Assessing Competitiveness In Moldova's Economy - Economic Growth

Development Alternatives, Inc. Moldova Competitiveness Assessment: Quality Assurance Infrastructure—Annex A
Conformity Assessment
ISO defines conformity assessment as an activity concerned with determining, directly or
indirectly, that relevant requirements are fulfilled. Conformity assessment is performed for
regulated and nonregulated products and services to verify conformance to a standard. This
may involve assessment of the design process, the production process, the final product, the
quality and environmental management systems, and personnel, in some cases. The
requirements for conformance are described in the standard.
Here is an example of conformity assessment of a regulated product. For an X-ray machine
to be placed on the market in Europe, it has to comply with EN60601, a European standard
on electrical medical device safety. The machine goes through many tests to ensure that it
meets both performance and safety requirements. In fact the conformity assessment of such a
product with the applicable standards also involves a review of the design and production
process, to ensure that adequate safety precautions were built into the product and that the
production process will consistently produce a product of the same level of quality and
specifications.
There are three types of conformity assessment:
Self-declaration by the producer or service provider: This is a risky approach unless the
provider is well recognized for its quality.
Buyer inspection and verification (referred to as second party assessment): This method is
expensive, as it requires inspection and verification by each buyer.
Third party certification: This method is the most preferred one and works quite well if the
conformity assessment body is recognized both locally and internationally.
Accreditation
Confidence in the competence and the impartiality of the conformity assessment body is key
to the acceptance of the certificates, both locally and internationally. National accreditation
bodies inspect the conformance of conformity assessment bodies to standards of operation to
ensure their competence and impartiality. International standards exist for product certifiers,
inspection bodies, testing labs, quality and environmental management systems, and
personnel involved in conformity assessment.
Market Surveillance
Advanced economies that allow self-declarations of conformity by the producer require a
tool to ensure that their markets are free from products that do not comply with the essential
safety requirements. Furthermore, market surveillance ensures fair competition by
eliminating products from the market that attempt to undercut prices by bypassing these
July 2004 • DRAFT Key terms Page 14