1、Designation: E1212 17Standard Practice forEstablishing Quality Management Systems forNondestructive Testing Agencies1This standard is issued under the fixed designation E1212; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the yea
2、r of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope*1.1 This practice covers general requirements for the estab-lishment and maintenance of a quality management system
3、foragencies engaged in nondestructive testing (NDT).1.2 This practice utilizes criteria contained in Practice E543.1.3 This practice utilizes criteria contained in AmericanNational Standard ANSI/ISO/ASQ Q90012008, Quality man-agement systemsRequirements.1.4 This practice recognizes the importance of
4、 establishingminimum 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 i
5、ts 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 prior to use.1.7 This international standard was developed in accor-dance with internationally recognized principles on standa
6、rd-ization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2E543 Specification for Agencies Performing Nond
7、estructiveTestingE1359 Guide for Auditing and Evaluating Capabilities ofNondestructive Testing Agencies2.2 ASNT/ANSI Standards:3ASNT Recommended Practice No. SNT-TC-1A PersonnelQualification and Certification in Nondestructive TestingANSI/ASNT CP 189 Qualification and Certification of Non-destructiv
8、e 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 equivalents to the ISO 9000 through ISO 9004series)2.4 AIA Standard:NAS 410 NAS Certificatio
9、n and Qualification of Nonde-structive Testing Personnel53. Terminology3.1 Definitions of Terms Specific to This Standard: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 ors
10、pecification.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, n an ongoing qualityimprovement activity for achieving results. Improvement maybe
11、 directed at individual processes, finished products, 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 “authorit
12、y.”3.1.5 process capability, nthe degree to which a processcan produce the same results without variation, that is, repro-ducibility.1This practice is under the jurisdiction of ASTM Committee E07 on Nonde-structive Testing and is the direct responsibility of Subcommittee E07.09 onNondestructive Test
13、ing Agencies.Current edition approved June 1, 2017. Published June 2017. Originallyapproved in 1987. Last previous edition approved in 2012 as E1212 - 12. DOI:10.1520/E1212-17.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. Fo
14、r 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.4Available from American Society for Qu
15、ality (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.*A Summary of Changes section appears at the end of this standardCopyr
16、ight ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of Internatio
17、nal Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.13.1.6 process control, nmanaging a process to ensure thatit is performing to its designed capability.3.1.7 quality management system, nthe organizationalstructure, responsibi
18、lities, 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 organizational structure,practices, and procedures necessary to empower the qualitypolicy and quality
19、management system.3.1.9 quality objectives, nspecific obtainable improve-ment goals supporting 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
20、exami-nation results or data supporting the quality managementsystem.3.1.11.1 DiscussionExamples 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 andmainta
21、ining a quality system for nondestructive testing agen-cies.4.2 Controlling the quality of service rendered is a continu-ing process. This practice provides guidelines for establishinga quality management system that provides for: calibration,standardization, reference samples, examination plans, an
22、dprocedures.4.3 The basic requirements for a quality management sys-tem encompass the following areas, all of which shall bedocumented.4.3.1 Quality policy statement, planning, andadministration,4.3.2 Organization,4.3.3 Human resources,4.3.4 Physical resources, and4.3.5 Quality management.5. Quality
23、 Policy Statement, Planning, andAdministration5.1 Policy StatementA policy statement shall 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 qualit
24、y parameters. It should be approved bythe chief executive officer for company-wide policies 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
25、 of performance such as safetyrequirements, internal performance levels, vendorperformance, 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 eac
26、h new or modifiedprocess or test method should define those characteristics to becontrolled. Quality planning also includes providing for ad-ministrative processes needed to implement compliance withthis practice.5.5 Quality ManualThe quality policy and system shall bedocumented and be in accessible
27、 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 description of the quality system,5.5.3 Ageneral description of quality planning requirementswith specifics for each product category where appropriate,5.5.4 The
28、requirements of Practice E543 pertaining to thelaboratory procedure manual, and5.5.5 Typically 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 w
29、ithin the organization shall be approved by the chiefoperation officer of each unit.5.6.2 Quality Performance ReportingResponsibility forreporting performance against stated quality objectives tohigher management should rest with functions independent ofthose responsible for the attainment of those
30、objectives. Pro-cedures for documentation and record retention should beestablished.5.6.3 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 mon
31、itor the effectivenessof various quality management system processes. It mayinclude, as 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 im
32、plementedand to identify areas where changes would be beneficial to thequality services 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 desc
33、ription 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 principal officers anddirectors,6.1.1.3 The agencys ownership, managerial structure, andprincipal members,E1212 1726.1.1.4 The functional description of the agen
34、cys organiza-tional structure, operational departments, and support depart-ments and services. This 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 principa
35、l officers of affiliates and directors of affiliateswhere applicable,6.1.1.6 External organizations 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 organizati
36、onal component affiliations and othersupporting information.6.1.2 A listing of the relevant technical services offered.6.1.3 A list giving applicable dates of qualifications andaccreditations.7. Human Resources7.1 GeneralThose aspects of the quality system where thework of the employees will affect
37、the quality of products shallbe identified, and specific action taken to control them.7.2 Management ResponsibilitiesThe quality-relatedrequirements, duties, and responsibilities of all personnel shallbe identified. Job criteria that are quality-related should bespecified in job descriptions to perm
38、it proper employee selec-tion.7.3 Employee Selection and TrainingEmployees shall beselected 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 (ND
39、T) personnel shall bequalified in accordance with a nationally recognized NDTpersonnel 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 agre
40、ement be-tween the using parties.7.4 The agency shall provide the following documentation:7.4.1 Awritten 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 techn
41、ical position category includ-ing the required education, training and experience,certification, 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 t
42、hepositions described in 7.4.2. The agency shall also provide adescription of its 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 descrip
43、tion of the agencys facilities forNDT related activities.8.1.2 An inventory of equipment 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 equipm
44、ent 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 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 se
45、rviceperformed by the agency. The procedures shall include adescription of the methods 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
46、 including a libraryof standards, applicable technical publications, and pertinentspecifications 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-m
47、ent for all purchased materials and services. Controls shall beprovided for materials, 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 qualit
48、y history,and industry history. Each suppliers quality capability shall beperiodically evaluated, including audit visits whereappropriate, based upon performance. The requirements forquality management shall be established in the purchaseagreement. The purchase agreement should include the ele-ments
49、 of the quality management system that are to beperformed by the supplier in assuring 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 perfor-mance is available. Adequate facilities and procedures forstorage, handling, protection, and controlled release of pur-chased materials shall be established. Ma
