ISO90012015质量手册-英文版

1、Quality Management SystemPolicy ManualISO 9001:201511-8-17Date Printed: Quality Man ageme nt System Policy Ma nualRevisio n: 11-8-171. Quality Man ageme nt System ScopeCOMPANY NAME establishes this quality policy man ual to impleme nt and mai ntain a quality man ageme nt system meeti ng the requirem

2、e nts of ISO 9001:2015, to en sure customer satisfaction in themanu facturi ng ofstamped, formed, machi ned and fabricated metal parts, weldme nts, subassemblies and pai nting of metal parts to customer and COMPANY NAME specificati ons1.1. Non-applicable Clauses of ISO 9001:1.1.1. 8.3 Product Desig

3、n & Developme nt of Products & Services COMPANY NAME is acustomman ufacturer and desig ns are provided by our customers.2. Quality Policy Stateme ntCOMPANY NAME is committed to continually improving all products and services to achieve our customer s expectati ons.We do this by:1) Liv ing our values

4、,2) Providi ng opport un ities for employee in volveme nt, motivati on and trai ning,3) Develop ing, docume nti ng and follow ing processes.3. Quality ObjectivesCOMPANY NAME s quality management system objectives are to enableCOMPANY NAMEto be our customers choice by:1) Achievi ng satisfactory rati

5、ngs on quality, delivery and other key metrics tracked and reported by our customers through their formal supplier evaluati on and performa nee systems,2) Achieving a level of 700 ppm as tracked through COMPANY NAME s RA system for customers without a3) fAcmial/sreuip|ailier5%aouatiiioiie sdetemr it

6、(q tiaiity, OMPANY NAME warehouse for customers without a formal supplier evaluation system for delivery.Policy Man ual Revisi ons LogDateSummary of Revisio nsMade By3/22/17Rewrite of Quality Policy Manual to meet ISO 9001:2015.JGV8/7/171. Revised 4.2 to include“ employees ” ,“ owners ” and“ regulat

7、ors ”.2. Added Figure 2 to support to support the COMPANY NAME QMSJGV11-8-17Updated oWarify risk, i nputs, out puts and KPIs forSupport and Man ageme nt Process in QMS ProcessRefere nee page (page 6)JGVMan ageme nt ApprovalSig nature:Date:Name:Title:Paul GintnerPreside ntPri nted copies are uncon tr

8、olled.COMPANY NAME Quality System Policy Ma nual -2015 (1)Page 7 of 19COMP Quality Management System Policy ANY Manual NAME Revision: 11-8-174. Context of the Organization4.1. Understanding the Organization & Its ContextTop Management determines the external and internal issues that are relevant to

9、our quality management system and its strategic direction, and that affect our ability to achieve the intended 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

10、 to maintain production capacities, including competent people, capable processes, and maintained equipment.COMPANY NAME monitors and reviews information relevant to internal and external issues through ourmanagement review meetings.4.2. Understanding the Needs and Expectations of Interested Parties

11、Due to their potential effect on the organizations 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

12、quality management system.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 with and will strive to meet their needs and expectations.Top Management monitors and revi

13、ews relevant measurements and information about these interested 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 management system to establ

14、ish 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

15、 applicable within the scope of the quality management system. With only one exclusion section 8.3 Product Design & Development of Products & Services - (Ref. Section 1.1.1)Top Management ensures the scope of the quality management system is available and maintained, as documented in Section 1, incl

16、uding the types of products and services covered by the quality management system, and justification for any requirements determined not applicable to the scope of the quality management system.Top Management ensures conformity to the standard(s) referred to in Section 1, and that any requirements d

17、etermined as not applicable do not affect our ability or responsibility to ensure the conformity of our products and services and the enhancement of customer satisfaction.Quality Management System PolicyManual Revision: 11-8-174.4. Quality Management System and Its Processes4.4.1. Top Management est

18、ablishes, implements, maintains, and continually improves aquality management system, including the processes needed and their interaction, in accordance with the requirements of the standard.Top Management determines the processes needed for the quality management system and their application throu

19、ghout 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 in

20、dicators) needed to ensure the effective operation 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 accord

21、ance with Section 6.1;g) Evaluates these processes and implements any changes needed to ensure that these processes achieve their intended results;h) Improves the processes and the quality management system.COMP ANY NAMEQuality Man ageme nt System Policy Ma nualRevisio n: 11-8-17Figure 1-Quality Man

