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I N TERNATIONAL S TANDARD

ISO 17034 First editio n 2 0 1 6- 1 1 - 0 1

General requirements for the competence of reference material producers Exigences générales pour la compétence des producteurs de matériaux de référence

Reference numb er I SO 1 7 0 3 4: 2 0 1 6(E )

I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n

©

I SO 2 0 1 6

ISO 17034:2016(E)

COPYRIGHT PROTECTED DOCUMENT © I SO 2 0 1 6, Published in Switzerland

All rights reserved. Unless otherwise specified, no part o f this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country o f the reques ter.

ISO copyright o ffice Ch. de B lando nnet 8 • C P 40 1 CH -1 2 1 4 Vernier, Geneva, Switzerland Tel. + 41 2 2 749 0 1 1 1 Fax + 41 2 2 7 49 0 9 47

[email protected] www.iso. o rg

ii

I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n

ISO 17034:2016(E)

Contents

Page

Foreword Introduction 1 Scope 2 Normative references

v vi 1 1 1 3

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3

Terms and definitions . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . .

4

General requirements 4.1

5 6

7

4.2 Impartiality 4.3 Confidentiality Structural requirements Resource requirements

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3

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4 5

6.1

Personnel . . . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . 5

6.2

Subcontracting . . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . 5

6.3

Provision of equipment, services and supp lies . .. . . . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . 6

6.4

Facilities and environmental conditions . . . . .. . . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . 7

Technical and production requirements

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7

7 .1

General requirements . . .. . . . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . .. . . 7

7 .2

Production planning . . . . . . .. . . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . 7

7 .3

Production control .. . . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . 8

7 .4

M aterial handling and storage . . . . . .. . . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . . 8

7 .5

M aterial processing . . . . . . . .. .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . .. . . . 9

7 .6

M easurement p rocedures . . . . . .. . . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. 9

7 .7

M easuring equipment . . .. . . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . . 1 0

7.8 7.9 7.10 7.11

Data integrity and evaluation Metrological traceability o f certified values Assessment o f homogeneity Assessment and monitoring o f stability

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10

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10

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11

7 .1 2

C haracterization . . . . .. . . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. 1 2

7 .1 4

RM documents and labels . . . . .. . . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . 1 4

7 .1 5

D istrib ution service . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . . 1 5

7 .1 7

M anagement of non-conforming work . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . 1 6

7 .1 8

C omplaints . . . . . . .. . . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . 1 7

7.13 7.16

8

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C ontractual matters . . . . . . .. . . . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . 3

Assignment o f property values and their uncertainties Control o f quality and technical records

Management system requirements 8 .1

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13

16

18

O ptions . . . . .. . . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . 1 8 8. 1 . 1

General . . . . . . .. . . . . . . . . .. .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . 1 8

8. 1 . 2

O ption A . . . .. . . . . . . . . .. . . . . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . 1 8

8. 1 . 3

O ption B . . . .. . . . . . . . . .. . . . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . 1 8

8.2 8.3 8.4

Quality policy (Option A) General management system documentation (Option A) Control o f management system documents (Option A)

8 .5

C ontrol of records (O ption A) . . . . . . . .. .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . 1 9

8 .6

M anagement review (O p tion A) . . .. . . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . 2 0

8 .7

I nternal audit (O ption A) . . . . . . .. . . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . 2 0

8 .8

Actions to address risks and op portunities (O p tion A) . . . .. . . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . 2 1

8 .9

C orrective actions (O ption A) . . . . . . . .. .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . 2 1

18

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19

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19

8. 9 . 1

General . . . . . . .. . . . . . . . . .. .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . 2 1

8. 9 . 3

Selection and implementation of corrective actions . .. . . . . . . . . .. . . . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . 2 1

8. 9 . 4

M onitoring of corrective actions . . .. . . . . . . . . .. . . . . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. 2 2

8.9.2

Cause analysis

© I SO 2 0 1 6 – All rights reserved

I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n

. . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . .

. . . . . . . . . .. . . . . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . ..

21

iii

ISO 17034:2016(E)

8 .9 .5

Additional audits . . .. . . . . . . . . .. . . . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . 2 2

8 .1 0

I mp rovement (O ption A) . . . . .. . . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. 2 2

8 .1 1

Feedb ack from customers (O ption A) . . . . . . . .. .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . 2 2

Annex A (informative) Summary of production requirements for RMs and CRMs . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . 23 Bibliography . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. 24

iv

I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n

ISO 17034:2016(E)

Foreword I S O (the I nternational O rgani zation for Standardi zation) is a worldwide federation of national s tandards

bodies (ISO member bodies). The work o f preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has b een es tabli shed has the right to b e represented on that committee. I nternational organi z ations , governmental and non- governmental, in l iaison with I SO, al so take p ar t in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters o f elec trotechnical s tandardiz ation . T he pro cedures us ed to develop this do cument and those intended for its fur ther maintenance are describ ed in the I SO/I EC D irec tives , Par t 1 . I n p ar ticu lar the di fferent approval criteria needed for the

di fferent types o f ISO documents should be noted. This document was dra fted in accordance with the editorial rules of the I SO/I EC D irec tives , Par t 2 (see www. iso . org/direc tives) .

Attention is drawn to the possibility that some o f the elements o f this document may be the subject o f patent rights. ISO shall not be held responsible for identi fying any or all such patent rights. Details o f any patent rights identified during the development o f the document will be in the Introduction and/or on the I SO l is t of p atent declarations received (see www. iso . org/p atents) .

Any trade name used in this document is in formation given for the convenience o f users and does not cons titute an endorsement.

For an explanation on the meaning o f ISO specific terms and expressions related to con formity assessment, as well as information about I SO ’s adherence to the World Trade O rganization ( WTO) principles in the Technical B arriers to Trade (TB T ) see the following URL: www.iso.org/iso/foreword. html.

ISO 17034 was prepared by the ISO Committee on Con formity A ssessm ent (C ASCO) , in col lab oration with the ISO Committee on Referen ce Materials (RE MCO) .

This first edition o f ISO 17034 cancels and replaces ISO Guide 34:2009, which has been technically revised.

The following major changes have been made compared with ISO Guide 34:2009: — inclusion o f requirements for production o f all types o f re ference materials, and additional specified requirements for certified re ference materials; — harmonization with the revisions o f ISO Guide 31 and ISO Guide 35; — inclusion o f more details on required re ference material documentation; — inclusion o f risks and opportunities; — restructuring based on the common structure adopted by other International Standards on con formity assessment developed by CASCO; — incorporation o f modifications based on ISO/CASCO PROC 33.

© I SO 2 0 1 6 – All rights reserved

I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n

v

ISO 17034:2016(E)

Introduction Reference material s (RM s) are used in al l s tages of the meas urement pro ces s , including for metho d va l idation,

c a l ibration

me tho d va l idation and

and

for

qua l ity control .

T hey are

also

used

in

i nterlab orator y comp a ri s on s

for

as s e s s i ng lab orator y pro ficienc y.

T he demon s tration o f the s cienti fic and te ch n ic a l comp e tence o f re ference materia l pro ducers (RM Ps) i s a b a s ic re qui rement

for

en s uri ng the qua l ity o f RM s . T he demand

for

new RM s o f h igher qua l ity

is increas ing as a consequence of b oth the improved precis ion of meas uring equipment and the re qu i rement

for

on ly ne ce s s ar y

more acc u rate and rel iable data i n the s c ienti fic and te ch nolo gic a l d i s cipl i ne s . I t i s no t

for

RM Ps to provide i n formation ab out thei r materi a l s i n the

form

o f RM do c uments , but

a l s o to demon s trate thei r comp e tence i n pro duci ng RM s o f appropri ate qua l ity.

T his I nternational Standard outlines the general requirements for the producers of RM s , including cer ti fie d re ference materia l s (C RM s) . I t s up ers e de s I S O Guide 3 4: 2 0 0 9 a nd i s a l igne d with the releva nt re qu i rements

o f I S O/I E C

170 2 5 .

Fur ther

guidance

(e . g.

content o f cer ti fic ate s

and

i s provide d i n I S O Guide 3 1

a nd

concern i ng

the de s ign o f cha rac teri z ation, homo geneity a nd s tabi l ity s tud ie s)

the

I S O Guide 3 5 . Whi le the appro aches outl ined in I SO Guide 3 1 and I SO Guide 3 5 meet the relevant re qu i rements o f th i s I nternationa l Standa rd, there m ight b e a lternative ways to ach ieve compl i ance to

thi s I nternational Standard. RM Ps that comply with th i s I nternationa l Stand ard wi l l a l s o op erate genera l ly i n accordance with the pri ncip le s o f I S O 9 0 01 . For te s ts p er forme d i n the me d ic a l field , I S O 1 51 8 9 c an b e u s e d a s the re ference

ins tead of I SO/I EC 1702 5 . I n th i s I nternationa l Standa rd, the term “cer ti fic ation” re fers to the cer ti fic ation o f RM s .

I n this I nternational Standard, the fol lowing verb al forms are used: —

“s ha l l” i nd ic ate s a re qui rement;

—

“s hou ld” i nd ic ate s a re com mendation;

—

“may” i nd ic ate s a p erm i s s ion;

—

“c an” i nd ic ate s a p o s s ibi l ity or a c ap abi l ity.

