ISO9001：2015内部审核程序英文版

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内部质量体系审核Internal Quality System Audit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内部质量体系审核Internal Quality System Audit1.0目的 Purpose:本程序规定了开展内部质量审核的策划，准备，实施，审核，报告，跟踪验证各阶段的控制要求和方法，以确定本公司的质量管理体系是否符合标准要求并得到有效地实施和保持。

This procedure give the methods and control requirements of internal quality audit planning, preparing, implementing, auditing, reporting and following-up, to ensure that the quality management system is in compliance with requirements and is implemented and maintained effectively.2.0范围Scope:适用于本公司内部质量管理体系审核及质量体系涉及的所有部门或个人。

FP internal audit and all departments and persons related to quality management system 3.0定义Definitions: N/A3.1IQAR:内部质量审核报告Internal Quality Audit Report3.2NC:不符项（不符合ISO要求的项目）Non-conformance (item against ISOrequirement.)a)Major严重不符合项: there are systematic problem, territorial problem,and the findings will cause the major result during the system run; 体系运行出现系统性失效，体系运行出现区域性失效，出现影响产品或体系运行的严重后果的不合格现象.b)Minor一般不合格项: aim at the systematic requirements, the finding isseparate, occasional and isolated minor problem; 对不满足质量体系过程或体系文件的要求而言，是个别的、偶然的、孤立的性质轻微的问题.。

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。

[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）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。

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。

Contents1Control of Internal Audits _________________________________________________________________________________ 3 1.1Introduction & Purpose _______________________________________________________________________________ 31.1.1 Process Activity Map _______________________________________________________________________________ 31.1.2 References _________________________________________________________________________________________ 31.1.3 Terms & Definitions ________________________________________________________________________________ 3 1.2Application & Scope __________________________________________________________________________________ 4 1.3Responsibilities ________________________________________________________________________________________ 4 1.4Controlling Internal Audits ___________________________________________________________________________ 41.4.1 Selecting Internal Auditors ________________________________________________________________________ 41.4.2 Developing the Audit Programme _________________________________________________________________ 41.4.3 Preparing for the Audit ____________________________________________________________________________ 41.4.4 Conducting the Audit ______________________________________________________________________________ 51.4.5 Data Review & Initial Reporting ___________________________________________________________________ 51.4.6 Monitoring _________________________________________________________________________________________ 51.4.7 Final Reporting _____________________________________________________________________________________ 51.4.8 Review _____________________________________________________________________________________________ 5 1.5Conducting Audits ____________________________________________________________________________________ 51.5.1 System Audits ______________________________________________________________________________________ 51.5.2 Process Audits _____________________________________________________________________________________ 61.5.3 Supplier Audits _____________________________________________________________________________________ 61.5.4 Legislation Audits __________________________________________________________________________________ 7 1.6Corrective Action ______________________________________________________________________________________ 7 1.7Forms & Records ______________________________________________________________________________________ 7 1.8Internal Audit Process Map ___________________________________________________________________________ 81.2Application & ScopeThe scope of this procedure is focused on assessing the effectiveness of your organization’s quality management system. Where such processes are found to be deficient, the audit will lead to improvement in those processes. By applying the principles of auditing, outlined by ISO 19011:2011, your organization ensures that all internal audits are conducted with due professional care, integrity and independence. All conclusions derived from the audit are based upon objective and traceable evidence.1.3ResponsibilitiesIt is the responsibility of the Quality Manager<amend as appropriate> to coordinate the whole internal audit programme. The Quality Manager<amend as appropriate> is required to:∙Determine the root causes of non-conformities;∙Maintain a system for reporting audit results;∙Determine conformity to planned arrangements;∙Determine proper implementation and maintenance;∙Provide the results of audits to top management;∙Review the effectiveness of corrective actions taken.1.4Controlling Internal Audits1.4.1 Selecting Internal AuditorsTo ensure impartiality and objectivity, the audit team will include personnel from departments not directly associated with the area, process or department being audited. The Internal Auditors are selected on the basis of their:∙Education: secondary or higher;∙Work Experience: more than 5 years;∙Relevant Training: provided in-house or externally;∙Audit Experience: demonstrable knowledge/skills.1.4.2 Developing the Audit ProgrammeThe Quality Manager<amend as appropriate>is required to:∙Determine the status and importance of each process;∙Establish audit frequency based on the status and importance of each process;∙Develop and communicate the audit schedule;∙Appoint audit team leader where required;∙Select audit team;∙Assign audit duties to the auditor team.1.4.3 Preparing for the AuditThe Internal Auditors <amend as appropriate>are required to:∙Review relevant management system documents and records;∙Determine their adequacy with respect to the audit criteria and with ISO 9001;∙Review and prepare the internal audit checklist;The audit team then reviews the process inputs and outputs using the Turtle Diagram at the front of this procedure. The audit is conducted using the ISO 9001-2015 Supplier Audit Checklist.1.5.4 Legislation AuditsAt least once per year, audit is conducted on the scope and applicability of the register of applicable legislation in order to verify continued compliance. Using the register of legislation, the auditor determines the most significant legislation applicable to our organization at the time of the audit, by taking a sample and seeking objective evidence that the legislation is current and is being complied with.Samples of legislation are noted and the register brought up to date as required. The samples taken are selected based on current risks but ensures that the whole register is audited at least once in each 3 year period.1.6Corrective ActionThe corrective actions are identified on the Internal Audit, Non-conformity & Correct Action Tracker along with the person responsible and the timescales for completion. The process or procedure is re-audited and the issue closed out when all corrective actions are completed. A member of the audit team will then sign off the audit report. An audit summary is prepared for management review.1.7Forms & RecordsAll documentation and records generated by the internal audit process are retained and managed in accordance with the Control of Documented Information procedure.。

