ISO9001-2015文件控制程序(中英文)
ISO9001：2015全套文件英文版(含质量手册及全套程序文件)
Ningbo XXX Material TechnologyCo.,LtdISO9001:2015 Quality ManualRevision [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 19TABLE OF CONTENTS0.0 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)Revision [A/0] - [2018/3/1]Page 2 of 198.0 Improvement ............................................................................................................................................... 15 8.1 General .................................................................................................................................................... 15 8.2 Customer Satisfaction ............................................................................................................................. 15 8.3 Internal Audit ........................................................................................................................................... 16 8.4 Corrective and Preventive Action ............................................................................................................ 16 Appendix A: Overall Process Sequence & Interaction ........................................................................................ 17 Appendix B: ISO 9001:2015 Cross Reference . (18)Revision [A/0] - [2018/3/1] 0.0 Revision History and ApprovalRev. Nature of changes Approval DateA/0 Original release. XXX 2018/3/1Page 3 of 19Revision [A/0] - [2018/3/1] 1.0 Welcome to Ningbo XXX Material Technology Co.,LtdNingbo XXX Material Technology Co., Ltd. Was established in 2000, with the UAE businessmen to build the joint venture company; 2004 Ming Shan founded Nissin special adhesive tape and adhesive tape company; 2008 due to the strategic adjustment of 3 company merger and reorganization, the establishment of Ningbo letter mountains adhesive products Manufacturing Co., Ltd..PVC insulation tape is one of China’s national standard drafting unit, the field of adhesive products governing unit of China, Ningbo, adhesives and related products Industry Association, honorary president of the unit.We produce more than 1000 varieties of products of 11 categories. The annual throughput more than 100,000,000 square of the adhesive and 10,000 ton of the adhesive.Our company located in Ningbo which the city of the east China sea, beside 500 kilometers of shanghai, 20 kilometers from Ningbo list airport and 50 kilograms of the Ningbo seaport. The transport is very convenient (Easy to ship to everywhere on the world).2.0 XXX Material: Who We Are2.1 Determining Our Strategic DirectionXXX Material has reviewed and analyzed key aspects of itself and its stakeholders to determine the strategic direction of the company. This involves:∙Understanding our core products and services, and scope of management system (see 2.2 below).∙Identifying “interested parties” (stakeholders) who receive our [Production of adhesive tape], or who may be impacted by them, or those parties who may otherwise have a significant interest in our company. These parties are identified in the document [Requirements and expectations list of interested parties].∙Understanding internal and external issues that are of concern to XXX Material and its interested parties; also identified in the document [Requirements and expectations list of interested parties]. Many such issues are identified through an analysis of risks facing either XXX Material or the interested parties. Such issues are monitored and updated as appropriate, and discussed as part of management reviews.This information is then used by senior management to determine the company’s strategic direction. This is defined in records of management review, and periodically updated as conditions and situations change.2.2 Scope of the Management System2.2.1 Scope StatementBased on an analysis of the above issues of concern, interests of stakeholders, and in consideration of its products and services, XXX Material has determined the scope of the management system as follows:Production of adhesive tapePage 4 of 19Revision [A/0] - [2018/3/1]Page 5 of 192.2.2 Facilities Within the ScopeThe quality system applies to all processes, activities and employees within the company. The facility is located at: Factory Add ：XXX Tel ：XXX Fax ：XXX XXX XXX2.2.3 Permissible ExclusionsThe following clauses of ISO 9001 were determined to be not applicable to XXX Material.∙ 8.3 Design and development of products and services 2.2.4Scope of the ISO9001：2015 Quality ManualThis manual is prepared for the purpose of defining the company’s interpretations of the ISO 9001:2015 international standard, as well as to demonstrate how the company complies with that standard.This manual does not follow the numbering structure of ISO 9001. Instead, Appendix B presents a cross reference between the sections of this manual and the clauses of ISO 9001:2015.This manual presents “Notes” which are used to define how XXX Material has tailored its management system to suit its purposes. These are intended to clarify implementation approaches and interpretations for concepts which are not otherwise clearly defined in ISO 9001:2015. Notes appear in italics, with gray background.Where subordinate or supporting documentation is reference in this manual, these are indicated by bold italics .∙ Quality PolicyThe Quality Policy of XXX Material is as follows:Quality first, customer satisfaction;Scientific management, continuous improvement. ∙ Management SystemStructure and Controls 4.1Process Approach4.1.1 Process IdentificationXXX Material has adopted a process approach for its management system. By identifying thetop-level processes within the company, and then managing each of these discretely, this reduces the potential for nonconforming [Production of adhesive tape] discovered during final processes or after delivery. Instead, nonconformities and risks are identified in real time, by actions taken within each of the top-level processes.Note: not all activities are considered “processes” – the term “process” in this context indicates the activity has been elevated to a higher level of control and management oversight.The controls indicated herein are applicable only to the top-level processes identified.。
ISO9001：2015全套程序文件英文版
ISO9001：2015全套程序文件英文版(本人辛苦原创)Code QM-COP-01Date2018.10.24Date2018.10.241.0 PurposeAll the documents required by the Company’s quality management system should be controlled to ensure the version applied by all the relevant departments is valid.2.0 ScopeIt is applicable to all the documents pertaining to the quality management system including external documents.3.0 Definition3.1 Controlled document: The document applied in and out of the Company is controlled in modifications, identities, versions, version numbers, formats, fonts, etc.3.2 DCC: Document Controlling Center3.3 External document: It refers to the document that has been handled by outside individuals like national/international standards, laws and regulations, documents provided by customers or suppliers, material certificates, amendment advice, etc.3.3.1 Administrative documents on quality management system or product, released from local government authorities and regulatory agencies such as the notices from Guangdong Food and Drug Administration.3.3.2 National laws and regulations such as Product Quality Law of the People’s Republic of China, Regulation on the Supervision and Administration of Medical Devices, 93/42/EEC, etc.3.3.3 International standards such as Medical devices—Quality management systems—Requirements for regulatory purposes.3.3.4 National standards such as Medical electrical equipment – Part 1: General requirements for safety.3.3.5 Regulations and standards provided by customers such as agreements and commitments signed with customers.3.3.6 Drawings provided by customers such as drawings, mold drawings provided by a certain customer.3.3.7 Other important external documents relating to the product, including official materials like customer’s notice.4.0 Duties4.1 General Manager: Responsible for approval of the Company’s quality manual.4.2 Management Representative: Responsible for the Company’s procedure files, quality plans and cross-department three-order files and approval of external documents.4.3 Principals of each department: Responsible for