ISO9001：2015内部审核报告英文版
ISO9001：2015全套文件英文版(含质量手册及全套程序文件)
Ningbo XXX Material TechnologyCo.,LtdISO9001:2015 Quality ManualRevision [A/0] - [2018/3/1](c) [Copyright Year Of 2018] [Ningbo XXX Material Technology Co.,Ltd]; all rights reserved. This document may contain proprietary information and may only be released to third parties with approval of management. Document is uncontrolled unless otherwise marked; uncontrolled documents are not subject to update notification.Revision [A/0] - [2018/3/1]Page 1 of 19TABLE OF CONTENTS0.0 Revision History and Approval ...................................................................................................................... 3 1.0 Welcome to Ningbo XXX Material Technology Co.,Ltd ................................................................................ 4 2.0 XXX Material: Who We Are ........................................................................................................................... 4 2.1 Determining Our Strategic Direction ......................................................................................................... 4 2.2 Scope of the Management System ........................................................................................................... 4 2.2.1 Scope Statement ............................................................................................................................... 4 2.2.2 Facilities Within the Scope ................................................................................................................ 4 2.2.3 Permissible Exclusions ..................................................................................................................... 5 2.2.4 Scope of the ISO9001:2015 Quality Manual ..................................................................................... 5 3.0 Quality Policy................................................................................................................................................. 5 4.0 Management System Structure and Controls ............................................................................................... 5 4.1 Process Approach .................................................................................................................................... 5 4.1.1 Process Identification ........................................................................................................................ 5 4.1.2 Process Controls & Objectives .......................................................................................................... 6 4.1.3 Outsourced Processes ...................................................................................................................... 7 4.2 Documentation & Records ....................................................................................................................... 7 4.2.1 General .............................................................................................................................................. 7 4.2.2 Control of Documents ....................................................................................................................... 7 4.2.3 Control of Records ............................................................................................................................ 7 4.3 Change Management ................................................................................................................................ 8 4.4 Risks and Opportunities ............................................................................................................................ 8 5.0 Management & Leadership ........................................................................................................................... 8 5.1 Management Leadership and Commitment .............................................................................................. 8 5.2 Customer Focus ........................................................................................................................................ 9 5.3 Quality Policy ............................................................................................................................................. 9 5.4 Organizational Roles Responsibilities & Authorities ................................................................................. 9 5.5 Internal Communication ............................................................................................................................ 9 5.6 Management Review .............................................................................................................................. 10 6.0 Resources ................................................................................................................................................... 10 6.1 Provision of Resources ........................................................................................................................... 10 6.2 Human Resources .................................................................................................................................. 10 6.3 Infrastructure ........................................................................................................................................... 11 6.4 Work Environment ................................................................................................................................... 11 6.5 Organizational Knowledge ...................................................................................................................... 11 7.0 Operation ..................................................................................................................................................... 