Four generations of quality: "measuring up" - Spectroscopy ...
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VOL. 33 NO. 5 (2021)
QUALITY MATTERS
Four generations of quality:
“measuring up”
New ISO committee for reference materials committed to excellence in accurate
measurement results
John P. Hammond
Technical Manager, Starna Scientific Limited, 52–54 Fowler Road, Hainault, Essex IG6 3UT, UK
Introduction TC 334—Reference Material continues Metrology (OIML) was held at NBS in
This article, the fourth in the series, in 2021 and beyond, and the key likely Washington, DC. Six international organ-
details the ISO technical committee changes are detailed here. isations and 12 countries were repre-
that is responsible for reference materi- sented. It was recommended that an
als (RMs) etc.1 This Reference Material 1st Generation: the years independent International Commission
committee, formally ISO/REMCO, has between 1940 and 1975 on Reference Materials (REMPA) be
now been reorganised by ISO as TC 334. The first serious effort towards interna- formed to define and gather and
The history of ISO/REMCO is discussed, tional cooperation in the field of RMs disseminate information on RMs as to
together with the probable changes in was the Symposium on an International their availability, ordering information,
this technical committee brought about Reference Materials Program held in properties certified etc. and recommend
by its conversion to TC 334. May 1969 at the then National Bureau a plan of action to increase their avail-
There has always been, and will of Standards (NBS), in Washington, ability on an international scale.
continue to be, collaboration between DC, under joint sponsorship by the
individual producers of RMs, and in many International Committee on Weights 2nd Generation: the years
countries around the World, you will find and Measures (CIPM) and NBS. It was 1975 to 2000
national “mirror” committees reflecting recognised that the need for RMs was REMPA met first in April 1975 at which
and inputting regional decisions into greater than ever before in history and time it established two working groups.
their appropriate ISO representatives. that cooperation on an international In September 1975, the ISO Council
However, many years ago, RM producers scale was needed to meet the World’s transformed REMPA into the Council
recognised that the growing need by the future needs. The Symposium recom- Committee on Reference Materials
analytical community for a number and mended that the International Bureau of (REMCO) with the following six terms
variety of RMs as well as a need for the Weights and Measures (BIPM) be asked of reference. It is interesting to compare
assurance of the quality of RMs called to establish an organisational mechanism the evolution of these terms with the
for collaboration at the international to gather and disseminate information final versions of ISO/REMCO from 2020
level. This has been achieved through on the availability of RMs, their charac- shown in blue.
REMCO, the Council Committee on teristics and prices, coordinate informa- 1) To establish definitions, categories,
Reference Materials of the International tion on the needs for standard reference levels and classification of RMs for
Organization for Standardization (ISO), materials (SRMs), identify potential use by ISO.
which celebrated its 40th anniversary in suppliers of RMs, and coordinate infor- To establish concepts, terms and
2016. The evolution of this organisation mation on potential RM certifying facil- definitions related to RMs.
and its conversion into the formal ISO ities. Subsequent to the symposium, 2) To determine the structure of related
CIPM had to decline this role because forms of RMs.
the limitations of its charter and available To specify the basic characteristics
DOI: 10.1255/sew.2021.a24 resources allowed it to assume only the of RMs as required by their intended
© 2021 The Author responsibility for SI base unit metrologi- use.
cal SRMs. 3) To formulate criteria to be applied
Published under a Creative Commons Given the lack of progress on this for choice of sources for mention in
BY-NC-ND licence important topic, in November 1973 ISO documents (covering also legal
an ad hoc International Meeting on aspects).
RMs, under the sponsorship of the To propose actions on RMs required
International Organization of Legal to support other ISO activities.
www.spectroscopyeurope.com SPECTROSCOPYEUROPE 41
VOL. 33 NO. 5 (2021)
QUALITY MATTERS
4) To prepare guidelines for technical ISO Guide 30 “Terms and defini- The 15th meeting of REMCO in May
committees for making reference to tions used in connection with refer- 1991 saw Mr S. Rasberry (ANSI, NIST)
RMs in ISO documents. ence materials”: harmonises the take the Chair of REMCO. A revised work
To prepare guidelines for ISO vocabulary used in connection with programme was set out for 1991–1996,
Technical Committees when dealing RMs and a specific Task Group “Accreditation”
with reference material issues. ISO Guide 31 “Reference materials— was added, tasked as follows:
5) To propose, as far as necessary, Contents of certificates and labels”: To assess the need for the accredita-
action to be taken on RMs required ensures that users have sufficient tion of RM producers.
for ISO work. information on a CRM To collect, assess and analyse
To communicate with other inter- ISO Guide 32 “Calibration of chem- viewpoints and documentation
national organisations on reference ical analysis and uses of certified concerning the accreditation of RM
material matters. reference materials” was intended for producers.