approval of three-order files and all kinds of tables as well as department-related external documents.4.4 Department: Responsible for compilation, number and review of the documents dominated by the department.Code QM-COP-01Date2018.10.24Date2018.10.244.5 Quality Management Department: Responsible for all the controlled documents of the Company to ensure the electronic document is the latest version, and responsible for the updating of the controlled document list of all the departments.5.0 Procedures5.1 Document classification: The management system documents includes four layers and external documents5.1.1The Quality Manual (including policies and goals) is a principle-based and master document guiding the implementation of the quality management system. As the first level document, it does not just explain the scope of application but also describe the interaction among all the procedures in the quality management system.5.1.2 The procedure document is the expansion and specification of the Quality Manual, providing the process, methods and controlling means for carrying out quality management. It belongs to the second level document.5.1.3 Supporting documents (operation/technical specifications, process/inspection standards, technical guidance and position description) specify the quality management goals, duties of the posts of all levels and specific operation methods. It belongs to the third level document.5.1.4 The table is applied to record the state and result of activities, belonging to the fourth level document.5.1.5 External document: It refers to the document directly obtained from outside and cited by the Company, including national/international standards, laws and regulations, documents provided by customers or suppliers, material certificates and amendment advice.5.1.6 The document is drawn up mainly in written or electronic form, and both shall be under control.5.2 Document compilation and approval5.2.1 The formats of the second and third level documents are the same as that of the document.5.2.2 The date of the document must be written in the form of “year month day”.5.2.3 Limits for examination and approving authority for documentsS/N Order Type ofdocumentPrepared byReviewedbyJointreviewed byApprovedbyRemark1 First ManagementManualQualityManagementDepartmentManagementRepresentativeSupervisorof eachdepartmentTopmanagement2 SecondProceduredocumentAlldepartmentDepartmentRelevantdepartmentManagementCodeQM-COP-01Date2018.10.24 Date2018.10.245.3 Document’s number and version/version number5.3.1 Number: The document compiler numbers the newly compiled documents according to the Basic Rules for Numbering the Controlled Documents and the document list of the department, and confirms the uniqueness of the numbers with the controlling center.5.3.2 Version/Version number: The version or version number of the controlled document is compiled insmanagermanagerRepresen tative3ThirdManagement documentAll department sDepartme nt managerRelevant department manager and Managemen tRepresentat iveManage ment Represen tativeJob Description of the personnel below the manager level is reviewed by the department manager and approved by the manager of HR Department.4ThirdProcess, inspection standarddocument and specification (including external document)All department sQuality Manageme nt Departme ntDepartm ent manager5Fourt hTablesAlldepartment sQualityManageme nt Departme ntDepartm entmanagerAdditional remarks: 1) The document can be compiled by the compilers or above the compiler level but must be approved by the personnel upper than the compiler.2) The relevant department refers to the departments having ties with others involved in this system. 3) When the approver of the above documents is absent, his agent or Management Representative can sign it up instead to make the document effective.Code QM-COP-01Date2018.10.24Date2018.10.24the form of 26 alphabets from A to Z. The initial version number is “A/0”, the next revised version is “A/1” and so on. Changing Arabic numbers is enough for minor revisions while changing alphabets, for instance, from “A” to “B”, is necessary in case of major revisions.5.4 Document distribution and storage5.4.1 The document compiler sends the copy of the approved document and its electronic version to the Quality Management Department where the document will be checked whether it has been approved by designated personnel. After that, the document will be registered, controlled with the controlled document list updated.5.4.2 The document controller determines the scope of distribution, makes copies of the electronic file ina required number according to the List of distributed controlled documents, add the watermarks of correspondent departments on these copies, save them to the folder for controlled documents of each department and notify the departments for making and using the documents by email.5.4.3 All the department are responsible for checking if the controlled document is correct or not.5.4.4 The authority for the controlled document folder of each department shall be set as follows:①Document controller is permitted to modify, delete the content or add new content to the document.②Each department can only read but cannot delete, modify or add the content of controlled documents.5.4.5 The document controller must copy the electronic document as a backup.5.4.6 Visual management of documentsAs for the documents which are frequently applied at production site, all the departments should take correspondent measures such as hanging them on the wall, beside the equipment or enveloping them with plastic so to make it easy for operators to use.5.5 Document reading5.5.1 In case of reading the documents, the relevant personnel can open the PDF file which are saved in the Company’s share disk.5.6 Document review, modification, recovery, invalidation and destruction5.6.1 Review①The documents of the quality management system should be reviewed once a year by the Quality Management Department and internal review team organized by the Management Representative along with the Company’s internal review and reviewed with the result put down in the internal review record.②In case of special circumstances, some documents should be reviewed by the relevant department.③The review must take into account the influence of both the internal factors like the Company’s organization and position changes and the external factors like laws, regulations, relevant standards and market demands upon the sufficiency and applicability of the documents with the Review Record filled in.5.6.2 Revision/alteration①The director and executor of each unit should check the effect after implementing the documents. If the documents are not applicable or in doubt in addition to the opinions on the content of the documents from other units, the documents can be revised or modified by the department which revised or compiledCode QM-COP-01Date2018.10.24Date2018.10.24them last time after the discussion among the relevant departments. Relevant approval process is the same as that in 5.2.2.②All the modifications or alterations must be underlined (“___”). In case of version change, the previous underline should be substituted by the latest one.③The revision record should be written on the first page of the documents, containing the content of the revision, identification of the affected documents, signature of the approver, date of approval and effective time.④The relevant departments shall be notified of review and confirmation of the alteration, and personnel training will be provided if necessary.