11 7.1 Operational Planning and Control ........................................................................................................... 12 7.2 Customer-Related Activities .................................................................................................................... 12 7.2.1 Capture of Customer Requirements ............................................................................................... 12 7.2.2 Review of Customer Requirements ................................................................................................ 12 7.2.3 Customer Communication ............................................................................................................... 12 7.3 Design and Development ........................................................................................................................ 13 7.4 Purchasing .............................................................................................................................................. 13 7.5 Provision of [Production of adhesive tape] .............................................................................................. 13 7.5.1 Control of Provision of [Production of adhesive tape] ..................................................................... 13 7.5.2 Identification and Traceability .......................................................................................................... 14 7.5.3 Property Belonging to Third Parties ................................................................................................ 14 7.5.4 Preservation .................................................................................................................................... 14 7.5.5 Post-Delivery Activities .................................................................................................................... 14 7.5.6 Process Change Control ................................................................................................................. 15 7.5.7 Measurement and Release of [Production of adhesive tape] ......................................................... 15 7.5.8 Control of Nonconforming Outputs .. (15)Revision [A/0] - [2018/3/1]Page 2 of 198.0 Improvement ............................................................................................................................................... 15 8.1 General .................................................................................................................................................... 15 8.2 Customer Satisfaction ............................................................................................................................. 15 8.3 Internal Audit ........................................................................................................................................... 16 8.4 Corrective and Preventive Action ............................................................................................................ 16 Appendix A: Overall Process Sequence & Interaction ........................................................................................ 17 Appendix B: ISO 9001:2015 Cross Reference . (18)Revision [A/0] - [2018/3/1] 0.0 Revision History and ApprovalRev. Nature of changes Approval DateA/0 Original release. XXX 2018/3/1Page 3 of 19Revision [A/0] - [2018/3/1] 1.0 Welcome to Ningbo XXX Material Technology Co.,LtdNingbo XXX Material Technology Co., Ltd. Was established in 2000, with the UAE businessmen to build the joint venture company; 2004 Ming Shan founded Nissin special adhesive tape and adhesive tape company; 2008 due to the strategic adjustment of 3 company merger and reorganization, the establishment of Ningbo letter mountains adhesive products Manufacturing Co., Ltd..PVC insulation tape is one of China’s national standard drafting unit, the field of adhesive products governing unit of China, Ningbo, adhesives and related products Industry Association, honorary president of the unit.We produce more than 1000 varieties of products of 11 categories. The annual throughput more than 100,000,000 square of the adhesive and 10,000 ton of the adhesive.Our company located in Ningbo which the city of the east China sea, beside 500 kilometers of shanghai, 20 kilometers from Ningbo list airport and 50 kilograms of the Ningbo seaport. The transport is very convenient (Easy to ship to everywhere on the world).2.0 XXX Material: Who We Are2.1 Determining Our Strategic DirectionXXX Material has reviewed and analyzed key aspects of itself and its stakeholders to determine the strategic direction of the company. This involves:∙Understanding our core products and services, and scope of management system (see 2.2 below).∙Identifying “interested parties” (stakeholders) who receive our [Production of adhesive tape], or who may be impacted by them, or those parties who may otherwise have a significant interest in our company. These parties are identified in the document [Requirements and expectations list of interested parties].∙Understanding internal and external issues that are of concern to XXX Material and its interested parties; also identified in the document [Requirements and expectations list of interested parties]. Many such issues are identified through an analysis of risks facing either XXX Material or the interested parties. Such issues are monitored and updated as appropriate, and discussed as part of management reviews.This information is then used by senior management to determine the company’s strategic direction. This is defined in records of management review, and periodically updated as conditions and situations change.2.2 Scope of the Management System2.2.1 Scope StatementBased on an analysis of the above issues of concern, interests of stakeholders, and in consideration of its products and services, XXX Material has determined the scope of the management system as follows:Production of adhesive tapePage 4 of 19Revision [A/0] - [2018/3/1]Page 5 of 192.2.2 Facilities Within the ScopeThe quality system applies to all processes, activities and employees within the company. The facility is located at: Factory Add ：XXX Tel ：XXX Fax ：XXX XXX XXX2.2.3 Permissible ExclusionsThe following clauses of ISO 9001 were determined to be not applicable to XXX Material.