Transcript Standardisation

Standardisation
The tool to prove compliance with legal
requirements…
Dr Fred Foubert,
Centexbel, Belgium
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The players
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Manufacturers, producers, distributors
Users, consumers (consumer associations)
Authorities
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European
Member State Authorities
Standardisation bodies
Conformity assessment bodies (notified bodies)
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less explicit role than in specific Directives
no CE marking obligation
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The role of standards in the GPSD
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Initial considerations (1)
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disparities in requirements lead to barriers to
trade and to distortion of competition
necessity to establish safety requirements for
any product placed on the market
safety assessment shall take all relevant aspects
into account, with special attention for
vulnerable groups (children, elderly people…)
GPSD is complementary to specific directives
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risks not addressed by the other directives can be taken
into account
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The role of standards
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Initial considerations (2)
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importance to establish European voluntary
standards covering certain products and risks
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standards to be established under mandates set
by the EU Commission
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presumption of conformity principle
general outline of requirements
harmonised standards, published in the OJEC
other standards or normative documents may
also be used
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The role of standards
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Initial considerations (3)
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independent certification by recognised
conformity assessment bodies may be used
adequate information is also an obligation
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The GPSD
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Art. 1.1 – The purpose of the directive is to ensure that
products placed on the market are safe.
Art. 1.2 – Where products are subject to specific
safety requirements imposed by Community
legislation, the Directive shall apply only to the aspects
and risks or categories of risks not covered by those
requirements.
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The GPSD
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Art. 2 (b) Safety of a product takes into account
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foreseeable conditions of use, including duration
putting into service, installation
maintenance
Hence requirements shall address
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product characteristics
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composition,
packaging,
instructions for assembly, installation, maintenance
effect on other products
product presentation, labelling, warnings, instructions for
use and safe disposal
consumer categories at risk (children, elderly people)
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Ways to prove compliance – Art. 3.2
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a product is deemed safe when:
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it meets national law requirements on H&S
of the MS where it is marketed
in the absence of Community provisions
a product is presumed safe when:
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it conforms to voluntary national standards
transposing European standards
published in the OJEC (harmonized standards)
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Ways to prove compliance – Art. 3.3
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Other possible elements to take into account in the
absence of legislation or harmonized standards:
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voluntary national standards from ENs (nonharmonized)
national standards (MS where product is
marketed)
Commission recommendations
product safety codes – sector related
state of the art and technology
reasonable consumer safety expectations
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Safeguard clause – Art. 3.4
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Member States have the right to take measures
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to impose restrictions on products being placed
on the market
if these products are dangerous
despite proof of conformity
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Procedure for harmonized standards –
Art. 4.1
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The Commission – assisted by a committee –
determines the requirements to ensure products will
meet the general safety requirement
The Commission calls on the European
standardisation bodies to draw up standards
(mandate)
European standardisation bodies adopt standards in
accordance with cooperation guidelines EU-CEN
Commission reports to EP every three years on
progress and future work
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Publication of harmonized standards –
Art. 4.2
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The Commission publishes the references of
mandated (harmonized) standards in the OJEC
Publication in the OJEC of standards adopted before
the entry into force of the Directive is possible
If a standard does not ensure compliance with the
general safety requirement, it can be withdrawn in
whole or in part
Commission decisions are taken after consulting the
advisory committee – Member States are notified of
the decision
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A standard is…
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A technical document
established by consensus
approved by a recognized body
for common and repeated use
provides rules, guidelines or characteristics for
activities or their results
aims at the achievement of the optimum degree of
order in a given context
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Source: ISO/IEC Guide 2 - 1996
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Who makes standards?
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on a company or sector level
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on a national level
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national standardisation bodies: MSZT, BSI, DIN, AFNOR
in Europe 1 standardisation body per country
US more sector oriented
on a European level
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multinational companies (cars, aircraft)
branch organisations (e.g. EDANA)
CEN: Comité Européen de Normalisation
European Union + Switzerland, Iceland, Norway
on an international level
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ISO: International Standards Organisation
more than 100 countries
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Types of normative documents:
European
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European documents
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European standard (EN)
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approved by a weighted voting procedure
three linguistic versions: E, F, D
translation into other languages possible, but not
mandatory
becomes a national standard in all CEN countries
reference: MSZ EN xxxxx-x:yyyy
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Types of normative documents:
European
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European Technical Specification
(CEN/TS – old: ENV)
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approved by a weighted voting procedure
not necessarily available in all languages
no obligation to make it a national standard
reference: CEN/TS xxxxx-x:yyyy
provisional document for three years
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Types of normative documents:
European
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CEN Technical Report
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approved by simple majority
no obligation for three linguistic versions
no obligation to make it a national standard
informative document (recommendations, inventory of
knowledge)
reference: CEN/TR xxxxx-x:yyyy
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Types of normative documents:
international
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International documents (ISO)
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similar to CEN (standard, technical specification,
technical report)
exists in E, F
no obligation to adopt them as national
standards
reference: ISO xxxxx-x:yyyy
EN ISO standards
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MSZ EN ISO xxxxx-x:yyyy
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The Vienna Agreement
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Agreement between CEN and ISO to avoid duplication
of work
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One of the organisations takes the lead (depends
on availability of expertise)
Voting occurs in parallel and in accordance with
the rules of each organisation
Decision to be taken for each individual work
item
ISO takes the lead for amendments or revision
of standards
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leads to a shift of activity from CEN to ISO
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Standardisation structures
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Structures are similar in CEN and ISO
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Technical committee (TC)
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Subcommittee (SC)
Working group (WG)
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scope: fairly broad (e.g. floor coverings, plastics, ….)