Fur ther detai l s can b e found in the I S O/I E C D irec tives , Par t 2 . For the purp os es of research, users are encouraged to share their views on thi s document and their prioritie s

for

ch ange s to

futu re

e d ition s . C l ick on the l i n k b elow to ta ke p a r t i n the on l i ne s u r vey:

http s: //w w w. s ur veymon key. com/r/C D Z Z W YH

vi

I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n

INTERNATIONAL STANDARD

ISO 17034:2016(E)

General requirements for the competence of reference material producers 1 Scope This

I nternationa l

Sta nda rd

s p e ci fie s

genera l

for

re qu i rements

the

comp e tence

and

con s i s tent

op eration of reference material producers . T his I nternational Standard s ets out the requirements in accordance with which reference material s are pro duce d . I t i s i ntende d to b e u s e d a s p ar t o f the genera l qua l ity a s s urance pro ce du re s o f the

reference material pro ducer. This

I nternationa l

Standard

covers

the

pro duc tion

of all

re ference

materia l s ,

i nclud i ng

cer ti fie d

reference material s .

NO TE

Re ference

m ateri a l

p ro ducers ,

re g u l ato r y

author itie s ,

o rga n i z atio n s

a nd

s cheme s

u s i ng

p e er

a s s e s s ment, acc re d itation b o d ie s a nd o thers c a n a l s o u s e th i s I nter n ation a l S ta nda rd i n co n fi r m i n g or re co gn i z i ng

the comp etence of reference materia l pro ducers .

2 Normative references T he

fol lowi ng

i nd i s p en s able

do c u ments , i n whole or i n p ar t, are normatively re ference d i n th i s do c u ment a nd are

for

its

appl ic ation .

For date d re ference s ,

on ly the

e d ition

cite d appl ie s .

For u ndate d

re ference s , the late s t e d ition o f the re ference d do c u ment (i nclud i ng any amend ments) appl ie s .

I S O/I E C 1702 5 , Gen eral requirem ents for th e com peten ce of testin g an d calibration laboratories

3 Terms and definitions For the pu r p o s e s o f th i s do c u ment, the term s and defi n ition s given i n I S O/I E C 170 0 0 , I S O Gu ide 3 0 , I S O/I E C Gu ide 9 9, I S O 9 0 0 0 and the

fol lowi ng

apply.

1)

I S O and I E C maintain term inological datab ases for use in s tandardiz ation at the fol lowing addres ses: —

I SO O nl ine brows ing platform: avai lable at http://www. iso . org/obp

—

I EC E lec trop edia: avai lable at http://www. elec trop edia. org/

3.1 reference material producer RMP b o dy (orga n i z ation or comp any, publ ic or private) th at i s

fu l ly

re s p on s ible

for

proj e c t pl an n i ng a nd

management; as s ign ment o f, a nd de ci s ion on prop er ty va lue s and relevant u ncer ta i ntie s; authori z ation o f prop er ty va lue s; and i s s ua nce o f a re ference materi a l cer ti fic ate or o ther s tatements

for the

re ference

material s it pro duces [S OURC E: I SO Guide 3 0 : 2 01 5 , 2 . 3 . 5 ]

1)

The definitio ns in I S O Guide 3 0 take p recedence where mo re than o ne definitio n

fo r

the s ame term related to

reference materials exist.

© I SO 2 0 1 6 – All rights reserved

I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n

1

ISO 17034:2016(E)

3.2 c

e

r

t

i

f i

e

d



r

e

CRM re ference

f

e

r

e

n

c

e

materi a l



m

a

t

e

r

i

a

l

charac teri z e d

by

a

me trolo gic a l ly

va l id

pro ce dure

for

one

or

more

s p e c i fie d

prop er tie s , accomp a nie d b y a re ference materi a l cer ti fic ate that provide s the va lue o f the s p e c i fie d prop er ty, its a s s o ci ate d u ncer tai nty, a nd a s tatement o f me trolo gic a l trace abi l ity N o te 1 to entr y: T he concep t o f va lue i nclude s a nom i n a l prop er ty o r a qu a l itative attr ibute s uch a s identity or s e quence . Uncer ta i ntie s

for

s uch attr ib ute s m ay b e e xp re s s e d a s p rob ab i l itie s o r le vel s o f co n fidence .

N o te 2 to entr y: M e tro lo gic a l l y va l id pro ce du re s

for

the p ro duc tion a nd cer ti fic atio n o f re ference m ater i a l s a re

given in, among o thers , I S O Guide 3 5 . N o te 3 to entr y: I S O Gu ide 3 1 give s g u id a nce o n the contents o f re ference m ateri a l cer ti fic ate s .

N o te 4 to entr y: I S O/ I E C Gu ide 9 9 : 2 0 0 7 h a s a n a n a lo gou s de fi n ition .

[S O U RC E : I S O Gu ide 3 0 : 2 01 5 , 2 .1 . 2 , mo d i fie d — Re ference to I S O Guide 3 4 ha s b e en remove d

from

No te

2 to entr y]

3.3 reference material RM materia l, s u fficiently homo gene ou s and s table with re s p e c t to one or more s p e c i fie d prop er tie s , wh ich has b e en e s tabl i s he d to b e fit

for

its i ntende d u s e i n a me a s u rement pro ce s s

N o te 1 to entr y: Re ference m ater i a l i s a gener ic ter m .

N o te 2 to entr y: P ro p er tie s c a n b e qu a ntitati ve o r qu a l itative , e . g. identity o f s ub s ta nce s o r s p e c ie s .

N o te 3

to entr y:

Us e s m ay i nclude the c a l ib ration o f a me a s u rement s ys tem , a s s e s s ment o f a me a s u rement

pro ce du re , a s s i gn i n g va lue s to o ther m ater i a l s , a nd qu a l ity co ntrol .

N o te 4 to entr y: I S O/I E C Gu ide 9 9 : 2 0 0 7 h a s a n a n a lo go u s de fi n itio n , b ut re s tr ic ts the ter m “me a s u rement” to app l y to qu a ntitati ve va lue s . H owever, N o te 3 o f the de fi n ition i n I S O/I E C Gu ide 9 9 : 2 0 0 7 s p e c i fic a l l y i nclude s qu a l itative prop er tie s , c a l le d “no m i n a l p rop er tie s ”.

[S O U RC E : I S O Gu ide 3 0 : 2 01 5 , 2 .1 .1 , mo d i fie d — S e cond s entence o f No te 4 to entr y ha s b e en mo d i fie d .]

3.4 c

e

r

t

i

f i

e

d



v

a

l

u

e

va lue, a s s igne d to a prop er ty o f a re ference materi a l that i s accomp a n ie d b y an uncer ta i nty s tatement and a s tatement o f me trolo gic a l trace abi l ity, identi fie d a s s uch i n the re ference materia l cer ti fic ate

[SOURC E: I SO Guide 3 0 : 2 01 5 , 2 . 2 . 3 ]

3.5 impartiality pre s ence o f obj e c tivity N o te 1 to entr y: O b j e c tivity me a n s th at con fl ic ts o f i ntere s t do no t e xi s t, o r a re re s ol ve d s o a s no t to advers el y i n fluence the ac tivitie s o f the re ference m ater ia l p ro ducer.

No te 2 to entr y: O ther ter m s th at a re u s e fu l i n conve yi n g the element o f i mp a r ti a l ity i nclude “i ndep endence”, “ fre e do m

from

con fl ic t o f i ntere s ts ”, “ fre e dom

fro m

b ia s ”, “l ack o f p rej ud ice”, “neutra l ity”, “ fa i r ne s s ”, “op en-

m i nde d ne s s ”, “e ven-h a nde d ne s s ”, “de tach ment”, “ b a l a nce”.

[S O U RC E :

I S O/I E C 1702 1-1 : 2 01 5 , 3 . 2 , mo d i fie d — I n No te 1

replace d by “re ference materi a l pro ducer ”.]

2

I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n

to entr y, “cer ti fic ation b o dy” h as b e en

ISO 17034:2016(E) 3.6 reference material document RM document document containing all the in formation that is essential for using any re ference material Note 1 to entry: The re ference material document covers both the product in formation sheet and re ference material certificate.

[SOURCE: ISO Guide 31:2015, 3.5, modified — The second pre ferred term “re ference material document” has b een added.]

3.7 measurand that is defined by re ference to a documented and widely accepted measurement procedure to which only results obtained by the same procedure can be compared o

p

e

r

a

t

i

o

n

a

l

l

y

d

e

f i

n

e

d



m

e

a

s

u

r

a

n

d

Note 1 to entry: Examples include crude fibre in foods, impact toughness, enzyme activities and extractable lead i n s oi l s .

4 General requirements 4.1 Contractual matters 4.1.1 Any request, tender or contract concerning the production o f an RM shall be reviewed, following documented policies and procedures established by the RMP, to ensure that: a) the requirements for RMs and their production are adequately defined, documented and understood; b) the RMP has the capability and resources to meet the requirements. NOTE 1 Capability means that the RMP has access to, for example, the necessary equipment, knowledge and in formation resources and that its personnel have the skills and expertise necessary for the production o f those RMs in question. The review o f capability can include an assessment o f previous RM production and/or the organization o f interlaboratory characterization programmes using samples o f similar composition to the RMs to b e pro duce d .

