REFERANS DOKÜMAN LİSTESİ Reference Document List Yürürlük Tarihi: Validity 09.01.2017 İlgili Bölüm: Kalite Yönetim Sistemi (Genel) Related Department Doküman Numarası Document Number 17011 Yayın Tarihi Date of Issue 2006 ISO 17011 2004 EA 1/06 A-AB 2015 EA 1/22 2016 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 2/02 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 3/01 2012 EA conditions for the use of accreditation symbols, text reference to accreditation and MLA signatory status EA 3/04 2001 Use of Proficiency Testing as a Tool for Accreditation in Testing IAF ML 2 2016 General Principles for Use of the IAF MLA Mark IAF/ILAC A5 2013 ILAC-G21 2012 ILAC-G3 2012 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-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 IAF MD 12 2016 Accreditation Assessment of Conformity Assessment Bodies with Activities in Multiple Countries ILAC G24 2007 Guidelines for the determination of calibration intervals of measuring instruments ISO/PAS 17001 2005 Conformity assessment -- Impartiality -- Principles and requirements L501-004/Rev.01/0117 Sayfa 1/12
ISO/PAS 17002 2004 Conformity assessment -- Confidentiality -- Principles and requirements ISO/PAS 17003 2004 Conformity assessment -- Complaints and appeals -- Principles and requirements ISO/PAS 17004 2005 Conformity assessement -- Disclosure of information -- Principles and requirements ISO/PAS 17005 2008 Conformity assessment -- Use of management systems -- Principles and requirements ISO Guide 23 1982 Methods of indicating conformity with standards for third party certification systems TS ISO Guide 27 2008 Guidelines for the corrective action to be taken by a certification body in the event of misuse of its mark of conformity 4703 2001 Ürünlere İlişkin Teknik Mevzuatın Hazırlanması ve Uygulanmasına Dair Kanun 28213 2012 Uygunluk Değerlendirme Kuruluşları ile Onaylanmış Kuruluşlar Yönetmeliği 28727 2013 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 339/93 2008 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 L501-004/Rev.01/0117 Sayfa 2/12
İlgili Bölüm: Laboratuvar Akreditasyon Başkanlığı Related Department Doküman Numarası Document Number Yayın Tarihi Date of Issue Tanımı Description ISO 15189 2012 Medical laboratories Particular requirements for quality and competence ISO/IEC 17043 2010 Conformity assessment - General requirements for proficiency testing ISO 22870 2016 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 31 2015 Reference materials Contents of certificates and labels ISO 17034 2016 General requirements for the competence of reference material producers ISO GUIDE 35 Reference materials General and statistical principles for 2006 certification ISO 13528 Statistical methods for use in proficiency testing by 2015 interlaboratory comparisons ISO/IEC 17025 2005 General requirements for the competence of testing and calibration laboratories ISO/TR 22869 2005 Medical laboratories -- Guidance on laboratory implementation of ISO 15189: 2003 TS EN ISO 15189 2014 Tıbbi laboratuvarlar - Kalite ve yeterlilik için şartlar Deney ve Kalibrasyon Laboratuvarlarının Yeterliliği İçin 2012 17025 Genel Şartlar 10743 2013 Yeterlilik Deneyi İçin Genel Şartlar CEN/TS 15675 2007 Air quality Measurement of stationary source emission EA 2/14 (Rev00) 2008 Procedure for Regional Calibration ILCs in Support of the EA MLA EA 2/15 2008 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 L501-004/Rev.01/0117 Sayfa 3/12
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 4/18 2010 Guidance on the level and frequency of proficiency testing participation EA 4/20 2015 Guidance for the Assessment of Laboratories against EN ISO 15189 and 22870 EA INF/12 2014 Benefits and importance of the participation in EA highlighted PT schemes EA-INF/13 2015 The Assessment and Accreditation of Opinions and 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 ILAC G 8 2009 Guidelines on the Reporting of Compliance with Specification ILAC G 18 2010 Guideline for the Formulation of Scopes of Accreditation for Laboratories ILAC G19 2014 Modules in a Forensic Science Process ILAC G 24 2007 Guidelines for the determination of calibration intervals of measuring instruments ILAC G 26 2012 Guidance for the Implementation of a Medical Laboratory Accreditation System ILAC P 8 2012 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 13 2010 Application of ISO/IEC 17011 for the Accreditation of Proficiency Testing Providers ILAC P 14 2013 ILAC Policy for Uncertainty in Calibration JCGM 100 2008 Evaluation of measurement data Guide to the expression of uncertainty in measurement WADA ISL 9.0 2016 International Standard For Laboratories (ISL) L501-004/Rev.01/0117 Sayfa 4/12
