA Dept
日期
货仓部
Date
WH. Dept
日期
采购开发部
Date
Sourcing Dept
日期
人事 & 行政部
Date
HR & Admin. Dept
日期 Date 日期 Date 日期 Date 日期 Date 日期 Date
Revision History 修订记录
E. 主要产品 Main products: 手袋及其它缝纫制品。
Bags and other sewing products. F. 主要生产流程 Main production processes:
开料→贴合/热压/电压/烫画→车缝→包装 Cutting→Lamination/Thermoforming/High frequency/Transfer sticker→Sewing→Packing G. 主要生产设备 Main production equipment: 裁床、贴合机、热压机、电压机、针车等. Cutting machine, lamination machine, thermoforming machine, high frequency machine, sewing machine, etc. H. 主要测试仪器 Main measuring devices: 盐雾试验机、破裂强度测试仪、卡尺、硬度计、千分尺、拉力计、推拉力计、电子天平、验布机及及其它布料测试设备等. Salt spray test machine, broken strength tester, caliper, hardness tester, microscope, pull gage, push-pull gage, electronic weight scale, fabric inspection machine and other fabric testing equipment.

ISO9001 2008 评估表(英文版)

Item #C NCR #Objective Evidence/Comments 4.1 General Requirements1A QMS has been established, documented, implemented, and maintained with evidence of continual effectiveness improvement2 a. QMS processes have been determined and applied3 b. Sequence and interaction determined for QMS processes Main process formally identified (e.g., list, flow diagram)4c. Criteria and methods determined to effectively operate and control QMS processes5d. Availability of resources and information necessary to support the operation and monitoring available for QM S processes6 e. QMS processes are monitored, measured, and analyzed7f. Actions implemented to continually improve planned results8Processes are managed in accordance with applicable standards9Outsourced processes are defined and controlled List outsourced processes Notes10Documented statement of a quality policy Quality Policy ref:11Documented quality objectives Quality objectives ref:12Documented quality manual Quality Manual ref:13Documented procedures required by standard List of procedures ref:14Documented records required by standard List of records ref:15Documents and records deemed necessary by theorganization to ensure effective planning, operation, andcontrol of processesAdditional document refs:Notes16Quality manual established, maintained, and17 a. Includes scope of the QMS18 b. Includes justification of exclusions List excluded clauses:19c. Includes QMS documented procedures or reference to them20d. Includes a description of the QMS processes and their interactionsNotes 4. QUALITY MANAGEMENT SYSTEM4.2 Documentation Requirements 4.2.1 General4.2.2 Quality ManualItem #C NCR #Objective Evidence/Comments4. QUALITY MANAGEMENT SYSTEM21Documents required by the QMS are controlled 22Records are controlled in accordance with 4.2.423Document procedure exists and includes:Procedure ref:24 a. Approval process25 b. Review, update, and re-approval process26 c. Identification of changes and current revision status 27Documents are available where needed 28Documents are legible and identifiable29External documents are identified and controlled 30Obsolete documents are identified and controlledNotes31Records, as required in 4.2.4, are established and controlled32 A documented procedure exists that includes controls for:Procedure ref:33 a. Identification 34 b. Storage 35 c. Protection 36 d. Retrieval 37 e. Retention 38 f. Disposition39Records are legible, identifiable, and retrievableSamples of records reviewed:Notes4.2.3 Control of Documents 4.2.4 Control of RecordsItem #CNCR #Objective Evidence/Comments4. QUALITY MANAGEMENT SYSTEM Evidence of top management commitment includes:Evidence ref:40 a. Communicating importance of meeting customer, statutory, and regulatory requirements 41 b. Establishing a quality policy 42 c. Establishing quality objectives 43 d. Conducting management reviews 44 e. Ensuring availability of resourcesNotesTop management ensures:45 a. Customer requirements are determined and metNotesTop management ensures the quality policy:46 a. Is appropriate47 b. Includes a commitment to comply with requirements and continually improve the effectiveness of the QMS48 c. Provides a framework to establish and review quality objectives49 d. Is communicated and understood 50 e. Is reviewed for suitabilityNotesTop management ensures quality objectives are:51 a. Established 52 b. Measurable53 c. Consistent with the quality policyNotesTop management ensures:54 a. QMS planning is carried out to meet the requirements defined in clause 4.1 and the quality objectives 55 b. QMS integrity is maintained when changes occurNotes5.4 Planning5.4.1 Quality Objectives5.4.2 Quality Management System Planning5.2 Customer Focus5.3 Quality Policy5. MANAGEMENT RESPONSIBILITY5.1 Management CommitmentItem #CNCR #Objective Evidence/Comments4. QUALITY MANAGEMENT SYSTEM Top management ensures responsibilities and authorities are:56 a. Defined 57 b. CommunicatedNotes58Top management appointed Management Representative existsManagement Representative responsibilities and authorities include:Job description ref:59 a. Ensuring QMS processes are established, implemented, and maintained60 b. Reporting QMS performance61 c. Promoting customer requirements awarenessNotes62Top management ensures communication processes are established and takes place on the effectiveness of the QMSNotes63Top management reviews the QMS for suitability, adequacy, and effectiveness at planned intervals 64Management review records are maintainedManagement review records ref:NotesManagement Review inputs include:65 a. Audit results 66 b. Customer feedback67 c. Process performance and product conformity 68 d. Corrective and Preventive actions 69 e. Follow up actions from previous reviews 70 f. Changes that could affect the QMS 71g. Improvement recommendationsNotes5.6.2 Review Input5.5.2 Management Representative5.5.3 Internal Communication5.6 Management Review 5.6.1 General5.5 Responsibility, Authority, and Communication5.5.1 Responsibility and AuthorityItem #C NCR #Objective Evidence/Comments4. QUALITY MANAGEMENT SYSTEM5.6.3 Review OutputManagement Review outputs include:72 a. QMS process improvements73 b. Customer requirement related product improvements74 c. Identification of resourcesNotesItem #CNCR #Objective Evidence/Comments4. QUALITY MANAGEMENT SYSTEM Resources determined and provided to:75 a. Implement and maintain the QMS and improve its effectiveness76 b. Enhance customer satisfactionNotes77Personnel competency is based on education, training, skills, and experienceThe organization:78 a. Determines the competence required for personnel affecting product quality79 b. Identifies and provides training to achieve required competence80 c. Evaluates effectiveness of actions taken81 d. Ensures personnel are aware of the relevance and importance of their activities and contribution to realizing quality objectives82 e. Maintains appropriate records per 6.2.2 requirementsTraining records ref:NotesDetermine, provide, and maintain an infrastructure needed to achieve product conformity including:83 a. Buildings, workspace, and associated utilities 84 b. Process equipment 85 c. Supporting servicesNotes86Determine and manage the work environment needed to achieve product conformityNotes6.4 Work Environment6.2 Human Resources 6.2.1 General6.2.2 Competence, Training, and Awareness6.3 Infrastructure6. RESOURCE MANAGEMENT6.1 Provision of ResourcesItem #CNCR #Objective Evidence/Comments4. QUALITY MANAGEMENT SYSTEM 87Plan and develop consistent product realization processes Product realization planning reflects the following:88 a. Quality objectives and product requirements 89 b. Processes, documents, and resources90 c. Verification, validation, monitoring, measurement, inspection, and test activities 91 d. RecordsPlanned product realization records ref:92Planning is in a suitable form for the organization's operationsNotesThe organization:93 a. Determines customer requirements, including delivery and post delivery activities94 b. Determines requirements not stated by the customer, but necessary for specified or intended use95 c. Determines applicable statutory and regulatory requirements96 d. Determines any additional requirements necessaryNotes97Reviews product requirements prior to commitment to supply a product to ensure:98 a. Product requirements are defined99 b. Differing contract requirements are resolved 100 c. Organization has the ability to meet the requirements 101Records of reviews and actions are maintainedContract review records ref:102Where the customer provides no documented requirements, they are confirmed before acceptance103Documents are amended and personnel made aware when product requirements are changedNotes7.2.2 Review of Requirements Related to the Product7. PRODUCT REALIZATION7.1 Planning of Product Realization7.2 Customer Related Processes7.2.1 Determination of Requirements Related to the ProductItem #CNCR #Objective Evidence/Comments4. QUALITY MANAGEMENT SYSTEMImplements effective customer communications for:104 a. Product information105 b. Enquiries, contracts, or order handling 106 c. Customer feedbackNotes107Plans and controls the product D&D process D&D process includes:108 a. Defined stages109 b. Reviews, verifications, and validations for each stage 110 c. Responsibilities and authorities111Interfaces between groups involved are managed to ensure effective communication and clear assignment of responsibilities112Planning output is updated as the D&D progressesPlanning output ref:Notes113Product input requirements are determined and records maintained Product input requirement record ref:D&D inputs include:114 a. Functional and performance requirements 115 b. Applicable statutory and