6) To deal with matters within its users of RM in calibration for chemi- To provide liaison with appropriate
competence arising in relation with cal analysis national and international organisa-
other international organizations and This Guide was incorporated into a tions concerned with accreditation of
to advise Council on action to be scheduled revision of ISO Guide 33 in RM producers.
taken. the 3rd Generation. To produce a draft ISO guide on
To advise the ISO Technical ISO Guide 33 “Uses of certified the requirements for accrediting RM
Management Board (TMB) on refer- reference materials”: describes producers.
ence material issues. how to use CRMs in widely diverse To coordinate future revisions of the
The first meeting of REMCO took fields” resultant ISO guide.
place in January 1976, just prior to the ISO Guide 34 “General require- The 17 th meeting of REMCO in
International Round Table on Reference ments for the competence of refer- April 1994 was given strong support
Materials. ence material producers”: was for its activities in accreditation by
The mandate of REMCO was to carry developed to give users increased the ISO Central Secretariat. The latter
out and encourage a broad international confidence in the “quality” of CRMs foresaw the need for the interna-
effort for the harmonisation, production ISO Guide 35 “Certification of refer- tional accreditation of RM producers
and application of certified reference ence materials—General and statistical under ISO 9002 or compatible qual-
materials (CRMs), and during this period principles”: was intended mainly for ity system and believed that REMCO
REMCO developed a broad series of ISO producers of CRMs had the potential to be recognised as
Guides on RMs: At the 14 th meeting in May 1989, the authoritative body to register RM
ISO Guide 6. “Mention of reference REMCO decided that the subjects of producers.
materials in International Standards” traceability and levels of RMs were The 18th meeting of REMCO in April
This Guide was incorporated into very complicated and reduced its terms 1995 led to an initiative to prepare a
the ISO Directives for technical work as of reference to revising ISO Guide position paper to examine possible
Annex 2c in February 1980 and is, there- 30—“Terms and definitions of reference options, including their pros and cons, for
fore, not recognised today as a separate materials” and harmonising it with the establishing some form of international
entity. terminology in metrology. recognition for RM producers.
1st Generation 2nd Generation 3rd Generation 4th Generation
1940 1975 2000 2021
42 SPECTROSCOPYEUROPE www.spectroscopyeurope.com
QUALITY MATTERS
The 20 th meeting of REMCO was for “certified reference material”, and
strongly focused on draft revised Guide to this day the vast majority are certi-
34 based on the ILAC document. The fied for specific applications within the
ILAC representative to REMCO agreed to pharmacopoeial requirements, and do
take the draft revised Guide 34 to ILAC not contain an associated Expanded The first company
for collaboration to produce a mutually Uncertainty budget for the assigned worldwide to achieve
agreed-to document. value. In 1998, the PDG wanted to
ISO/IEC 17025
The Accreditation Task Group also develop a mechanism to have their
agreed to produce a draft document on RMs accepted as “CRMs” since the term accreditation for liquid
establishing a “Register” of CRM produc- “reference materials” gives the percep- and glass CRMs
ers that also included “quality” state- tion of lower quality. REMCO members …and the preferred supplier
ments about each producer. The intent were divided on this issue but agreed to to leading pharmaceutical
was to put this Register of CRM produc- collaborate with PDG to harmonise the companies, instrument
ers on the Internet via the ISO server. concepts and principles related to the manufacturers and accredited
REMCO undertook a new work initia- certification of RMs. Over 20 years later, laboratories globally.