İlgili Bölüm: Sistem Akreditasyon Başkanlığı Related Department Doküman Numarası Document Number Yayın Tarihi Date of Issue Tanımı Description ISO/IEC 17021-1 2015 Requirements for bodies providing audit and certification of management systems- Part 1: Requirements 17021 2012 Uygunluk değerlendirmesi - Yönetim sistemlerinin tetkikini ve belgelendirmesini sağlayan kuruluşlar için şartlar ISO/IEC 17021 2011 Conformity assessment-requirements for bodies providing audit and certification of management systems ISO/IEC TS 17021-2 2012 Competence requirements for auditing and certification of environmental management systems ISO/IEC TS 17021-3 2013 Competence requirements for auditing and certification of quality management systems ISO 19011 2011 Guidelines for auditing management systems TS EN ISO 9004 2010 Kalite yönetim sistemleri - Performans iyileştirmeleri için kılavuz ISO 9000 2005 Quality Management Systems - Fundamentals and Vocabulary ISO 9000 2015 Quality Management Systems - Fundamentals and Vocabulary ISO 9001 2008 Quality Management Systems - Requirements ISO 9001 2015 Quality Management Systems - Requirements ISO 9004 2009 Quality Management Systems - Guideline for Performance Improvements ISO 14050 2009 Environmental Management - Vocabulary TS EN ISO 14004 2010 Çevre Yönetim Sistemleri -Prensipler,sistemler ve destekleyici tekniklere dair genel kılavuz ISO 14006 2011 Environmental management systems - Guidelines for incorporating ecodesign ISO 14001 2004 EMS- Requirements with guidance for use ISO 14001 2015 EMS- Requirements with guidance for use ISO/TR 14062 2002 Environmental management - Integrating environmental aspects into product design and development ISO 14020 2000 Environmental labels and declarations - General principles L501-004/Rev.01/0117 Sayfa 5/12
ISO 14063 2006 Environmental management - Environmental communication - Guidelines and examples ISO 14005 2010 Environmental management systems - Guidelines for the phased implementation of an environmental management system, including the use of environmental performance evaluation ISO 22000 2005 Food safety management systems - Requirements for any organization in the food chain TSE ISO/TS 22003 2015 Gıda güvenliği yönetim sistemleri - Gıda güvenliği yönetim sistemlerinin tetkikini ve belgelendirmesini sağlayan kuruluşlar için şartlar ISO/TS 22004 2014 Food safety management systems -- Guidance on the application of ISO 22000 ISO/TS 22002-1 2009 Prerequisite programmes on food safety -- Part 1: Food 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 ISO/TS 22002-4 2013 Prerequisite programmes on food safety -- Part 4: Food packaging manufacturing ISO 22005 2007 Traceability in the feed and food chain -- General principles and basic requirements for system design and implementation ISO/IEC 27001 2013 Information technology -- Security techniques -- Information security management systems -- Requirements ISO/IEC 27006 2011 Information technology -- Security techniques -- Requirements for bodies providing audit and certification of information security management systems ISO/IEC 27006 2015 Information technology -- Security techniques -- Requirements for bodies providing audit and certification of information security management systems EA 3/11 2009 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 18001 2007 Occupational health and safety management systems- Requirements ISO/TS 16949 2009 QMS- Particular requirements for the application of ISO 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 ISO 13485 2003 Medical devices Quality management systems Requirements for regulatory purposes EN ISO 13485 2012 Medical devices Quality management systems Requirements for regulatory purposes (ISO 13485:2003) L501-004/Rev.01/0117 Sayfa 6/12
