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REFERANS DOKÜMAN LİSTESİ Yürürlük Tarihi: Reference Document List Validity 09.01.2017

İlgili Bölüm: Kalite Yönetim Sistemi (Genel) Related Department Doküman Yayın Numarası Tarihi Tanımı Description Document Number Date of Issue Uygunluk Değerlendirmesi — Uygunluk Değerlendirmesi Yapan TS EN ISO/IEC 2006 Kuruluşları Akredite Eden Akreditasyon Kuruluşları İçin Genel 17011 Şartlar General Requirements for Bodies Providing Assessment and ISO 17011 2004 Accreditation of Conformity Assessment Bodies EA Multilateral Agreement Criteria for signing Policy and EA 1/06 A-AB 2015 procedure for development EA Procedure and Criteria For the Evaluation of Conformity EA 1/22 2016 Assessment Schemes by EA Accreditation Body Members EA 2/02 2016 EA Policy and Procedures for the Multilateral Agreement EA 2/13 2012 EA Cross Frontier Policy for Cooperation between EA Members EA 2/17 2016 EA Document on Accreditation for Notification Purposes EA conditions for the use of accreditation symbols, text EA 3/01 2012 reference to accreditation and MLA signatory status Use of Proficiency Testing as a Tool for Accreditation in EA 3/04 2001 Testing IAF ML 2 2016 General Principles for Use of the IAF MLA Mark IAF/ILAC A5 2013 IAF/ILAC Multi-Lateral Mutual Recognition Arrangements (Arrangements): Application of ISO/IEC 17011:2004 Cross Frontier Accreditation - Principles for Avoiding ILAC-G21 2012 Duplication ILAC-G3 2012 Guidelines for Training Courses for Assessors Used by Accreditation Bodies ILAC-G11 2006 ILAC Guidelines on Qualifications and Competence of Assessors and Technical Experts ILAC G19 2014 Modules in a Forensic Science Process ILAC-R7 2015 Rules for the Use of the ILAC MRA Mark ILAC P 9 2014 ILAC Policy for Participation in Proficiency Testing Activities ILAC P 10 2013 ILAC Policy on Traceability of Measurement Results IAF MD7 2010 Harmonisation of Sanctions Accreditation Assessment of Conformity Assessment Bodies IAF MD 12 2016 with Activities in Multiple Countries Guidelines for the determination of calibration intervals of ILAC G24 2007 measuring instruments Conformity assessment -- Impartiality -- Principles and ISO/PAS 17001 2005 requirements

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Conformity assessment -- Confidentiality -- Principles and ISO/PAS 17002 2004 requirements Conformity assessment -- Complaints and appeals -- Principles ISO/PAS 17003 2004 and requirements Conformity assessement -- Disclosure of information -- ISO/PAS 17004 2005 Principles and requirements Conformity assessment -- Use of management systems -- ISO/PAS 17005 2008 Principles and requirements Methods of indicating conformity with standards for third party ISO Guide 23 1982 certification systems Guidelines for the corrective action to be taken by a certification TS ISO Guide 27 2008 body in the event of misuse of its mark of conformity Ürünlere İlişkin Teknik Mevzuatın Hazırlanması ve 4703 2001 Uygulanmasına Dair Kanun Uygunluk Değerlendirme Kuruluşları ile Onaylanmış Kuruluşlar 28213 2012 Yönetmeliği 28727 2013 Bilim, Sanayi ve Teknoloji Bakanlığınca Onaylanmış Kuruluşların Görevlendirilmesi, İzlenmesi Ve Denetlenmesinde Esas Alınacak Temel Kriterlere Dair Tebliğ (Sgm: 2013/12) Regulation (EC) No 2008 Regulation (EC) No 765/2008 of The European Parliament And 765/2008 of The Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 Decision No 2008 Decision No 768/2008/EC of The European Parliament And of 768/2008/EC The Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC

