2019新版ISO17025质量手册模板

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实验室管理手册 ISO17025体系

ISO17025体系文件实验室管理手册编制：审核：批准：日期：文件修改履历目录发布令为提高本实验室管理水平，保证检测工作质量，建立相对完善的管理体系，提高内部管理综合素质，向客户提供公正、准确的检测报告，按照CNAS-CL01：2018《检测和校准实验室能力认可准则》、CNAS-CL01-G001:2018、CNAS-CL01-A003:2018《检测和校准实验室能力认可准则在电气检测领域的应用说明》、CNAS-CL01-G005:2018《检测和校准实验室能力认可准则在非固定场所外检测活动中的应用说明》、RB/T214-2017《检验检测机构通用要求》、《中华人民共和国计量法》、《中华人民共和国计量法实施细则》和质检总局163号令《检验检测机构的资质认定管理办法》的要求及行业有关质检法律法规，特编写本《实验室管理手册》。

本《实验室管理手册》对本实验室的管理体系、质量方针、目标、各项质量和技术活动的工作程序、操作方法、各种记录以及手册的使用和管理作了具体描述和规定，是本实验室各项质量和技术活动的依据和准则，现予批准发布，自2018年6月01日起实施。

全体人员须认真学习并贯彻执行，确保各项质量和技术活动遵循CNAS-CL01：2018《检测和校准实验室能力认可准则》、CNAS-CL01-G001:2018、CNAS-CL01-A003:2018《检测和校准实验室能力认可准则在电气检测领域的应用说明》、CNAS-CL01-G005:2018《检测和校准实验室能力认可准则在非固定场所外检测活动中的应用说明》、RB/T214-2017《检验检测机构通用要求》。

总经理：日期：公正性声明为了保持本实验室检验工作的公正公开、客观独立、诚实信用，保证用科学的方法，出具客观、公正的检验结果，特作如下声明：1 本实验室对任何受检单位均持公正态度，保持相同的工作质量，实验室各级人员严格遵守国家有关法律、法规，依照管理体系文件的规定，依据检验标准从事检测工作，选用先进的检验设备，使用科学的检验方法，在检验中不受任何势力的干扰和经济方面的诱惑，保证检验工作的独立性和诚实性、检测数据诚实和准确可靠性及检测结论的公正性，并为之负责；2 本实验室在承担检测任务时，拒绝本实验室以外的部门和人员以行政或其它方式干预本实验室正常业务活动或介入检测工作，比如实验室所有权、控制权、管理、人员、共享资源、财务、合同等方面；3 本实验室有责任为客户保守机密，绝不将客户提供的技术资料、检测数据和产品信息提供给无关人员并对实验室活动中获得或产生的所有信息承担管理责任；4 本实验室各级人员不得参与和被检测产品直接有关的单位的任何有损公正性（如：留用、使用客户提供的样品；参与样品的监制、监销；接受客户的投资和赞助和任何形式的商业贿赂；参与和被检测样品有关的研究开发；暗示客户接受任何不合理的附加要求（市场营销（包括品牌）、支付销售佣金或其他引荐新客户的奖酬等。

ISOIEC 17025质量指南(1)

