Page 1 of 49LABORATORY MANAGEMENT SYSTEM MANUALManual 200093Rev LApr 18, 2012Supersedes KFRONT PAGEISO/IEC 17025:2005Laboratory Management System Manual200093Site/LocationAddressTelephoneEMC Laboratory213 Harry Walker Parkway SouthNewmarket, Ontario, L3Y 8T3(905) 952-1000MASTER COPYTechnical & Marketing Facility26525 American DriveSouthfield, Michigan, 48034(248) 263-8700REFERENCE: 200093 LABORATORY MANAGEMENT SYSTEM MANUAL
Page 2 of 49LABORATORY MANAGEMENT SYSTEM MANUALFRONT PAGE 1INTRODUCTION 61.0 SCOPE 82.0 REFERENCES & CERTIFICATES OF REGISTRATION 83.0 TERMS AND DEFINITIONS 84.0 MANAGEMENT REQUIREMENTS 104.1 ORGANIZATION AND MANAGEMENT 104.1.1 LEGAL RESPONSIBILITY 104.1.2 LABORATORY RESPONSIBILITY 104.1.3 LABORATORY FACILITY 104.1.4 CONFLICT OF INTEREST POLICY 104.1.5 RESOURCES 22.214.171.124 Responsibility, authority and interrelationships 126.96.36.199 Laboratory Quality Manager 188.8.131.52 Laboratory Technical Manager 184.108.40.206 Personnel aware of the relevance and importance of their activities 220.127.116.11 Effectiveness of communication process within EMC lab 124.2 EMC LABORATORY QUALITY SYSTEM (ISOISO/IEC 17025 & TS16949) 124.2.1 DOCUMENTATION OF THE SYSTEM 124.2.2 EMC LABORATORY ISO/IEC 17025 QUALITY MANUAL 134.2.3 ISO/IEC 17025 QUALITY SYSTEM PROCEDURES 134.2.4 ISO-ISO/IEC 17025 QUALITY POLICY AND LABORATORY OBJECTIVES 134.2.5 MEETING CUSTOMER, STATUTORY, AND REGULATORY REQUIREMENTS 134.3 DOCUMENT CONTROL 154.3.1 GENERAL 154.3.2 DOCUMENT APPROVAL AND ISSUE 18.104.22.168 Maintaining and generating quality documents 22.214.171.124 Documents review, distribution, and retention 126.96.36.199 Documents uniquely identified 164.3.3 DOCUMENT CHANGES 188.8.131.52 Document revision change 184.108.40.206 Documents change/release approval 220.127.116.11 Amendment of documents by hand 18.104.22.168 Changes in computerized systems 174.4 REVIEW OF REQUESTS, TENDERS, AND CONTRACTS 174.4.1 CONTRACT - ORDER REVIEW 174.4.2 RECORDS OF REVIEWS 184.4.3 SUBCONTRACTED WORK REVIEW 184.4.4 DEVIATION FROM THE CONTRACT 184.4.5 CONTRACT AMENDMENTS 184.5 SUBCONTRACTING OF TESTS 184.5.1 SUBCONTRACTOR COMPETENCY 184.5.2 SUBCONTRACTED WORK ARRANGEMENT 184.5.3 SUBCONTRACTED WORK RESPONSIBILITY 184.5.4 APPROVED SUBCONTRACTORS LIST 18REFERENCE: 200093 LABORATORY MANAGEMENT SYSTEM MANUALManual 200093Rev LApr 18, 2012Supersedes K
Page 3 of 49LABORATORY MANAGEMENT SYSTEM MANUAL4.6 PURCHASING SERVICES AND SUPPLIES 194.6.1 PURCHASING OF SERVICES AND SUPPLIES PROCEDURE 194.6.2 SERVICES AND SUPPLIES COMPLIANCE RECORDS 194.6.3 PURCHASING DOCUMENTS 194.6.4 SUPPLIERS EVALUATION 194.7 SERVICE TO THE CLIENT 194.8 COMPLAINTS 204.9 CONTROL OF NONCONFORMING TESTING WORK 204.9.1 NONCONFORMING WORK INVESTIGATION 204.9.2 NONCONFORMING WORK CONCESSION 214.9.3 NONCONFORMING WORK IDENTIFICATION 214.9.4 NONCONFORMING WORK ROOT CAUSE 22.214.171.124 Corrective Action for Equipment 126.96.36.199 Corrective Action for test software applications 224.9.5 REPORT OF NONCONFORMITY 224.10 IMPROVEMENT 224.10.1 GENERAL 224.11 CORRECTIVE ACTION 224.11.1 GENERAL 224.11.2 CAUSE ANALYSIS 234.11.3 SELECTION AND IMPLEMENTATION OF CORRECTIVE ACTIONS 234.11.4 MONITORING OF CORRECTIVE ACTIONS 234.11.5 ADDITIONAL AUDITS 234.12 PREVENTIVE ACTION 234.12.1 Sources of non-conformances 234.12.2 Preventive Actions Procedures 234.13 CONTROL OF RECORDS 244.13.1 GENERAL 244.13.1.1 Quality records procedures 244.13.1.2 Records retention 244.13.1.3 Records security 244.13.1.4 Records back-up 244.13.2 TECHNICAL RECORDS 244.13.2.1 History records 244.13.2.2 Records per task 244.13.2.3 Records change history 244.14 INTERNAL AUDITS 254.14.2 CORRECTIVE ACTIONS DRIVEN BY INTERNAL AUDITS 254.14.3 INTERNAL AUDIT RECORDS 264.15 MANAGEMENT REVIEW 264.15.1 LABORATORY'S QUALITY SYSTEM REVIEW 265.0 TECHNICAL REQUIREMENTS 27REFERENCE: 200093 LABORATORY MANAGEMENT SYSTEM MANUALManual 200093Rev LApr 18, 2012Supersedes K