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İlgili Bölüm: Laboratuvar Akreditasyon Başkanlığı Related Department Doküman Numarası Yayın Document Number Tarihi Tanımı Date of Description Issue Medical laboratories – Particular requirements for quality ISO 15189 2012 and competence Conformity assessment - General requirements for ISO/IEC 17043 2010 proficiency testing Point-of-care testing (POCT) -- Requirements for quality and ISO 22870 2016 competence Terms and definitions used in connection with reference ISO GUIDE 30 2015 materials ISO GUIDE 31 2015 Reference materials — Contents of certificates and labels General requirements for the competence of reference ISO 17034 2016 material producers Reference materials — General and statistical principles for ISO GUIDE 35 2006 certification Statistical methods for use in proficiency testing by ISO 13528 2015 interlaboratory comparisons General requirements for the competence of testing and ISO/IEC 17025 2005 calibration laboratories Medical laboratories -- Guidance on laboratory ISO/TR 22869 2005 implementation of ISO 15189: 2003 TS EN ISO 15189 2014 Tıbbi laboratuvarlar - Kalite ve yeterlilik için şartlar TS EN ISO/IEC Deney ve Kalibrasyon Laboratuvarlarının Yeterliliği İçin 2012 17025 Genel Şartlar TS EN ISO/IEC 2013 Yeterlilik Deneyi İçin Genel Şartlar 10743 CEN/TS 15675 2007 Air quality – Measurement of stationary source emission Procedure for Regional Calibration ILCs in Support of the EA 2/14 (Rev00) 2008 EA MLA

EA 2/15 2008 Requirements for the Accreditation of Flexible Scopes Expressions of the Uncertainty of Measurements in EA 4/02 (Rev02) 2013 Calibration Accreditation for Sensory Testing Laboratories EA 4/09 (Rev01) 2003 Selection and Use of Reference Materials EA 4/14 (Rev00) 2003

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Accreditation for Bodies Performing non-Destructive EA 4/15 (rev01) 2015 Testing Guidelines on the expression of uncertainty in quantitative EA 4/16 (Rev00) 2003 testing EA Position Paper on the description of scopes of EA 4/17 (Rev00) 2008 accreditation of medical laboratories Guidance on the level and frequency of proficiency testing EA 4/18 2010 participation Guidance for the Assessment of Laboratories against EN ISO EA 4/20 2015 15189 and 22870 Benefits and importance of the participation in EA EA INF/12 2014 highlighted PT schemes The Assessment and Accreditation of Opinions and EA-INF/13 2015 Interpretations using ISO/IEC 17025:2005 2015 Guidelines for Accreditation Bodies on the Contents of the EA 2/18 INF Scopes of Accreditation for Proficiency Testing Providers Accreditation Requirements and Operating Criteria for ILAC G 7 2009 Horseracing Laboratories Guidelines on the Reporting of Compliance with ILAC G 8 2009 Specification Guideline for the Formulation of Scopes of Accreditation for ILAC G 18 2010 Laboratories ILAC G19 2014 Modules in a Forensic Science Process Guidelines for the determination of calibration intervals of ILAC G 24 2007 measuring instruments Guidance for the Implementation of a Medical Laboratory ILAC G 26 2012 Accreditation System ILAC Mutual Recognition Arrangement (Arrangement): Supplementary Requirements and Guidelines for the Use of ILAC P 8 2012 Accreditation Symbols and for Claims of Accreditation Status by Accredited Laboratories Application of ISO/IEC 17011 for the Accreditation of ILAC P 13 2010 Proficiency Testing Providers ILAC P 14 2013 ILAC Policy for Uncertainty in Calibration Evaluation of measurement data — Guide to the expression JCGM 100 2008 of uncertainty in measurement WADA ISL 9.0 2016 International Standard For Laboratories (ISL)

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İlgili Bölüm: Sistem Akreditasyon Başkanlığı Related Department

Doküman Numarası Yayın Tanımı Document Number Tarihi Description Date of Issue Requirements for bodies providing audit and certification of ISO/IEC 17021-1 2015 management systems- Part 1: Requirements Uygunluk değerlendirmesi - Yönetim sistemlerinin tetkikini TS EN ISO/IEC 17021 2012 ve belgelendirmesini sağlayan kuruluşlar için şartlar Conformity assessment-Requirements for bodies providing ISO/IEC 17021 2011 audit and certification of management systems Competence requirements for auditing and certification of ISO/IEC TS 17021-2 2012 environmental management systems Competence requirements for auditing and certification of ISO/IEC TS 17021-3 2013 quality management systems ISO 19011 2011 Guidelines for auditing management systems Kalite yönetim sistemleri - Performans iyileştirmeleri için TS EN ISO 9004 2010 kılavuz Quality Management Systems - Fundamentals and ISO 9000 2005 Vocabulary Quality Management Systems - Fundamentals and ISO 9000 2015 Vocabulary ISO 9001 2008 Quality Management Systems - Requirements ISO 9001 2015 Quality Management Systems - Requirements Quality Management Systems - Guideline for Performance ISO 9004 2009 Improvements ISO 14050 2009 Environmental Management - Vocabulary Çevre Yönetim Sistemleri -Prensipler,sistemler ve TS EN ISO 14004 2010 destekleyici tekniklere dair genel kılavuz Environmental management systems - Guidelines for ISO 14006 2011 incorporating ecodesign ISO 14001 2004 EMS- Requirements with guidance for use ISO 14001 2015 EMS- Requirements with guidance for use Environmental management - Integrating environmental ISO/TR 14062 2002 aspects into product design and development ISO 14020 2000 Environmental labels and declarations - General principles

