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GUIDE 34

General requirements for the competence of reference material

producers

ISO GUIDE 34:2009E!

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"ontents Page

#ore$ord %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%i&

Introduction%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%&

' Scope%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%'

2 (ormati&e references%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%'3 )erms and definitions %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%2

4 Or*ani+ation and mana*ement requirements%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%4

4%' ,ana*ement s-stem requirements %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%4

4%2 Or*ani+ation and mana*ement%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%.

4%3 Document and information control %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%/

4%4 equest1 tender and contract re&ie$s %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%

4% Use of sucontractors %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%

4%. 5rocurement of ser&ices and supplies %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%9

4%/ "ustomer ser&ice %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%9

4% "omplaints %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%9

4%9 "ontrol of non6conformin* $or7 and8or reference materials%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%9

4%'0 "orrecti&e actions %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%'0

4%'' 5re&enti&e actions%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%''

4%'2 Impro&ement %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%''

4%'3 ecords %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%''

4%'4 Internal audits %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%'2

4%' ,ana*ement re&ie$s %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%'3

)echnical and production requirements%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%'3

%' General %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%'3

%2 5ersonnel %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%'4

%3 Sucontractors %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%'4

%4 5roduction plannin*%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%'

% 5roduction control %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%'.

%. ccommodation and en&ironmental conditions%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%'.

%/ ,aterial handlin* and stora*e %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%'/

% ,aterial processin*%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%'

%9 ,easurement methods %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%'

%'0 ,easurin* equipment %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%'

%'' Data e&aluation %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%'9

%'2 ,etrolo*ical traceailit- %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%'9

%'3 ssessment of homo*eneit- %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%2'

%'4 ssessment of stailit- %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%2'

%' "haracteri+ation %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%22

%'. ssi*nment of propert- &alues and their uncertainties%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%23

%'/ "ertificates or documentation for users%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%23

%' Distriution ser&ice %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%24

nne (informative) ,etrolo*ical traceailit- of certified propert- &alues of reference materials %%%%%%2

nne ; (informative) "ommutailit- of reference materials %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%2/

nne " (informative) ISO8IE" '/028ISO Guide 34 cross6reference tale %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%29

;ilio*raph-%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%34

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#ore$ord

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies

(ISO member bodies). The work of preparing International Standards is normally carried ot throgh ISO

technical committees. !ach member body interested in a sb"ect for which a technical committee has been

established has the right to be represented on that committee. International organizations# governmental andnon$governmental# in liaison with ISO# also take part in the work. ISO collaborates closely with the

International !lectrotechnical %ommission (I!%) on all matters of electrotechnical standardization.

International Standards are drafted in accordance with the rles given in the ISO&I!% 'irectives# Part .

'raft ides adopted by the responsible %ommittee or rop are circlated to the member bodies for voting.

Pblication as a ide re*ires approval by at least +, - of the member bodies casting a vote.

ttention is drawn to the possibility that some of the elements of this docment may be the sb"ect of patent

rights. ISO shall not be held responsible for identifying any or all sch patent rights.

ISO ide /0 was prepared by the ISO Reference Materials Committee (1!2%O).

This third edition cancels and replaces the second edition (ISO ide /03444)# which has been technically

revised. It also incorporates the Technical %orrigendm ISO ide /03444&%or.5344/.

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Introduction

The se of reference materials enables the transfer of the vales of measred or assigned properties between

testing and measrement laboratories. Sch materials are widely sed# e.g. for the calibration of measring

e*ipment and for the evalation or validation of measrement procedres. In certain cases# they enable

properties to be e6pressed conveniently in arbitrary nits.7OT! The concept 8reference material9 is inclded in the concept 8measrement standard9# both of which also

inclde physical reference materials sed for calibrating instrments in mechanical# non$destrctive and constrction

type$testing facilities.

There are an increasing nmber of reference material prodcers# and a demonstration of their scientific and

technical competence is nowadays a basic re*irement for ensring the *ality of reference materials. The

demand for new reference materials of higher *ality is increasing as a conse*ence of both the increased

precision of measring e*ipment and the re*irement for more accrate and reliable data in the scientific

and technological disciplines. Some previosly acceptable reference materials may not meet these more

stringent re*irements anymore. It is# therefore# not only necessary for reference material prodcers to

provide information abot their materials in the form of reports# certificates and statements# bt also to

demonstrate their competence in prodcing reference materials of appropriate *ality.

The first edition of ISO ide /0 set ot specific gidelines on the interpretation of ISO&I!% ide , and the

International Standards prepared by ISO&T% 5+:5) in the conte6t of reference material prodction. The more

general re*irements of these International Standards were omitted. Since the first edition of ISO ide /0

was pblished in 5;;:# the assessment of the competence of reference material prodcers has gained

considerable impets. The second edition of ISO ide /0 set ot all the general re*irements in accordance

with which a reference material prodcer has to demonstrate that it operates. The present edition makes

these re*irements mandatory and in line with ISO&I!% 5+4,344,&%or.5344: in view of its se for the

assessment of the competence of reference material prodcers applying for accreditation.

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General requirements for the competence of reference material

producers

' Scope

'%' This ide specifies general re*irements in accordance with which a reference material prodcer hasto demonstrate that it operates# if it is to be recognized as competent to carry ot the prodction of reference

materials.

'%2 This ide is intended for the se by reference material prodcers in the development and

implementation of their management system for *ality# administrative and technical operations. 1eference

material cstomers# reglatory athorities and accreditation bodies may also se it in confirming and

recognizing the competence of reference material prodcers.

7OT! This ide is not intended to be sed as the basis for conformity assessment by certification bodies.

'%3 This ide sets ot the management system re*irements in accordance with which reference

materials shall be prodced. It is intended to be sed as part of a reference material prodcer>s general *ality

assrance (?) procedres.

'%4 This ide covers the prodction of certified and non$certified reference materials.

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ISO&I!% 5+444# Conformity assessment &ocabulary and $eneral principles

ISO&I!% 5+4,# General re)uirements for the competence of testin$ and calibration laboratories

3 )erms and definitions

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7OT! 0 single 12 cannot be sed for both calibration and validation of reslts in the same measrement procedre.

7OT! , BI2 has an analogos definition (ISO&I!% ide ;;344+# ,.5/)# bt restricts the term 8measrement9 to apply

to *antitative vales and not to *alitative properties. Cowever# 7ote / of ISO&I!% ide ;;344+# ,.5/# specifically

incldes the concept of *alitative attribtes# called 8nominal properties9.

DISO ide /435;;&md.5344=# definition .5E

3%certified reference material

",

reference material characterized by a metrologically valid procedre for one or more specified properties#

accompanied by a certificate that provides the vale of the specified property# its associated ncertainty# and

a statement of metrological traceability

7OT! 5 The concept of vale incldes *alitative attribtes sch as identity or se*ence. @ncertainties for sch

attribtes may be e6pressed as probabilities.

7OT! 2etrologically valid procedres for the prodction and certification of reference materials are given in# among

others# ISO ides /0 and /,.

7OT! / ISO ide /5 gives gidance on the contents of certificates.

7OT! 0 BI2 has an analogos definition (ISO&I!% ide ;;344+# ,.50).

DISO ide /435;;&md.5344=# definition .E

3%.

commutailit- of a reference material

property of a reference material# demonstrated by the closeness of agreement between the relation among

the measrement reslts for a stated *antity in this material# obtained according to two given measrement

procedres# and the relation obtained among the measrement reslts for other specified materials

7OT! 5 The reference material in *estion is normally a calibrator and the other specified materials are sally rotine

samples.

7OT! The measrement procedres referred to in the definition are the one preceding and the one following the

reference material (calibrator) in *estion in a calibration hierarchy.

7OT! / The stability of commtable reference materials is monitored reglarly.

