TÜV Rheinland Group, Accredited Laboratory for MD Testing in Italy -- MEDICA - World Forum for Medicine


TÜV Rheinland Group

TÜV Rheinland Group, Accredited Laboratory for MD Testing in Italy

Pogliano Milanese (MI), 11 Novembre 2009

The conformity evaluation of devices is fundamental for manufacturers, to protect consumers safety and to demonstrate to conformity assessment bodies that the requirements of the applicable directives have been satisfied. Laboratory tests are essential for this process because products are accepted or refused, with related economical consequences/results according to the comparison of results with regulatory, contractual or legal restrictions. Rules demand and the need of internationally uniform evaluation levels is fundamental.
Finally, tests results in our globalized market must be comparable, so, laboratories must guarantee the reference to SI, the international system of units, of the executed measures. “Quality” for test laboratories is a concept regarding not only management systems, but also technical features. The worldwide recognized word that meets the above-mentioned requirements concerning the competence of test laboratories is “Accreditation”. “Accreditation” is the process attesting that a test or calibration laboratory has been recognized as competent by an independent third part body for the execution of the activities included in the scope of the accreditation itself.
“Accreditation” is synonym of Quality and technical Competence of the laboratory.
The laboratory that wants to demonstrate its excellence must use the referential international standard ISO/IEC 17025.
ISO/IEC 17025 standard consists of management and technical requirements and it is used for the achievement of tests and calibrations recognition for the charged laboratories. The word “Accreditation” is preferred to “Certification” because in the Quality National System test and calibration laboratories are classified as Specialized operators for the conformity evaluation and are qualified for the execution of tests and calibrations where measures’ suitability and care are guaranteed and performed thanks to the use of “calibrated” instrumentation. The certification is achieved through the satisfaction of the ISO 9001 requirements and it concerns the quality system that a company implements to provide products and services satisfying customers requests. The accreditation is achieved for a unique test or calibration after a successful inspection of the competent accreditation body attesting the compliance to standard requirements. Therefore a laboratory accredited according to ISO/IEC 17025 has not been automatically accredited for all tests and calibrations it can offer, but only for specific tests and calibrations evaluated with a dedicated inspection.

ISO/IEC 17025 standard is an international reference point for the accreditation of tests and calibrations laboratories, that play a key role in the product development and evaluation and also in the guarantee and protection of consumer.
ISO/IEC 17025 includes all requirements that must be satisfied by Testing Houses to show their proper organizational system that allows a complete control of management processes, technical and scientific competence of resources.

Here the main features:
- qualification of the personnel for tests execution
- traceability of test instrumentation to international references
- definition of laboratory’s measurement uncertainty
- impartiality of measures execution
- classified data processing
- results presentation according to defined rules

In Italy the accreditation body is “ACCREDIA”. Other equivalent bodies are operating worldwide. The “European cooperation for Accreditation” (EA) is the European association including all the European accreditation bodies; the worldwide referential one is the “International Laboratory Accreditation Cooperation” (ILAC). These associations guarantee the full recognition of an associated laboratory activities in all the nations where EA and ILAC operate.

TÜVRheinland can boast ISO/IEC 17025 accredited laboratories for lots of standards and product types.
TÜV Rheinland Italia has achieved a ISO/IEC 17025 accreditation by DATech (DATech in der TGA GmbH), German accreditation body and EA and ILAC member. The related accreditation scope covers the following product families: medical devices, household appliances, furniture, office and laboratory’s equipments, devices for automotive and other.

For any further information please contact the nearest TÜV Rheinland Italia location or visit our website: www.tuvitalia.com