NOTE 2

A contract can be any written or verbal agreement.

NOTE 3

A request to prepare a specific RM can originate from the RMP.

4.1.2 The review shall include any work that needs to be subcontracted by the RMP. 4.1.3 The RMP shall maintain records o f these reviews, including any changes, records o f pertinent discussions with the customer relating to the customer’s requirements, and subcontracted work.

4.2 Impartiality 4.2.1 The RMP shall be structured and managed so as to safeguard impartiality. NOTE Impartiality implies that decisions are based on objective criteria and not on the basis o f bias, prejudice, or pre ferring the benefit o f one person over another for improper reasons.

4.2.2

The RM P shall:

a) have arrangements to ensure that its management and personnel are free from any undue internal and external commercial, financial and other pressures and influences that may adversely a ffect the quality o f their work; © I SO 2 0 1 6 – All rights reserved

I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n

3

ISO 17034:2016(E)

b) identi fy risks to its impartiality on an on-going basis, which shall include those risks that arise from its activities, or from its relationships, or from the relationships o f its personnel; however, such relationships do not necessarily present an RMP with a risk to impartiality; c) be able to demonstrate, i f a risk to impartiality is identified, how it eliminates or minimizes such risk; d) have top management commitment to impartiality. NOTE A relationship that threatens the impartiality o f the RMP can be based on ownership, governance, management, personnel, shared resources, finances or contracts for purposes other than the sale or

production of RMs.

4.3 Confidentiality 4.3.1

The RMP shall be responsible for and shall treat in an appropriate manner all information

obtained, including confidential information. Where information is received from another individual or body, such information shall be regarded as confidential unless the individual or body concerned places

the information in the public domain or agrees to its disclosure to others.

When the RMP is required by law or authorized by contractual arrangements to release confidential information, the individual or the body concerned shall, unless prohibited by law, be notified 4.3.2

of the information provided.

5 5.1

Structural requirements

The RMP shall be a legal entity, or a defined part o f a legal entity, that can be held responsible for all

its activities related to the production of RMs.

The RMP shall be organized and shall operate in such a way that it meets all the applicable requirements o f this International Standard, whether carrying out work at its permanent facilities or at other sites (including associated temporary or mobile facilities). 5.2

5.3

The RMP shall:

a) have a description o f its legal status, define the organizational and management structure o f the RMP, its place in any parent organization and the relations between management, technical operations, support services and subcontractors; b) define the parts o f the organization covered by the management system for the production o f RMs; c) speci fy the responsibility, authority and interrelationships o f all personnel who manage, per form or veri fy work a ffecting the quality o f RMs produced; d) have managerial personnel, supported by technical personnel, with the authority and resources needed to discharge their duties and to identi fy the occurrence o f departures from the management system or the procedures for the production o f RMs and to initiate actions to prevent or minimize such departures; e) have technical management with overall responsibility for the technical operations and the provision o f the resources needed to ensure the required quality o f each operation which forms part o f the RM production; f)

appoint personnel (however named) who, irrespective of other duties and responsibilities, shall

have defined responsibility and authority for ensuring that the requirements o f this International

Standard are implemented and followed at all times – these appointed personnel shall have direct

access to the highest level o f management at which decisions are taken on RM production policy or resources; 4

I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n

ISO 17034:2016(E)

g)

have adequate provis ion (e. g. ins urance or reser ves) to cover liabi l ities aris ing from its ac tivities .

5.4

The RM P management shall ensure that:

a)

i nterna l and e xterna l com mu n ic ation me ch an i s m s are e s tabl i s he d;

b)

com mun ic ation ta ke s pl ace regard i ng the e ffe c tivene s s o f the ma nagement s ys tem;

c)

the

imp or tance

of meeting

cus tomer

and

other

requirements

is

com municated

to

the

RM P

p ersonnel .

6 Resource requirements 6.1

Personnel

6.1.1

The RM P shall ensure that all p ersonnel involved in RM p roduction are supervised and comp etent

and that they wo rk in acco rdance with the RM P’ s management sys tem.

6.1.2

Personnel, including sub contractors, personnel of external b odies, or other individuals acting

o n the RM P’ s b ehal f, s hall co mp ly with the p o licies and p ro cedures

fo r

management o f co nfidential

in fo rmatio n that are s et by the RM P.

6.1.3

The

RM P

shall

ensure

the

competence

of all

personnel,

including

technical

management

p ers o nnel, o p erating under its management sys tem who undertake activities relating to the p ro ductio n o f each

p articular typ e

o f RM .

There

s hall

be

s u fficient p ers o nnel

having the

neces s ary educatio n,

training, technical knowledge and experience for their assigned functions.

6.1.4

The RM P s hall have p ro cedures

fo r identi fying training needs

and p roviding training o f p ers o nnel.

The training p rogramme shall be relevant to the p resent and anticipated tasks of the RM P.

6.1.5

The RM P s hall maintain reco rds o f j o b des crip tio ns

fo r

its p ers o nnel invo lved in RM p ro ductio n

activities.

6.1.6

The

RM P

shall

authorize

competent personnel

to

p erform

p articular

activities

relating

to

RM production. The RM P shall maintain records of the authorizations, comp etence, educational and p ro fes s io nal qualificatio ns o f tho s e p ers o nnel. Thes e reco rds s hall p rovide evidence that individuals have b een adequately trained and that their co mp etence to p er fo rm p articular activities in the RM p ro ductio n has b een as s es s ed. This in fo rmatio n s hall b e readily availab le and s hall include the date o n which the autho rizatio n and/o r co mp etence has b een co nfirmed.

6.2

Subcontracting

6.2.1

Where an RM P uses subcontractors to undertake p art of the production, including samp ling,

p ro ces s ing,

handling,

ho mo geneity and

s tab ility tes ting,

characterizatio n,

s to rage

or

dis trib utio n

of

an RM , the RM P shall have procedures to ensure that the subcontractors’ exp erience and technical co mp etence are s u fficient

fo r

their as s igned tas ks and that they co mp ly with the relevant claus es o f this

I nternational Standard and other appropriate standards.

NO TE 1

I t i s p o s s ib le th at a n RM P do e s no t h ave its own l ab orator y

fac i l itie s

o r p ro ce s s i ng

fac i l itie s ,

o r it c a n

cho o s e no t to us e its own faci l ities .

NO TE 2

6.2.2

Sub contrac tors c an b e p aid or unp aid .

The

RM P

s hall

s elect s ub co ntracto rs

o n the

b as is

o f their ab ility to

meet the

requirements

s tip ulated by the RM P.

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ISO 17034:2016(E)

6.2.3

RM Ps shall not sub contract the following p rocesses:

—

the pro duc tion pl an n i ng;

—

the s ele c tion o f s ub contrac tors;

—

the as s ign ment o f prop er ty va lue s and thei r u ncer tai ntie s;

—

the authori z ation o f prop er ty va lue s a nd thei r uncer ta i ntie s;

—

the authori z ation of RM do cuments .

6.2.4

The

RM P

s hall

es tab lis h

and

maintain

p ro cedures

to

as s es s

that

all

tas ks

p er fo rmed

by

s ub co ntracto rs co mp ly with the requirements s et by the RM P and with any relevant claus es o f this

I nternational Standard.

6.2.5

Evidence of the subcontractor’s competence shall b e established and maintained, including

reco rds o f evaluatio ns and any audits made o f their cap ab ility to carry o ut co ntracted tas ks .

NO T E

E xamples of evidence are as s es s ments of ta sks p erformed for the RM P i n the p a s t, evidence of

s ucce s s fu l p a r tic ip atio n i n rele va nt p ro fic ienc y te s ti n g , con fo r m ity a s s e s s ment cer ti fic ate s rele va nt

fo r

the ta s k

contrac ted and accep table res u lts on wel l- charac teri ze d materia ls of s i m i lar or equ iva lent nature to that of the cand idate RM .

6.2.6

Where the co mp etence o f s ub co ntracto rs canno t b e as certained via p rovis io n o f do cumentary

evidence, the RM P shall evaluate the comp etence of the subcontractor or sup ervise the operations carried o ut by the s ub co ntracto r.

6.2.7

The RM P s hall ens ure that res ults and the des crip tio ns o f p ro cedures us ed by s ub co ntracto rs are

availab le to allow the technical evaluation of data.

6.2.8

When

management

working sys tem

with

subcontractors,

having

s u fficient

the

RM P

kno wledge

of

shall the

have

personnel

s ub co ntracto r’ s

op erating

tas k

to

under

evaluate

its the

s ub co ntracto r’ s activity.

NO TE

Fo r

te s ti ng

ac tivitie s ,

th i s

i nclude s

knowle dge

of

the

ta s k

i nvol ve d

a nd

fa m i l ia r ity

with

th i s

I nternationa l Standard and I S O/I E C 1702 5 for c a libration and tes ti ng.

6.3

Provision of equipment, services and supplies

6.3.1

The RM P shall have p rocedures in place for the selection of equipment, services and supp lies

that a ffect the quality o f the RM s p ro duced.

6.3.2

The RM P s hall us e o nly equip ment, s ervices and s up p lies that co mp ly with s p ecified requirements

to ens ure the quality o f the RM s it p ro duces .

