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PRODUCT AND QUALITY
Lecture : Conformity assessment and
certification
IMPORTANCE OF FREE TRADE
� Trade as a motor for economic growth
� Early GATT trade rounds concentrated on tariffs & quotas
� Current situation - developed countries:� 44% of industrial products imports receive duty-free
treatment
� 3.8% average tariff for industrial products imports
� Shift of emphasis towards Non-Tariff Barriers:� Tokyo Round (1973-79): “Standards Code” signed by 47
governments
� Uruguay Round (1986-94): TBT and SPS Agreements binding for all WTO members
TECHNICAL BARRIERS TO TRADE (1)
� TBT Agreement covers :
� Standards
� Technical regulations & Conformity
assessment procedures
EXPERIENCE WITHIN EU (1)
� Harmonization of 15 differing national regulatory systems
� Until mid-1980s: “Old Approach” based on detailed technical regulations
� Since mid-1980s: “New Approach” -legislation only specifies essential health & safety requirements & offers choice of conformity assessment procedures
Greater flexibility for business
TECHNICAL BARRIERS TO TRADE (1)
� TBT Agreement covers :
� Standards
� Technical regulations & Conformity
assessment procedures
EXPERIENCE WITHIN EU
� Harmonization of 15 differing national regulatory systems� Until mid-1980s: “Old Approach” based on detailed
technical regulations
� Since mid-1980s: “New Approach” - legislation only specifies essential health & safety requirements & offers choice of conformity assessment procedures
Greater flexibility for business
� One set of technical specifications, common conformity assessment procedures and single marking requirement for fast-track access to whole EU market
� Wide range of industrial products now covered
INTERNATIONAL TRADE FACILITATION
� A range of instruments are available, such
as:
� Private sector agreements among Conformity
Assessment Bodies
� Mutual Recognition Agreements at
governmental level (bilateral or multilateral)
TRADE FACILITATION - INSTRUMENTS
Private agreements, for example:
� IEC CB Scheme: multilateral agreement among participating certification organisations (34 countries)
� IAF MLA: multilateral agreement among signatory accreditation bodies (27 signatories)
Advantages of private agreements
– Practical answer to market needs
– Increase mutual confidence in competence of CABs
– Can support/facilitate governmental agreements
TRADE FACILITATION - INSTRUMENTS
� Governmental Mutual Recognition Agreements:
� Applies to products regulated by a pre-market
approval regime in at least 1 party
� Certification carried out by exporting party’s CAB
against regulatory requirements of importing
party
� MRA Advantages
� Eliminates duplicate testing
� Reduction in Approval Costs
� Faster and more predictable time-to-market
MRAS - DRAWBACKS
� Implementation is resource intensive
� Acceptability to national
regulators/agencies?
� Legal complexity, e.g. liability legislation
� Only practical for countries at similar level of
technical development, what about others?
TECHNICAL ASSISTANCE
� TBT Agreement calls for technical
assistance to developing country members
to establish their conformity assessment
infrastructure
� Objective is to integrate developing
countries in world trade system to promote
economic development
WHAT IS CONFORMITY ASSESSMENT?
Conformity assessment is the name given to
processes that are used to demonstrate that a
product or a service or a management system
or a person meets specified requirements.
The specified requirements may be contained
in a technical standard, a regulation or a
contract
� First-party assessment. This is the technical term used when conformity assessment to a standard, specification or regulation is carried out by the supplier organization itself. In other words, it is a self-assessment.
� Second-party assessment. This indicates that the conformity assessment is carried out by a customer of the supplier organization. For example, the supplier invites a potential customer to verify that the products which it is offering conform to relevant ISO product standards.
� Third-party assessment. In this case, the conformity assessment is performed by a body that is independent of both supplier and customer organizations. An example is ISO 9000 certification where an organization's quality management system is assessed by an independent “certification” or “registration” body against the requirements of an ISO 9000 standard. If the system conforms to the requirements, the certification/registration body issues the organization with an ISO 9000 certificate.
� Such third-party assessment may be required in certain business sectors by government regulations. It may be specified by the customer, or the supplier organization may choose it as a way of differentiating its product or service from others on the market.
� In other circumstances, a supplier organization may give its own written assurance that a product, service, system, process or material meets specified requirements. This is known as a suppliers declaration of conformity.
MECHANISMS FOR PERFORMING CONFORMITY ASSESSMENT
Testing
This is the most common form of conformity assessment.Testing also provides the basis for other types of conformityassessment like inspection and product certification. Here aproduct is tested against a specified set of criteria. It can beused to make decisions on the performance of the product.
The general requirements for laboratories or otherorganizations to be considered competent to carry out testingcalibration and sampling are specified in the jointInternational Standard ISO/IEC 17025:2005 Generalrequirements for the competence of testing and calibrationlaboratories.
