TÜRKAK provides services in the mandatory field of accreditation of organizations that verify greenhouse gas emissions, depending on two different legal regulations and programs. In addition, it also provides accreditation services for voluntary verifications of organizations. Briefly, services provided in the legal field are the National MRV (monitoring, reporting and verification) legislation created by the Ministry of Environment, Urbanization and Climate Change and the ICAO CORSIA Program implemented by the General Directorate of Civil Aviation.
The accreditation service provided in the voluntary field started in 2023 and is limited to carbon footprint activities carried out within the context of the TS EN ISO 14064-1 standard at the organizational (business-facility) level.
In accreditation activities, TS EN ISO/IEC 17029 standard is used as a level 3 accreditation standard, regardless of whether the verification is mandatory or voluntary. TS EN ISO 14065 and TS EN ISO 14064-3 standards are also used as level 4 standards.
Verification Bodies wishing to be accredited shall meet the requirements of TS EN ISO/IEC 17029 and other relevant standard and normative documents. Standard and normative documents are given below.
Mandatory Standards and Normative Documents
· TS EN ISO/IEC 17029 General principles and requirements for validation and verification bodies
· TS EN ISO 14065 General principles and requirements for bodies validating and verifying environmental information
· TS EN ISO 14064-3 Part 3: Specification with guidance for the verification and validation of greenhouse gas statements
. TS EN ISO 14064-1 (voluntary area) Part 1: Specification with guidance at the organization level for quantification and reporting of greenhouse gas emissions and removals
· TS ISO 14066 Competence requirements for teams validating and verifying environmental information
· Regulation of Monitoring of Greenhouse Gas Emissions (Ministry of Environment, Urbanization and Climate Change)
· Communiqué on Monitoring and Reporting (Ministry of Environment, Urbanization and Climate Change)
· Communiqué on Verification of Emission Reports and Accreditation of Verifiers (Ministry of Environment, Urbanization and Climate Change)
· International Civil Aviation Authority Carbon Offsetting and Reduction Scheme (Annex 16, Uluslararası Sivil Havacılık Sözleşmesi Volume IV Version 2) (SARPSV2)
· ETM (Doc 9501) Volume IV (ICAO CORSIA)
· ICAO CORSIA in Turkish Legislation (General Directorate of Civil Aviation)
· Regulation on Greenhouse Gas Emissions Resulting From Aviation Activities (General Directorate of Civil Aviation (SHY-16.4))
· EA-6/03 EA document for accreditation of Verification Bodies for the purpose of EU ETS Directive
· EA-2/13 - EA Cross Border Accreditation Policy and Procedure for Cross Border Cooperation between EA Members
· ILAC G21 - Cross Frontier Accreditation - Principles for Cooperation
· IAF MD 6 IAF Mandatory Document for the Application of ISO 14065:2020
. IAF MD 7 IAF Mandatory Document for the Harmonization of Sanctions and Dealing with Fraudulent Behaviour
· TÜRKAK R40-10 (National MRV) Guideline on Accreditation of Greenhouse Gas Emission Verification Bodies
· TÜRKAK R40-11 (ICAO CORSIA) Guideline for Accreditation of Verification Bodies Operating in the Verification of Greenhouse Gas Emissions in Aviation
. TÜRKAK R40-13 (Voluntary field) Guideline on Accreditation of Organizations Verifying Greenhouse Gas Emissions in Voluntary Area (Organizational Level)
. TÜRKAK P701 Procedure for Accreditation of Conformity Assessment Bodies
· TÜRKAK P705 Procedure for the Principles On Remote Assessment
· TÜRKAK P706 Procedure for the Management of Extraordinary Events or Circumstances Affecting Accredited Bodies
· TURKAK R10.01 - Guideline on Professional Liability Insurance of the Accredited Bodies
· TÜRKAK R10.02 Guideline on Accreditation Service Fees
· TÜRKAK R10.06 Requirements for Using TURKAK Accreditation Symbol by the Accredited Bodies
· TÜRKAK R10.08 - Guideline on Complaints and Appeals
· TÜRKAK R10.09 Guideline on Calculations of Assessment Time (Person-Day) for Accreditation Assessments
· TÜRKAK R10.10 TURKAK Cross-Frontier Accreditation Rules
· TÜRKAK R10.11 Uzmanlık Alanları ve Kullanım Rehberi / Guideline for Areas of Expertise and their Usage
· TÜRKAK R10.14 Guidance on the Evaluation of Conformity Assessment Schemes
· Other mandatory documents published by the Ministry of Environment, Urbanization and Climate Change regarding Greenhouse Gas Verification activities
· Other mandatory documents published by the General Directorate of Civil Aviation on the subject
Guidance Documents / Other Related Documents
· Other relevant TÜRKAK, EA and IAF documents
· Relevant European Commission Guidelines (KGN, EGDI, etc.)