1Purpose1.1This procedure has been developed by MAS Solutions to define the requirements for theperiodic review of this Business Management System (BMS), to ensure that it continues to meetthe requirements of its intended use with regards to BMS policy, objectives, effectiveness,resources, planning and improvement.2General2.1It is the responsibility of Management Representative to ensure that:2.1.1The business management system is reviewed at least once annually to ensure itscontinued suitability and effectiveness.2.1.2The minutes of the meeting are recorded.2.1.3Any actions are identified and taken as decided.2.1.4Opportunities for improvement are identified and implemented.3Review Frequency3.1 A Management Review must be held at least annually (once per year) to address all parts ofMAS’ Business Management System:3.1.1To determine whether it is operating effectively to the benefit of the Company.3.1.2To identify opportunities for improvement.3.1.3To determine whether MAS is continuing to meet legal, regulatory and contractualrequirements.3.1.4To prevent nonconformity.3.1.5To identify risks and opportunities.4Review Attendance4.1The meeting must be attended by Top Management, with other staff as appropriate. Thismeeting shall be scheduled and chaired by the Management Representative.5Review Agenda5.1As a minimum, the Management Review meeting must address the following topics:5.1.1The status of actions from previous management reviews;5.1.2Changes in external and internal issues that are relevant to the BMS;5.1.3Feedback on BMS performance, including trends in:•Client satisfaction and feedback from relevant interested parties;•The extent to which BMS objectives have been met•Process performance and conformance of products and services;•Nonconformities and corrective actions;•Monitoring and measurement results;•Audit results; and•The performance of external providers;5.1.4Adequacy of resources;5.1.5The effectiveness of actions taken to address risks and opportunities; Opportunities forimprovement.5.2Outputs of the management review shall include decisions and actions related to opportunitiesfor improvement, any need for changes to this BMS, and resource needs.5.3The person responsible for any actions identified at the meeting must be recorded togetherwith target dates for completion where appropriate. The Company must allocate the necessarypersonnel and resources for these corrective actions.6Review Records6.1The minutes of the meeting must be recorded and copies must be provided to all personnelwho attended the meeting together with those who have actions placed upon them.6.2Records of Management Reviews shall be maintained in accordance with BMS.0750,Documented Information.7Revision HistoryRevision Date Description of Change Approval0 11/01/15 Initial Release SR。