DISO&I!% ide ;;344+# definition ,.5,E

3%/

metrolo*ical traceailit-

property of a measrement reslt whereby the reslt can be related to a reference throgh a docmented

nbroken chain of calibrations# each contribting to the measrement ncertainty

7OT! 5

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7OT! , 2etrological traceability of a measrement reslt does not ensre that the measrement ncertainty is

ade*ate for a given prpose or that there is an absence of mistakes.

7OT! : comparison between two measrement standards may be viewed as a calibration if the comparison is sed

to check and# if necessary# correct the *antity vale and measrement ncertainty attribted to one of the measrement

standards.

7OT! + The IF% considers the elements for confirming metrological traceability to be an nbroken metrologicaltraceability chain to an international measrement standard or a national measrement standard# a docmented

measrement ncertainty# a docmented measrement procedre# accredited technical competence# metrological

traceability to the SI# and calibration intervals (see IF%$P54344D;E).

7OT! = The abbreviated term 8traceability9 is sometimes sed to mean 8metrological traceability9 as well as other

concepts# sch as 8sample traceability9 or 8docment traceability9 or 8instrment traceability9 or 8material traceability9#

where the history (8trace9) of an item is meant. Therefore# the fll term of 8metrological traceability9 is preferred if there is

any risk of confsion.

DISO&I!% ide ;;344+# definition .05E

3%

measurement uncertaint-

non$negative parameter characterizing the dispersion of the *antity vales being attribted to a measrand#

based on the information sed

7OT! 5 2easrement ncertainty incldes components arising from systematic effects# sch as components

associated with corrections and the assigned *antity vales of measrement standards# as well as the definitional

ncertainty. Sometimes estimated systematic effects are not corrected for bt# instead# associated measrement

ncertainty components are incorporated.

7OT! The parameter may be# for e6ample# a standard deviation called standard measrement ncertainty (or a

specified mltiple of it)# or the half$width of an interval# having a stated coverage probability.

7OT! / 2easrement ncertainty comprises# in general# many components. Some of these may be evalated by

Type evalation of measrement ncertainty from the statistical distribtion of the *antity vales from series of

measrements and can be characterized by standard deviations. The other components# which may be evalated by

Type G evalation of measrement ncertainty# can also be characterized by standard deviations# evalated from

probability density fnctions based on e6perience or other information.

7OT! 0 In general# for a given set of information# it is nderstood that the measrement ncertainty is associated with

a stated *antity vale attribted to the measrand. modification of this vale reslts in a modification of the associated

ncertainty.

DISO&I!% ide ;;344+# definition .:E

4 Or*ani+ation and mana*ement requirements

4%' ,ana*ement s-stem requirements4%'%' General

The reference material prodcer shall establish# implement and maintain a docmented management system

appropriate to the scope of its activities# inclding the type# range and volme of the reference material

prodction it ndertakes.

It shall be recognized that a reference material property needs to be characterized mainly to the level of

accracy re*ired for its intended prpose (i.e. appropriate measrement ncertainty for a property vale of a

certified reference material). The reference material prodcer shall describe the procedre for establishing the

*ality of materials as a component of the management system.

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1eference material prodcers shall define their scope of activities in terms of the types of reference materials

(inclding the sample matrices# if applicable)# the properties to be certified and the ranges of assigned vales

(and their ncertainties) of the reference materials they prodce# and their involvement in the performance of

testing# calibration and measrements in relation to homogeneity# stability and characterization assessments

and their se of sbcontractors in these tasks.

4%'%2

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e) procedres for ndertaking characterization (if applicable)H

f) assessment of commtability (where appropriate)H

g) practical realization of metrological traceability of measrement reslts to a stated referenceH

h) assignment of property vales# inclding preparation of certificates or statements in accordance with

ISO ide /5 when appropriateH

i) arrangements for ensring ade*ate storage facilitiesH") arrangements for sitable identification# labelling and packaging facilities# packing and delivery

procedres in compliance with international safety reglations# and cstomer serviceH

k) assessment of post$certification stability monitoring as re*ired for the e6tension of the assigned period of

validity of the reference material certificate (if applicable)H

l) compliance with ISO ide /4 and with appropriate sections of ISO ides /5 and /,.

The docmented management system shall specify which activities are ndertaken by the reference material

prodcer and# where relevant# which activities are ndertaken by sbcontractors. It shall inclde policies and

procedres sed by the prodcer to ensre that all activities condcted by sbcontractors comply with the

relevant clases of this ide.

The docmented management system shall define the roles and responsibilities of the technical management

and the *ality manager (however named)# inclding their responsibilities for ensring compliance with this

ide.

4%2 Or*ani+ation and mana*ement

4%2%' The reference material prodcer# or the organization of which it is part# shall be an entity that can be

held legally responsible.

4%2%2 The reference material prodcer shall be organized and shall operate in sch a way that it meets all

the applicable re*irements of this ide# whether carrying ot work at its permanent facilities or at sites

(inclding associated temporary or mobile facilities) away from its permanent facilities.

4%2%3 The reference material prodcer shall

a) have managerial personnel# spported by technical personnel# with the athority and resorces needed to

discharge their dties and to identify the occrrence of departres from the management system or the

procedres for the prodction of reference materials and to initiate actions to prevent or minimize sch

departresH

b) have arrangements to ensre that its management and personnel are free from any nde internal and

e6ternal commercial# financial and other pressres and inflences that may adversely affect the *ality of

their workH

c) have policies and procedres to ensre the protection of its cstomer>s confidential information and

proprietary rightsH

d) have policies and procedres to avoid involvement in any activities that might diminish confidence in its

competence# impartiality# "dgement or operational integrityH

e) define# with the aid of organizational charts# the organization and management strctre of the reference

material prodcer# its place in any parent organization# and the relations between management# technical

operations# spport services# sbcontractors and the *ality management systemH

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f) specify the responsibility# athority and interrelationships of all personnel who manage# perform or verify

work affecting the *ality of reference materials prodcedH

g) have technical management# inclding a technical manager# who has overall responsibility for the

technical operations and the provision of the resorces needed to ensre the re*ired *ality of each

operation which forms part of the reference material prodctionH

h) appoint a member of staff as *ality manager (however named) who# irrespective of other dties andresponsibilities# shall have defined responsibility and athority for ensring that the re*irements of this

ide are implemented and followed at all timesH the *ality manager shall have direct access to the

highest level of management at which decisions are taken on prodction policy or resorcesH

i) appoint depties for key managerial personnel sch as the technical and *ality managers.

4%3 Document and information control

4%3%' General

The reference material prodcer shall establish and maintain procedres to control all docments (both

internally generated and from e6ternal sorces) and other information that form part of its management

system. These may inclde docments of e6ternal origin# sch as standards# gides# test and&or calibration

methods# as well as specifications# instrctions and manals related to the reference material nder

prodction.

7OT! In this conte6t# 8docment9 means any information or instrction inclding policy statements# te6t books#

procedres# specifications# calibration tables# charts# software# etc. These may be on varios media# whether in hard copy

or electronic# and they may be in digital# analoge# photographic or written form.

4%3%2 Document appro&al and issue

4%3%2%'ll docments issed to personnel as part of the management system shall be sitably controlled.

This shall inclde review and approval for se by athorized personnel prior to isse. master list or

e*ivalent# identifying the crrent revision stats of docments in the management system# shall be

established and be readily available to preclde the se of invalid and&or obsolete docments.

4%3%2%2 The procedres adopted shall also ensre that

a) athorized editions of appropriate docments are available at all locations where operations essential to

the effective prodction of reference materials are performedH

b) docments are periodically reviewed and# where necessary# revised to ensre contining sitability and

compliance with applicable re*irementsH

c) invalid or obsolete docments are promptly removed from all points of isse or se# or otherwise assred

against nintended seH

d) obsolete docments retained for either legal or information preservation prposes are sitably marked.

4%3%2%3 2anagement system docments generated by the reference material prodcer shall be ni*ely

identified. Sch identification shall inclde the date of isse and&or revision nmber# page nmbering# the total

nmber of pages or a mark to signify the end of the docment# and the issing athority(ies).