. Sectoral application documents to be used in the voluntary field (Example: API Compendium 2001)
Application Documents
· TÜRKAK F701-096- Application form for Verification Bodies (Başvuruda istenen belgeler, başvuru formunda belirtilmektedir.)
· TÜRKAK F701-097- Control Form for Verification Bodies
· TÜRKAK F701-039- Accreditation Contract (2 copies)
· TÜRKAK F701-071- Conformity Assessment Body Authorized Person Decleration Form
Medical laboratories are one of the important service areas in the national and international accreditation system. TS EN ISO 15189 - "Medical Laboratories - Requirements for Quality and Competence" standard is based on the accreditation of medical laboratories in order to ensure the reliability of medical analysis results and to make the data accurate, demonstrable and reproducible.
Within the scope of TS EN ISO 15189 standard; for the purpose of providing information on the diagnosis, management, prevention and treatment of disease or for evaluating a person’s health status the laboratories that perform biological, microbiological, immunological, chemical, immunohematological, hematological, biophysical, cytological, pathological, genetic or other analyzes of the materials obtained from the human body, interpret the results of tests, including recommendation for further studies and consultation services covering laboratory studies are accepted as Medical Laboratories.
TS EN ISO 15189 Standard sets out the general principles, general approaches, policies and the necessary measures to be taken in terms of technical competence. Laboratories wishing to be accredited shall have a quality system established and operated to meet the requirements of this standard. In addition to the standard, it shall also fulfill the requirements of the legal legislation containing additional criteria related to the working area of laboratories, mandatory documents, the relevant documents prepared by the International Laboratory Accreditation Cooperation (ILAC), European cooperation for Accreditation (EA) and TURKAK.
• EA-4/14 - Selection and use of reference materials
• EA-3/01 - EA Conditions for the use of Accreditation Symbols, Logos and other claims of accreditation and reference to the EA MLA Signatory status
• EA-4/18 - Guidance on the level and frequency of proficiency testing participation
• EA-4/20 - Guidance for the Assessment of Laboratories against EN ISO 15189 and 22870
• ILAC G18 - Guideline for the Formulation of Scopes of Accreditation for Laboratories
• ILAC G21 - Cross Frontier Accreditation - Principles for Cooperation
• ILAC G24 - Guidelines for the determination of calibration intervals of measuring instruments
• ILAC G26 - Guidance for the Implementation of a Medical Accreditation Scheme
• ILAC G27 - Guidance on measurements performed as part of an inspection process
• TURKAK F701-064 - The Requested Documents For Medical Laboratories at Application
• TURKAK F701-063 - Accreditation Application Form for Medical Laboratories
• TURKAK F701-039 – Accreditation Contract
Having sight at the national accreditation system, we see that one of the important service areas is the laboratory sector. In this sector; test, analysis and calibration laboratories are existing. Measurement reliability, traceability of the measurements carried out by the laboratory and homogeneity of measurement studies should be ensured by means of a measurement infrastructure that ensures the accuracy of the studies carried out by the aforementioned laboratories. From this point of view, the basic document used by TÜRKAK for the accreditation of calibration laboratories is the international standard TS EN ISO / IEC 17025.
In our country, the accreditation of laboratories is voluntary based, and a calibration laboratory becomes ready for accreditation by ensuring compliance with the TS EN ISO / IEC 17025 standard. However, in addition to this standard, it is also possible to use documents containing additional criteria related to the accreditation scope of the laboratories. TS EN ISO / IEC 17025 Standard sets out the general principles, general approaches, policies and measures to be taken in terms of technical competence. For specific applications, additional criteria have been prepared by the European Accreditation Association (EA) individually according to the fields of accreditation of the laboratories.
Guidance documents have been prepared by EA on how to apply the documents containing the standard and additional criteria created by EA to the bodies of laboratories and presented to the use of the parties. It is strongly recommended that parties interested in laboratory accreditation make use of them during the preparation process for accreditation.
Guidance Documents / Other Related Documents
Evaluation of participant performance according to predetermined criteria through interlaboratory comparisons is called proficiency test. Proficiency tests are a way of demonstrating technical competence.
