Choice of Standards
for Accreditation of Notified Bodies
Yiorgos Kallergis
EA CPR Conveyor
Content
• Background
• Alternative Approaches for the Accreditation of
Notified Bodies
• Key Issues
• Current Approach for the Selection of Standards
according to the European Commission
• A Future Model
• Overview of One (1) Plus (+) Model Approach
Requirements
• Conclusion
Background
A conformity assessment body wishing to be
notified under a directive for one or several
conformity assessment modules of the New
Legislative Framework (NLF) needs to be
assessed in order to determine if it is technically
competent to carry out the tasks required by the
module(s) in question.
Background
National accreditation bodies have been
assessing conformity assessment bodies for
many years. The NLF has introduced the choice
of use of accreditation for notification purposes,
which is considered as a reinforced system to
ensure that the bodies provide the high quality
services that manufacturers, consumers and
public authorities need.
Background
The conformity assessment system adopted in the
New Approach Directives and now under the NLF is
subdivided into modules, which comprise a limited
number of different procedures applicable to a wide
range of products. The modules relate to the design
phase of products, their production phase or both.
The eight basic modules and their eight possible
variants can be combined with each other in a variety
of ways in order to establish complete conformity
assessment procedures.
Background
EN ISO / IEC 17000 series of standards has
specific criteria for various types of conformity
assessment bodies such as laboratories,
certification bodies and inspection bodies (e.g.
EN ISO / IEC 17025 for laboratories).
Background
The European Commission’s ‘Blue Book’ (Guide to
implementation of directives based on the New
Approach and the Global Approach) published in
2000 and recently updated European Commission
CERTIF 2009 – 08 document SOGS N612 describes
for every NLF conformity assessment module which
of the standards reflect the criteria conformity
assessment bodies must fulfill in order to be notified
for the module in question.
Alternative Approaches for the Accreditation of
Notified Bodies
1. EA has produced mandatory guidance for
NABs, which is titled EA-2/17 - EA Guidance on
the horizontal requirements for the accreditation
of conformity assessment bodies.
• EA-2/17 document shall be used in combination with the
relevant harmonised standards for conformity assessment
bodies (CAB standards) and the related guidance documents
issued by EA, ILAC and IAF.
• It shall also be used together with the requirements specified in
the relevant community harmonisation legislation (e.g.
sectorial European Directives) and possible national requirements
for which the notification is to take place.
• Other relevant regulatory guidance and requirement documents
established at the European and national level, within the scope
of the relevant technical harmonisation legislation, should be
taken into account if and when applicable.
• EA-2/17 document provides for a reference framework to
the relevant requirements of the harmonized accreditation
standards creating a connection between requirements in the
document and the standards.
• It should be noted that there are assessment criteria in EA2/17 document which are covered by none or only some of
the harmonized accreditation standards.
• A notified body will still have to be assessed to all the
criteria stated in EA-2/17 document which are relevant to the
module in question when seeking accreditation for the purposes
of notification for the conformity assessment procedure in a
particular module.
Alternative Approaches for the Accreditation of
Notified Bodies
2. Before EA-2/17 document, some countries
used for the accreditation of CABs for notification
purposes, the following standards:
- EN 45011 & EN ISO/IEC 17020, for modules B,
C, F & G,
- EN ISO/IEC 17021, for modules D, E & H.
Key issues
• There is no one standard that would fit all the modules.
• Accrediting to one standard and assessing the additional
relevant requirements of other standard(s) to fill the gaps is
acceptable.
• Some TFG members are of the view that the choice of
standards should be narrowed and the others are of the view
that the choice should be widened.
• Some TFG members are of the view that only EN ISO/IEC
17021 should be used for modules D, E, H and others are of the
view that in addition to EN ISO/IEC 17021, EN 45011 or EN
ISO/IEC 17020 could also be used as alternatives.
Current Approach for the Selection of Standards
according to the European Commission
• The current approach for selecting a standard is based
on the European Commission’s Blue Book (Guide to
implementation of directives based on the New Approach
and the Global Approach) published in 2000.
