ISO9001：2015质量手册
ISO9001-2015三体系质量手册(适用于五金行业)
XXX金属制品有限公司质量手册QUALITY MANUAL(依据ISO9001:2015标准)XX--QM--01版本：A/0编制：批准：状态：受控总目录0.1发布令0.2任命书0.3 质量方针和质量目标1范围2引用标准和术语2.1引用标准2.2通用术语和定义2.3专用术语3概况3.1公司概况3.2手册管理4组织环境4.1理解组织及其环境4.2理解相关方的需求和期望4.3确定质量管理体系的范围4.4质量管理体系及其过程5领导作用5.1领导作用和承诺5.2方针5.3组织的角色、职责和权限6策划6.1应对风险的机遇和措施6.2质量目标及其实现的策划6.3变更的策划7支持7.1资源7.2能力7.3意识7.4沟通7.5形成文件的信息8运行8.1运行策划和控制8.2产品和服务的要求8.3产品和服务设计和开发(不适用）8.4外部提供过程产品和服务控制8.5生产和服务提供8.6产品和服务的放行8.7不合格输出的控制9绩效评价9.1监视、测量、分析和评价9.2内部审核9.3管理评审10改进11 附录：附录1：组织机构图附录2：职能分配表0.1发布令为规范公司行为，保证产品质量满足顾客和法定要求，提高公司信誉和产品竞争能力，增强顾客满意，公司建立了系统化、文件化的质量管理体系。
该体系符合ISO9001：2015标准的要求，编制了《质量手册》，规定了质量管理体系的组织结构、管理职责和质量管理体系过程的控制要求。
根据公司发展和管理提升的需要，结合2015版标准等要求，经领导层决策，发布本《质量手册》。
《质量手册》阐述了我公司新阶段的质量方针和质量目标，是实施、保持公司质量管理体系的纲领性文件和进行质量管理的公司法规，也是向顾客提供质量保证的证实文件，并作为第三方质量管理体系认证的依据，要求全体员工必须严格贯彻执行。
从规定之日起实施。
特批准发布总经理:XXXX年1月1日0.2任命书为了更好贯彻执行ISO9001：2015标准，加强对质量管理体系的管理，特任命XXX 为本组织的管理代表。
ISO9001：2015质量手册-英文版
Quality Management System Policy ManualISO 9001:201511-8-17Date Printed: _______________1. Quality Management System ScopeCOMPANY NAME establishes this quality policy manual to implement and maintain a quality management system meeting the requirements of ISO 9001:2015, to ensure customer satisfaction in the manufacturing ofstamped, formed, machined and fabricated metal parts, weldments, subassemblies and painting ofmetal parts to customer and COMPANY NAME specifications1.1. Non-applicable Clauses of ISO 9001:1.1.1. 8.3 Product Design & Development of Products & Services – COMPANY NAME is acustommanufacturer and designs are provided by our customers.2. Quality Policy StatementCOMPANY NAME is committed to continually improving all products and services to achieve our customer’sexpectations.We do this by:1) Living our values,2) Providing opportunities for employee involvement, motivation and training,3) Developing, documenting and following processes.3. Quality ObjectivesCOMPANY NAME’s quality management system objectives are to enable COMPANY NAME to be our customers’ first choice by:1) Achieving satisfactory ratings on quality, delivery and other key metrics tracked and reportedby our customers through their formal supplier evaluation and performance systems,2) Achieving a level of 700 ppm as tracked through COMPANY NAME’s RA system for customers without aformal supplier evaluation system for quality,3) Achieving a 95% on-time delivery to the COMPANY NAME warehouse for customers without a formalsupplier evaluation system for delivery.Policy Manual Revisions LogDate 3/22/17 8/7/17Summary of RevisionsRewrite of Quality Policy Manual to meet ISO 9001:2015.1. Revised 4.2 to include “employees”, “owners” and“regulators”.Made ByJGVJGV2. Added Figure 2 to support to support the COMPANYNAME QMSProcess Flow11-8-17 Updated to clarify risk, inputs, out puts and KPI’s forSupport and Management Process in QMS ProcessReference page (page 6)JGVManagement ApprovalName: Title: Signature: Date: Paul Gintner President4. Context of the Organization4.1. Understanding the Organization & Its ContextTop Management determines the external and internal issues that are relevant to our qualitymanagement system and its strategic direction, and that affect our ability to achieve theintended results.COMPANY NAME is a contract manufacturer in a competitive market, therefore we must maintain on-time delivery, product quality, and good customer service. Our key internal issues are to maintainproduction capacities, including competent people, capable processes, and maintainedequipment.COMPANY NAME monitors and reviews information relevant to internal and external issues throughourmanagement review meetings.4.2. Understanding the Needs and Expectations of Interested PartiesDue to their potential effect on the organization’s ability to consistently provide products thatmeet customer requirements, Top Management determines:a) The interested parties that are relevant to the quality management system;b) The requirements of these interested parties that are relevant to the quality managementsystem.COMPANY