ISO 9001:2015Compa ny: Clie nt- no.:DateLead Auditor(s)Note:1 Objective audit evide nee shall be docume nted and uploaded to iCert.2This Audit questi on list is reeomme nded as the primary source of docume ntatio n of objective audit evide nces. Alter natively, audit no tes, process sheets, etc. could be used.3As a rule, documented audit evidence (audit question list, audit notes or process sheets) should be completed separately for each audit and for each site (if applicable), for the pert inent process eleme nts.4The evaluatio n can be en tered in the audit evaluati on colu mn (E): 1 = Con formity (in cludi ng pote ntial for improveme nt, where applicable). 2 = Minor noncon formity (lower-level non-con formity). 3= Noncon formity (major noncon formity)n.a. = not applicable5The final result of the evaluati on shall always be docume nted in the action list (Ann ex1)Compa ny:Clie nt- no.:Requireme nts (Audit notes identified withAudit no tes“ * ” are to be reported in the Audit Report)(Implementation / Documented Information / reviewed evidence ...)Order- no.:4 Con text of the orga ni zati on4.1Understanding the org. and its contextdetermine external and internal issues monitor and reviewinfo.4.2Understanding the needs and expectations ofinterested partiesdetermine:a)the interested parties relevant to the QMSb)the req. of these interested parties monitor and review info. about interested parties and their relevant req.4.3Determining the scope of theQMSdetermine the boundaries and applicabilityof the its scope.consider:a)the external and internal issuesb)the req. of relevant interested partiesc)the prods & servs of the org.apply all the req. of this Standard if they are applicable within the scope of its QMS. The scope shall be docu. info . state the types of prods and servs covered, and provide justification for any req. not applicable. *Min. of 1 ex.: context of the org.*Min. of 1 ex.: interested parties*Min. of 1 ex.:statutory/regulatory req.*Appropriateness of scope:4.4 QMS and its processes *Min. of 1 ex.:Order- no.:Order- no.:Order- no.:Compa ny:Clie nt- no.:Requireme nts (Audit notes identified withAudit no tes“ * ” are to be reported in the Audit Repoit)(Implementation / Documented Information / reviewed evidence ...)Order- no.:resources:a)are suitable for the specific type of monitoring andmeasurementb)are maintained to ensure their fitness retain docu. Info. of fitness for purpose of monitoring and measurement resources.measuring equipment shall be:a)calibrated or verified, or both, at specified intervals, to measurement standards; when no standards exist, the basis for calibration shall be retained as docu. Info.b)identified to determine thestatusc)safeguarded from adjustments, damage or deteriorationdetermine if the validity of previous measurement results has been adversely affected when measuring equipment is found unfit for its intended purpose, and take action .7.1・6 Organizational knowledgedetermine knowledge for the operation of its processes and conformity of prods & servs.knowledge shall be maintained and made available.When addressing changing needs and trends, consider current knowledge and determine how to acquire additional knowledge and required updates.7.2 Competencea)determine the competence of person(s)b)ensure that persons are competentc)actions to acquire the necessary competence, evaluate the effectiveness of the actionsd)retain docu. Info. of competence7.3Awarenessensure that persons are aware of:a)Q-policyb)Q-objectivesc)their contribution to the QMS, including the benefits of improved performanced)implications of not conforming with the QMS req.7.4Communicationdetermine the communications relevant to the QMS:a)whatb)whenc)with whomd)how *Evidence of fitness for purpose of monitoring and measurement resources:*Evidence of basis used for calibration or verification (if applicable):*Min. of 1 ex.:Order- no.:Order- no.:Order- no.:Order- no.:。