ISOIEC 17025质量指南(1)ACBCOMPNAY 1800 NW 169TH PI, BEAVERTON , OR 97006ISO/IEC 17025 QUALITY MANUALRevision 1Date: 4/16/04UNCONTROLLED COPY □CONTROLLED COPY □Serial # _________Issued To: ___________________________ Date: ___________ABC CompanyISO/IEC 17025 QUALITY MANUALREV. 1 DATE: 4/16/04 PAGE 2 OF 17TABLE OF CONTENTS Introduction (4)Quality Manual Distribution and Approval (4)Quality Policy Statement (5)4.0 Management Requirements (6)4.1 Organization (6)4.2 Quality System (8)4.3 DocumentControl (8)4.4 Review of Requests, Tenders, and Contracts (9)4.5 Subcontracting of Tests andCalibrations (10)4.6 Purchasing Services and Supplies (10)4.7 Service to theCustomer (11)4.8 Complaints (11)4.9 Control of Nonconforming Testing and/or Calibration Work (11)4.10 Corrective Action (12)4.11 PreventiveAction (12)4.12 Control of Records (13)4.13 InternalAudits (14)4.14 Management Reviews (14)5.0 TechnicalRequirements .............................. .... (15)5.1 Technical Requirements –General (15)5.2 Personnel (15)5.3 Accommodations and Environmental Conditions (16)5.4 Test and Calibration Methods and Method Validation (17)5.5 Equipment (20)5.6 Measurement Traceability (22)5.7 Sampling (23)5.8 Handling and Transportation of Test and/or Calibration Items (23)5.9 Assuring the Quality of Test and Calibration Results .............................................245.10 Reporting the Results (24)ABC CompanyISO/IEC 17025 QUALITY MANUALREV. 1 DATE: 4/16/04 PAGE 3 OF 17 INTRODUCTIONABC Company recognizes its responsibility as a provider of quality testing services. To this end, ABC Company has developed and documented a quality management system to better satisfy the needs of its customers and to improve management of the company. The quality system complies with the international standard ISO/IEC 17025, 1999 and ISO 9001:2000. This manual has been prepared to define the quality system, establish responsibilities of the personnel affected by the system, and to provide general procedures for all activities comprising the quality system. In addition, this manual is utilized for the purpose of informing our customers of the quality system, and what specific controls are implemented to assure service quality.QUALITY MANUAL DISTRIBUTION AND APPROVALThis manual will be revised as necessary to reflect the quality system currently in use. It is issued on a controlled copy basis to all internal functions affected by the quality system and on an uncontrolled copy basis to customers and suppliers; although, it can be issued to customers on a controlled copy basis upon customer request. The methods for control and distribution of manuals are explained in Control of MPS Quality Manual, procedure # QA- 001.The Quality Manager and CEO approve changes to the Quality Manual. ABC Company records the revision level, issue date and authorized signatures in the master Quality Manual.ABC CompanyISO/IEC 17025 QUALITY MANUALREV. 1 DATE: 4/16/04 PAGE 4 OF 17QUALITY POLICY STATEMENTABC Company is committed to the continuous improvement of processes and products to achieve customer satisfaction. It is therefore our policy to:• Consistently provide quality products and services that conform to customer requirements.• Deliver our testing services with accurate and quick test results, while maintaining aneconomical value to the customer.• Comply with ISO 17025 standards at all times to ensure quality product and testingservices. It is ABC Company goal to encourage active participation of all employees in quality planning and continuous improvement efforts to meet all quality, service and cost objectives.__________________________________Chuck Weitzel, President / CEODon Harring, Quality ManagerABC CompanyISO/IEC 17025 QUALITY MANUALREV. 1 DATE: 4/16/04 PAGE 5 OF 174.0 Management Requirements4.1 Organization and Management4.1.1 ABC Company (MPS) is a registered Corporation in the State of Oregon and holds legal responsibility for its operation.4.1.2 MPS is organized to operate in accordance with the requirements of ISO/IEC 17025. The Quality Manager has the responsibility to maintain the Quality System to operate in accordance with the requirements of ISO/IEC 17025. It is the responsibility of all employees to work in accordance with the quality policies, and to satisfy the needs of our customers.4.1.3 MPS is organized to operate in accordance with the requirements of ISO/IEC 17025, whether carrying out work in its permanent facilities or on location, at customer sites.4.1.4 MPS is not part of an organization performing activities other than testing and/or calibration; therefore, there is no potential conflict of interest amongst its personnel.4.1.5 The organization of ABC Company is illustrated below in Figure 1.Figure 14.1.5 cont.a). The Test Engineer is responsible for being familiar with the test methods, procedures, test objectives and the assessment of test results. The Quality Manager has the responsibility to maintain the Quality Management Systems to ISO/IEC 17025 and has the authority to institute corrective action and procedures consistent with these quality goals. The process for updating the Quality Manual, and methods for determining the revision history and responsibilities are detailed in Control of MPS Quality Manual, procedure # QA-001. The Quality Manager reports directly to the Chief Executive Officer. b). Gifts or favors from suppliers, customers or internal activities that may be nefit from “in-spec” test results are prohibited to avoid any perception of conflict of interest, see Customer Confidentiality and Code of Ethics, procedure # QA-002.ABC CompanyISO/IEC 17025 QUALITY MANUALREV. 1 DATE: 4/16/04 PAGE 6 OF 17c) Propri etary rights and confidential information for both MPS and it’s customers are adequately secured (Customer Confidentiality Procedure # QA- 002).d). It shall be the responsibility of all MPS employees to conduct themselves in a manner that does not diminish the confidence in our competence, impartiality, judgment or operational integrity as viewed by both MPS employees and our customers. This responsibility includes activities both in and outside of normal operations at MPS.e). The organizational chart is maintained and stored by the Quality Manager and is part of this manual. MPS is a privately held company, not part of any other company or organization. In the absence of the Quality Manager, the Test Engineer or CEO will assume the duties of the Quality Manager. In the absence of the Test Engineer the Quality Manager or CEO will assume the duties of the Test Engineer. In the event of both the Quality Manager and the Test Engineer’s absence, the CEO, having knowledge of testing methods and systems for MPS, will assume these necessary management positions until the return of these key personnel.f). Job descriptions will be maintained for all personnel detailing responsibility, authority, and education and training requirements (ref.: Job Description and TrainingProgram, Procedure # QA-003).4.2.1.1 The Quality Manual is the principal document that defines the quality system at ABC Company. The Quality Manual and all documented procedures are available to all personnel on the Quality Systems Directory. The Quality Systems Directory, managed by the Quality Manager, maintains the Quality Manual andall relevant documents per Document Control Procedure # QA-004 and Control of MPS Quality Manual, procedure # QA-001.4.2.1.2 Quality System Procedures are documented to establish and maintain continuity of each activity or function affecting quality. Quality procedures will be readily available to personnel for reference and implementation. The quality document structure contains this Quality Manual, Quality Procedures, Work Instructions, and Quality Records.4.3 Document Control4.3.1 MPS shall establish and maintain procedures to control all documents that form part of its quality system.4.3.1.1 Documents required by the quality system are managed by t he Document Control Procedure # QA-004.4.3.1.2 The Document Control Procedure is established to define the means needed to:• Approve documents for adequacy prior to use.