EN ISO 17034-2016 en General requirements for the competence of reference material producers《对标准物质生产能力的一般要求(ISO 17034 2016)》.pdf

1、General requirements forthe competence of referencematerial producersBS EN ISO 17034:2016(ISO 17034:2016)BSI Standards PublicationBS EN ISO 17034:2016 BRITISH STANDARDNational foreword5IJT#SJUJTI4UBOEBSEJTUIF6,JNQMFNFOUBUJPOPG&/*40*UTVQFSTFEFT1%*40(VJEFBOE#4*40XIJDIBSFXJUIESBXOThe UK participation i

2、n its preparation was entrusted to Technical Committee CAS/1, Conformity assessment.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its

3、 correct application. The British Standards Institution 2016. Published by BSI Standards Limited 2016ISBN 978 0 580 91021 0ICS 03.120.20Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and

4、 Strategy Committee on 30 November 2016.Amendments/corrigenda issued since publicationDate Text affected31 December 2016 This corrigendum renumbers BS ISO 17034:2016 as BS EN ISO 17034:2016g3g3g3g3g3g3g3g3g3g3g3g3g3g3g3g3 g3g3g3g3g3g3g8g24g21g18g19g8g4g17g3g22g23g4g17g7g4g21g7g3g17g18g21g16g8g3g8g24

5、g21g18g19g50g8g17g17g8g3g8g24g21g18g19g34g12g22g6g11g8g3g17g18g21g16g3EN ISO 17034 g3g3g3 g17g145g152g135g143g132g135g148g3g884g882g883g888g3g12g6g22g3g882g885g484g883g884g882g484g884g882g3g3g3g3g8g144g137g142g139g149g138g3g152g135g148g149g139g145g144g3g3g10g135g144g135g148g131g142g3g148g135g147g151

6、g139g148g135g143g135g144g150g149g3g136g145g148g3g150g138g135g3g133g145g143g146g135g150g135g144g133g135g3g145g136g3g148g135g136g135g148g135g144g133g135g3g143g131g150g135g148g139g131g142g3g146g148g145g134g151g133g135g148g149g3g523g12g22g18g3g883g889g882g885g886g483g884g882g883g888g524g3g3g8g154g139g13

7、7g135g144g133g135g149g3g137g177g144g177g148g131g142g135g149g3g146g145g151g148g3g142g131g3g133g145g143g146g177g150g135g144g133g135g3g134g135g149g3g146g148g145g134g151g133g150g135g151g148g149g3g134g135g3g143g131g150g177g148g139g131g151g154g3g134g135g3g148g177g136g177g148g135g144g133g135g3g523g12g22g18

8、g3g883g889g882g885g886g483g884g882g883g888g524g3g3 g14g145g144g136g145g148g143g139g150g161g150g149g132g135g153g135g148g150g151g144g137g3g486g3g4g142g142g137g135g143g135g139g144g135g3g4g144g136g145g148g134g135g148g151g144g137g135g144g3g131g144g3g134g139g135g3g14g145g143g146g135g150g135g144g156g3g152g

9、145g144g3g21g135g136g135g148g135g144g156g143g131g150g135g148g139g131g142g138g135g148g149g150g135g142g142g135g148g144g3g523g12g22g18g3g883g889g882g885g886g483g884g882g883g888g524g3g23g138g139g149g3g8g151g148g145g146g135g131g144g3g22g150g131g144g134g131g148g134g3g153g131g149g3g131g146g146g148g145g152g

10、135g134g3g132g155g3g6g8g17g3g145g144g3g884g888g3g18g133g150g145g132g135g148g3g884g882g883g888g484g3g3g3g6g8g17g3g131g144g134g3g6g8g17g8g15g8g6g3g143g135g143g132g135g148g149g3g131g148g135g3g132g145g151g144g134g3g150g145g3g133g145g143g146g142g155g3g153g139g150g138g3g150g138g135g3g6g8g17g512g6g8g17g8g1

11、5g8g6g3g12g144g150g135g148g144g131g142g3g21g135g137g151g142g131g150g139g145g144g149g3g153g138g139g133g138g3g149g150g139g146g151g142g131g150g135g3g150g138g135g3g133g145g144g134g139g150g139g145g144g149g3g136g145g148g3g137g139g152g139g144g137g3g150g138g139g149g3g8g151g148g145g146g135g131g144g3g22g150g1