regulatory requirements 116 c. Information derived from previous designs 117 d. Other essential D&D requirements 118Inputs are reviewed for adequacyNotes119Outputs are in a suitable form for verification against the inputs and are approved prior to release Records ref:D&D outputs include:120 a. Meet the input requirements121 b. Provide appropriate information for purchasing 122 c. Contain or reference product acceptance criteria 123 d. Specify product characteristicsNotes7.3.2 Design and Development Inputs7.3.3 Design and Development Outputs7.2.3 Customer Communication7.3 Design and Development (D&D)7.3.1 Design and Development PlanningItem #CNCR #Objective Evidence/Comments4. QUALITY MANAGEMENT SYSTEMD&D reviews are performed to:124 a. Evaluate the ability of the results to meet requirements 125 b. Identify any problems and propose actions126Participants in reviews include representatives from all functions concerned with the D&D stage(s) being reviewed 127Records of reviews and actions are maintainedReview records ref:Notes128Verification performed in accordance with planned arrangements129Records of verification and actions are maintainedVerification records ref:Notes130Validation performed in accordance with planned arrangements131Records of validation and actions are maintainedValidation records ref:Notes132D&D changes are identified and records maintainedChange records ref:133Changes are reviewed, verified, validated, and approved before implementation134Records of change reviews and any actions are maintainedChange review records ref:Notes7.3.5 Design and Development Verification7.3.6 Design and Development Validation7.3.7 Control of Design and Development Changes7.3.4 Design and Development ReviewItem #CNCR #Objective Evidence/Comments4. QUALITY MANAGEMENT SYSTEM135Purchased product confirms to specified requirements136Criteria for supplier selection, evaluation, and re-evaluation are establishedSupplier eval/selection ref:NotesPurchasing information includes, as applicable:Supplier contracts reviewed ref:137 a. Product, procedures, process, and equipment approvals 138 b. Personnel qualifications 139 c. QMS requirements140Adequacy of purchase requirements prior to issuanceNotes141Activities to ensure purchased product meets purchase requirements are established and implementedSamples of product review including contract ref:142Purchasing information defines information about the verification activities at the supplier's premisesReviewed supplier contract ref:Notes7.4 Purchasing7.4.1 Purchasing Process7.4.2 Purchasing Information7.4.3 Verification of Purchased ProductItem #CNCR #Objective Evidence/Comments4. QUALITY MANAGEMENT SYSTEM 143Production and service provisions are planned and achieved under controlled conditions including:144 a. Availability of product characteristics 145 b. Availability of necessary work instructionsWork instruction reviewed ref:146 c. Use of suitable equipment147 d. Availability and use of monitoring and measurement (M&M) equipment148 e. Implementation of M&M149f. Implementation of product release, delivery, and post delivery activitiesPlanning appropriately considers:150 a. Managing critical items and key characteristics 151 b. Measurement tooling152 c. Identifying in-process verification points 153 d. Special processesNotes154Special processes are validated prior to use155Special process validation demonstrates the ability to achieve planned resultsEstablished arrangements include, as applicable:156 a. Criteria for review and approval157 b. Approval of equipment and qualification of personnel 158 c. Use of specific methods and procedures 159 d. Requirements for records 160 e. RevalidationNotes161Products identified throughout product realization 162Product status is identified throughout product realization163When required, traceability is controlled through unique product identifications and records are maintainedTraceability records ref:Notes7.5 Production and Service Provision7.5.1 Control of Production and Service Provision7.5.2 Validation of Processes for Production and Service Provision7.5.3 Identification and TraceabilityItem #CNCR #Objective Evidence/Comments4. QUALITY MANAGEMENT SYSTEM164Customer property is adequately controlled through identification, verification, protection, and safeguarding 165Lost, damaged, or product unsuitable for use is reported to the customer and records maintainedCustomer property records ref:Notes166Products are preserved during internal processing and delivery 167Preservation includes identification, handling, packaging, storage, and protection168Preservation controls are applied to the constituent partsNotes169Product M&M and appropriate M&M equipment have been determined170Processes are defined for M&M equipment calibration, and/or verification, including equipment type, identification, location, frequency, check method, and acceptance criteria Process definition ref:To ensure valid results, M&M equipment is171 a. Calibrated, and/or verified, at specified intervals against traceable standards 172 b. Adjusted, when necessary173 c. Uniquely identified to determine statusEquipment reviewed ref:174 d. Safeguarded from adjustments that invalidate results 175 e. Adequately protected during handling and storage 176Previous results are assessed, recorded, and acted upon when M&M equipment is found to be out of conformance177Calibration, and/or verification, records are retainedCalibration records ref:178Software used for M&M is confirmed before initial use and reconfirmed as necessaryNotes7.5.4 Customer Property7.5.5 Preservation of Product7.6 Control of Monitoring and Measuring (M&M) EquipmentItem #CNCR #Objective Evidence/Comments4. QUALITY MANAGEMENT SYSTEM 179Monitoring, measurement, analysis, and improvement processes planned and implemented to:180 a. Demonstrate product conformity 181 b. Ensure QMS conformity 182 c. Improve QMS effectiveness183Applicable methods (including statistical techniques) have been determined and are being usedSamples of methods:Notes184Methods for obtaining and using customer perception data are defined and implementedMethods ref:Notes185Internal audits conducted at planned intervals186 a. Audits ensure conformity to planned arrangements,requirements of applicable standards, and QMS requirements 187 b. Audits ensure the QMS is effectively implemented and maintained188Audits based on status and importance of processes and previous audit results to defined criteria, scope, frequency, and methods189Auditors do not audit their own work 190 A documented procedure existsProcedure ref:191Audit records are maintainedAudit records ref:192Timely corrective actions are taken by management in audited areas193Follow up activities verify and report actions takenNotes8.2.2 Internal Audit8. MEASUREMENT, ANALYSIS, AND IMPROVEMENT8.1 General8.2 Monitoring and Measurement8.2.1 Customer SatisfactionItem #CNCR #Objective Evidence/Comments4. QUALITY MANAGEMENT SYSTEM 194Methods for monitoring and measuring QMS processes are inplace and demonstrate that processes achieve planned results 195Correction and corrective actions are taken when results are not achievedNotes196Monitoring and measuring product characteristics is performed and records maintained197Records reflect person(s) authorizing release of product for deliveryRecords ref:198Release of product and/or delivery of services are not performed until all planned activities are successfully accomplished or without customer approvalNotes199NCP is identified and controlled200 A documented procedure exists for handling NCP NCP Procedure ref:NCP controls include:201 a. Actions to eliminate the nonconformity202 b. Use, release, or acceptance by customer concession 203 c. Actions to preclude its intended use or application204 d. Actions on the effects of NCP, when detected after delivery or use, including timely reporting205Corrected NCP is subjected to re-verification 206NCP records are maintainedNCP records ref:Notes207Data to demonstrate the suitability and effectiveness of the QMS is determined, collected, and analyzed, including:208 a. Customer satisfaction209 b. Conformity to product requirements210 c. Characteristics and trends of processes and products 211 d. Supplier performanceNotes8.3 Control of Nonconforming Product (NCP)8.4 Analysis of Data8.2.3 Monitoring and Measurement of Processes8.2.4 Monitoring and Measurement of ProductItem #CNCR #Objective Evidence/Comments4. QUALITY MANAGEMENT SYSTEM212QMS is continually improved through the quality policy, quality objectives, audit results, analysis of data,corrective/preventive actions, and management reviewsNotes213Actions are taken to eliminate the causes of nonconformities 214 A documented procedure exists that includes:CA procedure ref:215 a. Reviewing of nonconformities216 b. Determining the causes of nonconformities 217 c. Evaluating action to prevent recurrence 218 d. Determining and implementing actions 219 e. Record of actions takenCA records ref:220 f. Reviewing the effectiveness of actions takenNotes221Actions are taken to eliminate the causes of potential nonconformitiesA documented procedure exists that includes:PA procedure ref:222 a. Determining potential nonconformities and their causes 223 b. Evaluating action to prevent occurrence 224 c. Determining and implementing action 225 d. Record of actions taken226 e. Reviewing the effectiveness of actions takenPA records ref:NotesAuditor Name SignatureDate Completed8.5.2 Corrective Action (CA)8.5.3 Preventive Action (PA)8.5 Improvement8.5.1 Continual Improvement。