• Assure documents are uniquely identified and approved for use.• Review and update as necessary and re-approve documents.• Ensure that changes and the current revision status of the documents are identified• Ensure that relevant version of applicable documents are available at points of use• Ensure that documents remain legible and readily identifiable• Ensure that documents of external origin are identified and their distribution managed.• Prevent the unintended use of obsolete documents and to apply suitable identification to them if they are retained for any purpose.ABC CompanyISO/IEC 17025 QUALITY MANUALREV. 1 DATE: 4/16/04 PAGE 7 OF 174.3.2 Document Changes4.3.2.1 Changes to Documents are controlled by the Document Control procedure # QA-004. Changes to documents shall be reviewed by the same functions that performed the original review unless specifically designated otherwise. Approval functions have access to pertinent information to base their review and approval.4.3.2.2 A description of the change is listed on the document or attachment and the obsolete document is retained in the document history files.4.3.2.3 Quality system documents shall be uniquely identified to include:• Date of issue• Revision identification #• Page numbering• Total number of pages or a mark to signify the end of the document• Issuing authorities4.4 Review of Requests, Tenders, and Contracts4.4.1 Contract/order review is an integral part of the quality system at ABC Company. All contracts/orders are reviewed and accepted only if the requirements are clear and understood, and the company has the capability and capacity to assure full customer expectations. The process for contract review is further defined in the Contract Review Procedure, # QA-005.4.4.2 Records of reviews, including any significant changes, are maintained for minimum period of one year.4.4.3 The contract review will also cover any work that is subcontracted out.4.4.4 Communications are maintained with the customer from request/quote through commencement of work. This includes informing the customer of any deviation from the contract.4.4.5 If a contract needs to be amended after work has commenced, the same contract review process shall be repeated and any amendments shall be communicated to affected personnel.4.5 Subcontracting of Tests and Calibrations4.5.1 It is not the policy of MPS to subcontract testing. However, if it should become necessary to subcontract work for some unforeseen circumstance the following policies will apply: Work is only to be placed with a testing facility that complies with ISO 17025, or is approved by MPS Purchasing as an Approved Supplier, unless otherwise specified by customer.4.5.2 MPS will inform its customer in writing of the arrangement to subcontract, and if appropriate, obtain customer approval to subcontract.4.5.3 MPS is responsible for the subcontractor’s work, except when the customer specifies the subcontractor.4.5.4 MPS shall maintain a file for all subcontractors and a copy of their “scope of accreditation”, or Approved Supplier record, see Supplier Approval Process # QA-007.4.6 Purchasing Services and Supplies4.6.1 MPS purchasing department maintains approved suppliers for the purchase of supplies and services that have a direct affect on the quality product and testing performed. See Purchasing Services and Supplies Procedure # QA- 006 and Supplier Approval Process # QA-007.ABC CompanyISO/IEC 17025 QUALITY MANUALREV. 1 DATE: 4/16/04 PAGE 8 OF 174.6.2 Purchased supplies and consumable materials that affect the quality of tests are not used until inspected to ensure compliance with specified requirements, see Purchasing Services and Supplies Procedure # QA-006.4.6.3 MPS shall evaluate suppliers of critical consumables, and services which affect the quality of calibration and maintain a Approved Supplier list, s ee Purchasing Services and Supplies procedure # QA-006.4.7 Service to the customer4.7.1 MPS will do everything possible to assure that its customers receive the best possible service while maintaining the utmost in confidentiality when required.This may include, however is not limited to:• Cooperating with customers in the clarification of test requests and the performance of said tests.• Affording customers access to the laboratory to witness testing when requested. • Prepare, package and dispatch test items and reports as required by our customers for verification purposes.• Advise, guide and communicate with our customer in technical matters, opinions and interpretations in regards to testing performed or to be performed.• Communicate to our customers any major deviations in testing being performed. • Communicate to the customers any delays that may result in the customer not receiving their testing in a timely manner.• Customers will be notified of any event that casts doubt onto the validity of results supplied to them.4.8 ComplaintsComplaints, both verbal and written, shall be documented in accordance with Customer Complaint, procedure # QA-008, which covers the methods for documenting, investigating and resolving complaints.4.9 Control of Nonconforming Testing and/or Calibration Work4.9.1 In the event that a non-conformance is identified with regard to any aspect of testing, or the results of the work do not conform to its own procedures or to the agreed requirements of the customer, the Quality Manager or the Test Engineer will act to contain the non-conformance and initiate corrective action per the Control of Non-Conforming Testing, procedure # QA-009.4.9.2 Where the evaluation indicates that the nonconforming work could recur or that there is doubt about the compliance of MPS operations with its own policies and procedures, the Corrective Action procedure # QA-010 shall be followed to identify the root cause(s) of the problem and to eliminate this (these) cause(s).4.10 Corrective Action4.10.1Corrective Action procedure # QA-010 describes the methods for implementing corrective action and includes a process for the recording of relevant information for Management review.ABC CompanyISO/IEC 17025 QUALITY MANUALREV. 