1、Designation: E 1212 04Standard 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 (e) 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 establishi
4、ngminimum safety criteria.1.5 This practice does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this practice to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations pr
5、ior to use.2. Referenced Documents2.1 ASTM Standards:2E 543 Practice for Agencies Performing NondestructiveTestingE 1359 Guide for Evaluating Capabilities of NondestructiveTesting Agencies2.2 ASNT/ANSI Standards:3ASNT SNT-TC-1A Recommended Practice for PersonnelQualification and Certification in Non
6、destructive TestingANSI/ASNT CP 189 Qualification and Certification ofNondestructive Testing Personnel2.3 ANSI/ASQ Standards:A8402 Management and Quality Assurance-Vocabulary4Q9000 Series of Quality Management and Quality Assur-ance (Q9000 through Q9004 inclusive) Standards (Theseare exact equivalen
7、ts to the ISO 9000 through ISO 9004series)2.4 AIA Standard:NAS 410 NAS Certification and Qualification of Nonde-structive Testing Personnel53. Terminology3.1 Definitions of Terms Specific to This Practice:3.1.1 agency, nthe public, independent, or in-house non-destructive testing organization select
8、ed by the authority toperform the examination(s) required by the purchase order orspecification.3.1.2 authority, nthe owner, prime contractor, engineer,architect, or purchasing agent in responsible charge of thework, or duly recognized or designated representative.3.1.3 continual quality improvement
9、, nan ongoing qualityimprovement activity for achieving results. Improvement maybe directed at individual processes, finished products, oradministrative processes. The continual quality improvementprogram utilizes statistical methods, team projects, and othertools as appropriate to obtain and sustai
10、n improvements.3.1.4 customer, ncustomer is used with the same meaningas “authority.”3.1.5 process capability, nthe degree to which 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 desi
11、gned capability.3.1.7 quality management system, nthe organizationalstructure, responsibilities, practices, procedures, processes, andresources for implementing and maintaining the quality pro-gram.3.1.8 quality manual, na comprehensive document statingthe quality policy and specifying organizationa
12、l structure,practices, and procedures necessary to empower the qualitypolicy and quality management system.1This practice is under the jurisdiction of ASTM Committee E07 on Nonde-structive Testing and is the direct responsibility of Subcommittee E07.09 onNondestructive Testing Agencies.Current editi
13、on approved March 1, 2004. Published April 2004. Originallyapproved in 1987. Last previous edition approved in 1999 as E 1212 - 99.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume informa
14、tion, refer to the standards Document Summary page onthe ASTM website.3Available from The American Society for Nondestructive Testing (ASNT), P.O.Box 28518, 1711 Arlingate Ln., Columbus, OH 43228-0518.4Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203.5Ava
15、ilable from Aerospace Industries Association of America, 1250 Eye Street,NW, Suite 1200, Washington, DC 20005.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.3.1.9 quality objectives, nspecific obtainable improve-ment goals supportin
16、g the quality program.3.1.10 quality policy, nthe 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 DiscussionExamp
17、les are: audit reports, calibra-tion data, NDT records, 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 se
18、rvice rendered is a continu-ing process. This practice 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 followi
19、ng areas, all of which shall bedocumented.4.3.1 Quality 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
20、describemanagements specific intention and policy 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
21、 or bysubordinate officers for specialized policies. 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-manc
22、e, training, and qualification of personnel.5.3 Quality 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 becontroll
23、ed. Quality planning also includes providing for ad-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, asneces
24、sary:5.5.1 The general quality statement,5.5.2 A description of the quality system,5.5.3 A general 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 Ty
25、pically used examination procedures.5.6 AdministrationClear 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
26、.2 Quality Performance ReportingResponsibility forreporting 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
27、.3 Quality System AuditsTo provide assurance, a peri-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
28、 appropriate:5.6.3.1 Management audits to determine 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
29、 performed, and5.6.3.3 Records documenting findings 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 th
30、e mainoffice,6.1.1.2 The names and positions of the 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. T
31、his may be demonstrated in the form ofcharts that depict 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 organizati
32、ons and organizational compo-nents and their functions 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 tech
33、nical services offered.6.1.3 A list giving applicable dates of qualifications andaccreditations.E12120427. 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.
34、2 Management ResponsibilitiesThe quality-related re-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 bese
35、lected on the basis of capability and experience or 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 NDTpersonne
36、l qualification practice or standard such as ANSI/ASNT-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 documenta
37、tion:7.4.1 A written outline or chart giving operational 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, c
38、ertifica-tion, or professional licenses.7.5 The agency 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
39、means of ensuring confidence in its humanresources including 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 equ
40、ipment used to perform NDTincluding the following for 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
41、range of calibration,8.1.2.6 Reference to a recognized 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 met
42、hods used for NDT and the methods usedfor data recording, 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 pertinent
43、specifications and amendments.9. Quality Management9.1 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 materi
44、als, equipment, and any subcontractedservices.9.1.2 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 beperiodic
45、ally evaluated, including audit visits where appropri-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 assur
46、ing quality.9.1.3 Receiving InspectionFor those purchased 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 perfo
47、r-mance is available. Adequate facilities and procedures 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 o
48、f non-conforming purchased supplies or equipment shall 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 i
49、n 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 equipment shall be of the type,range, accuracy, precision, stability, and resolution appropriatefor its intended use.9.2.2 Measuring and test equipment shall be calibrated andcontrolled to ensure accuracy of measurement of product andprocesses to specifi
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