6.3.3

The RM P s hall ens ure that equip ment and co ns umab le materials are no t us ed until they have

b een ins p ected, calib rated o r o therwis e verified as co mp lying with the s p ecificatio ns o r requirements defined

fo r

6.3.4

The RM P shall maintain records of purchases of equip ment, services and sup plies, including

the RM p ro ductio n activities .

reco rds o f the s electio n criteria us ed, co nfirmatio n o f accep tance, and any co mmis s io ning data.

NO T E

6 . 3 applies to a l l equipment i nclud ing materia l pro ces s i ng and me as uri ng e quipment. 7.7 i ncludes

more provi s ion s on op eration of me as uri ng equipment.

6

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ISO 17034:2016(E) 6.4 Facilities and environmental conditions 6.4.1 The RMP shall ensure that all laboratory facilities, calibration and testing areas (i f applicable), material handling, storage, processing and packaging areas, energy sources, lighting, humidity, temperature, processing

pressure

and

and

packaging,

ventilation

are

as

proper

well

as

such

as

to

facilitate

performance

p rop er material

of calibration

and

handling,

storage,

testing activities

(if

ap plicable) .

6.4.2 When the environmental conditions could have an adverse effect on the RM , the environmental conditions in which the RM production activities are undertaken shall be monitored with appropriately calibrated equipment, and shall b e controlled and recorded, such that results and processes are not

adversely affected.

6.4.3 All RM processing and calibration and testing areas, in addition to satis fying requirements for humidity and temperature, shall be protected, where appropriate, from other environmental factors such as incompatib le activities, vibration, aerosols, airborne dust and microbiological contamination,

magnetic fields, light and electromagnetic and/or ionising radiation.

6.4.4 Access to and use o f areas shall be controlled as appropriate to maintain the quality o f the RMs.

7 Technical and production requirements 7.1 General requirements T he RM P shal l addres s the requirements in this clause for the produc tion of RM s , including C RM s .

NOTE 1

A CRM has at least one certified value.

NO TE 2

7.9

NO T E 3 An nex A

applies only to certified values.

7. 2 to 7.1 8 contain requirements for certified values and other property values where necessary. is a summary o f production requirements for RMs and CRMs.

7.2 Production planning 7.2.1 The RMP shall identi fy and plan those processes that directly affect the quality o f RM production, and the production plan shall be documented.

NOTE A mechanism (e.g. a management/technical advisory group) can be established to make recommendations on part or all o f the production processes, for example, assigning the property values o f i nteres t.

7.2.2 Technical input o f subcontractors involved shall be specified and the required information documented and regularly reviewed. 7.2.3

The RM P shall address, during the p lanning stage, the following:

a) material selection (including, where appropriate, sampling); b) verification o f the identity o f the material; c)

maintaining s uitable environments for al l as p ec ts of pro duc tion (s ee 6 .4

d)

material pro ces s ing (see 7. 5

e)

choice of meas urement pro cedures (see 7. 6

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); ,);

7

ISO 17034:2016(E)

f)

validation of meas urement pro cedures (see 7. 6 ) ;

g)

veri fic ation and c a l ibration o f me a s uri ng e qu ipment (s e e 7.7 ) ;

h)

s peci fication o f acceptance criteria

i)

s p e c i fic ation

o f accep tance

for,

c riteri a

and as ses s ment o f, homogeneity, including s ampling (see 7.10 ) ;

for,

a nd

as s e s s ment and

mon itori ng o f,

s tabi l ity,

i nclud i ng

s ampling (see 7.11 ) ; j)

de s ign i ng and organ i z i ng appropriate charac teri z ation, i nclud i ng s a mpl i ng (s e e 7.1 2 ) ;

k)

as s e s s i ng com mutabi l ity (where appropriate) ;

NO TE

Gu ida nce o n the ne e d

for

co m mutab i l ity a s s e s s ment o f RM s i s given i n a RE M C O p o s ition p ap er [1 5 ] .

l)

a s s ign i ng prop er ty va lue s (s e e 7.1 3 ) ;

m)

e s tabl i sh i ng uncer ta i nty budge ts a nd e s ti mati ng u ncer tai ntie s o f cer ti fie d va lue(s) (s e e 7.1 3 ) ;

n)

defi n i ng accep tance c riteria

o)

e s tabl i sh i ng me trolo gic a l trace abi l ity o f me as u rement re s u lt(s) and cer ti fie d va lue(s) (s e e 7.9 ) ;

p)

is s uing RM do cuments (see 7.14) ;

q)

ens uring adequate s torage facil ities and conditions (see 7.4) ;

r)

ens uring appropriate lab el l ing and p ackaging of the RM s (see 7.14) ;

s)

ens uring appropriate trans p or t arrangements (see 7.1 5 ) ;

t)

en s u ri ng p o s t-pro duc tion s tabi l ity mon itori ng , i f appl ic able (s e e 7.11 ) ;

u)

ens uring an adequate p os t- dis tribution ser vice for RM users (see 7.1 5 ) .

7.2.4

for

me as u rand level s a nd thei r u ncer tai ntie s;

Where multip le b atches o f RM s with equivalent p ro p erties are p ro duced by us ing s imilar s tarting

materials and by ap p lying the s ame p ro cedures , verificatio n s hall ens ure that in fo rmatio n o b tained

fro m

previous batches remains applicab le for the new batch (see 7 .2 .3 ) .

NO T E 1

Mu ltiple b atches c an b e b atches of the s ame material pro duced at the s ame ti me, or c an b e s ucces s ive

b atche s o f m ateri a l p ro duce d at s ub s ta nti a l l y d i fferent ti me s .

NO T E 2

Fur ther guidance for mu ltiple b atch pro duc tion s i s given i n I S O Guide 3 5 .

NO TE 3

W here mu ltip le b atche s a re p ro duce d , s o me te s ts c a n b e om itte d o r s i mp l i fie d

fo r

s ome b atche s (s e e

7.10 . 2 and 7.1 1 . 3 ) .

7.3

Production control

T he RM P s ha l l veri fy that the pro duc tion pl an h as b e en i mplemente d a s s p e ci fie d, and devi ation s

from

the plan shal l b e do cumented and approved.

7.4 Material handling and storage 7.4.1

The

RM P

s hall

make

arrangements

to

ens ure

the

integrity

o f its

candidate

RM s

and

RM s

thro ugho ut the p ro ductio n p ro ces s . Precautio ns s hall b e taken agains t advers e enviro nmental influences

(see 6.4) and possib le contamination of the candidate RM during its p rocessing.

8

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ISO 17034:2016(E)

NO TE

Fo r e xa mp le ,

the

p ackagi ng o f a cement m ater i a l re qu i re s

co nd ition s

o f low hu m id ity,

wh i le the

pro ces s ing and charac teri z ation of a materia l i n wh ich the content of traces of lead i s to b e me as ure d re qui res clea n ro om cond ition s to prevent contam i nation from dus t contai ni ng le ad . C le an ro om cond ition s c an a ls o b e re qu i re d

for

o ther typ e s o f trace a n a l ys i s . P rop er cho ice o f conta i ner m ater i a l a nd ade qu ate cle a n i ng p ro ce du re s

are a ls o i mp or tant to avoid contam i nation .

7.4.2

The RM P s hall identi fy, p res erve and s ep arate candidate RM s and RM s

fro m

chemicals and o ther

samples, from the time of processing through to their distribution to users. I t c a n b e u s e fu l to u n iquel y identi fy e ach u n it o f a (c a nd id ate) RM i n o rder to

NO TE

fac i l itate

s ub s e quent

s a mp l i ng , trend a n a l ys i s , d i s trib utio n s er vice s or co mp l a i nts i nve s tigation .

7.4.3

The RM P shall ensure adequate packaging of all RM s (e.g. where app rop riate, use light-shielding,

air-free, moisture-free or inert-gas p ackaging) and provide secure storage areas/stock rooms which p revent damage o r deterio ratio n o f any item o r material b etween characterizatio n and dis trib utio n.

7.4.4

The condition of all RM s shall b e assessed at appropriate intervals throughout the storage period,

in order to detect p ossible deterioration.

7.4.5

The

RM P

s hall

co ntro l

p ackaging and lab elling p ro ces s es

co n fo rmity with s a fety and trans p o rt requirements . Pro cedures

fo r

to

the

extent neces s ary to

ens ure

trans p o rt to the cus to mer s hall b e

defined.

7.4.6

The RM P s hall take meas ures to ens ure that the integrity o f each individual RM unit is maintained

until the s eal, i f any, has b een b ro ken o r up to the p o int when firs t us ed.

7.5

Material processing

7.5.1

The

RM P

shall

establish

procedures

to

ensure

that the

material

has

undergone

adequate

processing for its intended use. Procedures for material p rocessing shall address at least the following:

a)

b)

qua l itative a na lys i s

for

veri fic ation o f materia l typ e and/or identity;

s ynthe s i s , pu ri fic ation (e . g. d i s ti l lation, extrac tion) , i nc ub ation, a nd tra n s formation i nto the fi na l

form

(e . g. mach i n i ng , gri nd i ng , blend i ng , s ievi ng a nd ri ffl i ng , e xtru s ion, melti ng) ;

c)

homo gen i z ation;

d)

prop er handling (e. g. protec tion from contamination and use of iner t equipment) (see 7.4) ;

e)

me as u rements

f)

pre -tre atment, cle an i ng or s teri l i z ation o f pro ce s s i ng e qu ipment and s ample contai ners;

g)

s tabi l i z ation o f materi a l (e . g. d r yi ng , i rrad iation, s teri l i z ation) ;

h)

p ackagi ng (e . g. b o ttl i ng , amp ou l i ng) o f the materia l;

i)

s a fe ty pre c aution s .

