德信诚培训网 更多免费资料下载请进：https://www.doczj.com/doc/37510451.html, 好好学习社区 Document Control Procedure 文件管理程序 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 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 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,
文件控制程序 一、目的：对与组织质量管理体系有关的文件进行控制，确保各相关场所使用文件为有效版本。 二、范围：对与组织质量管理体系有关的文件进行控制，确保各相关场所使用文件为有效版本。 三、职责者：公司总经理、管理者代表、各部门负责收集。 四、内容： 1、职责 1.1总经理负责批准发布质量手册。 1.2管理者代表负责审核质量手册。 1.3各部门负责本部门相关文件的编制、使用和保管。 1.4办公室负责组织对现有体系文件的定期评审。 1.5各部门负责本部门与质量管理体系有关的文件的收集、整理和归档等。 2、程序 2.1文件分类及保管 2.1.1文件一级分类及代号 2.1.2 文件二级分类及代号 每一大类生产质量管理文件下，又规定作二级分类，即分为：
二类分类代号中的字母除SOP，SMP为英文缩写外，其它均为中文的拼音缩写。2.1.3第一级质量管理体系文件为质量手册，第二级质量管理体系文件为程序文件，由办公室备案保存。第三级质量管理体系文件，由各相关部门自行保存并报办公室 备案存档。 2.2文件的编号 2.2.1文件的编号与格式 编号格式 版本号（两位数字） 2.2.2 一级分类、二级分类、三级分类代号的编制按2.1.1、2.1.2的有关规定执行。 2.2.3 顺序号用三个阿拉伯数字表示，按文件编制的顺序排列。 2.2.4 版本号表示文件修订情况，文件的第一版用“00”表示，第一次修订用“01”表示，以后每次修订按顺序递增。 2.2.5例如： 程序文件《文件控制程序》编号：CX-SMP-001-00表示该文件是：程序文件 , 2.3文件的编写、审核、批准、发放文件发布前应得到批准，以确保文件是适宜的： a)质量手册由办公室负责组织编写，由管理者代表审核，上报总经理批准发布， 由办公室负责登记、发放； b)各部门工作文件由各部门负责人组织编写、汇总，由管理者代表审核，报总 经理批准，办公室负责登记、发放； c)应确保文件使用的各场所都应得到相关文件的适用版本。文件的发放、回收 要填写《文件发放、回收记录》。 2.4文件的受控状况 文件分为“受控”和“非受控”两大类，凡与质量体系运行紧密相关的文件应为受控，由各主管部门按规定执行。所有受控文件必须在该文件封面书写“受控”表 明其受控状态，并注明分发号。 2.5文件的修订或替换
文件控制程序 版本号： B 修改码： 0 LC/CX-7.5.3-07 1目的 本程序规定了质量管理体系文件编制、审批、发放及更改的管理，并规定了文件的标识、归档、保护、电子文档的管理和处置要求，确保各相关场所所用文件为有效版本。 2 范围 适用于与质量管理体系有关的所有文件的控制。 3 职责 3.1质量管理部是《质量手册》和程序文件的归口管理部门，负责《质量手册》和程序文件的编制、审批、发放、存档、回收及销毁。 3.2 人力资源部负责制定公司质量方针和质量目标。 3.3管理者代表负责审核质量手册/程序文件及公司质量方针和质量目标，总经理进行批准。 3.4质量管理部负责质量管理体系运行所需的外来文件得到识别和控制。 3.5质量管理部负责公司管理类文件的发布及归档保存；各主管部门负责相关管理类、技术类文件的编制，并组织评审，分管副总经理批准。 3.6各部门负责本部门文件的日常管理，确保文件的有效性。 4、程序 4.1 公司文件的分类及保管 公司文件分四个层级予以控制，分别为：质量手册、程序文件、执行文件、记录表单。 4.1.1 第一层级文件：《质量手册》，由质量管理部备案保存。 4.1.2 第二层级文件：程序文件，由质量管理部备案保存。 4.1.3 第三层级文件：支持性文件，包括管理类文件：如管理制度、管理规定等；技术类文件：如检验规程、操作规程、技术标准、作业指导书等；管理类文件由质量管理部备案，技术类文件由技术部档案室备案。 4.1.4 第四层级文件：质量记录表单，记录格式编制及修改按本程序进行控制，一般随相关文件一同审批。记录格式填写后形成的记录，依据《记录控制程序》进行管理。 4.2 质量管理体系文件编号 4.2.1 质量手册
These rules are supplemented to the QC Manual for material control. 1.Purchasing 1.1 The material requisition prepared by Design Dept. is the basis of material purchasing, and is supplemented with the purchase specification or drawings or other specific procedures which specifies requirements not covered by the material requisition. 1.2 The Purchase Department shall maintain a close contact with vendors and ask for information on procurement status and necessary documents from the vendor such as their procedures, the mill test reports or certificate of compliance etc, for reviewing by the Material QC Engineer. If necessary the Purchase Department will apply for source examination at vendor’s shop. 1.3 The Purchase Department Supervisor shall be responsible for purchasing materials. 1.4 The Purchase Engineer shall prepare the purchase order in accordance with the material requisition accompanying with its supplementary documents. The completed purchase order shall be approved by the Purchase Dept. Supervisor. The Purchase Engineer shall send the purchase order, accompanying with purchase specification as required, to the contracted vendor and also a copy to the Examination Section. 1.5 When any part of the specifications or contract conditions is amended, the revised Purchase Order shall be prepared in the same manner as the original. If the amendment is limited to condition which does not affect the quality or the technical matter, such as delivery date, the amended condition may be informed to the vendor by telephone or telex, and shall be noted on a copy of the Purchase Order retained by the Purchase Dept.. 1.6 All of the purchase orders shall be filed for reference. 2. Receiving Inspection and Storage 2.1 When materials are received, the Material Warehouse Keeper shall place the in-coming material and parts in designated area and request the Material QC Engineer for receiving inspection. 2.2 The receiving inspection/。n shall be made in accordance with the “Rules for Receiving Inspection”(QC P 02) 2.3 Acceptable materials for Code items shall be segregated from those materials for