⑤In the following circumstances that there is any alteration to the documents of the quality management system or the documents relating to the Company’s medical device products, the top management or Management Representative of the Company should be notified of deciding whether to inform the competent authority or notified bodies about it. If it is necessary, the notification should be implemented in accordance with the local laws and administrative regulations.a. Major alterations to the Quality Manual.b. Major alterations to the product’s functions, performance, safety, reliability and electromagnetic compatibility, caused by altering product standards.c. Major alterations to the product’s functions, performance, safety, reliability and electromagnetic compatibility, caused by changing key components of products.d. Stipulated by laws and regulations.5.6.3 Once the new version of controlled document is distributed, the old one becomes invalid automatically. The document controller should delete the copies of invalid controlled documents in the controlled document folder, upload the latest version and keep the original documents printed with an “invalid” stamp at the document controlling center till the expiry date (at least five years) before destruction.5.6.4 As for the invalid original documents, the document controlling center should destruct them uniformly after Document/Record Destruction Registration Form filled in by the center is approved by the Management Representative.5.7 The non-controlled document is identified as the “Reference”. If a Company’s customer or other personnel need it for their jobs, they must have the copies of the Company’s controlled documents and get its copies approved by the Management Representative and stamped with the ‘Reference’ seal by the Quality Management Department. The ‘Reference’ documents will not be withdrawn or changed to the latest version.5.8 Temporary documentIt is not yet official for some reasons but needed by each department. Such document should have a ‘Temporarily Controlled’ stamp as well as the time limit and distribution department on them. The temporary document cannot be valid for more than 3 months.Code QM-COP-01Date2018.10.24Date2018.10.245.9 Management of external documents5.9.1 Each department of the Company can collect external documents through the following channels.a. National, provincial, municipal governments and their relevant functional departments.b. All kinds of meetings, professional newspapers, magazines, publishers and suppliers.c. Internet, telephone and fax.5.9.2 The external document collected by each department should be selected timely and delivered to the relevant department to recognize its contents and decide whether make it a controlled document.a. The collected technical standards on our products should be delivered to the Technical Department to recognize its year, version and applicable articles.b. The laws, regulations and rules that are issued by the state on the quality and safety of the product should be delivered to the Quality Management Department to identify the required department and scope.c. Policy documents issued by the superior should be delivered to the administration department for recognition.d. The technical documents provided by suppliers or customers should be delivered to the Technical Department and Quality Management Department for recognition.f. The design input documents provided by customers should be delivered by the Market Department to the R&D Department for recognition. Saved in DHF format, they don’t have to be controlled by document controller.5.9.3 Numbering of external documentsAs for the external documents on technology and standards as well as other external documents, the Quality Management Department should number them in accordance with the Basic rules on numbering controlled documents.5.9.4 Distribution of external documentsa. After being recognized, the external documents should be kept on a file and put down on a list.b. The external documents should be distributed after the distribution scope is confirmed according to 5.4 of this procedure.5.9.5 Updating of external documentsAs for the external documents which need updating, the new version should be distributed with the invalid ones withdrawn immediately.5.9.6 Preservation and destruction of external documentsThe preservation and destruction should be implemented according to 5.6.3 of this procedure.5.10 The Quality Management Department should supervise and inspect irregularly the controlling process implemented by each department.6.0 Records and Tables6.1 Controlled Document Directory。
ISO9001：2015中文完整版
ISO/DIS 9001:2015质量管理体系—要求 Quality management system—Requirements目录 0 引言 (04)0.1 总则 (04)0.2 ISO标准的质量管理 (04)0.3 过程方法 (05)0.4 PDCA 循环 (06)0.5 基于风险的思维 (06)0.6 与其他管理体系标准的相容性 (06)1 范围 (08)2 规范性引用文件 (08)3 术语和定义 (08)4 组织的背景 (20)4.1 理解组织及其背景 (20)4.2 理解利益相关方的需求和期望 (20)4.3 确定质量管理体系的范围 (20)4.4 质量管理体系及其过程 (21)5 领导 (21)5.1 领导和承诺 (21)5.1.1 领导和质量管理体系承诺 (21)5.1.2 以顾客为关注焦点 (21)5.2 质量方针 (22)5.3 组织角色、职责和权限 (22)6 质量管理体系策划 (22)6.1 应对风险和机遇的措施 (22)6.2 质量目标及其实现策划 (23)6.3 变更策划 (23)7 支持 (23)7.1 资源 (23)7.1.1 总则 (23)7.1.2 人 (24)7.1.3 基础设施 (24)7.1.4 过程作业环境 (24)7.1.5 监视和测量资源 (24)7.1.6 组织的知识 (25)7.3 意识 (25)7.4 沟通..................................................... .................. .. (25)7.5 文件信息................................................... .................. (25)7.5.1 总则 (25)7.5.2 创建和更新............................................................... (26)7.5.3 文件信息控制....................................................... (26)8 运作........................................................................ . (26)8.1 运作策划和控制......................... .................. .. (26)8.2 产品和服务要求的确定 (27)8.2.1 顾客沟通............................................................... .. (27)8.2.2 与产品和服务有关的要求的确定................................... (27)8.2.3 与产品和服务有关的要求的评审 (27)8.3 产品和服务的设计与开发............................. .................. .. (27)8.3.1 总则 (27)8.3.2 设计和开发策划....................................... .. (28)8.3.3 设计和开发输入 (28)8.3.4 设计和开发控制 (28)8.3.5 设计和开发输出 (28)8.3.6 设计和开发变更 (29)8.4 外部供应产品和服务的控制 (29)8.4.1 总则 (29)8.4.2 外部供应的控制类型和程度 (29)8.4.3 外部供应商的信息 (29)8.5 产品和服务提供 (30)8.5.1 产品和服务提供的控制 (30)8.5.2 标识和可追溯性 (30)8.5.3 属于顾客或外部供应商的财产 (30)8.5.4 防护 (30)8.5.5 交付后活动 (30)8.5.6 变更控制 (31)8.6 产品和服务的放行 (31)8.7 不合格过程输出、产品和服务的控制 (31)9 绩效评价 (31)9.1 监视、测量、分析和评价 (31)9.1.2 顾客满意 (32)9.1.3 分析和评价 (32)9.2 内部审核 (32)9.3 管理评审 (33)10 改进 (33)10.1 总则 (33)10.2 不合格和纠正措施 (34)10.3 持续改进 (34)附录A（规范性附录）新结构、术语和概念的说明（省略） (35)附录B（规范性附录）质量管理原则（省略） (35)附录C（规范性附录）ISO10000 质量管理标准组合（略） (35)参考文献（省略） (35)0 引言 0.1 总则采用质量管理体系应该是组织的一项战略性决策。
iso9001：2015采购控制程序英文版
Procedure: [Purchasing Proc. Title]1.0SUMMARY1.1.This procedure defines the requirements for evaluation and selection of critical suppliers,purchasing critical materials and services, and monitoring supplier performance.1.2.The receipt and receiving inspection of incoming purchased items is defined in the procedure[Receiving Proc. Title].1.3.“Critical materials or services” are those materials or services which are incorporated into fproduc t, or which have a direct impact on the company’s product or quality system, or whare otherwise deemed as critical by management.1.4.Office supplies, administrative consumables, furniture, etc. are not critical materials, andtherefore not subject to this procedure.1.5.[Short Client Name] understands it is responsible for the conformity of all products purchasedfrom suppliers, including product from sources defined by the customer.1.6.The [who?] is responsible for implementation and management of this procedure.2.0REVISION AND APPROVALRev. Date Nature of Changes Approved By[Rev Number] [Date of Issue] Original issue.[ProcedureApprover Name]3.0SUPPLIER EVALUATION, SELECTION AND CONTROL3.1.The [who?] evaluates new suppliers. This person/these individuals has/have both theresponsibility and authority to approve and disapprove suppliers.3.2.New suppliers are evaluated in accordance with the following criteria:?Modify this list as needed?Pricing?Availability?Reputation / references?Location?Shipping terms and capabilities?Quality system certification status (ISO 9001 certification preferred)?Quality of samples received (incl. testing results)?On-site audit results?Telephone interview results?Written survey results?Customer mandate?Sole source / OEM status3.3.Where a customer mandates a special process source, both [Short Client Name] and anysuppliers must use the required supplier; this usage may override [Short Client Name]status rules.3.4.In some cases a formal risk assessment may be conducted as part of the evaluation andselection of a potential supplier, or in order to determine if a problematic supplier should be retained; see [Risk Management Proc. Title].