Page 4 of 49LABORATORY MANAGEMENT SYSTEM MANUAL5.1 TECHNICAL REQUIREMENTS - GENERAL 275.1.1 CORRECTNESS AND RELIABILITY OF THE TESTS FACTORS 275.1.2 DEVELOPING TEST METHODS AND PROCEDURES BASED ON RELIABILITY FACTORS 275.2 PERSONNEL 275.2.1 COMPETENCY 275.2.2 TRAINING 275.2.3 CONTRACTORS 285.2.4 JOB DESCRIPTIONS 285.2.5 PERSONNEL RECORDS 285.3 ACCOMMODATION AND ENVIRONMENTAL CONDITIONS 285.3.1 LABORATORY FACILITIES FOR TESTING 285.3.2 ENVIRONMENTAL CONDITIONS 285.3.3 LABORATORY LAYOUT 295.3.4 TEST AREA ACCESS CONTROL 295.3.5 HOUSEKEEPING 295.4 TEST METHODS AND METHOD VALIDATION 305.4.1 GENERAL 305.4.2 SELECTION OF METHODS 305.4.3 LABORATORY-DEVELOPED METHODS 305.4.4 NON-STANDARD METHODS 315.4.5 VALIDATION OF METHODS 3188.8.131.52 Correlation of test methods 3184.108.40.206 Test method records 315.4.6 UNCERTAINTY OF RESULTS 3220.127.116.11 Uncertainty of calibration 318.104.22.168 Uncertainty of measurement 322.214.171.124 Uncertainty components 325.4.7 CONTROL OF DATA 3126.96.36.199 Data verification 3188.8.131.52 Data transmission and storage 335.5 EQUIPMENT 345.5.1 EQUIPMENT INVENTORY 345.5.2 EQUIPMENT SELECTION 345.5.3 EQUIPMENT OPERATORS 345.5.4 EQUIPMENT ITEM UNIQUELY IDENTIFIED 345.5.5 EQUIPMENT RECORDS 345.5.6 EQUIPMENT SAFE HANDLING, TRANSPORT AND STORAGE 345.5.7 OUT OF SERVICE EQUIPMENT 355.5.8 EQUIPMENT LABELING 355.5.9 RETURNED EQUIPMENT VERIFICATION 355.5.10 INTERMEDIATE EQUIPMENT CHECK-UP 355.5.11 TEST SOFTWARE UPDATES 355.5.12 HW/SW SAFEGUARD 355.6 MEASUREMENT TRACEABILITY 355.6.1 GENERAL 355.6.2 SPECIFIC REQUIREMENTS 3184.108.40.206.1 External calibration services 3220.127.116.11.2 External calibration certificates 36REFERENCE: 200093 LABORATORY MANAGEMENT SYSTEM MANUALManual 200093Rev LApr 18, 2012Supersedes K
Page 5 of 49LABORATORY MANAGEMENT SYSTEM MANUALManual 200093Rev LApr 18, 2012Supersedes K18.104.22.168 Testing 322.214.171.124.1 Uncertainty of measurement evaluation 3126.96.36.199.2 Traceability of measurements 365.6.3 REFERENCE STANDARDS AND REFERENCE MATERIALS 3188.8.131.52 Reference standards 3184.108.40.206 Reference materials 3220.127.116.11 Intermediate checks 318.104.22.168 Transport and storage 375.7 SAMPLING 375.7.1 THE NUMBER OF SAMPLES TO BE TESTED 375.7.2 SAMPLING DEVIATIONS 375.7.3 SAMPLING RECORDS 375.8 HANDLING OF TEST ITEMS 385.8.1 TRANSPORTATION, RECEIPT, HANDLING, PROTECTION, STORAGE, RETENTION PROCEDURES 385.8.2 DUT LABELING 385.8.3 DUT AND E XERCISER HW/SW VERIFICATION 385.8.4 TEST ITEMS STORAGE AND HANDLING 385.9 ASSURING THE QUALITY OF TEST RESULTS 395.9.1 MONITORING AND REVIEWING TEST RESULTS 395.9.2 QUALITY CONTROL DATA ANALYSIS 395.10 REPORTING THE RESULTS 395.10.1 GENERAL 395.10.2 EMC TEST REPORTS 405.10.3 TEST REPORTS DATA 422.214.171.124 Test reports resolution 4126.96.36.199 Test samples info 415.10.4 CALIBRATION CERTIFICATES 4188.8.131.52 Test equipment calibration certificates data 4184.108.40.206 