TS EN ISO 14064-1 2007 TS ISO 14064-1:2007 2012 TS EN ISO 14064-2 2007 TS ISO 14064-2:2007 2012 TS EN ISO 14064-3 2007 TS ISO 14064-3:2007 2012 TS EN ISO 14065 2013 TS ISO 14066 2014 COMMISSION REGULATION (EU) 600/2012 COMMISSION REGULATION (EU) No 601/2012 DIRECTIVE 2003/87/EC 2012 2012 2003 ISO 19011 2011 ISO/IEC 27007 2011 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 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 TS EN ISO 22000 2006 TS EN ISO 13485 2014 Gıda Güvenliği Yönetim Sistemler- Gıda zincirindeki tüm kuruluşlar için şartlar Tıbbi Cihazlar Kalite yönetim sistemleri- Mevzuat amaçları bakımından şartlar L501-004/Rev.01/0117 Sayfa 7/12
TS EN ISO 13485 2016 Tıbbî cihazlar - Kalite yönetim sistemleri - Mevzuat amaçları bakımından şartlar TS EN ISO 27001 2014 Bilgi teknolojisi- Güvenlik teknikleri- Bilgi Güvenliği 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 IAF MD 3 2008 Advanced Surveillance and Recertification Procedures (ASRP) IAF MD 4 2008 Use of Computer Assisted Auditing Techniques ( CAAT ) for Accredited Certification of Management Systems IAF MD 5 2015 Determination of Audit Time of Quality and Environmental Management Systems IAF MD 6 2014 IAF Mandatory Document for the Application of ISO 14065:2013 IAF MD 7 2010 IAF Mandatory Document for Harmonization of Sanctions to be applied to Conformity Assessment Bodies IAF MD 8 2015 Application of ISO/IEC 17011:2004 in the Field of Medical Device Quality Management Systems (ISO 13485) IAF MD 9 2015 Application of ISO/IEC in the Field of Medical Device Quality Management Systems (ISO 13485) IAF MD 10 2013 IAF Mandatory Document for Assessment of Certification Body Management of Competence in Accordance with ISO/IEC 17021:2011 IAF MD 11 2013 Mandatory Document for Application of ISO/IEC 17021 for Audits of Integrated Management Systems (IMS) IAF MD 13 2015 Knowledge Requirements for Accreditation Body Personnel for Information Security Management Systems (ISO/IEC 27001) IAF MD 14 2014 Application of ISO/IEC 17011 in Greenhouse Gas Validation 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 2015 Application of ISO/IEC 17011 for the Accreditation of Food (app.date:15.12.2016) IAF MD 17 (app.date:07.01.2018) 2015 IAF MD 18 2015 IAF MD 19 (app.date: 31.03.2018) 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 20000-1) 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) L501-004/Rev.01/0117 Sayfa 8/12
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 ISO 50001 2011 Energy management systems -- Requirements with guidance for use ISO 50002 2014 Energy audits Requirements with guidance for use ISO 50003 2014 Energy management systems -- Requirements for bodies providing audit and certification of energy management systems L501-004/Rev.01/0117 Sayfa 9/12
İlgili Bölüm: Personel Akreditasyon Başkanlığı Related Department Doküman Numarası Document Number Yayın Tarihi Date of Issue Tanımı Description 17024 2012 ISO/IEC 17024 2012 Uygunluk Değerlendirmesi Personel Belgelendirmesi Yapan Kuruluşlar İçin Genel Şartlar Conformity Assessment General Requirements for Bodies Operating Certification of Persons L501-004/Rev.01/0117 Sayfa 10/12
İlgili Bölüm: Ürün, Hizmet ve Muayene Akreditasyon Başkanlığı Related Department Doküman Numarası Document Number Yayın Tarihi Date of Issue Tanımı Description ISO/IEC 17065 2012 Conformity assessment -- Requirements for bodies certifying products, processes and services Uygunluk değerlendirmesi - Ürün, proses ve hizmet 2013 17065 belgelendirmesi yapan kuruluşlar için şartlar ISO/IEC 17020 2012 Conformity assessment - Requirements for the operation of various types of bodies performing inspection 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 ISO/IEC 17067 2013 Conformity assessment Fundamentals of product certification and guidelines for product certification schemes Uygunluk değerlendirmesi - Ürün belgelendirme Temelleri ve 2015 17067 ürün belgelendirme programları için kurallar EA-3/12 2013 EA Policy For the Accreditation of Organic Production Certification EA 4/15 2015 Accreditation for Bodies Performing non-destructive Testing EA 5/02 2015 EA Guidance on the Application of ISO/IEC 17020 in Periodic 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-6/04 2011 EA Guidelines on the Accreditation of Certification of Primary Sector Products by Means of Sampling of Sites ILAC P15 2016 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 L501-004/Rev.01/0117 Sayfa 11/12
2000/14/EC 2000 2006/42/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 305/2011 2011 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 L501-004/Rev.01/0117 Sayfa 12/12