ISO9001-2015设备请购和验收管理程序(中英文)

ISO9001：2015全套程序文件英文版(本人辛苦原创)Code QM-COP-01Date2018.10.24Date2018.10.241.0 PurposeAll the documents required by the Company’s quality management system should be controlled to ensure the version applied by all the relevant departments is valid.2.0 ScopeIt is applicable to all the documents pertaining to the quality management system including external documents.3.0 Definition3.1 Controlled document: The document applied in and out of the Company is controlled in modifications, identities, versions, version numbers, formats, fonts, etc.3.2 DCC: Document Controlling Center3.3 External document: It refers to the document that has been handled by outside individuals like national/international standards, laws and regulations, documents provided by customers or suppliers, material certificates, amendment advice, etc.3.3.1 Administrative documents on quality management system or product, released from local government authorities and regulatory agencies such as the notices from Guangdong Food and Drug Administration.3.3.2 National laws and regulations such as Product Quality Law of the People’s Republic of China, Regulation on the Supervision and Administration of Medical Devices, 93/42/EEC, etc.3.3.3 International standards such as Medical devices—Quality management systems—Requirements for regulatory purposes.3.3.4 National standards such as Medical electrical equipment – Part 1: General requirements for safety.3.3.5 Regulations and standards provided by customers such as agreements and commitments signed with customers.3.3.6 Drawings provided by customers such as drawings, mold drawings provided by a certain customer.3.3.7 Other important external documents relating to the product, including official materials like customer’s notice.4.0 Duties4.1 General Manager: Responsible for approval of the Company’s quality manual.4.2 Management Representative: Responsible for the Company’s procedure files, quality plans and cross-department three-order files and approval of external documents.4.3 Principals of each department: Responsible for approval of three-order files and all kinds of tables as well as department-related external documents.4.4 Department: Responsible for compilation, number and review of the documents dominated by the department.Code QM-COP-01Date2018.10.24Date2018.10.244.5 Quality Management Department: Responsible for all the controlled documents of the Company to ensure the electronic document is the latest version, and responsible for the updating of the controlled document list of all the departments.5.0 Procedures5.1 Document classification: The management system documents includes four layers and external documents5.1.1The Quality Manual (including policies and goals) is a principle-based and master document guiding the implementation of the quality management system. As the first level document, it does not just explain the scope of application but also describe the interaction among all the procedures in the quality management system.5.1.2 The procedure document is the expansion and specification of the Quality Manual, providing the process, methods and controlling means for carrying out quality management. It belongs to the second level document.5.1.3 Supporting documents (operation/technical specifications, process/inspection standards, technical guidance and position description) specify the quality management goals, duties of the posts of all levels and specific operation methods. It belongs to the third level document.5.1.4 The table is applied to record the state and result of activities, belonging to the fourth level document.5.1.5 External document: It refers to the document directly obtained from outside and cited by the Company, including national/international standards, laws and regulations, documents provided by customers or suppliers, material certificates and amendment advice.5.1.6 The document is drawn up mainly in written or electronic form, and both shall be under control.5.2 Document compilation and approval5.2.1 The formats of the second and third level documents are the same as that of the document.5.2.2 The date of the document must be written in the form of “year month day”.5.2.3 Limits for examination and approving authority for documentsS/N Order Type ofdocumentPrepared byReviewedbyJointreviewed byApprovedbyRemark1 First ManagementManualQualityManagementDepartmentManagementRepresentativeSupervisorof eachdepartmentTopmanagement2 SecondProceduredocumentAlldepartmentDepartmentRelevantdepartmentManagementCodeQM-COP-01Date2018.10.24 Date2018.10.245.3 Document’s number and version/version number5.3.1 Number: The document compiler numbers the newly compiled documents according to the Basic Rules for Numbering the Controlled Documents and the document list of the department, and confirms the uniqueness of the numbers with the controlling center.5.3.2 Version/Version number: The version or version number of the controlled document is compiled insmanagermanagerRepresen tative3ThirdManagement documentAll department sDepartme nt managerRelevant department manager and Managemen tRepresentat iveManage ment Represen tativeJob Description of the personnel below the manager level is reviewed by the department manager and approved by the manager of HR Department.4ThirdProcess, inspection standarddocument and specification (including external document)All department sQuality Manageme nt Departme ntDepartm ent manager5Fourt hTablesAlldepartment sQualityManageme nt Departme ntDepartm entmanagerAdditional remarks: 1) The document can be compiled by the compilers or above the compiler level but must be approved by the personnel upper than the compiler.2) The relevant department refers to the departments having ties with others involved in this system. 3) When the approver of the above documents is absent, his agent or Management Representative can sign it up instead to make the document effective.Code QM-COP-01Date2018.10.24Date2018.10.24the form of 26 alphabets from A to Z. The initial version number is “A/0”, the next revised version is “A/1” and so on. Changing Arabic numbers is enough for minor revisions while changing alphabets, for instance, from “A” to “B”, is necessary in case of major revisions.5.4 Document distribution and storage5.4.1 The document compiler sends the copy of the approved document and its electronic version to the Quality Management Department where the document will be checked whether it has been approved by designated personnel. After that, the document will be registered, controlled with the controlled document list updated.5.4.2 The document controller determines the scope of distribution, makes copies of the electronic file ina required number according to the List of distributed controlled documents, add the watermarks of correspondent departments on these copies, save them to the folder for controlled documents of each department and notify the departments for making and using the documents by email.5.4.3 All the department are responsible for checking if the controlled document is correct or not.5.4.4 The authority for the controlled document folder of each department shall be set as follows:①Document controller is permitted to modify, delete the content or add new content to the document.