22、 ageme nt System ProcessesCOMPA NY NAME QMSProcess FlowOutputCustomer Feedback Capturedand Utilized for Con ti nu ousImproveme nt and FutureQuotesQuote Provided toCustomerInputsRiskCustomerRequireme ntsOrder Qty, Due dateand ContainerInputsOutputsInputsCustomerPlaces Order* Job CreatedOutputsMateria

23、l Delivery DateInputsOutputs -InputsJob scheduled, Material Delivery, WC Load, Contain ersOutputsJob PlannedProcess JoLabeled Product andIn specti on DataInputsk Product Placed in-Inventory(EDI/Forecast In accuracy andorder can celati onRiskMon itori ngZDaily forecast and ordercon firmati onMonitori

24、ngRiskMaterial availability, SupplierOTDMon itori ngComm uni cati on with Sales4 Team, Supplier Performa nee/Report CardsRiskfWC Capacity, BOM ItemAvailability, Man PowerVJMon itori ngDaily Excepti on Report ing,Comm un icati on withProducti on and Daily Pla nn ers,. .Weekly Load Report Meeti ngRjsk

25、f :Mach ine, Man power, Tooli ng,Safety, Process Adhere nee, 卜OSS OTD, Part Quality 】Mon itori ngProductivity, MDI data, LPA program, Safety Audit, Delivery to the Warehouse, . EQCP Supplier Report CardsRjskMonitoringDelivery to the Warehouse,Preservati on of product,Inven tory AccuracyMDI Data, Ran

26、 dom Inven tory Audits, FIFO processes, .Customer UsesProduct .*See Figure 2 to refere nee specific processes that facilitate the COMPANY NAME QMSProcess FlowQuality Man ageme nt System Policy Ma nualRevisio n: 11-8-17Figure 2 -Quality Man ageme nt System Refere nee ProcessesRev:11-08-17Core Flow Pr

27、ocessesSupport ProcessesMan ageme nt ProcessesQuote Provided to CustomerSLS2-001 QuotingCHN2-005 Obsolete Part*Launch (New Product) if applicableCustomer Places OrderSLS2-002 Process Customer Orders_AU2-001Product Realization_AU2-002Part Manufacturing QualificationAU2-003Proto Process_AU2-010New Cus

28、tomer Launch Process_AU2-006Customer Supplier Guide ReviewPRO2-002Non-Conforming ProductPRO2-004Production PartDeviationPRO2-005Corrective ActionJob CreatedMaterial PurchasedPRO2-008Master Planning of DirectMaterialsSHP2-002Receive Material orServiceSCH2-004Purchase Indirect Materials or ServicesSCH

29、2-005Supplier Assessment and SelectionSCH2-001Establish New VendorSCH2-006Outsourcing In-HousePainted PartsCHN2-001ECN Engineering Change NotificationCHN2-003Request for Operation or Rate ChangeSTD2-008COMPANY NAME ManagementSTD2-003ReviewInternal AuditSTD2-007Layered Process AuditSTD2-004Monitoring

30、 andMeasuring of ProcessesSTD2-005Risk Assessment MatrixHRE2-004Onboarding EmployeesSee STD2-004 and STD2-005 forInputs/Outsputs/KPIs for all Support and Management processesJob PlannedPRO2-007Daily Production PlanningPRO2-009Expedite CustomerOrdersSCH2-003Temporary OutsourcingSTD2-002BMS Document C

31、ontrolSTD2-001BMS Document RevisionSTD2-006Records ControlProcess JobProduct Placed in InventoryPRO2-003Part ProductionCHN2-002NSM Non-Standard ManufacturingCHN2-004QAD Addition.FAE2-007Work Center TransferLAU2-004Container DesignationProcessPRO2-001Monitoring andMeasuring of ProductPRO2-006Transfer

32、 of TemporaryWorkColor Key: Key ISO ProcessesQMS Processes Flow Steps Product Shipped to the Customer SHP2-001Ship Customer OrdersCOMPANYNAMEQuality Management System PolicyManualRevision: 11-8-174.4.2. Top Management ensures the organization:a) Maintains documented information to support the operat

33、ion of its processes;b) Retains documented information to have confidence that the processes are being carried 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 and controll

