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Annex 4
ISPO FAIR
"Revision of the Personal Protective Equipment Directive, what will change for the Sports sector?"
July 23, 2001 - MUNICH (GERMANY)
THE ROLE OF NOTIFIED BODIES IN CONFORMITY ASSESMENT
by Karl-Heinz NOETEL
Leader of the German
Centre for Safety Techniques
Topics:
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The role of notified bodies in conformity assessment |
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The Coordination of Notified Bodies for PPE |
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The interaction with European institutions, standardisation
bodies and associations |
The role of notified bodies in conformity assessment
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The general concept of conformity assessment and CE marking
is based on the 'Global Approach', as agreed in 1989. |
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Its underlying objectives:
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building of confidence through competence and transparency |
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setting up of a comprehensive policy and framework for conformity
assessment |
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Notified bodies carry out the tasks pertaining to the conformity
assessment procedures as defined in the relevant 'New Approach' directives
when third party intervention is required. |
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Certificates issued by notified bodies must be accepted throughout
the European Union. |
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Member States give notification on the basis of competence
criteria that are based on the requirements defined in the 'Global Approach'
and in the relevant 'New Approach' directive. |
General Competence criteria for notified bodies
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Operate in a competent, non-discriminatory, transparent, neutral,
independent and impartial manner, |
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Employ the necessary personnel which has sufficient and relevant
knowledge and experience to carry out conformity assessment in accordance with
the directive in question; |
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Make adequate arrangements to ensure confidentiality of the
information obtained in the course of conformity assessment; |
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Provide relevant information to their notifying authority,
market surveillance authorities and other notified bodies; |
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Be adequately insured to cover their professional activities; |
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Participate in coordination activities. |
Third party involvement in the field of PPE
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The PPE directive defines three categories of products: |
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Category I: PPE of simple design where the designer
assumes the user can himself assess the level of protection provided against the
minimal risks concerned. |
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Category II: PPE of neither simple nor complex design |
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Category III: PPE of complex design intended to protect
against mortal danger or against dangers that may seriously and irreversibly harm
the health, the immediate effects of which the designer assumes the user cannot
identify in sufficient time. |
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Most PPE for sports fall under category II |
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some examples of exceptions :
category I: swimming / diving goggles, sports shoes protecting against external
impact category III: equipment to protect against falls from a height |
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Intervention of a notified body is required for the two latter
categories of products:
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EC type examination for categories II and III |
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additional quality control measures of either the final product
or the production for PPE of category III |
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EC Type Examination
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Type testing to confirm compliance of the product with the
relevant Essential Health and Safety Requirements' (EHSRs) as defined in the PPE
directive (annex II). |
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The manufacturer assembles the technical documentation for
the product, specifying the relevant EHSRs to be met. |
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The manufacturer submits the product and the technical documentaion
to a notified body for assessment. |
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The notified body examines the technical documentation and
subjects the product to the relevant tests to prove conformity. |
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The notified body issues an EC type examination certificate. |
Quality Control
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Products of category III additionally have to be subjected
to quality control measures of either the final product (article 11A) or the production
(article 11B). |
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Under article 11B, the manufacturer maintains a quality system
that is verified by a notified body every year. |
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Under article 11A, the manufacturer ensures homogeneity of
production and the conformity of the PPE with the type-tested product and the
EHSRs and has this checked by a notified body at least once a year. |
Need for coordinating notified bodies' activities
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A harmonised approach of the notified bodies with regard to
conformity assessment is a prerequisite for the credibility of the system. |
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A forum for discussing any questions arising in the context
of conformity assessment was therefore created by the notified bodies for PPE
as early as in 1992, at the initiative of the 'Fachausschuss Pers nliche Schutzausr tstungen'
and the 'BIA' in Germany. |
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Since 1996, the work of the Coordination of Notified Bodies
in the field of PPE has been supported by the European Commission. |
General objectives of the coordination
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Coordinate activities of all notified bodies in the field of
PPE; |
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Ensure a harmonised approach of notified bodies with regard
to the application of the directive (e.g. type examination and quality control); |
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Ensure harmonised application of harmonised standards and other
specifications; |
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Ensure transparency of the system towards legislative bodies,
manufacturers, enforcement authorities etc. |
Structure of the coordination
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Technical Secretariat |
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Horizontal Committee
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Advisory Panel |
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Ad hoc group on questions related to article 11 A/B of the
directive |
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11 Vertical Groups |
Administrative secretariat: EOTC
Technical secretariat
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Funded by the European Commission to
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coordinate the work of the Coordination |
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manage the work of the Horizontal Committee and its sub-groups(Advisory
Panel, 11 A/B Ad hoc group) |
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coordinate activities and results of the Vertical Groups |
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represent the notified bodies in the CEN PPE Advisory Nucleus
and in the PPE Working Party of the Standing Committee 98/37/EC |
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ensure contact with European Commission |
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Horizontal Committee of notified bodies for PPE
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Membership:
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all notified bodies (current number. 97), either by direct
participation in the work or by being represented via national coordination groups |
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'notified bodies to be' from Central and Eastern European countries |
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European institutions and various interested associations (e.g
CEN, ESF, FESI) |
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representative from the European Commission |
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Horizontal Committee
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Activities:
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discuss generic questions of general interest e.g.