4%3%3 Document chan*es

4%3%3%' %hanges to docments shall be reviewed and approved by designated personnel performing the

same fnction as that condcted for the original review and approval nless specifically decided otherwise.

The designated personnel shall have access to pertinent backgrond information pon which to base their

review and approval.

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4%3%3%2 here practicable# the natre of the change shall be identified in the docment or appropriate

attachments.

4%3%3%3 If the reference material prodcer>s docment control system allows for the amendment of

docments by hand# pending the re$isse of the docments# the procedres and athorities for sch

amendments shall be defined. mendments shall be clearly marked# initialled and dated. revised docment

shall be formally re$issed as soon as practicable.4%3%3%4 Procedres shall be established to describe how changes in docments maintained in

compterized systems are made and controlled.

4%4 equest1 tender and contract re&ie$s

4%4%' !ach re*est# tender or contract concerning the prodction of a reference material shall be reviewed#

following docmented policies and procedres# established by the reference material prodcer to ensre that

a) the re*irements are ade*ately defined# docmented and nderstoodH

b) the reference material prodcer has the capability and resorces to meet the re*irementsH

c) in the case of contracts# any differences between the contract or order re*irements and those in a tender

are resolved to the satisfaction of the reference material prodcer and the cstomer.

7OT! 5 %apability means that the reference material prodcer has access to# for e6ample# the necessary e*ipment#

intellectal and information resorces and that its personnel have the skills and e6pertise necessary for the prodction of

those reference materials in *estion. The review of the capability can inclde an assessment of previos reference

material prodctions and&or the organization of interlaboratory characterization programmes sing samples of similar

composition to the reference materials to be prodced.

7OT! contract can be any written or verbal agreement to provide a cstomer with reference materials from stock

or cstom$prodced.

4%4%2 1ecords of sch reviews# inclding any changes# shall be maintained. 1ecords shall also be

maintained of pertinent discssions with a cstomer relating to the cstomer>s re*irements or the reslts of

the work dring the period of e6ection of the contract or re*est.

4%4%3 The review shall inclde any work that has to be contracted by the reference material prodcer.

4% Use of sucontractors

4%%' The reference material prodcer shall have policies and se docmented procedres to select

competent sbcontractors and shall establish and maintain procedres to ensre that all tasks performed by

sbcontractors comply with specifications set by the reference material prodcer for sch tasks. The reference

material prodcer shall also ensre that sbcontractors comply with any clases of this ide relevant to the

tasks performed by them for the reference material prodcer.

4%%2 The reference material prodcer shall select sbcontractors on the basis of their ability to meet the

re*irements stiplated by the reference material prodcer in terms of both their technical competence and

any specific *ality management system re*irements relevant to their tasks. The technical re*irements that

the sbcontractors shall meet shall be e*ivalent to either all# or the applicable# technical re*irements

specified in %lase , of this ide.

4%%3 ork carried ot by sbcontractors shall be performed according to the specifications set by the

reference material prodcer. Sbcontractors can be paid or non$paidH in all cases# a protocol shall specify the

re*irements for e6ecting their tasks.

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The reference material prodcer shall assess the competence of the sbcontractors by appropriate means.

hilst it is encoraged that sbcontractors e6ecting measrements and testing be accredited to

ISO&I!% 5+4,# this is not a mandatory re*irement. There are other ways to assess sbcontractor

competence# e.g. adit# performance on *ality control materials# historical performance on inter$laboratory

comparisons (see also ,./.).

4%%4 The reference material prodcer shall maintain a register of all sbcontractors sed and inclde arecord of any assessments made of their abilities to carry ot contracted tasks according to the re*irements

of this ide. These records shall inclde any *ality assrance approval the sbcontractor holds.

4%. 5rocurement of ser&ices and supplies

4%.%' The reference material prodcer shall have policies and procedres in place for the selection of

services and spplies that affect the *ality of its reference materials.

4%.%2 The reference material prodcer shall se only those services and spplies that comply with specified

re*irements to ensre the *ality of the reference materials it prodces.

4%.%3 hen no formal approval of the *ality of services and spplies is available# the reference material

prodcer shall have procedres to ensre that prchased spplies and services comply with specified

re*irements# and records of actions taken shall be maintained.

4%.%4 The reference material prodcer shall ensre that prchased e*ipment and consmable materials

are not sed ntil they have been inspected# calibrated or otherwise verified as complying with the

specifications or re*irements defined in specifications for prodction# characterization and certification of the

reference materials it prodces.

4%.% The reference material prodcer shall maintain records of the sppliers and sbcontractors from

whom it obtains services and spplies. These records shall inclde any *ality assrance approval the

sppliers and&or sbcontractors hold.

4%/ "ustomer ser&ice

4%/%' The reference material prodcer shall be willing to cooperate with cstomers or their representatives

in clarifying the cstomer>s re*ests and *estions.

4%/%2 The reference material prodcer shall seek feedback# both positive and negative# from its cstomers.

The feedback shall be sed and analysed to improve the management system# reference material prodction

activities and cstomer service.

4% "omplaints

The reference material prodcer shall have a policy and procedre for the resoltion of complaints received

from cstomers or other parties. 1ecords shall be maintained of all complaints and of the investigations and

corrective actions taken by the reference material prodcer (see also 0.54).

4%9 "ontrol of non6conformin* $or7 and8or reference materials

4%9%' The reference material prodcer shall have a policy and procedres that shall be implemented when it

establishes that any aspect of its prodction activities does not conform to its own specified prodction

procedres or the agreed re*irements of the cstomer.

The policy and procedres shall ensre that

a) responsibilities and athorities for the management of non$conforming work are designatedH

b) the actions# which shall be taken when any non$conforming work and&or reference materials are identified#

are defined# together with a system which ensres that they are effectively implementedH

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c) an evalation of the significance of the non$conforming work is madeH

d) where necessary# work is halted and# if appropriate# isse of the affected reference material and its

certificates (and statements) withheldH

e) remedial actions are taken within a defined time$frameH

f) where necessary# the cstomers who# within an appropriate period# have prchased the reference

material are notified of the possible effects identified and# where necessary# non$conforming referencematerials and&or their certificates&statements already distribted# are recalledH

g) the responsibility for athorization of the resmption of work is defined.

The decision on recall of reference materials shold be taken in a timely manner to limit the se of

non$conforming reference materials by cstomers.

The identification of non$conforming reference materials or problems with the management system or with

certification activities can occr at varios places within the management system# sch as cstomer

complaints# *ality control# checking of consmable materials# staff observations or spervision# certificate

checking# management reviews and internal or e6ternal adits.

4%9%2 here the evalation indicates that the non$conforming work and&or reference materials cold recr

or that there is dobt abot the reference material prodcer>s compliance with its own policies and procedres#

the corrective action procedres in 0.54 shall be promptly followed to identify the cases of the problem and to

eliminate them.

4%'0 "orrecti&e actions

4%'0%' General

The reference material prodcer shall establish a policy and procedres and shall designate appropriate

athorities for implementing corrective actions when non$conforming reference materials# non$conforming

work on the prodction of reference materials or departres from the policies and procedres in the

management system have been identified.

7OT! problem with the management system or with technical operations may be identified throgh a variety of

activities within the management system# sch as control of non$conforming reference materials# internal or e6ternal adits#

management reviews and feedback from cstomers or staff observations.

4%'0%2 "ause anal-sis

%orrective action procedres shall start with an investigation to identify the root cases of the problem. This is

sometimes the most difficlt# bt is the key part in the corrective action procedre.

Often the root case is not obvios and ths a carefl analysis of all potential cases of the problem is

re*ired. Potential cases cold inclde# inter alia# the natre of the reference material and its specifications#

methods and procedres sed for characterization# staff skills and training# and the materials and e*ipment

(and&or its calibration) sed in the prodction processes. This shall be reviewed for both in$hose prodction

and# where re*ired# any work performed by sbcontractors.

4%'0%3 Selection and implementation of correcti&e actions

here corrective actions are needed# the reference material prodcer shall identify potential corrective actions.

