ISOIEC17025质量的指南

1、 ACB COMPNAY1800 NW 169TH PI, BEAVERTON , OR 97006ISO/IEC 17025 QUALITY MANUALRevision 1Date: 4/16/04UNCONTROLLED COPYCONTROLLED COPYSerial # _Issued To: _ Date: _ABC CompanyISO/IEC 17025 QUALITY MANUALREV. 1 DATE: 4/16/04 PAGE 2 OF 17TABLE OF CONTENTSIntroduction.4Quality Manual Distribution and Ap

2、proval.4Quality Policy Statement. 54.0 Management Requirements.64.1 Organization.64.2 Quality System.84.3 Document Control .84.4 Review of Requests, Tenders, and Contracts.94.5 Subcontracting of Tests and Calibrations .104.6 Purchasing Services and Supplies.104.7 Service to the Customer .114.8 Compl

3、aints .114.9 Control of Nonconforming Testing and/or Calibration Work.114.10 Corrective Action.124.11 Preventive Action .124.12 Control of Records.134.13 Internal Audits .144.14 Management Reviews.145.0 Technical Requirements . . .155.1 Technical Requirements General.155.2 Personnel .155.3 Accommoda

4、tions and Environmental Conditions.165.4 Test and Calibration Methods and Method Validation.175.5 Equipment .205.6 Measurement Traceability.225.7 Sampling .235.8 Handling and Transportation of Test and/or Calibration Items.235.9 Assuring the Quality of Test and Calibration Results . 245.10 Reporting

5、 the Results.24ABC CompanyISO/IEC 17025 QUALITY MANUALREV. 1 DATE: 4/16/04 PAGE 3 OF 17INTRODUCTIONABC Company recognizes its responsibility as a provider of quality testing services.To this end, ABC Company has developed and documented a quality managementsystem to better satisfy the needs of its c

6、ustomers and to improve management of thecompany. 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 ofthe personnel affected by the system, and to provide general pro

7、cedures for all activitiescomprising the quality system. In addition, this manual is utilized for the purpose ofinforming our customers of the quality system, and what specific controls are implementedto assure service quality.QUALITY MANUAL DISTRIBUTION AND APPROVALThis manual will be revised as ne

8、cessary to reflect the quality system currently in use. It isissued on a controlled copy basis to all internal functions affected by the quality system andon an uncontrolled copy basis to customers and suppliers; although, it can be issued tocustomers on a controlled copy basis upon customer request

9、. The methods for control anddistribution 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 masterQuality Manual.ABC Comp

10、anyISO/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 toachieve customer satisfaction. It is therefore our policy to:· Consistently provide quality products and services that confo

11、rm 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 part

12、icipation of all employees in qualityplanning 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 Organiza

13、tion and Management4.1.1 ABC Company (MPS) is a registered Corporation in the State ofOregon and holds legal responsibility for its operation.4.1.2 MPS is organized to operate in accordance with the requirements of ISO/IEC17025. The Quality Manager has the responsibility to maintain the QualitySyste

14、m to operate in accordance with the requirements of ISO/IEC 17025.It is the responsibility of all employees to work in accordance with the qualitypolicies, and to satisfy the needs of our customers.4.1.3 MPS is organized to operate in accordance with the requirements of ISO/IEC17025, whether carryin

15、g out work in its permanent facilities or on location, atcustomer sites.4.1.4 MPS is not part of an organization performing activities other than testingand/or calibration; therefore, there is no potential conflict of interest amongstits personnel.4.1.5 The organization of ABC Company is illustrated

16、 below in Figure 1.Chuck WeitzelPresident/CEODon HarringQuality ManagerJim RogersEngineerMarc JuzkowChief TechnologyOfficerMary PiestrakOffice ManagerFigure 14.1.5 cont.a). The Test Engineer is responsible for being familiar with the test methods,procedures, test objectives and the assessment of tes

17、t results. The QualityManager has the responsibility to maintain the Quality Management Systemsto ISO/IEC 17025 and has the authority to institute corrective action andprocedures consistent with these quality goals. The process for updating theQuality Manual, and methods for determining the revision

18、 history andresponsibilities 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 maybenefit from “in-spec” test results are prohibited to avoid

19、any perception ofconflict 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) Proprietary rights and confidential information for both MPS and itscustomers are adequately secured (Customer Confiden

20、tiality Procedure # QA-002).d). It shall be the responsibility of all MPS employees to conduct themselvesin a manner that does not diminish the confidence in our competence,impartiality, judgment or operational integrity as viewed by both MPSemployees and our customers. This responsibility includes

21、activities both inand outside of normal operations at MPS.e). The organizational chart is maintained and stored by the Quality Managerand is part of this manual. MPS is a privately held company, not part of anyother company or organization. In the absence of the Quality Manager, theTest Engineer or

22、CEO will assume the duties of the Quality Manager. In theabsence of the Test Engineer the Quality Manager or CEO will assume theduties of the Test Engineer. In the event of both the Quality Manager and theTest Engineers absence, the CEO, having knowledge of testing methods andsystems for MPS, will a

23、ssume these necessary management positions untilthe 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 andTraining Program, Procedure # QA-003).4.2.1.1 The Quality

24、Manual is the principal document that defines thequality system at ABC Company. The Quality Manual andall documented procedures are available to all personnel on theQuality Systems Directory. The Quality Systems Directory,managed by the Quality Manager, maintains the Quality Manual andall relevant d