Test equipment calibration statement of compliance 4220.127.116.11 Equipment repaired during calibration process 418.104.22.168 Test equipment calibration time interval 425.10.5 TEST RESULT OPINIONS AND INTERPRETATIONS 425.10.6 TESTING OBTAINED FROM SUBCONTRACTORS 425.10.7 ELECTRONIC TRANSMISSION OF RESULTS 425.10.8 FORMAT OF REPORTS 425.10.9 AMENDMENTS TO TEST REPORTS 426.0 A2LA ADVERTISING POLICY 437.0 A2LA TRACEABILITY POLICY 438.0 A2LA PROFICIENCY TESTING REQUIREMENTS 439.0 ABBREVIATIONS TABLE 44ANNEX A - EMC LABORATORY MANAGEMENT WITHIN PARENT ORGANIZATION STRUCTURE 45ANNEX B - LABORATORY QUALITY MANAGEMENT SYSTEM POLICY 46ANNEX C - REFERENCED DOCUMENTS 47QUALITY MANUAL REVISION HISTORY: 49REFERENCE: 200093 LABORATORY MANAGEMENT SYSTEM MANUAL
Page 6 of 49LABORATORY MANAGEMENT SYSTEM MANUALManual 200093Rev LApr 18, 2012Supersedes KINTRODUCTIONCorporate HistoryInvotronics Manufacturing was established in 1988 as a result of the consolidation of Invotronics Research andDevelopment, Modu-tronics and Invotek, Anatron. Invotronics Manufacturing was previously owned 100% byAtoma a division of Magna International. Invotronics Manufacturing moved to its present location in 1989.Invotronics Manufacturing was acquired by C-MAC Industries on September 5, 2000. The company thenchanged its name to C-MAC Invotronics. On December 5, 2001 C-MAC Invotronics was acquired by Solectronand changed its name to C-MAC Invotronics dba Solectron Invotronics. Solectron was a supplier of electronicand electro-mechanical products to the OEM automotive industry, and the consumer electronics industry. Startingwith October 2007 the entire Solectron organization was acquired by Flextronics and our laboratory namechanged to Flex Automotive EMC Laboratory. In July 2010 Flextronics Automotive Inc was re-located fromScarborough to Newmarket Ontario.Flextronics Automotive Inc recognizes its responsibility as provider of quality services. To this end, FlextronicsAutomotive Inc has developed and documented a quality management system to better satisfy the needs of itscustomers and to improve management of all departments, including the EMC Laboratory. The quality systemcomplies with the international standards.REFERENCE: 200093 LABORATORY MANAGEMENT SYSTEM MANUAL
Page 7 of 49Manual 200093Rev LApr 18, 2012Supersedes KLABORATORY MANAGEMENT SYSTEM MANUAL***EMC LABORATORYDOCUMENT STRUCTUREQUALITYISO-17025Policy StatementOrganizational ChartTECHNICALINTERNALCAPABILITY 705304Customer FocusEMC LAB DATABASE JOB#LMS001 C.O.I.Continual ImprovementLMS002 Test RequestProfessional PracticeEXERCISERLMS004 Test PlanISO/TS16949 CompliantDUT SPECSTESTPLANLMS005 Test SetupISO/IEC 17025 CertifiedEQUIPMENTLMS006 HandlingCALIBRATIONMAINTENANCESCHEDULERLMS007 EquipmentLMS008 SW ControlSTORAGETEST#REPORTSAPPROVALOEM SETUPRESULTS LOGBACKUP201709 Competency721178 SuppliesOEM900712 1003TS-16949GMGMW3097ADM114Document 735Internal AuditsQMS090Management ReviewsCISPR-25ADM035Corrective ActionISO-10605ADM035Preventive ActionISO-1145 (1,2,3,4)ADM906/ ADM140TrainingISO-6100-4-2ADM105ProceduresISO-7637 (1,2,3)MAT007Purchase REFERENCE:MIL-STDE-416EADM160 200093 LABORATORYAppraisalsMANAGEMENT SYSTEM MANUAL
