UK Weighing Federation Technical Articles

1.4.4 SELF-VERIFICATION
European Self-verification or UK Weights and Measures Act 1985 Self-verification?
The term “self-verification” has become the colloquial expression for the process whereby an
organisation that is suitably accredited/authorised can carry out the conformity assessment
and performance testing on weighing instruments that it has manufactured or, in certain
circumstances, has repaired, installed or distributed. In contrast, “verification” is the term used
when weighing equipment undergoes performance testing and conformity assessment carried
out by a Notified Body such as a Trading Standards Department or an accredited third party
organisation.

There are now three types of self verification:

• UK national self verification, which has its origins under the Weights and
Measures Act 1985
• EC Declaration of Type Conformity which has its origins in the Non-Automatic
Weighing Instruments Directive (NAWI) 2009/23/EC
• Declaration of Conformity to Type based on quality assurance of the
production process, with its origin in the Measuring Instruments Directive
(MID) 2004/22/EC

In practice, there is little difference between the last two, and the obligations that have to be
met by the manufacturer are very similar. It should be noted, however, that there is a subtle
difference in the way these requirements have been implemented in UK legislation. A
manufacturer who is accredited as a “self-verifier” under the NAWI Directive is also allowed to
carry out re-verification of the products that he can initially verify, because the NAWI
concerned do not fall under the control of the Weights and Measures Act 1985 after they have
been placed on the market and taken into service. However, the MID has been implemented in
the UK on a different basis; Automatic Weighing Instruments (AWI) that are subject to the MID
do become subject to the Weights and Measures Act 1985 once they have been placed on the
market and taken into service, therefore re-verification can be carried out either by a Notified
Body or by a manufacturer, repairer, installer or distributor that is accredited under the UK
national self-verification system. A table showing who can verify is given at the end of this
document.

European Self-verification (EC Declaration of Type Conformity under NAWI Directive

2009/23/EC)
Non Automatic Weighing Instruments (NAWI’s), (weighing instruments that require the action
of gravity to determine the mass and require the intervention of an operator during weighing),
which are first placed on the EU market and put into use in EU member states must comply
with the NAWI Directive.

NAWI’s used for controlled applications must have gone through EC type-examination and
been given an EC Type Approval Certificate. They must be manufactured in conformity with
the EC Type Approval Certificate and must be labelled and CE marked in accordance with the
NAWI Directive and other applicable directives.

These NAWI’s must be subject to initial conformity assessment (verification) procedures

whereby either:
• a NAWI notified body examines and tests the instrument and applies the conformity
assessment mark (i.e. TSO Verification) or
• a manufacturer who has in place a quality system which has been approved by a NAWI
notified body as complying with the Directive gives his own EC Declaration of Type
Conformity and applies the conformity assessment mark (i.e. self-verification)

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Getting Quality System approval to make EC Declarations of Type Conformity

An organisation, in the EU or outside it, who is the “manufacturer” of NAWI’s can apply in
writing to a European Commission Notified Body that has NAWI Directive Annex II(2) approval
to assess their quality management system, as complying with the Annex II paragraph 2.3 of
the Directive. In the UK, these notified bodies include:
BSI Management Systems
SGS UK Ltd
NMO

The “manufacturer” must undertake to carry out the obligations arising from the approved
quality system and to maintain the approved quality system to ensure its continuing suitability
and effectiveness. They must make available all relevant information including the
documentation of the quality system presented in a systematic and orderly manner in the form
of written rules, procedures and instructions with a view to ensuring a proper understanding of
the quality programmes, plans, manuals and records and the “design documentation” of the
instruments.

The Notified Body will evaluate the quality system to determine whether it satisfies the
requirements referred to in paragraph 2.3.2 of Annex II to the NAWI Directive. If it does, the
Notified Body will grant to the “manufacturer” an approval of the quality system; which then
permits the “manufacturer” to make EC Declarations of Type Conformity.

Making EC Declarations of Type Conformity

Providing the “manufacturer” adequately implements the approved quality system; carries out
all the examinations and tests consistent with his obligations in the quality system and is
satisfied that the instruments conform with the Type Approval Certificate and meet the
requirements of the NAWI Directive, he can apply the CE marking including the green M and
the identification number of the notified body that approved the quality system. If the
manufacturer has appointed authorised representatives within an EU Member State then they
may also carry out these functions, provided that they are operating under the manufacturers
control and approved quality system. The manufacturer or his authorised representative shall
draw up a written declaration of conformity detailing compliance with the NAWI Directive and
any other applicable directives.

Note: the Directive uses terminology that is sometimes confusing and this is a good example:
“EC Declaration of Type Conformity” is the process whereby the approved
manufacturer carries out the activities defined in his quality system, and applies the CE
mark, the green M and the Notified Body number
“Declaration of Conformity” is the document that identifies the model type and declares
that it complies with all the relevant identified directives.

