ASTM E1212-2009 Standard Practice for Quality Management Systems for Nondestructive Testing Agencies《无损检测机构的质量管理系统的标准实施规程》.pdf

1、Designation: E 1212 09Standard Practice forQuality Management Systems for Nondestructive TestingAgencies1This standard is issued under the fixed designation E 1212; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last r

2、evision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This practice covers general requirements for the estab-lishment and maintenance of a quality management system foragencies

3、engaged in nondestructive testing (NDT).1.2 This practice utilizes criteria contained in PracticeE 543.1.3 This practice utilizes criteria contained in AmericanNational Standard ANSI/ISO/ASQ Q90012000, Quality man-agement systemsRequirements.1.4 This practice recognizes the importance of establishin

4、gminimum safety criteria.1.5 The use of SI or inch-pound units, or combinationsthereof, will be the responsibility of the technical committeewhose standards are referred to in this standard.1.6 This practice does not purport to address all of thesafety concerns, if any, associated with its use. It i

5、s theresponsibility of the user of this practice to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2E 543 Specification for Agencies Performing Nondestruc-tive TestingE 1359 Guide fo

6、r Evaluating Capabilities of NondestructiveTesting Agencies2.2 ASNT/ANSI Standards:3ASNT SNT-TC-1A Recommended Practice for PersonnelQualification and Certification in Nondestructive TestingANSI/ASNT CP 189 Qualification and Certification ofNondestructive Testing Personnel2.3 ANSI/ASQ Standards:A840

7、2 Management and Quality Assurance-Vocabulary4Q9000 Series of Quality Management and Quality Assur-ance (Q9000 through Q9004 inclusive) Standards (Theseare exact equivalents to the ISO 9000 through ISO 9004series)2.4 AIA Standard:NAS 410 NAS Certification and Qualification of Nonde-structive Testing

8、 Personnel53. Terminology3.1 Definitions of Terms Specific to This Practice:3.1.1 agency, nthe public, independent, or in-house non-destructive testing organization selected by the authority toperform the examination(s) required by the purchase order orspecification.3.1.2 authority, nthe owner, prim

9、e contractor, engineer,architect, or purchasing agent in responsible charge of thework, or duly recognized or designated representative.3.1.3 continual quality improvement, nan ongoing qualityimprovement activity for achieving results. Improvement maybe directed at individual processes, finished pro

10、ducts, oradministrative processes. The continual quality improvementprogram utilizes statistical methods, team projects, and othertools as appropriate to obtain and sustain improvements.3.1.4 customer, ncustomer is used with the same meaningas “authority.”3.1.5 process capability, nthe degree to whi

11、ch a processcan produce the same results without variation, that is, repro-ducibility.3.1.6 process control, nmanaging a process to ensure thatit is performing to its designed capability.3.1.7 quality management system, nthe organizationalstructure, responsibilities, practices, procedures, processes

12、, andresources for implementing and maintaining the quality pro-gram.3.1.8 quality manual, na comprehensive document statingthe quality policy and specifying organizational structure,1This practice is under the jurisdiction of ASTM Committee E07 on Nonde-structive Testing and is the direct responsib

13、ility of Subcommittee E07.09 onNondestructive Testing Agencies.Current edition approved June 1, 2009. Published July 2009. Originally approvedin 1987. Last previous edition approved in 2008 as E 1212 - 04(2008).2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Cust

14、omer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Available fromAmerican Society for Nondestructive Testing (ASNT), P.O. Box28518, 1711 Arlingate Ln., Columbus, OH 43228-0518, http:/www.asnt.org.4Ava

15、ilable from American Society for Quality (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203, http:/www.asq.org.5Available from Aerospace Industries Association of America, Inc. (AIA), 1000Wilson Blvd., Suite 1700,Arlington, VA22209-3928, http:/www.aia-aerospace.org.1Copyright ASTM International, 100

16、Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.practices, and procedures necessary to empower the qualitypolicy and quality management system.3.1.9 quality objectives, nspecific obtainable improve-ment goals supporting the quality program.3.1.10 quality policy, nthe

17、overall intentions and directionof an organization regarding quality as formally expressed bytop management.3.1.11 quality records, nformal documentation of exami-nation results or data supporting the quality managementsystem.3.1.11.1 DiscussionExamples are: audit reports, calibra-tion data, NDT rec