②Each department can only read but cannot delete, modify or add the content of controlled documents.5.4.5 The document controller must copy the electronic document as a backup.5.4.6 Visual management of documentsAs for the documents which are frequently applied at production site, all the departments should take correspondent measures such as hanging them on the wall, beside the equipment or enveloping them with plastic so to make it easy for operators to use.5.5 Document reading5.5.1 In case of reading the documents, the relevant personnel can open the PDF file which are saved in the Company’s share disk.5.6 Document review, modification, recovery, invalidation and destruction5.6.1 Review①The documents of the quality management system should be reviewed once a year by the Quality Management Department and internal review team organized by the Management Representative along with the Company’s internal review and reviewed with the result put down in the internal review record.②In case of special circumstances, some documents should be reviewed by the relevant department.③The review must take into account the influence of both the internal factors like the Company’s organization and position changes and the external factors like laws, regulations, relevant standards and market demands upon the sufficiency and applicability of the documents with the Review Record filled in.5.6.2 Revision/alteration①The director and executor of each unit should check the effect after implementing the documents. If the documents are not applicable or in doubt in addition to the opinions on the content of the documents from other units, the documents can be revised or modified by the department which revised or compiledCode QM-COP-01Date2018.10.24Date2018.10.24them last time after the discussion among the relevant departments. Relevant approval process is the same as that in 5.2.2.②All the modifications or alterations must be underlined (“___”). In case of version change, the previous underline should be substituted by the latest one.③The revision record should be written on the first page of the documents, containing the content of the revision, identification of the affected documents, signature of the approver, date of approval and effective time.④The relevant departments shall be notified of review and confirmation of the alteration, and personnel training will be provided if necessary.⑤In the following circumstances that there is any alteration to the documents of the quality management system or the documents relating to the Company’s medical device products, the top management or Management Representative of the Company should be notified of deciding whether to inform the competent authority or notified bodies about it. If it is necessary, the notification should be implemented in accordance with the local laws and administrative regulations.a. Major alterations to the Quality Manual.b. Major alterations to the product’s functions, performance, safety, reliability and electromagnetic compatibility, caused by altering product standards.c. Major alterations to the product’s functions, performance, safety, reliability and electromagnetic compatibility, caused by changing key components of products.d. Stipulated by laws and regulations.5.6.3 Once the new version of controlled document is distributed, the old one becomes invalid automatically. The document controller should delete the copies of invalid controlled documents in the controlled document folder, upload the latest version and keep the original documents printed with an “invalid” stamp at the document controlling center till the expiry date (at least five years) before destruction.5.6.4 As for the invalid original documents, the document controlling center should destruct them uniformly after Document/Record Destruction Registration Form filled in by the center is approved by the Management Representative.5.7 The non-controlled document is identified as the “Reference”. If a Company’s customer or other personnel need it for their jobs, they must have the copies of the Company’s controlled documents and get its copies approved by the Management Representative and stamped with the ‘Reference’ seal by the Quality Management Department. The ‘Reference’ documents will not be withdrawn or changed to the latest version.5.8 Temporary documentIt is not yet official for some reasons but needed by each department. Such document should have a ‘Temporarily Controlled’ stamp as well as the time limit and distribution department on them. The temporary document cannot be valid for more than 3 months.Code QM-COP-01Date2018.10.24Date2018.10.245.9 Management of external documents5.9.1 Each department of the Company can collect external documents through the following channels.a. National, provincial, municipal governments and their relevant functional departments.b. All kinds of meetings, professional newspapers, magazines, publishers and suppliers.c. Internet, telephone and fax.5.9.2 The external document collected by each department should be selected timely and delivered to the relevant department to recognize its contents and decide whether make it a controlled document.a. The collected technical standards on our products should be delivered to the Technical Department to recognize its year, version and applicable articles.b. The laws, regulations and rules that are issued by the state on the quality and safety of the product should be delivered to the Quality Management Department to identify the required department and scope.c. Policy documents issued by the superior should be delivered to the administration department for recognition.d. The technical documents provided by suppliers or customers should be delivered to the Technical Department and Quality Management Department for recognition.f. The design input documents provided by customers should be delivered by the Market Department to the R&D Department for recognition. Saved in DHF format, they don’t have to be controlled by document controller.5.9.3 Numbering of external documentsAs for the external documents on technology and standards as well as other external documents, the Quality Management Department should number them in accordance with the Basic rules on numbering controlled documents.5.9.4 Distribution of external documentsa. After being recognized, the external documents should be kept on a file and put down on a list.b. The external documents should be distributed after the distribution scope is confirmed according to 5.4 of this procedure.5.9.5 Updating of external documentsAs for the external documents which need updating, the new version should be distributed with the invalid ones withdrawn immediately.5.9.6 Preservation and destruction of external documentsThe preservation and destruction should be implemented according to 5.6.3 of this procedure.5.10 The Quality Management Department should supervise and inspect irregularly the controlling process implemented by each department.6.0 Records and Tables6.1 Controlled Document Directory。