∙ 8.3 Design and development of products and services 2.2.4Scope of the ISO9001：2015 Quality ManualThis manual is prepared for the purpose of defining the company’s interpretations of the ISO 9001:2015 international standard, as well as to demonstrate how the company complies with that standard.This manual does not follow the numbering structure of ISO 9001. Instead, Appendix B presents a cross reference between the sections of this manual and the clauses of ISO 9001:2015.This manual presents “Notes” which are used to define how XXX Material has tailored its management system to suit its purposes. These are intended to clarify implementation approaches and interpretations for concepts which are not otherwise clearly defined in ISO 9001:2015. Notes appear in italics, with gray background.Where subordinate or supporting documentation is reference in this manual, these are indicated by bold italics .∙ Quality PolicyThe Quality Policy of XXX Material is as follows:Quality first, customer satisfaction;Scientific management, continuous improvement. ∙ Management SystemStructure and Controls 4.1Process Approach4.1.1 Process IdentificationXXX Material has adopted a process approach for its management system. By identifying thetop-level processes within the company, and then managing each of these discretely, this reduces the potential for nonconforming [Production of adhesive tape] discovered during final processes or after delivery. Instead, nonconformities and risks are identified in real time, by actions taken within each of the top-level processes.Note: not all activities are considered “processes” – the term “process” in this context indicates the activity has been elevated to a higher level of control and management oversight.The controls indicated herein are applicable only to the top-level processes identified.。
ISO9001内部质量体系审核(中英文)
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.。
ISO9001-2015管理评审程序(中英文)
管理评审程序ManagementReviewControlProcedure（ISO9001：2015）1.0目的Purpose:建立一个文件化的系统规范公司管理评审活动的进行，确保管理体系的适宜性、充分性和有效性。
Thepurposeofthisprocedureistohaveasystemtocontrolthemanagementreview activitytoensurethecontinualsuitability,adequacyandeffectivenessofma nagementsystem.2.0范围Scope:适用于质量与环境管理评审活动的控制。
ThisprocedureisapplicabletothecontrolofQMSandEMSmanagementreviewinFl extronicsPlasticsTechnology(Shenzhen)Co.,Ltd.3.0定义Definition:无No.4.0职责和权限Responsibilityandauthority：4.1总经理:负责主持管理评审活动。
GeneralManager:GMshouldbethechairmanofthemanagementreviewmeeting.4.2管理者代表:负责管理评审计划的制定,落实及组织协调工作；负责评审报告的整理发放及改善行动的跟踪验证工作。
Managementrepresentative:MRshouldpreparemanagementreviewplan,carryou tandcoordinatethemanagementreviewmeeting;preparemanagementreviewrepo rtandfollowup/verifycorrectiveandpreventiveactions.4.3各有关部门:负责准备并提供与本部门工作有关的评审所需的资料，并对涉及本部门的不符合采取纠正或预防措施。
ISO9001：2015内部审核计划英文版
Date Scheduled
Date Conducted
Lead Auditor
OFI
Start by customCAizing PA
the
SETUP
form
tab
OFI
usingCAthe
PA
first.OFI
CA
PA
CA
PA
OFI
PA
OFI
CA
PA
OFI
If you need to unlock this form to access all the cells, click REVIEW -> UNPROTECT SHEET
ISO 9001 Clause
4.1 Understanding the Context 4.2 Interested Parties 4.3 Determining the Scope 4.4 QMS Processes 5.1 Leadership & Commitment 5.2 Policy 5.3 Organizational Roles Resp & Authorities 6.1 Risks and Opportunities 6.2 Quality Objectives 6.3 Planning of Changes 7.1.1 Resources: General 7.1.2 People 7.1.3 Infrastructure 7.1.4 Environment 7.1.5 Monitoring and Measuring Resources 7.1.6 Organizational Knowledge 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented Information 8.1 Operational Planning and Control 8.2.1 Customer Communication 8.2.2 Determining the Requirements 8.2.3 Review of Requirements 8.2.4 Changes to Requirements 8.3.1 Design & Development: General 8.3.2 Design and Development Planning 8.3.3 Design and Development Inputs 8.3.4 Design and Development Controls 8.3.5 Design and Development Outputs 8.3.6 Design and Development Changes 8.4 Control of Externally Provided… 8.5.1 Control of Production… 8.5.2 Identification and Traceability 8.5.3 Property Belonging to Customers … 8.5.4 Preservation 8.5.5 Post-Delivery Activities 8.5.6 Control of Changes 8.6 Release of Products and Services 8.7 Control of Nonconforming Outputs 9.1 Monitoring, Measurement… 9.2 Internal Audit 9.3 Management Review 10.1 Improvement: General 10.2 Nonconformity and Corrective Action 10.3 Continual Improvement
ISO 9001 2015 中英文
strategic direction of the organization. Management of the processes and the system as a whole can be achieved using the PDCA cycle (see 0.3.2) with an overall focus on risk-based thinking (see 0.3.3) aimed at taking advantage of opportunities and preventing undesirable results.The application of the process approach in a quality management system enables:a) understanding and consistency in meeting requirements; b) the consideration of processes in terms of added value; c) the achievement of effective process performance;d) improvement of processes based on evaluation of data and information.Figure 1 gives a schematic representation of any process and shows the interaction of its elements. The monitoring and measuring check points, which are necessary for control, are specific to each process and will vary depending on the related risks.Figure 1 — Schematic representation of the elements of a single process0.3.2 Plan-Do-Check-Act cycleThe PDCA cycle can be applied to all processes and to the quality management system as a whole. Figure 2 illustrates how Clauses 4 to 10 can be grouped in relation to the PDCA cycle.NOTE Numbers in brackets refer to the clauses in this International 维（见0.3.3）对过程和整个体系进行管理，旨在有效利用机遇并防止发生不良结果。