12、31g144g134g131g148g134g3g150g138g135g3g149g150g131g150g151g149g3g145g136g3g131g3g144g131g150g139g145g144g131g142g3g149g150g131g144g134g131g148g134g3g153g139g150g138g145g151g150g3g131g144g155g3g131g142g150g135g148g131g150g139g145g144g484g3g24g146g486g150g145g486g134g131g150g135g3g142g139g149g150g149g

13、3g131g144g134g3g132g139g132g142g139g145g137g148g131g146g138g139g133g131g142g3g148g135g136g135g148g135g144g133g135g149g3g133g145g144g133g135g148g144g139g144g137g3g149g151g133g138g3g144g131g150g139g145g144g131g142g3g149g150g131g144g134g131g148g134g149g3g143g131g155g3g132g135g3g145g132g150g131g139g144g

14、135g134g3g145g144g3g131g146g146g142g139g133g131g150g139g145g144g3g150g145g3g150g138g135g3g6g8g17g486g6g8g17g8g15g8g6g3g16g131g144g131g137g135g143g135g144g150g3g6g135g144g150g148g135g3g145g148g3g150g145g3g131g144g155g3g6g8g17g3g131g144g134g3g6g8g17g8g15g8g6g3g143g135g143g132g135g148g484g3g3g23g138g13

15、9g149g3g8g151g148g145g146g135g131g144g3g22g150g131g144g134g131g148g134g3g135g154g139g149g150g149g3g139g144g3g150g138g148g135g135g3g145g136g136g139g133g139g131g142g3g152g135g148g149g139g145g144g149g3g523g8g144g137g142g139g149g138g481g3g9g148g135g144g133g138g481g3g10g135g148g143g131g144g524g484g3g4g3g

16、152g135g148g149g139g145g144g3g139g144g3g131g144g155g3g145g150g138g135g148g3g142g131g144g137g151g131g137g135g3g143g131g134g135g3g132g155g3g150g148g131g144g149g142g131g150g139g145g144g3g151g144g134g135g148g3g150g138g135g3g148g135g149g146g145g144g149g139g132g139g142g139g150g155g3g145g136g3g131g3g6g8g17

17、g3g131g144g134g3g6g8g17g8g15g8g6g3g143g135g143g132g135g148g3g139g144g150g145g3g139g150g149g3g145g153g144g3g142g131g144g137g151g131g137g135g3g131g144g134g3g144g145g150g139g136g139g135g134g3g150g145g3g150g138g135g3g6g8g17g486g6g8g17g8g15g8g6g3g16g131g144g131g137g135g143g135g144g150g3g6g135g144g150g148

18、g135g3g138g131g149g3g150g138g135g3g149g131g143g135g3g149g150g131g150g151g149g3g131g149g3g150g138g135g3g145g136g136g139g133g139g131g142g3g152g135g148g149g139g145g144g149g484g3g3g6g8g17g3g131g144g134g3g6g8g17g8g15g8g6g3g143g135g143g132g135g148g149g3g131g148g135g3g150g138g135g3g144g131g150g139g145g144g

19、131g142g3g149g150g131g144g134g131g148g134g149g3g132g145g134g139g135g149g3g131g144g134g3g144g131g150g139g145g144g131g142g3g135g142g135g133g150g148g145g150g135g133g138g144g139g133g131g142g3g133g145g143g143g139g150g150g135g135g149g3g145g136g3g4g151g149g150g148g139g131g481g3g5g135g142g137g139g151g143g48

20、1g3g5g151g142g137g131g148g139g131g481g3g6g148g145g131g150g139g131g481g3g6g155g146g148g151g149g481g3g6g156g135g133g138g3g21g135g146g151g132g142g139g133g481g3g7g135g144g143g131g148g141g481g3g8g149g150g145g144g139g131g481g3g9g139g144g142g131g144g134g481g3g9g145g148g143g135g148g3g28g151g137g145g149g142g

21、131g152g3g21g135g146g151g132g142g139g133g3g145g136g3g16g131g133g135g134g145g144g139g131g481g3g9g148g131g144g133g135g481g3g10g135g148g143g131g144g155g481g3g10g148g135g135g133g135g481g3g11g151g144g137g131g148g155g481g3g12g133g135g142g131g144g134g481g3g12g148g135g142g131g144g134g481g3g12g150g131g142g15

22、5g481g3g15g131g150g152g139g131g481g3g15g139g150g138g151g131g144g139g131g481g3g15g151g154g135g143g132g145g151g148g137g481g3g16g131g142g150g131g481g3g17g135g150g138g135g148g142g131g144g134g149g481g3g17g145g148g153g131g155g481g3g19g145g142g131g144g134g481g3g19g145g148g150g151g137g131g142g481g3g21g145g1