优质参考文档ISO9001 ：2015 标准目录1范围2规范性引用文件3术语和定义4组织的背景4.1理解组织及其背景4.2理解相关方的需求和期望4.3质量管理体系范围的确定4.4 质量管理体系5领导作用5.1领导作用和承诺5.2质量方针 5.3组织的作用、职责和权限6策划6.1风险和机遇的应对措施6.2质量目标及其实施的策划6.3变更的策划7支持7.1资源7.2能力7.3意识7.4沟通7.5形成文件的信息8运行8.1 运行的策划和控制8.2市场需求的确定和顾客沟通8.3运行策划过程8.4外部供应产品和服务的控制8.5产品和服务开发 8.6产品生产和服务提供8.7产品和服务放行 8.8不合格产品和服务 9绩效评价9.1 监视、测量、分析和评价9.2内部审核9.3管理评审10持续改进10.1 不符合和纠正措施10.2 改进附录A质量管理原则文献1范围本标准为有下列需求的组织规定了质量管理体系要求：a）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）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。

注1：在本标准一中，术语产品”仅适用于：a）预期提供给顾客或顾客所要求的商品和服务；b）运行过程所产生的任何预期输出。

注2:法律法规要求可称作为法定要求。

2规范性引用文件下列文件中的条款通过本标准的引用而构成本标准的条款。

凡是注日期的引用文件，只有引用的版本适用。

凡是不注日期的引用文件，其最新版本（包括任何修订）适用于本标准。

IS09000 : 2015质量管理体系基础和术语3术语和定义本标准采用IS09000 : 2015中所确立的术语和定义。

4组织的背景环境4.1理解组织及其背景环境组织应确定外部和内部那些与组织的宗旨、战略方向有关、影响质量管理体系实现预期结果的能力的事务。

需要时，组织应更新这些信息。

在确定这些相关的内部和外部事宜时，组织应考虑以下方面：a）可能对组织的目标造成影响的变更和趋势；b）与相关方的关系，以及相关方的理念、价值观；c）组织管理、战略优先、内部政策和承诺；d）资源的获得和优先供给、技术变更。