34、ed 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 quality management system by:a) Taking accountability for the effectiveness of the quality management system

35、;b) Ensuring the quality policy statement and objectives are established for the quality management system and are compatible with the context and strategic direction of the organization;c) Ensuring the integration of the quality management system requirements into the organization s business rpoces

36、ses;d) Promoting the use of the process approach and risk-based thinking;e) Ensuring that the resources needed for the quality management system are available;f) Communicating the importance of effective quality management and of conforming to the quality management system requirements;g) Ensuring t

37、hat the quality management system achieves its intended results;h) Engaging, directing, and supporting personnel to contribute to the effectiveness of the quality management system;i) Promoting improvement;j) Supporting other relevant management roles to demonstrate their leadership as it applies to

38、 their areas of responsibility.5.1.2. Customer FocusTop Management demonstrates leadership and commitment with respect to customer focus by ensuring that:a) Customer and applicable statutory and regulatory requirements are determined, understood, and consistently met;b) The risks and opportunities t

39、hat can affect conformity of products and services and the 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 qual

40、ity policy statement that:a) Is appropriate to the purpose and context of the organization and supports its strategic 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

41、quality management system.5.2.2. Communicating the Quality PolicyTop Management ensures the quality policy statement is:a)b)c)Available and maintained as documented information, ref. Section 2; Communicated, understood, and applied within the organization; Available to relevant interested parties, a

42、s appropriate.5.3.Organizational Roles, Responsibilities, & AuthoritiesTop Management ensures that the responsibilities and authorities for relevant roles are assigned, communicated, and understood within the organization.Top Management assigns responsibility and authority for: a)b)c)d)e)Ensuring th

43、at the quality management system conforms to the requirements of the standard, per Section 1;Ensuring that the processes are delivering their intended outputs;Reporting on the performance of the quality management system and on opportunities for improvement , in particular to top management;Ensuring

44、 the promotion of customer focus throughout the organization;Ensuring that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.Printed copies are uncontrolled.COMPANY NAME Quality System Policy Manual -2015 (1)Page 9

45、of 196. Planning6.1. Actions to Address Risks & OpportunitiesGive assurance that the quality management system can achieve its intended result(s);Enhance desirable effects; Prevent, or reduce, undesired effects;Achieve improvement.6.1.1. When planning for the quality management system, Top Managemen

46、t considers the issues referred to in 4.1 and the requirements referred to in 4.2, and determines the risks and opportunities that need to be addressed to:a) b)c)d)6.1.2. Top Management plans:a) Actions to address these risks and opportunities;b) How to:1) Integrate and implement the actions into it

47、s quality management system processes;2) Evaluate the effectiveness of these actions.Top Management ensures actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products and services.Top Management has addressed risks and opportunities

48、through the implementation of the quality management system, specifically through the procedures and processes we ve defined with the intention to prevent risks and address opportunities.6.2. Quality Objectives & Planning to Achieve ThemCOMPANYNAMEQuality Management System PolicyManual Revision: 11-

49、8-176.2.1. Top Management establishes quality objectives at relevant functions, levels, and processes 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 requirem

50、ents;d) Are relevant to conformity of products and services and to enhancement of customer 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 objecti

51、ves, 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 management system procedures and processes. Top Manag

52、ement evaluates results and improvement actions through the management review process, including document and tracking actions.6.3. Planning of ChangesWhen the need for changes to the quality management system are determined, Top Management ensures the changes are carried out in a planned manner, co

53、nsidering: 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 provi

54、des the resources needed for the establishment, implementation, maintenance, and continual improvement of the quality management system, considering:a) The capabilities of, and constraints on, existing internal resources;b) What needs to be obtained from external providers.7.1.2. PeopleTop Managemen

55、t determines and provides the personnel resources necessary for the effective implementation of its quality management system and for the operation and control of its processes.7.1.3. InfrastructurePri nted copies are uncon trolled.COMPANY NAME Quality System Policy Ma nual -2015 (1)Page 11 of 19COM

56、PANYNAMEQuality Management System PolicyManualRevision: 11-8-17Top 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 for the operation of its process and to achieve conformity of products and services.7.1.5. Monitoring & Measuring Resources. GeneralTop Management determines and provides resources needed to ensure valid and reliable results when mo