ISO 9001质量手册英文版(ISO 9001 Quality Manual)

ISO 9001：2000 QUALITY MANUALWOLSTENHOLME INTERNATIONAL LIMITEDCONTENTS1.0 Scope of the Quality Management System at Wolstenholme International Limited 1。

1 Statement of Quality Policy2。

0 Quality Management System Documented Procedures2.1 Document Control2。

2 Control of Quality Records2.3 Internal Quality Audits2。

4 Control of Nonconforming Product2.5 Corrective Action2.6 Preventative Action3.0 Quality Management System Processes and Interrelations3。

1 Organisation Charts3.2 Responsibilities3.3 Interrelation of Processes3.4 Processes1。

0 Scope of the Quality Management System at Wolstenholme International LimitedWolstenholme 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。

质量手册(2008版本B0)

02颁布令本《质量手册》按照国际标准ISO9001：2008《质量管理体系—要求》，结合本公司的实际情况编制，参考相关行业标准及其它支持性文件合成本文件化质量管理体系，致力于实现本公司质量方针和目标，成为公司质量管理系统的一套严谨的逻辑步骤和运作程序。

本手册经审核、批准颁布后，即成为本公司的质量管理大纲，公司全体员工在实施质量活动中必须严格遵循。

本手册对外是证实本公司具有稳定地提供满足顾客和适用法规要求的产品能力的文件，亦可作为公司内审及顾客或第三方对本公司质量审核和认证的依据。

公司授权管理者代表对本手册的条款进行解释。

总经理：辛忠礼日期：2010年02月10日03手册说明1、本手册适用于滁州市佳和电器配件有限公司金属配件和塑料的生产和服务提供的质量管理工作，以保证公司质量体系持续有效地运行和向顾客提供他们所期望的产品和服务。