In Turkey; The accreditation of proficiency testing providers is on a voluntary basis and the accreditation activities are carried out by the Turkish Accreditation Agency (TÜRKAK). Proficiency testing providers organize proficiency testing to measure and monitor the performance of the laboratory. The accreditation of proficiency testing providers is granted according to the TS EN ISO / IEC 17043 " Conformity assessment — General requirements for proficiency testing" standard.
TS EN ISO / IEC 17043 Standard sets out the general principles, general approaches, policies and measures to be taken in terms of technical competence. Proficiency testing providers who want to be accredited must have a established and operated quality system to meet the requirements of this standard. However, in addition to the standard, the proficiency testing provider must also fulfill the requirements of the legal regulations, mandatory documents, the relevant documents prepared by the International Laboratory Accreditation Association (ILAC), European Accreditation Association (EA) and TÜRKAK.
Mandatory Documents
Guidance Documents / Other Related Documents
Application Documents
TURKAK’s accreditation assessments for inspection bodies are based on the standard "TS EN ISO / IEC 17020: 2012 Conformity assessment- Conditions for the operation of various types of inspection bodies", which is used in the accreditation of inspection bodies all over the world. In addition to the standard, inspection bodies which are accredited or seeking for accreditation must also fulfill the requirements of the legal regulations, TURKAK mandatory documents and the mandatory and guidance documents prepared by ILAC and EA, of which TURKAK is a member.
Applications of accreditation are made online via the accreditation process operating system (asist.turkak.org.tr). In order to apply, applicant first creates a “company executive” account on ASİST. Bodies enters the all required information to proceed with the application and select the scopes which they are seeking for accreditation online. After that, bodies can see the preview of the application form and accreditation contract which they should be checked before e-signed. Once application form and accreditation contract e-signed* application would be completed and application would be sent to TÜRKAK for evaluation.
The list of the documents which inspection body would upload to ASİST when application is evaluated as acceptable and registered can be found in “TURKAK F701-012 Requested Documents for Applications of Inspection Bodies (according to ISO/IEC 17020)”.
* Application form and accreditation contract shall be signed by person/s who has legal signing authority in the name of the applicant body.
Guidance Documents / Other Related Documents
Product certification is a way of providing the assurance that a product complies with specified standards and other decisive documents by a third party. Product certification body accreditation is to determine whether the organization has a system that complies with the requirements of the TS EN ISO / IEC 17065 standard, EA and IAF mandatory documents and applicable guidance documents.
Product Certification Bodies wishing to be accredited must fulfill the requirements specified in TS EN ISO/IEC 17065 standard.In order to be accredited, a Product Certification body must meet the applicable requirements of ISO/IEC 17025 for testing, ISO/IEC 17020 for inspection and ISO/IEC 17021-1 for management system audit, according to the module (if any) required by the normative document of the product/product group.
Accreditation applications in the field of Product Certification must be made online via TÜRKAK Corporate Service Portal (https://portal.turkak.org.tr). In order for the accreditation application to be accepted; the conformity assessment body (CAB) must have completed all the information and documents requested in the application.
Guidance Documents / Other Related Documents
Application Documents
• TÜRKAK F701-006 - Application Form for Product Certification Body
• TÜRKAK F701-039 - Accreditation Agreement (2 copies)
• TÜRKAK F701-071 - Accreditation Services, Conformity Assessment Agency Authorized Notification Form
• TÜRKAK F701-011 - Documents Required for Application for Product Certification Bodies
The accreditation of bodies operating certification of persons is generally voluntary. On the other hand, there are also areas where accreditation is required by regulatory bodies. Accreditation activities of bodies operating certification of persons are carried out by the Turkish Accreditation Agency (TÜRKAK). Certification for persons is one means of providing assurance that the certified person meets the requirements of the certification scheme. Confidence in the respective certification schemes for persons is achieved by means of a globally accepted process of assessment and periodic re-assessments of the competence of certified persons. Personnel Certification Bodies wishing to be accredited in this field shall fulfil the requirements of TS EN ISO/IEC 17024:2012 standard and the following EA, IAF and TÜRKAK documents.
Guidance Documents / Other Related Documents
Application Documents
· TÜRKAK F701-003 - Application Form for a Personnel Certification Body
·TÜRKAK F701-009 – Requested Documents for Applications of Personnel Certification Bodies
·TÜRKAK F701-039 – Accreditation Contract (2 Copy)
·TÜRKAK F701-071 - Conformity Assessment Body Authorized Person Declaration Form
TURKAK carries out the accreditation services for the bodies that certify the Management Systems. Certification Bodies that want to be accredited in this field shall fulfill the requirements of ISO/IEC 17021-1 and other related standards and normative documents.