ISO9001-2015_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。
ISO 9001 2015 中英文
strategic direction of the organization. Management of the processes and the system as a whole can be achieved using the PDCA cycle (see 0.3.2) with an overall focus on risk-based thinking (see 0.3.3) aimed at taking advantage of opportunities and preventing undesirable results.The application of the process approach in a quality management system enables:a) understanding and consistency in meeting requirements; b) the consideration of processes in terms of added value; c) the achievement of effective process performance;d) improvement of processes based on evaluation of data and information.Figure 1 gives a schematic representation of any process and shows the interaction of its elements. The monitoring and measuring check points, which are necessary for control, are specific to each process and will vary depending on the related risks.Figure 1 — Schematic representation of the elements of a single process0.3.2 Plan-Do-Check-Act cycleThe PDCA cycle can be applied to all processes and to the quality management system as a whole. Figure 2 illustrates how Clauses 4 to 10 can be grouped in relation to the PDCA cycle.NOTE Numbers in brackets refer to the clauses in this International 维（见0.3.3）对过程和整个体系进行管理，旨在有效利用机遇并防止发生不良结果。
ISO9001：2015内部审核程序英文版
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.。
ISO9001：2015管理评审程序英文版
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。
ISO90012015内审检查表-英文版
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.:。
ISO 9001 2015 FDIS版 中英文版
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。
ISO9001：2015一整套程序文件英文版
ISO9001：2015一整套程序文件英文版Procedure: [Change Mgmt Doc Title]1.0SUMMARY1.1.The purpose of this procedure is to define the methods for managing changes to processes andother aspects of the management system in a controlled manner.1.2.Where this document discusses changes to processes, this shall be understood to mean the top-level processes identified in the [Quality Manual Doc Title].1.3.The [who?] is responsible for implementation and management of this procedure.2.0REVISION AND APPROVALRev.Date Nature of Changes Approved By[RevNumber][Date of Issue]Original issue.[Procedure Approver Name]3.0CHANGES TO PROCESSES3.1.Management system processes will undergo changes, typically when:3.1.1.Improvement opportunities have been identified, typically to improve processeffectiveness3.1.2.Nonconformities within a process are identified and require corrective action3.1.3.Conditions in the industry or company change, requiring a process to be updated3.1.4.New processes are added which impact on existing processes, requiring changes3.1.5.Customer requirements result in a need to change processes3.1.6.Any other reason determined by management3.2.In such cases, the process must be changed in a controlled manner to ensure proper authorizationand implementation of the changes.3.3.At a minimum, process changes shall include the steps herein:3.3.1.The request for a process change shall be documented, typically in a [CAR Form Name]per the procedure [Corrective Preventive Action Proc. Title]. The justification for thechange shall be recorded.3.3.2.The change shall be reviewed by appropriate management, including the senior mostmanager responsible for the process. Changes must be approved prior toimplementation.3.3.3.The appropriate [Process Definition Doc Title] will be updated to reflect the change.This document will undergo review and approval per the procedure [Control ofPage 1 of 2Documents Proc. Title]. The revision indicator of the [Process Definition Doc Title] willbe incremented, and the nature of the change recorded. [ Delete last sentence if youare not using Process Definition documents.]3.3.4.The follow-up verification step of the [CAR Form Name] process shall seek to ensurethe change has had the intended effect, and/or has improved the process. If not, thechange may be rolled back or a new change made to correct any new issues that ariseas a result of the change.4.0CHANGES TO DOCUMENTATION4.1.Management system documents undergo changes when there is a need to revise them.4.2.Changes to documentation are done in accordance with the procedure [Control of DocumentsProc. Title].5.0CHANGES TO ORDERS OR CONTRACTS5.1.Changes to active orders or contracts may occur when the customer changes the requirementsafter the work has begun, or may be initiated by [Short Client Name] when unforeseencircumstances are encountered.5.2.Changes to orders or contracts are done in accordance with the procedure [Quoting and OrdersDoc Title].Page 2 of 2Procedure: [Identification & Traceability Proc. Title]1.SUMMARY1.1.This procedure defines the methods used to identify and (where applicable) provide uniquetraceability for [Short Client Name] products. This procedure includes methods:1.1.1.To define the methods for identifying products (what they are)1.1.2.To define the methods for identifying products as to their current inspection or teststatus1.1.3.To define the methods for segregating and discriminating between product andtooling when their appearance is similar1.1.4.To define the methods for providing traceability, including unique serialization, orproduct as applicable1.2.The [who?] is responsible for implementation and management of this procedure.2.REVISION AND APPROVALRev.Date Nature of Changes Approved By[Rev Number][Date ofIssue]Original issue.[ProcedureApproverName]3.APPLICATION3.1.This procedure applies to all departments which use, handle, transport, store, inspect ormanufacture product, raw materials and tooling, at all [Short Client Name] facilities.3.2.This procedure not only applies to typical product, but also deliverables from services, such asreports, schedules, etc.3.3.Non-critical materials or supplies, which are not incorporated into final product or which serveonly to support facilities or operations, are not subject to this procedure.4.DEFINITIONS4.1.Product4.1.1.