It shall select and implement the action(s) most likely to eliminate the problem and to prevent recrrence.

ny corrective action taken to eliminate the cases of non$conformities or other departres shall be

appropriate to the magnitde of the problem and commensrate with the risks encontered.

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The reference material prodcer shall docment and implement any re*ired changes to the operational

procedres reslting from corrective action investigations.

4%'0%4 ,onitorin* of correcti&e actions

fter having implemented the corrective actions# the reference material prodcer shall monitor the reslts to

ensre that the corrective actions taken have been effective in eliminating the root cases of the problems.

4%'0% dditional auditshere the identification of non$conformities or departres casts dobt on the prodcer>s compliance with its

own policies and procedres# or on its compliance with this ide# the prodcer shall ensre that the

appropriate areas of activity are adited in accordance with 0.50 as soon as possible.

4%'' 5re&enti&e actions

4%''%' 1e*ired improvements and potential sorces of non$conformities# either technical or concerning the

management system# shall be identified. hen improvement opportnities are identified or if preventive action

is re*ired# action plans shall be developed# implemented and monitored to redce the likelihood of the

occrrence of sch non$conformities and to take advantage of the opportnities for improvement.

4%''%2fter the implementation of the preventive actions# the reference material prodcer shall monitor the

reslts to establish any redction in deficiencies or other improvements in this operational area# thereby

establishing the effectiveness of the preventive action.

4%'2 Impro&ement

The reference material prodcer shall continally improve the effectiveness of its management system

throgh the se of the *ality policy# *ality ob"ectives# adit reslts# analysis of data# corrective and

preventive actions and management review.

4%'3 ecords

4%'3%' General

4%'3%'%' The reference material prodcer shall establish and maintain procedres for identification#

collection# inde6ing# access# storage# maintenance and disposal of *ality and technical records.

a) ?ality records

?ality records are records providing ob"ective evidence of the e6tent of the flfilment of the re*irements for

*ality or the effectiveness of the operation of the management system. They inclde reports from internal

adits and management reviews# and corrective and preventive action records.

b) Technical records

Technical records are accmlations of data and information which reslt from carrying ot testing and (if

applicable) calibration procedres and which indicate whether specified *ality or process parameters are

achieved. They inclde forms# contracts# work sheets# work books# check sheets# control charts&graphs#

calibration reports&certificates# reports# certificates and other statements to cstomers.

The reference material prodcer shall ensre that it has recorded sch information that might be needed in a

ftre dispte sitation.

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4%'3%'%2ll records shall be legible and shall be stored and retained in sch a way that they are readily

retrievable and in facilities that provide a sitable environment to prevent damage# deterioration or loss.

1etention time of records shall be established in accordance with legal# accreditation body or cstomer

re*irements# where relevant# and shall be docmented.

1ecords may be in the form of any type of media# sch as hard copy or electronic media.

4%'3%'%3 hen mistakes occr in records# each mistake shall be crossed ot# not erased# made illegible ordeleted# and the correct information entered alongside. ll sch alterations to records shall be signed or

initialled by the person making the correction. In the case of records stored electronically# e*ivalent

measres shall be taken to avoid the loss or change of original information.

4%'3%'%4ll records shall be held secrely and# where appropriate# in confidence.

4%'3%'% The reference material prodcer shall have procedres to protect electronically held data at all

times and to prevent nathorized access to# or amendment of# sch data.

4%'3%2 ecords and reports

The reference material prodcer shall establish and maintain a record system to sit its particlar

circmstances and to comply with any applicable reglations. The reference material prodcer shall arrange

for all individal measrement observations# appropriate calclations and derived data (e.g. statistical

treatments and ncertainty bdgets)# 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 accont the period for

which the reference material remains valid.

The reslts of each calibration or measrement (or series of either) carried ot by the reference material

prodcer shall be reported in accordance with ISO&I!% 5+4,.

0.5/. refers to internal reports of the reference material prodcer which shold not be confsed with a

certificate of analysis or certification report which is spplied with a reference material to the cstomer.

4%'4 Internal audits

4%'4%' The reference material prodcer shall# periodically and in accordance with a predetermined schedle

and procedre# condct internal adits of its activities to verify that its operations contine to comply with the

re*irements of the management system and the re*irements of this ide. The internal adit programme

shall address all elements of the management system# inclding the technical and prodction activities leading

to the finished prodct (reference material). It is the responsibility of the *ality manager to plan and organize

adits as re*ired by the schedle and re*ested by management. Sch adits shall be carried ot by trained

and *alified personnel who are# wherever resorces permit# independent of the activity to be adited.

Personnel shall not adit their own activities.

7OT! The cycle for internal aditing shold normally be completed in one year.

4%'4%2 hen adit findings cast dobt on the effectiveness of the operations or on the integrity of the

reference materials or on the correctness of their docmentation# the reference material prodcer shall take

timely corrective actions and shall notify# in writing# its cstomers whose activities may have been adversely

affected.

4%'4%3ll adit findings and corrective actions that arise from them shall be recorded. The reference material

prodcer>s management shall ensre that these actions are discharged within an appropriate and agreed

timescale.

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4%' ,ana*ement re&ie$s

4%'%' In accordance with a predetermined schedle and procedre# the reference material prodcer>s top

management shall periodically condct a review of its management system and prodction processes to

ensre their contining sitability and effectiveness and to introdce any necessary changes or improvements.

The review shall take accont of

the sitability of policies and procedresHreports from managerial and spervisory personnelH

the otcome of recent internal aditsH

corrective and preventive actionsH

assessments by e6ternal bodiesH

changes in volme and type of workH

feedback from cstomersH

recommendations for improvement inclding complaintsH

other relevant factors sch as resorces# staff training and# where re*ired# technical isses relating to

the competence of the sbcontractor and distribtor of the reference materials.

1eslts shold feed into the corporate planning programme# shold inclde the goals# ob"ectives and action

plans for the coming year and shold be commnicated to the staff.

7OT! typical period for condcting a management review is once every year.

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d) characterization of the material (,.5,)H

e) assignment of property vales and their ncertainties (,.5:)H

f) establishing metrological traceability of assigned vales (,.5.0).

%2 5ersonnel

%2%' The prodcer of reference materials shall have# where possible# competence in the prodction of the

particlar type of reference material (or related material)# as well as having access to e6perience in themeasrement of the properties being determined.

It is recognized that# for the prodction of novel reference materials# persons or organizations with sitable

competence may not be available. In sch cases# the reference material prodcer shold be able to

demonstrate the accmlation of knowledge and e6perience throgh the prodction records of its reference

materials.

%2%2 The reference material prodcer shall ensre the ade*ate competence of all personnel who

ndertake activities relating to the prodction of reference materials. There shall be sfficient personnel

having the necessary edcation# training# technical knowledge and e6perience for their assigned fnctions.

%2%3 The reference material prodcer shall formlate goals with respect to edcation# training and skills of

its personnel. The reference material prodcer shall have a policy and procedres for identifying training

needs and providing training of personnel. The training programme shall be relevant to the present and

anticipated tasks of the prodcer. The effectiveness of training actions shall be evalated.

The need to retrain staff periodically shold be considered (e.g. the reference material prodcer shold have

in place a policy for retraining staff when a method or measrement techni*e is not in reglar se). Staff

training and retraining policies shold take into accont technological changes and aim at continos

pgrading of skills.

%2%4 The reference material prodcer shall maintain an p$to$date record of "ob descriptions for the

managerial# technical and spport staff involved in reference material prodction activities.

%2% The reference material prodcer shall se personnel who are employed by# or nder contract to# the

prodcer. here contracted and additional technical and spport personnel are sed# the prodcer shall

ensre that sch personnel are spervised and competent and that they work in accordance with the

prodcer>s management system.

%2%. The reference material prodcer shall athorize specific personnel to perform particlar activities

relating to reference material prodction. The reference material prodcer shall maintain an p$to$date record

of the athorizations# competence and edcational and professional *alifications of all staff members. These

records shall provide evidence that individal staff members have been ade*ately trained and that their

competence to complete particlar types of material processing and measrement has been assessed. This

information shall be readily available and shall inclde the date on which athorization and&or competence is

confirmed.

