International standard: ISO/IEC 17021-1:2015 Swiss standard: SN EN ISO/IEC 17021-1:2015 Bureau Veritas Switzerland AG Grossächerstrasse 25 Postfach 165 8104 Weiningen ZH Head: Responsible for MS: Pascal Singh Beat Hurni Telephone: +41 44 752 11 55 E-Mail: Internet: Initial accreditation: 21.07.1992 beat.hurni@ch.bureauveritas.com http://www.bureauveritas.ch Current accreditation: 30.07.2017 to 29.07.2022 Scope of accreditation see: www.sas.admin.ch (Accredited bodies) Scope of accreditation as of 26.07.2017 Certification body for management systems in the domain of quality, environment and security ISO 9001:2015 Agriculture, fishing 1 Mining and quarrying 2 Food products, beverages and tobacco Textiles and textile products 4 Leather and leather products 5 Wood and wood products 6 Pulp, paper and paper products 7 Publishing companies 8 Printing companies 9 Chemicals, chemical products and fibres 3 12 Pharmaceuticals 13 Rubber and plastic products 14 26.07.2017 / Y gbm/asv 0003scesvz_engl 1/5
ISO 9001:2015 Non-metallic mineral products 15 Concrete, cement, lime, plaster etc. Basic metals and fabricated metal products 16 17 Machinery and equipment 18 Electrical and optical equipment 19 Shipbuilding 20 Machinery and equipment 22 Electrical and optical equipment 23 Shipbuilding 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 Health and social work 38 Other social services 39 ISO 14001:2015 Agriculture, fishing 1 Mining and quarrying 2 Food products, beverages and tobacco Textiles and textile products 4 3 26.07.2017 / Y gbm/asv 0003scesvz_engl 2/5
ISO 14001:2015 Leather and leather products 5 Wood and wood products 6 Pulp, paper and paper products 7 Publishing companies 8 Printing companies 9 Chemical, chemical products and fibres 12 Pharmaceuticals 13 Rubber and plastic products 14 Non-metallic mineral products 15 Concrete, cement, lime, plaster etc. Basic metals and fabricated metal products 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 Transport, storage and communication Financial intermediation, real estate, renting 31 32 Information technology 33 Engineering services 34 Other services 35 Public administration 36 26.07.2017 / Y gbm/asv 0003scesvz_engl 3/5
ISO 14001:2015 Education 37 Other social services 39 Already granted certificates according to the standard ISO 13485:2003 keep their validity until 28.02.2019, at the latest. ISO 13485:2003 EN ISO 13485:2012 EN ISO 13485:2016 ISO 13485:2003 EN ISO 13485:2012 EN ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes Non-active medical devices: MD 0100 Non-active devices for anaesthesia, emergency and intensive caresoft tissue implants Active medical devices: Orthopaedic and rehabilitation devices Non-active medical devices with measuring function MD 0101 MD 0103 MD 0104 Ophthalmologic devices MD 0105 Non-active instruments MD 0106 Disinfecting, cleaning, rinsing MD 0108 Orthopaedic implants MD 0202 Bandages and wound dressings MD 0301 Suture material and clamps MD 0302 Other medical devices for wound care MD 0303 Dental equipment and instruments MD 0401 Dental materials MD 0402 Dental implants MD 0403 Surgical devices MD 1104 Dental devices MD 1106 Patient positioning and transport MD 1109 26.07.2017 / Y gbm/asv 0003scesvz_engl 4/5
BS OHSAS 18001:2007 Specifics of medical devices and active medical devices: Medical devices referencing the Directive 2006/42/EC on machinery Medical devices referencing the Directive 89/686/EEC on personal protective equipment (PPE) Occupational health and safety management systems - Guidelines for the implementation of OHSAS 18001 MDS 7004 MDS 7005 Abbreviation Signification Economic Activity Code; see also IAF ID1, Informative Document for QMS and EMS Scopes of Accreditation * / * / * / * / * 26.07.2017 / Y gbm/asv 0003scesvz_engl 5/5