[Use this next section if the ASL is a spreadsheet, database or document – NOT if the ASL is part of an ERP system.]3.5.The [who?] will maintain an Approved Supplier List (modify name if needed) which lists allevaluated and approved suppliers, and their approval status.3.6.Suppliers who meet any of the evaluation criteria, in the judgment of the person conducting theevaluation, may then be entered into the purchasing system and items may be purchased.However, the supplier is entered into the Approved Supplier List (ASL) on a CONDITIONAL basis, pending inspection or review of products or services rendered.3.7.Upon successful receipt or review of products or services, the manager may then advance thesupplier’s status to APPROVED.3.8.If the results of review of product or service received are insufficient or otherwise lacking, thestatus to DISAPPROVED, or to leave it at buyer may then elect to change the supplier’sCONDITIONAL until further orders are received and reviewed.3.9. A supplier may also be listed as RESTRICTED, where certain purchasing restrictions are placed onthe supplier. This may be useful to limit what products may be purchased from a supplier, or toplace other conditions.3.10.The Approved Supplier List indicates the supplier, location, approval status (Approved,Conditional, Disapproved, Restricted), and the scope of approval (typically commodity type orproduct family). Re-approval of suppliers is continual and ongoing based on the suppliers abilityto meet the criteria of paragraph 3.2. For Restricted status, a note of the restriction must alsobe included.3.11.Suppliers used for at least six months prior to [Date of Issue], have been grandfathered into thesystem as Approved, provided they have no outstanding quality issues on record, and only uponthe decision by [who?] to do so.[Use this next section if the ASL is part of the ERP system]。
ISO9001：2015变更控制程序英文版
Procedure: [Change Mgmt Doc Title]1.0SUMMARY1.1.The purpose of this procedure is to define the methods for managing changes to processes andother aspects of the management system in a controlled manner.1.2.Where this document discusses changes to processes, this shall be understood to mean the top-level processes identified in the [Quality Manual Doc Title].1.3.The [who?] is responsible for implementation and management of this procedure.2.0REVISION AND APPROVAL3.0CHANGES TO PROCESSES3.1.Management system processes will undergo changes, typically when:3.1.1.Improvement opportunities have been identified, typically to improve processeffectiveness3.1.2.Nonconformities within a process are identified and require corrective action3.1.3.Conditions in the industry or company change, requiring a process to be updated3.1.4.New processes are added which impact on existing processes, requiring changes3.1.5.Customer requirements result in a need to change processes3.1.6.Any other reason determined by management3.2.In such cases, the process must be changed in a controlled manner to ensure properauthorization and implementation of the changes.3.3.At a minimum, process changes shall include the steps herein:3.3.1.The request for a process change shall be documented, typically in a [CAR Form Name]per the procedure [Corrective Preventive Action Proc. Title]. The justification for thechange shall be recorded.3.3.2.The change shall be reviewed by appropriate management, including the senior mostmanager responsible for the process. Changes must be approved prior toimplementation.3.3.3.The appropriate [Process Definition Doc Title] will be updated to reflect the change.This document will undergo review and approval per the procedure [Control ofDocuments Proc. Title]. The revision indicator of the [Process Definition Doc Title]will be incremented, and the nature of the change recorded. [ Delete last sentenceif you are not using Process Definition documents.]3.3.4.The follow-up verification step of the [CAR Form Name] process shall seek to ensurethe change has had the intended effect, and/or has improved the process. If not, thechange may be rolled back or a new change made to correct any new issues that ariseas a result of the change.4.0CHANGES TO DOCUMENTATION4.1.Management system documents undergo changes when there is a need to revise them.4.2.Changes to documentation are done in accordance with the procedure [Control of DocumentsProc. Title].5.0CHANGES TO ORDERS OR CONTRACTS5.1.Changes to active orders or contracts may occur when the customer changes the requirementsafter the work has begun, or may be initiated by [Short Client Name] when unforeseencircumstances are encountered.5.2.Changes to orders or contracts are done in accordance with the procedure [Quoting and OrdersDoc Title].5.3.。
ISO9001-2015管理评审程序(中英文)
管理评审程序ManagementReviewControlProcedure（ISO9001：2015）1.0目的Purpose:建立一个文件化的系统规范公司管理评审活动的进行，确保管理体系的适宜性、充分性和有效性。
Thepurposeofthisprocedureistohaveasystemtocontrolthemanagementreview activitytoensurethecontinualsuitability,adequacyandeffectivenessofma nagementsystem.2.0范围Scope:适用于质量与环境管理评审活动的控制。
ThisprocedureisapplicabletothecontrolofQMSandEMSmanagementreviewinFl extronicsPlasticsTechnology(Shenzhen)Co.,Ltd.3.0定义Definition:无No.4.0职责和权限Responsibilityandauthority：4.1总经理:负责主持管理评审活动。
GeneralManager:GMshouldbethechairmanofthemanagementreviewmeeting.4.2管理者代表:负责管理评审计划的制定,落实及组织协调工作；负责评审报告的整理发放及改善行动的跟踪验证工作。
Managementrepresentative:MRshouldpreparemanagementreviewplan,carryou tandcoordinatethemanagementreviewmeeting;preparemanagementreviewrepo rtandfollowup/verifycorrectiveandpreventiveactions.4.3各有关部门:负责准备并提供与本部门工作有关的评审所需的资料，并对涉及本部门的不符合采取纠正或预防措施。
ISO90012015记录控制程序英文版
[Full Client Name Reg Caps]Procedure: [Control of Records Proc. Title]Rev. [Rev Number]Procedure: [Control of Records Proc. Title]1.0 SUMMARY1.1.This procedure defi nes the requireme nts for the ide ntificati on, storage, protect ion, retrieval, rete nti on timeand dispositi on of con trolled quality records.1.2.“ Quality records ” are those records which provide evidenee of [Short Client Name] having met or not met-requirements. This may include requirements related to inspection requirements, purchas ing requireme nts, contractual requireme nts, etc. The full list ing of records affected bythis procedure is give n in the table at the end of this procedure.1.3.Records outside of this scope do not require con trol, but may be con trolled at the discreti on of man ageme nt.1.4.The [who?] is resp on sible for impleme ntati on and man ageme nt of this procedure.2.0 REVISION AND APPROVAL3.0 IDENTIFICATION3.1.[Short Client Name] maintains records that are needed to provide evidenee of conformity to requirements and of theeffective operation of the quality management system. The records are identified in the table below, along with thecontrols for each record type.4.0 STORAGE4.1.Storage methods are in dicated in the table below, for each record type.4.2.Softcopy records and data are stored on the company server or computers; in all cases, computers are subject to backup.4.3.Hardcopy records are stored in suitable cab in ets that preve nt damage or deteriorati on.5.0 RETENTION, RETRIEVAL & DISPOSITION5.1.Records shall be main tai ned a minimum of XX years [ defi ne actual rete nti on time; should not be less tha n 3years due to ISO audit cycle requireme nts] uni ess otherwise in dicated below or as defi ned by customer, statutoryor regulatory requireme nts.5.2.Training records and other records pertai ning to employees must be reta ined at least one year beyond that employee' s end of employment.5.3.Records that are discarded after rete nti on shall be perma nen tly destroyed.[Full Client Name Reg Caps] Procedure: [Controlof Records Proc. Title] Rev. [Rev Number]5.4.When archived records are stored offsite or in another location, these shall be stored in a con trolled en vir onmentthat also protects them from damage or deteriorati on.5.5.As required by customer con tract or regulatory requireme nts, quality records shall be made readily available forreview by the requesting authority. Such review is limited to those records applicable to the customer or regulatory authority, and shall not allow for the accidental or inten ti onal release of con fide ntial in formati on to an un authorized party.56 PROTECTION & PRESERVATION5.7.The listed “ con troller sho” n in the table below must en sure their assig ned records rema in legible, readilyidentifiable and retrievable.5.8.In order to en sure protect ion of records, electr onic records are subject to periodic backups, with the backup storedon a separate server. [Add details of backup procedures and methods here; if complex, a separate procedure may be required.]5.9.The [who?] is resp on sible for backup of data.5.10.Quality records data stored on individuals computers must either be backed up through the server (as above), or backedup manu ally onto the server. The in dividual users of such data are responsible when data is not backed up by the server. [Delete if not applicable.]5.11.En tries made by hand on hardcopy forms shall be made in ink.5.12.White-out or correct ion tape is not to be used on any quality records. The correct procedure for maki ng corrections is to cross the error out, make the correct ion and in itial it. Opti on ally, datesen sitive correcti ons should be dated as well.。