“Product” includes any of the following:∙Any part, assembly or item ordered by the customer∙Deliverable reports or documents∙Product may refer to finished product, or work in process (WIP)Page 1 of 44.2.Raw Materials4.2.1.“Raw materials” include any of the following:∙Any materials or items (metals, plastics, components, pre-built assemblies, small parts) which become part of the finished product’s physical construction; some of these itemsmay sometimes be referred to as “consumables”.∙Coatings, paint, plating, adhesives, chemicals or materials which will be incorporated into (or onto) the final product.4.3.Tooling4.3.1. “Tooling” can include any of the following:∙Devices used by manufacturing for setup or production, including fixtures and jigs.∙Devices used by inspection for determining acceptance of product, including test fixtures.∙Shop aids, which are simple devices (blocks, spacers, shapes) used to assist in production or development, but which are not precision tools and which can be usedfor a variety of applications.4.3.2.Tooling does not include:∙Cutting tools, drill bits, etc.∙Hand tools∙Machining equipment5.PRODUCT5.1.There are many ways to identify product; this procedure presents the most typical, acceptablemethods. Additional product identification methods may be called out in the design or production documentation.5.2.Identification typically includes the part number, revision, Work Order # and unique serialnumber (if applicable).5.3.Identification is done through any of the following methods:5.3.1.Part marking, by way of ink marking, etching or some other method.5.3.2.Bag-and-tag methods, especially for small parts.5.3.3.Placement of parts on shelves or in containers that are properly marked, withsignage or other methods.5.3.4.Placement of parts near associated paperwork, for the purpose of identification andtraceability, may be used if the paperwork can clearly be identified as relating to theparts in question, typically by way of the inclusion of a drawing which can becompared to the product.5.3.5.Segregating entire areas of the production floor with belt stanchions and attachedsignage, indicating what type of items are allowed, or disallowed, within the enclosedarea.Page 2 of 45.4.Where unique serialization is required for traceability, the parts shall be identified with a serialnumber in accordance with customer requirements, or in a manner developed to ensure that no two parts are given the same number. Serial number logs may be used to control this; workorders shall reference the serial numbers under which the unique parts were built.5.5.All product may be assumed to be inspected and/or tested and found to be acceptable for use ifidentified in accordance with the rules above, unless it is marked as nonconforming product. For the methods of identifying nonconforming product, see procedure [Control of NCP Proc. Title].6.RAW MATERIALS6.1.Raw materials requiring traceability back to heat lot numbers, manufacturer lot or batchnumbers, certificates of conformity or analysis, etc., must be marked in a way that provides this traceability. This is typically done by marking the raw materials with the [Short Client Name]purchase order number under which the items were purchased, and the supplier’s lot number.6.2.When raw materials are used, any remaining material that will be returned to stock and used inthe future must be re-identified before re-entry into inventory.6.3.Raw materials which are determined to require identification and traceability, but which lacksuch identification, may not be used for flight hardware. These may be used for tooling stock or other non-product purposes.6.4.All raw materials may be assumed to be inspected and/or tested and found to be acceptable foruse if identified in accordance with the rules above, unless it is marked as nonconforming. For the methods of identifying nonconforming raw materials, see procedure [Control of NCP Proc.Title].7.PRODUCTION TOOLING7.1.Tooling used for production (fixtures, molds, jigs, setup devices, product supports or stands,etc.) shall be designed and built according to engineering data, and then validated to ensure the tool performs the intended function without risk or harm to product. Validation of tooling istypically done by using the tooling and inspecting the resulting parts to ensure the tooling results in parts that meet dimensional or other requirements.7.2.Once validated and approved for use, the tool will be marked with a tooling ID number, which istypically the part number for which the tool is to be used.7.3.Tools that produce production hardware or are used to accept hardware must undergoinspection before release. [QC or QA Preferred Term] must stamp or mark the tool as accepted before it can be used.7.4.Shop aids for setup of production operations, supporting a part temporarily, or other simple ortemporary use, may not require identification with a unique identifier. Instead, these must beidentified as tooling by either marking the item itself as “TOOLING” (or similar language) orplacement in an area, shelf, cabinet or other container that is properly marked as “TOOLING” or “SHOP AIDS”(or similar language). The marking must allow tooling to clearly be distinguishedfrom raw material or product (whether flight or development).Page 3 of 47.5.Tooling used for lifting shall be proof load tested and include an upper load lift limit, as requiredby regulations.7.6.Tooling found to be nonconforming shall be tagged to prevent use until fixed, repaired ordeemed acceptable. Segregation of nonfonconforming tooling from the production area should be performed when possible.7.7.When approved tooling undergoes modification, the identification must be updated to reflect