23、43g131g144g139g131g481g3g22g142g145g152g131g141g139g131g481g3g22g142g145g152g135g144g139g131g481g3g22g146g131g139g144g481g3g22g153g135g134g135g144g481g3g22g153g139g150g156g135g148g142g131g144g134g481g3g23g151g148g141g135g155g3g131g144g134g3g24g144g139g150g135g134g3g14g139g144g137g134g145g143g484g3g3

24、g3g3CEN-CENELEC Management Centre:g3Avenue Marnix 17, B-1000 Brussels g825g3g884g882g883g888g3g6g8g17g512g6g8g17g8g15g8g6g3 g4g142g142g3g148g139g137g138g150g149g3g145g136g3g135g154g146g142g145g139g150g131g150g139g145g144g3g139g144g3g131g144g155g3g136g145g148g143g3g131g144g134g3g132g155g3g131g144g155

25、g3g143g135g131g144g149g3g148g135g149g135g148g152g135g134g3g153g145g148g142g134g153g139g134g135g3g136g145g148g3g6g8g17g3g144g131g150g139g145g144g131g142g3g16g135g143g132g135g148g149g3g131g144g134g3g136g145g148g3g6g8g17g8g15g8g6g3g16g135g143g132g135g148g149g484g3g21g135g136g484g3g17g145g484g3g8g17g3g1

26、2g22g18g3g883g889g882g885g886g483g884g882g883g888g3g8European foreword This document (EN ISO 17034:2016) has been prepared by Technical Committee ISO/CASCO “Committee on conformity assessment“ in collaboration with Technical Committee CEN/CLC/TC 1 “Criteria for conformity assessment bodies” the secr

27、etariat of which is held by BSI. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by May 2017, and conflicting national standards shall be withdrawn at the latest by May 2017. Attention is drawn to th

28、e possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following count

29、ries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Pol

30、and, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 17034:2016 has been approved by CEN as EN ISO 17034:2016 without any modification. BS EN ISO 17034:2016g8g17g3g12g22g18g3g883g889g882g885g886g483g884g882g883g888g

31、3g525g8g526BS ISO 17034:2016ISO 17034:2016(E)Foreword vIntroduction vi1 Scope .12 Normative references 1g885g3 g23g135g148g143g149g3g131g144g134g3g134g135g976g139g144g139g150g139g145g144g149 .14 General requirements .34.1 Contractual matters 3g886g484g884g3 g12g143g146g131g148g150g139g131g142g139g15

32、0g155 3g886g484g885g3 g6g145g144g976g139g134g135g144g150g139g131g142g139g150g155 .45 Structural requirements 46 Resource requirements .56.1 Personnel .56.2 Subcontracting 56.3 Provision of equipment, services and supplies .66.4 Facilities and environmental conditions 77 Technical and production requ

33、irements .77.1 General requirements .77.2 Production planning .77.3 Production control .87.4 Material handling and storage .87.5 Material processing .97.6 Measurement procedures97.7 Measuring equipment 10g889g484g890g3 g7g131g150g131g3g139g144g150g135g137g148g139g150g155g3g131g144g134g3g135g152g131g

34、142g151g131g150g139g145g144 10g889g484g891g3 g16g135g150g148g145g142g145g137g139g133g131g142g3g150g148g131g133g135g131g132g139g142g139g150g155g3g145g136g3g133g135g148g150g139g976g139g135g134g3g152g131g142g151g135g149 .10g889g484g883g882g3 g4g149g149g135g149g149g143g135g144g150g3g145g136g3g138g145g14

35、3g145g137g135g144g135g139g150g155 .11g889g484g883g883g3 g4g149g149g135g149g149g143g135g144g150g3g131g144g134g3g143g145g144g139g150g145g148g139g144g137g3g145g136g3g149g150g131g132g139g142g139g150g155.117.12 Characterization .12g889g484g883g885g3 g4g149g149g139g137g144g143g135g144g150g3g145g136g3g146g

36、148g145g146g135g148g150g155g3g152g131g142g151g135g149g3g131g144g134g3g150g138g135g139g148g3g151g144g133g135g148g150g131g139g144g150g139g135g149 .137.14 RM documents and labels .147.15 Distribution service .15g889g484g883g888g3 g6g145g144g150g148g145g142g3g145g136g3g147g151g131g142g139g150g155g3g131g