ISO9001：2015标准目录1范围2规范性引用文件3术语和定义4组织的背景4.1理解组织及其背景4.2理解相关方的需求和期望4.3质量管理体系范围的确定4.4质量管理体系5领导作用5.1领导作用和承诺5.2质量方针5.3组织的作用、职责和权限6策划6.1风险和机遇的应对措施6.2质量目标及其实施的策划6.3变更的策划7支持7.1资源7.2能力7.3意识7.4沟通7.5形成文件的信息8运行8.1运行的策划和控制8.2市场需求的确定和顾客沟通8.3运行策划过程8.4外部供应产品和服务的控制8.5产品和服务开发8.6产品生产和服务提供8.7产品和服务放行8.8不合格产品和服务9绩效评价9.1 监视、测量、分析和评价9.2 内部审核9.3 管理评审10 持续改进10.1 不符合和纠正措施10.2 改进附录A 质量管理原则文献1 范围本标准为有下列需求的组织规定了质量管理体系要求：a)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)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。

注1：在本标准一中，术语“产品”仅适用于：a) 预期提供给顾客或顾客所要求的商品和服务；b) 运行过程所产生的任何预期输出。

注2：法律法规要求可称作为法定要求。

2 规范性引用文件下列文件中的条款通过本标准的引用而构成本标准的条款。

凡是注日期的引用文件，只有引用的版本适用。

凡是不注日期的引用文件，其最新版本（包括任何修订)适用于本标准。

ISO9000：2015 质量管理体系基础和术语3 术语和定义本标准采用ISO9000：2015 中所确立的术语和定义。

4 组织的背景环境4.1 理解组织及其背景环境组织应确定外部和内部那些与组织的宗旨、战略方向有关、影响质量管理体系实现预期结果的能力的事务。

需要时，组织应更新这些信息。

在确定这些相关的内部和外部事宜时，组织应考虑以下方面：a) 可能对组织的目标造成影响的变更和趋势；b) 与相关方的关系，以及相关方的理念、价值观；c) 组织管理、战略优先、内部政策和承诺；d) 资源的获得和优先供给、技术变更。

ISO9001：2015标准目录1 范围2 规范性引用文件3 术语和定义4 组织的背景4。

1 理解组织及其背景4。

2 理解相关方的需求和期望4。

3 质量管理体系范围的确定4.4 质量管理体系5 领导作用5.1 领导作用和承诺5.2 质量方针5.3 组织的作用、职责和权限6 策划6。

1 风险和机遇的应对措施6.2 质量目标及其实施的策划6.3 变更的策划7 支持7。

1 资源7。

2 能力7。

3 意识7。

4 沟通7。

5 形成文件的信息8 运行8.1 运行的策划和控制8.2 市场需求的确定和顾客沟通8.3 运行策划过程8.4 外部供应产品和服务的控制8。

5 产品和服务开发8。

6 产品生产和服务提供8。

7 产品和服务放行8.8 不合格产品和服务9 绩效评价9。

1 监视、测量、分析和评价9。

2 内部审核9.3 管理评审10 持续改进10。

1 不符合和纠正措施10。

2 改进附录A 质量管理原则文献1 范围本标准为有下列需求的组织规定了质量管理体系要求:a)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）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。

注1：在本标准一中,术语“产品”仅适用于：a) 预期提供给顾客或顾客所要求的商品和服务;b）运行过程所产生的任何预期输出。

注2：法律法规要求可称作为法定要求。

2 规范性引用文件下列文件中的条款通过本标准的引用而构成本标准的条款。

凡是注日期的引用文件，只有引用的版本适用.凡是不注日期的引用文件,其最新版本（包括任何修订）适用于本标准。

ISO9000：2015 质量管理体系基础和术语3 术语和定义本标准采用ISO9000：2015 中所确立的术语和定义。

4 组织的背景环境4。

1 理解组织及其背景环境组织应确定外部和内部那些与组织的宗旨、战略方向有关、影响质量管理体系实现预期结果的能力的事务.需要时，组织应更新这些信息.在确定这些相关的内部和外部事宜时,组织应考虑以下方面:a) 可能对组织的目标造成影响的变更和趋势;b）与相关方的关系，以及相关方的理念、价值观；c) 组织管理、战略优先、内部政策和承诺；d）资源的获得和优先供给、技术变更。