本手册只对ISO9001：2008&GB/T19001-2008质量管理体系要求中7.3条款进行删减，具体见7.3条款的描述。

2、本手册是本公司质量体系的纲领性文件，详细地规定了本公司质量体系的构成内容及实施要求，该手册对内用于实施质量管理，对外用于证实本公司的质量保证能力。

3、本手册分受控版本和非受控版本两种发放控制形式，受控版本发放到本公司内部各部门负责人及以上职务的人员，以及有关认证机构等。

非受控版本发送给有一定业务需要的单位或个人供宣传介绍之用。

当质量手册正本发生修改时，各受控版本均应得到相应修改。

4、本手册经总经理批准后生效，各部门必须严格遵守和执行。

5、本手册之全部内容乃本公司之财产，公司拥有该文件之所有版权。

如未经许可而以任何形式翻印、复制或使用，均属违法，公司保留法律上之追究权力。

6、本手册通过公司内外质量审核、管理评审等活动进行复核，以便对质量手册的适用性进行评定。

7、本手册出现下列情况时应更换版本：a)手册的修改已超过六次；b)公司的组织机构、业务、质量方针、质量目标、依据标准发生重大改动时。

2008质量手册样板DOC

0.1 目录章节号内容0.1目录0.2批准页0.3手册说明0.4手册管理0.5管理者代表任命书0.6术语和定义1.0企业概况2.0质量方针与质量目标3.0质量管理体系架构与职责4.0质量管理体系要素4 质量管理体系5 管理职责6 资源管理7 产品实现8监视测量和改进附表职能分布表附表内部沟通表0.2 批准页为向用户按时提供质量好的产品和完善的服务，满足客户的要求，公司按照GB/T19001-ISO9001：2008系列标准的要求，特制定此手册；同时，这是我们公司每位员工的职责。

我要求：员工的质量工作必须完全按照质量手册所规定的内容来实施，任何人不得违反。

我重申：本手册是公司质量体系的纲领性文件，是公司实施质量管理的基本章程。

不论任何情况，全体员工都必须以质量方针指导自己的工作。

我授权：管理者代表负责处理公司内外部质量工作，各部门须积极配合，共同努力建设和维护质量管理体系，并使之持续有效。

我宣布：本手册自签发之日起生效，并在公司质量管理体系中实施。

总经理：0.3 手册说明1、本手册的目的是确定本公司的质量方针、质量目标、程序和要求，实施有效的质量管理和质量管理体系。

2、本手册适用于本公司生产的产品、代理、经销的国内外其它公司的产品。

3、本手册经公司总经理批准后生效，各部门都应确保遵守本手册的规定。

4、本公司是根据客户样品生产，不涉及设计和开发；因此，删减标准中7.3条款。

0.4 手册管理1、本手册在总经理的授权下，由管理者代表负责组织编写。

2、本手册由管理者代表审查，总经理批准。

3、本手册分文件原件和受控文件发行件。

原件由ISO办保存；发行文件参见《文件控制管理程序》，发行状态为最新有效之版本。

本手册未经公司授权人书面同意，不得泄漏和翻印。

4、本手册由ISO办负责编号、登记、发放、回收、销毁。

5、本手册更改或换版依《文件控制管理程序》执行。

6、本手册解释权归属管理者代表。

0.5 管理者代表任命书根据ISO9001：2008标准之要求，兹任命 XXX 先生为************有限公司之管理者代表。

ISO14001运行控制程序(中英文)

ISO14001运行控制程序Operational control procedure1.0Purpose目的:To use effective and efficient operational controls to manage the company’s significant environmental aspects ensure consistency with its environmental policy, achieve its objectives and targets and continual improvements of environmental performance.对与公司的重要环境因素有关的运行与活动进行有效控制，确保其符合环境方针、目标与指标的要求，以实现环境效绩的改进。

2.0Scope适用范围:It is applicable to operational controls to manage environmental aspects.适用于公司环境因素的运行控制。

3.0Responsibility 职责:3.1 FM is responsible to supervise the environmental impactoccurred by the new or improvement projects.设施管理部负责新上或改进工程项目的环境影响控制。

3.2 FM is responsible to maintain the environmental equipments.设施管理部负责环境设备的维护保养。

3.3 Warehouse is responsible to manage the chemicals storage inwarehouse and transportation inside factory, M is responsibleto control use of chemical on production line.仓库部门负责管理化学物品贮存和厂内运输，生产部门负责控制生产线化学品的使用。