NAME’s Top Management has determined that our customers, suppliers, employees, owners (Ottertail) and regulators (OSHA) are the interested parties that we need to be concerned withand will strive to meet their needs and expectations.Top Management monitors and reviews relevant measurements and information about theseinterested parties and their relevant requirements through management review meetings.4.3. Determining the Scope of the Quality Management SystemTop Management determines the boundaries and applicability of the quality managementsystem to establish its scope. (Ref. Section 1.)When determining this scope, Top Management has considered:a) The external and internal issues referred to in 4.1.b) The requirements of relevant interested parties.c) The products and services of the organization.We apply all the requirements of the standard that are applicable within the scope of the qualitymanagement system. With only one exclusion section 8.3 Product Design & Development ofProducts & Services - (Ref. Section 1.1.1)Top Management ensures the scope of the quality management system is available andmaintained, as documented in Section 1, including the types of products and services coveredby the quality management system, and justification for any requirements determined notapplicable to the scope of the quality management system.Top Management ensures conformity to the standard(s) referred to in Section 1, and that anyrequirements determined as not applicable do not affect our ability or responsibility to ensurethe conformity of our products and services and the enhancement of customer satisfaction.4.4. Quality Management System and Its Processes4.4.1. Top Management establishes, implements, maintains, and continually improves aquality management system, including the processes needed and their interaction, inaccordance with the requirements of the standard.Top Management determines the processes needed for the quality management systemand their application throughout the organization, and:a) Determines the inputs required and the outputs expected from these processes;b) Determines the sequence and interaction of these processes (Ref. Figure 1);c) Determines and applies the criteria and methods (including monitoring,measurements, and related performance indicators) needed to ensure the effectiveoperation and control of these processes;d) Determines the resources needed for these processes and ensures their availability;e) Assigns the responsibilities and authorities for these processes;f) Addresses the risks and opportunities as determined in accordance with Section6.1;g) Evaluates these processes and implements any changes needed to ensure thatthese processes achieve their intended results;h) Improves the processes and the quality management system.Figure 1 – Quality Management System ProcessesCOMPANY NAME QMS Process FlowCustomer Feedback Captured and Utilized for Continuous Improvement and FutureQuotesQuote Provided toCustomerOutputRiskMonitoringCustomer Places OrderCustomer RequirementsEDI/Forecast Inaccuracy andorder cancelationDaily forecast and orderconfirmationInputsRiskMonitoringOutputsInputsOrder Qty, Due date and ContainerJob CreatedChanging customer orders and WC capacity limitationsDaily exception reporting and weekly WC load meetings.RiskOutputsInputsMonitoringMaterial PurchasedMaterial needs, Due Date, Work Center AssignmentCommunication with Sales Team, Supplier Performance/Report CardsMaterial availability, SupplierOTDOutputsInputsRiskMonitoringDaily Exception Reporting, Communication withProduction and Daily Planners, Weekly Load Report MeetingJob PlannedProcess JobWC Capacity, BOM Item Availability, Man PowerMaterial Delivery DateOutputsInputsRiskMonitoringProductivity, MDI data, LPA program, Safety Audit, Delivery to the Warehouse, EQCP’s , Supplier Report CardsJob scheduled, Material Delivery, WC Load, ContainersMachine, Manpower, Tooling, Safety, Process Adherence, OSS OTD, Part QualityInputsOutputsInputsRiskMonitoringProduct