Accreditation, not certification

The report entitled "Government interested in using Synergene services" (The Sunday Times, October 9) needs some very important clarifications.

The article states: "The company, which specialises in DNA profiling and forensic testing, was awarded the prestigious ISO17025 certification by the International Standards Organisation."

This sentence is not correct in two instances: Synergene has not been awarded "certification" but "accreditation" and the International Standards Organisation was not involved in any way in this process.

There is a distinct difference between the terms "accreditation" and "certification" in the world of conformity assessment activities. Such activities range from laboratory testing to inspection and to certification.

Accreditation is a special term reserved for the service provided by a country's national accreditation body. In Malta's case this is the NAB-MSA (National Accreditation Body of the Malta Standards Authority). Accreditation is the formal recognition of the competence of an organisation to carry out a specific conformity assessment task such as testing, calibration, inspection or certification.

This formal recognition is based on international standards which are issued by the International Standards Organisation (ISO). These standards are concerned specifically with the aspects of competence, independence, impartiality and continuity of conformity assessment bodies such as laboratories.

Synergene Technologies Limited has been assessed by the NAB-MSA according to the requirements of the international standard ISO17025. It was awarded accreditation on July 15 following a positive decision taken by the Accreditation Advisory Board set up within the NAB-MSA. The International Standards Organisation (ISO) was not involved in any part of the process.

ISO does not provide any conformity assessment services such as accreditation or certification. ISO is a federation of national standardisation bodies and it is only responsible for developing and issuing ISO standards. Referring to the "certification" of Synergene actually reduces the effort this company made to achieve it current accredited status.

ISO17025, which is the International Standard issued by the ISO and which defines the general requirements for the competence of testing and calibration laboratories, can only be used by accreditation bodies and cannot be used by certification bodies. The assessment of a laboratory against ISO17025 is called accreditation and not certification.

As the name implies, the activity of "certification" is carried out by "certification bodies" and it is limited to certification of management systems in line with other international standards such as the widely used ISO9001 standard for quality management systems, ISO14001, etc; certification of products and certification of personnel.

An accreditation body, such as the NAB-MSA, "accredits" a certification body" for its competence to "certify" companies against ISO9001.

This "accreditation" process of a certification body entails the NAB-MSA assessing such a body against the requirements of other international standards.

These standards define how a certification body should be set up and how it should operate to enable it to be assessed and eventually achieve "accreditation" by an accreditation body. Such an "accreditation" would ultimately imply that this certification body is competent to "certify" other companies.