7.5.2

for

control o f materi a l pro ce s s i ng (e . g. p ar ticle s i ze d i s tribution, moi s ture content) ;

Equip ment used in material

processing shall

be

operated in accordance with documented

procedures.

NO TE

M anu fac turer ’s i ns tr uc tions are one form of do c umente d pro ce dure .

7.6 Measurement procedures T he RM P shal l ens ure that the relevant requirements of I SO/I EC 1702 5

are met with res p ec t to

calibration and tes ting. T hese ac tivities shal l, where appropriate, b e cons is tent with the required

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ISO 17034:2016(E)

accuracy o f the property values o f the RM, and with any standard specifications relevant to the meas urement concerned.

7.7

Measuring equipment

T he RM P shal l ens ure that meas uring equipment used in RM produc tion is used in compliance with the relevant requirements of I SO/I E C 1702 5 .

NOTE

Additional in formation on the management o f measurement systems, including in formation on

equ ipment that i s fou nd to dri ft outs ide accep table li m its , ca n b e found i n I S O 10 01 2 .

7.8 Data integrity and evaluation 7.8.1

The RMP shall ensure that all calculations and data trans fers are subject to appropriate checks.

7.8.2

The RM P shall ensure that:

a) computer so ftware developed in-house or o ff-the-shel f so ftware further developed for specific use is validated and shown to be adequate for use; NO T E

E xamples of s oftware va l idation c an b e a computer-b as ed s pre ad she et ca lc u lation that i s checke d

by manual calculation or using test data sets with known solutions.

b) procedures are established and implemented for protecting the integrity o f data; such procedures shall include, but are not limited to, integrity o f data entry and capture, data storage, data transmission and data processing; c)

equipment and software are maintained to ens ure prop er func tioning and are provided with the

environmental and operating conditions necessary to maintain data integrity;

d) appropriate procedures are established and implemented for the maintenance o f data security, including prevention of unauthori zed acces s and changes to records , including computer records .

7.8.3

Statistical procedures used in monitoring, testing, calibration or value assignment of RM s shall

be app rop riate for their app lication.

NOTE 1

Validation o f statistical procedures can include evidence o f a sound theoretical basis (usually by

reference to appropriate l iterature) , known p erformance u nder the exp ec te d cond ition s of us e and as s ump tions

or conditions which can be shown to apply to the data su fficiently for the purpose at hand. NO T E 2

7

.

9



Add itiona l i n formation on control of data i s provided i n I S O/I E C 1702 5 .

M

7.9.1

e

t r o

l

o

g

i

c

a

l



t r a

c

e

a

b

i

l

i

t y

o

f

c

e

r

t i

f i

e

d



v a

l

u

e

s

When producing CRMs, the metrological traceability o f the certified values shall be established

in comp liance with the relevant requirements of I SO /I EC 1 7 0 2 5 . The RM P shall provide evidence of the

metrological traceability o f the certified value to a stated re ference. NOTE 1

A combination o f results obtained by di fferent measurement procedures and/or laboratories all being

traceable to the s ame reference i s a l s o traceable to that reference .

NOTE 2 The evidence can be based on evaluation o f the measurement process or on confirmation o f metrological traceability by comparison o f results with independent traceable values. NOTE 3 Clear identification o f the property o f interest, traceability o f the numerical value and the stated re ference contribute to the traceability o f results. NO T E 4

I S O/ TR 16 476 contai n s additiona l i nformation on es tabli sh ment and expres s ion of me trologic a l

traceability o f certified values. 10

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ISO 17034:2016(E)

7.9.2

The stated re ference shall be a definition o f a measurement unit through its practical realization,

or a measurement procedure including the measurement unit, or a measurement standard.

Where it is technically possible, the RMP shall demonstrate that the stated re ference is traceable to the International System o f Units (SI). 7.9.3

Where metrological traceability to the SI units is not technically possible, the RMP shall demonstrate metrological traceability to an appropriate re ference (see traceability requirements in

7.9.4

I SO /I EC 1 70 2 5 ) .

For studies in which the values need to be traceable to a higher order re ference system (e.g. characterization studies with measurements under reproducibility conditions), it shall be ensured that the measurements are calibrated with standards with metrologically traceable values. 7.9.5

Secondary parameters that have a significant influence on the certified value or its uncertainty shall have evidence o f metrological traceability. 7.9.6

NOTE

Examples o f secondary parameters are temperature and humidity.

7.10 Assessment of homogeneity

The RMP shall carry out an assessment o f the homogeneity o f any candidate RM in its final packaged form to ensure its fitness for purpose. 7.10.1

NOTE 1 Assessment o f homogeneity can include the use o f prior evidence (including prior experimental evidence), the conduct o f an experimental homogeneity study on the candidate RM or both. In most cases, an experimental study is necessary. Guidance on the need for an experimental homogeneity study is provided in I S O Guide 3 5 .

NOTE 2 In most cases, experimental homogeneity tests require measurements o f a representative number o f randomly chosen units. The units can be chosen for example by random selection, stratified random selection or systematic selection from a random start point. 7.10.2

When the material is produced in multiple b atches, the equivalence of the batches shall b e

7.10.3

Validated measurement procedures shall be selected so that the precision and selectivity are fit

demonstrated or the homogeneity o f each batch shall be evaluated separately. for the purp ose required.

Where homogeneity needs to be determined experimentally, the RMP shall determine the homogeneity for every property o f interest unless it can be shown, using scientific evidence or previous experience, that particular groups o f properties are sufficiently closely associated that measurement o f one property in such a group furnishes evidence o f homogeneity for other properties in the same group. 7.10.4

NOTE

Guidance for homogeneity testing and the establishment o f minimum sample size is given in

I S O Guide 3 5 .

7.10.5 For certified values, homogeneity shall be quantified as an uncertainty contribution to the certified value or shall be shown to be a negligible contribution to the uncertainty o f the certified value.

7.11 Assessment and monitoring of stability 7.11.1

The RM P shall:

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ISO 17034:2016(E)

a)

a s s e s s , by exp eri mentation i f ne ce s s ar y, the s tabi l ity o f a l l relevant prop er tie s o f an RM u nder

prop osed

s torage

conditions

and

cho ose

pre-treatment,

p ackaging and

s torage

conditions

in

accordance with the re s u lts o f the as s e s s ment;

b)

a s s e s s , b y exp eri mentation i f ne ce s s ar y, the s tabi l ity o f a l l relevant prop er tie s o f an RM u nder prop o s e d cond ition s o f tran s p or t, and cho o s e tra n s p or t cond ition s to mai nta i n s tabi l ity du ri ng tran s p or t;

c)

e s tabl i sh any ne ce s s ar y advice on s torage and u s e o f the materi a l to ma i ntai n s tabi l ity at the u s er‘s prem i s e s;

d)

s ele c t a s cheme

for

mon itori ng the s tabi l ity o f materi a l s held i n long term s torage that p erm its

promp t de te c tion o f change, ta ki ng i nto accou nt the p o s s ible rate o f ch ange;

e)

where

the

s tabi l ity o f a cer ti fie d va lue

u ncer tai nty

for

c an no t b e

en s u re d ,

ma ke

due

a l lowance

i n the

s tate d

p o s s ible ch ange i n the va lue prior to u s e or, where the cha nge with ti me c a n b e

pre d ic te d, provide a me an s o f corre c ti ng the cer ti fie d va lue and its u ncer tai nty

for

the exp e c te d

ch ange over ti me;

f)

where rep eate d s ampl i ng from an RM un it or rep eate d u s e of an enti re RM un it i s p erm itte d b y the i n s tr uc tio n s

fo r

u s e , a s s e s s the p o s s ib le e ffe c ts o n the s tab i l ity o f the m ater i a l a nd ta ke

appropriate ac tion . NO T E 1

Where rep eated s ampl i ng i s p erm itted [s ee bu l let f) ab ove] , appropriate ac tion s c an b e, for example,

provi s ion of detai led i ns truc tion s for hand li ng and us e a fter op eni ng of the RM unit.

NO T E 2

I S O Gu ide 3 5 provides detai led guidance on pro cedu res i n bu l le ts a) to f) ab ove .

NO TE 3

T he re s u l ts o f s tabi l ity a s s e s s ments c a n co ntr ib ute to u ncer ta i nty e va lu ation (s e e 7.1 3 . 6) .

7.11.2

The RM P s hall co nduct an exp erimental as s es s ment o f s tab ility b e fo re releas e unles s the RM P has

evidence o f s tab ility o r p rio r exp erience o f s tab ility

fro m

clo s ely s imilar materials held

fo r

an extended

period under the same p lanned storage conditions.