Placed inInventoryDelivery to the Warehouse, Preservation of product, Inventory AccuracyLabeled Product and Inspection DataMDI Data, Random Inventory Audits, FIFO processes,OutputsInputsRiskMonitoringProduct Shipped to CustomerShort/Over shipments, late shipments, Understanding Customer Ship RequirementsPicking Verification Processes and Software, Customer Ship Notes, OTD to Customer, Shipping Errors Reported byCustomerLabeled Product and Inspection Data*See Figure 2 to reference specific processes that facilitate the COMPANY NAME QMS Process FlowCustomer Uses ProductFigure 2 – Quality Management System Reference ProcessesRev:11-08-17 Core Flow Processes Support Processes Management Processes Quote Provided to Customer * LAU2-001 Product Realization PRO2-002 Non-Conforming ProductSLS2-001 Quoting * LAU2-002 Part ManufacturingQualification PRO2-004 Production PartDeviationCHN2-005 Obsolete Part * LAU2-003 Proto Process* LAU2-010 New Customer LaunchProcess PRO2-005 Corrective Action*Launch (New Product) if applicable* LAU2-006 Customer Supplier GuideReview STD2-008STD2-003STD2-007STD2-004STD2-005COMPANY NAMEManagementReviewInternal AuditCustomer Places OrderSLS2-002 Process Customer OrdersSCH2-005 SCH2-001 SCH2-006 Supplier Assessment andSelectionEstablish New VendorLayered Process AuditJob CreatedMonitoring andMeasuring of ProcessesRisk Assessment MatrixOutsourcing In-HousePainted PartsMaterial PurchasedPRO2-008 Master Planning of DirectMaterialsHRE2-004 Onboarding EmployeesSHP2-002 Receive Material orService CHN2-001 ECN Engineering ChangeNotificationSCH2-004 Purchase IndirectMaterials or Services CHN2-003 Request for Operation orRate ChangeSee STD2-004 and STD2-005 forInputs/Outsputs/KPI's for all Supportand Management processesJob PlannedPRO2-007 Daily Production Planning STD2-002STD2-001BMS Document ControlBMS Document RevisionPRO2-009 Expedite CustomerOrdersSTD2-006 Records Control SCH2-003 Temporary OutsourcingProcess JobProduct Placed in Inventory PRO2-003 Part Production Color Key:Key ISO ProcessesCHN2-002 NSM Non-StandardManufacturingQMS Processes Flow Steps CHN2-004 QAD AdditionFAE2-007 LAU2-004 Work Center Transfer Container Designation ProcessPRO2-001 Monitoring andMeasuring of Product PRO2-006 Transfer of TemporaryWorkProduct Shipped to the Customer SHP2-001 Ship Customer Orders4.4.2. Top Management ensures the organization:a) Maintains documented information to support the operation of its processes;b) Retains documented information to have confidence that the processes are beingcarried out as planned.This documentation includes the “Quality Manual”, which consists of this Quality SystemPolicy Manual, as well as the quality system procedures, which are located andcontrolled as defined under documentation requirements per Section 7.5.5. Leadership5.1. Leadership & Commitment5.1.1. GeneralTop Management demonstrates leadership and commitment with respect to the qualitymanagement system by:a) Taking accountability for the effectiveness of the quality management system;b) Ensuring the quality policy statement and objectives are established for the qualitymanagement system and are compatible with the context and strategic direction ofthe organization;c) Ensuring the integration of the quality management system requirements into theorganization’s business p rocesses;d) Promoting the use of the process approach and risk-based thinking;e) Ensuring that the resources needed for the quality management system areavailable;f) Communicating the importance of effective quality management and of conformingto the quality management system requirements;g) Ensuring that the quality management system achieves its intended results;h) Engaging, directing, and supporting personnel to contribute to the effectiveness ofthe quality management system;i) j) Promoting improvement;Supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.5.1.2. Customer FocusTop Management demonstrates leadership and commitment with respect to customerfocus by ensuring that:a) Customer