decisions on work programme
national delegates (representatives of a national mirror committee)
very specific scope e.g. terry towel fabrics
work items allocated by parent TC
do the actual standardisation work
experts (selected for their knowledge, but also represent national
interests)
Task groups, ad hoc groups etc. (informal)
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The standardisation process
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The standardisation process
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Draft stage – public enquiry
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WG drafts the standard and decides when it is ready for
public enquiry
in principle in all languages (often only in E)
draft receives a reference number
a period of 5 months to give everyone the opportunity to
make comments
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in practice the draft is discussed in the relevant mirror committee
a second enquiry (2 months) may be necessary
enquiry ends with a comments report, forwarded to the
WG
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The standardisation process
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Formal vote stage
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WG discusses comments and replies to each one
A final draft is made, taking accepted comments
into account
TC approves release for formal vote
Formal vote = weighted vote
Pass criteria
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71 % of votes positive and
more countries in favour than against
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The standardisation process:
weighting of votes
Germany
UK
France
Italy
Spain
Poland
Netherlands
Greece
Czech Rep
Belgium
Hungary
Portugal
Sweden
Austria
DIN
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BSI
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AFNOR29
UNI
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AENOR27
PKN
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NEN 13
ELOT 12
CSNI 12
IBN
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MSZT 12
IPQ
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SIS
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ON
10
Switzerland
Slovakia
Denmark
Finland
Norway
Ireland
Lithuania
Latvia
Slovenia
Estonia
Cyprus
Luxembourg
Malta
Iceland
SNV
SUTN
DS
SFS
NSF
NSAI
LST
LVS
SIST
EVS
CYS
SEE
MSA
IST
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4
4
4
4
3
3
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The standardisation process
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Approval and publication
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approved text is finalized (editorial comments)
final text is released by CEN for publication by national
standardisation bodies
national standardisation bodies
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make standard available (printing, catalogue, web site)
within 6 months after release by CEN
withdraw conflicting national standards
for harmonized standards: see legislation
Review/revision
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after 5 years or sooner, if necessary
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Standards and legislation
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European New Approach Directives
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only general H&S requirements in Directive
specify attestation of conformity rules (certification
schemes)
encourage use of harmonized European standards
 technical translation of requirements
 made on explicit request of the EU Commission (mandate)
 presumption of conformity (publication in OJEC)
 ZA-annex is link between standard and Directive
often lead to CE marking
 conformity marking, not a quality mark
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Standards and legislation
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Examples
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89/106 Construction Products Directive
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89/686 Personal Protective Equipment Directive
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ca. 300 harmonized standards
93/42 Medical Devices Directive
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ca. 150 harmonized standards
ca. 250 harmonized standards
2001/95 General Product Safety Directive
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10 standards
- furniture
- child care articles
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Standards in support of the GPSD (1)
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EN 1130-1:1996
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Furniture - Cribs and cradles for domestic use –
Part 1: Safety requirements
EN 1130-2: 1996
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Furniture - Cribs and cradles for domestic use Part 2: Test methods
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Standards in support of the GPSD (2)
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EN 12586:1999
 Child care articles – Soother holder - Safety requirements and
test methods (amended 2002)
EN 1400-1: 2002
 Child use and care articles – Soothers for babies and young
children - Part 1: General safety requirements and product
information
EN 1400-2: 2002
 Child use and care articles – Soothers for babies and young
children - Part 2: Mechanical requirements and tests
EN 1400-3: 2002
 Child use and care articles – Soothers for babies and young
children – Part 3: Chemical requirements and tests
EN 1466: 2004
 Child care articles – Carry cots and stands – Safety
requirements and test methods
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Standards in support of the GPSD (3)
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EN ISO 9994:2002
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Lighters. Safety specifications (ISO 9994:2002)
EN 14059:2002
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Decorative oil lamps - Safety requirements and
test methods
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Searching for standards
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Standards are protected by copyright
Web sites of standardisation institutes
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CEN: www.cenorm.be
ISO: www.iso.org
Hungary: www.mszt.hu
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Live-link
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A system operated by ISO, CEN and all major national
standardisation bodies
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most standardisation bodies have their own Livelink system
password protected
per TC or WG
all types of working documents: agendas,
minutes of meetings, resolutions, drafts, …
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can be downloaded by authorised users
uploading by TC or WG secretary
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The future
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Standardisation has proven to be a good tool to prove
compliance with legal requirements
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Growing internationalisation of standards
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growing number of standards to underpin
European Directive provisions
increasing importance of ISO and Vienna
Agreement
A speedier standardisation process
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3 year rule
live-link
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