ISO9001-2015供应商质量管理程序（中英文）
ISO9001-2015供应商质量管理程序（中英文）供应商质量管理程序Supplier Quality Management Procedure（ISO9001：2015）1.PURPOSE 目的:To establish a guideline to control and monitor supplier quality performance, manage supplier to improve quality system and product quality to meet DXC expectations. 建立监控供货商质量绩效的方针,管理供货商改进质量系统及产品质量以达到的期望目标.2.SCOPE 范围:2.1This procedure applies to all suppliers that provides production material products to DXC .此程序适合于提供生产性物料的所有供货商.2.2This procedure is applicable for QA to manage supplier quality and related issue only.此文件仅适用于QA管理供货商质量及相关问题.3.DEFINITIONS 定义:3.1Key Supplier :The supplier provides the material that is either valuable and / or critical impact to product’s characteristics关键供货商: 提供对产品价值或性能有关键影响物料的供货商.3.2SRS: Supplier Rating System.SRS: 供货商评估系统.3.3FAI: First Article Inspection.FAI: 首件检验.3.4LAR: Lot Accept Rate from incoming inspection.LAR: 来料检查批接收率.4.REFERENCE DOCUMENT 参考文件:4.1 BZQP-7-06 Supplier Rating System Procedure 供货商评估系统程序.4.2 BZQP-8-07 Corrective and preventive actions procedure 纠正及预防措施程序.5.RESPONSIBILITY 职责:5.1Purchasing staff 采购5.1.1 Arrange consolidation of the overall material supplier performance and distribute to related parties.整理供货商质量绩效并发布给相关部门5.1.2Review the supplier performance and enhance supplier improvement management.评估供货商绩效加强供货商改善管理.5.1.3 Coordinate and plan supplier’s support both for ongoing & future if necessary. 协调和规划供货商现在及将来的支持5.2QA质量工程师.5.2.1Follow supplier corrective action in line complaint. 跟进产线投诉问题和供货商的改善行动.5.2.2 Define key supplier for evaluation or assessment with purchasing staff.与采购定义关键供货商以便评估.5.2.3 Review the assessment result for further improvement or supplier quality related matters..审核供货商质量相关的事项的评估结果,达到持续改善.5.3 ME制造工程If necessary, ME will support QA to perform supplier process audit and technology evaluation.必要时,ME将协助QA执行供货商制程审核及技朮评估.6.PROCEDURE 程序:6.1 Supplier Rating System 供货商级别评估体系.Purchasing and QA shall select the key supplier and perform SRS. Refer to Supplier Rating System Procedure(BZQP-7-6).采购和QA 选择关键供货商进行评估, 参照供货商评估系统程序(BZQP-7-6)6.2 Material qualification 物料资格认证.6.2.1 Under selection of a potential supplier, Sourcing or purchasing sends the specification or drawing component requirements to supplier and Engineer instruct supplier to submit sample and related document (Attachment 1.)选定部分供货商后，资材部或采购将部件规格要求或图纸转交给供货商﹐工程部工程师指导供货商按照提交样品和相关档(附檔1)6.2.2Engineer will cooperate to complete FAI, detail operation process refer to “Incoming First Article Inspection Instruction (BZQAWI-003)”.工程师将完成物料的FAI检查,具体作业方法请参考“来料首件检查指示(BZWIQA-003)”6.2.3After the internal inspection completed, QA submit the passed part and FAI documents to customer for make final approve if need. After customer approve the sample, QA distribute the approved sample and relative files to IQC and buyer as the proof of approved by DXC .内部检查完成后, 如客户要求, QA将零件批准的数据 (零件样板) 和FAI报告送与客户批准. 客户检查并批准后, QA将客户最终承认的样板及相关文件分发至IQC和采购, 作为样板被承认的依据.6.2.4If material is rejected by customer, the original copy of material approval should return back to QA. Return process from 6.2.1 to 6. 2.4 如零件承认被客户否决, 则承认零件退回给QA. 重复步骤6.2.1至6.2.4.6.2.4.1For the critical to quality indirect material and not customer specified ,new developed supplier material needs to pass Engineer’s approval, and send to customer for approval as required.对于客户未指定的间接物料,在其对产品质量有重要影响的状况下,新物料需要经过工程师批准,如果客户要求将送给客户进行批准.6.2.5Material disqualification procedure.物料资格取消程序。
iso9001：2015目标和指标控制程序英文版
1Purpose1.1This procedure has been developed to describe the process established by MAS Solutions forestablishing, implementing and documenting BMS objectives and targets at relevant functionsand levels within the organization in order to move MAS to improved levels of performance.2Objectives and Targets2.1Objectives and targets are defined goals esablished by MAS, measureable in terms of BMSBMS Policy. Applicable BMS requirements shall also be performance and relevant to MAS’ considered, as well as identified risks and opportunties.2.2As a minimum, MAS shall establish new BMS objectives and targets and review theorganization’s performance toward meeting existing objectives and targets, as part of the MASannual Management Review process.*Note: The requirements stated above are not intended to be exclusive. BMS objectives and targets may beestablished and/or reviewed at any time, as deemed appropriate by the Management Representative.management shall determine if the2.3In the review of existing objectives and targets, MAS’ objectives under consideration have been met, or if adjustment to the correspondingmanagement plan is necessary (see below).2.4BMS objectives and targets and any subsequent reviews shall be documented andcommunicated within the organization as shown below.3Programs3.1As part of the BMS objective setting process, MAS’ Management Representativa Management Plan (Form 0620.1), detailing the steps intended by MAS to meet stated BMSobjectives.3.2These plans shall detail key considerations, such as:3.2.1General information (fiscal year, submittal date, revision, etc.),3.2.2Responsibility and authority for achievement of the objectives,3.2.3The current performance of the organization (where known and/or applicable),3.2.4The future (desired) state of the organization,3.2.5The time-frame by which the objectives are to be achieved,3.2.6The means, including an overview of tasks and activities by which objectives are to beachieved,3.2.7Any training required, and3.2.8Any other pertinent information.3.3Management plans shall be documented and communicated to all affected personnel. Theprogress towards Management Representative shall report to affected personnel on MAS’meeting stated objectives on at least a semi-annual basis (i.e., by bulletin board postings, email,meetings, newsletters, etc.).3.4Management plans shall be periodically reviewed (e.g., MAS’ Managemenas necessary, to reflect any changes in the organization, this management system or toactivities performed by MAS.3.5Where it is determined the established BMS objectives cannot be met, corrective action isrequired (see Procedure QP.1020).4Revision HistoryRevision Date Description of Change Approval0 Initial Release SR。
ISO9001：2015一整套程序文件英文版
ISO9001:2015一整套程序文件-英文版Procedure: [Change Mgmt Doc Title]1.0SUMMARY1.1.The purpose of this procedure is to define the methods for managing changes to processes andother aspects of the management system in a controlled manner.1.2.Where this document discusses changes to processes, this shall be understood to mean the top-level processes identified in the [Quality Manual Doc Title].1.3.The [who?] is responsible for implementation and management of this procedure.2.0REVISION AND APPROVAL3.0CHANGES TO PROCESSES3.1.Management system processes will undergo changes, typically when:3.1.1.Improvement opportunities have been identified, typically to improve processeffectiveness3.1.2.Nonconformities within a process are identified and require corrective action3.1.3.Conditions in the industry or company change, requiring a process to be updated3.1.4.New processes are added which impact on existing processes, requiring changes3.1.5.Customer requirements result in a need to change processes3.1.6.Any other reason determined by management3.2.In such cases, the process must be changed in a controlled manner to ensure properauthorization and implementation of the changes.3.3.At a minimum, process changes shall include the steps herein:3.3.1.The request for a process change shall be documented, typically in a [CAR Form Name]per the procedure [Corrective Preventive Action Proc. Title]. The justification for thechange