NO TE

“C lo s el y s i m i l a r ” m ateri a l s a re m ater ia l s ch a rac ter i z e d

fo r

the s a me p rop er tie s , wh ich s h a re the s a me

matri x comp o s ition, pro ces s i ng cond itions , s i m i lar or les s effec tive p ackagi ng , etc .

7.11.3 RM P

Where an RM is p ro duced in multip le b atches that are no t individually tes ted

s hall veri fy the

s tab ility o f a s u fficient numb er o f di fferent b atches

fo r

s tab ility, the

exp erimentally to

p rovide

co nfidence in the s tab ility o f all b atches .

NO TE 1

Veri fic ation c a n b e a s i mp le te s t to co n fi r m th at d i fferent b atche s b eh ave s i m i l a rl y or,

fo r

s ucce s s ive

b atche s , do no t ch a n ge over thei r l i fe ti me , wh i le the e xp er i menta l a s s e s s ment o f s tab i l ity typic a l l y i nvol ve s a n e x tende d s tudy a i me d at de ter m i n i ng rate s o f ch a nge .

NO T E 2

Fur ther guidance for mu ltiple b atch pro duc tion s i s given i n I S O Guide 3 5 .

7.12 Characterization 7.12.1

Where the RM P as s igns p ro p erty values , characterizatio n o f the RM is required.

7.12.2

The RM P s hall clearly define whether a quantitative o r a qualitative p ro p erty will b e characterized

and, i f quantitative, whether the meas urand is o p eratio nally defined o r is defined indep endently o f any s p ecific p ro cedure.

7.12.3 NO T E 1

a)

12

The RM P s hall s elect a characterizatio n s trategy ap p ro p riate

fo r

the intended us e o f the RM .

Such charac teri z ation c an i nclude, but i s no t li m ite d to, the fol lowi ng appro aches:

u s i ng a s i n gle re ference me a s u rement p ro ce du re (a s de fi ne d i n I S O/ I E C Gu ide 9 9) i n a s i n gle l ab orator y;

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ISO 17034:2016(E)

b) characterization o f a non-operationally defined measurand using two or more methods o f demonstrable accuracy in one or more competent laboratories; c) characterization o f an operationally-defined measurand using a network o f competent laboratories; d) value trans fer from an RM to a closely matched candidate RM per formed using a single measurement procedure per formed by one laboratory; e)

cha rac teri z ation b as ed on mas s or volume of ingred ients u s e d in the prep aration of the RM .

NO TE 2

I S O Guide 3 5 provides gu idance on charac teri z ation .

The RMP shall speci fy the characterization study so that the properties o f interest are each characterized with appropriate traceability and sufficient reliability whether or not traceability and measurement uncertainty are reported on the RM documentation. To this end, the RMP shall:

7.12.4

a) document a measurement plan that clearly describes the tasks to be per formed and communicate this to all personnel responsible for measurements used in characterization; b)

or certified values, demonstrate the competence o f each involved laboratory by using data from each laboratory that was not obtained on the material to be characterized.

f

7.12.5

When evaluating the characterization data, the RM P shall perform a technical evaluation of the

data and documents involved in characterization to confirm adherence to the measurement plan as defined in 7 .1 2 . 4, b ullet a) , and, in the case of deviations from the plan, assess whether the deviation necessitates exclusion of the data from characterization.

7.13 Assignment of property values and their uncertainties 7.13.1

The RMP shall use documented procedures for the assignment o f property values.

7.13.2

These p rocedures shall include, as app rop riate:

a) details o f the experimental designs and statistical techniques used; b) policies on treatment and investigation o f anomalous results, including outliers; c) whether weighting techniques are used for contributions to assigned property values derived from di fferent procedures or laboratories with di fferent measurement uncertainties; d) the approach used to assign uncertainties to the property values; e) any other significant factors that may a ffect the assignment o f property values. 7.13.3

The RM P shall take due account of technical information on test methods and equipment,

including reported uncertainty information, and o f any evidence o f laboratory performance when assigning the property values o f interest. NO TE

I S O Guide 3 5 provides gu idance on va lid appro aches for va lue as s ign ment.

7.13.4 Outliers shall not be excluded solely on statistical evidence until they have been investigated and, where possible, the reasons for the discrepancies identified. Robust statistical methods may be applied where appropriate.

NOTE 1

An apparent outlier can be the only technically valid result in the data set.

NO TE 2

I S O Guide 3 5 provides gu idance on the us e of robus t s tati s tic a l metho d s .

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ISO 17034:2016(E)

7.13.5

Fo r certified values , the RM P s hall identi fy the uncertainty co ntrib utio ns to b e included in the

as s igned uncertainty.

NO T E

7.13.6

Fur ther guidance on the es ti mation of u ncer tai nties i s given i n I S O Guide 3 5 and I S O/I E C Guide 9 8 -3 .

Fo r certified values , the RM P s hall co ns ider, at a minimum, uncertainty co ntrib utio ns o f each o f

the following:

a)

ch arac teri z ation, i nclud i ng a ny d i fference b e twe en mu ltiple pro ce du re s u s e d

b)

b e twe en-u nit a nd with i n-u n it i n homo geneity;

c)

ch ange s o f prop er ty va lue s du ri ng s torage;

d)

ch ange s o f prop er ty va lue s du ri ng tra n s p or t.

NO TE 1

for

ch arac teri z ation;

O ther u ncer ta i nty contr ibutio n s c a n b e i mp or ta nt s uch a s ch a nge s o f prop er ty va lue s i n u s e o r on

rep e ated s ampl i ng.

NO TE 2

W here va lue s o ther th a n cer ti fie d va lue s a re a s s igne d to RM s (e . g. “i nd ic ative va lue s ” or “i n for m atio n

va lue s ” ) , a s tatement o f u ncer ta i ntie s c a n b e ap propr i ate to i mprove the u s e o f the m ateri a l .

7.14 RM documents and labels 7.14.1

The RM P s hall is s ue and make availab le an RM certificate

fo r

C RM s and p ro duct in fo rmatio n

sheet for other RM s.

7.14.2

The co ntents o f RM certificates and p ro duct in fo rmatio n s heets s hall include the

a)

title o f the do c u ment;

b)

u n ique identi fier o f the RM ;

c)

the na me o f the RM ;

d)

name a nd contac t de tai l s o f the RM P;

e)

i ntende d u s e;

f)

m i n i mu m s a mple s i z e (whenever appl ic able) ;

g)

p erio d o f va l id ity;

h)

s torage i n formation;

i)

i n s truc tion s

j)

p age nu mb er and the to ta l nu mb er o f p age s;

k)

do c u ment vers ion;

l)

i n formation on com mutabi l ity o f the materia l (where appropri ate) .

7.14.3

for

hand l i ng a nd u s e that a re s u fficient to en s u re the i ntegrity o f the materia l;

I n addition to the minimum requirements given in 7 .1 4. 2 , RM certificates s hall co ntain the

following additional information:

a)

de s c rip tion o f the C RM ;

b)

prop er ty o f i ntere s t, prop er ty va lue and a s s o ci ate d u ncer tai nty;

c)

me as u rement pro ce du re

14

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for

op erationa l ly defi ne d me a s urand s;

ISO 17034:2016(E)

d) metrological traceability o f the certified values; e) name and function o f RMP’s approving o fficer. NOTE 1

Further in formation on the content o f certificates and accompanying documentation is given in

I S O Guide 3 1 .

NOTE 2

Sector-specific requirements for RM certificates and product in formation sheets can exist and can be

cons idere d (e . g. I S O 1 519 4 for in vitro d iagno s tic med ica l devices) .

The RM label shall be securely attached to the product container o f an individual RM unit, and shall be designed to remain legible and intact under the defined storage and handling conditions within the li fetime o f the RM, i.e. the period during which the RM is available from the RMP extended by the period o f validity o f its certificate. The label shall identi fy the material, the RMP, its batch, and any other information necessary to enable the material to be uniquely distinguished and re ferenced (such as the individual sample number), where appropriate, to its product information sheet or RM certificate.

7.14.4

7.14.5 Where the physical size o f the RM unit limits the amount o f in formation that can be contained on the label, the information shall be included elsewhere (e.g. in an RM document). A unique identifier shall be given [see 7 .1 4.2 , bullet b ) ] .

NOTE

Further guidance concerning the contents o f RM certificates, labels and accompanying documentation

can b e fou nd i n I S O Guide 3 1 .

7.15 Distribution service 7.15.1

The distribution process shall be specified including precautions needed to avoid deterioration

of the RM (see 7 .1 1 .1 ) . The RM P shall determine the conditions of shipment and ensure that approp riate documentation is provided to allow customs clearance.

NO TE 1

T he cond ition s of sh ipment can i nclude for example sh ippi ng temp erature, p ackagi ng , duration of

transport and other precautions necessary for integrity o f the material.

NOTE 2 For some RMs, additional documentation related to, for example, origin and, con formity o f the material to sa fety requirements, might be required for customs clearance. 7.15.2

The RM P shall maintain up-to-date records of all RM sales and distribution.

7.15.3

The RM P shall offer to users reasonable guidance and technical sup port related to the RM s it

produces.

7.15.4 The RMP shall employ best e fforts to noti fy users o f any change to the property value or uncertainty for any RM within the validity period o f the RM certificate or product information sheet.