Page 8 of 49LABORATORY MANAGEMENT SYSTEM MANUALManual 200093Rev LApr 18, 2012Supersedes K1.0 ScopeThis Laboratory Management Manual describes the quality assurance program used to perform activities withinlaboratory's scope of accreditation per ISO/IEC 17025 as well as complying with Flextronics Automotive IncISO/TS16949 Quality System.Flextronics Automotive Inc recognizes its responsibility as provider of quality services. To this end, FlexAutomotive has developed and documented a quality management system to better satisfy the needs of itscustomers and to improve management of the company.EMC Test Laboratory ISO/IEC 17025 Quality Manual, together with a set of quality related procedures, createsthe documentary base for the effective lab activity. This manual assures laboratory's compliance to ISO/IEC17025 and establishes the duties and responsibilities of the personnel. In addition, this manual is utilized for thepurpose of informing our customers of the laboratory's scope, and what specific controls are implemented toassure service quality.2.0 References & Certificates of RegistrationISO/IEC 17025, ISO/TS16949. See also Abbreviations.3.0 Terms and DefinitionsLaboratory Quality Management System: The operations or processes of the laboratory which define its policiesand objectives and the manner in which they are implemented to ensure that the objectives are met.REFERENCE: 200093 LABORATORY MANAGEMENT SYSTEM MANUAL
Page 9 of 49LABORATORY MANAGEMENT SYSTEM MANUALManual 200093Rev LApr 18, 2012Supersedes KQuality: The ability of the qualitative analytic identification and quantitative (accuracy, precision) data to satisfy therequirements of their purpose.QA Management: The part of the laboratory management system that focuses on the quality of the datagenerated by the laboratory.Quality Assurance: Documented procedures in place within an EMC laboratory that define how the laboratory’swork is to be conducted so as to be confident that the obtained data are of the required quality. QA consists ofquality control and quality assessment activities:Quality Control: The practices and procedures that lead to the achievement of quality analytical data(suitable facilities, staff competence and training, good laboratory practices, standard operating andreporting procedures).Quality Assessment: The practices and the data generated by them that illustrate that the QC activitieshave been effectuated and that the data generated are of the quality required (inter-laboratorycomparisons, control charts, auditing, and statistical analyses).Internal Client: in this manual refers to testing performed for Flextronics products/projects.External Client: in this manual refers to testing contracted by third party companies for their products/projects.OEM: in this manual refers to original automotive car makers.Item: an all-inclusive term used in place of any of the following: assembly, component, equipment, material,module, part, structure, system, unit, software or results.Uncertainty: is a measure of the precision of an instrument or test method. As a good rule of thumb, theuncertainty of a measuring device is 20% of the least count. Whenever reported, the uncertainty of themeasurement should be given with the actual measurement, for example, 41.64 0.02 dBuV." FlexAutomotiveEMC Laboratory does not report the measurements uncertainty for compliance to OEM test methods and/orinternational standards. Flextronics maintains records of equipment calibration from accredited laboratories thatreports the uncertainty of their data as contributors to a test method uncertainty budget.REFERENCE: 200093 LABORATORY MANAGEMENT SYSTEM MANUAL