%3 Sucontractors

%3%' here a reference material prodcer ses sbcontractors to ndertake part of the procedre for the

prodction# inclding processing# homogeneity and stability testing# characterization# handling# storage or

distribtion of a reference material# the prodcer shall be able to demonstrate that the sbcontractor is

competent to perform the concerned part of the procedre# and that the work carried ot and&or the reslts

prodced are of the re*ired *ality. hen assessing the competence of a sbcontractor# the reference

material prodcer shall ac*ire and evalate information on the sbcontractor>s knowledge of the sb"ect and

details of past e6perience in the field and make sre that e6perienced staff is available as well as appropriate

accommodation and environmental conditions# instrmentation and measring e*ipment as re*ired.

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Processes that shall not be carried ot by sbcontractors are pro"ect planning# selection of sbcontractors and

the assignment of and decision on property vales. lso# athorization of property vales and isse of

certificates&statements&analysis reports&information sheets (or however named) shall be done by the reference

material prodcer.

%3%2 !vidence of the sbcontractor>s competence shall be established and records of its competence

maintained. This can be done by different means. ccreditation to ISO&I!% 5+4, when testing or calibrationis carried ot# or certification of the *ality management system to ISO ;445 for other (non$testing&calibration)

activities by a recognized body# is generally appropriate. In cases where accreditation is not practical#

evidence of sbcontractors sccessflly participating in a relevant proficiency testing scheme and prodcing

acceptable reslts on well$characterized materials of similar or e*ivalent natre to that of the candidate

reference material may also be considered appropriate. In cases where the competence of sbcontractors

cannot be ascertained via provision of docmentary evidence# the reference material prodcer may need to

assess the competence of the sbcontractor on$site or may need to spervise on$site the operations carried

ot by the sbcontractor.

The prodcer may consider distribting materials of a comparable matri6 whose property vales are well

established and at appropriate concentration levels# etc.# prior to or together with distribting any candidate

reference material samples to help in the evalation of the sbcontractor.

%3%3 In certain cases# the reference material prodcer may have no laboratory facilities or processing

facilities# or may choose not to se its own facilities. It shall ensre that all work carried ot by sbcontractors

who may contribte to the assignment of the property vales of interest is fit for that prpose and in

compliance with this ide and ISO&I!% 5+4, for measrement# calibration and testing.

@nder these circmstances the reference material prodcer shall

employ personnel having knowledge to ensre that sbcontracted activities are e6ected in compliance

with this ide and ISO&I!% 5+4, for measrement and testing# and

evalate the reslts of all sbcontracted activities (e.g. analytical and statistical aspects).

%3%4 The reference material prodcer shall ensre that all details of the methodology# reslts and the

descriptions of procedres of any sbcontractor are available. Sitable details of methodology shall be

maintained by the reference material prodcer to allow the technical evalation of data. If re*ired# it shall

ensre that a register&database of all sbcontractors and the accreditation for testing# calibration and

measrement activities# certification of the management system or other forms of competence stats are

maintained.

%4 5roduction plannin*

%4%' The reference material prodcer shall identify and plan those processes which directly affect the

*ality of reference material prodction and shall ensre that they are carried ot in accordance with specified

procedres. here available# procedres given in technical standards for the prodction of specific reference

materials shall be sed.

%4%2 Technical inpt of the different sbcontractors involved shall be identified and the necessary

information docmented and reglarly reviewed. mechanism (e.g. a management&technical advisory grop)

may be established to make recommendations on how to plan the prodction processes.

7OT! These cold inclde recommendations for prodction# setting p a monitoring system (to ensre timeliness

and *ality for each prodction phase) and having an evalation procedre to assess the prodction processes

retrospectively.

%4%3 In planning the prodction processes# the reference material prodcer shall have procedres and

service facilities# for

a) definition of storage conditionsH

b) material selection (inclding# where appropriate# sampling)H

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c) maintaining sitable environments for all aspects of prodction (,.:)H

d) material processing (,.=)H

e) measring&testing (,.;# ,.54)H

f) validation of measrement methods (,.;)H

g) verification and calibration of e*ipment (,.54)H

h) assessing material homogeneity (,.5/)Hi) assessing material stability (,.50)H

") designing and organizing appropriate interlaboratory e6ercises for the prpose of assigning property

vales# if applicable (,.5,)H

k) assessing commtability (where appropriate) (nne6 G)H

l) assigning property vales based on the reslts of measrements# if applicable (,.5:)H

m) establishing ncertainty bdgets and estimating ncertainties of the assigned property vales# if

applicable (,.5:)H

n) defining acceptance criteria for verifying that ncertainty estimates are applicable for replacement

batches of reference materials prodced nder conditions described in ,.5H

o) establishing metrological traceability of the measrement reslt(s) (,.5)H

p) issing certificates and&or other docmentation (,.5+)H

*) ensring ade*ate storage facilities and conditions (,.+)H

r) ensring appropriate labelling and packaging of the samples meeting safety reglations (,.+)H

s) ensring appropriate transport arrangements which comply with shipping reglations (,.5=)H

t) ensring post$certification stability monitoring# if applicable (,.50)H

) ensring an ade*ate post$distribtion service for reference material cstomers (,.5=).

% 5roduction control

The reference material prodcer shall identify the verification procedres necessary to ensre the *ality of

each stage of reference material prodction# and shall assign ade*ate resorces and personnel for sch

activities. These activities shall inclde inspection# testing and monitoring of all stages of prodction.

%. ccommodation and en&ironmental conditions

%.%' The reference material prodcer shall ensre that all laboratory accommodation# calibration and

measrement areas (if applicable)# material processing and packaging areas# energy sorces# lighting#

hmidity# temperatre# pressre and ventilation are sch as to facilitate proper material processing and

packaging# as well as proper performance of calibration and measrements (if applicable).

Precations shall be taken against possible contamination of the reference material dring its processing and

characterization. ll reference material processing and testing areas# in addition to satisfying re*irements for

hmidity and temperatre# shall be protected from vibration# airborne dst and microbiological contamination#

magnetic fields and electromagnetic radiation (as appropriate). The technical re*irements for

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% ,aterial processin*

The reference material prodcer shall establish procedres to ensre that the item or material has ndergone

ade*ate processing for its intended se. Procedres for material processing shall inclde# where appropriate#

a) *alitative analysis for verification of material type and&or identityH

b) synthesis# prification (e.g. distillation# e6traction)# transformation into the final form (e.g. machining#

grinding# blending# sieving and riffling# e6trsion# melting)Hc) homogenizationH

d) proper handling (e.g. protection from contamination and se of inert e*ipment)H

e) measrements for processing control (e.g. particle size distribtion# moistre content)H

f) cleaning of sample containersH

g) stabilization of material (e.g. drying# irradiation# sterilization)H

h) packaging (e.g. bottling# ampoling) of the batch.

%9 ,easurement methods

%9%' The reference material prodcer shall meet the re*irements of ISO&I!% 5+4,/) with respect to tests#

calibrations and measrements nder their responsibility (inclding preparation of items# sampling# handling#

preservation# storage# packaging# transport to sbcontractors# estimation of measrement ncertainty and

analysis of measrement data). These activities shall be consistent with the re*ired accracy# where

appropriate# of the assigned vales of the reference material# and with any standard specifications relevant to

the measrement concerned.

%9%2 2easrement methods developed in$hose by the reference material prodcer shall be validated and

athorized before se. Sch methods shall be thoroghly investigated# and shall clearly and e6actly describe

the necessary conditions and procedres for which the measrement of the property vales of interest is valid

at the level of accracy commensrate with the intended se of the reference material. 1ecords of the method

of validation shall be retained. Balidation shall meet the re*irements of ISO&I!% 5+4,.