ISO 9001：2015Quality management systems —RequirementsIntroduction0.1 GeneralThe 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. 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.0.2 Quality management principlesThis International Standard is based on the quality management principles described in ISO 9000. The descriptions include a statement of each principle, a rationale of why the principle is important for the organization, some examples of benefits associate d with the principle and examples of typical actions to improve the organization’s performance when applying the principle. The quality management principles are:— customer focus;— leadership;— engagement of people;— process approach;— improvement;— evidence-based decision making;— relationship management.0.3 Process approach0.3.1 GeneralThis International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements. Specific requirements considered essential to the adoption of a process approach are included in 4.4. Understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its intended results. This approach enables the organization to control the interrelationships and interdependencies among the processes of the system, so that the overall performance of the organization can be enhanced. The process approach involves the systematic definition and management of processes, and their interactions, so as to achieve the intended results in accordance with the quality policy and 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.0.3.2 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.The PDCA cycle can be briefly described as follows:—Plan: establish the objectives of the system and its processes, and the resources needed to deliver results in accordance with customers’ requirements and the organization’s policies; and identify and address risks and opportunit ies; — Do: implement what was planned;—Check: monitor and (where applicable) measure processes and the resulting products and services against policies, objectives and requirements and planned activities, and report the results;— Act: take actions to improve performance, as necessary.0.3.3 Risk-based thinkingRisk-based thinking (see Clause A.4) is essential for achieving an effective quality management system. The concept of risk-based thinking has been implicit in previous editions of this International Standard including, for example, carrying out preventive action to eliminate potential nonconformities, analyzing any nonconformities that do occur, and taking action to prevent recurrence that is appropriate for the effects of the nonconformity. To conform to the requirements of this International Standard, an organization needs to plan and implement actions to address risks and opportunities. Addressing both risks and opportunities establishes a basis for increasing the effectiveness of the quality management system, achieving improved results and preventing negative effects. Opportunities can arise as a result of a situation favorable to achieving an intended result, for example, a set of circumstances that allow the organization to attract customers, develop new products and services, reduce waste or improve productivity. Actions to address opportunities can also include consideration of associated risks. Risk is the effect of uncertainty and any such uncertainty can have positive or negative effects. A positive deviation arising from a risk can provide an opportunity, but not all positive effects of risk result in opportunities.0.4 Relationship with other management system standards与其他管理体系标准的关系This International Standard applies the framework developed by ISO to improve alignment among its International Standards for management systems (see Clause A.1). This International Standard enables an organization to use the process approach, coupled with the PDCA cycle and risk-based thinking, to align or integrate its quality management system with the requirements of other management system standards. This International Standard relates to ISO 9000 and ISO 9004 as follows: — ISO 9000 Quality management systems —Fundamentals and vocabulary provides essential background for the proper understanding and implementation of this International Standard; — ISO 9004 Managing for the sustained success of an organization — A quality management approach provides guidance for organizations that choose to progress beyond the requirements of this International Standard. Annex B provides details of other International Standards on quality management and quality management systems that have been developed by ISO/TC 176. This International Standarddoes not include requirements specific to other management systems, such as those for environmental management, occupational health and safety management, or financial management. Sector-specific quality management system standards based on the requirements of this International Standard have been developed for a number of sectors. Some of these standards specify additional quality management system requirements, while others are limited to providing guidance to the application of this International Standard within the particular sector.A matrix showing the correlation between the clauses of this edition of this International Standard and the previous edition (ISO 9001:2008) can be found on the ISO/TC 176/SC 2 open access web site at: /tc176/sc02/public.1 ScopeThis International Standard specifies requirements for a quality management system when an organization: a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. All the requirements of this International Standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides. NOTE 1 In this International Standard, the terms “product” or “service” only apply to products and services intended for, or required by, a customer. NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 9000:2015, Quality management systems —Fundamentals and vocabulary3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 9000:2015 apply.4 Context of the organization4.1 Understanding the organization and its contextThe organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system. The organization shall monitor and review information about these external and internal issues.NOTE 1 Issues can include positive and negative factors or conditions for consideration.NOTE 2 Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, market, cultural, social and economic environments, whether international, national, regional or local. NOTE 3 Understanding the internal context can be facilitated by considering issues related to values, culture, knowledge and performance of the organization.4.2 Understanding the needs and expectations of interested partiesDue to their effect or potential effect on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine: a) the interested parties that are relevant to the quality management system; b) the requirements of these interested parties that are relevant to the quality management system. The organization