SCESm Directory Accreditation number: SCESm 0001

Transcription

1 International standard: ISO/IEC :2015 Swiss standard: SN EN ISO/IEC :2015 Swiss Association for Quality and Management Systems (SQS) Bernstrasse Zollikofen Head: Responsible for MS: René Wasmer Felix Müller Telephone: Internet: mailto: Initial accreditation: Current accreditation: to Scope of accreditation see: (Accredited bodies) Scope of accreditation as of Certification body for management systems in the domain of quality, environment and security ISO 9001:2008 ISO 9001:2015 Already granted certificates according to the standard ISO 9001:2008 keep their validity until , at the latest. Agriculture, fishing 1 Mining and quarrying 2 IAF Code Food products, beverages and tobacco 3 Textiles and textile products 4 Leather and leather products 5 Wood and wood products 6 Pulp, paper and paper products 7 Publishing companies / BU geh/zej 0001scesmvz_engl 1/13

2 ISO 9001:2008 ISO 9001:2015 Printing companies 9 Manufacture of coke and refined petroleum products Manufacture and processing of nuclear fuel Chemicals, chemical products and fibres Pharmaceuticals 13 Rubber and plastic products 14 Non-metallic mineral products 15 Concrete, cement, lime, plaster etc. Basic metals and fabricated metal products Machinery and equipment 18 Electrical and optical equipment 19 Shipbuilding 20 Code NACE pleasure and sporting boats 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 / BU geh/zej 0001scesmvz_engl 2/13

3 ISO 9001:2008 ISO 9001:2015 Financial intermediation, real estate, renting 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 14001:2004 ISO 14001:2015 Already granted certificates according to the standard ISO 14001:2004 keep their validity until , at the latest. Agriculture, fishing 1 Mining and quarrying 2 IAF Code Food products, beverages and tobacco 3 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 Manufacture of coke and refined petroleum products Manufacture and processing of nuclear fuel Chemicals, chemical products and fibres Pharmaceuticals 13 Rubber and plastic products 14 Non-metallic mineral products / BU geh/zej 0001scesmvz_engl 3/13

4 ISO 14001:2004 ISO 14001:2015 Concrete, cement, lime, plaster etc. Basic metals and fabricated metal products Machinery and equipment 18 Electrical and optical equipment 19 Shipbuilding 20 Code NACE pleasure and sporting boats 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 Information technology 33 Engineering services 34 Other services 35 Public administration 36 Education 37 Health and social work 38 Other social services / BU geh/zej 0001scesmvz_engl 4/13

5 ISO 45001:2018 BS OHSAS 18001:2007 Already granted certificates according to the standard BS OHSAS 18001:2007 keep their validity until , at the latest. Agriculture, fishing 1 Mining and quarrying 2 IAF Code Food products, beverages and tobacco 3 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 Manufacture of coke and refined petroleum products Manufacture and processing of nuclear fuel Chemicals, chemical products and fibres Pharmaceuticals 13 Rubber and plastic products 14 Non-metallic mineral products 15 Concrete, cement, lime, plaster etc. Basic metals and fabricated metal products Machinery and equipment 18 Electrical and optical equipment 19 Shipbuilding 20 Aerospace 21 Other transport equipment / BU geh/zej 0001scesmvz_engl 5/13

6 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 Information technology 33 Engineering services 34 Other services 35 Public administration 36 Education 37 Health and social work 38 Other social services 39 ISO 50001:2011 AQAP 2110: 2003 NATO-QS-Requirements Energy Management Systems - Industry light to medium - Industry heavy - Mining - Energy supply - Buildings - Building complexes - Transport Agriculture Same scope as ISO 9001:2000 The certification body fulfils the requirements of the standard ISO 50003:2014 Only in combination with a certification according to ISO 9001 eduqua:2012 Education Corresponds to IAF Code 37 ISO 29990:2010 Provider of learning services for non-formal education and training / BU geh/zej 0001scesmvz_engl 6/13

7 SVOAM-2010 Measures of the employment market Food safety management systems for the clusters (according to ISO/TS 22003) Cluster 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 3. Catering (E) E Catering 4. Retail, transport and storage (F + G) F Distribution G Provision of Transport and Storage Services 5. Auxiliary Services (H + I + J) H Services I Production of Food Packaging and Packaging Materials J Equipment Manufacturing 6. (Bio) Chemicals (K) K Production of (Bio) Chemicals ISO/TS :2009 ISO/TS :2016 Food Safety System Certification (FSSC 22000) for the categories: CI Processing of perishable animal products CII Processing of perishable plant products CIII Processing of perishable animal and plant products (mixed products) CIV Processing of ambient stable products (ambient temperature) DII Production of Pet Food for dog and cat DI Production of Feed DII Production of Pet Food for other pet than dog and cat Including ISO/TS 22003:2013 Inclusive ISO/TS 22003:2013 ISO/TS :2013 E Catering Inclusive ISO/TS 22003: / BU geh/zej 0001scesmvz_engl 7/13