MECHANISMS FOR PERFORMING CONFORMITY
ASSESSMENT
Inspection bodies
These organizations examine a huge range of products,
materials, installations, plants, processes, work procedures
and services, in the private as well as the public sector, and
report on such parameters as quality, fitness for use and
continuing safety in operation. The overall aim is to reduce
risk to the buyer, owner, user or consumer of the item being
inspected.
The general requirements for the operation of various types
of inspection body are given in the joint International
Standard ISO/IEC 17020:1998 General criteria for the
operation of various types of bodies performing inspection.
THE "TOOLS" OF CONFORMITY ASSESSMENT AND WHO
USES THEM.
First
Party
Second
Party
Third
Party
Manufacturer's declaration *
Inspection * * *
Testing * * *
Auditing * * *
Certification *
WHY CONFORMITY ASSESSMENT IS IMPORTANT
� Conformity assessment provides benefits to
everyone in the supply and demand chain. This
includes the consumer, manufacturer and the
supplier. It also includes regulators who are
responsible for ensuring the health and safety
of the general public.
BENEFITS FOR CONSUMER
� The consumer benefits from conformity
assessment, as it is a mechanism providing
confidence to consumers that the products and
services they purchase are fit for the purpose.
It may also allow the consumer the possibility
to seek appropriate remedies should the
product be found not to meet the specified
requirements.
BENEFITS FOR MANUFACTURERS
� For manufacturers, it allows them to have
peace of mind that they have implemented
systems within their own organizations to
ensure that the products and services they
deliver meet the necessary criteria. The fact
that their product or service meets National
or International Standards also gives them
a competitive edge over those that do not.
BENEFITS FOR REGULATORS
� For regulators, it allows them to use the conformity
assessment infrastructure as part of the process
they use to ensure health and safety as well as
environmental conditions are being continuously
met. The regulator will often make conformity
assessment obligatory when it involves health,
safety and/or environmental issues. Without official
assessment and approval the regulator may
prohibit the sale of products and services.
MECHANISMS FOR PERFORMING
CONFORMITY ASSESSMENT
The overall aim of certifying products, processes or services is to give confidence to all interested parties that a product, process or service fulfills specified requirements.
The value of certification is the degree of confidence and trust that is established by an impartial and competent demonstration of fulfillment of specified requirements by a third-party.
MECHANISMS FOR PERFORMING CONFORMITY
ASSESSMENT
Product certification
� Relevant product standards and guides are used to
demonstrate that a product complies with specified
criteria. There are other standards within this family of
standards that give guidance of the various types of
product certification schemes which can be used.
ISO/IEC Guide 65:1996 specifies general
requirements for bodies operating product
certification systems
MECHANISMS FOR PERFORMING CONFORMITY
ASSESSMENT
Management system certification
The most well-known examples are the certification ofquality management systems and environmentalmanagement systems as conforming, respectively, to ISO9000 and ISO 14000 standards. More than 800 000organizations worldwide have been certified to ISO 9001and/or ISO 14001. It should be noted that ISO itself doesnot assess the conformity of quality or environmentalmanagement systems to ISO 9000 or ISO 14000standards. ISO does not issue certificates of conformity tothese standards. ISO 9001 and ISO 14001 certification iscarried out independently of ISO by the many certificationor registration bodies active nationally or internationally.
MECHANISMS FOR PERFORMING CONFORMITY
ASSESSMENT
Personnel certification
� Personnel certification is a requirement in certain
technical professions. Welders, Boiler Operators are
two examples. ISO/IEC 17024:2003 specifies
requirements for a body certifying persons against
specific requirements, including the development and
maintenance of a certification scheme for personnel.
PRODUCT, PROCESS AND SERVICE CERTIFICATION
Parties that have an interest in certification
include, but are not limited to:
the clients of the certification
bodies; the customers of the
organizations whose products,
processes or services are
certified;
governmental authorities;
non-governmental organizations;
and
consumers and other members of the public.
Relation between certification body andscheme owner
Scheme owner
runs a scheme
Guidelines for
schemes are
given in
ISO/IEC 17067
Requirements
for certification
bodies are
given in
ISO/IEC 17065
Scheme
Stakeholder Scheme owner
manufactorer,
operator,
deliverer of a
product, process or services
Certification Body
and
Conformityassessment
Customer
Scheme owner can be the certification body, governmenal authority,
trade association, group of CB‘S, …..