TURKAK provides accreditation services for Management System Certification Bodies in the following scopes;
• ISO 9001
When Certification Bodies, which carry out certification activities for ISO 9001 standard, want to be accredited, they shall fulfill the requirements given in ISO/IEC 17021-1 and ISO/IEC 17021-3 standards, IAF mandatory documents and related EA and TURKAK documents.
• ISO 14001
When Certification Bodies, which carry out certification activities for ISO 14001 standard, want to be accredited, they shall fulfill the requirements given in ISO/IEC 17021-1 and ISO/IEC 17021-2 standards, IAF mandatory documents and related EA and TURKAK documents.
• ISO 22000
When Certification Bodies, which carry out certification activities for ISO 22000 standard, want to be accredited, they shall fulfill the requirements given in ISO/IEC 17021-1 standard and ISO/TS 22003 technical specification, IAF mandatory documents and related EA and TURKAK documents.
• ISO 27001
When Certification Bodies, which carry out certification activities for ISO 27001 standard, want to be accredited, they shall fulfill the requirements given in ISO/IEC 17021-1 and ISO/IEC 27006 standards, IAF mandatory documents and related EA and TURKAK documents.
• ISO 13485
When Certification Bodies, which carry out certification activities for ISO 13485 standard, want to be accredited, they shall fulfill the requirements given in ISO/IEC 17021-1 standard and IAF MD 9 and other IAF mandatory documents and related EA and TURKAK documents.
• FSSC 22000
When Certification Bodies, which carry out certification activities for FSSC 22000 scheme, want to be accredited, they shall fulfill the requirements given in ISO/IEC 17021-1 standard, ISO/TS 22003 technical specification and FSSC 22000 scheme documents and IAF mandatory documents and related EA and TURKAK documents.
• ISO 45001
When Certification Bodies, which carry out certification activities for ISO 45001 standard, want to be accredited, they shall fulfill the requirements given in ISO/IEC 17021-1 standard and ISO/IEC TS 17021-10 technical specification, IAF mandatory documents and related EA and TURKAK documents.
• ISO 50001
When Certification Bodies, which carry out certification activities for ISO 50001 standard, want to be accredited, they shall fulfill the requirements given in ISO/IEC 17021-1 and ISO 50003 standards, IAF mandatory documents and related EA and TURKAK documents.
• ISO/IEC 20000-1
When Certification Bodies, which carry out certification activities for ISO/IEC 20000-1 standard, want to be accredited, they shall fulfill the requirements given in ISO/IEC 17021-1 and ISO/IEC 20000-6 standards, IAF mandatory documents and related EA and TURKAK documents.
• ISO/IEC 27701
When Certification Bodies, which carry out certification activities for ISO/IEC 27701 standard, want to be accredited, they shall fulfill the requirements given in ISO/IEC 17021-1 and ISO/IEC 27006 standards, IAF mandatory documents and related EA and TURKAK documents.
• EN/AS 9100 Series
When Certification Bodies, which carry out certification activities for EN/AS 9100, 9110 and 9120 standards, want to be accredited, they shall fulfill the requirements given in ISO/IEC 17021-1, AS 9104-1:2022, AS 9104-003:2020,AS 9101:2022 and IAQG ICOP AQMS certification scheme, related IAF mandatory documents and TURKAK documents.
• ISO/IEC 17021-1- Conformity assessment — Requirements for bodies providing audit and certification of management systems — Part 1: Requirements
• ISO/IEC 17021-2- Conformity assessment — Requirements for bodies providing audit and certification of management systems — Part 2: Competence requirements for auditing and certification of environmental management systems
• ISO/IEC 17021-3- Conformity assessment — Requirements for bodies providing audit and certification of management systems — Part 3: Competence requirements for auditing and certification of quality management systems
• ISO/IEC TS 17021-10- Conformity assessment — Requirements for bodies providing audit and certification of management systems — Part 10: Competence requirements for auditing and certification of occupational health and safety management systems
• ISO/TS 22003- Food safety management systems -Requirements for bodies providing audit and certification of food safety management systems
• ISO/IEC 27006- Information technology — Security techniques — Requirements for bodies providing audit and certification of information security management systems
• ISO 50003- Energy management systems — Requirements for bodies providing audit and certification of energy management systems
• ISO/IEC 20000-6- Information technology — Service management — Part 6: Requirements for bodies providing audit and certification of service management systems
• Relevant FSSC 22000 scheme documents
• Relevant IAF Mandatory Documents (MD series, ID series etc.)