shall monitor and review information about these interested parties and their relevant requirements.4.3 Determining the scope of the quality management systemThe organization shall determine the boundaries and applicability of the quality management system to establish its scope. When determining this scope, the organization shall consider: a) the external and internal issues referred to in 4.1; b) the requirements of relevant interested parties referred to in 4.2; c) the products and services of the organization. The organization shall apply all the requirements of this International Standard if they are applicable within the determined scope of its quality management system. The scope of the organization’s quality management system shall be available and be maintained as documented information. The scope shall state the types of products and services covered, and provide justification for any requirement of this International Standard that the organization determines is not applicable to the scope of its quality management system. Conformity to this International Standard may only be claimed if the requirements determined as not being applicable do not affect the organization’s ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction.4.4 Quality management system and its processes4.4.1 The organization shall establish, implement, maintain and continually improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of this International Standard. The organization shall determine the processes needed for the quality management system and their application throughout the organization, and shall:a) determine the inputs required and the outputs expected from these processes;b) determine the sequence and interaction of these processes;c) determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes;d) determine the resources needed for these processes and ensure their availability;e) assign the responsibilities and authorities for these processes;f) address the risks and opportunities as determined in accordance with the requirements of 6.1;g) evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results;h) improve the processes and the quality management system.4.4.2 To the extent necessary, the organization shall:a) maintain documented information to support the operation of its processes;b) retain documented information to have confidence that the processes are being carried out as planned.5 Leadership5.1 Leadership and commitment5.1.1 GeneralTop management shall demonstrate leadership and commitment with respect to the quality management system by:a) taking accountability for the effectiveness of the quality management system;b) ensuring that the quality policy and quality objectives are established for the quality management system and are compatible with the context and strategic direction of the organization;c) ensuring the integration of the quality management system requirements into the organization’s business processes;d) promoting the use of the process approach and risk-based thinking;e) ensuring that the resources needed for the quality management system are available;f) communicating the importance of effective quality management and of conforming to the quality management systemrequirements;g) ensuring that the quality management system achieves its intended results;h) engaging, directing and supporting persons to contribute to the effectiveness of the quality management system;i) promoting improvement;j) supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility. NOTE Reference to “business” in this International Standard can be interpreted broadly to mean those activities that are core to the purposes of the organization’s existence, whether the organization is public, private, for profit or not for prof it.5.1.2 Customer focusTop management shall demonstrate leadership and commitment with respect to customer focus by ensuring that:a) customer and applicable statutory and regulatory requirements are determined, understood and consistently met;b) the risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed;c) the focus on enhancing customer satisfaction is maintained.5.2 Policy5.2.1 Establishing the quality policyTop management shall establish, implement and maintain a quality policy that:a) is appropriate to the purpose and context of the organization and supports its strategic direction;b) provides a framework for setting quality objectives;c) includes a commitment to satisfy applicable requirements;d) includes a commitment to continual improvement of the quality management system.5.2.2 Communicating the quality policyThe quality policy shall:a) be available and be maintained as documented information;b) be communicated, understood and applied within the organization;c) be available to relevant interested parties, as appropriate.5.3 Organizational roles, responsibilities and authoritiesTop management shall ensure that the responsibilities and authorities for relevant roles are assigned, communicated and understood within the organization. Top management shall assign the responsibility and authority for:a) ensuring that the quality management system conforms to the requirements of this International Standard;b) ensuring that the processes are delivering their intended outputs;c) reporting on the performance of the quality management system and on opportunities for improvement (see 10.1), in particular to top management;d) ensuring the promotion of customer focus throughout the organization;e) ensuring that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.6 Planning6.1 Actions to address risks and opportunities6.1.1 When planning for the quality management system, the organization shall consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed to:a) give assurance that the quality management system can achieve its intended result(s);b) enhance desirable effects;c) prevent, or reduce, undesired effects;d) achieve improvement.6.1.2 The organization shall plan:a) actions to address these risks and opportunities;b) how to:1) integrate and implement the actions into its quality management system processes (see 4.4);2) evaluate the effectiveness of these actions.Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products and services.NOTE 1 Options to address risks can include avoiding risk, taking risk in order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decision.NOTE 2 Opportunities can lead to the adoption of new practices, launching new products, opening new markets, addressing new customers, building partnerships, using new technology and other desirable and viable possibilities to address the organization’s or its customers’ needs.6.2 Quality objectives and planning to achieve them6.2.1 The organization shall establish quality objectives at relevant functions, levels and processes needed for the quality management system.The quality objectives shall:a) be consistent with the quality policy;b) be measurable;c) take into account applicable requirements;d) be relevant to conformity of products and services and to enhancement of customer satisfaction;e) be monitored;f) be communicated;g) be updated as appropriate.The organization shall maintain documented information on the quality objectives.6.2.2 When planning how to achieve its quality objectives, the organization shall determine:a) what will be done;b) what resources will be required;c) who will be responsible;d) when it will be completed;e) how the results will be evaluated6.3 Planning of changesWhen the organization determines the need for changes to the quality management system, the changes shall be carried out in a planned manner (see 4.4).The organization shall consider:a) the purpose of the changes and their potential consequences;b) the integrity of the quality management system; c) the availability of resources;d) the allocation or reallocation of responsibilities and authorities.7 Support7.1 Resources7.1.1 GeneralThe organization shall determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system. The organization shall consider:a) the capabilities of, and constraints on, existing internal resources;b) what needs to be obtained from external providers.7.1.2 PeopleThe organization shall determine and provide the persons necessary for the effective implementation of its quality management system and for the operation and control of its processes.7.1.3 InfrastructureThe organization shall determine, provide and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products and services. NOTE Infrastructure can include: a) buildings and associated utilities; b) equipment, including hardware and software; c) transportation resources; d) information and communication technology.7.1.4 Environment for the operation of processesThe organization shall determine, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services.NOTE :A suitable environment can be a combination of human and physical factors, such as:a) social (e.g. non-discriminatory, calm, non-confrontational);b) psychological (e.g. stress-reducing, burnout prevention, emotionally protective);c) physical (e.g. temperature, heat, humidity, light, airflow, hygiene, noise).These factors can differ substantially depending on the products and services provided.7.1.5 Monitoring and measuring resources7.1.5.1 GeneralThe organization shall determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements. The organization shall ensure that the resources provided:a) are suitable for the specific type of monitoring and measurement activities being undertaken;b) are maintained to ensure their continuing fitness for their purpose.The organization shall retain appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources.7.1.5.2 Measurement traceabilityWhen measurement traceability is a requirement, or is considered by the organization to be an essential part of providing confidence in the validity of measurement results, measuring equipment shall be:a) calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; when no such standards exist, the basis used for calibration or verification shall be retained as documented information;b) identified in order to determine their status;c) safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results.The organization shall determine if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and shall take appropriate action as necessary.7.1.6 Organizational knowledgeThe organization shall determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services.This knowledge shall be maintained and be made available to the extent necessary.When addressing changing needs and trends, the organization shall consider its current knowledge and determine how to acquire or access any necessary additional knowledge and required updates.NOTE 1 Organizational knowledge is knowledge specific to the organization; it is gained by experience. It is information that is used and shared to achieve the organization’s objectives.NOTE 2 Organizational knowledge can be based on:a) internal sources (e.g. intellectual property; knowledge gained from experience; lessons learned from failures and successful projects; capturing and sharing undocumented knowledge and experience; the results of improvements in processes, products and services);b) external sources (e.g. standards; academia; conferences; gathering knowledge from customers or external providers).7.2 CompetenceThe organization shall:a) determine the necessary competence of person(s) doing work under its control that affects the performance and effectiveness of the quality management system;.b) ensure that these persons are competent on the basis of appropriate education, training, or experience;c) where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken;d) retain appropriate documented information as evidence of competence.NOTE Applicable actions can include, for example, the provision of training to, the mentoring of, or the reassignment of currently employed persons; or the hiring or contracting of competent persons.7.3 AwarenessThe organization shall ensure that persons doing work under the organization’s control are aware of:a) the quality policy;b) relevant quality objectives;c) their contribution to the effectiveness of the quality management system, including the benefits of improved performance;d) the implications of not conforming with the quality management system requirements.7.4 CommunicationThe organization shall determine the internal and external communications relevant to the quality management system, including:a) on what it will communicate;b) when to communicate;c) with whom to communicate;d) how to communicate;e) who communicates.7.5 Documented information7.5.1 GeneralThe organization’s quality management system shall include:a) documented information required by this International Standard;b) documented information determined by the organization as being necessary for the effectiveness of the quality management system.NOTE The extent of documented information for a quality management system can differ from one organization to another due to:— the size of organization and its type of activities, processes, products and services;— the complexity of processes and their interactions;— the competence of persons.7.5.2 Creating and updatingWhen creating and updating documented information, the organization shall ensure appropriate:a) identification and description (e.g. a title, date, author, or reference number);b) format (e.g. language, software version, graphics) and media (e.g. paper, electronic);c) review and approval for suitability and adequacy.7.5.3 Control of documented Information7.5.3.1 Documented information required by the quality management system and by this International Standard shall be controlled to ensure:a) it is available and suitable for use, where and when it is needed;b) it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity).7.5.3.2 For the control of documented information, the organization shall address the following activities, as applicable:。