and applicable statutory and regulatory requirements are determined,understood, and consistently met;b) The risks and opportunities that can affect conformity of products and services andthe ability to enhance customer satisfaction are determined and addressed;c) The focus on enhancing customer satisfaction is maintained.5.2. Policy5.2.1. Establishing the Quality PolicyTop Management establishes, implements, and maintains a quality policy statementthat:a) Is appropriate to the purpose and context of the organization and supports itsstrategic direction;b) Provides a framework for setting quality objectives;c) Includes a commitment to satisfy applicable requirements;d) Includes a commitment to continual improvement of the quality managementsystem.5.2.2. Communicating the Quality PolicyTop Management ensures the quality policy statement is:a) Available and maintained as documented information, ref. Section 2;b) Communicated, understood, and applied within the organization;c) Available to relevant interested parties, as appropriate.5.3. Organizational Roles, Responsibilities, & AuthoritiesTop Management ensures that the responsibilities and authorities for relevant roles areassigned, communicated, and understood within the organization.Top Management assigns responsibility and authority for:a) Ensuring that the quality management system conforms to the requirements of thestandard, per Section 1;b) Ensuring that the processes are delivering their intended outputs;c) Reporting on the performance of the quality management system and on opportunities forimprovement , in particular to top management;d) Ensuring the promotion of customer focus throughout the organization;e) Ensuring that the integrity of the quality management system is maintained when changesto the quality management system are planned and implemented.6. Planning6.1. Actions to Address Risks & Opportunities6.1.1. When planning for the quality management system, Top Management considers theissues referred to in 4.1 and the requirements referred to in 4.2, and determines therisks and opportunities that need to be addressed to:a) Give assurance that the quality management system can achieve its intendedresult(s);b) Enhance desirable effects;c) Prevent, or reduce, undesired effects;d) Achieve improvement.6.1.2. Top Management plans:a) Actions to address these risks and opportunities;b) How to:1) Integrate and implement the actions into its quality management systemprocesses;2) Evaluate the effectiveness of these actions.Top Management ensures actions taken to address risks and opportunities shall beproportionate to the potential impact on the conformity of products and services.Top Management has addressed risks and opportunities through the implementation ofthe quality management system, specifically through the procedures and processeswe’ve defined with the intention to prevent risks an d address opportunities.6.2. Quality Objectives & Planning to Achieve Them6.2.1. Top Management establishes quality objectives at relevant functions, levels, andprocesses needed for the quality management system.Top Management ensures the quality objectives:a) Are consistent with the quality policy statement;b) Are measureable;c) Take into account applicable requirements;d) Are relevant to conformity of products and services and to enhancement ofcustomer satisfaction;e) Are monitored;f) Are communicated;g) Are updated as appropriate.Top Management maintains documented information on the quality objectives.6.2.2. When planning how to achieve its quality objectives, Top Management determines:a) What will be done;b) What resources will be required;c) Who will be responsible;d) When it will be completed;e) How the results will be evaluated.Top Management plans to achieve objectives by defining our quality managementsystem procedures and processes. Top Management evaluates results andimprovement actions through the management review process, including document andtracking actions.6.3. Planning of ChangesWhen the need for