25、ocuments per Document Control Procedure # QA-004and Control of MPS Quality Manual, procedure # QA-001.4.2.1.2 Quality System Procedures are documented to establish andmaintain continuity of each activity or function affecting quality.Quality procedures will be readily available to personnel forrefer

26、ence and implementation. The quality document structurecontains 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 thatform part of its quality system.4.3.1.1 Documents required

27、 by the quality system are managed by theDocument Control Procedure # QA-004.4.3.1.2 The Document Control Procedure is established to define themeans needed to:· Approve documents for adequacy prior to use.· Assure documents are uniquely identified and approved for use.· Review and up

28、date as necessary and re-approve documents.· Ensure that changes and the current revision status of thedocuments are identified· Ensure that relevant version of applicable documents areavailable at points of use· Ensure that documents remain legible and readily identifiable· Ensu

29、re that documents of external origin are identified and theirdistribution managed.· Prevent the unintended use of obsolete documents and to applysuitable identification to them if they are retained for anypurpose.ABC CompanyISO/IEC 17025 QUALITY MANUALREV. 1 DATE: 4/16/04 PAGE 7 OF 174.3.2 Docu

30、ment Changes4.3.2.1 Changes to Documents are controlled by theDocument Controlprocedure # QA-004. Changes to documents shall be reviewed bythe same functions that performed the original review unlessspecifically designated otherwise. Approval functions have accessto pertinent information to base the

31、ir review and approval.4.3.2.2 A description of the change is listed on the document or attachmentand 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 #· Pa

32、ge numbering· Total number of pages or a mark to signify the end of thedocument· 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

33、requirements are clear and understood, and the company has the capabilityand capacity to assure full customer expectations. The process for contractreview is further defined in the Contract Review Procedure, # QA-005.4.4.2 Records of reviews, including any significant changes, are maintained formini

34、mum 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 throughcommencement of work. This includes informing the customer of any deviationfrom the contract.4.4.5 If a contract needs t

35、o be amended after work has commenced, the samecontract review process shall be repeated and any amendments shall becommunicated 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 shouldbecome necessary to subcon

36、tract work for some unforeseen circumstance thefollowing policies will apply: Work is only to be placed with a testing facilitythat complies with ISO 17025, or is approved by MPS Purchasing as anApproved Supplier, unless otherwise specified by customer.4.5.2 MPS will inform its customer in writing o

37、f the arrangement to subcontract, and ifappropriate, obtain customer approval to subcontract.4.5.3 MPS is responsible for the subcontractors work, except when the customerspecifies the subcontractor.4.5.4 MPS shall maintain a file for all subcontractors and a copy of their “scope ofaccreditation”, o

38、r 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 purchaseof supplies and services that have a direct affect on the quality product andtesting performed. See Purchasing Services a

39、nd 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 testsare not used until inspected to ensure compliance with specifiedrequirements

40、, see Purchasing Services and Supplies Procedure # QA-006.4.6.3 MPS shall evaluate suppliers of critical consumables, and services whichaffect the quality of calibration and maintain a Approved Supplier list, seePurchasing Services and Supplies procedure # QA-006.4.7 Service to the customer4.7.1 MPS

41、 will do everything possible to assure that its customers receive the bestpossible 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 theperformance of said test

42、s.· Affording customers access to the laboratory to witness testing whenrequested.· Prepare, package and dispatch test items and reports as required byour customers for verification purposes.· Advise, guide and communicate with our customer in technical matters,opinions and interpreta

43、tions in regards to testing performed or to beperformed.· Communicate to our customers any major deviations in testing beingperformed.· Communicate to the customers any delays that may result in thecustomer not receiving their testing in a timely manner.· Customers will be notified of

44、 any event that casts doubt onto the validityof results supplied to them.4.8 ComplaintsComplaints, both verbal and written, shall be documented in accordance withCustomer Complaint, procedure # QA-008, which covers the methods fordocumenting, investigating and resolving complaints.4.9 Control of Non

45、conforming Testing and/or Calibration Work4.9.1 In the event that a non-conformance is identified with regard to any aspect oftesting, or the results of the work do not conform to its own procedures or tothe agreed requirements of the customer, the Quality Manager or the TestEngineer will act to con

46、tain the non-conformance and initiate corrective actionper the Control of Non-Conforming Testing, procedure # QA-009.4.9.2 Where the evaluation indicates that the nonconforming work could recur orthat there is doubt about the compliance of MPS operations with its ownpolicies and procedures, the Corr

47、ective Action procedure # QA-010 shall befollowed 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 forimplementing corrective action and includes a process for the recording ofrel

48、evant 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 appropriatemagnitude, documented, and

49、 implemented.4.10.4 Corrective action shall be monitored for effectiveness.4.10.5 Where the identification of nonconformance raises doubt on MPS compliancewith its own policies and procedures, or with ISO 17025, additional internalaudits will be performed to monitor the effectiveness of Corrective A

50、ction andthe quality system.4.11 Preventative Action4.11.1 MPS has established the following procedures to reduce the likelihood that anon-conformance will occur:· Non-conformance· Corrective Action· Management Review· Internal Quality AuditsPreventative action is a pro-active pr

51、ocess to identify improvementopportunities. The policies and procedures should reduce the likelihood that anon-conformance will occur. Once a need to improve has been identified, anaction plan should be developed, which included tasks, assignedresponsibility, and timing, see Preventative Action, Procedure # QA-011.4.11.2 Once a plan is implemented, it should be monitored to verify that the neededimprovements have been realized and are