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质量管理体系要求原文翻译完全版1 范围本标准为有下列需求的组织规定了质量管理体系要求：a）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）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。

注 1：在本标准一中，术语“产品”仅适用于：预期提供给顾客或顾客所要求的商品和服务；注 2：法律法规要求可称作为法定要求。

2 规范性引用文件下列文件中的条款通过本标准的引用而构成本标准的条款。

凡是注日期的引用文件，只有引用的版本适用。

凡是不注日期的引用文件，其最新版本（包括任何修订）适用于本标准。

ISO9000：2015 质量管理体系-基础和术语3 术语和定义本标准采用ISO9000：2015 中所确立的术语和定义。

4 组织的背景环境4.1 理解组织及其背景环境组织应确定哪些与其宗旨和战略方向有关且影响质量管理体系实现其预期结果的能力的外部和内部情况。

组织应监视和评审这外部和内部情况的信息。

注 1：事宜可能是正面和负面的因素或要考虑的情况注 2：理解外部的环境，可以通过考虑源于国际、国家、地区的或本地的法律法规、技术、竞争、市场、文化、社会和经济环境的情况，促进对外部情境的了解。

注3：理解组织内部环境，可以通过考虑与价值、文化、知识和组织绩效有关的情况，促进对内部情境的了解。

4.2 理解相关方的需求和期望：出于对组织持续地提供满足顾客和适用法律法规要求的产品和服务的能力的影响或潜在影响，组织应确定：a）与质量管理体系有关的相关方；b）与质量管理体系有关的相关方的要求。

组织应监视和评审有关相关方及其有关要求的信息。

4.3 确定质量管理体系的范围组织应界定质量管理体系的边界和应用，以确定其范围。

在确定此范围时，组织应考虑：a）标准 4.1 条款中提到的内部和外部情况；b）标准 4.2 条款中涉及的有关相关方的要求；c）组织的产品和服务。

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。

GB/T19001-2015, ISO 9001:2015 idt, (Version:FDIS)Introduction引言0.1General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。

The potential benefits to an organization of implementing a quality management system based on this International Standard are:对于根据本标准实施质量管理体系的组织来说，潜在的收益是：a) the ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements;a) 稳定提供满足顾客要求和法律法规要求的产品和服务的能力；b) facilitating opportunities to enhance customer satisfaction;b) 获取增强顾客满意的机会；c) addressing risks and opportunities associated with its context and objectives;c) 应对与组织情境和目标相关的风险；d) the ability to demonstrate conformity to specified quality management system requirements.d) 证实符合质量管理体系特定要求的能力。

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)。