International standard: ISO/IEC 17021-1:2015 Swiss standard: SN EN ISO/IEC 17021-1:2015 Swiss Safety Center AG Certifications Richtistrasse 15 8304 Wallisellen Head: Responsible for MS: Heinrich A. Bieler Markus Stauffer Telephone: +41 44 877 62 30 E-Mail: Internet: Initial accreditation: 16.03.1994 heinrich.bieler@safetycenter.ch http://www.safetycenter.ch Current accreditation: 01.07.2014 to 30.06.2019 Scope of accreditation see: www.sas.admin.ch (Accredited bodies) Scope of accreditation as of 12.08.2018 Certification body for management systems in the areas of quality, environment and safety ISO 9001:2008 ISO 9001:2015 Agriculture, fishing 1 Mining and quarrying 2 Food, beverages and tobacco Textiles and textile 4 Leather and leather 5 Wood and wood 6 Pulp, paper and paper 7 Publishing companies 8 Printing companies 9 Manufacture of coke and refined petroleum Already granted certificates according to the standard ISO 9001:2008 keep their validity until 14.09.2018, at the latest. IAF Code 3 10 15.08.2018 / AP rol/dil 0013scesvz en 3005.00059 V01 1/7
Nuclear fuel 11 Chemicals, chemical and fibres 12 Pharmaceuticals 13 Rubber and plastic 14 Non-metallic mineral 15 Concrete, cement, lime, plaster etc. Basic metals and fabricated metal 16 17 Machinery and equipment 18 Electrical and optical equipment 19 Shipbuilding 20 Aerospace 21 Other transport equipment 22 Manufacturing not elsewhere classified 23 Recycling 24 Electricity supply 25 Gas supply 26 Water supply 27 Construction 28 Wholesale and retail trade; repair of motor vehicles, motorcycles and personal and household goods 29 Hotels and restaurants 30 Transport, storage and communication Financial intermediation, real estate, renting 31 32 Information technology 33 Engineering services 34 Other services 35 Public administration 36 Education 37 15.08.2018 / AP rol/dil 0013scesvz en 3005.00059 V01 2/7
Health and social work 38 Other social services 39 ISO 14001:2004 ISO 14001:2015 Agriculture, fishing 1 Food, beverages and tobacco Textiles and textile 4 Wood and wood 6 Pulp, paper and paper 7 Publishing companies 8 Printing companies 9 Chemicals, chemical and fibres Already granted certificates according to the standard ISO 14001:2004 keep their validity until 14.09.2018, at the latest. IAF Code 3 12 Pharmaceuticals 13 Rubber and plastic 14 Concrete, cement, lime, plaster etc. Basic metals and fabricated metal 16 17 Machinery and equipment 18 Electrical and optical equipment 19 Other transport equipment 22 Manufacturing not elsewhere classified 23 Recycling 24 Electricity supply 25 Gas supply 26 Water supply 27 Construction 28 Wholesale and retail trade; repair of motor vehicles, motorcycles and personal and household goods 29 Hotels and restaurants 30 15.08.2018 / AP rol/dil 0013scesvz en 3005.00059 V01 3/7
Transport, storage and communication 31 BS OHSAS 18001:2007 ISO 50001:2011 ISO 3834-2:2006 ISO 29990:2010 Information technology 33 Engineering services 34 Other services 35 Occupational safety and health management systems Energy Management Systems - Industry light to medium - Industry heavy - Mining - Energy supply - Buildings - Building complexes - Transport - Agriculture Quality requirements for welding, Part 2: Comprehensive quality requirements Provider of learning services for non-formal education and training The certification body fulfils the requirements of the standard ISO 50003:2014 eduqua:2012 Continuing education Corresponds to IAF-Code 37 SR 930.114: Ordinance on the safety of pressure equipment (pressure equipment ordinance) Pressure equipment directive 2014/68/EU SCC ISO/IEC 20000-1:2011 ISO/IEC 27001:2013 Certification body 2) for evaluation methods, modules D, D1, E, E1, H. Module H1 without design examination and surveillance. Indication, modules A1, B, B1, C1 F, G and module H1 without inspection (see SIS 0073) Safety Certificate Contractors IT Service Management (ITSM) Information Security Management Systems ISMS 2) Conformity assessment body according to SR 930.114 Notified body EU identification number NB 1253 according to directive 2014/68/EU The certification body fulfils the requirements of the standard ISO/IEC 27006:2015 15.08.2018 / AP rol/dil 0013scesvz en 3005.00059 V01 4/7