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Environmental management - Environmental communication ISO 14063 2006 - Guidelines and examples Environmental management systems - Guidelines for the phased implementation of an environmental management ISO 14005 2010 system, including the use of environmental performance evaluation Food safety management systems - Requirements for any ISO 22000 2005 organization in the food chain Gıda güvenliği yönetim sistemleri - Gıda güvenliği yönetim TSE ISO/TS 22003 2015 sistemlerinin tetkikini ve belgelendirmesini sağlayan kuruluşlar için şartlar Food safety management systems -- Guidance on the ISO/TS 22004 2014 application of ISO 22000 Prerequisite programmes on food safety -- Part 1: Food ISO/TS 22002-1 2009 manufacturing ISO/TS 22002-2 2013 Prerequisite programmes on food safety -- Part 2: Catering ISO/TS 22002-3 2011 Prerequisite programmes on food safety -- Part 3: Farming Prerequisite programmes on food safety -- Part 4: Food ISO/TS 22002-4 2013 packaging manufacturing Traceability in the feed and food chain -- General principles ISO 22005 2007 and basic requirements for system design and implementation Information technology -- Security techniques -- Information ISO/IEC 27001 2013 security management systems -- Requirements Information technology -- Security techniques -- ISO/IEC 27006 2011 Requirements for bodies providing audit and certification of information security management systems Information technology -- Security techniques -- ISO/IEC 27006 2015 Requirements for bodies providing audit and certification of information security management systems EA 3/11 2009 Food Safety Management Systems Scope of Accreditation Legal Compliance as a part of Accredited ISO 14001:2004 EA 7/04 (rev.02) 2010 Certification Occupational health and safety management systems- OHSAS 18001 2007 Requirements QMS- Particular requirements for the application of ISO ISO/TS 16949 2009 9001:2008 for automotive production and relevant service part organizations. TS ISO 10015 2000 Kalite yönetimi-Konfigürasyon yönetimi için kılavuz TS EN ISO 10007 2006 Kalite Yönetimi – Konfigürasyon yönetimi için Kılavuz Medical devices—Quality management systems— ISO 13485 2003 Requirements for regulatory purposes Medical devices—Quality management systems— EN ISO 13485 2012 Requirements for regulatory purposes (ISO 13485:2003)

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Sera gazları - Bölüm 1: Sera gazı emisyonlarının ve TS EN ISO 14064-1 2007 uzaklaştırmalarının kuruluş seviyesinde hesaplanmasına ve rapor edilmesine dair kılavuz ve özellikler Sera gazları - Bölüm 1: Sera gazı emisyonlarının ve TS ISO 14064-1:2007 2012 uzaklaştırmalarının kuruluş seviyesinde hesaplanmasına ve rapor edilmesine dair kılavuz ve özellikler Sera gazları - Bölüm 2: Sera gazı emisyon azaltmalarının veya TS EN ISO 14064-2 2007 uzaklaştırma iyileştirmelerinin hesaplanma, izlenme ve rapor edilme faaliyetleri için kılavuz ve özellikler Sera gazları - Bölüm 2: Sera gazı emisyon azaltmalarının veya TS ISO 14064-2:2007 2012 uzaklaştırma iyileştirmelerinin hesaplanma, izlenme ve rapor edilme faaliyetleri için kılavuz ve özellikler Sera gazları - Bölüm 3: Sera gazı beyanlarının onaylanmasına TS EN ISO 14064-3 2007 ve doğrulanmasına dair kılavuz ve özellikler Sera gazları - Bölüm 3: Sera gazı beyanlarının onaylanmasına TS ISO 14064-3:2007 2012 ve doğrulanmasına dair kılavuz ve özellikler Sera gazları - Akreditasyon veya diğer karşılıklı tanıma TS EN ISO 14065 2013 formlarında kullanmak üzere sera gazı geçerli kılma ve doğrulaması yapan kuruluşlar için şartlar (ISO 14065:2013) Sera gazları - Sera gazlarını geçerli kılma takımları ve TS ISO 14066 2014 doğrulama takımları için yetkinlik gerekleri The verification of greenhouse gas emission reports COMMISSION and tonne-kilometre reports and the REGULATION (EU) 2012 accreditation of verifiers pursuant to Directive 600/2012 2003/87/EC of the European Parliament and of the Council COMMISSION The monitoring and reporting of greenhouse gas emissions REGULATION (EU) 2012 pursuant to Directive 2003/87/EC of No 601/2012 the European Parliament and of the Council Establishing a scheme for greenhouse gas emission DIRECTIVE 2003 allowance trading within the Community and 2003/87/EC amending Council Directive 96/61/EC Guidelines for Quality and/or Environmental Management ISO 19011 2011 System Auditing Information technology -- Security techniques -- Guidelines ISO/IEC 27007 2011 for information security management systems auditing TS EN ISO 9000 2007 Kalite yönetim sistemleri- Temel esaslar, terimler ve tarifler TS EN ISO 9001 2009 Kalite yönetim sistemleri- Şartlar TS EN ISO 9001 2015 Kalite yönetim sistemleri - Şartlar TS EN ISO 14001 2005 Çevre Yönetim Sistemi- Şartlar ve kullanım kılavuzu TS EN ISO 14001 2015 Çevre yönetim sistemleri – Şartlar ve kullanım kılavuzu Gıda Güvenliği Yönetim Sistemler- Gıda zincirindeki tüm TS EN ISO 22000 2006 kuruluşlar için şartlar Tıbbi Cihazlar – Kalite yönetim sistemleri- Mevzuat amaçları TS EN ISO 13485 2014 bakımından şartlar