Page 10 of 49LABORATORY MANAGEMENT SYSTEM MANUALManual 200093Rev LApr 18, 2012Supersedes K4.0 Management Requirements4.1 Organization and Management4.1.1 Legal responsibilityFlextronics Automotive Inc as part of Flextronics Corporation holds legal responsibility for its FlexAutomotive EMCand Electrical Test Laboratory operation. The laboratory is organized to operate in a permanent facility inaccordance with the requirements of ISO/IEC 17025, and to satisfy the needs of automotive electronics OEMs,the regulatory authorities, or organizations providing recognition (A2LA, AEMCLRP).4.1.2 Laboratory responsibilityThe EMC laboratory carries out its testing activities to meet the requirements of ISO/IEC 17025 and to satisfy theneeds of the client, the regulatory authorities or organizations providing recognition.4.1.3 Laboratory facilityEMC laboratory is part of Flextronics Automotive Inc, a supplier of products to the OEM automotive electronicsindustry. The FlexAutomotive EMC Laboratory Management System is designed to cover work carried out in thelaboratory's permanent facility.4.1.4 Conflict of interest policyOur services provider policy ensures that no potential conflict of interest (LMS001) amongst EMC lab personnelwill affect their work quality.LMS001EMC LAB, CONFLICT OF INTERESTS POLICYFor deputies key managerial personnel see Annex-A in this manual.4.1.5 ResourcesEMC lab personnel is free from any undue internal and external commercial, financial and other pressures andinfluences that may adversely affect the quality of their work.22.214.171.124 Responsibility, authority and interrelationshipsLaboratory's policies and procedures ensure the protection of its clients' confidential information and proprietaryrights, including procedures for protecting the electronic storage and transmission of results. Customerproprietary documentation (manuals, schematics, test results) is subject to the confidentiality restrictionsprohibiting unauthorized copying and disclosure to other parties as outlined in confidentiality agreement 201497between Flextronics and internal/external clients.201497CONFIDENTIALITY AGREEMENTThe management avoids lab personnel involvement in any activities that would diminish confidence in itscompetence and minimize chances of success before starting achieving a task. All decisions are made based onimpartiality, fairness, correct judgment, and operational integrity.The EMC LAB ORGANIZATION CHART (see Annex A) shows its place in Flextronics parent organization, andthe relationships between quality management, technical operations and support services.REFERENCE: 200093 LABORATORY MANAGEMENT SYSTEM MANUAL
Page 11 of 49LABORATORY MANAGEMENT SYSTEM MANUALManual 200093Rev LApr 18, 2012Supersedes KAll employees must complete and obtain the certificate for the annual ethics training made available online byFlextronics University. All employees must acknowledge Flextronics Code of Conduct corporate document madeavailable by document control over the intranet website.MAT010SOURCING OF SUPPLIERS, CONTRACTORS OR SUB-CONTRACTORS PROCEDURE126.96.36.199 Laboratory Quality ManagerThe quality manager responsibility: Establish, review and improve the documented system of the Lab.Effectively implement Quality Management System and ISOISO/IEC 17025 compliance.Determine resource needs and