Keeping the approval to make EC Declarations of Type Conformity

Notified Bodies that have approved the quality systems carry out what is known as EC
surveillance. They periodically carry out audits in order to ensure that the manufacturer is
maintaining and applying the quality system and provide the manufacturer with an audit report.
They carry out visits at the places of manufacture, inspection, testing and storage. They can
carry out full or partial audits, announced or unannounced. The “manufacturer” is required, in
respect of each instrument, to keep available for inspection the documentation of the quality
system; the design documentation of the instrument; and all related quality records. The
manufacturer is also required to inform the notified body of any changes in his quality system.

Self-verifying repaired NAWI Directive Instruments

Once a NAWI Directive weighing instrument has had its first conformity assessment, i.e. EC
Declaration of Type Conformity or EC Verification (see section 1.4.2) and has been put into
use, it ceases to come under the full first-placed-on-the-market arrangements detailed above.
If it has undergone any repair or maintenance process which has affected its metrological
integrity or accuracy it should be submitted for re-qualification. Manufacturers who have an

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approved quality system can also re-qualify any instruments included in the scope of their
approval that have been rejected by an authorised officer and repaired, or that underwent
significant repair such that they should be re-qualified before being placed back into use.

They follow the same basic process for examination and conformity assessment but finish the
process by applying a re-qualification crown and alongside it the notified body number of the
notified body that approved their system. Additionally they are not required to issue a
declaration of conformity.

Definition of a manufacturer
Unfortunately, the scope of the legislation for EC self-verification is significantly different to that
for UK national self-verification as the EC system is limited to only manufacturers, whereas the
UK system included installers and repairers (and therefore the distinction is less of an issue). It
will be up to the notified body that assesses the company for self-verification to determine
whether it qualifies as a manufacturer for a range of instruments and hence be eligible for
approval.

When a company has the design, component production and instrument assembly all
completely under their direct control then it is more than likely that they will be considered a
manufacturer. However, the situation has become blurred from both sides in that traditional
manufacturer’s contract out many services and, especially with the modular approach, an
organisation may well be able to assemble an instrument from components without actually
being the manufacturer.

To satisfy an assessor that they qualify as a manufacturer, the company will have to show that
they have exercised control over the design of the instrument, even if they have assembled an
indicator sourced from another manufacturer holding the TAC to a platform with load cells from
another manufacturer holding test certificates. In any case, they will have to show that they
have the full support of the component manufacturers in attaining approval for self-verification
so that they can demonstrate that they will be able to keep the necessary information up to
date. Other actions that will support qualification as a manufacturer include:
• labelling the instrument under the companies own name or own brand
• holding the type approval certificate or test certificate (either as the
manufacturer or as a parallel approval)
• making the full CE declaration of conformity and hence taking full legal
responsibility for compliance with all applicable EC directives

European Self-Verification (Declaration of conformity to type based on quality

assurance of the production process under MID 2004/22/EC)
Automatic Weighing Instruments that are used for applications that come under the heading
“Use for Trade”, as defined in Section 7 of the Weights and Measures Act 1985, must either be
type approved under Section 12 of that Act and be stamped either by a Weights and Measures
Inspector or an authorised self-verifier under Section 11 of the Act; or be manufactured under
a European Type Approval granted under the MID and then be initially verified either by a
Notified Body or an accredited manufacturer.

The process and requirements for a manufacturer to become accredited under the MID are
essentially the same as those under the NAWI Directive. The same rules relating to
documentation of the Quality System, record keeping, auditing, training and so on apply. The
accreditation to be a self-verifier under this Directive however does not extend to the re-
verification of instruments that have been repaired following either rejection by a Trading
Standards Officer or failure such that a repair was necessary that could have impacted on the
metrological performance of the instrument. (See the Table “Who can verify?”)

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Who can verify?

INITIAL VERIFICATION REVERIFICATION
Repairer, Repairer
TSO Notified Body Manufacturer Installer or TSO Notified Body Manufacturer Installer or
adjuster adjuster
No, unless No, unless
Any Weighing the Notified Yes if he is Yes if he is the Notified Yes if he is Yes if he is
Instrument Body is also an an Body is also an an
Type a Trading “authorised “authorised a Trading “authorised “authorised
Approved Standards verifier” under verifier” under Standards verifier” under verifier” under
under Sec 12 Department Section 11A Section 11A Department Section 11 of Section 11 of
of the in which case of the of the in which case the Weights the Weights
Weights and Yes they act as a Weights and Weights and Yes they act as a and and
Measures Act TSD and not Measures Act Measures Act TSD and not Measures Act Measures Act
1985 as a Notified 1985 1985 as a Notified 1985 1985
Body Body
Non-
automatic
Yes, if
weighing Yes, if
accredited for
instrument accredited for
Yes initial No
Type No that purpose No No Yes
verification by
Approved by a Notified
a Notified
under the Body
Body
NAWI
Directive
No, unless he No, unless he
Automatic No, unless
has an has an
Weighing accredited as
accreditation accreditation
Instrument Yes, if an
as an as an
Type accredited for “authorised
“authorised “authorised
Approved No Yes that purpose No Yes verifier” under
verifier” under verifier” under
under the by a Notified Sec 11 of the
Sec 11 of the Sec 11 of the
Measuring Body Weights and
Weights and Weights and
Instruments Measures Act
Measures Act Measures Act
Directive 1985
1985 1985

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