ISO/IEC 17030
for the labels
and their use
EXAMPLES OF RESOURCES USED FOR TESTING,
INSPECTION AND AUDITING
Testing withown ressource /
equipment
Use equipment fromManufacturer (under
the CB control)
Test reports frombodies or parties other than the CB
Full outsourcing
All those examples are covered in Clauses 6 of ISO/IEC 17065
Certification body
EXAMPLES OF RESOURCES PERSONNEL
Certification Body
Own Personnel
Work Contract
Free Lancer
Contract
related Company
Agreement
All those examples are covered in Clause 6 of ISO/IEC 17065
EXAMPLE OF POSSIBLE ARRANGEMENT FOR
ORGANIZATIONAL CONTROL
Certification
Body
Person/employeeRelatedcompany
Organizational Control is to supervise that the relatedcompany does not influence the person in its work for the CB
Agreement to follow CB rules and procedure
Work contract
This relates to Clause 7.6.4 of ISO/IEC 17065. This is one possibility for
organisational control among many
FUNCTIONAL APPROACH
…•Selection
…•Determination
…•Review
…•Attestation
…•Surveillance
Evaluation
Insuance of a
certificate after
decision
The right part of the chart (evaluation – Insuance of certificate) is the terminology
used in ISO/IEC 17065
The functional approach is described in ISO/IEC 17000 (left part of the chart below)
PROCESS STEPS / REQUIREMENTS
•7.1 General
•7.2 Application
•7.3 Application review
•7.4 Evaluation
•7.5 Review
•7.6 Certification decision
•7.7 Certification documentation
•7.8 Directory of certified products
•7.9 Surveillance
•7.10 Changes affecting certification
•7.11 Termination, reduction, suspension or withdrawal of certification
•7.12 Records
•7.13 Complaints and appeals
CONFORMITY WITH TECHNICAL
REGULATIONS AND STANDARDS - ARTICLE
� Article 6 - Recognition of Conformity Assessment
by Central Government Bodies
� member acceptance of results from other members
� ensure procedures are open to others
� MRA’s for acceptance of results encouraged
� no less favorable participation by bodies of others
encouraged
CONFORMITY WITH TECHNICAL
REGULATIONS AND STANDARDS - ARTICLE
� Article 5 - Procedures for Assessment of Conformity by
Central Government Bodies
� no less favorable treatment
� no unnecessary TBT’s
� ensure implementation of procedures follows good practice*
� use international guidelines
� Good Practice includes
� process expeditiously
� minimize information required
� confidentiality
� fair fees
� minimize change implications
� complaints procedure
CONFLICT OF INTEREST
A body shall ensure that activities of related bodies do not affect
the confidentiality, objectivity or impartiality of its (conformity
assessments) and shall not offer
1. Those services that it (recognizes) others to perform,
2. Consulting services to obtain or maintain (conformity
approval),
3. Services to design, implement or maintain (assessed)
systems.PRODUCT AND QUALITY
Lecture : New approach of European Union
EUROPEAN COMMISSION WHITE PAPER-MARCH, 1985
� Key technical statement from the EU
commission
� Contained 300 pieces of legislation (reduced to
286 )
White Paper pledged to eliminate fiscal, technical
and physical barriers
� Replace national standards with EU standards
� Eliminate national regulations that restrict trade
� Agree on EU wide certification and test procedures
EU CREATED NEW APPROACH DIRECTIVES
� Create a framework for compliance and conformity assessment
� Identify essential safety requirements
� Create EN harmonized standards to implement the directive
� Create both safety and quality requirements
� Multiple EN harmonized standards have been created to implement each directive
� Example- Machinery Safety Directive contains approximately 1000 standards for implementation
� EU Medical Devices Directives are being harmonized with the FDA (USA regulation)
NEW APPROACH DIRECTIVES
� CE marking is a legal requirement for all products affected by new approach directives
� The operative language is “placing on the market”
� Unmarked or illegally marked products are subject to civil fines and criminal sanctions
� Compliance with directive requirements means market entry throughout the EU
� Compliance is not a casual response-it will require time, money and effort
� Other countries are adopting EU approaches to product safety
GENERAL PRINCIPLE – PROHIBITION OF
OBSTACLES
� Quantitative restrictions (quotas) and
measures having equivalent effect applied on
both importations and exportations (Art. 34-35
TFEU)
INTERPRETING CASE-LAW
� Judgement Dassonville: „any measure of the Member State affection actually or potentially interstate trade in goods is measure having equivalent effect“).
� Nevetheless, it later accepted that some generally applied reasonable measures for the protection of general interests are not covered (judgement Cassis de Dijon: „judicial quasi-exceptions“ are allowed if „rule of reason“ is respected).
� It also allowed various rules of sales (judgement Keck).