changes to the quality management system are determined, TopManagement ensures the changes are carried out in a planned manner, considering:a) The purpose of the changes and their potential consequences;b) The integrity of the quality management system;c) The availability of resources;d) The allocation or reallocation of responsibilities and authorities.7. Support7.1. Resources7.1.1. GeneralTop Management determines and provides the resources needed for the establishment,implementation, maintenance, and continual improvement of the quality managementsystem, considering:a) The capabilities of, and constraints on, existing internal resources;b) What needs to be obtained from external providers.7.1.2. PeopleTop Management determines and provides the personnel resources necessary for theeffective implementation of its quality management system and for the operation andcontrol of its processes.7.1.3. InfrastructureTop Management determines, provides, and maintains the infrastructure necessary for the operation of its processes and to achieve conformity of products and services.7.1.4. Environment for the Operation of ProcessesTop Management determines, provides, and maintains the environment necessary forthe operation of its process and to achieve conformity of products and services.7.1.5. Monitoring & Measuring Resources7.1.5.1. GeneralTop Management determines and provides resources needed to ensure validand reliable results when monitoring or measuring is used to verify theconformity of products and services to requirements, ensuring the resourcesprovided:a) Are suitable for the specific type of monitoring and measurement activitiesbeing undertaken;b) Are maintained to ensure their continuing fitness for their purpose.Top Management ensures appropriate documented information is retained asevidence of fitness for purpose of the monitoring and measurement resources.7.1.5.2. Measurement TraceabilityWhen measurement traceability is a requirement, or is considered to be an essentialpart of providing confidence in the validity of measurement results, the QualityDepartment ensures measuring equipment is:a) Calibrated or verified, or both, at specified intervals, or prior to use, againstmeasurement standards traceable to international or national measurementstandards; when no such standards exist, the basis used for calibration orverification are retained as documented information;b) Identified in order to determine their status;c) Safeguarded from adjustments, damage, or deterioration that would invalidate thecalibration status and subsequent measurement results.Assigned personnel determine if the validity of previous measurement results havebeen adversely affected when measuring equipment is found to be unfit for itsintended purpose, and take appropriate action as necessary.7.1.6. Organizational KnowledgeTop Management determines the knowledge necessary for the operation of itsprocesses and to achieve conformity of products and services.Top Management ensures this knowledge is maintained and made available to theextent necessary.When addressing changing needs and trends, Top Management ensures currentknowledge is considered and determines how to acquire or access any necessaryadditional knowledge and required updates.Top Management has addressed this requirement through the documented processes and procedures of the quality management system, as well as through the retainedinformation supporting the quality management system processes.。
ISO9001-2015版 质量手册
有限公司文件编号：CC-QM-2015质量手册编制：审核：批准：版本号：A1文件发放号：地址：电话：传真：邮编：修订记录目录1.0 前言1.1 手册说明1.2 质量手册颁布令1.3 公司简介2.0 规范性引用文件3.0 术语和定义4. 组织环境4.1 理解组织及其环境4.2 理解相关方的需求和期望4.3 确定质量管理体系的范围4.4.质量管理体系及其过程5 领导作用5.1 领导作用和承诺5.1.1总则5.1.2以顾客为关注焦点5.2 质量方针5.2.1制定质量方针5.2.2沟通质量方针5.3 组织的角色、职责和权限6策划6.1 应对风险和机遇的措施6.2 质量目标及其实现的策划6.3变更的策划7支持7.1 资源7.1.1 总则7.1.2 人员7.1.3 基础设施7.1.4 过程运行环境7.1.5监视和测量资源7.1.6组织知识7.2 能力7.3意识7.4 沟通7.5 形成文件的信息7.5.1总则7.5.2编制和更新7.5.3文件化信息的控制8运行8.1 运行策划和控制8.2 产品和服务的要求8.2.1顾客沟通8.2.2与产品和服务有关要求的确定8.2.3 与产品和服务有关要求的评审8.2.4 产品和服务要求的变更8.3产品和服务的设计和开发8.3.1总则8.3.2设计和开发的策划8.3.3设计和开发的输入8.3.4设计和开发的控制8.3.5设计和开发的输出8.3.6设计和开发的更改8.4外部提供过程、产品和服务的控制8.4.1总则8.4.2 控制类型与程度8.4.3 外部供方信息8.5生产和服务提供8.5.1生产和服务提供的控制8.5.2标识和可追溯性8.5.3顾客或外供方的财产8.5.4防护8.5.5交付后活动8.5.6变更的控制8.6产品和服务的放行8.7不合格输出的控制9绩效评价9.1监视、测量、分析和评价9.1.1总则9.1.2顾客满意9.1.3 分析与评价9.2内部审核9.3管理评审10改进10.1总则10.2不合格与纠正措施10.3持续改进附件1 程序文件清单附件2 组织结构图附件3 质量管理体系职能分配表1.前言1.1手册说明1.1.1 质量手册的编制在管理者代表领导下，由质量管理部组织编写。