文件管理与控制程序 Documents management and control procedure 1.目的Purpose 确保环境管理体系文件、适用的外来文件（有关的法律、法规、标准、相关方提供的文 件或规范）使用的有效性。To assure the 2.适用范围 scope 适用于对环境管理体系相关文件及适用的外来文件的控制。It is apply to the environment management system relation documents and usable external documents’ control. 3.职责Responsibility 3.1 环工组：负责环境管理体系文件及适用的外来文件的归口管理；负责监控文件的执行。 The environment team: to manage and be in charge of environment management documents and external documents. 3.2 各部门individual department：确保各相关场所均使用现行文件的有效版本。To ensure The relative workplace is using the current effective documents. 4.工作程序Work procedure 4.1文件控制范围包括：documents control’s scope a）环境管理手册；environment management manual; b）环境管理体系程序文件；environment management system procedure documents; c）环境管理体系作业指导文件；the work instruction documents for environment management system; d）环境记录表格；environment record form; e）外来文件。External documents. 4.2 文件的编写writing the documents 4．2．1环境管理手册和环境管理体系程序文件由环境管理者代表组织各部门人员编写。 Environment management manual and the environment management system procedure documents, which will be written by each department’s people that
编号：SY-AQ-01352 ( 安全管理) 单位：_____________________ 审批：_____________________ 日期：_____________________ WORD文档/ A4打印/ 可编辑 质量手册、程序文件的管理制 度 Management system of quality manual and procedure documents
质量手册、程序文件的管理制度 导语：进行安全管理的目的是预防、消灭事故，防止或消除事故伤害，保护劳动者的安全与健康。在安全管理的四项主要内容中，虽然都是为了达到安全管理的目的，但是对生产因素状态的控制，与安全管理目的关系更直接，显得更为突出。 1、目的与适用范围 为了确保在质量体系运行中的各个场所使用的文件是有效版本,特制 定本制度。 本制度适用于《质量手册》、《程序文件》的更改,发放和回收的管 理。 2、管理要求 2.1全质办是《质量手册》、《程序文件》的归口管理部门。 2.2《质量手册》、《程序文件》在贯彻实施过程中若发现差距或不 符合实际情况时,各职能部门要以书面形式反馈全质办,全质办向管理 者代表提出更改报告,填写文件更改通知单,经管理者代表报准后进行 更改、控版和回收。 2.3全质办指定专人负责《质量手册》、《程序文件》按规定范围进 行发放、更改和因收,对其使用和保管进行监控。
2.4全质办受管理者代表委托解释《质量手册》和《程序文件》的有关内容。 2.5技术科负责对《质量手册》、《程序文件》进行标准化审查。 2.6《质量手册》、《程序文件》持有者要保证其有固定的存放位置,以便在任何情况下都能对其进行更改、回收等。 2.7《质量手册》、《程序文件》持有者要妥善保管,不得丢失,不准外借,更 不准私自提供他人转抄或复印,若发现类似问题,应予以追究责任。 这里填写您的公司名字 Fill In Your Business Name Here
XX有限公司 文件编号： 版本版次： 制定部门： 制定日期： 修定日期： 总页次： 会签：
1.0 目的Purpose 建立公司采购过程的管理程序，对产品采购的过程及价格进行有效控制，以确保所采购的物品/服务质量能符合和满足公司的各项生产需求。 To establish a management procedure for purchasing process control, ensure to control the product purchasing process and price effectively, in order to ensure the products/service purchased can satisfy the company’s requirements and needs. 2.0 范围Scope 本文件适用于公司内部所有采购过程(指满足公司最终产品所需要的各种原材料、辅助材料、设备及维修材料、外协加工服务、工具以及其它物品的采购)。 This procedure apply to all purchase process happen in our company (all kinds of raw material, auxiliary material, equipments and maintain material, outside machining service, tooling and all other goods needed by the company’s production or work.) 3.0 适用文件Applicable documents 以下文件的最新版本有效 The latest issue of the following documents are effect. COP037 《供应商管理程序》
Ningbo XXX Material Technology Co.,Ltd ISO9001:2015 Quality Manual Revision [A/0] - [2018/3/1] (c) [Copyright Year Of 2018] [Ningbo XXX Material Technology Co.,Ltd]; all rights reserved. This document may contain proprietary information and may only be released to third parties with approval of management. Document is uncontrolled unless otherwise marked; uncontrolled documents are not subject to update notification.
Revision [A/0] - [2018/3/1] Page 1 of 19 TABLE OF CONTENTS 0.0 Revision History and Approval ...................................................................................................................... 3 1.0 Welcome to Ningbo XXX Material Technology Co.,Ltd ................................................................................ 4 2.0 XXX Material: Who We Are ........................................................................................................................... 4 2.1 Determining Our Strategic Direction ......................................................................................................... 4 2.2 Scope of the Management System ........................................................................................................... 4 2.2.1 Scope Statement ............................................................................................................................... 4 2.2.2 Facilities Within the Scope ................................................................................................................ 