**2. Accreditation**

Accreditation is a quality infrastructure tool which supports the credibility and value of the work carried out by conformity assessment bodies. Accreditation provides formal recogni‐ tion that an organisation is meeting internationally accepted standards of quality, perform‐ ance, technical expertise, and competence.

A product or service accompanied by a conformity attestation delivered by an accredit‐ ed conformity assessment body inspires trust as to the compliance with applicable speci‐ fied requirements. Thereby accreditation favours the elimination of technical barriers to trade. Accreditation provides a global acceptance of the services and establishs a confi‐ dence for the quality.

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

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 serves as international accreditation agency.

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

Accredited bodies have benefits as below:

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‐

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

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

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

Accreditation is a quality infrastructure tool which supports the credibility and value of the work carried out by conformity assessment bodies. Accreditation provides formal recogni‐ tion that an organisation is meeting internationally accepted standards of quality, perform‐

A product or service accompanied by a conformity attestation delivered by an accredit‐ ed conformity assessment body inspires trust as to the compliance with applicable speci‐

cepted as inspection bodies.

80 Practical Concepts of Quality Control

**2. Accreditation**

ance, technical expertise, and competence.

17020:2004 (ISO IEC 17025, 2005; ISO IEC 17020, 2004).

intensive care rooms, causes many unexpected problems.

should be preferred for which medical device or medical system.


Accredited service provides benefits for customers:


Generally, accreditation applications are classified as 4 items.


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 and offers an easy method to customers in determining and choosing reliable testing, analy‐ sis and calibration services.

**2.1. Proficiency Testing & Interlaboratory Comparisons**

significant benefits to laboratories.

staff training and method validation.

**Figure 2.** The factors in accreditation process.

cording to defined criterias.

(ISO/IEC 17043, 2007)

ciency Testing Schemes (ILAC G13, 2007)

other purposes (introduction to Part 1)

For accreditation studies, the quality assurance of the test results is obtained by interla‐ boratory comparisons and proficiency testing (PT) (Bode, 2008; Kubota et al., 2008; Ko‐ pler et al., 2005). The interlaboratory comparisons and proficiency testing bring

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Proficiency Testing provides the infrastructure for a laboratory to monitor and improve the quality of its routine measurements (fig. 2). Proficiency Testing is the only quality measure which is specifically concerned with a laboratory's outputs. Proficiency Testing gives a pos‐ sibility to identify any problems caused from other aspects of its quality system, such as

Proficiency Testing is treated as important performance criteria regarding the evaluation of the technical competence of the laboratories. Laboratories that will be accredited should par‐ ticipate to Proficiency Testing programme or/and interlaboratory comparison for the main and sub disciplines they demand for accreditation and should submit satisfactory results ac‐

Proficiency Testing providers demonstrate the quality of their Proficiency Testing pro‐ grammes. There are two important international guides to which Proficiency Testing pro‐

**1.** ISO/IEC 17043: Conformity assessment - General requirements for proficiency testing

**2.** ILAC G13: Guidelines for the Requirements for the Competence of Providers of Profi‐

The basic of the ISO/IEC 17043 is the ISO/IEC Guide 43. For several years, this document has provided several guidance on the development and operation laboratory proficiency testing for a relatively new field of activity. It contained very basic guidance and little attention to

**•** to distinguish between use of interlaboratory comparisons for Proficiency Testing and for

viders can demonstrate the quality of their Proficiency Testing programmes:

the use of the outcomes by laboratory accreditation bodies (Tholen, 2007). Guide 43 have provided guidance in 5 areas (ISO Guide 43, 1997). They are;

The process of laboratory accreditation is regulated and standardized according to the inter‐ national standards. Reports and certificates issued by accredited laboratories are interna‐ tionally accepted. While the standard for testing and calibration laboratories is ISO IEC 17025:2005, the standard for inspection bodies is ISO IEC 17020:2004.

Accreditation activities of certification bodies of management system provide quality of cer‐ tification of management system. Accreditation services in this field is generally given for ISO 9001:2008 certification, ISO 14001:2004 certification, ISO 22000:2005 certification, ISO 27001:2005 certification and ISO 13485:2003 certification. For this type of accreditation, ISO/IEC 17021:2011 standard is used (ISO/IEC 17021, 2011).

Accreditation of personal certification bodies that certificate the personnel making conformi‐ ty assessments to make their activities in accordance with specified national and internation‐ al standards, is provided by using the standard of ISO/IEC 17024:2003 (ISO/IEC 17024, 2003).

Accreditation bodies use accreditation mark or logo over their certificates or reports that contain their measurement/test results. But, such logo or marks must be used only over the certificates or reports including accredited facilities. TURKAK also provides accredita‐ tion symbol to be used in the output documents to be issued for the accredited services. It contains information about the accreditation field, accreditation standard and unique number of the accredited body, the accreditation number. The logo used by TURKAK can be seen in figure 1.

**Figure 1.** The accreditation logo used by TURKAK (TURKAK website).

#### **2.1. Proficiency Testing & Interlaboratory Comparisons**

and offers an easy method to customers in determining and choosing reliable testing, analy‐

The process of laboratory accreditation is regulated and standardized according to the inter‐ national standards. Reports and certificates issued by accredited laboratories are interna‐ tionally accepted. While the standard for testing and calibration laboratories is ISO IEC

Accreditation activities of certification bodies of management system provide quality of cer‐ tification of management system. Accreditation services in this field is generally given for ISO 9001:2008 certification, ISO 14001:2004 certification, ISO 22000:2005 certification, ISO 27001:2005 certification and ISO 13485:2003 certification. For this type of accreditation,

Accreditation of personal certification bodies that certificate the personnel making conformi‐ ty assessments to make their activities in accordance with specified national and internation‐ al standards, is provided by using the standard of ISO/IEC 17024:2003 (ISO/IEC 17024, 2003).