shall be recorded.3.3.2.The change shall be reviewed by appropriate management, including the senior mostmanager responsible for the process. Changes must be approved prior toimplementation.3.3.3.The appropriate [Process Definition Doc Title] will be updated to reflect the change.This document will undergo review and approval per the procedure [Control ofDocuments Proc. Title]. The revision indicator of the [Process Definition Doc Title]will be incremented, and the nature of the change recorded. [ Delete last sentenceif you are not using Process Definition documents.]3.3.4.The follow-up verification step of the [CAR Form Name] process shall seek to ensurethe change has had the intended effect, and/or has improved the process. If not, thechange may be rolled back or a new change made to correct any new issues that ariseas a result of the change.4.0CHANGES TO DOCUMENTATION4.1.Management system documents undergo changes when there is a need to revise them.4.2.Changes to documentation are done in accordance with the procedure [Control of DocumentsProc. Title].5.0CHANGES TO ORDERS OR CONTRACTS5.1.Changes to active orders or contracts may occur when the customer changes the requirementsafter the work has begun, or may be initiated by [Short Client Name] when unforeseencircumstances are encountered.5.2.Changes to orders or contracts are done in accordance with the procedure [Quoting and OrdersDoc Title].Procedure: [Identification & Traceability Proc. Title]1. SUMMARY1.1. This procedure defines the methods used to identify and (where applicable) provide uniquetraceability for [Short Client Name] products. This procedure includes methods:1.1.1. To define the methods for identifying products (what they are)1.1.2. To define the methods for identifying products as to their current inspection or teststatus1.1.3. To define the methods for segregating and discriminating between product andtooling when their appearance is similar1.1.4. To define the methods for providing traceability, including unique serialization, orproduct as applicable1.2. The [who?] is responsible for implementation and management of this procedure.2. REVISION AND APPROVAL3. APPLICATION3.1. This procedure applies to all departments which use, handle, transport, store, inspect ormanufacture product, raw materials and tooling, at all [Short Client Name] facilities.3.2. This procedure not only applies to typical product, but also deliverables from services, such asreports, schedules, etc.3.3. Non-critical materials or supplies, which are not incorporated into final product or which serveonly to support facilities or operations, are not subject to this procedure.4. DEFINITIONS4.1. Product4.1.1. “Product” includes any of the following:∙Any part, assembly or item ordered by the customer∙Deliverable reports or documents∙Product may refer to finished product, or work in process (WIP)4.2. Raw Materials4.2.1. “Raw materials” include any of the following:∙Any materials or items (metals, plastics, components, pre-built assemblies, small parts) which become part of the finished product’s physical construction; some ofthese items may sometimes be referred to as “consumables”.∙Coatings, paint, plating, adhesives, chemicals or materials which will be incorporated into (or onto) the final product.4.3. Tooling4.3.1. “Tooling” can include any of the following:∙Devices used by manufacturing for setup or production, including fixtures and jigs.∙Devices used by inspection for determining acceptance of product, including test fixtures.∙Shop aids, which are simple devices (blocks, spacers, shapes) used to assist in production or development, but which are not precision tools and which can be usedfor a variety of applications.4.3.2. Tooling does not include:∙Cutting tools, drill bits, etc.∙Hand tools∙Machining equipment5. PRODUCT5.1. There are many ways to identify product; this procedure presents the most typical, acceptablemethods. Additional product identification methods may be called out in the design orproduction documentation.5.2. Identification typically includes the part number, revision, Work Order # and unique serialnumber (if applicable).5.3. Identification is done through any of the following methods:5.3.1. Part marking, by way of ink marking, etching or some other method.5.3.2. Bag-and-tag methods, especially for small parts.5.3.3. Placement of parts on shelves or in containers that are properly marked, withsignage or other methods.5.3.4. Placement of parts near associated paperwork, for the purpose of identification andtraceability, may be used if the paperwork can clearly be identified as relating to theparts in question, typically by way of the inclusion of a drawing which can becompared to the product.5.3.5. Segregating entire areas of the production floor with belt stanchions and attachedsignage, indicating what type of items are allowed, or disallowed, within theenclosed area.5.4. Where unique serialization is required for traceability, the parts shall be identified with a serialnumber in accordance with customer requirements, or in a manner developed to ensure that no two parts are given the same number. Serial number logs may be used to control this; workorders shall reference the serial numbers under which the unique parts were built.5.5. All product may be assumed to be inspected and/or tested and found to be acceptable for useif identified in accordance with the rules above, unless it is marked as nonconforming product.For the methods of identifying nonconforming product, see procedure [Control of NCP Proc.Title].6. RAW MATERIALS6.1. Raw materials requiring traceability back to heat lot numbers, manufacturer lot or batchnumbers, certificates of conformity or analysis, etc., must be marked in a way that provides this traceability. This is typically done by marking the raw materials with the [Short Client Name]purchase order number under which the items were purchased, and the supplier’s lot number.6.2. When raw materials are used, any remaining material that will be returned to stock and used inthe future must be re-identified before re-entry into inventory.6.3. Raw materials which are determined to require identification and traceability, but which lacksuch identification, may not be used for flight hardware. These may be used for tooling stock or other non-product purposes.6.4. All raw materials may be assumed to be inspected and/or tested and found to be acceptable foruse if identified in accordance with the rules above, unless it is marked as nonconforming. For the methods of identifying nonconforming raw materials, see procedure [Control of NCP Proc.Title].7. PRODUCTION TOOLING7.1. Tooling used for production (fixtures, molds, jigs, setup devices, product supports or stands,etc.) shall be designed and built according to engineering data, and then validated to ensurethe tool performs the intended function without risk or harm to product. Validation of tooling istypically done by using the tooling and inspecting the resulting parts to ensure the toolingresults in parts that meet dimensional or other requirements.7.2. Once validated and approved for use, the tool will be marked with a tooling ID number, which istypically the part number for which the tool is to be used.7.3. Tools that produce production hardware or are used to accept hardware must undergoinspection before release. [QC or QA Preferred Term] must stamp or mark the tool as accepted before it can be used.7.4. Shop aids for setup of production operations, supporting a part temporarily, or other simple ortemporary use, may not require identification with a unique identifier. Instead, these must beidentified as tooling by either marking the item itself as “TOOLING” (or similar language) orplacement in an area, shelf, cabinet or other container that is properly marked as “TOOLING”or “SHOP AIDS”(or similar language). T he marking must allow tooling to clearly bedistinguished from raw material or product (whether flight or development).7.5. Tooling used for lifting shall be proof load tested and include an upper load lift limit, as requiredby regulations.7.6. Tooling found to be nonconforming shall be tagged to prevent use until fixed, repaired ordeemed acceptable. Segregation of nonfonconforming tooling from the production area shouldbe performed when possible.7.7. When