tive to compile a list of problems faced this debate still rumbles on; the pros and
by CRM producers due to differences in cons of which will be expanded upon
legal and other requirements for label- in the next article in this series, when
ling, packaging and shipping these mate- the history/development of the Quality Certifi
c
2000 of Ac ate
rials to different countries in the World. requirements of the whole GxP pharma- cred
itatio
n
This resulted in the associated Technical ceutical environment will be reviewed. Starna
Scient
2001
ific Lt
d
Report, ISO/TR 11773:2013—Global At the 22nd meeting of REMCO in April
Calib
ratio
n Labo
Is ac ratory
credit
ed in
No. 06
– Ge
nera acco 59
distribution of reference materials. 1999, REMCO approved the final draft
l Requ rd
labor
ator ireme ance with
ies. nts for Int
This the co ernationa
2002
acc
sched reditation mpete l Sta
ndar
ule to de nce of
ISO-IL
AC
this cer monstrat
es testin d ISO/IEC
tific 17
accred -IAF Comm ate, and technical g an
The 21st meeting of REMCO was held
d calib 025:201
of ISO Guide 34 for submission to the
itation uniqu the op com ratio 7
docum é dat eration peten
ent ed ce for n
The mo and fro April of a ma a define
st rec m tim 2017). Th nagem d
ent sys scope spe
2003
numb ent iss e to tim e sch
er as edule tem cified
this cer ue of the e ma
y be to (refer in the
tificate sched revise this certific joint
This , is ava ule of d and ate is
in April 1998 and saw the beginning of ISO TMB for acceptance by its national
acc ilable accred reissue an ess
Servic reditation from itat d. ential
e req is www.u ion, which
uireme subject kas.co bears
nts. to con m. the
tinuing same
confor accred
2004
mity itation
with
United
collaboration with the Pharmacopoeial member bodies, and also requested its
Kingd
om Ac
credit
Matt ation
Ga
United ntley,
Kingdo Chief Exe
m Acc cut
reditat ive Officer
2005
ion Servic
Discussion Group (PDG). This Group ILAC representative to ask ILAC to accept
e
accreditation to ISO 17034
Initial
Certifi
Accred
itation
2006
cate
Issued: : 4 June 200
has prepared reference substances for and to use the revised Guide 34 instead
25 Jan 1
uary
2021
UKAS
under
is appo
a Mem
(formerly Guide 34)
inted
orandum
as the
sole natio
of Und nal accr
over 70 years and the use of most of of the corresponding ILAC document. 2007
ersta edita
nding tion bod
(MoU y for
) with
the Dep the UK by Scan
artment The Accr QR Cod
for Busi edita e to
ness, tion Regu verify
Energy latio
and Indu ns 2009 (SI
strial No
Strategy 3155/200
(BEIS). 9) and
operates
these reference substances is mandated After its publication in 2000, some 2008
by legislation in the member coun- national standards bodies selected ISO
2009
tries. However, these materials do not Guide 34 “General requirements for
strictly comply with the VIM definition the competence of reference material
2010
2011
2012
2013
Secretary Chair Chairman’s Advisory
Stéphane
Sauvage
Angelique Botha Group (CAG)
Chair, Vice Chair, Past
2014
Chair,
WG and AHG
2015
Convenors,
CASCO Representative 2016
2017
2018
WG 6 Information Vice Chair WG 17 Liaison 2019
John P. Hammond Coordination
Services
John P. He Ping 2020
Hammond
2021
WG 10 WG 13 RMs for WG 18 Organic WG 19 Purity RMs
Definitions, qualitative purity reference for inorganic
including review analysis materials materials
of ISO Guide 30 Stefanie Takeshi Saito Zoltan Mester
Michael Trapmann
Winchester
Starna Scientific Ltd
www.starna.com
Figure 1. ISO/REMCO Committee structure (2020).
www.spectroscopyeurope.com SPECTROSCOPYEUROPE 43
VOL. 33 NO. 5 (2021)
QUALITY MATTERS
producers” as the basis for the accredita- until its disbandment in 2021, was Guide(s) under development
tion of RM producers instead of the corre- approved. The “Executive Committee” ISO Guide 85:202x RMs for qualita-
sponding ILAC Guide 12, and so began was renamed the “Chairman’s Advisory tive property values
the process of converting a “Guide” into Group” and was composed of the ISO ISO Guide 86:202x Purity RMs for
a “Standard”, i.e. ISO Guide 34 into ISO Secretary, the Chair and Chair-elect and small organic molecules
17034, a project previously documented the Convenors of the Task Groups, which ISO Guide 87:202x Purity RMs for
in this publication.2 As we shall see later were renamed Steering Groups. metals and metalloids
this conversion did set a precedent, that During this period, this structure was ISO/TR 79:2015 Reference materi-
could be seen as the process that initi- maintained and adjusted to reflect the als—Examples of reference materials
ated the formation of TC 334, but more current work programme, but the format for qualitative properties
of that later. shown in a graphical format in Figure 1, ISO/TR 10989:2009 Reference
It was during this period (in 1995) provides a valuable reference for the 4th m a te r i a l s — G u i d a n c e o n , a n d
that, from a personal perspective, I was Generation discussions detailed below. keywords used for RM categorization
invited by Dr Michael Parkany from ISO During this period the committee ISO/TR 11773:2013 Global distribu-
to present a paper at an International continued to produce both new and tion of reference materials
symposium in Melbourne on “Quality revised guidance documents as follows: ISO/TR 16476:2016 Reference mate-
Assurance and TQM for Analytical labo- ISO Guide 30:2015 Reference mate- rials—Establishing and expressing
ratories”.3 It was also at this symposium rials—Selected terms and definitions metrological traceability of quantity
that I met key personal active in REMCO, ISO Guide 31:2015 Reference mate- values assigned to reference mate-
and as a consequence was invited on rials—Contents of certificates, labels rials
to the Cooperation on International and accompanying documentation The interrelationship of these docu-
Traceability in Analytical Chemistry ISO Guide 33:2015 Reference mate- ments is shown graphically in Figure 2,
(CITAC), and ultimately on to the REMCO rials—Good practice in using refer- in which one should note the following
committee as a UK Industrial representa- ence materials structural aspects:
tive, in a role that continues to this day. ISO Guide 35:2017 Reference mate- At the centre is the standard for
rials—Guidance for characterization Reference Material producers,
3rd Generation: the years and assessment of homogeneity namely ISO 17034.4
2000 to 2020 and stability The adjacent ring provides the asso-
The 23rd meeting of REMCO was held in ISO Guide 80:2014 Guidance for ciated Guide documents, which are
May 2000, and a completely new struc- the in-house preparation of quality either normative references to ISO
ture, which was essentially maintained control materials (QCMs) 17034, or at the very least should be
used for additional guidance associ-
ated with ISO 17034.