4 2.2.3 Permissible Exclusions ..................................................................................................................... 5 2.2.4 Scope of the ISO9001:2015 Quality Manual ..................................................................................... 5 3.0 Quality Policy................................................................................................................................................. 5 4.0 Management System Structure and Controls ............................................................................................... 5 4.1 Process Approach .................................................................................................................................... 5 4.1.1 Process Identification ........................................................................................................................ 5 4.1.2 Process Controls & Objectives .......................................................................................................... 6 4.1.3 Outsourced Processes ...................................................................................................................... 7 4.2 Documentation & Records ....................................................................................................................... 7 4.2.1 General .............................................................................................................................................. 7 4.2.2 Control of Documents ....................................................................................................................... 7 4.2.3 Control of Records ............................................................................................................................ 7 4.3 Change Management ................................................................................................................................ 8 4.4 Risks and Opportunities ............................................................................................................................ 8 5.0 Management & Leadership ........................................................................................................................... 8 5.1 Management Leadership and Commitment .............................................................................................. 8 5.2 Customer Focus ........................................................................................................................................ 9 5.3 Quality Policy ............................................................................................................................................. 9 5.4 Organizational Roles Responsibilities & Authorities ................................................................................. 9 5.5 Internal Communication ............................................................................................................................ 9 5.6 Management Review .............................................................................................................................. 10 6.0 Resources ................................................................................................................................................... 10 6.1 Provision of Resources ........................................................................................................................... 10 6.2 Human Resources .................................................................................................................................. 10 6.3 Infrastructure ........................................................................................................................................... 11 6.4 Work Environment ................................................................................................................................... 11 6.5 Organizational Knowledge ...................................................................................................................... 11 7.0 Operation ..................................................................................................................................................... 