ASTM E1212-2017 Standard Practice for Establishing Quality Management Systems for Nondestructive Testing Agencies 《制定无损检测机构质量管理体系的标准实施规程》.pdf

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1、Designation: E1212 12E1212 17Standard Practice forEstablishing Quality Management Systems forNondestructive Testing Agencies 1This 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

2、, the year 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*Scope1.1 This practice covers general requirements for the establishment and maintenance of a quality manag

3、ement system foragencies engaged in nondestructive testing (NDT).1.2 This practice utilizes criteria contained in Practice E543.1.3 This practice utilizes criteria contained in American National Standard ANSI/ISO/ASQ Q90012008, Quality managementsystemsRequirements.1.4 This practice recognizes the i

4、mportance of establishing minimum safety criteria.1.5 The use of SI or inch-pound units, or combinations thereof, will be the responsibility of the technical committee whosestandards are referred to in this standard.1.6 This practice does not purport to address all of the safety concerns, if any, as

5、sociated with its use. It is the responsibilityof the user of this practice to establish appropriate safety and health practices and determine the applicability of regulatorylimitations prior to use.1.7 This international standard was developed in accordance with internationally recognized principle

6、s on standardizationestablished in the Decision on Principles for the Development of International Standards, Guides and Recommendations issuedby the World Trade Organization Technical Barriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2E543 Specification for Agencies Perfor

7、ming Nondestructive TestingE1359 Guide for Evaluating Capabilities of Nondestructive Testing Agencies2.2 ASNT/ANSI Standards:3ASNT Recommended Practice No. SNT-TC-1A Personnel Qualification and Certification in Nondestructive TestingANSI/ASNT CP 189 Qualification and Certification of Nondestructive

8、Testing Personnel2.3 ANSI/ASQ Standards:A8402 Management and Quality Assurance-Vocabulary4Q9000 Series of Quality Management and Quality Assurance (Q9000 through Q9004 inclusive) Standards (These are exactequivalents to the ISO 9000 through ISO 9004 series)2.4 AIA Standard:NAS 410 NAS Certification

9、and Qualification of Nondestructive Testing Personnel53. Terminology3.1 Definitions of Terms Specific to This Standard:1 This practice is under the jurisdiction of ASTM Committee E07 on Nondestructive Testing and is the direct responsibility of Subcommittee E07.09 on NondestructiveTesting Agencies.C

10、urrent edition approved Nov. 1, 2012June 1, 2017. Published November 2012June 2017. Originally approved in 1987. Last previous edition approved in 20092012 asE1212 - 09.E1212 - 12. DOI: 10.1520/E1212-12.10.1520/E1212-17.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactA

11、STM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary page on the ASTM website.3 Available from American Society for Nondestructive Testing (ASNT), P.O. Box 28518, 1711 Arlingate Ln., Columbus, OH 43228-0518, http:/www.a

12、snt.org.4 Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203, http:/www.asq.org.5 Available from Aerospace Industries Association of America, Inc. (AIA), 1000 Wilson Blvd., Suite 1700, Arlington, VA 22209-3928, http:/www.aia-aerospace.org.This document is

13、not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropri

14、ate. In all cases only the current versionof the standard as published by ASTM is to be considered the official document.*A Summary of Changes section appears at the end of this standardCopyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1

15、3.1.1 agency, nthe public, independent, or in-house nondestructive testing organization selected by the authority to performthe examination(s) required by the purchase order or specification.3.1.2 authority, nthe owner, prime contractor, engineer, architect, or purchasing agent in responsible charge

16、 of the work, orduly recognized or designated representative.3.1.3 continual quality improvement, n an ongoing quality improvement activity for achieving results. Improvement may bedirected at individual processes, finished products, or administrative processes. The continual quality improvement pro

17、gramutilizes statistical methods, team projects, and other tools as appropriate to obtain and sustain improvements.3.1.4 customer, ncustomer is used with the same meaning as “authority.”3.1.5 process capability, nthe degree to which a process can produce the same results without variation, that is,r

18、eproducibility.3.1.6 process control, nmanaging a process to ensure that it is performing to its designed capability.3.1.7 quality management system, nthe organizational structure, responsibilities, practices, procedures, processes, andresources for implementing and maintaining the quality program.3

19、.1.8 quality manual, na comprehensive document stating the quality policy and specifying organizational structure, practices,and procedures necessary to empower the quality policy and quality management system.3.1.9 quality objectives, nspecific obtainable improvement goals supporting the quality pr

20、ogram.3.1.10 quality policy, nthe overall intentions and direction of an organization regarding quality as formally expressed by topmanagement.3.1.11 quality records, nformal documentation of examination results or data supporting the quality management system.3.1.11.1 DiscussionExamples are: audit

21、reports, calibration data, NDT records, process qualification results, qualification data, and test data.4. Significance and Use4.1 This practice covers procedures for establishing and maintaining a quality system for nondestructive testing agencies.4.2 Controlling the quality of service rendered is

22、 a continuing process. This practice provides guidelines for establishing aquality management system that provides for: calibration, standardization, reference samples, examination plans, and procedures.4.3 The basic requirements for a quality management system encompass the following areas, all of

23、which shall be documented.4.3.1 Quality policy statement, planning, and administration,4.3.2 Organization,4.3.3 Human resources,4.3.4 Physical resources, and4.3.5 Quality management.5. Quality Policy Statement, Planning, and Administration5.1 Policy StatementApolicy statement shall describe manageme

24、nts specific intention and policy with respect to quality. Thepolicy statement should specify an organized approach for carrying out those intentions and should address itself to all majorquality parameters. It should be approved by the chief executive officer for company-wide policies or by subordi