• Under these circumstances, it is appropriate for EA to
review table 6/2 and SOGS 612 annex with a view to
selecting the most appropriate requirements for
assessment of modules and the most appropriate
standards for accrediting a NB for conformity assessment
of modules of directives.
A Future Model
• The annex of the SOGS 612 provides with justification a good
choice of standards for assessment of modules. However, as this
table originated from the ‘Blue Book’ published in 2000, some of
the developments in accreditation activities since the year 2000
need to be considered.
• It is also noted that the SOGS 612 analysis with respect to the
use of EN ISO/IEC 17021 for modules D, E and H states,
supporting the view that EN ISO/IEC 17020 (standard for
inspection) and EN 45011(which requires knowledge of
inspection and testing requirements) could be used as
alternatives for QA modules subject to assessment of
additional relevant requirements of EN ISO/IEC 17021.
One (1) Plus (+) Model Approach
Module
Description
EN 45011
ISO / IEC ISO / IEC ISO / IEC
17020
17021
17025
Internal production
control
N/A
N/A
A1
Internal production
control plus supervised
product testing
1+ t
1+ t
1 + cd
A2
Internal production
control plus supervised
product checks at
random intervals
1 +t
1 +t
1 + cd
B
EC type examination
1 +t
1 +t
C
Conformity to type based
on internal production
control
N/A
N/A
C1
Conformity to type based
on internal production
control plus supervised
product testing
1 +t
1 +t
1 + cd
Conformity to type based
on internal production
control plus supervised
product checks at
random intervals
1 +t
1 +t
1 + cd
D
Conformity to type based
on quality assurance of
the production process
1 + qa
1 + qa
1 + pj
D1
Quality assurance of the
production process
1 + qa
1 + qa
1 + pj
A
C2
N/A
N/A
N/A
N/A
One (1) Plus (+) Model Approach
ISO / IEC ISO / IEC ISO / IEC
17020
17021
17025
Module
Description
EN 45011
E
Conformity to type based
on product quality
assurance
1 + qa
1 + qa
1 + pj
E1
Quality assurance of final
product inspection and
testing
1 + qa
1 + qa
1 + pj
Conformity with type
based on product
verification
1 +t
1 +t
1 + cd
Conformity based on
product verification
1 +t
1 +t
1 + cd
G
Conformity based on unit
verification
1 +t
1 +t
H
Conformity based on full
quality assurance
1 + qa
1 + qa
1 + pj
H1
Conformity based on full
quality assurance plus
design examination
1+qa +t
1+qa +t
1 + pj
F
F1
Key
1
The possible standards used for accreditation.
+
Additional relevant requirements of the other relevant standards used for assessing the NB. These requirements are identified by performing a gap analysis using
EA 2/17.
t
Additional relevant requirements of ISO 17025 if testing is required.
cd
Capability of and procedures for judging and deciding based on results of tests, if the essential requirements are fulfilled and / or the harmonised standards have
been applied. In this case additional relevant requirements of EN 45011 or ISO 17020 to be applied.
pj
Ability to make professional judgements related to product requirements based on additional relevant requirements of EN 45011 or ISO 17020.
qa
Ability to assess and approve manufacturer’s quality systems based on additional relevant requirements of ISO 17021.
Conclusion
• The conclusion resulting from the analysis of the
members of the TFG and discussions with NABs is that
there is variation in the views of the NABs on the use of
standards for modules.
• These views broadly represent two approaches:
a) those who prefer the choice of standards to be either
maintained as or narrowed further than currently reflected
in SOGS 612 Annex, and
b) those who prefer widening of the choice.
Conclusion
• The proper use of EA 2/17 to analyse the gaps in accreditation
standards used for accreditation of a NB for a particular module
or a set of modules and for the assessment of those relevant
additional requirements as well as any specific requirements of
Directives that are necessary to assess the technical competence
of NBs is likely to be one of the key factors for avoiding possible
confusion in the market place and for achieving harmonisation.
• It is noted that some Directives (e.g. machinery, construction
products) do not exactly follow the modular approach.
Thank you for your attention!
Contact details:
e-mail address: [email protected]