18、ords, process qualification results, qualifi-cation data, and test data.4. Significance and Use4.1 This practice covers procedures for establishing andmaintaining a quality system for nondestructive testing agen-cies.4.2 Controlling the quality of service rendered is a continu-ing process. This prac

19、tice provides guidelines for establishinga quality management system that provides for: calibration,standardization, reference samples, examination plans, andprocedures.4.3 The basic requirements for a quality management sys-tem encompass the following areas, all of which shall bedocumented.4.3.1 Qu

20、ality policy statement, planning, and administra-tion,4.3.2 Organization,4.3.3 Human resources,4.3.4 Physical resources, and4.3.5 Quality management.5. Quality Policy Statement, Planning, andAdministration5.1 Policy StatementA policy statement shall describemanagements specific intention and policy

21、with respect toquality. The policy statement should specify an organizedapproach for carrying out those intentions and should addressitself to all major quality parameters. It should be approved bythe chief executive officer for company-wide policies or bysubordinate officers for specialized policie

22、s. Periodic auditsshould be required to ensure adherence to quality policies.5.2 Quality ObjectivesObjectives should be establishedfor appropriate key elements of performance such as safetyrequirements, internal performance levels, vendor perfor-mance, training, and qualification of personnel.5.3 Qu

23、ality Management SystemA quality managementsystem shall be established that will carry out the statedpolicies and objectives.5.4 Quality PlanningPlanning for each new or modifiedprocess or test method should define those characteristics to becontrolled. Quality planning also includes providing for a

24、d-ministrative processes needed to implement compliance withthis practice.5.5 Quality ManualThe quality policy and system shallbe documented and be in accessible form, such as a qualitymanual or series of manuals. Key elements should include, asnecessary:5.5.1 The general quality statement,5.5.2 A d

25、escription of the quality system,5.5.3 Ageneral description of quality planning requirementswith specifics for each product category where appropriate,5.5.4 The requirements of Practice E 543 pertaining to thelaboratory procedure manual, and5.5.5 Typically used examination procedures.5.6 Administrat

26、ionClear lines of authority shall be estab-lished to administer the quality management system.5.6.1 Quality ResponsibilityThe quality responsibility ofeach unit within the organization shall be approved by the chiefoperation officer of each unit.5.6.2 Quality Performance ReportingResponsibility forr

27、eporting performance against stated quality objectives tohigher management should rest with functions independent ofthose responsible for the attainment of those objectives. Pro-cedures for documentation and record retention should beestablished.5.6.3 Quality System AuditsTo provide assurance, a per

28、i-odic audit of the quality management system should be madeby an organizational element independent of the unit beingaudited or by a qualified third party to monitor the effectivenessof various quality management system processes. It mayinclude, as appropriate:5.6.3.1 Management audits to determine

29、 how well qualitypolicy and objectives are being met,5.6.3.2 System audits, including examination process auditsto determine how well quality planning has been implementedand to identify areas where changes would be beneficial to thequality services performed, and5.6.3.3 Records documenting findings

30、 and corrective andpreventive actions taken.6. Organization6.1 The following information concerning the organizationof the agency shall be documented.6.1.1 A description of the organization including:6.1.1.1 The complete legal name and address of the mainoffice,6.1.1.2 The names and positions of the

31、 principal officers anddirectors,6.1.1.3 The agencys ownership, managerial structure, andprincipal members,6.1.1.4 The functional description of the agencys organiza-tional structure, operational departments, and support depart-ments and services. This may be demonstrated in the form ofcharts that d

32、epict all the divisions, departments, sections andunits, and their relationships,6.1.1.5 All relevant organizational affiliates of the agencyand principal officers of affiliates and directors of affiliateswhere applicable,6.1.1.6 External organizations and organizational compo-nents and their functi

33、ons that are utilized for significanttechnical support services, and6.1.1.7 A brief history of the agency including its relation-ship with its organizational component affiliations and othersupporting information.6.1.2 A listing of the relevant technical services offered.E12120926.1.3 A list giving

34、applicable dates of qualifications andaccreditations.7. Human Resources7.1 GeneralThose aspects of the quality system where thework of the employees will affect the quality of products shallbe identified, and specific action taken to control them.7.2 Management ResponsibilitiesThe quality-related re