1 DATE: 4/16/04 PAGE 9 OF 174.10.2 The Corrective action procedure must start with root cause analysis.4.10.3 Corrective action shall be selected for anticipated effectiveness of appropriate magnitude, documented, and implemented.4.10.4 Corrective action shall be monitored for effectiveness.4.10.5 Where the identification of nonconformance raises doubt on MPS compliance with it’s own policies and procedures, or with ISO 17025, additional internal audits will be performed to monitor the effectiveness of Corrective Action and the quality system.4.11 Preventative Action4.11.1 MPS has established the following procedures to reduce the likelihood thata non-conformance will occur:• Non-conformance• Corrective Action• Management Review• Internal Quality AuditsPreventative action is a pro-active process to identify improvement opportunities. The policies and procedures should reduce the likelihood that a non-conformance will occur. Once a need to improve has been identified, an action plan should be developed, which included tasks, assigned responsibility, and timing, see Preventative Action, Procedure # QA-011.4.11.2 Once a plan is implemented, it should be monitored to verify that the needed improvements have been realized and are effective. All action plans shall be formally reviewed a t the management quality review meeting, and the plan’s effectiveness shall be evaluated.4.12 Control of Records4.12.1.1 The Record Control Procedure # QA-012 is established to define the means needed to identify, collect, index, access, file, store, maintain and dispose of quality and technical records such as:• Internal Audit Records• Management Reviews• Corrective Actions• Preventative ActionsThe collection and retention of records can be defined by individual procedures 4.12.1.2 Records are legible, stored in a suitable environment to prevent damage or deterioration and are readily retrievable. Records may be in hard copy or electronic format. Electronic data is protected, backed up, stored and access controlled by the Computer Network and Security Procedure # QA- 013.4.12.1.3 All records are held securely and in confidence.4.12.1.4 A back up copy of electronic data will be made periodically, and stored in a fire proof safe, access to which is controlled by t he Computer Network and Security Procedure # QA-013.ABC CompanyISO/IEC 17025 QUALITY MANUALREV. 1 DATE: 4/16/04 PAGE 10 OF 174.12.2.1 MPS shall retain records of original observations, derived data and sufficient information to establish an audit trail, calibration records, staff records and a copy of each test report for a period of one year. The records shall include the identity of personnel responsible for the sampling, performance of each test of checking of results, see Records Control Procedure # QA-012.4.12.2.2 Observations, data and calculations shall be recorded at the time they are made and shall be identifiable to the specific task.4.12.2.3 When mistakes occur in records, each mistake shall be crossed out, not erased, made illegible or deleted, and the correct value entered alongside. In thecase of electronically stored data, a hard copy of the data will be produced and a brief note shall be added to the document specifying the nature of the mistake and why the correction was necessary. All such mistakes / alterations to records and electronic data shall be signed or initialed by the person making the correction and maintained on file.4.13 Internal Audits4.13.1 Periodic audits of MPS operations are performed in accordance with MPS’s Internal Quality Auditing procedure # QA-014. Internal Auditors are trained and wherever resources permit, independent of the area being audited.4.13.2 When audit findings cast doubt on the effectiveness of the operations of the correctness or validity of the MPS test results, MPS shall take timely corrective action, and shall notify customers in writing if investigations show that the test results may have been affected.4.13.3 The area of activity audited, audit findings, follow up audit activities and corrective action are recorded in MPS computer system using the Internal Quality Auditing Procedure # QA-014.4.14 Management Reviews4.14.1 Management Review meetings for all MPS functions are held at defined intervals. Management Reviews access the effectiveness and continuing stability of the Quality System to satisfy the requirements of ISO/IEC 17025 and MPS Quality Policy and Objectives. The CEO is responsible for scheduling and conducting the reviews. Detailed rules for scheduling, conducting and the recording of Management reviews are specified in Management Review procedure # QA-021. The review shall take account of:• The suitability of policies and procedures• Reports from managerial and supervisory personnel• The outcome of recent internal audits• Corrective and preventative actions• Assessments by external bodies• The results of interlaboratory comparisons or proficiency tests• Changes in the volume and type of work• Customer feedback• Complaints• Other relevant factors, such as quality control activities, resources and staff training.5.0 Technical RequirementsABC CompanyISO/IEC 17025 QUALITY MANUALREV. 1 DATE: 4/16/04 PAGE 11 OF 175.1 Technical Requirements – General5.1.1 ABC Company recognizes that many factors determine the correctness and reliability of the tests and/or calibration performed by a laboratory. These factors include contributions from: human factors (5.2), accommodation and environmental conditions (5.3), test and calibration methods and method validation (5.4), equipment(5.5), measurement traceability (5.6), sampling (5.7), and handling of test and calibration items (5.8).5.1.2 The extent to which the factors contribute to the total uncertainty of measurement differs considerably between types of tests. ABC Company takes into account these factors in developing test and calibration methods and procedures, in the training and qualification of personnel, and in the selection and calibration of the equipment it uses.5.2 Personnel5.2.1 Mobile Power Solution’s management ensures the competency of all who operate specific equipment, who perform tests and/or calibrations, evaluate results and sign test reports. When using staff that is undergoing training, adequate and appropriate supervision is provided. Personnel performing specific tasks are qualified on the basis of appropriate education, training, experience, and/or demonstrated skills, as required. See Job Description and Training Program procedure # QA-003.5.2.2 It is the policy of MPS to evaluate the education and training needs of it’s personnel based on their level of expertise, as a part of the Management Review procedure # QA-021.5.2.3 All personnel utilized within the laboratory are employed by or under contract to MPS. Where additional personnel are utilized that are not under contract or employed by MPS, the MPS Test Engineer shall assure that said personnel are supervised, competent, and that they work in accordance MPS quality systems. 5.2.4 MPS maintains current job descriptions for all managerial, technical, and key support personnel involved in testing. The following will be defined:• The responsibilities with respect to performing tests and calibrations.