obtain sanction for effective Management of the Lab Operation.Identify opportunities for continual improvement and take effective corrective and preventive action.Maintain operational integrity of lab operations to assure confidence in test results and report to topManagement regarding performance of Lab Quality Management system.Participates in meetings to assure a strong customer relationship:o test requisition processo contract reviewo internal client test requisitiono external client test requisitiono services proposal for external clientso complaints - examines all documents and records associated with complaints, coordinates rootcause analysis, corrective actions, and customer follow upAssure the quality of testing through:o Establishment and implementation of Quality Policy, Quality objectives and QMS.o Continuous professional development of self and subordinates, formulating goals with respect tothe education, training and skills of the lab's personnel.o Analyses data and records for identifying nonconforming work.o Initiate internal audits and investigates adverse audit findings.o Encourage participating in inter-laboratory comparison for proficiency testing to enhancecompetencies of the lab's operation.o Participate in Management Reviews and report to top management about the effectiveness of theQuality Management system of the Lab.o Providing adequate support in ordering required lab equipment.o Monitoring the performance of subordinates and proactively supports them in meeting the qualityobjectives.o Maintaining the Quality ManualQMS090ADM160ADM910201696201692MANAGEMENT REVIEW PROCEDUREPERFORMANCE APPRAISALS PROCEDUREBUILDING AND INFORMATION SECURITYTEST PROPOSALCUSTOMER COMPLAINT FORM188.8.131.52 Laboratory Technical ManagerThe technical manager responsibility: Controls technical operations and the provision of the resources needed to ensure the required quality oflaboratory operations, being involved in hiring and staffing, managing and measuring workFollows the evolution of OEM and international standards for automotive electronic compliance testingREFERENCE: 200093 LABORATORY MANAGEMENT SYSTEM MANUAL
Page 12 of 49LABORATORY MANAGEMENT SYSTEM MANUAL Manual 200093Rev LApr 18, 2012Supersedes KEstablishes and maintains a cooperative working relationship with customers and associated companystaff solving test issues and failuresUses leadership, integrity, responsibility in promoting team work environmentPerforms data analysis, reviews, technical reports following the testingCoordinates the EMC lab relationship with internal engineering teamsCustomer focused, action oriented, and evaluates prioritiesPrepares budget requests and manages approved budgetParticipates in planning, scheduling, preparing and presenting staff safety and technical trainingPrepares requests for proposals and specifications for purchases of major itemsApproves contractors work for EMC lab maintenance servicesParticip
changed to Flex Automotive EMC Laboratory. In July 2010 Flextronics Automotive Inc was re-located from Scarborough to Newmarket Ontario. Flextronics Automotive Inc recognizes its responsibility as provider of quality services. To this end, Flextronics Automotive Inc has developed and documented a quality management system to better satisfy the needs of its customers and to improve management .
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