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1 REFERANS DOKÜMAN LİSTESİ Reference Document List Yürürlük Tarihi: Validity İlgili Bölüm: Kalite Yönetim Sistemi (Genel) Related Department Doküman Numarası Document Number Yayın Tarihi Date of Issue 2006 ISO EA 1/06 A-AB 2015 EA 1/ Tanımı Description Uygunluk Değerlendirmesi Uygunluk Değerlendirmesi Yapan Kuruluşları Akredite Eden Akreditasyon Kuruluşları İçin Genel Şartlar General Requirements for Bodies Providing Assessment and Accreditation of Conformity Assessment Bodies EA Multilateral Agreement Criteria for signing Policy and procedure for development EA Procedure and Criteria For the Evaluation of Conformity Assessment Schemes by EA Accreditation Body Members EA 2/ EA Policy and Procedures for the Multilateral Agreement EA 2/ EA Cross Frontier Policy for Cooperation between EA Members EA 2/ EA Document on Accreditation for Notification Purposes EA 3/ EA conditions for the use of accreditation symbols, text reference to accreditation and MLA signatory status EA 3/ Use of Proficiency Testing as a Tool for Accreditation in Testing IAF ML General Principles for Use of the IAF MLA Mark IAF/ILAC A ILAC-G ILAC-G IAF/ILAC Multi-Lateral Mutual Recognition Arrangements (Arrangements): Application of ISO/IEC 17011:2004 Cross Frontier Accreditation - Principles for Avoiding Duplication Guidelines for Training Courses for Assessors Used by Accreditation Bodies ILAC-G ILAC Guidelines on Qualifications and Competence of Assessors and Technical Experts ILAC G Modules in a Forensic Science Process ILAC-R Rules for the Use of the ILAC MRA Mark ILAC P ILAC Policy for Participation in Proficiency Testing Activities ILAC P ILAC Policy on Traceability of Measurement Results IAF MD Harmonisation of Sanctions IAF MD Accreditation Assessment of Conformity Assessment Bodies with Activities in Multiple Countries ILAC G Guidelines for the determination of calibration intervals of measuring instruments ISO/PAS Conformity assessment -- Impartiality -- Principles and requirements L /Rev.01/0117 Sayfa 1/12

2 ISO/PAS Conformity assessment -- Confidentiality -- Principles and requirements ISO/PAS Conformity assessment -- Complaints and appeals -- Principles and requirements ISO/PAS Conformity assessement -- Disclosure of information -- Principles and requirements ISO/PAS Conformity assessment -- Use of management systems -- Principles and requirements ISO Guide Methods of indicating conformity with standards for third party certification systems TS ISO Guide Guidelines for the corrective action to be taken by a certification body in the event of misuse of its mark of conformity Ürünlere İlişkin Teknik Mevzuatın Hazırlanması ve Uygulanmasına Dair Kanun Uygunluk Değerlendirme Kuruluşları ile Onaylanmış Kuruluşlar Yönetmeliği Bilim, Sanayi ve Teknoloji Bakanlığınca Onaylanmış Kuruluşların Görevlendirilmesi, İzlenmesi Ve Denetlenmesinde Regulation (EC) No 765/2008 Decision No 768/2008/EC Esas Alınacak Temel Kriterlere Dair Tebliğ (Sgm: 2013/12) 2008 Regulation (EC) No 765/2008 of The European Parliament And 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/ Decision No 768/2008/EC of The European Parliament And of The Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC L /Rev.01/0117 Sayfa 2/12

3 İlgili Bölüm: Laboratuvar Akreditasyon Başkanlığı Related Department Doküman Numarası Document Number Yayın Tarihi Date of Issue Tanımı Description ISO Medical laboratories Particular requirements for quality and competence ISO/IEC Conformity assessment - General requirements for proficiency testing ISO Point-of-care testing (POCT) -- Requirements for quality and competence ISO GUIDE 30 Terms and definitions used in connection with reference 2015 materials ISO GUIDE Reference materials Contents of certificates and labels ISO General requirements for the competence of reference material producers ISO GUIDE 35 Reference materials General and statistical principles for 2006 certification ISO Statistical methods for use in proficiency testing by 2015 interlaboratory comparisons ISO/IEC General requirements for the competence of testing and calibration laboratories ISO/TR Medical laboratories -- Guidance on laboratory implementation of ISO 15189: 2003 TS EN ISO Tıbbi laboratuvarlar - Kalite ve yeterlilik için şartlar Deney ve Kalibrasyon Laboratuvarlarının Yeterliliği İçin Genel Şartlar Yeterlilik Deneyi İçin Genel Şartlar CEN/TS Air quality Measurement of stationary source emission EA 2/14 (Rev00) 2008 Procedure for Regional Calibration ILCs in Support of the EA MLA EA 2/ Requirements for the Accreditation of Flexible Scopes EA 4/02 (Rev02) 2013 Expressions of the Uncertainty of Measurements in Calibration EA 4/09 (Rev01) 2003 Accreditation for Sensory Testing Laboratories EA 4/14 (Rev00) 2003 Selection and Use of Reference Materials L /Rev.01/0117 Sayfa 3/12