approved tooling undergoes modification, the identification must be updated to reflect thechange; this is typically done by editing or re-marking the item with the latest revision of theengineering part number.8. SERVICE DELIVERABLES (← delete if not applicable)8.1. Service deliverables, such as reports and schedules, shall be identified with a title and, ifapplicable, reference to the project or contract under which they are developed.8.2. Customer contracts may indicate additional methods for identification of service deliverables.8.3. In all cases, the deliverable will be identified in a way that makes it clearly understood forwhich contract or project the deliverable is subject to.8.4. As required, service deliverables may be subject to date and revision control, to distinguishearlier versions or submittals.9. STAMP CONTROL (← delete this section if QC stamps are not used)9.1. Quality stamps or employee initials are used to indicate product acceptance or for other quality-related notations. Individual authorities for signing off for inspection, testing and operations aredefined on the Stamp & Signature Control Log; this log is maintained to identify the owner of each stamp.9.2. The [who?] shall maintain the Stamp and Signature Control Log.9.3. Stamps are numbered, and taken out of service for six months after an employee leaves thecompany; after the six-month period, the stamp may be reissued to a different employee.9.4. No employee may use any stamp except that which was issued to them.。
ISO 9001 2015 中英文
strategic direction of the organization. Management of the processes and the system as a whole can be achieved using the PDCA cycle (see 0.3.2) with an overall focus on risk-based thinking (see 0.3.3) aimed at taking advantage of opportunities and preventing undesirable results.The application of the process approach in a quality management system enables:a) understanding and consistency in meeting requirements; b) the consideration of processes in terms of added value; c) the achievement of effective process performance;d) improvement of processes based on evaluation of data and information.Figure 1 gives a schematic representation of any process and shows the interaction of its elements. The monitoring and measuring check points, which are necessary for control, are specific to each process and will vary depending on the related risks.Figure 1 — Schematic representation of the elements of a single process0.3.2 Plan-Do-Check-Act cycleThe PDCA cycle can be applied to all processes and to the quality management system as a whole. Figure 2 illustrates how Clauses 4 to 10 can be grouped in relation to the PDCA cycle.NOTE Numbers in brackets refer to the clauses in this International 维（见0.3.3）对过程和整个体系进行管理，旨在有效利用机遇并防止发生不良结果。
ISO9001：2015一整套程序文件-英文版
Quality System Procedures(ISO 9001:2015)GENERAL INFORMATION Name of the Organisation:Address:E-Mail:Web:QUALITY SYSTEM STATUSQuality System:ISO 9001: 2015 Issue No.:01Issue Date: System Effective Date:December 2017 December 2017Copy No.:01LIST OF CONTENTSection-1 Control of DocumentSection-2Control of RecordsSection-3Management Review MeetingSection-4Resource ManagementSection-5Customer Related ProcessSection-6Purchase ProcessSection-7Supplier Evaluation and Selection Process Section-8Service ProcessSection-9Receipt Storage and Issue of Product Section-10Customer SatisfactionSection-11Internal AuditSection-12Control of Nonconforming Product Section-13Analysis of dataSection-14Continual ImprovementSection-15Corrective Action and Preventive ActionSection-1Control of Documents1.0Purpose1.1To establish a procedure to ensure that the documents required for Quality ManagementSystem are in controlled condition.1.2To ensure that pertinent versions of documents are available at the point of use.2.0Scope2.1Applicable to all documents and data generated for Quality Management System via theProcedures, Work Instructions, Documents, Lists, Formats and Registers etc.2.2This procedure also covers the external origin documents such as Standards and CustomerDocuments.3.0Responsibility3.1 Management Representative is responsible for controlling all the documents of Quality ManagementSystem being originated internally and the documents from External origin.3.2 It is the responsibility of Management Representative to ensure that pertinent documents are available atpoint of use.4.0Procedure4.1The numbering of all Quality Management System documents is done as per the Annexure.4.2Document Generation / Creation4.2.1 Management Representative issues the copies of the Quality System Manual / Procedures /Guidelines / Formats to all concerned personnel and records in Issue Control Register.4.2.3Any Departmental member, who perceives the need for a new quality system documentfor upgrading the system, prepares a draft procedure and forwards it to the ManagementRepresentative.4.2.3Management Representative studies the possibility of modifying any existing procedurein consultation with approving authority or accepts the draft procedures with or withoutmodifications and approves it before issue.4.3Document Change / Modification4.3.1Changes / Modification in document arises in any one of the following area;A.Change in Organization structureB.Any change in the departmental functioningC.Change in / addition / deletion of existing systemD.Change in International / National StandardsE.Findings of Internal Quality Audit4.3.2Departmental members prepares Document Change Request and forwards it toManagement Representative4.3.4 If the changes are acceptable, Management Representative makes necessary changes in thedocumentation and gets it signed by the concerned authority.4.3.5If the document is added or deleted, all linked procedures are updated in theAmendment Record Sheet.4.3.6While issuing the revised copies to all concerned, Management Representative ensures thatthe obsolete documents are retrieved back from all personnel and the same are destroyed.The respective Master copy is stamped as “OBSOLETE” and maintained for a period of oneyear from the date of next revision or till the next revision, which ever is later.4.3.7The Issue No. will be incremented when number of revisions in any section/page ofdocument exceeds 09 revisions. The Issue No. will be TBA…etc. and Revision No. of all thesection / pages shall be reset to 004.4Management Representative shall maintain and update the Master List of Documents.4.5The document status shall be maintained as follows:MASTER“MASTER COPY”(Seal affixed on rear side of each page of document)CONTROLLED“CONTROLLED COPY”(Seal affixed on front right hand side of the document)OBSOLETE“OBSOLETE COPY”(Seal affixed on front side of the document)4.6 The approval authority for various documents is as mentioned below:Document Type Description Approved by Apex ManualProceduresDocument Type Description Approved byGuidelines & Formats As per Master List of Documents4.7External Originated Documents (National / International Standards And Customer Drawings)4.7.1Documents of National / International Standards / any other Guidelines are procured, revisedand implemented by Management Representative.4.7.2 A List of External Origin Documents is maintained by Management Representative and willbe updated whenever necessary.4.7.3All the standards are stamped as “CONTROLLED COPY” on the cover page of the standardand issued to the concerned by making necessary entries in Issue Control Register.4.7.4Documents of customers / suppliers are maintained only after receiving concrete ordersfrom them. If the order does not mature, the documents are either destroyed or returned tothem as the case may warrant.5.0Reference5.1Issue Control Register5.2Document Change Request5.3Amendment Record Sheet5.4Master List of Documents5.5List of External Origin DocumentsAnnexureNumbering System shall be as follows1.Quality System ManualAAG/QSM-XX, whereAAG–refers to the company, AAG Land SurveyQSM–refers to Quality System ManualXX–refers to Section No.2.Quality System ProceduresAAG/QSP/YYAAG–refers to the company, AAG Land SurveyQSP–refers to type of proceduresQSP – Quality Management System ProceduresYY–refers to running Serial Number of procedures3.Documents & RecordsAAG-AXX:YYAAG–refers to the company, AAG Land Survey。
ISO-9001-2015-中英文
