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)