• IAF MD1- IAF Mandatory Document for the Audit and Certification of a Management System Operated by a Multi-Site Organization
• IAF MD2- IAF Mandatory Document for the Transfer of Accredited Certification of Management Systems
• IAF MD4- IAF Mandatory Document for the Use of Information and Communication Technology (ICT) for Auditing/Assessment Purposes
• IAF MD5- Determination of Audit Time Of Quality, Environmental, And Occupational Health & Safety Management System
• IAF MD7- IAF Mandatory Document for the Harmonization of Sanctions and Dealing with Fraudulent Behaviour
• IAF MD9- Application of ISO/IEC 17021-1 in the Field of Medical Device Quality Management Systems (ISO 13485)
• IAF MD11- IAF Mandatory Document for the Application of ISO/IEC 17021-1 for Audits of Integrated Management Systems
• IAF MD12- Accreditation Assessment of Conformity Assessment Bodies with Activities in Multiple Countries
• IAF MD15- IAF Mandatory Document for the Collection Of Data to Provide Indicators of Management System Certification Bodies Performance
• IAF MD16- Application of ISO/IEC 17011 for the Accreditation of Food Safety Management Systems (FSMS) Certification Bodies
• IAF MD17- Witnessing Activities for The Accreditation of Management Systems Certification Bodies
• IAF MD22- Application of ISO/IEC 17011 for the Certification of Occupational Health & Safety Management System (OH&SMS)
• IAF MD23- Control of Entities Operating on Behalf of Accredited Management Systems Certification Bodies
• EA-7/04- Legal Compliance as a part of Accredited ISO 14001:2015 Certification
• EA-1/22- EA Procedure and Criteria for the Evaluation of Conformity Assessment Schemes by EA Accreditation Body Members
EA 2/17 EA Document on Accreditation for Notification Purposes
• TURKAK P701-Procedure for the Accreditation of Conformity Assessment Bodies
• TURKAK P705- Procedure for the Principles On Remote Assessment
• TURKAK P706-Procedure for the Management of Extraordinary Events or Circumstances Affecting Accredited Bodies
• TURKAK R10.01-Regulatory Guideline on Professional Liability Insurance Obligation of Conformity Assessment Bodies
• TURKAK R10.02-Guideline on Accreditation Service Fees
• TURKAK R10.06-Requirements for Using TURKAK Accreditation Symbol by the Accredited Bodies
• TURKAK R10.08 - Guideline on Complaints and Appeals
• TURKAK R10.09-Guideline on Calculations of Assessment Time (Person-Day) for Accreditation Assessments
• TURKAK R10.10- TURKAK Cross-Frontier Accreditation Rules
• TÜRKAK R10.11 Uzmanlık Alanları ve Kullanım Rehberi / Guideline for Areas of Expertise and their Usage
. TURKAK R10.13- Guidance on Accreditation for Notification Purposes
• TURKAK R10.14- Guidance on the Evaluation of Conformity Assessment Schemes
• TURKAK R40.01- Accreditation Scope for System Certification Bodies
• TURKAK R40.02- Guidance on Requirements for Audit Team Members of Management Systems Certification Bodies
• TURKAK R40.05- Guidance on Accreditation of Management Systems Certifiction Bodies
• TURKAK R40.07- Guideline on Competence Analysis for Environmental Management System Certification
• TURKAK R40.12- Guidance on Accreditation of Certification Activities for ISO/IEC 27701 and ISO/IEC 20000-1
• TURKAK F701-004 - Application Form For Management Systems Certification Bodies
• TURKAK F701-010 - Requested Documents for Applications of Management Systems Certification Bodies
• TURKAK F701-029 - Checklist for Management Systems Certification Bodies
• TURKAK F701-071 - Conformity Assessment Body Representing Person Declaration for Accreditation Services Form
• TURKAK F701-039 – Accreditation Contract
Organizations serving in the public, university or private sector that are fully responsible for planning and managing the reference material production project are called Reference Material Producers. This responsibilities include determining and assigning property values and uncertainties for the reference materials it produces, issuing a reference material certificate.