11 7.1 Operational Planning and Control ........................................................................................................... 12 7.2 Customer-Related Activities .................................................................................................................... 12 7.2.1 Capture of Customer Requirements ............................................................................................... 12 7.2.2 Review of Customer Requirements ................................................................................................ 12 7.2.3 Customer Communication ............................................................................................................... 12 7.3 Design and Development ........................................................................................................................ 13 7.4 Purchasing .............................................................................................................................................. 13 7.5 Provision of [Production of adhesive tape] .............................................................................................. 13 7.5.1 Control of Provision of [Production of adhesive tape] ..................................................................... 13 7.5.2 Identification and Traceability .......................................................................................................... 14 7.5.3 Property Belonging to Third Parties ................................................................................................ 14 7.5.4 Preservation .................................................................................................................................... 14 7.5.5 Post-Delivery Activities .................................................................................................................... 14 7.5.6 Process Change Control ................................................................................................................. 15 7.5.7 Measurement and Release of [Production of adhesive tape] ......................................................... 15 7.5.8 Control of Nonconforming Outputs .. 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ABC用品有限公司 质量管理体系程序文件 编制: 日期: 审核: 日期: 批准: 日期: 发放范围：公司各部门2013年10月01日生效
目录 序号章节名页码 1 目的Objective (2) 2 适用范围Applicable Scope (2) 3 职责Responsibility (2) 4 工作程序Work Procedures (3) 文件更改履历表 (7)
1 目的Objective 最高管理者按规定的时间间隔对质量体系现状进行评审，对所选定的质量体系的适宜性、有效性和充分性做出综合评价，保证满足标准的要求和实现质量方针及质量目标。 The top management shall review the present status of the quality s ystem at a specified time interval and make comprehensive assessment of its suitability, effectiveness and sufficienc y, e nsuring to meet the standards, quality policies and quality objectives. 2适用范围Applicable Scope 适用于最高管理者对现行的QS-9000:1998/ISO9001:1994质量体系的评审。 This is applicable to the review of QS-9000:1998 / ISO9001:1994 Quality System by the top management. 3职责Responsibility 3.1 公司总经理负责主持管理评审会议，审批管理评审报告，并对管理评审的全过程进行监督。 The General Manager is responsible to preside over the management review meeting, examine and approve the management review reports, and supervise the whole process of management review. 3.2 管理者代表负责向总经理汇报质量体系运行情况，提出改进建议，组织编写管理评审报告。负责组织 对管理评审中的持续改进、纠正预防措施的实施跟踪和验证 The management representative is responsible to report the status of quality system to the General Manager, submit improvement recommendations and formulate management review reports. It shall also responsible to follow and verify the continuous improvement and corrective & preventative actions as defined in management review. 3.3 各职能部门负责提供与本部门工作有关的评审资料，负责评审报告中所涉及的与本部门相关联的决定 的落实。 Each functional department is responsible to provide relevant information for review and implement the applicable decisions as in the review reports. 3.4 质量部负责编制管理评审计划，收集并提供管理评审所需的资料，负责对评审的纠正预防措施和持续 改进计划进行跟踪和验证，对管理评审资料整理归档。 The Quality Department is responsible to formulate management review plans, collect and provide necessary information for management review, follow and verify the corrective & preventative