4 EA 4/15 (rev01) 2015 Accreditation for Bodies Performing non-destructive Testing EA 4/16 (Rev00) 2003 Guidelines on the expression of uncertainty in quantitative testing EA 4/17 (Rev00) 2008 EA Position Paper on the description of scopes of accreditation of medical laboratories EA 4/ Guidance on the level and frequency of proficiency testing participation EA 4/ Guidance for the Assessment of Laboratories against EN ISO and EA INF/ Benefits and importance of the participation in EA highlighted PT schemes EA-INF/ The Assessment and Accreditation of Opinions and Interpretations using ISO/IEC 17025: 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 Horseracing Laboratories ILAC G Guidelines on the Reporting of Compliance with Specification ILAC G Guideline for the Formulation of Scopes of Accreditation for Laboratories ILAC G Modules in a Forensic Science Process ILAC G Guidelines for the determination of calibration intervals of measuring instruments ILAC G Guidance for the Implementation of a Medical Laboratory Accreditation System ILAC P ILAC Mutual Recognition Arrangement (Arrangement): Supplementary Requirements and Guidelines for the Use of Accreditation Symbols and for Claims of Accreditation Status by Accredited Laboratories ILAC P Application of ISO/IEC for the Accreditation of Proficiency Testing Providers ILAC P ILAC Policy for Uncertainty in Calibration JCGM Evaluation of measurement data Guide to the expression of uncertainty in measurement WADA ISL International Standard For Laboratories (ISL) L /Rev.01/0117 Sayfa 4/12

5 İlgili Bölüm: Sistem Akreditasyon Başkanlığı Related Department Doküman Numarası Document Number Yayın Tarihi Date of Issue Tanımı Description ISO/IEC Requirements for bodies providing audit and certification of management systems- Part 1: Requirements Uygunluk değerlendirmesi - Yönetim sistemlerinin tetkikini ve belgelendirmesini sağlayan kuruluşlar için şartlar ISO/IEC Conformity assessment-requirements for bodies providing audit and certification of management systems ISO/IEC TS Competence requirements for auditing and certification of environmental management systems ISO/IEC TS Competence requirements for auditing and certification of quality management systems ISO Guidelines for auditing management systems TS EN ISO Kalite yönetim sistemleri - Performans iyileştirmeleri için kılavuz ISO Quality Management Systems - Fundamentals and Vocabulary ISO Quality Management Systems - Fundamentals and Vocabulary ISO Quality Management Systems - Requirements ISO Quality Management Systems - Requirements ISO Quality Management Systems - Guideline for Performance Improvements ISO Environmental Management - Vocabulary TS EN ISO Çevre Yönetim Sistemleri -Prensipler,sistemler ve destekleyici tekniklere dair genel kılavuz ISO Environmental management systems - Guidelines for incorporating ecodesign ISO EMS- Requirements with guidance for use ISO EMS- Requirements with guidance for use ISO/TR Environmental management - Integrating environmental aspects into product design and development ISO Environmental labels and declarations - General principles L /Rev.01/0117 Sayfa 5/12

6 ISO Environmental management - Environmental communication - Guidelines and examples ISO Environmental management systems - Guidelines for the phased implementation of an environmental management system, including the use of environmental performance evaluation ISO Food safety management systems - Requirements for any organization in the food chain TSE ISO/TS Gıda güvenliği yönetim sistemleri - Gıda güvenliği yönetim sistemlerinin tetkikini ve belgelendirmesini sağlayan kuruluşlar için şartlar ISO/TS Food safety management systems -- Guidance on the application of ISO ISO/TS Prerequisite programmes on food safety -- Part 1: Food manufacturing ISO/TS Prerequisite programmes on food safety -- Part 2: Catering ISO/TS Prerequisite programmes on food safety -- Part 3: Farming ISO/TS Prerequisite programmes on food safety -- Part 4: Food packaging manufacturing ISO Traceability in the feed and food chain -- General principles and basic requirements for system design and implementation ISO/IEC Information technology -- Security techniques -- Information security management systems -- Requirements ISO/IEC Information technology -- Security techniques -- Requirements for bodies providing audit and certification of information security management systems ISO/IEC Information technology -- Security techniques -- Requirements for bodies providing audit and certification of information security management systems EA 3/ Food Safety Management Systems Scope of Accreditation EA 7/04 (rev.02) 2010 Legal Compliance as a part of Accredited ISO 14001:2004 Certification OHSAS Occupational health and safety management systems- Requirements ISO/TS QMS- Particular requirements for the application of ISO 9001:2008 for automotive production and relevant service part organizations. TS ISO Kalite yönetimi-konfigürasyon yönetimi için kılavuz TS EN ISO Kalite Yönetimi Konfigürasyon yönetimi için Kılavuz ISO Medical devices Quality management systems Requirements for regulatory purposes EN ISO Medical devices Quality management systems Requirements for regulatory purposes (ISO 13485:2003) L /Rev.01/0117 Sayfa 6/12