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Tıbbî cihazlar - Kalite yönetim sistemleri - Mevzuat amaçları TS EN ISO 13485 2016 bakımından şartlar Bilgi teknolojisi- Güvenlik teknikleri- Bilgi Güvenliği TS EN ISO 27001 2014 Yönetim Sistemleri- Gereksinimler IAF MD 1 2007 Certification of Multiple Sites Based on Sampling IAF MD 2 2007 Transfer of Accredited Certification of Management Systems Advanced Surveillance and Recertification Procedures IAF MD 3 2008 (ASRP) Use of Computer Assisted Auditing Techniques (“CAAT”) IAF MD 4 2008 for Accredited Certification of Management Systems Determination of Audit Time of Quality and Environmental IAF MD 5 2015 Management Systems IAF Mandatory Document for the Application of ISO IAF MD 6 2014 14065:2013 IAF Mandatory Document for Harmonization of Sanctions to IAF MD 7 2010 be applied to Conformity Assessment Bodies Application of ISO/IEC 17011:2004 in the Field of Medical IAF MD 8 2015 Device Quality Management Systems (ISO 13485) Application of ISO/IEC in the Field of Medical Device IAF MD 9 2015 Quality Management Systems (ISO 13485) IAF Mandatory Document for Assessment of Certification IAF MD 10 2013 Body Management of Competence in Accordance with ISO/IEC 17021:2011 Mandatory Document for Application of ISO/IEC 17021 for IAF MD 11 2013 Audits of Integrated Management Systems (IMS) Knowledge Requirements for Accreditation Body Personnel IAF MD 13 2015 for Information Security Management Systems (ISO/IEC 27001) Application of ISO/IEC 17011 in Greenhouse Gas Validation IAF MD 14 2014 and Verification (ISO 14065:2013) IAF Mandatory Document fort he Collection of Data to IAF MD 15 2014 Provide Indicators of Management System Certification (app.date:14.07.2016) Bodies’ Performance IAF MD 16 Application of ISO/IEC 17011 for the Accreditation of Food 2015 (app.date:15.12.2016) Safety Management Systems (FSMS) Certification Bodies IAF MD 17 Witnessing Activities fort he Accrediation of Management 2015 (app.date:07.01.2018) Systems Certification Bodies Application of ISO/IEC 17021:2011 in the Service IAF MD 18 2015 Management Sector (ISO/IEC 20000-1) IAF Mandatory Document For The Audit and Certification of IAF MD 19 2016 a Management System operated by a Multi-Site Organization (app.date: 31.03.2018) (where application of site sampling is not appropriate)

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IAF MD 20 Generic Competence for AB Assessors: Application to 2016 (app.date: 25.05.2018) ISO/IEC 17011 Security management systems for the supply chain -- Best ISO 28001 2007 practices for implementing supply chain security, assessments and plans -- Requirements and guidance Energy management systems -- Requirements with guidance ISO 50001 2011 for use ISO 50002 2014 Energy audits—Requirements with guidance for use Energy management systems -- Requirements for bodies ISO 50003 2014 providing audit and certification of energy management systems