thechange; this is typically done by editing or re-marking the item with the latest revision of theengineering part number.8.SERVICE DELIVERABLES (← delete if not applicable)8.1.Service deliverables, such as reports and schedules, shall be identified with a title and, ifapplicable, reference to the project or contract under which they are developed.8.2.Customer contracts may indicate additional methods for identification of service deliverables.8.3.In all cases, the deliverable will be identified in a way that makes it clearly understood forwhich contract or project the deliverable is subject to.8.4.As required, service deliverables may be subject to date and revision control, to distinguishearlier versions or submittals.9.STAMP CONTROL (← delete this section if QC stamps are not used)9.1.Quality stamps or employee initials are used to indicate product acceptance or for other quality-related notations. Individual authorities for signing off for inspection, testing and operations are defined on the Stamp & Signature Control Log; this log is maintained to identify the owner of each stamp.9.2.The [who?] shall maintain the Stamp and Signature Control Log.9.3.Stamps are numbered, and taken out of service for six months after an employee leaves thecompany; after the six-month period, the stamp may be reissued to a different employee.9.4.No employee may use any stamp except that which was issued to them.Page 4 of 4Procedure: [Control of NCP Proc. Title]1.0SUMMARY1.1.This procedure defines the requirements for identifying, processing and dispositioningnonconforming product (“NCP”).1.2.While nonconforming product is typically found during an inspection or test, it can be discoveredat any time, by any person or organization, including the customer, regulatory authorities, etc.1.3.The [who?] is responsible for implementation and management of this procedure.2.0REVISION AND APPROVALRev.Date Nature of Changes Approved By[RevNumber][Date of Issue]Original issue.[Procedure Approver Name]3.0DEFINITIONS SPECIFIC TO THIS PROCEDURE3.1.Nonconforming product: This is any product, at any point along its life cycle, which is found tonot conform to requirements. These requirements may be customer requirements, designrequirements, statutory/regulatory requirements, or any other requirement deemed by [ShortClient Name]. “Nonconforming Product” is referred to herein as “NCP”.3.2.Rework: Parts may be “reworked” when additional machining or processing is conducted withoutaffecting the design of the part. Typically this means simply doing more of the already-approvedprocesses or activities listed on the traveler (additional machining, etc.)3.3.Repair: Any work done on NCP which affects the original design is considered “repair” and issubject to the special controls defined below. Such work includes but is not limited to the addingwelds to correct a problem, adding or removing material beyond design specifications, addingplating or metal finishing not originally included in the design specs, or adding any other materials(epoxy, patches, etc.) not provided for in the original design.[This procedure is divided into two sections, one for companies which utilize an Material Review Board (MRB), and one for companies that do not. Delete whichever section does not apply, and modify theremaining section accordingly.]4.0CONTROLLING NCP [ use if MRB is utilized.]4.1.Discovery and Reporting of NCP4.1.1.When NCP is discovered, the operator must report this immediately to the [who?]4.1.2.The [who?] will review the problem to confirm the nonconformity. If the nonconformityis confirmed, the product will be identified clearly to distinguish it from acceptablePage 1 of 4product, or product awaiting inspection or test. [enter method here: tagging,segregating, MRB cage, etc.?].4.1.3.The [who?] will determine if the nature of the nonconformity necessitates full MRBreview. A full MRB review is required if the [who?] thinks that any of the followingdispositions may be required:∙Accept as is, with customer waiver∙Accept as is, with regulatory approval∙Repair – see special rules below below.4.1.4.Typically, a full MRB is not required if the [who?] determines the part only needsrework, or if it can be scrapped without impacting the quantity required for an order,if applicable.4.1.5.If full MRB is not deemed necessary, the [who?] may direct a disposition of rework orscrap.4.1.6.The operator may scrap nonconforming parts that are not serialized during production,provided that the operator makes a note of this action on the traveler.4.2.Disposition Authority4.2.1.Disposition authority is granted to the following personnel:∙Title∙Title∙Title4.2.2.The selection of these staff members has been made by top management, and is basedon their role in the company, previous experience, and knowledge of [Short ClientName]’s processes and products.4.3.MRB Review4.3.1.When a part is submitted for Material Review Board (MRB) review, this must beindicated on the Nonconforming Part Disposition form, and the parts staged in an MRBquarantine area.4.3.2.The nature of the nonconformity, along with all necessary product information,including serial numbers, shall be recorded on the Nonconforming Part Dispositionform. The description of must be a detailed explanation as to why a part or parts arebeing rejected; the form must include nominal/tolerance and actual measurements.4.3.3.The MRB consists of [list members by title here].4.3.4.The MRB shall research the issue and determine a possible disposition:∙Accept as is∙Repair (see special rules for repair below)Page 2 of 4∙Rework∙Scrap (see rules for processing scrap below)∙Return to Vendor4.3.5.If “accept as is” will require the acceptance of the part which deviates from acustomer’s design, the customer approval must be obtained and documented on theNonconforming Disposition Form. In addition, in some case regulatory authorityapproval may