**3. Accreditation Standards**

The accreditation standards used in biomedical calibration measurements can be classified into 2 groups. TS EN ISO / IEC 17025 and TS EN ISO / IEC 17020. While the standard of 17025 is used for the accreditation of testing and calibration laboratories, the standard of 17020 is used for the accreditation of inspection bodies.

The laboratory accreditation standards should not be confused with ISO 9001 standard. ISO 9001 is widely used in the assessment of the quality systems of production and service or‐ ganizations. Certification of organizations according to the ISO 9001 system expresses the compliance of that organization's quality system with this standard (ISO 9001). When certi‐ fying laboratories according to ISO 9001, this certification makes no statement on the techni‐ cal competence of laboratories. From this point, the certificate's power to convince the market and prospects of laboratories is quiet insufficient.

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

**•** the development and operation of Proficiency Testing schemes (Part 1)

**•** guidance on statistical methods (Annex A) and

schemes (Annex B)

84 Practical Concepts of Quality Control

**•** the selection and the use of schemes by laboratory accreditation bodies (Part 2)

**•** guidelines for development of a quality manual for the operation of Proficiency Testing

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,

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‐

The accreditation standards used in biomedical calibration measurements can be classified into 2 groups. TS EN ISO / IEC 17025 and TS EN ISO / IEC 17020. While the standard of 17025 is used for the accreditation of testing and calibration laboratories, the standard of

The laboratory accreditation standards should not be confused with ISO 9001 standard. ISO 9001 is widely used in the assessment of the quality systems of production and service or‐ ganizations. Certification of organizations according to the ISO 9001 system expresses the compliance of that organization's quality system with this standard (ISO 9001). When certi‐ fying laboratories according to ISO 9001, this certification makes no statement on the techni‐ cal competence of laboratories. From this point, the certificate's power to convince the

and not all Proficiency Testing providers wish to be accredited.

bility for your purpose (ISO Guide 34, 2000; ISO Guide 43, 1997).

17020 is used for the accreditation of inspection bodies.

market and prospects of laboratories is quiet insufficient.

**3. Accreditation Standards**

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

First–party Laboratories: Manufacturer Laboratories, Second-party Laboratories: Customer Laboratories, Third-party Laboratories: Independent Laboratories.

This standard can be applied to all laboratories regardless of the scope of test or calibration activities and the number of personnel.

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‐ ers technical competence requirements, not covered by ISO 9001.

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

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‐ tent of 17025 standard is as follows:

0 Introduction

1 Scope


*Type B:* Inspection services should be given to the organization that consists of the inspection

Accreditation of Biomedical Calibration Measurements in Turkey

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

87

*Type C:* This type of bodies give services to both the organization that consists of the inspec‐

TS EN ISO 17020 standard can be applied regardless of the scope of inspection activities in the company. TS EN ISO 17020 certification can be given all kinds of inspection bodies that

In the standard of TS EN ISO IEC 17020, the technical requirements are the main aspect. TS

As it was mentioned earlier, there are 3 accreditation types for biomedical calibration meas‐

body. Type B bodies can not service to other organizations.

are willing to give service in accordance with this standard.

*3.2.1. The content of the standard of TS EN ISO / IEC 17020*

EN ISO 17020 standard consists of 16 items. They are:

4 Independence, impartiality and integrity

6 Organization and management

10 Inspection methods and procedures 11 Samples and materials to be inspected

14 The use of subcontractors 15 Complaints and appeals

**4. Accreditation Types**

**•** Calibration laboratories

13 Inspection reports and inspection certificates

tion body and other organizations.

0 Introduction

2 Definitions

3 Administrative Rules

1 Scope

5 Privacy

7 Quality System

8 Personnel 9 Equipment

12 Records

16 Co-operation

urements. They are:


The laboratory must be an institution that can be held legally responsible. Laboratory man‐ agement system must consist of facilities in fixed laboratory and temporary or mobile facili‐ ties that are linked to the laboratory.

#### **3.2. The standard of TS EN ISO / IEC 17020**

ISO 17020, entitled "General Criteria for the Operation of Various Types of Bodies Perform‐ ing Inspection", is an internationally recognized standard for the competence of inspection bodies. Inspection parameters may include such aspects as the quantity, quality, safety, suit‐ ability, facilities or systems (ISO IEC 17020; 2004).

There are 3 types of inspection organizations. They are:

*Type A:* Inspection body must be independent. Both the inspection organization and its per‐ sonnel must not be related to the inspected materials. They must not be the material's de‐ signers, manufacturers, suppliers, installers, purchasers, owners or operators.

*Type B:* Inspection services should be given to the organization that consists of the inspection body. Type B bodies can not service to other organizations.

*Type C:* This type of bodies give services to both the organization that consists of the inspec‐ tion body and other organizations.

TS EN ISO 17020 standard can be applied regardless of the scope of inspection activities in the company. TS EN ISO 17020 certification can be given all kinds of inspection bodies that are willing to give service in accordance with this standard.

### *3.2.1. The content of the standard of TS EN ISO / IEC 17020*

In the standard of TS EN ISO IEC 17020, the technical requirements are the main aspect. TS EN ISO 17020 standard consists of 16 items. They are:


4.6 Purchasing of service and materials 4.7 Customer service 4.8 Complaints

4.9 Control of nonconforming testing and / or calibration work

5.3 Accommodation and environmental conditions

5.4 Test and calibration methods and method validation

5.9 Assuring the quality of test and calibration results

The laboratory must be an institution that can be held legally responsible. Laboratory man‐ agement system must consist of facilities in fixed laboratory and temporary or mobile facili‐

ISO 17020, entitled "General Criteria for the Operation of Various Types of Bodies Perform‐ ing Inspection", is an internationally recognized standard for the competence of inspection bodies. Inspection parameters may include such aspects as the quantity, quality, safety, suit‐

*Type A:* Inspection body must be independent. Both the inspection organization and its per‐ sonnel must not be related to the inspected materials. They must not be the material's de‐

signers, manufacturers, suppliers, installers, purchasers, owners or operators.

4.8 Complaints

86 Practical Concepts of Quality Control

4.10 Improvement 4.11 Corrective action 4.12 Preventive action 4.13 Control of records 4.14 Internal controls

4.15 Management reviews 5 Technical requirements

5.6 Measurement traceability

5.8 Calibration procedures

5.10 Reporting of the results

ties that are linked to the laboratory.

**3.2. The standard of TS EN ISO / IEC 17020**

ability, facilities or systems (ISO IEC 17020; 2004).

There are 3 types of inspection organizations. They are:

5.1 General 5.2 Personnel

5.5 Devices

5.7 Sampling