• The responsibility with respect to the planning of test and/or calibrations and evaluations of results.• The responsibilities for reporting opinions and interpretations.• The responsibilities with respect to method modification and development and validation of new methods.• Expertise and experience required.• Qualifications and training programs• Managerial dutiesSee Job Description and Training Program procedure # QA-003.5.2.5 The management at MPS shall authorize specific personnel to perform certain types of testing and calibration, to issue test reports, to give opinions and interpretations and to operate particular types of equipment. MPS shall maintain records of authorization(s), competence, educational and professional qualifications, training, skills and experience of all technical personnel, including contracted personnel. This information shall be readily available and shall include the date on which authorization and/or competence is confirmed. See “Technical Qualification List” (ref.: Job Description and Training Program Procedure # QA-003). ABC CompanyISO/IEC 17025 QUALITY MANUALREV. 1 DATE: 4/16/04 PAGE 12 OF 175.3 Accommodation and environmental conditions5.3.1 Environmental controls for the test laboratory are appropriate for the test(s) being performed. A temperature-controlled environment is maintained as required by those tests being performed. Human factors relating to light, ventilation andspace are considered with respect to performing required tasks safely and effectively. For each area that requires a controlled environment, MPS shall document the conditions that might affect the test, s ee Record Control Procedure # QA-012.5.3.2 Environmental factors that may adversely affect test measurements are controlled to the degree necessary so as not to invalidate test results or increase the measuring uncertainty. Tests shall be stopped when the environmental conditions jeopardize the results of the tests.5.3.3 A calibrated temperature-monitoring device is available and operating, whenever testing necessitating temperature is being performed. The Laboratory room temperature is recorded and maintained in file in the Laboratory and is readily accessible.5.3.4 Effective separation is maintained in work areas for safety and quality purposes.5.3.5 It is the policy of MPS to maintain all areas in a clean and orderly manner. Tools, equipment and materials are stored in their proper location at the end of each workday, unless extended or continuous testing requires the use of the equipment. Desktops, countertops, floors, etc, are cleaned as needed by the Laboratory personnel. Housekeeping is included as an audit item, see Internal Quality Auditing, procedure # QA-014.5.4 Test and Calibration methods and method validation5.4.1 All instructions, standards, manuals and reference data relevant to the work of the laboratory shall be part of the document control system. Work instructions are written for each test performed. The latest valid edition of all instructions and manuals shall be used.5.4.2 Where the customer does not specify a testing method, the Test Engineer will select a published national or international standard. Methods that have not been established as a standard are fully documented, statistically validated and agreed to by the involved parties.5.4.3 When MPS must develop a procedure for performing a test, it must be a planned activity. The test plan must identify how the test will progress from start to finish. Whatever testing plan is used, it must be documented.5.4.4 When developing procedures for performing new tests, the procedure should contain the following information:• Appropriate identification• Revision of the document• Scope• Description of the type of item to be tested• Parameters or quantities and ranges to be determined• Apparatus and equipment, including technical performance requirements• Reference standards and reference materials required• Environmental conditions required and any stabilization period needed.• Description of the procedure including:ABC CompanyISO/IEC 17025 QUALITY MANUALREV. 1 DATE: 4/16/04 PAGE 13 OF 171. Affixing of identification marks, handling transporting, storing and preparation of items.2. Checks to be made before the work is started.3. Checks that the equipment is working properly and, whererequired, calibration and adjustment of the equipment before each use.4. Method of recording the observations and results.5. Any safety measures to be observed.• Criterion and/or requirements for approval/rejection.• Data to be recorded and method of analysis and presentation.• The uncertainty or procedure for estimating uncertainty, where needed.5.4.5 Validation of methods5.4.5.1 All standard and non-standard test methods and procedures are validated to ensure that such methods and procedures are fit for their intended use as well as the customer.5.4.5.2 The results of such validation are recorded together with the procedure utilized and any other relevant information. The record states whether the method or procedure is fit for the intended use.5.4.5.3 The range and accuracy of the values obtainable from validated methods shall be relevant to the customers needs.5.4.6 Estimation of Uncertainty of measurement5.4.6.1 All testing equipment calibrated in house shall have and shall apply a procedure to estimate the uncertainty of measurement for all calibrations and all types of calibrations see Estimation of Measurement Uncertainty Procedure # QA-015.5.4.6.2 Documented procedures detail the methods used for estimating uncertainty of measurement and include all uncertainty components, which are of importance in the given situation, see Estimation of Measurement Uncertainty Procedure # QA-015.5.4.6.3 When estimating the uncertainty of measurement, factors which are of importance in the given situation shall be taken into account using appropriate methods of analysis.5.4.7 Control of Data5.4.7.1 Calculations and data transfer are subject to checks by someone other than the person performing the work, prior to reporting the data to the customer. The person checking the work initials the data as evidence of review.5.4.7.2 MPS utilizes computers and automated equipment for the capture, processing, manipulation, recording, reporting, storage and retrieval of test data, MPS maintains supporting evidence that the software is suitably validated as being adequate for use (commercial off the shelf software not subject to this requirement). Procedures are established to ensure integrity and confidentiality of data entry and data collection, data storage, and data transmission. Ref Computer Network security and Data Protection procedure # QA-013.5.5 Equipment5.5.1 MPS laboratory is furnished with all items of sampling, measurement and test equipment required to correctly perform all testing specified. In those cases where personnel need to use equipment outside of MPS’s permanent control such equipment must first be first be approved by the Technology director and said equipment must be investigated to assure that the requirements of both the test specification and the ISO/IEC17025 are met.ABC Company。