ISO9001：2015版质量手册《附录清单》
程序文件目录
适用的法律法规及其他要求清单
JL-Q-4.1-01
附录3
作业文件清单
附录4
主要记录清单
附录5:
质量手册管理
4.4.1手册的编写
（1）本手册是公司质量管理体系手册，由公司管理者组织体系文件编写组进行编写，经总经理批准，颁布实施。
（2）本手册依据GB/T19001-2016 IDT ISO9001：2015《质量管理体系要求》标准并结合公司实际情况编制，作为质量管理的依据，以取信国内外顾客，并向顾客提供符合法律法规要求的产品和服务。
4.4.2手册的管理
（1）本手册的解释权归公司管理者代表。
（2）手册的发放范围由工程品质部提出，经管理者代表批准后，行政部负责组织发放、回收、销毁和作废。
（3）手册封面加盖“受控”或“非受控”标识。
“受控”手册为公司内部使用的有效版本，并向第三方认证机构报送；“非受控”手册经管理者代表批准，可用于投标或向认证咨询机构备案。
（4）手册实施后，由工程品质部定期组织有关部门对手册的适应性和有效性进行评审，并按《文件控制程序》中的规定对手册进行修改完善。
（5）“受控”手册修改时，由工程品质部统一负责；“非受控”手册不再跟踪修改。
（6）手册持有者应对手册进行妥善保管，不得损坏、丢失、随意涂改。
未经管理者代表批准，任何人不得将手册借给公司以外人员。
（7）手册持有者因岗位变动或调离本公司时，应将手册交回行政部并办理移交手续。
ISO9001：2015质量管理体系手册编写模板解析
ISO9001：2015质量管理体系⼿册编写模板解析⾸先是封⾯类似与以下：第⼆页⼀版是修定的页⾯：接下来是⽬录，⽬录是质量⼿册跟据ISO9001：2015版本中的条款对应编写，虽然2015版本已明确企业可根据⾃⾝的实际条件编写，在⼀定条件下也可省略质量⼿册，但那是不可能的，有以下⽅⾯：1、需要第三⽅体系认证需要系统的⽂件，根据⾃⼰编写可能，有些认证⽼师不认可。
2、标准中，每个条款就是最⼩的公司也需要⽤到，最多是合并在⼀起。
3、客户提出的第三⽅验⼚需要体系的认证证书，以及他们需要的体系⽂档，公司还是需要根据⾃⾝要要求每个岗位细节都需要管理，这就需要⼀个标准。
这还是需要质量⼿册⽂档。
以下是⼤⾄⽬录，可根据⾃⾝的要求进⾏删减，或都合并：0 引⾔0.1 发布令0.2 ⼿册说明0.3 术语和定义1 公司概况2 公司组织结构图、部门职责3 ⼿册章节4. 组织环境4.1 理解组织及其环境4.2 理解相关⽅的需求和期望4.3 确定质量管理体系的范围4.4.质量管理体系及其过程5 领导作⽤5.1 领导作⽤和承诺5.1.1总则5.1.2以顾客为关注焦点5.2 质量⽅针5.2.1本公司的质量⽅针 07 5.2.2沟通质量⽅针5.3 组织的岗位、职责和权限6策划6.1 应对风险和机遇的措施6.2 质量⽬标及其实现的策划6.3变更的策划7⽀持7.1 资源7.1.1 总则7.1.2 ⼈员7.1.3 基础设施7.1.4 过程运⾏环境7.1.5监视和测量资源7.1.6组织知识7.2 能⼒7.3意识7.4 沟通7.5 形成⽂件的信息7.5.1总则7.5.2创建和更新7.5.3形成⽂件的信息的控制8运⾏8.1 运⾏策划和控制8.2 产品和服务的要求8.2.1顾客沟通8.2.2产品和服务要求的确定8.2.3产品和服务要求的评审8.2.4 产品和服务要求的变更8.3产品和服务的设计和开发（如果没有设计和开发可删减）8.4外部提供的过程、产品和服务的控制8.4.1总则8.4.2 控制类型和程度8.4.3 提供给外部供⽅的信息8.5⽣产和服务提供8.5.1⽣产和服务提供的控制8.5.2标识和可追溯性8.5.3顾客或外部供⽅的财产8.5.4防护8.5.5交付后的活动8.5.6更改的控制8.6产品和服务的放⾏8.7不合格输出的控制9绩效评价9.1监视、测量、分析和评价9.1.1总则9.1.2顾客满意9.1.3 分析与评价9.2内部审核9.3管理评审9.3.1总则9.3.2管理评审输⼊9.3.3管理评审输出10改进10.1总则10.2不合格与纠正措施10.3持续改进具体内容如下：0.引⾔0.1发布令本⼿册是依据ISO9001:2015《质量管理体系要求》标准编制的质量管理体系纲领性⽂件,它阐述了公司的质量⽅针及质量⽬标，并对质量管理体系的过程顺序和相互作⽤进⾏了描述。
ISO9001：2015质量管理体系手册(模具加工行业)
XXX模具制造有限公司企业标准QM/XX-2020质量手册按ISO9001:2015要求编制版本号：A/0受控号：2020-5-1发布2020-5-1实施xxx有限公司发布修订记录目录批准令本《质量手册》是依据ISO9001：2015质量管理体系标准要求，结合本公司产品生产特点、生产规模和体制实际情况，为确保和提高产品质量，健全质量管理体系而编制。
本手册规定了本公司的质量方针和目标，对产品实现过程的持续改进、质量管理体系的有效运行规定了准则和方法。
本手册是本公司质量管理体系运行开展各项质量活动的指导性文件、法规性文件，现予以发布。
本公司全体员工务必认真学习，严格遵照执行，确保本手册得以认真有效的实施。
本手册于2020年五月一日起正式实施。
凡于本手册不一致的质量文件一律以本手册为准。
总经理：***2020年五月一日管理者代表任命书为了便于公司ISO9001质量管理体系的有效推行，由总经理任命***先生为本公司管理者代表，其职责和权限为：1、负责按ISO9001标准建立保持并经济有效地实施文件化质量体系，领导各职能部门开展质量活动；2、负责方针目标管理，及时向总经理汇报质量管理体系运行情况，负责质量管理体系内部审核的组织领导工作，并提供质量体系改进的依据和建议；3、负责组织贯彻实施企业经营管理决策、目标方针，完善各项管理制度，不断提高公司管理水平；4、领导内部质量审核活动，协调解决质量管理体系运行中的不一致等问题；5、负责做好对过程的监视和测量及数据分析的领导控制工作；6、负责质量管理体系有关事宜的外部联络工作；7、负责提高公司员工文化、生活水平，营造良好的作业环境和安全舒适的生活环境；8、负责公司重大纠正/预防措施的审批和组织实施。
总经理：***本公司宗旨：品质稳定----我们成功的基石公司的质量方针：开拓进取，群策群力；持续精进，客户满意。
释义：1、在当前的市场竞争中，保持质量管理体系运行的持续有效性是企业承诺的主题，其根本目的在于为社会和顾客提供满足要求的产品。
ISO9001-2015体系管理质量手册(母婴用品行业)
XXX集团有限公司质量手册ISO9001-2015文件编号：XX-XX-XX-XX版本状态: A/1编制：审核：批准：生效日期：2022年1月10日修订页签批页目录章节号标题页次第1章发布及任命令 (5)第2章公司概况 (6)第3章手册说明 (12)第4章组织环境 (13)4.1 理解组织及其环境 (13)4.2 理解相关方的需求和期望 (13)4.3 确定质量管理体系的范围 (14)4.4 质量管理体系及其过程 (14)第五章领导作用 (17)5.1 领导作用和承诺 (17)5.2 方针 (18)5.3 本公司的岗位、职责和权限 (18)第六章策划 (20)6.1 应对风险和机遇的措施 (20)6.2 质量目标及其实现的策划 (21)6.3 变更的策划 (22)第七章支持 (23)7.1 资源 (23)7.2 能力 (25)7.3 意识 (25)7.4 沟通 (26)7.5 形成文件的信息 (26)第八章运行 (28)8.1 运行策划和控制 (28)8.2 产品和服务的要求 (28)8.3 产品和服务的设计和开发 (30)8.4 外部提供过程、产品和服务的控制 (30)8.5 生产和服务提供 (32)8.6 产品和服务的放行 (34)8.7 不合格输出的控制 (34)第九章绩效评价 (36)9.1 监视、测量、分析和评价 (36)9.2 内部审核 (37)9.3 管理评审 (38)第十章持续改进 (40)10.1 总则 (40)10.2 不合格和纠正措施 (40)10.3 持续改进 (41)附件1：质量职能分配表 (42)附件2：产品实现流程图： (43)附件3：支持手册的程序文件清单 (44)附件4：公司组织结构图 (45)第1章发布及任命令1.1发布令为提高我公司的整体管理水平和核心竞争力，公司根据ISO9001：2015《质量管理体系―要求》标准建立了质量管理体系，编制了本《质量手册》，现批准正式发布。
服务型企业ISO9001-2015质量手册
本质量手册引用ISO9000：2015标准的相关术语和定义。
4.