25、nate officers forspecialized policies. Periodic audits should be required to ensure adherence to quality policies.5.2 Quality ObjectivesObjectives should be established for appropriate key elements of performance such as safetyrequirements, internal performance levels, vendor performance, training,

26、and qualification of personnel.5.3 Quality Management SystemA quality management system shall be established that will carry out the stated policies andobjectives.5.4 Quality PlanningPlanning for each new or modified process or test method should define those characteristics to becontrolled. Quality

27、 planning also includes providing for administrative processes needed to implement compliance with thispractice.5.5 Quality ManualThe quality policy and system shall be documented and be in accessible form, such as a quality manualor series of manuals. Key elements should include, as necessary:5.5.1

28、 The general quality statement,5.5.2 A description of the quality system,5.5.3 A general description of quality planning requirements with specifics for each product category where appropriate,5.5.4 The requirements of Practice E543 pertaining to the laboratory procedure manual, and5.5.5 Typically u

29、sed examination procedures.E1212 1725.6 AdministrationClear lines of authority shall be established to administer the quality management system.5.6.1 Quality ResponsibilityThe quality responsibility of each unit within the organization shall be approved by the chiefoperation officer of each unit.5.6

30、.2 Quality Performance ReportingResponsibility for reporting performance against stated quality objectives to highermanagement should rest with functions independent of those responsible for the attainment of those objectives. Procedures fordocumentation and record retention should be established.5.

31、6.3 Quality System AuditsTo provide assurance, a periodic audit of the quality management system should be made by anorganizational element independent of the unit being audited or by a qualified third party to monitor the effectiveness of variousquality management system processes. It may include,

32、as appropriate:5.6.3.1 Management audits to determine how well quality policy and objectives are being met,5.6.3.2 System audits, including examination process audits to determine how well quality planning has been implemented andto identify areas where changes would be beneficial to the quality ser

33、vices performed, and5.6.3.3 Records documenting findings and corrective and preventive actions taken.6. Organization6.1 The following information concerning the organization of the agency shall be documented.6.1.1 A description of the organization including:6.1.1.1 The complete legal name and addres

34、s of the main office,6.1.1.2 The names and positions of the principal officers and directors,6.1.1.3 The agencys ownership, managerial structure, and principal members,6.1.1.4 The functional description of the agencys organizational structure, operational departments, and support departmentsand serv

35、ices. This may be demonstrated in the form of charts that depict all the divisions, departments, sections and units, and theirrelationships,6.1.1.5 All relevant organizational affiliates of the agency and principal officers of affiliates and directors of affiliates whereapplicable,6.1.1.6 External o

36、rganizations and organizational components and their functions that are utilized for significant technicalsupport services, and6.1.1.7 A brief history of the agency including its relationship with its organizational component affiliations and othersupporting information.6.1.2 A listing of the releva

37、nt technical services offered.6.1.3 A list giving applicable dates of qualifications and accreditations.7. Human Resources7.1 GeneralThose aspects of the quality system where the work of the employees will affect the quality of products shall beidentified, and specific action taken to control them.7

38、.2 Management ResponsibilitiesThe quality-related requirements, duties, and responsibilities of all personnel shall beidentified. Job criteria that are quality-related should be specified in job descriptions to permit proper employee selection.7.3 Employee Selection and TrainingEmployees shall be se

39、lected on the basis of capability and experience or the potentialto fully qualify for the job. A training program shall be maintained to ensure employees develop and retain skill competence.Nondestructive testing (NDT) personnel shall be qualified in accordance with a nationally recognized NDT perso

40、nnel qualificationpractice or standard such as ANSI/ASNT-CP-189, ASNT/SNT-TC-1A, AIA/NAS 410, or a similar document. The practice orstandard used and the applicable revision shall be specified in the contractual agreement between the using parties.7.4 The agency shall provide the following documenta

41、tion:7.4.1 A written outline or chart giving operational personnel positions and their lines of responsibility and authority, and7.4.2 A summary job description for each professional, scientific, supervisory, and technical position category including therequired education, training and experience, c

42、ertification, or professional licenses.7.5 The agency shall provide a description of its methods of maintaining personnel records to document the qualifications, workexperience, and training history of each person in the positions described in 7.4.2. The agency shall also provide a description ofits

43、 means of ensuring confidence in its human resources including the maintenance of records.8. Physical Resources8.1 The agency shall provide an inventory of its relevant physical resources including:8.1.1 A general description of the agencys facilities for NDT related activities.8.1.2 An inventory of

44、 equipment used to perform NDT including 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,E1212 1738.1.2.4 Properties of the equipment subject to standardization or calibration,8.1.2.5 The range of o

45、peration 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 Asystem of written procedures for each NDT service performed by the agency. The procedures shall include a descript

46、ionof the methods used for NDT and the methods used for data recording, data processing, data reporting, and for certification of theresults. When required, customer approval shall be obtained.8.1.4 An inventory of reference material including a library of standards, applicable technical publication

47、s, and pertinentspecifications and amendments.9. Quality Management9.1 Purchased NDT Equipment, Materials, and Services:9.1.1 GeneralThe quality management system shall include procedures to ensure effective supplier quality management forall purchased materials and services. Controls shall be provi

48、ded for materials, equipment, and any subcontracted services.9.1.2 Supplier Quality Program and Selection MethodsProcedures shall be established for the selection and qualification ofsuppliers, such as supplier surveys, past quality history, and industry history. Each suppliers quality capability sh

49、all be periodicallyevaluated, including audit visits where appropriate, based upon performance. The requirements for quality management shall beestablished in the purchase agreement. The purchase agreement should include the elements of the quality management system thatare to be performed by the supplier in assuring quality.9.1.3 Receiving InspectionFor those purchased items where inspection upon receipt is acceptable, inspection of submitteditems shall be performed to the degree and extent needed to determine acceptability. Receiving inspecti