ISO/TS 22002-1:2009 Inclusive additional FSSC 22000 requirements version 4 ISO/TS 22002-4:2013 Inclusive additional FSSC 22000 requirements version 4 ISO/TS 22002-1:2009 Inclusive additional FSSC 22000 requirements version 4 ISO 13485:2003 ISO 13485:2012 ISO 13485:2016 Food safety management systems for the clusters (according to ISO/TS 22003) 2. Food and Feed Processing (C + D) The certification body satisfies the requirements according to ISO/TS 22003:2013 for the sectors C Food Manufacturing D Animal Feed Production 5. Auxiliary Services (I) I Production of Food Packaging and Packaging Materials 6. (Bio) Chemicals (K) K Production of (Bio) Chemicals Food Safety System Certification 22000 (FSSC 22000) for the categories: CI Processing of perishable animal CII Processing of perishable plant CIII Processing of perishable animal and plant (mixed ) CIV Processing of ambient stable (ambient temperature) DII Production of Pet Food for dog and cat I K Production of Food Packaging and Packaging Material Production of food and feed additives, vitamins, minerals, bio-cultures, flavourings, enzymes and processing aids, (Excluded: pesticides, drugs, fertilizers, cleaning agents) MD 0100 Non Active Medical Devices MD 0100 General non-active, nonimplantable medical devices MD0101 Non-active devices for anaesthesia emergency and intensive care Including ISO/TS 22003:2013 Inclusive ISO/TS 22003:2013 Inclusive ISO/TS 22003:2013 Only certification of quality management systems; no procedures for assessing the conformity; no label according to SR 946.512 15.08.2018 / AP rol/dil 0013scesvz en 3005.00059 V01 5/7
MD 0102 Non-active devices for injection, infusion, transfusion and dialysis MD 0103 Non-active orthopaedic and rehabilitation devices MD 0104 Non-active medical devices with measuring function MD 0105 Non-active ophthalmologic devices MD 0106 Non-active instruments MD 0108 Non-active medical devices for disinfecting, cleaning, rinsing MD 0300 Devices for wound care MD 0301 Bandages and wound dressings MD 0302 Suture material and clamps MD 0303 Other medical devices for wound care MD 0400 Non-active dental devices and accessories MD 0401 Non-active dental equipment and instruments MD 0402 Dental materials MD 0403 Dental implants MD 1000 Active Medical Devices MD 1100 General active medical devices MD 1104 Active surgical devices MD 1106 Active dental devices MD 1107 Active devices for disinfection and sterilisation MD 1108 Active rehabilitation devices and active prostheses MD 1109 Active devices for patient positioning and transport MD 1400 Devices for radiation therapy and thermo therapy 15.08.2018 / AP rol/dil 0013scesvz en 3005.00059 V01 6/7
MD 1403 Devices for hyperthermia / hypothermia MDS 7000 Specifics of medical devices and active medical devices MDS 7004 Medical devices referencing the Directive 2006/42/EC on machinery MDS 7006 Medical devices in sterile condition Limitations: MD 0102: - probes and catheters for urology, gastroenterology, respiratory tract and surgical aspiration - equipment for parenteral and enteral nutrition - needles for infusion and excision - canulas, probes, tubes - plastic tubes for infusion and excision - filters for blood and liquor, other filters Abbreviation IAF Code eduqua ITSM Signification International Accreditation Forum Code; see also IAF ID1, Informative Document for QMS and EMS Scopes of Accreditation Certification body for quality management system in adult training institutes, Ref. www.eduqua.ch IT Service Management MDO Swiss Medical Device Ordinance, SR 812.213, of the 17 October 2001 (State of 7 September 2004) Ref. 93/42/EEC Council directive 93/42/EEC of 14 June 1993 concerning medical devices SCC Safety Certificate Contractors, Ref: http://www.scc-sekretariat.de/ * / * / * / * / * 15.08.2018 / AP rol/dil 0013scesvz en 3005.00059 V01 7/7