35、-quirements, duties, and responsibilities of all personnel shall beidentified. Job criteria that are quality-related should be speci-fied in job descriptions to permit proper employee selection.7.3 Employee Selection and TrainingEmployees shall beselected on the basis of capability and experience or

36、 thepotential to fully qualify for the job. A training program shallbe maintained to ensure employees develop and retain skillcompetence. Nondestructive testing (NDT) personnel shall bequalified in accordance with a nationally recognized NDTpersonnel qualification practice or standard such as ANSI/A

37、SNT-CP-189, ASNT/SNT-TC-1A, AIA/NAS 410, or a simi-lar document. The practice or standard used and the applicablerevision shall be specified in the contractual agreement be-tween the using parties.7.4 The agency shall provide the following documentation:7.4.1 Awritten outline or chart giving operati

38、onal personnelpositions and their lines of responsibility and authority, and7.4.2 A summary job description for each professional,scientific, supervisory, and technical position category includ-ing the required education, training and experience, certifica-tion, or professional licenses.7.5 The agen

39、cy shall provide a description of its methods ofmaintaining personnel records to document the qualifications,work experience, and training history of each person in thepositions described in 7.4.2. The agency shall also provide adescription of its means of ensuring confidence in its humanresources i

40、ncluding the maintenance of records.8. Physical Resources8.1 The agency shall provide an inventory of its relevantphysical resources including:8.1.1 A general description of the agencys facilities forNDT related activities.8.1.2 An inventory of equipment used to perform NDTincluding the following fo

41、r each item of equipment:8.1.2.1 Type of equipment and use,8.1.2.2 Name of manufacturer,8.1.2.3 The equipment model and serial number,8.1.2.4 Properties of the equipment subject to standardiza-tion or calibration,8.1.2.5 The range of operation and range of calibration,8.1.2.6 Reference to a recogniz

42、ed calibration procedure,8.1.2.7 Frequency of calibration, and8.1.2.8 Allowable tolerances or maximum sensitivity.8.1.3 A system of written procedures for each NDT serviceperformed by the agency. The procedures shall include adescription of the methods used for NDT and the methods usedfor data recor

43、ding, data processing, data reporting, and forcertification of the results. When required, customer approvalshall be obtained.8.1.4 An inventory of reference material including a libraryof standards, applicable technical publications, and pertinentspecifications and amendments.9. Quality Management9

44、.1 Purchased NDT Equipment, Materials, and Services:9.1.1 GeneralThe quality management system shall in-clude procedures to ensure effective supplier quality manage-ment for all purchased materials and services. Controls shall beprovided for materials, equipment, and any subcontractedservices.9.1.2

45、Supplier Quality Program and Selection MethodsProcedures shall be established for the selection and qualifica-tion of suppliers, such as supplier surveys, past quality history,and industry history. Each suppliers quality capability shall beperiodically evaluated, including audit visits where appropr

46、i-ate, based upon performance. The requirements for qualitymanagement shall be established in the purchase agreement.The purchase agreement should include the elements of thequality management system that are to be performed by thesupplier in assuring quality.9.1.3 Receiving InspectionFor those purc

47、hased itemswhere inspection upon receipt is acceptable, inspection ofsubmitted items shall be performed to the degree and extentneeded to determine acceptability. Receiving inspection shallinclude well-maintained records so that past supplier perfor-mance is available. Adequate facilities and proced

48、ures forstorage, handling, protection, and controlled release of pur-chased materials shall be established. Materials inspected,tested, and approved shall be separated from withheld orrejected materials.9.1.4 Nonconforming Material ControlControl of non-conforming purchased supplies or equipment sha

49、ll be main-tained to ensure that such items are not used.9.1.5 Subcontracted ServicesWhen the agency utilizesthe services of another agency to perform all or part of itsservices, provisions shall be made to ensure that the activitiesare performed in accordance with the purchasers require-ments. Actions to be taken shall be included in the agencysquality assurance manual. The requirements of Guide E 1359shall be used as a guide in evaluating the quality system of thesubcontracted agency.9.2 Measuring and Test Equipment:9.2.1 Measuring and test eq