1、Designation: E 2159 01(Reapproved 2008)An American National StandardStandard Guide forSelection, Assignment, and Monitoring of Persons To BeUtilized as Assessors/Auditors or Technical Experts1This standard is issued under the fixed designation E 2159; the number immediately following the designation
2、 indicates the year oforiginal adoption or, in the case of revision, 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. Scope1.1 This guide provides guidance to organ
3、izations that needto utilize persons to perform assessments/audits (assessingbodies) of other organizations (assessed bodies) for purposes ofrecognition, accreditation or other type of approval to performa function.1.2 An assessing body should consider the contents of thisguide and apply it accordin
4、g to its unique situation. Theelements of this guide should be applicable to the selection,assignment, and monitoring of assessors whether they arecontract or permanent staff members.2. Terminology2.1 DefinitionsThe following definitions apply to theterms used in this guide.2.1.1 assessment teama gr
5、oup of two or more personsconsisting of a combination of assessors, auditors and technicalexperts, as required by the specific assessment to be performed.2.1.2 assessor/auditoran individual who has the skillsnecessary to perform a comprehensive assessment of anotherbody which includes assessment of
6、the quality managementsystem, policies and procedures, etc. An assessor/auditorshould be fully qualified in the performance of a fullassessment/audit with the exception of evaluating specifictechnical areas. An assessor may also be qualified as atechnical expert and bring such additional skills to t
7、heassessment/audit.2.1.3 technical experta technical expert is an individualwho has extensive technical expertise in a specific area(s). Thetechnical expert does not need to have the assessment skills ofan assessor. A person designated only as a technical expertshould not be deemed qualified to cond
8、uct a full assessment,but qualified merely to assist in the evaluation of technicalareas within the persons scope of expertise.3. Significance and Use3.1 In a situation where an organization is performing anevaluation of another, either formally or informally, the singlemost important element in the
9、 evaluation may well be theselection and assignment of a properly qualified assessor/assessment team to perform an on-site assessment. Therefore itis imperative that the person(s) performing the assessment beselected and assigned with care by the assessing organization.Two basic types of individuals
10、 normally participate in anon-site assessment: assessors/auditors and technical experts;each perform separate functions (see definitions).3.2 This guide focuses on providing guidance regarding theresponsibilities and obligations of an assessing body in theselection, training, assignment and monitori
11、ng of assessors/auditors and technical experts to carry out their evaluationfunctions.NOTE 1In some cases, others may also participate in an assessmentwho are beyond the control of the assessing body: e.g., governmentregulatory personnel, or other observers specified by a client. Suchparticipants ar
12、e not covered by this guide.4. Quality System4.1 An assessing body should have in place a documentedsystem describing how it fulfills the elements of its assessor/auditor, technical expert selection, training, assignment andmonitoring process.4.2 Assessor CriteriaAn assessing body should havewritten
13、 qualification criteria for the selection of requiredassessors/auditors, and technical experts. These criteria shouldaddress such factors as the candidates education and experi-ence, assessment/audit participation, training, and any exami-nation(s) passed. Requirements for qualification renewal and
14、ifapplicable, re-qualification. Technical experts should be quali-fied based on their previous experience and demonstrated skill.4.2.1 An assessing body should have written evaluationcriteria for assessors/auditors, and technical experts.4.3 Continuous Interactions w/Staff-Other AssessorsAnassessing
15、 body may find it advantageous to periodically havetheir assessors/auditors and technical experts have the oppor-tunity to meet with other similar persons to discuss theirexperiences and develop proposals to improve the evaluationprocess.4.4 Rating/Categorization/Listing SystemsAn assessingbody shou
16、ld have a documented system to rate and/or classifyassessors according to its needs and situation.1This guide is under the jurisdiction of ASTM Committee E36 on Laboratoryand Inspection Agency Accreditation and is the direct responsibility of Subcommit-tee E36.50 on Support Operations.Current editio
17、n approved May 1, 2008. Published October 2008. Originallyapproved in 2001. Last previous edition approved in 2001 as E 215901.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.NOTE 2Categories could be based on length of experience, d
18、emon-strated capability or rating other factors. Some systems currently use termssuch as lead assessor, assessor, and assessor trainee, whereas others mayuse designations such as senior and junior assessors.4.5 DatabaseAn assessing body should maintain a func-tional database of all assessors/auditor
19、s as an effective way toeasily select persons for a particular assignment.4.6 RecordsAn assessing body should maintain a com-plete file of all assessors/auditors and technical experts whoperform assessments on its behalf. The file should, at aminimum, contain pertinent education and background mate-
20、rial, dates and results of all pertinent training, appraisal reports,specific skill categories and any areas/situations which maycause a conflict of interest and, if available, appraisal formsfrom assessed bodies.4.6.1 Assessing bodies may find it advantageous to maintaina historical record of all a
21、ssignments performed by eachassessor/auditor and technical expert.4.6.2 The qualification record should identify the date andbasis of initial qualification, date of last renewal or re-qualification, and expiration date.5. Assessor Selection5.1 Sources of Potential AssessorsPotential assessors maybe
22、identified from many sources e.g., academic institutions,professional societies, industry, government, personnel certifi-cation bodies, advertisements, etc.5.2 QualificationsThe assessing body should select asses-sors based on their background and expertise in (1) theoperation of the specific type o
23、f body to be assessed, e.g.,laboratory operations, quality system auditing, manufacturingprocesses; (2) quality assurance, quality management systems;and (3) the specific technology requiring assessment.5.3 ProceduresThe assessing body should have proce-dures in place to adequately determine that an