Where RMs are subject to resale through a distributor with whom the RMP has a contractual relationship, the RMP shall pass on to the authorized distributor all necessary information to ensure

7.15.5

that an effective post-distribution service is maintained and make arrangements with the distributor to ensure that its activities are executed in accordance with the relevant clauses of this I nternational Standard.

NOTE

Where RMs are subject to resale by other organizations, the RMP has no control over these

organi z ation s ’ ac tivities a fter the RM s have b e en purchas ed . T he re qui rements regard i ng d i s tribution s er vice to

such resellers are limited to the first reseller.

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ISO 17034:2016(E)

7.16 Control of quality and technical records

The RMP shall establish and maintain procedures for identification, collection, indexing, access, storage, maintenance and disposal o f quality and technical records. 7.16.1

NOTE 1 Quality records are records providing objective evidence o f the extent o f the fulfilment o f the requirements for quality or the e ffectiveness o f the operation o f the management system. They include reports from i nterna l aud its and management reviews , a nd correc tive ac tion and i mprovement re cord s .

NOTE 2 Technical records are accumulations o f data and in formation which result from carrying out RM production, measurement, testing and calibration procedures and which indicate whether specified quality or process parameters are achieved. They include forms, contracts, work sheets, work books, check sheets, control charts/graphs, calibration reports/certificates, reports, certificates and other statements to users. 7.16.2

The RM P shall ensure that it has recorded such information that might be needed in a future

disp ute situation.

7.16.3

All records shall be legible and shall be stored and retained in such a way that they are readily

retrievable and in facilities

that provide

a suitab le

environment to

prevent damage,

deterioration

or loss. Retention time of records shall be established in accordance with customer or other relevant requirements, and shall be documented.

NOTE 7.16.4

Records can be in the form o f any type o f media, such as hard copy or electronic media. When mistakes occur in records, each mistake shall be crossed out, not erased, made illegible

or deleted, and the correct information entered alongside. All such alterations to records shall be signed

or initialled, and dated by the person making the correction. In the case o f records stored electronically, equivalent measures shall be taken to avoid the loss or change of original information.

7.16.5

All records shall be held securely and, where appropriate, in confidence.

7.16.6

The RMP shall have procedures to protect electronically held data at all times and to prevent

unauthorized access to, or amendment of, such data.

7.16.7

The RM P shall arrange for all individual measurement observations, appropriate calculations and

derived data (e.g. statistical treatments and uncertainty budgets), calibration records and preparation reports to be retained for a defined period beyond which it is no longer probable that they will be referred to, taking into account the period for which the RM remains valid.

7.16.8

The results o f each calibration or measurement (or series o f either) carried out by the RMP or by

a sub contractor shall b e reported in accordance with I SO /I E C 1 7 0 2 5 .

7.17 Management of non-conforming work

The RMP shall have procedures that shall be implemented when it establishes that any aspect o f its production activities does not con form to its own specified production procedures or the agreed 7.17.1

requirements of the customer.

7.17.2

The procedures shall ensure that:

a) responsibilities and authorities for the management o f non-con forming work are designated; b) the actions to be taken when any non-con forming work and/or RMs are identified including rootcause analysis and a system that ensures that they are e ffectively implemented; c) an evaluation o f the significance o f the non-con forming work is made and identification and implementation o f correction and corrective action; 16

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ISO 17034:2016(E) d) where necessary, work is halted and, i f appropriate, issue o f the a ffected RM and its certificates and other appropriate documentation is withheld; e) remedial actions such as customer notifications are taken within a defined time- frame; f

) where necessary, best e fforts are employed to noti fy the users o f the possible e ffects, within an appropriate period and, where necessary, non-con forming RMs and/or their certificates and other appropriate documentation already distributed, are recalled;

g) the responsibility for authorization o f the resumption o f work is defined; h) where necessary, an internal audit is conducted to veri fy the closure and e ffectiveness o f the correc tive ac tions taken .

7.17.3 The decision on recall o f RMs shall be taken in a timely manner to limit the use o f nonconfo rming RM s .

NOTE The identification o f non-con forming RMs or problems with the management system or with production activities can occur at various places within the management system, such as complaints, quality control, checking o f consumable materials, sta ff observations or supervision, certificate and other appropriate do c umentation che cki ng, management reviews and i nterna l or externa l audits .

7.18 Complaints 7.18.1

The RM P shall have a documented process to receive, evaluate and make decisions on complaints.

7.18.2 A description o f the handling process for complaints shall be available to any interested party on request.

7.18.3 Upon receipt o f a complaint, the RMP shall confirm whether the complaint relates to con formity assessment activities that it is responsible for and, if so, shall deal with it.

7.18.4

The RM P shall be responsib le for all decisions at all levels of the handling p rocess for complaints.

7.18.5 Investigation and decision on complaints shall not result in any discriminatory actions. 7.18.6 a)

The p rocess for handling complaints shall include at least the following elements and methods:

a descrip tion of the pro ces s for receiving, validating, inves tigating the complaint, and deciding

what actions are to be taken in response to it;

b) tracking and recording complaints, including actions undertaken to resolve them; c) ensuring that any appropriate action is taken. 7.18.7 The RMP receiving the complaint shall be responsible for gathering and veri fying all necessary information to validate the complaint.

7.18.8

Whenever possib le,

the

RM P shall

acknowledge

receipt of the

complaint,

and p rovide

the

complainant with p rogress rep orts and the outcome.

7.18.9 The decision to be communicated to the complainant shall be made by, or reviewed and approved

by, individual(s) not involved in the original RM activities in question. 7.18.10

Whenever p ossible, the RM P shall give formal notice of the end of the complaint handling

process to the complainant.

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ISO 17034:2016(E)

8 Management system requirements 8.1 Options 8.1.1

General

The RMP shall establish and maintain a management system that is capable o f achieving the consistent ulfilment o f the requirements o f this International Standard in accordance with either Option A or Option B. f

8.1.2

Option A

8.1.2.1 The RMP shall establish, implement and maintain a documented management system that addresses the scope o f its RM production activities, which covers the type, range and scale o f the RM production it undertakes. 8.1.2.2 The RMP shall define and document its scope o f activities. 8.1.2.3 The management system o f the RMP shall address the following: — quality policy (see 8.2 ); — general management system documentation (see 8.3 ); — control o f management system documents (see 8.4); — control of records (see 8.5 ); — management review (see 8.6 ); — internal audit (see 8.7 ); — actions to address risks and opportunities (see 8.8 ); — corrective actions (see 8.9 ); — improvement (see 8.10 ) ; — feedback from customers (see 8.11).

8.1.3

Option B

An RMP that has established and maintains a management system, in accordance with the requirements o f ISO 9001, and that is capable o f supporting and demonstrating the consistent fulfilment o f the requirements of Clauses 4 to 7 o f this International Standard (ISO 17034), fulfils the management system clause requirements in 8.2 to 8.11.

8.2 Quality policy (Option A) 8.2.1 The RMP shall define and document its policy, objectives and commitment to ensure and maintain the quality o f all aspects o f RM production, storage and distribution procedures. 8.2.2 The RMP’s management system policies related to quality, including a quality policy statement, shall be documented under the authority o f the top management. 8.2.3 The quality policy shall include the following commitments: a) to produce RMs which con form to the requirements o f this International Standard;

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ISO 17034:2016(E)

b)

to conduc t al l tes ting and calibration in s upp or t of the produc tion of RM s in compl iance with the

requirements o f ISO/IEC 17025;

c) to require that all personnel concerned with the quality o f any aspect o f RM production activities familiarize themselves with the quality documentation and implement the policies and procedures in their work; d)

for the management to continually improve the e ffectiveness o f the management system and to be committed to good pro fessional practice and to the quality o f its RMs.

8.2.4 The overall objectives shall be reviewed during the management review.

8.3 General management system documentation (Option A) The RMP shall document all o f its systems, programmes, procedures, instructions, findings, etc., to the extent necessary to enable the RMP to ensure the quality o f the RMs produced. Documentation used in this management system shall be communicated to, understood by, available to and implemented by all p ersonnel concerned.

8.4 Control of management system documents (Option A) 8.4.1 The RMP shall control the documents (internal and external) that relate to the fulfilment o f this I nternational Standard.

8.4.2

The RM P shall ensure that:

a) documents are approved for adequacy prior to issue by authorized personnel; b) documents are periodically reviewed and updated (as necessary); c) changes and the current revision status o f documents are identified; d) relevant versions o f applicable documents are available at points o f use; e) documents are uniquely identified and where necessary their distribution controlled; f

) the unintended use o f obsolete documents is prevented, and suitable identification applied to them i f they are retained for any purpose.

NO TE 1

T hes e c an i nclude do cuments of externa l origin, s uch as s tanda rd s , guides , tes t and/or ca l ibration

procedures, as well as specifications, instructions and manuals related to the RM under production.

NOTE 2 In this context, “document” means any in formation or instruction including policy statements, text books, procedures, specifications, calibration tables, charts, so ftware, etc. These can be on various media, whether in hard copy or electronic, and they can be in digital, analogue, photographic or written form.

8.5 Control of records (Option A) 8.5.1 The RMP shall establish procedures to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition o f its records related to the fulfilment o f this I nternational Standard.