2019年最新版17025质量手册

GGGGGGGGG 公司检测中心质量手册文件编号：GG/NN-1706-2017 编制:审核:批准：批准日期：受控状态：□受控/ □非受控分发号：发布日期：实施日期:文件编号：GG/NN-1706-2017 质量手册章节条号：0.6第1页共1页标题：保护客户机密信息和所有权的承诺第1版第0次修改0 • 8质量手册的管理0.8.1总则质量手册的管理主要是对其进行控制并保持其现行有效，明确管理者和持有者的责任。

0.8.2职责0.8.2.1质量手册由质量负责人归口管理，负责组织其编制、发放、宣贯、借阅、回收、归档并监督执行。

0.8.2.2质量手册由实验室主任批准和发布实施。

0.8.2.3当质量手册编制或做出重大修订后，由质量负责人组织全体员工进行学习和贯彻。

0.8.2.4质量负责人应维护质量手册的现行有效。

0.8.3质量手册的版本和修订0.8.3.1质量手册分受控和非受控。

受控和非受控均应在首页加注相应的标记。

0.8.3.2受控手册编号登记发放。

手册内容需作更改时，应对受控副本进行跟踪更换。

更换下来的手册或手册插页应及时加注“作废”标识，归档保存或者销毁。

0.8.3.3非受控手册文本仅作发放登记，不作发放编号。

0.8.3.4遇到下列情况应考虑对手册进行改版：1 ）认可准则改版；2）组织机构发生重大变化；3 ）检测标准和服务能力发生重大变化；4）评审中出现较大管理体系问题；5 ）法律法规变化。

0.8.3.5遇有以下情况，手册应予修订：实际执行中发现手册条款不适应现实工作或有不完善之处；组织机构或人员岗位调整，影响手册的执行；现行手册的条款与有关标准和法律、法规有矛盾；内审和评审中认为需要进行调整。

0.8.3.6质量负责人提出修改计划报实验室主任批准后实施。

修改的手册报实验室主任批准［发点实用参考文档资料］0.8.3.7质量负责人应定期对质量手册进行审核，对不适应的部分进行及时的修改和调整，文件编号：GG/NN-1706-2017 质量手册章节条号：0.8第2页共2页标题：质量手册的管理第1版第0次修改。

【8A版】2019版17025程序文件

4.2.4对于违反上述规定工作人员，检测中心主任有义务查清问题并追究责任。
5相关文件
5.1《检测中心公正行为控制程序》
5.2《文件控制程序》
编制
审批
GGGGGGGGGGG检测中心
文件编号
AA.BB-02-2017
版本
第A版
第0次修改
保证检测中心诚信度的程序
页码
共1页
第1页
1目的
确保检测中心人员在公正性、判断力以及工作诚实性方面的可信度。Байду номын сангаас
文件编号
AA.BB-03-2017
版本
第A版
第0次修改
文件控制程序
页码
共2页
第2页
4.3.3文件管理人员应根据文件分发记录于声明文件作废或修订批准后，按收旧领新的原则。确保各相关场所使用文件的有效性。
4.4文件的使用、保存、存档要求
4.4.1文件管理员应建立有效文件目录，并每年审查一次，非现场使用的文件，由检测中心专人管理。
4.6文件编号
4.6.1质量手册编码规则如下：CC.BB.SQM-GGGG&
CC.BB.：公司质量文件代码，SQM：检测中心质量手册，GGGG：版本年号，&：版次以A,B,C依次更替
4.6.2程序文件编码规则如下：AA.BB-GGGG&
CC.BB.：公司质量文件代码，SQP：检测中心程序文件，GGGG：版本年号，&：版次以A,B,C依次更替
GGGGGGGGGGG检测中心
文件编号
AA.BB-01-2017
版本
第A版
第0次修改
保护客户的机密信息和所有权的程序
页码
共1页
第1页

化验室ISO17025质量手册(ppt 110页)

2.5 质量手册的宣贯、实施
质量手册批准发布后，由质量保证室制定质量手册宣贯工作计划，并组织实施。
第15章外部支持服务和供应（暂缺） 15.1 概述 15.2 外部支持服务和供应方的选择 15.3 质量保证措施 15.4 供应与服务的质量承诺 15.5 相关文件
第16章抱怨（暂缺） 16.1 概述 16.2 抱怨的处理 16.3 质量体系的审核 16.4 相关文件
通用部分描述实例
质量手册
质量体系各要素之间具有一定的相互依赖、相互配合、相互促进和相互制约的关系，形成了具有一定活动规律的有机整体。在编写质量体系文件时必须树立系统的观念，应从检测机构的整体出发进行设计、编排。对影响检测质量的全部因素进行有效的控制，接口要严密、相互协调、构成一个有机的整体。
1.4 质量体系文件的编写原则
2.3 质量手册的管理
质量手册的编制、审批、发布程序文件、质量文件的编制、审批、发布监测业务室为质量手册归口管理部门质量手册的受控管理质量手册对外发放的管理对质量手册持有者的要求
2.4 质量手册的编制、修订、再版
中心总技术负责人负责组织编制和修改质量手册
质量手册中修订的页次应全页更换关于手册再版的规定质量手册的再版条件
第3章 3 4.6 4.7 4.8
质量方针和质量目标质量方针质量目标质量承诺组织和管理概述组织机构（包括组织机构框图）职责与权限权利委派保护委托方机密和所有权的规定指令性检测任务相关文件附录
第5章质量体系、审核和评审 5.1 概述 5.2 质量体系建立 5.3 质量体系文件 5.4 质量体系运行 5.5 内部质量体系审核 5.6 质量体系管理评审 5.7 检测工作偏离程序、标准规范的例外许可规定 5.8 验证和比对实验 5.9 相关文件 5.10 附录