4.1理解组织及其环境
各种影响公司战略方向和质量管理体系绩效的内部和外部因素（外部因素诸如：国内外法律、技术、竞争、文化、社会、经济和自然环境；内部因素诸如:：公司的知识、价值观和文化）是建立公司质量方针、质量目标以及风险分析的重要参考依据，应予以确定，并每年定期监视和评审。
2)努力识别影响顾客满意的各种风险和机遇，并采取措施积极应对；
5.2关于质量方针
质量方针是最高管理者正式发布的公司的质量管理的理念、意图和指南，务必谨慎制定并努力贯彻落实。
5.1.1制定质量方针
最高管理者负责制定公司质量方针，且方针应符合以下要求：
1)适应公司的宗旨和环境，支持其战略方向；
2)包括始终满足顾客要求和法规要求的承诺；
ISO9001:2015
（服务型企业）
1.范围
2.引用标准
3.术语和定义
4.组织环境
4.1理解组织及其环境
4.2理解相关方的需求和期望
4.3确定质量管理体系的范围
4.4质量管理体系及过程
5.领导作用
5.1领导作用和承诺
5.2质量方针
5.3组织的岗位、职责和权限
6.策划
6.1应对风险和机遇的措施
6.2质量目标及其实现的策划
6.
6.1风险和机遇的确定和应对
6.1.1策划质量管理体系和过程时，应考虑直接或间接影响公司绩效实现能力的各种内外部因素和相关方要求（4.1、4.2），并识别、评价、确定其中需应对的风险和机遇。公司建立《风险管理程序》，规定相关职责和管理过程，以达到以下目的：
a）确保质量管理体系目标的实现；
b）增强机遇带来的有利影响；
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附件2组织结构图
附件3质量管理体系职能分配表
1.0前言
1.1手册说明
本手册按照ISO9001:2015标准要求编写,适用于本公司生产及服务在质量管理中的应用。
本手册是本公司质量管理的纲领性、法规性文件,经最高管理者批准后生效,任何部门及个人必须遵照执行。为了将本手册中的规定落实到实际工作中去,本公司制订了一套程序文件及相应的作业指导书。
5.2质量方针
5.2.1制定质量方针
5.2.2沟通质量方针
5.3组织的角色、职责和权限
6策划
6.1应对风险和机遇的措施
6.2质量目标及其实现的策划
6.3变更的策划
7支持
7.1资源
7.1.1总则
7.1.2人员
7.1.3基础设施
7.1.4过程运行环境
7.1.5监视和测量资源
7.1.6组织知识
7.2能力
7.3意识
组织应考虑以下相关方：
--顾客；
--最终用户或受益人；
--业主，股东；
--银行；
--外部供应商；
--雇员及其他为组织工作者；
--法律法规及监管机关；
--地方社区团体；
--非政府组织；。
理解相关方的需求和期望可以帮助本公司更好的建立清晰的方针和目标，做到目的明确。满足相关方的要求并争取做到更高的期望值。具体见《相关方需求和期望控制程序》（QMS/B02-2016）。
8.5.3顾客或外供方的财产
8.5.4防护
8.5.5交付后活动
8.5.6变更的控制
8.6产品和服务的放行
8.7不合格输出的控制
9绩效评价
9.1监视、测量、分析和评价
9.1.1总则
9.1.2顾客满意
9.1.3分析与评价
9.2内部审核
9.3管理评审
10改进
10.1总则
10.2不合格与纠正措施
10.3持续改进
质量手册是规定组织质量管理体系的文件。它说明了本公司质量管理体系的范围，程序文件的提要，说明了产品和服务实现过程的顺序和相互关系，以及对它们的管理和控制办法。
本公司的“质量方针、质量目标”，它是我们企业的宗旨和方向，是企业领导向顾客所作的质量承诺，是我们全体职工努力追求的目标和过程活动的准则。
最高管理者负责对本公司质量管理பைடு நூலகம்系的建立、保持和改进，组织对职工进行质量意识教育，促进其树立以顾客为中心的指导思想。
ISO9001：2015质量手册
1.0前言
1.1手册说明
1.2质量手册颁布令