also be required to be obtained and recorded.4.3.6.The processing of NCP must take into consideration any actions necessary to containthe effect of the nonconformity on other processes or products.5.0CONTROLLING NCP [ use if MRB is NOT utilized.]5.1.Discovery and Reporting of NCP5.1.1.When NCP is discovered, the operator must report this immediately to the [who?][NOTE: in some companies, operators are allowed to scrap parts without any otherapproval, provided they note it on the traveler. If so, add that language here.]5.1.2.The [who?] shall confirm if a nonconformity exists, and if so document it on the [whatform?]5.1.3.The NCP shall then be identified clearly to distinguish it from acceptable product, orproduct awaiting inspection or test. [enter method here: tagging, segregating, MRBcage, etc.?].5.1.4.The NCP shall then be dispositioned. Disposition authority is granted to the followingpersonnel:∙Title∙Title∙Title5.1.5.The selection of these staff members has been made by top management, and is basedon their role in the company, previous experience, and knowledge of [Short ClientName]’s processes and products.5.1.6.Possible dispositions are:∙Accept as is∙Repair (see special rules for repair below)∙Rework∙Scrap∙Return to VendorPage 3 of 45.1.7.All repair or reworked product must be re-inspected, with the results recorded on[what form?]5.1.8.If “accept as is” will require the acceptance of the part which deviates from acustomer’s design, the customer’s approval must be obtained and documented on the[what form?] form. In addition, when applicable, regulatory authority approval(s) mayalso be required to be obtained and recorded.5.1.9.The disposition, dispositioning authority and any subsequent work and re-inspectionare to be recorded on the [what form?]5.1.10.The processing of NCP must take into consideration any actions necessary to containthe effect of the nonconformity on other processes or products.6.0SPECIAL RULES FOR REPAIRS ( delete this section if not applicable)6.1.“Repair” is defined in section 1 above.6.2.Any repair affecting a customer designed part must be approved by the customer in advance.6.3.Repairs without customer approval are disallowed in all circumstances!6.4.All approvals must be documented and the records maintained with the part records.7.0NONCONFORMANCE DATA ANALYSIS & TRENDING7.1.The [who?] will present product quality trend data regularly to top management as part ofperiodic Management Review Meetings.Procedure: [Purchasing Proc. Title]1.0SUMMARY1.1.This procedure defines the requirements for evaluation and selection of critical suppliers,purchasing critical materials and services, and monitoring supplier performance.1.2.The receipt and receiving inspection of incoming purchased items is defined in the procedure[Receiving Proc. Title].1.3.“Critical materials or services” are those materials or services which are incorporated into finalproduct, or which have a direct impact on the company’s product or quality system, or which areotherwise deemed as critical by management.1.4.Office supplies, administrative consumables, furniture, etc. are not critical materials, andtherefore not subject to this procedure.1.5.[Short Client Name] understands it is responsible for the conformity of all products purchasedfrom suppliers, including product from sources defined by the customer.1.6.The [who?] is responsible for implementation and management of this procedure.2.0REVISION AND APPROVALRev.Date Nature of Changes Approved By[RevNumber][Date of Issue]Original issue.[Procedure Approver Name]3.0SUPPLIER EVALUATION, SELECTION AND CONTROL3.1.The [who?] evaluates new suppliers. This person/these individuals has/have both theresponsibility and authority to approve and disapprove suppliers.3.2.New suppliers are evaluated in accordance with the following criteria:•Modify this list as needed•Pricing•Availability•Reputation / references•Location•Shipping terms and capabilities•Quality system certification status (ISO 9001 certification preferred)•Quality of samples received (incl. testing results)。
ISO9001：2015管理评审会议记录英文版
This template is intended as a tool to prepare records of Management Review Meetings. Please complete each section; this form may be used as the final report, or used as a template to type and publish more formal Management Review Meeting records. At all stages, management must consider proper, proactive measures to take to improve the company, and where it is necessary to apply preventive action. Record [CAR Form Name] ([CAR Form Abbreviation]s) filed in last section of this template.Date of Review:Recorded by:In attendance:NAME TITLEAbsent:NAME TITLEFor absent members, the minutes of this meeting must be sent to them afterwards, and opportunity for review and comment given. Any comments, changes, or additional inputs from these individuals must be incorporated into the final minutes or issued as an addendum.ITEM 1. Review of the Quality Policy for current adequacy, and the need for changes to it. Review the Quality Policy to ensure it still represents the company’s goals.ENTER QUALITY POLICY HERE.Quality Policy reviewed and accepted as is.Quality Policy needs revision. Following changes recommended:ITEM 2. Review of internal and external issues of concern. Review the COTO Log and update it with any new or revised issues of concern.ITEM 3. Review of risks. Review the Risk Register within the COTO Log with a focus on managing the negative risks indicated therein, and assessing the effectiveness of actions taken to date.ITEM 4. Review of opportunities. Review the Opportunity Register within the COTO Log with a focus on managing the positive opportunities indicated therein, and assessing the effectiveness of actions taken to date.ITEM 5. Internal and external audit results.Report on the status of internal quality audits: review results of audits conducted since last meeting, and issues