Accreditation bodies use accreditation mark or logo over their certificates or reports that contain their measurement/test results. But, such logo or marks must be used only over the certificates or reports including accredited facilities. TURKAK also provides accredita‐ tion symbol to be used in the output documents to be issued for the accredited services. It contains information about the accreditation field, accreditation standard and unique number of the accredited body, the accreditation number. The logo used by TURKAK can

17025:2005, the standard for inspection bodies is ISO IEC 17020:2004.

ISO/IEC 17021:2011 standard is used (ISO/IEC 17021, 2011).

**Figure 1.** The accreditation logo used by TURKAK (TURKAK website).

sis and calibration services.

82 Practical Concepts of Quality Control

be seen in figure 1.

For accreditation studies, the quality assurance of the test results is obtained by interla‐ boratory comparisons and proficiency testing (PT) (Bode, 2008; Kubota et al., 2008; Ko‐ pler et al., 2005). The interlaboratory comparisons and proficiency testing bring significant benefits to laboratories.

Proficiency Testing provides the infrastructure for a laboratory to monitor and improve the quality of its routine measurements (fig. 2). Proficiency Testing is the only quality measure which is specifically concerned with a laboratory's outputs. Proficiency Testing gives a pos‐ sibility to identify any problems caused from other aspects of its quality system, such as staff training and method validation.

**Figure 2.** The factors in accreditation process.

Proficiency Testing is treated as important performance criteria regarding the evaluation of the technical competence of the laboratories. Laboratories that will be accredited should par‐ ticipate to Proficiency Testing programme or/and interlaboratory comparison for the main and sub disciplines they demand for accreditation and should submit satisfactory results ac‐ cording to defined criterias.

Proficiency Testing providers demonstrate the quality of their Proficiency Testing pro‐ grammes. There are two important international guides to which Proficiency Testing pro‐ viders can demonstrate the quality of their Proficiency Testing programmes:


The basic of the ISO/IEC 17043 is the ISO/IEC Guide 43. For several years, this document has provided several guidance on the development and operation laboratory proficiency testing for a relatively new field of activity. It contained very basic guidance and little attention to the use of the outcomes by laboratory accreditation bodies (Tholen, 2007).

Guide 43 have provided guidance in 5 areas (ISO Guide 43, 1997). They are;

**•** to distinguish between use of interlaboratory comparisons for Proficiency Testing and for other purposes (introduction to Part 1)


**3.1. The standard of TS EN ISO / IEC 17025**

the first-party, second-party and third-party laboratories.

activities and the number of personnel.

tent of 17025 standard is as follows:

2 Cited in standards and / or documents

4.4 Review of requests, tenders and contracts

4.5 Subcontracting of tests and calibrations

0 Introduction

3 Terms and definitions

4.2 Management system

4.3 Document control

4.1 Organization

4 Management requirements

1 Scope

Laboratories, Third-party Laboratories: Independent Laboratories.

ers technical competence requirements, not covered by ISO 9001.

*3.1.1. The content of the standard of TS EN ISO / IEC 17025*

ISO IEC 17025, entitled "General Requirements for the Competence of Testing and Calibra‐ tion Laboratories", is an international standard describing the general requirements to meet for the recognition of that a laboratory is competent to perform specific tests (ISO IEC 17025; 2005). This international standard is used to develop the quality, management and technical systems of laboratories (Abdel-Fatah, 2010; Glavic-Cindro et al., 2006; Brantner et al., 2011; Zapata-Garcia et al., 2007; Jerone et al., 2008). Technical requirements are updated to include the addition of formal personnel training plans and detailed records, method development and validation procedures, measurement of method uncertainty, and a defined equipment calibration and maintenance program (Honsa et al., 2003). ISO 17025 certification can be ap‐ plied to all organizations that give services of testing or calibration. These organizations are

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First–party Laboratories: Manufacturer Laboratories, Second-party Laboratories: Customer

This standard can be applied to all laboratories regardless of the scope of test or calibration

If testing and calibration laboratories comply with the requirements of this standard, a qual‐ ity management system to meet the principles of ISO 9001 will be also applied. There is a cross-match among TS EN ISO 17025 standard and ISO 9001. TS EN ISO 17025 standard cov‐

TS EN ISO 17025 standard is assessed in two main categories. The standard of TS EN ISO IEC 17025 contains both the management and technical requirements. In standard, 4th item describes the management system and 5th item describes the technical activities. The con‐

The statistical annex led to the development of ILAC Guide 13. ILAC G13 contains the techni‐ cal guidelines from Guide 43-1 expressed as requirements and includes the quality manage‐ ment system requirements from ISO/IEC Guide 25. Since G13 has management system requirements that are consistent with ISO/IEC 17025, Proficiency Testing providers accredited to this document are considered to be in conformity with the requirements of ISO 9001:2000 (Tholen, 2007). The standard ISO/IEC 17043 describes the criteria concerning the quality to be respected when developing proficiency tests and the use that can be made of these tests by the accreditation bodies. ILAC-G13 is useful to organizers for competence (Fraville et al., 2010).

The Proficiency Testing programmes of many Proficiency Testing providers around the world are now accredited by their national accreditation bodies, normally against the above documents. However, not all countries are ready to accredit Proficiency Testing providers, and not all Proficiency Testing providers wish to be accredited.

Proficiency Testing programmes are operated by a variety of organizations within Europe and the rest of the world. Many Proficiency Testing programmes are international. There is a database of available Proficiency Testing programmes. In selecting the most appropriate Proficiency Testing it is important to consider a number of issues in order to judge its suita‐ bility for your purpose (ISO Guide 34, 2000; ISO Guide 43, 1997).
