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Conformity Certification For Product Validation MATPOST 07 PDF
Conformity Certification For Product Validation MATPOST 07 PDF
Conformity Certification For Product Validation MATPOST 07 PDF
ABSTRACT
For MV and HV switchgear, Utilities (and generally speaking
Users) most often request a reliable demonstration of safety
and performances. The purpose of this paper is to describe
a way to adapt the concept of Product Certification to
electrical equipment for Transmission and Distribution
networks.
The main features of this certification scheme are :
o Independence based on the strong involvement of each
party : Manufacturers, End Users, Testing Laboratories
and independent experts,
o Competence based on Testing Laboratories,
o Certification scope limited to the conformity of the type of
product,
o International recognition through accreditation.
The main advantages of this system are :
o The organisation is cost effective,
o The organisation is time effective and flexible,
o Responsibilities are clearly split between
stakeholders,
o Certificates are well accepted.
the
KEYWORDS
Conformity Assessment, Testing, Laboratory, Certification,
Accreditation.
INTRODUCTION
Testing is only part of conformity assessment
Assessing the conformity of a product is part of the
relationship between the Manufacturer and the possible
Users of a product. For Medium Voltage and High Voltage
electrical equipment, assessment is based on the results of
tests in most cases. However, it is not only the result of a
single type test that allows to decide that a product fulfils all
the requirements of a specification.
Tens of type tests have to be performed, addressing various
sharp technical competences. Several samples of
equipment may be required to perform the complete list of
type tests. And when a range of products is concerned, it is
often cost effective to combine different tests with various
options of equipment in order to cover the whole range of
rated values with the minimum set of tests.
Some tests may fail (it is part of the game, otherwise testing
would be useless), leading to adjustments or improvements
of the product design. In such a case it is important to avoid
ways
to
split
the
Product Certification
Product Certification is described by EN 45011 [2] that is
identical to ISO/IEC Guide 65 [3]. It is a broad concept that
encompasses all kinds of products (including processes
and services) and may be implemented in different ways,
including or not including : initial testing, assessment of the
suppliers quality systems, surveillance of the factory quality
system, subsequent surveillance testing of samples from
the factory, and son on (see Introduction in [2] or [3]).
It is important to keep in mind that the concept of Product
Certification ranges from certification systems based on
type testing, to certification systems including type testing
and surveillance of the manufacturing process. The choice
of a given system within this range depends of product
specificities and market needs.
It is important also to note that the scope of the standards
[2] and [3] is so broad that each Certification Body is
responsible to adapt the general requirements of the
standard to its specific domain of activity.
Accreditation
According to the International Vocabulary [4], Accreditation
is a third-party attestation related to a conformity
assessment body conveying formal demonstration of its
competence to carry out specific conformity assessment
tasks. It is described by EN ISO/CEI 17011 [5].
According to European Regulation, Accreditation is a non
profit activity that is operated in each Member State by a
single national accreditation body (see article 4 in [6]).
Following these principles :
o a Laboratory that complies with ISO/IEC 17025 [7] may
be accredited according to this standard by an
Accreditation Body,
o a Certification Body that complies with EN 45011 [2] may
be accredited according to this standard by an
Accreditation Body.
In both cases, it is important to note the difference between
complying with and being accredited according to
that means providing an evidence of compliance with.
Only Accreditation provides a formal evidence of
compliance.
It is to be noted that Quality Requirements of ISO
9001:2000 are fully covered by ISO/IEC 17025:2005, as
stated in [8] : The management system requirements in
ISO/IEC 17025 (Section 4) [] meet the principles of ISO
9001:2000 Quality Management systems Requirements
and are aligned with its pertinent requirements. As a
consequence a Laboratory has no need for ISO 9001
certification if it is already accredited against ISO/IEC
17025.
On the contrary, it is important to mention that ISO/IEC
17025 goes further than ISO 9001, with additional
requirements for technical competence and metrology that
are specific to Laboratories.
