**1. Introduction**

Biomedical calibration measurement is the measurement of the accuracy of the medical de‐ vice or the medical system by using the standard measurement system whose accuracy is known, and is the determination and the record of the deviations. In shortly, by the biomed‐ ical calibration measurements, it is established whether the medical devices are appropriate to the international standards or not, and the problems are also determined if the device is not adequate to the international standards (Sezdi, 2012).

Biomedical calibration measurement is different from other industrial calibration studies. Measurements are generally performed where the medical device that will be tested, is used in hospital. Only some medical devices, for example pipettes, thermometers are tested in laboratory environment.

Accreditation is the appraising of a measurement service in according to the international technical criterias, is the acception of its qualification and the controlling of it regularly. For an enterprise, being accredited is a reputable status. It shows that the enterprise has a quality management system and performs the requirements of the implemented stand‐ ards. The enterprices are periodically recontrolled by an accreditation agency to protect the status and to continue fulfilling of the requirements of the business standards. The controls create the most important quality assurance of the businesses that take service from these laboratories.

In many countries, from Brazilia to China, there are accreditation studies (Boldyrev et al., 2004; Boschung et al., 2001; Iglicki et al., 2006; Kartha et al., 2003; Alexander et al., 2008; Goff et al., 2009; McGrowder et al., 2010). In Turkey, the studies of accreditation is controlled by Turkish Accreditation Agency (TURKAK). If the list of the accredited laboratory is investi‐

gated from the web site of TURKAK, it is seen that there are approximately 14 accredited enterprises that give services in biomedical calibration measurements (TURKAK website). But these are not in a single accredited enterprise type. While some of them are accepted as testing laboratories, some of them are accepted as calibration laboratories, the others are ac‐ cepted as inspection bodies.

fied requirements. Thereby accreditation favours the elimination of technical barriers to trade. Accreditation provides a global acceptance of the services and establishs a confi‐

Accreditation of Biomedical Calibration Measurements in Turkey

http://dx.doi.org/10.5772/51075

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The trusting mechanism between accreditation bodies is constructed on the multi literal agreements at the international and regional accreditation body organisations, like IAF ( In‐ ternational Accreditation Forum), ILAC (International Laboratory Accreditation Coopera‐

Turkish Accreditation Agency (TURKAK) started to provide accrediation services in 2001 and became a cooperator of Europian Cooperation for Accreditation (EA) for all available accreditation schemes at 2008. Currently TURKAK is a full member of EA, IAF and ILAC. It

Accreditation is beneficial to the accredited body itself, to Government and to users of ac‐

**1.** the laboratories are controlled by independent conformity assessment bodies and they

**3.** the measurements are demonstrated as traceble in according to the national or interna‐

**1.** assurance that tests are performed by using calibrated equipment by personnel with the

**2.** assurance that calibration or test devices are controlled and traced periodically in ac‐

**4.** addition of credibility to the test results by accredited conformity assessment bodies,

In laboratory and inspection accreditation, high respectability both at the national and inter‐ national level as an indicator of technical competence is essential. Laboratory and inspection accreditation aim to give services accurate and reliable testing, analysis or calibration meas‐ urements. Laboratory accreditation ensures the official recognition of laboratory competence

dence for the quality.

credited bodies.

tional standards,

right level of expertise,

tion), EA (Europen Cooperation for Accreditation), etc.

meet international standards for competence,

Accredited service provides benefits for customers:

cording to the international standards, **3.** elimination of technical barriers to trade,

**•** accreditation of product, service or inspection,

**•** accreditation of personal certification bodies.

Generally, accreditation applications are classified as 4 items.

**•** accreditation of certification of management systems, and

**•** Accreditation of testing, calibration and medical laboratories,

serves as international accreditation agency.

Accredited bodies have benefits as below:

**2.** an effective marketing tool is provided,

The standard used in the accreditation of testing laboratories and calibration laboratories is TS EN ISO/IEC 17025:2005. ISO 17025 contains the quality management system of the testing and calibration laboratory. It examines all work flows, organization structure and technical suffiency. The standard used in the accreditation of inspection bodies is TS EN ISO/IEC 17020:2004 (ISO IEC 17025, 2005; ISO IEC 17020, 2004).

There is not yet a specific study about the medical accreditaton in TURKAK. If hospitals de‐ mand the medical accreditation during they take the medical calibration service, they must work with the accredited laboratory in according to their measured medical device or system. It can be a medical device, radiological system or only a parameter such as temperature, mass…etc. There is a confusion about which accreditation studies should preferred for which medical devices. Is the accreditation certificate about non-medical parameters sufficient tech‐ nically for biomedical calibration? In other words, is testing of a defibrilator by the mass ac‐ creditation or testing of an anesthetic machine by the temperature accreditation, ethical?

There may be many parameters that must be considered during the biomedical calibration measurements of any medical device. For example, testing of a ventilator contains flow, pressure and volume parameters. If a sufficieny is wanted, sufficiency about three parame‐ ters must be wanted seperately. In addition to this, the personnel who will perform the measurement, must be professional. The biomedical calibration needs the specialization of the biomedical personnel. It brings many problems that the biomedical calibration is per‐ formed by the non-educated personnel about biomedical and that the industrial accredita‐ tion is accepted as sufficient. Particularly, inattentive studies, in operation rooms and intensive care rooms, causes many unexpected problems.

The important point that attracts the attention in this study is that the hospitals take the in‐ adequate services if they don't investigate the accreditation content. If the content of the ac‐ creditation studies is known, the customer will be knowledgeable about which accreditation should be preferred for which medical device or medical system.