%9%3 here sampling is carried ot as part of the measrement method (e.g. sb$sampling a

representative *antity from a batch of material)# the reference material prodcer shall se docmented

procedres and appropriate statistical techni*es to take test portions.

%'0 ,easurin* equipment

%'0%' 2easring e*ipment sed in reference material prodction shall be sed in compliance with

ISO&I!% 5+4,. It shall be properly calibrated# verified and maintained# with all procedres being docmented

and the reslts recorded. here appropriate# periodic performance checks shall be carried ot and recorded

(e.g. to check the response# stability# linearity# resoltion# alignment# repeatability) to ensre that the

measrement e*ipment is performing ade*ately. The fre*ency of sch performance checks shall be

determined by e6perience and based on the type and previos performance of the e*ipment. Intervals

between checks shall be shorter than the defined time within which the e*ipment has been fond to drift

otside acceptable limits# in accordance with the re*irements of ISO 5445.

%'0%2ny item of e*ipment that has been sb"ected to overloading or mishandling# shown to provide

sspect reslts# or shown by verification or otherwise to be defective# shall be clearly identified# withdrawn

from service and# wherever possible# stored at a specified location ntil repaired and shown by calibration#

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verification or testing to perform satisfactorily. The reference material prodcer shall review the implications for

reslts obtained sing sch e*ipment# with particlar regard to the e6tent of the calibration deviation# the

reslts involved and the allowable tolerance on the reslts. here reslts have been significantly in error# the

reference material prodcer shall have the reslts checked and shall take appropriate remedial action.

1ecords of the review and any checks&remedial action shall be maintained.

%'0%3 !ach item of e*ipment# inclding any measrement standard# that is sed in thecalibration&validation of e*ipment&measrement methods sed for reference material prodction shall# where

appropriate# be labelled# marked or otherwise identified to indicate its calibration stats and e6piry date. This

shall also inclde reference materials# standard soltions and chemical reagents sed in chemical analysis#

microbiological testing# etc.

%'0%4ll measring and testing e*ipment having an effect on the traceability and accracy of the

measrement reslts shall be calibrated and&or verified before being commissioned into service. The

reference material prodcer shall have an established programme for the calibration and verification of

measring and testing e*ipment.

%'0% The overall programme of calibration and&or verification of e*ipment shall be designed and operated

so as to ensre that# wherever applicable# measrement reslts obtained by the reference material prodcer

are traceable to a stated reference throgh an nbroken chain of calibrations with stated ncertainties.

%alibration certificates of measrement instrments shall# wherever appropriate# indicate the metrological

traceability to this stated reference.

%'' Data e&aluation

%''%' The reference material prodcer shall ensre that calclations and data transfers are sb"ect to

appropriate checks# inclding those from its own sorces.

%''%2 here compters or compter$controlled systems are sed for the captre# processing# evalation#

recording# reporting# storage or retrieval of calibration or testing data# the reference material prodcer shall

ensre that

a) compter software developed in$hose or off$the$shelf software frther developed for specific se# which

affects the characterization or the properties of the reference material# shall be validated and shown to be

ade*ate for seH

b) procedres are established and implemented for protecting the integrity of dataH sch procedres shall

inclde# bt are not limited to# integrity of data entry and captre# data storage# data transmission and

data processingH

c) e*ipment is maintained to ensre proper fnctioning and is provided with the environmental and

operating conditions necessary to maintain data integrityH

d) appropriate procedres are established and implemented for the maintenance of data secrity# inclding

prevention of nathorized access to# and amendment of# compter records.

%''%3ll technical data relating to the prodction of reference materials shall be retained in accordance with

the re*irements of 0.5/..

%'2 ,etrolo*ical traceailit-

%'2%' The reference material prodcer shall provide docmentary evidence on the metrological traceability#

of the measrement reslts to a stated reference (see also /.+).

7OT! The concept of 8metrological traceability9 incldes identification of the property of interest of the reference

material# the nmerical vale and the stated reference.

%'2%2 The stated reference shall be a definition of a measrement nit throgh its practical realization# a

measrement procedre inclding the measrement nit# or a measrement standard. herever possible#

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metrological traceability shall be achieved throgh an nbroken chain of calibrations# all having stated

ncertainties. here this cannot be achieved# the reference material prodcer shall provide satisfactory

evidence of the correlation of reslts with other stated vales# either by e6hastive evalation of the

measrement process or by comparison with known and accepted certified reference materials# which have

certified vales preferably with comparatively small ncertainty and which are higher in the metrological

traceability hierarchy with few steps of comparison.The concept of 8metrological traceability9 applies to the measrement reslts for the assessment of

homogeneity and stability as well as to the assignment of vales as the reslt of the characterization process.

The definition of reference material as 8sfficiently homogeneos and stable with respect to one or more

specified properties9 inherently re*ires a clear definition of these properties. 2etrological traceability of

measrement reslts to the chosen reference shall be ensred to make relevant statements on the degree of

homogeneity and stability.

%'2%3 'ifferent re*irements apply for relative assessments and absolte assessments.

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7OT! These re*irements are met if appropriate selectivity# limit of *antification# working range# precision and

treness of a method have been established.

%'2%4 To ensre the metrological traceability of the assigned vales# the reference material prodcer shall

provide docmentary evidence that all measrement reslts sed for vale assignment are traceable to the

same reference as the assigned vale.

7OT! combination of reslts obtained by different methods and&or laboratories K all being traceable to the samereference K is also traceable to this reference.

n additional discssion on the concept and re*irements of metrological traceability is given in nne6 .

%'3 ssessment of homo*eneit-

%'3%'ssessment of homogeneity is always re*ired to establish that the degree of homogeneity of the

reference material with respect to the property(ies) of interest is fit for prpose.

The definition of reference material as 8sufficiently homogeneos9 inherently re*ires *antification or limits

for heterogeneity to demonstrate fitness for prpose. Therefore# the provisions of ISO ide /, for

homogeneity testing also apply for the prodction of non$certified reference materials.

%'3%2 The reference material prodcer shall carry ot an assessment of the homogeneity of any candidate

reference material. In most cases# this involves analysing a representative nmber of randomly# systematically

or stratified randomly chosen nits. Testing# calibration# measrement# sampling or other activities performed

for the assessment of homogeneity shall be carried ot in compliance with ISO&I!% 5+4,. 2easrement

procedres shall be selected so that the repeatability is fit for the prpose re*ired. The homogeneity stdies

shall be designed and performed in accordance with ISO ide /,. lthogh the measrement vales do not

have to be commnicated to cstomers# the degree of homogeneity (e.g. e6pressed as ma6imm betweenbottle

variation) shall be indicated in the docmentation accompanying the reference material.

If the material is prodced in several batches# it is necessary to test the e*ivalence of the batches (or to

assign property vales to each batch separately).

The assessment shall be performed after the material has been packaged in its final form nless stability

stdies indicate that storage shold be maintained in blk form. In some cases# intermediate homogeneity

checks may be necessary (e.g. prior to bottling&ampoling).

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The definition of reference material as 8sufficiently stable9 inherently re*ires *antification or limits for

degradation to demonstrate fitness for prpose. Therefore# the provisions of ISO ide /, for stability testing

also apply for the prodction of non$certified reference materials.

%'4%2 The stability of the reference material shall be assessed. Testing# calibration# measrement# sampling

and other activities performed for the assessment of stability shall be carried ot in compliance with

ISO&I!% 5+4,. Stability testing can be performed only if sfficient homogeneity is demonstrated. The stabilitystdies shall be designed and performed in accordance to ISO ide /,.

The evalation of measrement data as described in ISO ide /, covers only apparently stable materials. In

case of detectable degradation# both the degradation and its ncertainty shall be inclded in the assessment.

The properties of interest of the candidate reference material shall be evalated for the adopted storage

conditions. !ffects of# for e6ample# light# moistre and temperatre shall be evalated in fnction of time for

estimating a lifetime of the reference material and hence establishing a period of validity of the certificate.

lthogh the measrement vales do not have to be commnicated to cstomers# the degree of stability shall

be indicated in the docmentation accompanying the reference material.