In Turkey; the accreditation of reference material producers is on a voluntary basis and the accreditation activities are carried out by the Turkish Accreditation Agency (TÜRKAK). Accreditation services are provided to ensure that the produced reference materials are produced according to technically valid and internationally accepted criteria and to show that the manufacturer is authorized and competent in producing reference materials. The accreditation of referencematerial producers is granted according to the TS EN ISO 17034 " General requirements for the competence of reference material producers " standard.
TS EN ISO 17034 Standard sets out the general principles, general approaches, policies and measures to be taken in terms of technical competence for the reference material producers. Reference material producers who want to be accredited must have a established and operated quality system to meet the requirements of this standard. However, in addition to the standard, the reference material producers must also fulfill the requirements of the legal regulations, mandatory documents, the relevant documents prepared by the International Laboratory Accreditation Association (ILAC), European Accreditation Association (EA) and TÜRKAK.
Mandatory Documents
Guidance Documents / Other Related Documents
Testing laboratories are one of the important areas in the national and international accreditation system. Laboratory accreditation is voluntary in our country. On the other hand there are also testing areas where accreditation is required by regulatory agencies. In Turkey, accreditation activities of testing laboratories are carried out by the Turkish Accreditation Agency (TÜRKAK). The accreditation of laboratories is granted according to the TS EN ISO / IEC 17025 " General requirements for the competence of testing and calibration laboratories " standard in order to ensure the reliability of test results,
Laboratories belonging to a wide range of sectors such as environment, food, chemistry, veterinary diagnosis and analysis, occupational hygiene, construction materials, textiles, electricity, electronics and informatics, mining, metallic materials laboratories serving in the public, university or private sector can be accredited within the scope of TS EN ISO/IEC 17025 standard.
TS EN ISO / IEC 17025 Standard sets out the general principles, general approaches, policies and measures to be taken in terms of technical competence. Testing laboratories who want to be accredited must have a established and operated quality system to meet the requirements of this standard. However, in addition to the standard, testing laboratories must also fulfill the requirements of the legal regulations, mandatory documents, the relevant documents prepared by the International Laboratory Accreditation Association (ILAC), European Accreditation Association (EA) and TÜRKAK.
Mandatory Documents
Guidance Documents / Other Related Documents
Application Documents
Good Laboratory Practices (GLP) is a quality assurance system that includes the conditions and management procedures for planning, monitoring, recording, archiving and reporting of health and environmental research other than clinical research.
Non-clinical health and environmental safety studies within the scope of ILU principles can be performed under laboratory conditions, greenhouses and on the site. TÜRKAK’s GLP program covers all test and chemical groups. By testing these substances, data regarding the safety of these substances for human health and / or the environment is able to obtain.
As stated in the 632 numbered article of the Presidential Decree number 4 and the Regulation on Good Laboratory Practices Principles, Harmonization of Test Units, Good Laboratory Practices and Inspection of Studies published in the official gazette no 27516 dated 9 March 2010, TURKAK is the only institution that has legal responsibility as a national monitoring authority. TÜRKAK is a member of the Mutual Acceptance of Data System established by OECD.
Test facilities that are willing to be in the Good Laboratory Practices Conformity Monitoring Program are assessed according to OECD Good Laboratory Practices and Compliance Monitoring Principles, Good Laboratory Practices Principles, Harmonization of Test Units, Regulation on Good Laboratory Practices and Inspection of Studies and TURKAK Procedures and then the GLP Declaration of Conformity is given to the appropriate test facilities.
Mandatory Documents
Application Documents
TS EN ISO 20387 "Biotechnology-Biobanking-General Requirements for Biobanking" standard specifies the conditions that biobanks must comply with in terms of competence, impartiality, quality assurance and general operation in order to ensure the collection, storage and distribution of biological materials and/or related data under appropriate conditions. It covers all organizations that conduct biobanking activities for research and development activities. Organizations that perform biobanking activities of biological samples obtained from multicellular organisms (e.g. humans, animals, fungi and plants) and microorganisms are included in the scope of the standard. TS EN ISO 20387 standard does not apply to biological material intended for food/feed production, laboratories undertaking analysis for food/feed production, and/or therapeutic use.
Accreditation in the field of biobanking is based on a voluntary basis in our country and biobanks that want to be accredited shall have a quality system established and operated to meet the requirements of this standard. In addition to the standard, it shall also fulfill the requirements of the legal legislation, mandatory documents containing additional criteria related to the field of biobanks, the relevant documents prepared by the International Laboratory Accreditation Association (ILAC), the European Accreditation Association (EA) (where applicable) and TÜRKAK.