37、144g134g3g150g135g133g138g144g139g133g131g142g3g148g135g133g145g148g134g149 167.17 Management of non-conforming work .167.18 Complaints .178 Management system requirements .188.1 Options 188.1.1 General.188.1.2 Option A 188.1.3 Option B 18g890g484g884g3 g20g151g131g142g139g150g155g3g146g145g142g139g

38、133g155g3g523g18g146g150g139g145g144g3g4g524 18g890g484g885g3 g10g135g144g135g148g131g142g3g143g131g144g131g137g135g143g135g144g150g3g149g155g149g150g135g143g3g134g145g133g151g143g135g144g150g131g150g139g145g144g3g523g18g146g150g139g145g144g3g4g524 19g890g484g886g3 g6g145g144g150g148g145g142g3g145g1

39、36g3g143g131g144g131g137g135g143g135g144g150g3g149g155g149g150g135g143g3g134g145g133g151g143g135g144g150g149g3g523g18g146g150g139g145g144g3g4g524 .198.5 Control of records (Option A)198.6 Management review (Option A) 208.7 Internal audit (Option A) 208.8 Actions to address risks and opportunities (O

40、ption A) 218.9 Corrective actions (Option A) 218.9.1 General.21g890g484g891g484g884g3 g6g131g151g149g135g3g131g144g131g142g155g149g139g149 .218.9.3 Selection and implementation of corrective actions .218.9.4 Monitoring of corrective actions .22 ISO 2016 All rights reserved iiiContents PageBS EN ISO

41、17034:2016g12g22g18g3g883g889g882g885g886g483g884g882g883g888g525g8g526BS ISO 17034:2016ISO 17034:2016(E)8.9.5 Additional audits.228.10 Improvement (Option A) .228.11 Feedback from customers (Option A) 22Annex A (informative) Summary of production requirements for RMs and CRMs .23Bibliography .24iv

42、ISO 2016 All rights reservedBS EN ISO 17034:2016g12g22g18g3g883g889g882g885g886g483g884g882g883g888g525g8g526BS ISO 17034:2016ISO 17034:2016(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards g132g145g134g139g135g149g3g523g12g22g18g3g14

43、3g135g143g132g135g148g3g132g145g134g139g135g149g524g484g3g23g138g135g3g153g145g148g141g3g145g136g3g146g148g135g146g131g148g139g144g137g3g12g144g150g135g148g144g131g150g139g145g144g131g142g3g22g150g131g144g134g131g148g134g149g3g139g149g3g144g145g148g143g131g142g142g155g3g133g131g148g148g139g135g134g3

44、g145g151g150g3g150g138g148g145g151g137g138g3g12g22g18g3g150g135g133g138g144g139g133g131g142g3g133g145g143g143g139g150g150g135g135g149g484g3g8g131g133g138g3g143g135g143g132g135g148g3g132g145g134g155g3g139g144g150g135g148g135g149g150g135g134g3g139g144g3g131g3g149g151g132g140g135g133g150g3g136g145g148g

45、3g153g138g139g133g138g3g131g3g150g135g133g138g144g139g133g131g142g3committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. g12g22g18g3g133g145g142g142g131g132g14

46、5g148g131g150g135g149g3g133g142g145g149g135g142g155g3g153g139g150g138g3g150g138g135g3g12g144g150g135g148g144g131g150g139g145g144g131g142g3g8g142g135g133g150g148g145g150g135g133g138g144g139g133g131g142g3g6g145g143g143g139g149g149g139g145g144g3g523g12g8g6g524g3g145g144g3g131g142g142g3g143g131g150g150g

47、135g148g149g3g145g136g3electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the g134g139g136g136g135g148g135g144g150g3g150

48、g155g146g135g149g3g145g136g3g12g22g18g3g134g145g133g151g143g135g144g150g149g3g149g138g145g151g142g134g3g132g135g3g144g145g150g135g134g484g3g23g138g139g149g3g134g145g133g151g143g135g144g150g3g153g131g149g3g134g148g131g136g150g135g134g3g139g144g3g131g133g133g145g148g134g131g144g133g135g3g153g139g150g1

49、38g3g150g138g135g3editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).g4g150g150g135g144g150g139g145g144g3g139g149g3g134g148g131g153g144g3g150g145g3g150g138g135g3g146g145g149g149g139g132g139g142g139g150g155g3g150g138g131g150g3g149g145g143g135g3g145g136g3g150g138g135g3g135g142g135g143g135g144g150g149g3g145g136g3g150g138g139g149g3g134g145g133g151g143g135g144g150g3g