%'4%3 The stability of the material nder transport conditions shall be assessed.

%'4%4 here appropriate# an assessment of the stability of the reference material shall be performed at

periodic intervals after characterization# to confirm that all vales are maintained from prodction ntil the

e6piry date. The reference material prodcer shall provide a period of validity of the certificate which is stated

in the docmentation accompanying the material. It shall be made clear on the docmentation on which

starting date the period of validity is based (e.g. the date of certification# the date of shipment of the reference

material or the date of opening the packaging).

%'4% The reference material prodcer shall inform its cstomers abot shelf$life changes of the reference

material inclding possible conse*ences for its se.

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%'. ssi*nment of propert- &alues and their uncertainties

%'.%' The reference material prodcer shall se docmented procedres# as otlined in ISO ide /,# for

the assignment of property vales.

These procedres shall inclde# as appropriate3

a) details of the e6perimental designs and statistical techni*es sedH

b) policies on treatment and investigation of statistical otliers and&or the se of robst statisticsHc) whether weighting techni*es are sed for contribtions to assigned property vales derived from

different methods with different measrement ncertaintiesH

d) the approach sed to assign ncertainties to the property valesH

e) any other significant factors which may affect the assignment of property vales.

The reference material prodcer shall never rely entirely on only a statistical analysis of the characterization

data when assessing the property vales of interest. Otliers shall not be e6clded on statistical evidence ntil

they have been thoroghly investigated and# where possible# the reasons for the discrepancies identified.

lternatively# the se of robst statistics may be appropriate in some cases.

hen several methods have been sed to characterize a reference material# difficlty may arise when the

reslts show significant differences# in which case a property vale based on the mean is inappropriate. It is

essential in sch cases that the reference material prodcer and its sbcontractors have considerable

e6perience of the different methods and are able to give more or less weight to the reslts from the se of a

particlar measrement method. In some cases# the reslts may be weighted according to the inverse of the

variance of each method. In some cases# measrement methods will prodce irreconcilable reslts and it may

be necessary to assign separate property vales according to the methods sed (i.e. a method$specific

approach).

In assigning the property vales of interest# the reference material prodcer shall consider establishing a

grop of independent e6perts whose responsibility is to check that all work# data and docments are fit for

their prpose.

%'.%2n important aspect of establishing the property vales of the reference material being prodced is an

assessment of their ncertainties. The reference material prodcer shall carry ot an assessment of the

measrement ncertainties to be inclded in the assignment of the property vales in accordance with the

re*irements of the @2 (ISO&I!% ide ;=$/). In the process of estimating ncertainties of the property

vales of interest# any ncertainties reslting from between$nit variations and&or from possible dobts on

stability (both dring storage and dring transportation) shall be assessed in accordance with ISO ide /,

and shall be inclded in the assigned ncertainty.

statement of the measrement ncertainty is mandatory for certified vales. In case vales are assigned to

non$certified reference materials (e.g. 8indicative vales9 or 8information vales9)# a statement of ncertainties

is highly recommended to improve the se of the material.

%'/ "ertificates or documentation for users

The reference material prodcer shall isse a certificate for certified reference materials and provide

appropriate docmentation for non$certified reference materials in the form of a statement# analysis report# or

information sheet howsoever named.

The contents of certificates for certified reference materials shall comply with the re*irements of

ISO ide /5. If the certificate also contains non$certified vales# a clear distinction shall be made between

certified and non$certified vales.

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The docmentation for non$certified reference materials shall inclde information on homogeneity and stability

and on the period of validity of the stated information. It shall also contain information for the ser on the

proper application and storage conditions of the reference material.

7OT! In some cases which are covered by specific legislation (e.g. most pharmacopoeia assay standards)# the

ncertainties of the assigned vales are not stated since they are considered to be negligible in relation to the defined

limits of the method$specific assays for which they are sed.%' Distriution ser&ice

%'%' The distribtion process shall be careflly stdied to avoid deterioration of the reference material

(see ,.50./). The prodcer shall determine the conditions of shipment# the ma6imal time the shipment may

endre nder the conditions chosen and what docmentation is re*ired to allow cstoms clearance.

7OT! activities after they have prchased. Therefore# the re*irements regarding distribtion service

to sch resellers are limited to the first reseller as with any direct cstomer.

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(informative)

,etrolo*ical traceailit- of certified propert-

&alues of reference materials

%' "oncept of metrolo*ical traceailit-

2etrological traceability is defined in the BI2 (ISO&I!% ide ;;344+# .05) as the 8property of a

measrement reslt whereby the reslt can be related to a reference throgh a docmented nbroken chain

of calibrations# each contribting to the measrement ncertainty9. In other words# when the reslt of a

measrement is described as traceable# it is essential to specify to which reference metrological traceability

has been established. It can be to a base *antity of the International System of @nits (SI) (sch as the

ampere)# to a derived *antity (sch as mass fraction)# to a defined scale (sch as pC or hardness)# to a vale

represented by a reference material or to a vale reslting from the se of a method described in a national or

international standard.

In the case of reference materials for physical properties# it is sally possible to establish metrological

traceability via a series of instrment calibrations to the appropriate base *antities of the SI.

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(informative)

"ommutailit- of reference materials

;%' "oncept of commutailit-

material is said to be commtable when e*ivalent mathematical ratios are observed for the reslts for a

stated measrand obtained from the application of different measrement procedres both to the material and

to a set of rotine test samples containing the measrand.

In the particlar case of a reference material# the assessment of commtability re*ires a comparison of the

relationship between the property vales assigned to a reference material and to standard test samples sing

both a 8higher$order9 reference measrement procedre and one or more 8lower$order9 rotine measrement

procedres. If the ratio between the reslts obtained for the reference material by the reference procedre and

each of the rotine measrement procedres is the same as the ratio of the reslts for representative test

samples analysed by the same set of measrement procedres# the reference material is said to be

commtable and can be sed for establishment of metrological traceability.

If a 8higher order9 reference measrement procedre is not available# at least harmonization can be achieved

if commtability has been established throgh comparison of the relationship between the property vale

assigned to a reference material and to representative rotine test samples sing the two measrement

procedres to be harmonized.

In other words# a reference material is commtable if the behavior of the target analyte towards a given

measrement procedre is e*ivalent in the reference material and in rotine test samples. This implies that

the application of the procedre to the reference material wold prodce the same *antitative response as a

normal test sample containing the same amont&activity&concentration of the analyte. It is important to note

that there is no a priori re*irement that the application of different procedres nominally for determination of

the same measrand to a commtable reference material will necessarily prodce *antitative reslts for the

measrand that are in close absolte agreement. The only constraint for the establishment of commtability is

that the ratio of the reslts obtained with the different procedres be e*ivalent both for the reference material

and for the rotine samples.

Statements abot the commtability of a reference material always re*ire specification of the measrement

procedres for which it is fond to be commtable. Fikewise# commtability of the reference material may be

demonstrated relative to some rotine procedres bt not towards others. In cases where the reference

material is commtable with all methods investigated# it does not imply that it is commtable with any method.

There are a nmber of definitions of commtability given in varios standard or gidance docments. They all

agree on the basic principles of the concept and the process for the establishment of commtability# bt differ

in wording and details of the natre of the materials sed in the assessment of commtability and the

description of how the relationship between measrement procedres is to be established.

In this ide# the BI2 (ISO&I!% ide ;;344+# ,.5,) definition of commtability is sed (see /.:).

The desirability of determining the commtability of reference materials was first established in clinical

chemistry# where a range of measrement procedres are sed for the rotine clinical testing of particlar

measrands in patient samples. These procedres rely on a nmber of different physicochemical or

biochemical principles or are based on the detection and measrement of varios sb$components of a

comple6 biomoleclar species that are assmed to relate directly to the level of the clinically significant forms

of the molecle present in the sample. The procedres are sensitive to varying degrees to interferences

arising from differences between the matri6 of a reference material and that of clinical samples# or to

differences in response de to alterations of the analyte (sch as denatration# changes in aggregation#

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oligomeric state# metal binding) and the matri6 in the corse of the prodction of the reference material.