strategicdirection of the organization. Management of theprocesses and the system as a whole can be achieved using thePDCA cycle (see 0.3.2) with an overall focus on risk-basedthinking (see 0.3.3) aimed at taking advantage of opportunitiesand preventing undesirable results.The application of the process approach in a quality managementsystem enables:a) understanding and consistency in meeting requirements;b) the consideration of processes in terms of added value;c) the achievement of effective process performance;d) improvement of processes based on evaluation of data andinformation.Figure 1 gives a schematic representation of any process andshows the interaction of its elements. The monitoring andmeasuring check points, which are necessary for control, arespecific to each process and will vary depending on the relatedrisks.Figure 1 — Schematic representation of the elements of asingle process0.3.2 Plan-Do-Check-Act cycleThe PDCA cycle can be applied to all processes and to the qualitymanagement system as a whole. Figure 2 illustrates how Clauses4 to 10 can be grouped in relation to the PDCA cycle.NOTE Numbers in brackets refer to the clauses in this International维（见0.3.3）对过程和整个体系进行管理，旨在有效利用机遇并防止发生不良结果。
ISO9001文件控制程序(中英文)
ISO9001文件管理程序Document Control Procedure文件更改历史记录Amendment History版次Revision更改日期Change Date更改概要Description of Changes更改人Prepared by批准人Approved byPrepared by编制Reviewed by审核Approved by批准ISO9001文件管理程序Document Control Procedure1.0 Purpose目的Define the requirements and responsibilities for Document control.定义出文件控制的要求和权责。
2.0 Scope范围This procedure applies to all QMS documentation, including: quality manual, procedure, WI, external document and form.适用于与质量管理体系有关的所有文件。
包括:手册、程序文件、操作指导书、外来文件及表单。
3.0 Definitions定义3.1 Quality Manual: According to the requirements of International and national standard (such as ISO9001), describe quality management system documentation in Co-active.3.1质量手册：根据相关国际或国家标准(如ISO9001)要求，阐述本公司质量管理体系的文件。
3.2 Procedure: Define the function of QMS requirement allocation bydepartment. Such as document control, management review, internalaudit procedure.3.2程序文件：描述为实施质量管理体系要求所涉及的各职能部门的活动的文件。
ISO9001-2015-标准中英文
ISO9001-2015-标准中英文ISO 9001：2015Quality management systems —Requirements质量管理体系-要求Introduction引言0.1 General 总则The adoption of a quality management system is a strategic decision for an organization that can helpto improve its overall performance and provide a sound basis for sustainable development initiatives.The potential benefits to an organization of implementing a quality management system based on this International Standard are:a) the ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements;b) facilitating opportunities to enhance customer satisfaction;c) addressing risks and opportunities associated with its context and objectives;d) the ability to demonstrate conformity to specified quality management system requirements.This International Standard can be used by internal and external parties.It is not the intent of this International Standard to imply the need for:—uniformity in the structure of different quality management systems;— alignment of documentation to the clause structure of this International Standard;— the use of the specific terminology of this International Standard within the organization.The quality management system requirements specified in this International Standard are complementary to requirements for products and services.This International Standard employs the process approach, which incorporates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking.The process approach enables an organization to plan its processes and their interactions.The PDCA cycle enables an organization to ensure that its processes are adequately resourced and managed, and that opportunities for improvement are determined and acted on.Risk-based thinking enables an organization to determine the factors that could cause its processes and its quality management system to deviate from the planned results, to put in place preventive controls to minimize negative effects and to make maximum use of opportunities as they arise (see Clause A.4).Consistently meeting requirements and addressing future needs and expectations poses a challenge for organizations in an increasingly dynamic and complex environment. To achieve this objective, the organization might find it necessary to adopt various forms of improvement in addition to correction and continual improvement, such as breakthrough change, innovation and re-organization.In this International Standard, the following verbal forms are used:—“shall” indicates a requirement;—“should” indicates a recommendation;—“may” indicates a permission;—“can” indicates a possibility or a capability.Information marked as “NOTE” is for guidance in understanding or clarifying the associated requirement.采用质量管理体系应该是组织的一项战略性决策，可以帮助组织改进其整体绩效，并为可持续发展计划提供良好的基础。
ISO9001-2015供应商控制程序(中英文)
供应商控制程序SUPPLIER Control PROCEDURE（ISO9001：2015）1.Purpose目的:1.1.To define supplier management procedure, and ensure that the suppliermaterial will follow DXC quality requirements.确立供应商管理程序，确保供应商之产品能满足DXC公司品质要求。
2.Scope范围:2.1.This procedure applies to all DXC suppliers.该程序适用于DXC公司所有供应商。
3.Reference Document参考文件3.1.Quality Manual 品质手册3.2.Purchasing Procedure 采购程序3.3.Incoming Quality Control Procedure进料品质控制程序3.4.IQC monthly report IQC月报3.5.Sourcing Procedure. 供应商开发程序4.Definition定义4.1.AVL– Approved supplier list 合格供应商清单4.2.CPAR –Corrective and preventive action request.纠正与预防措施申请4.3.P.O.–Purchase order.采购订单5.Responsibility职责：5.1.QA Department 品质部:5.1.1.R esponsible for the verification of the supplier’s qualitymanagement system, imposed requirement for the corrective and preventive action.负责确认供应商质量管理体系，纠正与预防措施的要求。
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文件控制程序
Document Control Procedure
（ISO9001：2015）
1.0 Purpose目的
Define the requirements and responsibilities for Document control.
定义出文件控制的要求和权责。
2.0 S cope范围
This procedure applies to all QMS documentation, including: quality manual, procedure, WI, external document and form.
适用于与质量管理体系有关的所有文件。
包括:手册、程序文件、操作指导书、外来文件及表单。
3.0 Definitions定义
3.1 Quality Manual: According to the requirements of International and national standard (such as ISO9001), describe quality management system documentation in Co-active.
3.1质量手册：根据相关国际或国家标准(如ISO9001)要求，阐述本公司质量管理体系的文件。
3.2 Procedure: Define the function of QMS requirement allocation by department. Such as document control, management review, internal audit procedure.
3.2程序文件：描述为实施质量管理体系要求所涉及的各职能部门的活动的文件。
如文件控制程序、管理评审控制程序、内部审核控制程序。
3.3 Working Instruction: Operation procedures, inspection standards, design drawing and etc.
3.3操作指导书：操作规程、检验标准、加工图纸等。
3.4 Form: Records of operation results.
3.4表单：用于记录作业结果所用的文件。
4.0 Procedure 程序
4.1 Responsible for the formulation of documents to file the proper approval, and timely send the electronic document and the paper version to DCC, ensure that the relevant departments to understand the change. Once the document released, the relevant departments must follow procedures. When the file changes do not affect the contents of the file (such as correcting typos, wording changes), it will not requires re-approval, but such changes must be notify DCC to ensure the consistency of documentation.
4.1文件的制订者负责使文件得到适当的审批后,及时将文件的电子版本和批准后的纸张版本交给文控,并确保相关部门理解文件。
一旦文件发放，各相关部门必须依程序执行。
当文件的修改不影响到文件内容(如纠正错别字,措辞修改)时,可以不进行版本升级,也就不需要重新审批,但是类似修改必须经过文控,以确保文件的各种形式保持一致。
4.2 Classification and description of controlled documents 文件的分类及受控说明
4.2.1 Documents classification文件的分类：
Quality management system documents chart as below:质量管理体系文件分为以下几类：
A一级:Quality Manual质量手册→
B二级:Procedure程序文件→
C三级:WI作业指导书→
D四级:Form记录
表单→
External documents, including the customer documents (procedure, products standards, drawing and etc. , standards organization documents (national/ international products/system standards.) laws and regulations, design operational instruction.
外来文件，包括来自顾客的文件（程序文件、产品规范、图纸等）、来自标准化组织的文件（国家和国际的产品标准及体系标准）及来自法制机构的文件、设施操作说明书等。
4.2.2 Document control 文件的受控说明
DCC issue the paper files with `controlled”stamp, issue the electronic files on S drive, Only DCC has the authority to amend the document, other users only has the authority to read.
经文控中心发行的纸档文件，每页均有跨页`受控`章的为受控文件;”受控的电子版文件保存在公共盘上，仅文控中心有修改权限，其它用户仅有只读权限。
4.3 Creation and review of documents 文件制定及评审过程
4.3.1 Creation of documents 文件的制定:。