质量手册翻译中英文对照

质量手册翻译中英文术语表3.1.1质量quality3.1.2要求requirement3.1.3等级grade3.1.4顾客满意customer satisfaction3.1.5能力capability3.2.1体系(系统)system3.2.2管理体系management system3.2.3质量管理体系quality management system 3.2.4质量方针quality policy3.2.5质量目标quality objective3.2.6管理management3.2.7最高管理者top management3.2.8质量管理quality management3.2.9质量策划quality planning3.2.10质量控制quality control3.2.11质量保证quality assurance3.2.12质量改进quality improvement3.2.13持续改进continual improvement3.2.14有效性effectiveness3.2.15效率efficiency3.3.1组织organization3.3.2组织结构organizational structure3.3.3基础设施infrastructure3.3.4工作环境'77ork environment 3.3.5顾客customer3.3.6供方supplier3.3.7相关方interested party3.4.1过程process3.4.2产品product3.4.3项目project3.4.4设计和开发design and development 3.4.5程序procedure3.5.1特性characteristic3.5.2质量特性quality characteristic 3.5.3可信性dependability3.5.4可追溯性traceability3.6.1合格（符合）conformity3.6.2不合格（不符合）nonconformity 3.6.3缺陷defect3.6.4预防措施preventive action3.6.5纠正措施corrective action3.6.6纠正correction3.6.7返工rework3.6.8降级regrade3.6.9返修repair3.6.10报废scrap3.6.11让步concession3.6.12偏离许可deviation permit3.6.13放行release3.7.1信息information3.7.2文件document3.7.3规范specification3.7.4质量手册quality manual3.7.5质量计划quality plan3.7.6记录record3.8.1客观证据objective evidence3.8.3试验test3.8.4验证verification3.8.5确认validation3.8.6鉴定过程qualification process3.8.7评审review3.9.1审核audit3.9.2审核方案audit programme3．9．3审核准则audit criteria3．9．4审核证据audit evidence3．9．5审核发现audit findings3．9．6审核结论audit conclusion3．9．7审核委托方audit client3．9．8受审核方auditee3．9．9审核员auditor3．9．10审核组audit team3．9．11技术专家technical expert3．9．12能力competence3.10.1测量控制体系measurement control system 3.10.2测量过程measurement process3.10.3计量确认metrological confirmation3.10.4测量设备measuring equipment3.10.5计量特性metrological characteristic 3.10.6计量职能metrological function Aaudit3.9.1审计audit client 3.9.7客户审计audit conclusion3.9.6审计结论audit criteria3.9.3审计标准audit evidence3.9.4审计证据audit findings3.9.5audit programme3.9.2审计大纲audit team3.9.10审计团队auditee3.9.8auditor3.9.9Ccapability3.1.5characteristic3.5.1concession3.6.11conformity3.6.1continual improvement3.2.13 correction3.6.6corrective action3.6.5customer 3.3.5customer satisfaction3.1.4 competence3.9.12Ddefect3.6.3dependability 3.5.3design and development3.4.4deviation permit3.6.12document 3.7.2Eeffectiveness 3.2.14efficiency3.2.15Ggrade3.1.3Iinformation3.7.1infrastructure3.3.3inspection3.8.2interested party3.3.7Mmanagement3.2.6management system3.2.2 measurement control system3.10.1 measurement process 3.10.2 measuring equipment 3.10.4 metrological characteristic3.10.5 metrological confirmation3.10.3 metrological function3.10.6Nnonconformity 3.6.2Oobjective evidence3.8.1客观证据organization3.3.1organizational structure3.3.2Ppreventive action3.6.4 procedure3.4.5process3.4.1product3.4.2project3.4.3Qqualification process3.8.6 quality3.1.1quality assurance3.2.11quality characteristic3.5.2 quality control3.2.10quality improvement 3.2.12 quality management3.2.8quality management system3.2.3 quality manual3.7.4quality objective3.2.5quality plan 3.7.5quality planning3.2.9质量计划quality policy3.2.4Rrecord3.7.6记录regrade3.6.8release3.6.13放行repair3.6.9requirement3.1.2review3.8.7rework3.6.7返工Sscrap3.6.10specification 3.7.3supplier 3.3.6供应商system3.2.1系统Ttechnical expert<audit>3.9.11技术出口test3.8.3测试top management3.2.7高层管理traceability3.5.4可塑性Vvalidation3.8.5verification3.8.4验证Wwork environment3.3.4工作环境质量管理体系基础和术语Quality management syst ems－－Fundamentals and vocabulary质量管理和质量保证标准第2部分:GB/T19001、GB /T19002和GB/T19003实施通用指南Quality mana gement and quality assurance standards－－Part 2:Generic guidelines for the application of GB /T19001、GB/T19002and GB/T19003质量管理和质量保证标准第3部分:GB/T19001在计算机软件开发、供应、安装和维护中的使用指南Qu ality management and quality assurance standard s－－Part3:Guidelines for the application of GB/T19001to the development,supply,installa tion and maintenance of computer software质量管理和质量保证标准第4部分:可信性大纲管理指南Quality management and quality assurance s tandards－－Part4:Guide to dependability prog ramme management质量管理体系要求Quality management systems－－Requirements质量管理体系业绩改进指南Quality management sy stems－－Guidelines for performance improvement s质量管理和质量体系要素第2部分:服务指南Quali ty management and quality system elements－－Pa rt2:Guidelines for services质量管理和质量体系要素第3部分:流程性材料指南Quality management and quality system elements －－Guidelines for processed materials质量管理和质量体系要素第4部分:质量改进指南Q uality management and quality system elements－－Guidelines for quality improvement质量管理质量计划指南Quality management－－Gui delines for quality plans质量管理项目管理质量指南Quality management－－Guidelines to quality in project management 质量管理技术状态管理指南Quality management－－Guidelines for configuration management质量体系审核指南审核Guidelines for auditing q uality systems－－Part1:Auditing质量体系审核指南质量体系审核员的评定准则Guide lines for auditing quality systems－－Part2:Q ualification criteria for quality systems audit ors质量体系审核指南审核工作管理Guidelines for au diting quality systems－－Part3:Management of audit programmes测量设备的质量保证要求第一部分:测量设备的计量确认体系Quality assurance requirements for mea suring equipment Part1:Metrological confirmat ion system for measuring equipment测量设备的质量保证第2部分:测量过程控制指南Q uality assurance for measuring equipment－－Par t2:Guidelines for control of measurement proc esses质量手册编制指南Guidelines for developing qual ity manuals质量经济性管理指南Guidelines for managing the economics of quality质量管理培训指南Quality management－－Guideli nes for trainingEnglish Chinesereceipt（入厂）接受，验收，进货handling搬运packaging包装storage保存protection保护comparison比较identification标识replacement of identification mark标识标志更换maintenance of identification标识的保持records of identification control标识控制记录tender标书normative document标准文件supplemental补充nonconforming product不合格品control of nonconforming product不合格品控制control procedure of nonconforming products不合格品控制程序tendency of nonconformance不合格倾向purchasing采购verification of purchased product采购的产品验证purchasing process采购过程purchasing control procedure采购控制程序purchasing information采购信息reference standard参照标准reference instructions参照细则stockhouse仓库measurement,analysis and improvement测量，分析和改进measurement result测量结果control procedure of monitoring and measuring d evices测量设备控制程序planning策划preservation of product产品保护control procedure for maintenance,replacement and records of product identification产品标识的保持,更换及记录控制程序procedure for product identification and tracea bility产品标识和可追溯性程序conformity of product产品的符合性monitoring and measurement of product产品的监督和测量product plan产品方案control procedure for product preservation产品防护控制程序method of product release产品放行方法conformity of product,product conformity产品符合性product realization产品实现planning of product realization产品实现策划product characteristics产品特性input