1.3 公司简介
2.0规范性引用文件
3.0术语和定义
4.组织环境
4.1理解组织及其环境
4.2理解相关方的需求和期望
4.3 确定质量管理体系的范围
4.4.质量管理体系及其过程
5领导作用
5.1领导作用和承诺
5.1.1总则
5.1.2以顾客为关注焦点
根据本公司产品和服务特点，未对标准进行删减。
对于本公司的外包过程也进行了充分识别，就公司目前生产运营情况，本公司暂无外包过程。
本手册分“受控”版和“非受控”版两种发放控制形式,作为受控版发放到本公司各部门负责人及以上职位之人员,非受控版发给外部单位或个人,以作宣传、介绍之用,所有受控版皆有各自的编号（非受控版不编号）,受控版由持有人妥善保管,不得丢失,并由持有人负责在所在部门贯彻实施,当手册正本发生修改时,各受控版本将随之修改,本公司不负责修改非受控版。
4.4质量管理体系及其过程
4.4.1本公司确保按照本标准的要求，建立、实施、保持和持续改进质量管理体系，包括所需过程及其相互作用。
本公司应确定质量管理体系所需的过程及其在整个组织中的应用，且应：
a) 确定这些过程所需的输入和期望的输出；
b) 确定这些过程的顺序和相互作用；
c) 确定和应用所需的准则和方法（包括监视、测量和相关的绩效指标），以确保这些过程的运行和有效控制；
d) 确定并确保获得这些过程所需的资源；
e) 规定与这些过程相关的的责任和权限；
8.3.2设计和开发的策划
8.3.3设计和开发的输入
8.3.4设计和开发的控制
8.3.5设计和开发的输出
8.3.6设计和开发的更改
8.4外部提供过程、产品和服务的控制
8.4.1总则
8.4.2控制类型与程度
8.4.3外部供方信息
8.5生产和服务提供
8.5.1生产和服务提供的控制
8.5.2标识和可追溯性
1.3 公司简介
略
2.0规范性引用文件
ISO9000:2015质量管理体系—基础和术语
3.0术语和定义
ISO9000:2015质量管理体系—基础和术语
4.0组织环境
4.1理解组织及其环境
最高管理者应确定与本公司质量目标和战略方向相关并影响实现质量管理体系预期结果的各种内部因素（公司的价值观、文化、知识、绩效等相关因素）和外部因素（国际、国家、地区和当地的各种法律法规、技术、竞争、文化和社会因素等）。这些因素可以包括需要考虑的正面和负面因素或条件。
4.3确定质量管理体系的范围
组织应明确质量管理体系的边界和适用性，以确定其范围。
在确定质量管理体系范围时，组织应考虑：
a）各种内部和外部因素，见4.1；
b）相关方的要求，见4.2；
C) 组织的产品和服务。
根据本组织产品和服务特点，标准的所有条款均适用于本组织并决定全部予以实施。
本公司质量管理体系的范围为：位于XX地址的XX产品的生产和服务。
7.4沟通
7.5形成文件的信息
7.5.1总则
7.5.2编制和更新
7.5.3文件化信息的控制
8运行
8.1运行策划和控制
8.2产品和服务的要求
8.2.1顾客沟通
8.2.2与产品和服务有关要求的确定
8.2.3与产品和服务有关要求的评审
8.2.4产品和服务要求的变更
8.3产品和服务的设计和开发
8.3.1总则
质量手册每年由最高管理者组织评审一次，若最高管理者认为有必要时也可随时组织评审，质量手册的管理执行本公司《文件控制程序》的规定。
1.2质 量 手 册 颁 布 令
为了满足顾客的要求和期望，切实保证本公司产品质量和服务质量，本公司按照ISO9001:2015《质量管理体系 要求》，编制了“质量手册”和“程序文件”、“作业文件”等一系列体系管理文件。
本公司定期对这些内部和外部因素的相关信息进行监视和评审，以确保其充分和适宜。
具体见《公司环境分析控制程序》（QMS/B01-2016)。
4.2理解相关方的需求和期望
公司应确定：
a）与质量管理体系有关的相关方；
b）这些相关方的要求；
公司应对这些相关方及其要求的相关信息进行监视和评审，以便于理解和持续满足相关方的需求和期望。