24、 assessor/auditorhas (1) met the requirements for qualification; (2) the ability towork effectively with other people; (3) communications skills,both written and verbal; and (4) the ability to probe for neededinformation to effect an audit.5.4 Training:5.4.1 The assessing body should ensure that eac
25、h assessor/auditor has obtained adequate training in the general tech-niques of conducting an assessment/audit to fulfill the requiredduties.5.4.2 The assessing body should provide adequate trainingto all assessors/auditors and technical experts to explain itsown specific assessment technique, in-ho
26、use procedures,evaluation criteria, applicable documentation, and/or specificinstructions, operations, procedures and program requirements.6. Evaluation/Monitoring6.1 Each assessor/auditor and technical expert should beevaluated initially and thereafter on a continual basis by theassessing body. Eva
27、luation may be performed by:6.1.1 On-the-Job ObservationEach assessor/auditor andtechnical expert should be evaluated for the ability to conductan adequate assessment. This can be accomplished in severalways e.g., being accompanied by an experienced assessor orqualified assessing body staff person,
28、through a trial assess-ment (pre-arranged conditions), or through observation by aperson unknown to the assessor/auditor and technical expert. Awritten appraisal should be prepared and filed with the assess-ing organization by the evaluator.6.1.2 Staff AppraisalThe assessing body staff responsiblefo
29、r training/monitoring should take care to observe and ap-praise each candidate during training. A written appraisalshould be prepared and filed.6.1.2.1 The responsible assessing body staff manager shouldbe familiar with the style, methods, personality, and/or othertraits of each assessor/auditor and
30、 technical expert in theircharge.6.1.3 Other Assessor AppraisalDuring training or regularassessments, a more experienced or senior assessor(s) could beused to make careful observation of the trainee assessor/auditoror technical expert and, when appropriate, prepare a writtenreport of all observation
31、s and appraisals.6.1.4 Feedback from Assessed BodyAn assessing bodyshould provide a rating form for each assessed body to allowfeedback on each assessor/auditor and technical expert.6.1.5 Skills MaintenanceAn assessing body should havean on-going system to assure that all assessors/auditors andtechn
32、ical experts are kept up-to-date with all internal evalua-tion policies and procedures. The body shall encourageassessors/auditors to maintain their auditing and/or technicalskills to the current state-of-the-art.7. Assessor Qualities and Ethics7.1 An assessor/auditor, technical expert must be total
33、lyobjective in all situations. Each must be honest, ethical, andable to maintain information in confidence.7.2 An assessing body should have documented proceduresin place to determine and monitor the objectivity, honesty,ethical conduct, and ability to maintain confidentiality of all ofits assessors
34、/auditors and technical experts.7.3 Conflict-of-InterestThe assessing body must be alertto ascertain whether or not a conflict is, or appears to be,present regarding any assessor/auditor, or technical expert. Noconflict of interest should be present which could bias thepersons judgement either posit
35、ively or negatively with respectto the assessment of any body.7.3.1 The point must be stressed to each assessor/auditor,and technical expert in the selection, training and evaluationprocess that any actual or potential conflict of interest must bemade known to the assessing body.7.4 Ethics Statement
36、The assessing body should requireall assessors/auditors and technical experts to sign an ethicsstatement/agreement. The statement should also contain aconfidentiality clause.8. Assignment of Assessors8.1 An assessing body should have established documentedpolicies and procedures for the assignment o
37、f a specificassessor/auditor, or technical expert to specific assessments.Assignments should be made to best match the qualities of theassessor/assessment team to the body needing assessment aswell as consideration of the needs and capabilities of theassessing body.E 2159 01 (2008)28.2 An assessing
38、body should have documented proceduresto address the selection and assignment of assessors/auditors,and technical experts for reassessments. For example, someassessing bodies send the same assessor/team time after time,others rotate assessors/teams to obtain different perspectives.8.3 Depending on t
39、he size and structure of the body to beassessed, an assessment may need to conducted by more thanone person. The assessing body will need to name an assess-ment team of several persons. In such a case one assessorshould be named to lead the team. The team may be comprisedof one or more assessors/aud
40、itors and/or technical experts.APPENDIX(Nonmandatory Information)X1. REFERENCED DOCUMENTSX1.1 ASTM Standards:E 548 Guide for General Criteria Used for EvaluatingLaboratory CompetenceE 994 Guide for Calibration and Testing Laboratory Ac-creditation SystemsGeneral Requirements for Operation andRecogni
41、tionE 1187 Terminology Relating to Laboratory AccreditationE 1884 Guide for General Requirements for Bodies Oper-ating Assessment and Certification/Registration of QualitySystemsE 1905 Guide for General Requirements for Assessmentand Accreditation of Certification/Registration BodiesE 1906 Guide for
42、 General requirements for Bodies Oper-ating Product Certification SystemsX1.2 ISO/IEC Documents:Guide 25 General Requirements for the Competence ofCalibration and Testing LaboratoriesGuide 39 General Requirements for the Acceptance ofInspection BodiesGuide 58 Calibration and Testing LaboratoryAccred
43、itationSystemsGeneral Requirements for Operation and Recogni-tionGuide 61 General Requirements for Assessment and Ac-creditation of Certification/Registration BodiesGuide 62 General Requirements for Bodies OperatingAssessment. and Certification/Registration of Quality SystemsGuide 65 General Require
44、ments for Bodies OperatingProduct Certification Systems9000 Series Quality Management StandardsStandard 10011-1 Guidelines for Auditing QualitySystemsPart 1Auditing, Part 2Qualification Criteria forQuality System Auditors, Part 3Management of Audit Pro-gramsStandard 17025 General Requirements for th
45、e Compe-tence of Testing and Calibration LaboratoriesASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly advised that determination of the validity of any such patent ri
46、ghts, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years andif not revised, either reapproved or withdrawn. Your comments are invited either fo
47、r revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearin
48、g you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org).E 2159 01 (2008)3