discovered.ITEM 6. Status of corrective and preventive actions via the [CAR Form Abbreviation] System. Review overdue [CAR Form Abbreviation]s. Review trends indicated by the [CAR Form Abbreviation]s filed.ITEM 7. Review of resources needed to maintain and improve the effectiveness of the company and its quality management system.Discuss resource needs for each of the following points.EQUIPMENT RESOURCES REQUIREMENTS:WORK ENVIRONMENT & INFRASTRUCTURE REQUIREMENTS:QUALITY SYSTEM & OTHER RESOURCE REQUIREMENTS:HUMAN RESOURCES & TRAINING NEEDS:ITEM 8. Review of the effectiveness of training and training programs in place. Include opportunities for improvement for training.ITEM 9. Review of suppliers.Discuss issues regarding suppliers of critical materials, hardware or software. Review supplier performance and any quality or delivery issues. Review open supplier corrective action notices issued since last meeting. Note any trends for individual suppliers. Indicate changes of supplier status or restrictions.ITEM 10. Review of quality objectives, data and goals. Review the current Quality Objectives as outlined in the [Quality Manual Doc Title] and modify goals plete the Objectives table on the next page.[Short Client Name]Management Review Meeting Minutes Rev. [Rev Number]Page 4 of 6。
ISO9001_2015_中英对照介绍
Secretariat of ISO/TC 176/SC 2Date: 3 June 2013To the Members ofISO/TC 176/SC 2 -Quality Management andQuality Assurance/Quality SystemsISO/CD 9001目录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组织的背景4.1 Understanding the organization and its context理解组织及其背景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质量管理体系范围的确定4.4 Quality management system质量管理体系5 Leadership领导作用5.1 Leadership and commitment领导作用和承诺5.2 Quality policy质量方针5.3 Organizational roles, responsibilities and authorities组织的作用、职责和权限6 Planning策划6.1 Actions to address risks and opportunities风险和机遇的应对措施6.2 Quality objectives and planning to achieve them质量目标及其实施的策划6.3 Planning of changes变更的策划7 Support支持7.1 Resources资源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8 Operation运行8.1 Operational planning and control运行的策划和控制8.2 Determination of market needs and interactions with customers市场需求的确定和顾客沟通8.3 Operational planning process运行策划过程8.4 Control of external provision of goods and services外部供应产品和服务的控制8.5 Development of goods and services产品和服务开发8.6 Production of goods and provision of services产品生产和服务提供8.7 Release of goods and services产品和服务放行8.8 Nonconforming goods and services不合格产品和服务9 Performance evaluation绩效评价9.1 Monitoring, measurement, analysis and evaluation监视、测量、分析和评价9.2 Internal Audit内部审核9.3 Management review管理评审10 Continual improvement持续改进10.1 Nonconformity and corrective action不符合和纠正措施10.2 Improvement改进附录A Annex A Quality management principles (Informative)质量管理原则文献1．Scope范围This International Standard specifies requirements for a quality management system where an organization本标准为有下列需求的组织规定了质量管理体系要求：a）needs to demonstrate its ability to consistently provide goods and services that meet customer and applicable statutory and regulatory requirements, and需要证实其具有稳定地提供满足顾客要求和适用法律法规要求的产品和服务的能力；b）aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements通过体系的的有效应用，包括体系持续改进的过程，以及保证符合顾客和适用的法律法规要求，旨在增强顾客满意。
- 1、下载文档前请自行甄别文档内容的完整性，平台不提供额外的编辑、内容补充、找答案等附加服务。
- 2、"仅部分预览"的文档,不可在线预览部分如存在完整性等问题,可反馈申请退款(可完整预览的文档不适用该条件!)。
- 3、如文档侵犯您的权益，请联系客服反馈,我们会尽快为您处理(人工客服工作时间：9:00-18:30)。
Y/N
(or N/A)
Evidence or Notes Sheet Ref. #
In general, does the[Short Client Name]documentation meet the requirements of[ISO 9001 or AS9100]?
Review any customer requirements that may be applicable to this process. (If there are none, enter “N/A” in the middle column.) In general, does the[Short Client Name]documentation meet these requirements?
Indicate any suggestions for improvement related to the documentation:
STEP T
Compare the requirements of[ISO 9001 or AS9100], the[Quality Manual Doc Title]and other documentation against whatemployees are actually doing in everyday practice.
Indicate any problemovide brief details on any areas that you found were well-implemented, particularly effective or worth noting as positive traits of the process.
Does the process appear to adequately meet the requirements of[ISO 9001 or AS9100]and the[Short Client Name]documentation?
Does the process appear to adequately meet all customer or regulatory requirements?
Requirement
Reference
Question
Y/N
(or N/A)
Evidence or Notes Sheet Ref. #
Review previous audits for this process. Review previous[CAR Form Abbreviation]s issued against this process, or as a result of previous audits for this process. Add additional checklist questions here, based on the previous audits,[CAR Form Abbreviation]s or other documents or requirements, as you see fit.
STEP ONE: Audit
Process to Audit (Audit Scope):
Audit Date(s):
Lead Auditor:
Audit #:
Auditor(s):
Site(s) to Audit:
Applicable Clauses of[ISO 9001 or AS9100]Standard:
STEP F
Based on the findings andnonconformitiesyou have recorded in the previous sections, summarize the necessary actions needed. For type, choose one of the following:
Question
Y/N
(or N/A)
Evidence or Notes Sheet Ref. #
Are theprocedure stepsaccurate and complete as compared to true practice?
Are there sufficient check steps (inspections, tests, reviews, approvals, sign-offs, etc.) that ensure theprocessoutputs meet requirements before passing onto the next process?
Review any statutory or regulatory requirements that may be applicable to this process. (If there are none, enter “N/A” in the middle column.) In general, does the[Short Client Name]documentation meet these requirements?
Requirement
Reference
Question
Y/N
(or N/A)
Evidence or Notes Sheet Ref. #
STEP
Review the applicableprocedure(s)for this processand answer the questions below.
Applicable Documents to Audit
Rev.
[Quality Manual Doc Title]
STEP T
Compare the[Short Client Name]documentation with the applicable clauses of[ISO 9001 or AS9100].