to product requirements产品要求的输入product status产品状态final acceptance of product产品最后验收procedure程序program documents程序文件continual improvement持续改进procedure for continual improvement of quality management system持续改进质量体系程序adequacy充分性storage location存放地点agency personnel代理人员submission of tenders递交标书adjustment调整，调节statutory and regulatory requirements法律法规要求rework,vt返工repair,vt返修subcontractor分承包方annex附录improvement改进improvement actions改进措施on-the-job training岗位技能培训responsibility of individual department and pos t各部门,各岗位职责change identification更改标记change order number更改单编号process sheets工艺单process specification工艺规程procedure(process card)工艺规程(工艺卡) process characteristics工艺特性Job Description Format工种描述单work environment工作环境impartiality公正性functional requirements功能要求supplier供方supplier evaluation procedure供方评价程序supplier provided special processes供方提供的特殊过程verification at supplier's premises供方现场验证supply chain供应链criteria for supplier selection,evaluation and re-evaluation供应商选择、评估和再评估准则communication沟通customer顾客customer property顾客财产control procedure for customer property顾客财产控制程序customer feedback顾客反馈Customer Service Contact Form顾客服务联系表customer communications顾客沟通customer satisfaction顾客满意statistical analysis of customer satisfaction 顾客满意度统计分析customer complaint顾客投诉identification of customer requirements顾客要求的识别management review管理评审records from management review管理评审记录management review control procedure管理评审控制程序management representative管理者代表management responsibility管理职责specified limits of acceptability规定的可接受界限specified use规定的用途process过程complexity of processes过程的复杂性monitoring and measurement of processes过程的监视和测量operation of process过程的运行status of processes过程的状态process approach过程方法process controls过程控制process control documents过程控制文件process performance过程业绩appropriateness合适性changes to contractor合同的更改contract review control procedure合同评审控制程序internet sales互联网销售environmental conditions环境条件monogram pragram requirements会标纲要要求type of activities活动类型infrastructure基础建设infrastructure基础设施fundamentals and vocabulary基础与词汇control of records记录控制technical specificaion技术规范process trace sheet加工跟踪单monitoring and measurement监视和测量monitoring and measuring device监视和测量装置control of monitoring and measuring devices监视和测量装置控制check method检查方法frequency of checks检查频次calibration status检定状态inspection and test control procedure检验和试验控制程序identification procedure for inspection and tes t status检验和试验状态标识程序inspection witness point检验见证点inspection hold point检验停止点buildings建筑物delivery交付post-delivery activities交付后的活动delivery activities交付活动interface接口acceptance of contract or orders接受合同或定单type of medium介质类型experience经验correction action纠正措施Corrective action response time纠正措施答复时间，纠正措施响应时间management procedure for corrective actions纠正措施管理程序corrective action response times纠正措施响应时间development activity开发活动traceability mark可追溯性标志objectivity客观性Customer Service Log客户服务记录簿control feature控制特性，控制细节control features控制细则periodic assessment of stock库存定期评估justification理由routine例程，惯例，常规质量职能分配表论证范围internal communication内部沟通internal audit内部审核internal audit procedure内部审核程序internally controlled standard内控标准internal audit内审results of internal and external audits内外部审核结果competence能力training培训training needs培训需要evaluate评价records of the results of the review评审结果的记录review output评审输出review input评审输入Purchase Requisition请购单authority权限validation确认concession让步human resources人力资源job training of personnel人员岗位培训qualification of personnel人员资格equipment control procedure设备控制程序device type设备类型order of design changes设计更改通知单design and development control procedure设计和开发控制程序design and development设计开发design and development planning设计开发策划control of design and development changes设计开发更改控制design and development review设计开发评审design and development validation设计开发确认design and development outputs设计开发输出design and development inputs设计开发输入design and development verification设计开发验证design validation设计确认design documentation设计文件编制design acceptance criteria设计验收准则design verification设计验证audit program审核大纲conduct of audits审核行为audit criteria审核准则production process control生产过程控制production process control procedure生产过程控制程序production and service provision生产和服务提供control of production and service provision生产和服务提供的控制validation of processes for production and serv ice provision生产和服务提供过程的确认production order生产令identification and traceability识别和可追溯性identification and traceability maintenance and replacement识别和可追溯性维护与替换invalidate使失效market survey市场调研suitability适宜性scope适用范围controlled condition受控状态terms and definitions术语与定义analysis of data数据分析sequence顺序transfer of ownership所有权转移system document体系文件statistical technique统计方法outsource(vt)a process外包过程external source外部来源documents of external origin外来文件outsource,vt外协unique identification唯一的标识maintenance维护Document Change Control文件更改控制Request For Document Change(RDC)文件更改需求单control of documents文件控制documentation requirements文件要求enquiry问询，询价field nonconformity analysis现场不符合分析relevance相关性interaction相互作用detail design详细设计，详图设计，零件设计，施工设计sales department销售部sales contract销售合同checklist校验表，一览表，检查一览表calibration校准submission of action plans行动计划的递交documented procedures形成文件的程序documented statement形成文件的声明performance requirements性能要求licensee responsibilities许可证持有者责任acceptance criteria验收准则verification arrangement验证安排verification results验证结果customer focus以客户为关注点，以客户为焦点awareness意识introduction引言，概述，介绍normative references引用标准application应用visit to user用户访问review of requirements related to the product 有关产品的要求评审competent有能力的effectiveness有效性determination of requirements related to the pr oduct与产品有关的要求的确定customer-related processes与顾客有关的过程preventive action预防措施management procedure for preventive actions预防措施管理程序planned results预期的结果intended use预期的用途procedure for competence,knowledge and trainin g of personnel员工能力,知识和培训程序personnel training procedure员工培训程序supporting services支持性服务functions职能部门responsibility职责assignment of responsibility职责分工workmanship制造工艺manufacturing acceptance criteria制造验收准则quality policy质量方针quality programs质量纲领quality management system质量管理体系quality management system planning质量管理体系策划performance of the quality management system质量管理体系业绩quality plan质量计划quality records质量记录quality objectives质量目标quality audit质量审核quality manual质量手册quality problem handling form质量问题处理单quality requirements质量要求allocation table of quality responsibilities质量职能分配表availability of resources资源的可获得性resource management资源管理allocation of resources资源配置provision of resources资源提供general requirements总要求，一般要求constituent part组成部件organization组织continual improvement of the organization组织的持续改进size of organization组织的规模Organizational Diagram组织机构图final acceptance最终验收work instructions作业指导书。