FINAL DRAFTISO/TC 176/SC 2 Secretariat: BSI Voting begins on:2015­07­09 Voting terminates on:2015­09­09RECIPIENTS OF THIS DRAFT ARE INVITED TOSUBMIT, WITH THEIR COMMENTS, NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE AND TO PROVIDE SUPPOR TING DOCUMENTATION.IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFTINTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THELIGHT OF THEIR POTENTIAL TO BECOMESTANDARDS TO WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.INTERNATIONAL ISO/FDISSTANDARD 9001Quality management systems — RequirementsSystèmes de management de la qualité — ExigencesPlease see the administrative notes on page iii质量管理体系 要求ISO/FDIS 9001:2015(E)ii© ISO 2015 – All rights reservedISO/CEN PARALLEL PROCESSINGThis final draft has been developed within the International Organization for Standardization (ISO), and processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement. The final draft was established on the basis of comments received during a parallel enquiry on the draft. This final draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel two-month approval vote in ISO and formal vote in CEN. Positive votes shall not be accompanied by comments.Negative votes shall be accompanied by the relevant technical reasons.COPYRIGHT PROTECTED DOCUMENT© ISO 2015, Published in SwitzerlandAll rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of the requester.ISO copyright officeCh. de Blandonnet 8 • CP 401CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47copyright@ ISO/FDIS 9001:2015(E)© ISO 2015 – All rights reservediiiContents 目录Foreword 前言0 Introduction 引言0.1 General 总则0.2 Quality management principles 质量管理原则0.3 Process approach 过程方法0.4 Relationship with other management system standards 与其他管理体系标准的关系1 Scope 范围2 Normative references 规范性引用文件3 Terms and definitions 术语和定义4 Context of the organization 组织环境4.1 Understanding the organization and its context 理解组织及其环境4.2 Understanding the needs and expectations of interested parties 理解相关方的需求和期望4.3 Determining the scope of the quality management system 确定质量管理体系的范围4.4 Quality management system and its processes 质量管理体系及其过程5 Leadership5.1 Leadership and commitment 领导作用和承诺5.1.1 General 总则5.1.2 Customer focus 以顾客为关注焦点5.2 Policy 方针5.2.1 Developing the quality policy 制定质量方针5.2.2 Communicating the quality policy 沟通质量方针5.3 Organizational roles, responsibilities and authorities 、职责和权限组织的岗位领导作用ISO/FDIS 9001:2015(E)6 Planning for the quality management system 质量管理体系策划6.1 Actions to address risks and opportunities 应对风险和机遇的措施6.2 Quality objectives and planning to achieve them 质量目标及其实现的策划6.3 Planning of changes 变更的策划7 Support 支持7.1 Resources 资源7.1.1 General 总则7.1.2 People 人员7.1.3 Infrastructure 基础设施7.1.4 Environment for the operation of processes 过程运行环境7.1.5 Monitoring and measuring resources 监视和测量资源7.1.6 Organizational knowledge 组织的知识7.2 Competence 能力7.3 Awareness 意识7.4 Communication 沟通7.5 Documented information 形成文件的信息7.5.1 General 总则7.5.2 Creating and updating 创建和更新7.5.3 Control of documented information 形成文件的信息的控制8 Operation 运行8.1 Operational planning and control 运行的策划和控制8.2 Determination of requirements for products and services 产品和服务要求的确定8.2.1 Customer communication 顾客沟通8.2.2 Determination of requirements related to products and services与产品和服务有关的要求的确定8.2.3 Review of requirements related to products and services与产品和服务有关的要求的评审8.2.4 Change to requirements for products and services 产品和服务要求的更改iv© ISO 2015 – All rights reservedISO/FDIS 9001:2015(E)8.3 Design and development of products and services 产品和服务的设计和开发8.3.1 General 总则8.3.2 Design and development planning 设计和开发策划8.3.3 Design and development Inputs 设计和开发输入8.3.4 Design and development controls 设计和开发控制8.3.5 Design and development outputs 设计和开发输出8.3.6 Design and development changes 设计和开发更改8.4 Control of externally provided processes, products and services外部提供过程、产品和服务的控制8.4.1 General 总则8.4.2 Type and extent of control 控制类型和程度8.4.3 Information for external providers 外部供方的信息8.5 Production and service provision 生产和服务提供8.5.1 Control of production and service provision 生产和服务提供的控制8.5.2 Identification and traceability 标识和可追溯性8.5.3 Property belonging to customers or external providers 顾客或外部供方的财产8.5.4 Preservation 防护8.5.5 Post-delivery activities 交付后的活动8.5.6 Control of changes 更改控制8.6 Release of products and services 产品和服务的放行8.7 Control of nonconforming process outputs 不合格输出的控制9 Performance evaluation 绩效评价9.1 Monitoring, measurement, analysis and evaluation 监视、测量、分析和评价9.1.1 General 总则9.1.2 Customer satisfaction 顾客满意9.1.3 Analysis and evaluation 分析与评价9.2 Internal audit 内部审核© ISO 2015 – All rights reserved vISO/FDIS 9001:2015(E)9.3 Management review 管理评审9.3.1 General 总则9.3.2 Management review input 管理评审输入9.3.3 Management review output 管理评审输出10 Improvement 改进10.1 General 总则10.2 Nonconformity and corrective action 不合格和纠正措施10.3 Continual improvement 持续改进Annex A (informative) Clarification of new structure, terminology and concepts附录A（资料性附录）新结构、术语和概念说明Annex B (informative) Other International Standards on quality management and qualitymanagement systems developed by ISO/TC176附录B（资料性附录）ISO/TC176 开发的其他有关质量管理和质量管理体系的国际标准Bibliography 参考文献vi© ISO 2015 – All rights reservedISO/FDIS 9001:2015(E) Foreword 前言ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for whicha technical committee has been established has the right to be represented on that committee.International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see /directives).Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patentrights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see /patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO’s adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL:/iso/foreword.html.The committee responsible for this document is Technical Committee ISO/TC 176, Quality management and quality assurance, Subcommittee SC 2, Quality systems.This fifth edition cancels and replaces the fourth edition (ISO 9001:2008), which has been technically revised, through the adoption of a revised clause sequence and the adaptation of the revised quality management principles and of new concepts.© ISO 2015 – All rights reserved viiISO/FDIS 9001:2015(E)viii© ISO 2015 – All rights reservedIntroduction 引言0.1 General 总则The adoption of a quality management system is a strategic decision for an organization that can help to improve its overall performance and provide a sound basis for sustainable development initiatives.采用质量管理体系是组织的一项战略决策，能够帮助其提高整体绩效，基础。

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。