8 PAS 221:2013 FI Retail/Wholesail Inclusive ISO/TS 22003:2013 NEN/NTA 8059:2016 GI Provision of Transport and Storage Services for Perishable Food and Feed GII Provision of Transport and Storage Services for Ambient Stable Food and Feed. Inclusive ISO/TS 22003:2013 ISO/TS :2013 I Production of Food Packaging and Packaging Material Inclusive ISO/TS 22003:2013 ISO/TS :2009 K Production of food and feed additives, vitamins, minerals, bio-cultures, flavourings, enzymes and processing aids, (Excluded: pesticides, drugs, fertilizers, cleaning agents) Inclusive ISO/TS 22003:2013 FAMI-QS:2014 Version 5.1, February 2014 European Code of Practice for Feed Additives and Premixture Operators DIN EN 15593:2008 ISO/IEC :2011 ISO/IEC 27001:2013 Production of feed additives and premixes for the feed industry Packaging - Management of hygiene in the production of packaging for foodstuffs. Requirements. IT Service Management Information Security Management Systems ISMS Including ISO/TS 22003:2013 The certification body fulfils the requirements of the standard ISO/IEC 27006:2015 ODPC - (SR ) including the directives of the Swiss Federal Data Protection and Information Commissioner (FDPIC) with respect to the minimum requirements for a data protection management system and its Appendix (Guidelines for the Management of Data Protection) Management system certification (all international standards of the series ISO 13485) Data Protection Management Systems (DPMS) in accordance with Article 4 ODPC: Certification of Organization and Procedures Based on Swiss Federal Data Protection Law (SR 235.1) including special legal data protection regulations Ordinance on the Swiss Federal Data Protection Law (SR ) / BU geh/zej 0001scesmvz_engl 8/13

9 MD 0000 Non Active Medical Devices MD 0100 General non-active, non-implantable medical devices MD 0101 Non-active devices for anaesthesia emergency and intensive care 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 0110 Medical devices for ingestion MD 0200 Non-active implants MD 0202 Non-active orthopaedic implants MD 0203 Non-active functional implants MD 0204 Non-active soft tissue implants MD 0300 Devices for wound care / BU geh/zej 0001scesmvz_engl 9/13

10 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 1101 Devices for extra-corporal circulation, infusion and haemopheresis Limitation: MD 1101 without heart lung machine MD 1102 Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia MD 1103 Devices for stimulation or inhibition MD 1104 Active surgical devices MD 1105 Active ophthalmologic devices MD 1106 Active dental devices MD 1107 Active devices for disinfection and sterilisation MD 1108 Active rehabilitation devices and active prostheses MD 1111 Software Limitation: MD 1102 only respiratory protection apparatus/device / BU geh/zej 0001scesmvz_engl 10/13

11 MD 1112 Medical gas supply systems and parts thereof MD 1200 Devices for imaging MD 1201 Imaging devices utilising ionizing radiation MD 1202 Imaging devices utilising non-ionizing radiation MD 1300 Monitoring devices MD 1301 Monitoring devices of non-vital physiological parameters MD 1302 Monitoring devices of vital physiological parameters MD 1400 Devices for radiation therapy and thermo therapy MD 1404 Devices for (extracorporal) shock-wave therapy (lithotripsy) MDS 7000 Specifics of Medical Devices MDS 7004 Medical devices referencing the Directive 2006/42/EC on machinery MDS 7006 Medical devices in sterile condition MDS 7009 Medical devices utilising biological active coatings and/or materials or being wholly or mainly absorbed MDS 7010 Medical devices with build-in and/or employed software and/or with application of software / BU geh/zej 0001scesmvz_engl 11/13

12 ISO 15378:2015 Good Medical Practice :2009 RQS:2004 EN 9100:2009 AS 9100D EN 9120:2010 AS 9120B SN EN ISO :2006 SN EN ISO :2006 SN EN ISO :2006 SR Regulation on the safety of pressure equipment (Pressure Equipment Ordinance) (EC Pressure Equipment Directive 2014/68/EU) Primary packaging materials for medicinal products Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2015) General practitioner's practices Health Maintenance Organization (HMO) group medicine Reference document for Hospital Pharmacies developed by GSASA and APEQ Management Systems for Aerospace industry Management Systems for Aerospace industry / requirements for stockist distributors Quality requirements for fusion welding of metallic materials Comprehensive quality requirements Standard quality requirements Elementary quality requirements Quality assurance production Quality assurance products Quality assurance production Quality assurance products Complete quality assurance without draft examination and surveillance of the final verification Certification combined with ISO 9001 Certification of management system for medical practices quality label for medical practices The body satisfies the requirements of EN :2013 and since the , the body satisfies the requirements of AS 9101F. Already granted certificates according to the standard EN 9100:2009 keep their validity until , at the latest. The body satisfies the requirements of EN :2013 and since the , the body satisfies the requirements of AS 9101F. Already granted certificates according to the standard EN 9120:2010 keep their validity until , at the latest. Combined with a certification on the base of ISO 9001 Annex lll module D1 Annex lll module E1 Annex lll module D Annex lll module E Annex lll module H / BU geh/zej 0001scesmvz_engl 12/13

13 Notified Body EU identification number NB 1250 according to 2014/68/EU Indication The modules A2, B, C2, F, G and module H1 without quality assurance are covered by SCESp Ordinance on the safety of lifts, SR Directive 2014/33/EU on the harmonisation of the laws of the Member States relating to lifts and safety components for lifts ("Lift Safety Directive") Lifts Lift Safety Directive 2014/33/EU - Annex X (Module E) - Annex XI (Module H1) - Annex XII (Module D) Explicitly excluded are design examinations according to Lift Safety Directive, Annex XI (3.3) Abbreviation APEQ IAF Code eduqua FAMI-QS GSASA Signification Agence pour la promotion et l évaluation de la qualité dans les institutions sanitaires IAF ID1, Informative Document for QMS and EMS Scopes of Accreditation Certification body for quality management system in adult training institutes. Ref. FAMI-QS European Feed Additives and Premixtures Quality System, Brussels, Actual version of the standard document Gesellschaft Schweizerischer Amts- und Spitalapotheker MDO Swiss Medical Device Ordinance of the 17 October 2001 (state of 28 December 2001), SR ODPC ref. SVOAM Ordinance on Date Protection Certification Council Directive of the 14 June 1993 on medical devices Swiss association of the organizers of measures of the employment market * / * / * / * / * / BU geh/zej 0001scesmvz_engl 13/13