ISO14001中英文对照16页

ISO14001中英文对照1 Scope1.范围This international Standard specifies requirements for an environmental management system1 to enable an organization to formulate a policy and objectives taking into account legislative requirements and information about significant environmental impacts. it applies to those environmental aspects which the organization can control and over which it can be expected to have an influence. It does not itself state specific environmental performance criteria.本标准规定了对环境管理体系的要求，使一个组织能够根据法律要求和重大环境影响信息，制定环境方针与目标。

它适用于那些可为组织所控制，以及可能希望组织对其施加影响的环境因素。

但它本身并未提出具体的环境表现（行为）准则。

This international Standard is applicable to any organization that wishes to本标准适用于任何有下列愿望的组织：a)implement, maintain and improve an environmentalmanagement system;a）实施、保持并改进环境管理体系；b)assure itself of its conformance with its statedenvironmental policy;b）使自己确信能符合所声明的环境方针；c)demonstrate such conformance to others;c）向外界展示符合性；d)seek certification/registration of its environmentalmanagement system by an external organization;d）寻求外部组织对其环境管理体系的认证/注册；e) make a self-determination and self-declaration of conformance with this international Standard.e）对符合本标准的情况进行自我鉴定和自我声明。

ISO14001质量手册英文版模板(2008版)

ABC FarmsISO 14001 - Environmental Management System ManualPrepared By:Approved By:Signature: ____________________________ Date: _________/ Revision #: 0 / Revision Date: / Effective Date:SECTION 0 - TABLE OF CONTENTSMANUAL ISOSECTION SECTION TITLE PAGE SECTION 0TABLE OF CONTENTS x SECTION I INTRODUCTION x SECTION II DISTRIBUTION, REVISION & CONTROL x4.2 4.2ENVIRONMENTAL POLICY x4.3 4.3PLANNING x4.3.1 4.3.1 Environmental Aspects x4.3.2 4.3.2 Legal and Other Requirements x4.3.3 4.3.3 Objectives and Targets x4.3.4 4.3.4 Environmental Management Programs x4.4 4.4IMPLEMENTATION & OPERATION x4.4.1 4.4.1 Structure and Responsibility x4.4.2 4.4.2 Training, Awareness and Competence x4.4.3 4.4.3 Communication x4.4.4 4.4.4 Environmental Management System Documentation x4.4.5 4.4.5 Document Control x4.4.6 4.4.6 Operational Control x4.4.7 4.4.7 Emergency Preparedness and Response x4.5 4.5CHECKING AND CORRECTIVE ACTION x4.5.1 4.5.1 Monitoring and Measurement x4.5.2 4.5.2 Non-conformance and Corrective Action x4.5.3 4.5.3 Records Management x4.5.4 4.5.4 Environmental Management System Audits x4.6 4.6MANAGEMENT REVIEW xSECTION I - INTRODUCTIONABC Farms is located XX.In order to improve management of environmental issues related to these operations and sites, ABC Farms has implemented an ISO 14001 environmental management system. This Environmental Management System (EMS) manual presents the environmental policy, structure of the management system, and related documents.The EMS is designed according to the requirements set forth by the ISO-14001 Standard. Sections 4.2-4.6 parallel the ISO-14001 Standard number scheme. Each of these sections provide specific information or instructions necessary for complying with the requirements in the ISO-14001 Standard.SECTION II - DISTRIBUTION, REVISION AND CONTROLThere will be a “Master Copy” in hard copy form maintained by the owner in his office. This copy shall have the signature of the owner and the date of approval. Any part of the manual in hard copy form, other than the master copy, sh all be considered “UNCONTROLLED” and will have “****THIS IS AN UNCONTROLLED COPY OF A CONTROLLED DOCUMENT****” automatically inserted at the bottom of each page when printed.The Responsible Party will review the EMS manual for changes annually.The Responsible Party will make all requested revisions to the manual as needed throughout the year.SECTION 4.2 - ENVIRONMENTAL POLICYABC Farm’s top management has defined its environmental policy.DocumentationEnvironmental Policy Procedure #xxx.ENVIRONMENTAL POLICYPOLÍTICA AMBIENTALSECTION 4.3 - PLANNINGDefinitions to be used during planning stages.Environmental Aspects -Elements of the organization’s activities, products or services that can interact with the environment.Environmental Impact - Any change to the environment, whether adverse or beneficial, wholly or partially resulting from an organization’s activities, products or services.Significant Environmental Aspect- An environmental aspect that has or can have a significant environmental impact.4.3.1 Environmental AspectsABC Farms has identified all known environmental aspects and related impacts of our activities and products that we can control and have influence over in order to determine which can have a significant impact on the environment.DocumentationAspects and Impacts Procedure #xxx.Significant Aspect Ranking Form #xxx4.3.2 Legal and Other RequirementsABC Farms is required to comply with a variety of legal and other requirements that are applicable to the environmental aspects of its activities, products or services.DocumentationLegal and Other Requirements Procedure #xxx4.3.3 Objectives and TargetsABC Farms has established and maintains documented environmental objectives and targets. DocumentationObjectives and Targets and Environmental Management Program Procedure #xxxObjectives and Targets and Environmental Management Program Form #xxx4.3.4 Environmental Management ProgramsABC Farms has developed an environmental management program. This program is established to assist in achieving the objectives and targets and includes the designation of responsibility for achieving the objectives and targets at each relevant function and level of organization and means and time frame by which they are to be achieved. With any projects that relate to new developments and new or modified activities, products or services, the program shall be amended where relevant to ensure that environmental management applies to such projects.DocumentationObjectives and Targets and Environmental Management Program Procedure #xxxObjectives and Targets and Environmental Management Program Form #xxxSECTION 4.4 - IMPLEMENTATION & OPERATION4.4.1 Structure and ResponsibilityABC Farms has defined, documented and communicated the roles, responsibility and authority of personnel in order to facilitate effective environmental management.DocumentationRoles and Responsibilities Procedure #xxx4.4.2 Training, Awareness and CompetenceABC Farms has identified training needs of all employees in relation to its environmental management system.DocumentationTraining Procedure #xxxTraining & Document Control Matrix #xxxTraining Sign-In Form #xxx4.4.3 CommunicationABC Farms has developed procedures for handling internal communications between the various levels and functions of the organization and external communications with interested parties.DocumentationCommunications Procedure #xxxExternal Communications Form #xxx4.4.4 Environmental Management System DocumentationABC Farms has developed an EMS documentation system that is organized in a four-tier structure.EMS Manual Level 1EMS Procedures Level 2Standard Operating Procedures/Work Instructions Level 3Forms/Records Level 4Each of these levels will provide direction to relative documents in other levels.DocumentationEMS Manual #xxx4.4.5 Document ControlABC Farms has established a document control system that controls all documents and data that relate to satisfying the elements of the ISO 14001 standard.DocumentationDocument Control Procedure #xxxEMS Documentation Template #xxx4.4.6 Operational ControlABC Farms has identified and developed operating procedures for operations and activities associated with the identified significant environmental aspects.DocumentationOperational Control Procedure #xxxListing of SOPs4.4.7 Emergency Preparedness and ResponseABC Farms has identified the potential for accidents and emergency situations that could result in environmental impacts.DocumentationEmergency Response Procedure #xxxEmergency Action Plan #xxxSECTION 4.5 CHECKING AND CORRECTIVE ACTION4.5.1 Monitoring and MeasurementABC Farms has established and maintains a system for measuring and monitoring the key characteristics of our operations that can have a significant impact on the environment. This system includes recording information to track performance, relevant operational controls, and conformance with the established objectives and targets.DocumentationMonitoring and Measuring Procedure #xxxMRB Progress Report Form #xxx4.5.2 Non-Conformance and Corrective ActionABC Farms has established and maintains a procedure to determine the need for and implementing corrective and preventive actions.DocumentationCorrective and Preventive Action Procedure #xxxCorrective and Preventive Action Report Form #xxxCorrective and Preventive Action Log #xxx4.5.3 Records ManagementABC Farms has established procedures for identification, maintenance and disposition of all environmental records. These records are kept to demonstrate conformance to ABC Farms’ EMS, the ISO 14001 standard, and applicable regulations.DocumentationRecords Procedure #xxx4.5.4 Environmental Management System AuditsABC Farms has established and maintains procedures to carry out periodic audits of the environmental management system.DocumentationAudit Procedure #xxxSECTION 4.6 MANAGEMENT REVIEWABC Farms has established a process for top management to review the environmental management system. DocumentationManagement Review Procedure #xxxMRB Progress Report Form #xxx。