7 TS EN ISO TS ISO : TS EN ISO TS ISO : TS EN ISO TS ISO : TS EN ISO TS ISO COMMISSION REGULATION (EU) 600/2012 COMMISSION REGULATION (EU) No 601/2012 DIRECTIVE 2003/87/EC ISO ISO/IEC Sera gazları - Bölüm 1: Sera gazı emisyonlarının ve uzaklaştırmalarının kuruluş seviyesinde hesaplanmasına ve rapor edilmesine dair kılavuz ve özellikler Sera gazları - Bölüm 1: Sera gazı emisyonlarının ve uzaklaştırmalarının kuruluş seviyesinde hesaplanmasına ve rapor edilmesine dair kılavuz ve özellikler Sera gazları - Bölüm 2: Sera gazı emisyon azaltmalarının veya uzaklaştırma iyileştirmelerinin hesaplanma, izlenme ve rapor edilme faaliyetleri için kılavuz ve özellikler Sera gazları - Bölüm 2: Sera gazı emisyon azaltmalarının veya uzaklaştırma iyileştirmelerinin hesaplanma, izlenme ve rapor edilme faaliyetleri için kılavuz ve özellikler Sera gazları - Bölüm 3: Sera gazı beyanlarının onaylanmasına ve doğrulanmasına dair kılavuz ve özellikler Sera gazları - Bölüm 3: Sera gazı beyanlarının onaylanmasına ve doğrulanmasına dair kılavuz ve özellikler Sera gazları - Akreditasyon veya diğer karşılıklı tanıma formlarında kullanmak üzere sera gazı geçerli kılma ve doğrulaması yapan kuruluşlar için şartlar (ISO 14065:2013) Sera gazları - Sera gazlarını geçerli kılma takımları ve doğrulama takımları için yetkinlik gerekleri The verification of greenhouse gas emission reports and tonne-kilometre reports and the accreditation of verifiers pursuant to Directive 2003/87/EC of the European Parliament and of the Council The monitoring and reporting of greenhouse gas emissions pursuant to Directive 2003/87/EC of the European Parliament and of the Council Establishing a scheme for greenhouse gas emission allowance trading within the Community and amending Council Directive 96/61/EC Guidelines for Quality and/or Environmental Management System Auditing Information technology -- Security techniques -- Guidelines for information security management systems auditing TS EN ISO Kalite yönetim sistemleri- Temel esaslar, terimler ve tarifler TS EN ISO Kalite yönetim sistemleri- Şartlar TS EN ISO Kalite yönetim sistemleri - Şartlar TS EN ISO Çevre Yönetim Sistemi- Şartlar ve kullanım kılavuzu TS EN ISO Çevre yönetim sistemleri Şartlar ve kullanım kılavuzu TS EN ISO TS EN ISO Gıda Güvenliği Yönetim Sistemler- Gıda zincirindeki tüm kuruluşlar için şartlar Tıbbi Cihazlar Kalite yönetim sistemleri- Mevzuat amaçları bakımından şartlar L /Rev.01/0117 Sayfa 7/12

