Transcript WHY CONFORMITY ASSESSMENT?

WHY CONFORMITY ASSESSMENT?
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
How Conformity assessment works
Conformity assessment activities can be characterized as:
 First party - 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.
This is known as a supplier's declaration of conformity.
 Second party - this is defined as the conformity assessment activity
which is performed by the customer of the organization. For example
the manufacturer would allow his customer to do an assessment of the
product against the requirements.
 Third party - this is defined as the conformity assessment activity that
is performed by a body that is independent of the organization that
provides the product and is not a user of the product. An example of
this would be when an independent certification body certifies that
another organization complies with ISO 9001 and issues it with a
certificate to this effect.
Mechanisms for performing conformity assessment
 Testing
 This is the most common form of conformity assessment.
Testing also provides the basis for other types of conformity
assessment like inspection and product certification. Here a
product is tested against a specified set of criteria. It can be
used to make decisions on the performance of the product.
 The general requirements for laboratories or other
organizations to be considered competent to carry out
testing calibration and sampling are specified in the joint
International Standard ISO/IEC 17025:2005 General
requirements for the competence of testing and calibration
laboratories.
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.
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 of quality
management systems and environmental management systems as
conforming, respectively, to ISO 9000 and ISO 14000 standards. More
than 800 000 organizations worldwide have been certified to ISO 9001
and/or ISO 14001. It should be noted that ISO itself does not assess the
conformity of quality or environmental management systems to ISO 9000
or ISO 14000 standards. ISO does not issue certificates of conformity to
these standards. ISO 9001 and ISO 14001 certification is carried out
independently of ISO by the many certification or registration bodies
active nationally or internationally.
 Although ISO does not control the certification bodies, it contributes to
best practice and consistency in their activities through the development
of standards and guides. ISO/IEC 17021:2011 gives general requirements
for bodies providing audit and certification of management systems.
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.
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.
Why conformity assessment is important (continued)
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.
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Why conformity assessment is important (continued)
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.
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Why conformity assessment is important (continued)
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.
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National quality infrastructure
Parliament of Sri Lanka
Government of Sri Lanka
National
Standards
Body (SLSI)
National
Metrology
Institute
(MUSSD)
National
Accreditation
Body (SLAB)
Regulatory
Bodies
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VOLUNTARY
SECTOR
REGULATED SECTOR
GOVERNMENT
Sets policy, laws &
technical regulations
CUSTOMER
REQUIREMENTS
SUPPLIER
MEASUREMENTS
Underpins testing & calibration
through national measurement
standards
STANDARDS
Specific technical
requirements of product or
system
CONFORMITY ASSESSMENT
Prove technical
requirements are met
Testing & calibration
Inspection
Certification
REGUALATORS
Administer
regulations
CUSTOMER
ACCREDITATION
Assures competence
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THANK YOU
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