The outer ring details other
published/pending documents from
the TC.
ISO Guide 86
ISO Guide 33 Purity RMs for
proper RM use
ISO Guide 30
small organic
molecules 4th Generation: from
RM
terminology
2021 forward
This essential role of supporting ISO
17034 continues as the primary mandate
ISO Guide 80 ISO Guide 87 of TC 334, but here is the first significant
in-house
preparation of
Purity RMs for
metals and
change in this TC.
in-house RMs ISO 17034 metalloids
covering the By definition, an ISO Technical
required “RMP
competence” Committee’s main role is to write stand-
ISO Guide 35
TR 79
ISO Guide 31
Establishing
RM ards, appropriate to its defined area of
RMs for qualitative RM characteristics
properties documentation expertise.
ISO Guide 85 Also, in the language of ISO, a “Guide”,
RMs for
TR 16476
qualitative
property values
is defined as an informative document
Traceability & RMs
which assists an ISO TC in the construc-
tion of standards, appropriate to the TC.
TR 11773
RM distribution TR 10989 However, as you can see from the
RM categorization
above list the ISO/REMCO Guides, in
some cases, are not designed for this
purpose, but are informative documents
Figure 2. ISO/REMCO Guides and TRs (2020). for RM producers per se. So, the first
44 SPECTROSCOPYEUROPE www.spectroscopyeurope.com
VOL. 33 NO. 5 (2021)
QUALITY MATTERS
task that the new TC 334 has to consider keep you updated in the Quality Matters Guide 34”, Spectrosc. Europe 29(4),
is how to meet this requirement and column, as these details are released. 11 (2017). https://www.spectrosco-
convert these Guides into the appropri- So, on reflection, and given the histori- pyeurope.com/quality/future-part-2-
ate standards. cal evolution of “Guides” into “Standards”, changes-iso-17025-and-iso-guide-34
In addition, in a TC structure a Working c.f. ISO Guides 25, and 34 into ISO 3. M. Parkany (Ed.), Quality Assurance
Group is tasked with a specific project 170255 and ISO 17034,4 respectively, and TQM for Analytical Laboratories.
plan, and associated timeframe to inves- ISO/REMCO to ISO TC/334 is not really The Royal Society of Chemistry,
tigate (and produce if appropriate) a an unexpected transition, is it? Special Publication No. 169 (1995).
related standard; and as one can see The next (and future) article(s) will ISBN 0-85404-760-3
from the final ISO/REMCO structure discuss similar and evolving Quality envi- 4. ISO 17034, General Requirements
there are a couple of currently defined ronments. for the Competence of Reference
Working Groups (WG6 and WG17) that “Will their paths converge… only time Material Producers. International
do not meet this requirement. Therefore, will tell?” Organization for Standardization
a structural rearrangement with respect (ISO), Geneva, Switzerland (2016).
to these essential requirements will be References 5. I S O / I E C 17 0 2 5 , G e n e r a l
required. 1. ISO Press Release, https://www. Requirements for the Competence of
These changes, together with other spectroscopyeurope.com/news/ Testing and Calibration Laboratories.
inter-related communication/liaison new-iso-committee-reference-mate- International Organization for
requirements will be discussed at the rials Standardization (ISO), Geneva,
upcoming inaugural virtual TC 334 meet- 2. J. Hammond, “Into the future (Part Switzerland (2017).
ing in early September 2021; and we will 2): changes to ISO 17025 and ISO
John Hammond is an experienced analytical scientist,
spectroscopist and technical marketing professional, skilled
in the development, production and marketing of analytical
systems into highly regulated and controlled industries. A
Fellow of the Royal Society of Chemistry (FRSC), executive
member of ISO/TC334 and an Expert Advisor to the United
States Pharmacopeia, General Chapters, Chemical Analysis
committee.
j.p.hammond@starna.com
www.spectroscopyeurope.com SPECTROSCOPYEUROPE 45
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