NEW APPOACH
� "New Approach" Directives (Community Law) set out the
essential requirements (on safety for example)
� Written in general terms and must be met before products
may be sold in the UK or anywhere else in the European
Community
� European harmonised (EN) standards provide detailed
technical information enabling manufacturers to meet the
essential requirements
� Directives explain how manufacturers are able to
demonstrate conformity with the essential requirements
� Products which meet essential requirements are to display
the CE marking which means they can be sold anywhere in
the Community / European Economic Area (EEA)
NEW APPROACH CE MARKING DIRECTIVES
There are 21 CE marking Directives
Directive Amended by Title of directive
2006/95/EC Low Voltage
87/404/EEC 90/488/EEC
93/68/EEC
Simple Pressure Vessels
88/378/EE 93/68/EEC Safety of toys
89/106/EEC 93/68/EEC Construction products
2004/108/EC Electromagnetic compatibility (EMC)
2006/42/EC Machinery
89/686/EEC 93/68/EEC
93/95/EEC
96/58/EC
Personal protective equipment (PPE)
90/384/EEC 93/68/EEC Non-automatic weighing instruments
90/385/EEC 93/42/EEC
93/68/EEC
2007/47/EC
Active implantable medical devices
90/396/EEC 93/68/EEC Appliances burning gaseous fuels
CE MARKING DIRECTIVES
Directive Amended
by
Title of directive
92/42/EEC 93/68/EEC
2004/8/EC
2005/32/EC
Efficiency requirements for new hot-water boilers fired with
liquid or gaseous fuels
93/15/EEC Explosives for civil uses
93/42/EEC 98/79/EC
2000/70/EC
2001/104/EC
2007/47/EC
Medical devices
94/9/EC Equipment explosive atmospheres (ATEX)
94/25/EC 2003/44/EC Recreational craft
95/16/EC Lifts
97/23/EC Pressure equipment
98/79/EC In vitro diagnostic medical devices
1999/5/EC Radio Equipment and Telecommunications Terminal Equipment
2000/9/EC Cableway installations designed to carry persons
2004/22/EC Measuring instruments
SUMMARY OF APPLICABLE DIRECTIVES
Directive Title of Directive
2006/95/EC Low Voltage Directive (LVD)
2004/108/EC Electromagnetic compatibility (EMC)
1999/5/EC Radio Equipment and Telecommunications Terminal
Equipment
The CE marking Directives listed below are the ones that
would most typically be applicable to your products.
OTHER APPLICABLE DIRECTIVES
“Just because a Directive does not call for CE marking does not mean the Directive is not applicable.”
Other typically applicable directives:-
Directive Title of Directive
2001/95/EC General Product Safety Directive (GPSD)
2002/96/EC Waste from Electrical and Electronic Equipment (WEEE)
2002/95/EC Restriction of Hazardous Substances (RoHS)
Directive UK Law
2006/95/EC
Low Voltage Directive
The Electrical Equipment (Safety)
Regulations 1994 (SI 1994/3260)
2004/108/EC
EMC Directive
EMC Regulations 2006 (SI 2006/3418)
1999/5/EC
RTTE Directive
The Radio Equipment and
Telecommunications Terminal Equipment
Regulations 2000 (SI 2000 No.730)
LEGAL STATUS OF DIRECTIVES
� Directives are agreed, adopted & accepted by the
governments of the member states into their own national law
Gives the Directives the same status as other laws in this
country
BASIC MODULES
SIMPLIFIED FLOW CHART OF CONFORMITY
ASSESSMENT PROCEDURES VARIANTS OF BASIC MODULES
• Manufacturer demonstrates product complies with European-wide
standard, on the basis of:
– One-off External testing (“Initial Type Test”)
– Factory Production control (on-going)
• When product compliant, manufacturer makes a legal and
transparent declaration
• Allows CE Marking of product
• Product can be made available for sale in EU
• Supporting documentation held and maintained in event of legal
challenge (Technical File)
CE Marking principles
• Level of involvement of third party (Notified Body) for initial
type testing dependent upon:
– Product type
– Product use
• Higher the “risk” if product fails, the greater involvement of third
party
– Fire resistance
– Bullet resistance
– Explosion resistance
here the third party is involved in Factory Production Control as
well
CE Marking principles
Other than the legal requirement to do so, benefits of CE Marking
for customers include:
• Declared performance from manufacturers will be more
transparent than in the past and more open to challenge
• Opportunity to be seen as ahead of the market as a result of
understanding and knowledge of CE Marking
• Security for customers, Architects and Specifiers as
Pilkington proves the performance of their products on a
European scale
• One set of data per product
• No legal requirement for maintaining national voluntary marks
- CE Marking states that a product is ‘fit for purpose’ therefore
a money-saving opportunity
What are the benefits of CE Marking? -(1)
Other than the legal requirement to do so, benefits of CE Marking
include:
• Testing independently undertaken by accredited third party
• Products can be compared across borders (harmonised product and
test standards)
• Some of the testing goes beyond traditional national requirements
• Product standards introduced to some countries where none
previously existed
• Manufacturer’s responsibility clearly defined
• Higher ‘risk’ products require greater involvement of third parties
e.g. fire resistance, etc.
• Manufacturer much more accountable under a common legal
framework
What are the benefits of CE Marking? -(2)