质量环境管理手册HKEFQEM01

《质量治理体系要求》/ 《环境治理体系要求及使用指南》编制16.1.4质量/环境治理体系的治理和实施承担职责的部门和它们之间的关系详见“治理体系职能要素分配表”。

16.2质量/环境治理体系的治理和实施承担职责的部门和人员，其职责和权限如下：16.2.1.总经理职责A制定公司进展策略、年度经营目标；B制定治理方针和治理目标，确保本公司按照标准的要求建立、实施和保持治理体系；C确保本公司能稳固地提供满足顾客要求和适用的法律、法规要求的产品；D核准各部门主管工作职责、甄选各部门经理级以上主管人选；E任命治理者代表，并授权负责治理体系的建立及运行治理；F批准环境目标、指标和治理方案；16.2.2.治理者代表职责：A履行治理者代表的职权，对公司质量或环境治理体系的建立、实施和保持负责；B向总经理汇报质量/环境治理体系运行情形，提供治理评审和治理体系改进意见；C负责对本公司质量/环境治理体系运行过程进行监控；D负责治理体系有关事宜与外事的联系工作；16.2.3. 市场部A销售推测；B承接订单，确保交期；C产品库存治理；16.2.4. 采购部：A通过寻价方式提供适质、适量、适时、适价的物料；B采购订单的下达及物料的跟催；C对采购过程进行监控，包括供货商的评鉴等；D负责采购周期表的建立，以配合月生产打算的安排；16.2.5.PMC部：A负责库存操纵、缺料预防、呆料处理；B负责入库齐套、物料调度；C物料的接收、送验、入库、储存、配料；D负责仓储的治理；E负责生产打算总控，合理调控生产进度；16.2.6. 人力资源部：A职员聘请和在职职员调配、升迁、考核；B全员教育训练实施督导；C职员薪资与考勤治理、档案治理；D公司后勤设施（非生产性设备工具等）资源供给、职员福利及安全保卫；E政府公关、项目申报事宜；F制定人事政策，传达公司宣传指示，以达全员的共识；G负责厂区的消防设施的点检与布置工作；。

ISO9001-2008质量手册（中英文）

ISO9001-2008质量手册（中英文）Quality ManualISO9001-2008质量手册目录 Table of Contents章节(Chapter) 内容(Contents)0 目录Table of Contents0.1 质量手册颁布令Quality Manual Approval Statement0.2 公司简介Company Introduction0.3 管理者代表任命书Management Representative Appointing Letter0.4 质量政策Quality Policy0.5 质量手册说明Quality Manual Description0.6 质量管理体系结构图Quality Management System Structure Chart1.0 质量管理体系过程间的关系图Process Relation Map of QMS2.0 质量管理体系过程职能分配表QMS Process Function Distribution Table3.0 ISO9001条文与本公司程序文件对照表Comparison Table of Standard and Quality Procedure4.1 质量管理体系总要求Quality Management System General Requirements4.2 文件要求Documentation Requirements5.1/5.2 管理职责Management Responsibility5.3 质量方针Quality Policy5.4 体系策划System Planning5.5.1/5.5.2 职责、权限Responsibility and Authority5.5.3 内部沟通Internal Communication5.6 管理评审Management Review6.0 资源管理Resource Management7.1 产品实现的策划Product Realization Planning7.2 与顾客有关的过程Customer-related Process7.3 设计和开发Research and Development7.4 采购Purchasing7.5.1 生产和服务的提供Production and Service Provision7.5.3 标识和可追溯性Identification and Traceability7.5.5 产品防护Product Preservation7.6 监控和测量装置的控制Control of Monitoring and Measurement Device8.1 策划Plan8.2.1 顾客满意Customer Satisfaction8.2.2 内部审核Internal Audit8.2.3 过程监视和测量Monitoring and Measurement of Process 8.2.4 产品监视和测量Monitoring and Measurement of Product 8.3 不合格品控制Non-conforming Product Control8.4 数据分析Data Analysis8.5 改进Improvement9.0 质量手册管理办法Quality Manual Management Method10.0 更改记录Revision History。