ISO-IEC17025-实验室管理体系全套文件质量手册及程序文件目录框架和部分内容

ISO IEC17025-2017实验室管理体系全套文件质量手册及程序文件实施日期:2018年01月01 0XXX公司实验室目录A批准页B修改页C目录D质量手册发布令E公正性声明F质量方针和质量目标G质量手册管理0引言0.1公司概况0.2组织架构1范围1.1总则1.2应用2规范性引用文件3术语和定义4通用要求4.1公正性4.2保密性5结构要求6资源要求6.1总则6.2人员6.3设施和环境条件6.4设备6.5计量溯源性6.6外部提供的产品和服务7过程要求7.1要求、标书和合同评审7.2方法的选择、验证和确认7.3抽样7.4检测或校准物品的处置7.5技术记录7.6测量不确定度的评定7.7结果有效性的保证7.8结果的报告7.9投诉7.10不符合工作7.11数据控制和信息管理8管理要求8.1方式8.2管理体系文件8.3管理体系文件的控制8.4记录控制8.5风险和机会的管理措施8.6改进8.7纠正措施&8内部审核8.9管理评审附录A计量溯源性附录B管理体系方式附件1任命书附件2授权书附件3授权签字人识别附件4检定、校准和检测项目一览表附件5管理体系程序文件清单附件6公司和实验室平面图部分内容展示D质量手册发布令公司全体职工：为了保证本公司检验检测工作的质量，确保检验检测结果的公正性、准确性和科学性，公司为满足实验室要求，依据ISO/IEC17025:2017《检测和校准实验室能力的通用要求》，并结合实验室实际情况重新编制了《实验室管理体系质量手册》现予以批准。

本手册于二。

一八年一月一日起正式实施。

《实验室管理体系质量手册》是描述实验室管理体系的纲领性文件，是实验室管理体系运行的行为准则和评审的依据，也是实验室质量保证能力的证实，手册所涉及的单位和员工都必须严格执行，确保实验室质量方针的实现。

总经理:XXXX年月曰E公正性声明i公正性声明：为了提高服务质量，维护客户的合法权益，保证实验室检验检测活动的独立性，保持中心良好信誉，特作如下声明：l.i.本公司实验室具有独立法律地位和独立开展业务的权利，其检验检测结果不受任何行政、商业、金融干预，不受经济利益或其他外界压力的影响，保证做到检验检测活动的独立性和公正性。

Iso新17025实验室品质管理

ISO 17025 實驗室品質管理
實驗室的主要工作？？
確
報
保
送
收
備
測
告
報
產
件
件
樣
試
審
告
品
查
品
質
‧數據 ‧標準 ‧方法
‧正確性 ‧追溯
‧規格
驗證
ISO 17025 之內涵
• 以技術能力為核心，即在於是否能有效執行校正/測試作業。
• 以品質循環PDCA之精神建立管理架構的環境。
P：PLAN D：DO C：CHECK A：ACTION
內部稽核
記錄管制矯正措施
管理審查服務客戶預防措施
抱怨
客戶 (REPORT)
ISO 17025 技術要求
• 5.1 概述 • 5.2 人員 • 5.3 設施與環境條件 • 5.4 試驗與校正方法與方法確認 • 5.5 設備 • 5.6 量測追溯性 • 5.7 抽樣 • 5.8 試驗件與校正件之處理 • 5.9 試驗與校正結果之品質保證 • 5.10 結果報告
量測結果的表達
• 用卡尺量測一鋼板厚度結果如下： 15.02mm 14.88mm 14.92mm 15.04mm 14.94mm
• 平均值：14.96mm • 表示方式：
14.88～15.04mm 14.96±0.08mm 14.96±0.06mm
量測／校正結果之表達
• 量測／校正結果：14.96mm (y) • （擴充）不確定度：0.06mm (U) • Y＝y±U • 信賴水準為：？％ (95%) • 擴充係數K＝？ (2.00)
不符合之來源
• 過程（程序）的不符合 • 產品（結果）的不符合 • 顧客要求的不符合 • 儀器設備的不符合 • 環境監控的不符合 • 試驗樣品的不符合 • 人員資格的不符合 • 試驗方法的不符合 • 試驗結果的不符合 • ………………….