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different approaches in the application of the Directive |
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harmonisation of procedures |
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propose solutions to the PPE Working Party of the Standing
Committee 98/37/EC (e.g. by way of Technical Sheets for Coordination) |
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bring questions to the attention of EU and national authorities |
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Agreed solutions on problems are issued in the form of a 'Technical
Sheet for Coordination - Recommendation for Use' |
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There are currently 58 Recommendation for Use Sheets endorsed
by the Member States in the PPE Working Party of the Standing Committee 98/37/EC |
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Access via the CIRCA database of the European Commission is
under discussion |
Advisory Panel to the Horizontal Committee
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Small group of technical experts; |
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Supports the Technical Secretariat in the organisation of meetings; |
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Prepares solutions to questions and problems the notified bodies
encounter in their work; |
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Verifies documents for consistency. |
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In order to support the Vertical Groups in preparing their
documents, a Checklist was produced which asks for clarity and consistency,
e.g.
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Clear, single question and answer - nothing else |
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No abbreviations that are not explained on the sheet |
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All standard references to include the year |
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Clear cross-references e.g. Clause Numbers, Directive Articles
etc. |
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Very clear completion of the keyword section |
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Clarity of the language - must be easily understood by a wide
variety of people, not all experts |
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Ad hoc group on Article 11 A/B
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Sub-group to discuss questions relating to article 11 of the
directive (quality control); |
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Comprises members from all bodies notified for the assessment
of quality control measures according to the directive; |
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Prepares solutions to harmonise activities and presents them
to the Horizontal Committee; |
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Takes account of developments in relation with ISO 9000 standards. |
Vertical Groups
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11 Vertical Groups specialised in individual types of PPE; |
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Discuss technical matters in their respective fields of PPE; |
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Agree solutions to apply harmonised test procedures (harmonised
standards and other specifications) and e.g issue 'Recommendation for Use sheets'; |
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Bring questions on the application of harmonised standards
to the attention of the relevant CEN committees; |
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Contribute to the harmonisation of test results by organising
Round-Robin tests; |
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Bring questions to the attention of the Horizontal Committee.
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Interaction with European Institutions, standardisation bodies and associations
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Conformity assessment as carried out by the notified bodies
involves various interested parties (manufacturers, notified bodies, standardisers,
authorities, users etc.). |
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Transparency and coordination in the activities of all parties
concerned is a crucial factor to make the overall system work and ensure credibility
of CE marking. |
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The Coordination of Notified Bodies for PPE there fore ensures
contact to the various interest groups. |
Interactions with standardisation bodies
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Solutions that are suggested by the notified bodies in order
to overcome problems with the application of standards can be a starting point
for the discussion on the revision of standards and thus contribute to improve
the documents provided by the standards bodies (e.g. through harmonisation between
sectors). |
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Experience with innovative products or the use of test methods
from other areas can help speed up the process of standards development. |
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Round-Robin tests are an important contribution to verify the
reproducibility of test results and thus a major contribution to standardisation. |
Interactions with European Institutions
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Mutual representation in committee meetings to ensure transparency
and a good flow of information between the Commission services and the Coordination
of Notified Bodies. |
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This is of particular importance in the context of the revision
of the PPE directive: The Coordination of Notified Bodies is involved in the drafting
group to enable the European Commission to benefit from the experience of the
notified bodies with the practical implementation of the directive. |
Items of interest for the revision of the PPE directive
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Numerous discussions with manufacturers about the categories
of products require a clearer definition in the new directive. A number of
products that should be category III are currently classified as category II,
e.g. lifejackets, bulletproof vests, hearing protectors. |
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The proposed possibility to have products tested against the
procedures specified for a higher category bears the risk of confusion
on the market. |
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The category should be firm and visible form the marking. |
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The 'Recommendation for Use sheets' produced by the
Coordination to find solutions to some of the problems encountered in the past
should be taken into account. |
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The introduction of some limitation to the validity
of certificates will help avoid deviations between the tested type and the
actual products found on the market (category II products). This is not to call
for complete re-testing after a fixed period of time, but just some review to
monitor product changes.
Certificates for products that are no longer manufactured
will not be extended.
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The problem of custom-made equipment and single production
PPE needs a clear definition, specifying who the manufacturer is and who has
to take responsibility for the product. |
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Some of the wording of the Essential Health and Safety Requirements
in Annex II of the directive has shown to be misleading and unclear and
has caused a lot of problems in drawing up and verifying the technical documentation
for PPE products. Clarifications need to be introduced. |
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Disparities in the interpretation of article II of the current
directive call for more detailed specifications as regards the quality control
procedures to follow for products of category III (following the modules). |
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The experience of notified bodies, also in comparison to other
directives, shows that the introduction of a module H approach would not
solve the current problems in ensuring a harmonised application of the procedures.
Especially small manufacturers would suffer disadvantages at the market place. |
Coordination of notified bodies as a partner
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The experience of notified bodies in the practical application
of the procedures, the discussions they have had for the past 10 years and their
awareness of the concerns of the manufacturers can be beneficial in the drafting
of the new directive. |
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With the background of the political discussions on different
levels (Standing Committee, standardisation) and in our cooperation with the manufacturers,
the notified bodies are in a position to contribute to finding practical solutions
for all questions related to conformity assessment in accordance with the PPE
directive. |
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