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İlgili Bölüm: Personel Akreditasyon Başkanlığı Related Department

Doküman Yayın Tanımı Numarası Tarihi Description Document Number Date of Issue

TS EN ISO/IEC Uygunluk Değerlendirmesi – Personel Belgelendirmesi Yapan 2012 17024 Kuruluşlar İçin Genel Şartlar Conformity Assessment – General Requirements for Bodies ISO/IEC 17024 2012 Operating Certification of Persons

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İlgili Bölüm: Ürün, Hizmet ve Muayene Akreditasyon Başkanlığı Related Department

Doküman Yayın Tanımı Numarası Tarihi Description Document Number Date of Issue

Conformity assessment -- Requirements for bodies certifying ISO/IEC 17065 2012 products, processes and services TS EN ISO/IEC Uygunluk değerlendirmesi - Ürün, proses ve hizmet 2013 17065 belgelendirmesi yapan kuruluşlar için şartlar Conformity assessment - Requirements for the operation of ISO/IEC 17020 2012 various types of bodies performing inspection TS EN ISO/IEC Uygunluk değerlendirmesi - Çeşitli tiplerdeki muayene 2012 17020 kuruluşlarının işletimi için şartlar ISO/IEC 17030 Conformity assessment - General requirements for third-party 2006 marks of conformity ISO/IEC 17050-1 Conformity assessment-Supplier's declaration of conformity - 2010 Part 1: General requirements ISO/IEC 17050-2 Conformity assessment - Supplier's declaration of conformity - 2005 Part 2: Supporting documentation TSE ISO/IEC TR Uygunluk değerlendirme - Maddi ürünler için belgelendirme 2015 17026 programı örneği Conformity assessment — Fundamentals of product ISO/IEC 17067 2013 certification and guidelines for product certification schemes TS EN ISO/IEC Uygunluk değerlendirmesi - Ürün belgelendirme Temelleri ve 2015 17067 ürün belgelendirme programları için kurallar EA Policy For the Accreditation of Organic Production EA-3/12 2013 Certification EA 4/15 2015 Accreditation for Bodies Performing non-Destructive Testing EA Guidance on the Application of ISO/IEC 17020 in Periodic EA 5/02 2015 Inspection of the Roadworthiness of Motor Vehicles and their Trailers EA-6/02 2013 EA Guidelines on the Use of EN 45 011 and ISO/IEC 17021 EA Guidelines on the Accreditation of Certification of Primary EA-6/04 2011 Sector Products by Means of Sampling of Sites Application of ISO/IEC 17020:2012 for the Accreditation of ILAC P15 2016 Inspection Bodies 89/686/EEC 1989 Personal protective equipment 90/385/EEC 1990 Active implantable medical devices 92/42/EEC 1992 Hot-water boilers 93/42/EEC 1993 Medical devices 98/79/EC 1998 In vitro diagnostic medical devices 2000/9/EC 2000 Cableway installations designed to carry persons

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Noise emission in the environment by equipment for use 2000/14/EC 2000 outdoors 2006/42/EC 2006 Machinery Interoperability of the rail system within the Community 2008/57/EC 2008 (Recast) 2009/48/EC 2009 Safety of toys 2009/142/EC (ex- 2009 Appliances burning gaseous fuels 90/396/EEC) 2010/35/EU 2010 Transportable pressure equipment Regulation (EU) No 2011 Construction products 305/2011 2013/29/EU 2013 Pyrotechnic articles 2013/53/EU 2013 Recreational craft and personal watercraft 2014/28/EU 2014 Explosives for civil uses 2014/29/EU 2014 Simple pressure vessels 2014/31/EU 2014 Non-automatic weighing instruments 2014/32/EU 2014 Measuring Instruments Directive 2014/33/EU 2014 Lifts and safety components for lifts Equipment and protective systems intended for use in 2014/34/EU 2014 potentially explosive atmospheres (recast) 2014/53/EU 2014 Radio equipment 2014/68/EU 2014 Pressure equipment 2014/90/EU 2014 Marine equipment 2016/424/EU 2016 Cableway installations 2016/425/EU 2016 Personal protective equipment 2016/425/EU 2016 Gas appliances 2016/797/EU 2016 Interoperability of the rail system within the European Union Regulation (EC) No Interoperability of the European Air Traffic Management 2004 552/2004 network Decision 2009/750/EC (implementing 2009 Interoperability of Electronic Road Toll Systems Directive 2004/52/EC)

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