8 TS EN ISO Tıbbî cihazlar - Kalite yönetim sistemleri - Mevzuat amaçları bakımından şartlar TS EN ISO Bilgi teknolojisi- Güvenlik teknikleri- Bilgi Güvenliği Yönetim Sistemleri- Gereksinimler IAF MD Certification of Multiple Sites Based on Sampling IAF MD Transfer of Accredited Certification of Management Systems IAF MD Advanced Surveillance and Recertification Procedures (ASRP) IAF MD Use of Computer Assisted Auditing Techniques ( CAAT ) for Accredited Certification of Management Systems IAF MD Determination of Audit Time of Quality and Environmental Management Systems IAF MD IAF Mandatory Document for the Application of ISO 14065:2013 IAF MD IAF Mandatory Document for Harmonization of Sanctions to be applied to Conformity Assessment Bodies IAF MD Application of ISO/IEC 17011:2004 in the Field of Medical Device Quality Management Systems (ISO 13485) IAF MD Application of ISO/IEC in the Field of Medical Device Quality Management Systems (ISO 13485) IAF MD IAF Mandatory Document for Assessment of Certification Body Management of Competence in Accordance with ISO/IEC 17021:2011 IAF MD Mandatory Document for Application of ISO/IEC for Audits of Integrated Management Systems (IMS) IAF MD Knowledge Requirements for Accreditation Body Personnel for Information Security Management Systems (ISO/IEC 27001) IAF MD Application of ISO/IEC in Greenhouse Gas Validation and Verification (ISO 14065:2013) IAF Mandatory Document fort he Collection of Data to IAF MD Provide Indicators of Management System Certification (app.date: ) Bodies Performance IAF MD Application of ISO/IEC for the Accreditation of Food (app.date: ) IAF MD 17 (app.date: ) 2015 IAF MD IAF MD 19 (app.date: ) 2016 Safety Management Systems (FSMS) Certification Bodies Witnessing Activities fort he Accrediation of Management Systems Certification Bodies Application of ISO/IEC 17021:2011 in the Service Management Sector (ISO/IEC ) IAF Mandatory Document For The Audit and Certification of a Management System operated by a Multi-Site Organization (where application of site sampling is not appropriate) L /Rev.01/0117 Sayfa 8/12

9 IAF MD 20 Generic Competence for AB Assessors: Application to 2016 (app.date: ) ISO/IEC Security management systems for the supply chain -- Best ISO practices for implementing supply chain security, assessments and plans -- Requirements and guidance ISO Energy management systems -- Requirements with guidance for use ISO Energy audits Requirements with guidance for use ISO Energy management systems -- Requirements for bodies providing audit and certification of energy management systems L /Rev.01/0117 Sayfa 9/12

10 İlgili Bölüm: Personel Akreditasyon Başkanlığı Related Department Doküman Numarası Document Number Yayın Tarihi Date of Issue Tanımı Description ISO/IEC Uygunluk Değerlendirmesi Personel Belgelendirmesi Yapan Kuruluşlar İçin Genel Şartlar Conformity Assessment General Requirements for Bodies Operating Certification of Persons L /Rev.01/0117 Sayfa 10/12

11 İlgili Bölüm: Ürün, Hizmet ve Muayene Akreditasyon Başkanlığı Related Department Doküman Numarası Document Number Yayın Tarihi Date of Issue Tanımı Description ISO/IEC Conformity assessment -- Requirements for bodies certifying products, processes and services Uygunluk değerlendirmesi - Ürün, proses ve hizmet belgelendirmesi yapan kuruluşlar için şartlar ISO/IEC Conformity assessment - Requirements for the operation of various types of bodies performing inspection Uygunluk değerlendirmesi - Çeşitli tiplerdeki muayene kuruluşlarının işletimi için şartlar ISO/IEC Conformity assessment - General requirements for third-party 2006 marks of conformity ISO/IEC Conformity assessment-supplier's declaration of conformity Part 1: General requirements ISO/IEC Conformity assessment - Supplier's declaration of conformity Part 2: Supporting documentation TSE ISO/IEC TR Uygunluk değerlendirme - Maddi ürünler için belgelendirme programı örneği ISO/IEC Conformity assessment Fundamentals of product certification and guidelines for product certification schemes Uygunluk değerlendirmesi - Ürün belgelendirme Temelleri ve ürün belgelendirme programları için kurallar EA-3/ EA Policy For the Accreditation of Organic Production Certification EA 4/ Accreditation for Bodies Performing non-destructive Testing EA 5/ EA Guidance on the Application of ISO/IEC in Periodic Inspection of the Roadworthiness of Motor Vehicles and their Trailers EA-6/ EA Guidelines on the Use of EN and ISO/IEC EA-6/ EA Guidelines on the Accreditation of Certification of Primary Sector Products by Means of Sampling of Sites ILAC P Application of ISO/IEC 17020:2012 for the Accreditation of 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 L /Rev.01/0117 Sayfa 11/12

12 2000/14/EC /42/EC 2006 Machinery Noise emission in the environment by equipment for use outdoors 2008/57/EC 2008 Interoperability of the rail system within the Community (Recast) 2009/48/EC 2009 Safety of toys 2009/142/EC (ex- 90/396/EEC) 2009 Appliances burning gaseous fuels 2010/35/EU 2010 Transportable pressure equipment Regulation (EU) No 305/ Construction products 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 2014/34/EU 2014 Equipment and protective systems intended for use in 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 552/2004 Decision 2009/750/EC (implementing Directive 2004/52/EC) 2004 Interoperability of the European Air Traffic Management network 2009 Interoperability of Electronic Road Toll Systems L /Rev.01/0117 Sayfa 12/12