2019年最新ISO IEC17025-2017实验室管理体系全套文件(质量手册和程序文件)共210页

ISO/IEC 17025-2017检测和校准实验室全套体系文件（1份手册+40份程序文件=210页）文件清单序号文件编号文件名称0 LQM01 -2019 实验室质量管理手册1 LQP01-2019保护客户机密信息和所有权程序2 LQP02-2019保证实验室诚信度程序3 LQP03-2019质量管理手册的管理4 LQP04-2019文件控制程序5 LQP05-2019网络系统检测用计算机及软件管理程序6 LQP06-2019要求、标书和合同评审程序7 LQP07-2019分包管理程序8 LQP08-2019服务和供应品采购程序9 LQP09-2019投诉处理程序10 LQP10-2019不符合检测工作控制程序11 LQP11-2019纠正措施程序12 LQP12-2019预防措施程序13 LQP13-2019记录控制程序14 LQP14-2019内部审核程序15 LQP15-2019管理评审程序16 LQP16-2019质量监督工作程序17 LQP17-2019人员培训考核和技术档案管理程序18 LQP18-2019检测环境控制程序19 LQP19-2019实验室管理程序20 LQP20-2019检测方法及方法确认程序21 LQP21-2019新项目评审程序22 LQP22-2019测量不确定度评定程序23 LQP23-2019 仪器设备管理程序24 LQP24-2019期间核查程序25 LQP25-2019量值溯源程序26 LQP26-2019实验室间比对、能力验证程序27 LQP27-2019标准物质管理程序28 LQP28-2019采样程序29 LQP29-2019 样品管理程序30 LQP30-2019 检测工作程序31 LQP31-2019 现场检测管理程序32 LQP32-2019 应急检测工作程序33 LQP33-2019 检测过程发生异常情况处理程序34 LQP34-2019 事故处理程序35 LQP35-2019 质量控制程序36 LQP36-2019 例外允许偏离程序37 LQP37-2019 检测报告管理程序38 LQP38-2019 档案管理程序39 LQP39-2019 数据控制和信息管理程序40 LQP40-2019 风险和机遇管理程序说明：《CNAS-CL01-2018检测和校准实验室能力认可准则》等同ISO/IEC 17025:2017标准，是实验室认证所依据的标准，本文档依据最新标准编制而成，绝非照搬标准内容，文件间的引用无冲突。

ISO17025管理手册(制度范本、DOC格式).DOC

ISO17025管理手册（制度范本、DOC格式）.DOC1、范围1、1 本准则规定了实验室进行检测和/或校准的能力（包括抽样能力）的通用要求。

这些检测和校准包括应用标准方法、非标准方法和实验室制定方法进行的检测和校准。

1、2 本准则适用于所有从事检测和/或校准的组织，包括诸如第一方、第二方和第三方实验室，以及将检测和/或校准作为检查和产品认证工作一部分的实验室。

本准则适用于所有实验室，不论其人员数量的多少或检测和/或校准活动范围的大小。

当实验室不从事本准则所包括的一种或多种活动，例如抽样和新方法的设计（开发）时，可不采用本准则中相关条款的要求。

1、3 本准则中的注是对正文的说明、举例和指导。

它们既不包含要求，也不构成本标准的主体部分。

1、4 本准则用于对检测和校准实验室能力的认可。

寻求认可的检测和校准实验室应按本准则建立质量、管理和技术体系并控制其运作。

1、5 本准则不包含实验室运作中应符合的法规和安全要求。

1、6 如果检测和校准实验室符合本准则的要求，当它们从事新方法的设计（开发）和/或结合标准的和非标准的检测和校准方法制定试验方案时，其检测和校准所运作的质量体系也符合ISO9001：1994的要求；在实验室仅使用标准方法时，则符合ISO9002：1994的要求。

本准则包含了ISO9001和ISO9002中未包含的一些技术能力要求。

2、引用标准下列标准所包含的条文，通过在准则中引用而构成为本准则的条文。

所有标准都会被修订，使用本标准的各方应探讨使用下列标准最新版本的可能性：ISO9001:1994 《质量体系设计、开发、生产、安装和服务的质量保证模式》ISO9002:1994 《质量体系生产、安装和服务的质量保证模式》ISO/IEC指南2 《标准化及相关活动的一般术语和定义》VIM《国际通用计量学基本术语》，由国际计量局(BIPM)、国际电工委员会(IEC)、国际临床化学和实验医学联合会(IFCC)、国际标准化组织(ISO)、国际理论化学和应用化学联合会(IUPAC)、国际理论物理和应用物理联合会(IUPAP)和国际法制计量组织(OIML)发布。

矿产

矿产资源开发利用方案编写内容要求及审查大纲
矿产资源开发利用方案编写内容要求及《矿产资源开发利用方案》审查大纲一、概述
㈠矿区位置、隶属关系和企业性质。

如为改扩建矿山, 应说明矿山现状、
特点及存在的主要问题。

㈡编制依据
(1简述项目前期工作进展情况及与有关方面对项目的意向性协议情况。

(2 列出开发利用方案编制所依据的主要基础性资料的名称。

如经储量管理部门认定的矿区地质勘探报告、选矿试验报告、加工利用试验报告、工程地质初评资料、矿区水文资料和供水资料等。

对改、扩建矿山应有生产实际资料, 如矿山总平面现状图、矿床开拓系统图、采场现状图和主要采选设备清单等。

二、矿产品需求现状和预测
㈠该矿产在国内需求情况和市场供应情况
1、矿产品现状及加工利用趋向。

2、国内近、远期的需求量及主要销向预测。

㈡产品价格分析
1、国内矿产品价格现状。

2、矿产品价格稳定性及变化趋势。

三、矿产资源概况
㈠矿区总体概况
1、矿区总体规划情况。

2、矿区矿产资源概况。

3、该设计与矿区总体开发的关系。

㈡该设计项目的资源概况
1、矿床地质及构造特征。

2、矿床开采技术条件及水文地质条件。

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