Technical competence
o Competence of the French Certification Body is made of
the competence of the members forming the Body. And
the core of the competence is located in their
Laboratories. This is the reason why technical experts
acting as observers and reviewers are chosen amongst
the teams of experienced test engineers of the
homologated Laboratories. This brings the guarantee
that competence of observers and reviewers is kept up to
date thanks to their everyday professional activity.
o Observers never come from the laboratory which is
performing the test. Observers always belong to a
separate Company.
Recognition
The competence and independence of the French
Certification Body is recognized through its accreditation by
COFRAC (the French Accreditation Body) according to EN
45011 [2], [3]. It is a voluntary choice of the French
Certification Body to go through the accreditation process to
demonstrate its transparency and competence, and to enter
into a continuous improvement process.
Flexibility
Although it is made of very strict procedures, the whole
certification system that is operated by the French
Certification Body, remains flexible :
o The Body is opened to new members (Manufacturers,
Users, Laboratories) as soon as they fulfil membership
requirements,
o The French Certification Body offers services to any
client (not only members),
o The scope of accreditation may be extended to new
references, including specifications of Utilities,
o The amount of activity may be easily adjusted to the
yearly needs by calling skilled technical resources in the
Laboratories of the members,
o Personal involvement of the experts is an actual reality
since all technical experts involved in the certification
process are active in the Company members,
o The possibility to take into account the results of tests in
the Manufacturers Laboratory (assuming the whole
testing process in under control of the French
Certification Body) avoids tests repetition,
o Costs are restricted to the minimum since French
Certification Body is a non profit organisation,
o Additional cost related to supervision of tests, review of
test results, review of identification and impartial decision
process are justified by the added value of the
Conformity Certificate that is issued.
FUTURE TENDENCIES
Although Certification is not the only way for assessing the
conformity of a product, Manufacturers and Utilities may
tend to rely more and more on Third Party assessment in
order to clarify the border lines of their responsibilities. But
the French example shows that this does not prevent them
from being involved in the process of assessment to keep
competence, impartiality and transparency at a high level.
What is important for a Utility is to get choice between
different offers in order to select the solution that fits the
best his need. This is true also for assessment schemes.
The development of Third Party assessment is a
complement to First Party assessment and Second Party
assessment. It allows the Utility to select the assessment
profile according to the stake.
As far as Certification is requested, there is not a unique
solution to erect a Third Party Certification System and the
French example is just one possibility. Other systems do
exist and may give also good results. But whatever the
organisation may be, it seems important that it fulfils the
deep needs of the market.
On that purpose, more the Utilities requirements will be
stated clearly (in terms of competence, transparency, scope
of activity), more will be the possibility to harmonize the
different existing schemes into a Mutual Recognition
Agreement. Such an Agreement is useful to avoid test
repetition and minimize cost and delay for assessment. It is
also useful to clarify the status of the various assessment
documents that are circulated on the marketplace.
REFERENCES
[1] ISO/CEI Guide 67, 2004, "Conformity assessment
Fundamentals of product certification,
[2] EN 45011, 1998, "General requirements for bodies
operating product certification systems,
[3] ISO/CEI Guide 65, 1996, "General requirements for
bodies operating product certification systems,
[4] ISO/IEC 17000, 2004, Conformity assessment
Vocabulary and general principles,
[5] EN ISO/CEI 17011, 2005, General requirements for
accreditation
bodies
accrediting
conformity
assessment bodies (cancels and replaces EN 45010,
1998).
[6] Commission of the European Communities,
2007/0029, 14/02/2007, Proposal for a regulation of
the European Parliament and of the council setting out
the requirements for accreditation and market
surveillance relating to the marketing of products
[7] ISO/CEI 17025, 2005, "General requirements for the
competence of testing and calibration laboratories.
[8] 601946.2005-08, August 2005, Joint ISO ILAC IAF
Communiqu