%onse*ently# it is not possible to attribte discrepancies observed among measrement procedres that

have been calibrated or validated by reference materials of nknown commtability to genine problems with

the measrement procedre(s) or to a bias introdced by differences in response of the reference materials

towards the varios procedres nder test.

%alibration or treness control sing reference materials of demonstrated commtability prodces test resltsthat are in principle comparable# traceable to the reference measrement system sed to assign the reference

material property vales and withot a calibration bias among the assessed procedres.

The need for the establishment of the commtability of reference materials is not limited to clinical chemistry.

It is desirable in any field where the measrement procedres in rotine se are based on different physical or

chemical principles in comparison to the reference method sed to assign the property vales of a reference

material. It is particlarly important to assess commtability where differences between the matri6 of the

reference material or changes to the secondary&tertiary strctre of the analyte in the reference material

relative to normal test samples cold potentially introdce a bias between reslts obtained with one

measrement procedre relative to the reslts obtained with (an)other procedre(s) when sed on

representative test samples. In the particlar case of clinical chemistry# it is desirable that the commtability of

reference materials be assessed relative to representative clinical samples from healthy individals and if

necessary also from diseased individals.

;%2 ssessment of the commutailit- of reference materials

There are varios approaches reported for assessing commtability of reference materials and leading

references are provided in the accompanying bibliography. In particlar# the %linical and Faboratory Standards

Institte (%FSI) prodces gidelines relevant to the establishment of commtability for reference materials for

se in clinical chemistry.

The simplest case is the establishment of the commtability of a reference material relative to two

measrement procedres# one of them preferably being a measrement procedre of higher metrological

order. The mathematical relationship between the reslts obtained sing rotine test samples is determined

sing both measrement procedres. 1egression analysis can be sed to establish the relation between the

reslts obtained with the two procedres and typically a ;, - prediction interval is calclated to describe the

distribtion of the reslt ratio e6pected for rotine samples. If the reslt ratio obtained for the reference

material sing the two methods is consistent with the confidence interval calclated for representative test

samples# the reference material is commtable with respect to the rotine measrement procedre. The ;, -

prediction interval shold be consistent with the precision level allowable for given applications of the

measrement procedres. Therefore# a large scatter in the correlation plot shold trigger either a refinement

of the measrement procedres to make them detect the same analyte or different analytes in a constant

concentration ratio in typical rotine samples or shold lead to a redefinition of the analyte and eventally

e6isting reference measrement procedres. Only then can comparability between reslts of different

measrements procedres on typical rotine samples be achieved.

!6amples of references to more comple6 approaches sing mltivariate statistical assessments that can be

sed to establish the commtability of a reference material to mltiple test procedres are given in the

Gibliography (see 1eferences DE# D/E# D0E# D5:E).

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nne "

(informative)

ISO8IE" '/028ISO Guide 34 cross6reference tale

Only closely corresponding sbclases are listed in the same row. %ells are left empty if the respective

docment has no closely corresponding sbclase.

ISO8IE"'/02:200 ISO Guide 34:2009

' = Scope ' = Scope

2 = (ormati&e reference 2 = (ormati&e references

3 = )erms and definitions 3 = )erms and definitions

4 = ,ana*ement requirements 4 = Or*ani+ation and mana*ement requirements

4%' Or*ani+ation 4%2 Or*ani+ation and mana*ement

0.5.5 0..5

0.5. 0..

0.5./ 0..

0.5.0 0../b)# d)

0.5., 0../

0.5.:

4%2 ,ana*ement s-stem 4%' ,ana*ement s-stem requirements

0..5 0.5.5

0.. 0.5.

0../ 0.5.e)

0..0

0..,

0..: 0.5./

0..+

4%3 Document control 4 %3 Document and information control

0./.5 0./.5

0./. 0./.

0././ 0././

4%4 e&ie$ of requests1 tenders and contracts 4%4 equest1 tender and contract re&ie$s

0.0.5 0.0.50.0. 0.0.

0.0./ 0.0./

0.0.0

0.0.,

4% Sucontractin* of tests and calirations 4% Use of sucontractors

0.,.5 0.,.5

0.,.

0.,./

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ISO8IE"'/02:200 ISO Guide 34:2009

0.,.0 0.,.0

0.,.

0.,./

4%. 5urchasin* ser&ices and supplies 4%. 5rocurement of ser&ices and supplies

0.:.5 0.:.5

0.:. 0.:.0

0.:./

0.:.0 0.:.,

0.:.

0.:./

4%/ Ser&ice to the customer 4%/ "ustomer ser&ice

0.+.5 0.+.5

0.+. 0.+.

4% "omplaints 4% "omplaints

4%9 "ontrol of nonconformin* testin* and8or

caliration $or7

4%9 "ontrol of non6conformin* $or7 and8or

reference materials

0.;.5 0.;.5

0.;. 0.;.

4%'0 Impro&ement 4%'2 Impro&ement

4%'' "orrecti&e action 4%'0 "orrecti&e actions

0.55.5 0.54.5

0.55. 0.54.

0.55./ 0.54./

0.55.0 0.54.0

0.55., 0.54.,

4%'2 5re&enti&e action 4%'' 5re&enti&e actions

0.5.5 0.55.5

0.5. 0.55.

4%'3 "ontrol of records 4%'3 ecords

0.5/.5. 0.5/.5

0.5/. 0.5/.4%'4 Internal audits 4%'4 Internal audits

0.50.5 0.50.5

0.50. 0.50.

0.50./ 0.50./

0.50.0 0.50.0

4%' ,ana*ement re&ie$s 4%' ,ana*ement re&ie$s

0.5,.5 0.5,.5

0.5,. 0.5,.

= )echnical requirements = )echnical and production requirements

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ISO8IE"'/02:200 ISO Guide 34:2009

%' General %' General

,.5.5

,.5.

%2 5ersonnel %2 5ersonnel,..5 ,..

,.. ,../

,../ ,..,

,..0 ,..0

,.., ,..:

,..5

%3 ccommodation and en&ironmental

conditions

%. ccommodation and en&ironmental

conditions

,./.5 ,.:.5

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,././ ,.:.5

,./.0

,./.,

,.:.

%4 )est and caliration methods and method

&alidation

%9 ,easurement methods

,.0.5 ,.;.5

,.0.

,.0./

,.0.0 ,.;.

,.0.,

,.0.:

,.0.+ ,.55.5# ,.55.

,.;./

% Equipment %'0 ,easurin* equipment

,.,.5

,.,. ,.54.5# ,.54.0

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,.,.:

,.,.+ ,.54.

,.,.= ,.54./

,.,.;

,.,.54

,.,.55

,.,.5,.54.,

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ISO8IE"'/02:200 ISO Guide 34:2009

%. ,easurement traceailit- %'2 ,etrolo*ical traceailit-

,.:.5

,.:.

,.:./,.5.5

,.5.

,.5./

,.5.0

%/ Samplin*

,.+.5

,.+. ,.;./

,.+./

% >andlin* of test and caliration items

,.=.5

,.=.

,.=./

,.=.0

%9 ssurin* the qualit- of test and caliration

results

,.;.5

,.;.

%'0 eportin* of results

,.54.5

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%3 Sucontractors

,./.5

,./.

,././

,./.0

%4 5roduction plannin*

,.0.5

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ISO8IE"'/02:200 ISO Guide 34:2009

% 5roduction control

%/ ,aterial handlin* and stora*e

,.+.5

,.+.,.+./

,.+.0

,.+.,

,.+.:

% ,aterial processin*

%'' Data e&aluation

,.0.+.5 ,.55.5

,.0.+. ,.55.

,.55./

%'3 ssessment of homo*eneit-

,.5/.5

,.5/.

,.5/./

%'4 ssessment of stailit-

,.50.5

,.50.

,.50./

,.50.0

,.50.,

%' "haracteri+ation

%'.