8.5.2 The RM P shall establish p rocedures for retaining records for a p eriod consistent with its contractual and legal obligations. Access to these records shall be consistent with the confidentiality arrangements.

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ISO 17034:2016(E)

8.6 Management review (Option A) 8.6.1

I n accordance with a predetermined schedule and procedure, the RM P’s top management shall

periodically conduct a review o f its management system and production processes to ensure their continuing suitability and e ffectiveness and to introduce any necessary changes or improvements. The review shall take account of, b ut not be limited to:

a) the suitability o f policies and procedures; b) reports from managerial and supervisory personnel; c) the outcome o f internal audits; d) corrective actions; e) result o f risk identification; f

) assessments by external bodies;

g) changes in scale and type o f work; h)

f

eedback from customers;

i)

recommendations for improvement including complaints;

j)

other relevant factors such as resources, sta ff training and, where required, technical issues relating to the competence o f the subcontractor and distributor o f the RMs;

k) the quality objectives (see 8 . 2 ) . NOTE 1 Results can feed into the corporate planning programme, can include the goals, objectives and action plans for the coming year and can be communicated to the sta ff. NOTE 2 8.6.2

A typical period for conducting a management review is once every year. Findings from management reviews and the actions that arise from them shall be recorded. The

management shall ensure that these actions are discharged within an app ropriate and agreed timescale.

8.7

Internal audit (Option A)

The RMP shall, periodically and in accordance with a predetermined schedule and procedure, conduct internal audits o f its activities to veri fy that its operations continue to comply with the requirements o f the management system and the requirements o f this International Standard. The internal audit programme shall address all elements o f the management system, including the technical and production activities leading to the finished product (RM). It is the responsibility o f the RMP to plan and organize audits as required by the schedule and requested by management. Such audits shall be carried out by trained and qualified personnel who are, wherever resources permit, independent o f the activity to be audited. Personnel shall not audit their own activities. 8.7.1

When audit findings cast doubt on the e ffectiveness o f the operations, or on the integrity o f the RMs, or on the correctness o f their documentation, the RMP shall take timely corrective actions and shall noti fy, in writing, its customers whose activities may have been adversely affected.

8.7.2

8.7.3

All audit findings and corrective actions that arise from them shall be recorded. The RMP’s

management shall ensure that these actions are discharged within an app ropriate and agreed timescale.

8.7.4

Follow-up activities shall veri fy and record the implementation and e ffectiveness o f the corrective

actions taken.

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ISO 17034:2016(E) 8.8 Actions to address risks and opportunities (Option A) 8.8.1

The RM P shall consider the risks and op portunities to:

a) give assurance that the management system can achieve its intended result(s); b) enhance desirable e ffects; c) prevent, or reduce, undesired e ffects; d)

achieve improvement.

8.8.2

The organization shall take actions to:

a) address these risks and opportunities; b) integrate and implement the actions into its management system processes; c)

evaluate the effec tivenes s of these ac tions .

8.8.3 Actions taken to address risks and opportunities shall be proportionate to the potential impact on the quality o f the RM production and service. NOTE 1 Options to address risks can include avoiding risk, taking risk in order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by i nforme d deci s ion .

NO TE 2

O pp or tu nities c an lead to the adop tion of new prac tices , launch i ng new pro duc ts , op en ing new

markets, addressing new customers, building partnerships, using new technology and other desirable and viable p o s s ibi l ities to add res s the organi z ation’s or its cu s tomers ’ ne ed s .

8.9 Corrective actions (Option A) 8.9.1

General

The RMP shall establish a policy and procedure(s) and shall designate appropriate authorities for implementing correc tive ac tions when non- con forming RM s , non- conforming work on the pro duc tion

o f RMs, or departures from the policies and procedures in the management system have been identified.

NOTE A problem with the management system or with technical operations can be identified through a variety o f activities within the management system, such as control o f non-con forming RMs, internal or external aud its , management reviews and fe edb ack from c us tomers or s ta ff ob s er vation s .

8.9.2

Cause analysis

Corrective action procedures shall start with an investigation to identi fy the root causes o f the problem. The investigation shall be conducted for both in-house production and, where required, any work per formed by subcontractors. NOTE The root cause is o ften not obvious and a care ful analysis o f all potential causes o f the problem is required. Potential causes could include the nature o f the RM and its specifications, general procedures and pro cedures us ed for charac teri z ation, s ta ff ski l l s and trai ni ng, and the materia l s and equ ipment (and/or its ca l ibration) u s ed i n the pro duc tion pro ces s es .

8.9.3

Selection and implementation of corrective actions

8.9.3.1 Where corrective actions are needed, the RMP shall identi fy potential corrective actions. It shall select and implement the action(s) most likely to eliminate the problem and to prevent recurrence.

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8.9.3.2

Any corrective action taken to eliminate the causes o f non-con formities or other departures

shall be app ropriate to the magnitude of the prob lem and commensurate with the risks encountered.

8.9.3.3

The RMP shall document and implement any required changes to the operational procedures

resulting from corrective action investigations.

8.9.4

Monitoring of corrective actions

After having implemented the correc tive ac tions , the RM P shal l monitor the res ults to ens ure that the correc tive ac tions taken have b een effec tive in eliminating the root causes of the problems .

8.9.5

Additional audits

Where the identification o f non-con formities or departures casts doubt on the RMP’s compliance with its own p olicies and pro cedures , or on its compliance with this I nternational Standard, the RM P shal l

ensure that the appropriate areas o f activity are audited in accordance with 7.17, as s oon as p os s ible. 8.10 Improvement (Option A)

The RMP shall continually improve the e ffectiveness o f its management system through the use o f the quality policy, quality objectives, audit results, analysis o f data, corrective and preventive actions 8.10.1

and management review.

8.10.2

Required

improvements

and

potential

sources

of

non-conformities,

either

technical

or

concerning the management system, shall be identified. When improvement opportunities are identified or if improvement is required, action plans shall b e develop ed, imp lemented and monitored to reduce

the likelihood of the occurrence of such non-conformities and to take advantage of the opp ortunities for improvement.

8.10.3

After the implementation of the improvement, the RM P shall monitor the results to establish

any reduction in deficiencies or other improvements in this operational area, thereby establishing the effectiveness of the preventive action.

8.11 Feedback from customers (Option A) T he RM P shal l seek feedb ack, b oth p os itive and negative, from its cus tomers . T he feedb ack shal l b e

used and analysed to improve the management system, RM production activities and customer service.

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ISO 17034:2016(E)

Annex A (informative)

Summary of production requirements for RMs and CRMs Table A.1 gives guidance on the appl ication of the requirements of C lause 7 related to the pro duc tion of

RMs, including specific requirements for CRMs.

Table A.1 — Production requirements for RMs and CRMs General requirements

All RMs

CRMs

Applicable subclause

P ro duc tion planni ng

Re qui re d

Re qui re d

7. 2

P roduc tion control

Re qui re d

Re qui re d

7. 3

M aterial handling and s torage

Re qui re d

Re qui re d

7. 4

M ateria l pro ces s i ng

Re qui red

Re qui red

7. 5

M ea s u rement pro cedures

Re qui re d

Re qui re d

7. 6

M ea s uring equ ipment

Re qui re d

Re qui re d

7.7

Data integrity and evaluation Metrological traceability o f certified values Assessment o f homogeneity As s es s ment and monitori ng

o f stability

C harac teri z ation

Re qui re d

Re qui re d

7. 8

No t re qui re d

Re qui red

7.9

Re qui red

Re qui red

7.10

Re qui re d

Re qui re d

7.11

Re qui red, where va lues are

Re qui red

7.1 2

Requi red

7.1 3

No t re qui re d

Required for certified values

7.1 3

Re qui re d

Re qui re d

7.14

to b e as s igned

Assignment o f property va lues As s ign ment of the uncer tai n-

ties o f the property values RM do c uments and lab el s

Requi red, where va lues are to b e as s igne d

D i s tribution s er vice

Re qui re d

Re qui re d

7.1 5

Control o f quality and techni-

Re qui red

Re qui red

7.16

Re qui re d

Re qui re d

7.17

Re qui re d

Re qui re d

7.1 8

c al record s M anagement of non- conform ing work H and l i ng of complai nts

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ISO 17034:2016(E)

Bibliography Quality management systems — Fundamentals and vocabulary

[1]

ISO 9000,

[2 ]

I S O 10 01 2 ,

[3 ]

I S O 1 518 9,

[4]

Measurement management systems — Requirements for measurement processes and measuring equipment ISO

Medical laboratories — Requirements for quality and competence

1 519 4,

In vitro diagnostic medical devices — Measurement of quantities in samples of

biological origin — Requirements for certified reference materials and the content of supporting

documentation [5 ] [6]

I S O 1 5195 ,

Laboratory medicine — Requirements for reference measurement laboratories

I S O/ TR 16 476 , Reference materials — Establishing and expressing metrological traceability of quantity values assigned to reference materials

Conformity assessment — Vocabulary and general principles

[7 ]

I S O/I EC 170 0 0 ,

[8]

I S O/I EC 17011 ,

[9]

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ILAC Policy on Traceability of Measurement Results

I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n

ISO 1 703 4: 2 01 6(E)

ICS  03.120.20 Price b as ed o n 2 4 pages

© I SO 2 0 1 6 – All rights reserved

I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n