This annex is valid from: to Replaces annex dated: Location(s) where activities are performed under accreditation

Transcription

1 Institute Quality & Control Ltd. Location(s) where activities are performed under accreditation Head Office 6 Ravnitzky St. Shohan House i.z. Sgula Petah Tikva Israel Location 6 Ravnitzky St. Shohan House i.z. Sgula Petah Tikva Israel Certification Scheme - ISO , ISO , ISO/TS Additional FSSC - / ISO / ISO ISO 13485: ISO 13485: ISO This annex has been approved by the Board the Dutch Accreditation Council, on its behalf, J.A.W.M. de Haas Director Operations 1 If no date or version number is mentioned for a normative document, the accreditation concerns the most current version the document or scheme. 1 If there is a reference to a code starting with NAW, NAP, EA or IAF, this concerns a scheme mentioned on the RvA-BR010-lijst. Dutch Accreditation Council RvA Page 1 5

2 Institute Quality & Control Ltd. ISO 9001 Quality management system for the scopes (reference to IAF-codes and NACE Rev. 2 where relevant) : 1 agriculture, forestry and fishing 3 food products, beverages and tobacco 4 textiles and textile products 7 pulp, paper and paper products 9 printing companies 12 chemicals, chemical products and fibres 14 rubber and plastic products 17 basic metals and fabricated metal products 18 machinery and equipment 19 electrical and optical equipment 23 manufacturing not elsewhere classified 24 recycling 25 electricity supply 28 construction 29 wholesale and retail trade; repair motor vehicles, motorcycles and personal and household goods 30 hotels and restaurants 31 transport, storage and communication 33 information technology 34 engineering services 35 other pressional services 36 public administration 37 education 38 health and social work 39 other social services Certification Food Safety Management Systems for the clusters 2. Food and feed processing: - category C, Food manufacturing - category I, Production food packaging and packaging materials 6. (Bio)chemicals: - category K, Production (bio)chemicals ISO Certification food safety management systems (FSSC 22000) for the clusters 2. Food and feed processing: - category C, Food manufacturing 6. (Bio)chemical: - category K, Production (bio)chemicals Dutch Accreditation Council RvA Page 2 5

3 Institute Quality & Control Ltd. (EA-0180) ISO Certification food safety management systems (FSSC 22000) for the clusters - category I, Production food packaging and packaging materials (EA-0180), ISO/TS Additional FSSC Food Safety System Certification (FSSC 22000) for the following clusters and categories: 2. Food and feed processing - Category C, Food manufacturing C I: processing perishable animal products C II: processing perishable plant products C III: processing perishable animal and plant products (mixed products) C IV: processing ambient stable products - Category D, Feed production 6. (Bio)chemical - Category K, Production (bio)chemicals (excluding pesticides, drugs, fertilizers and cleaning agents) (EA-0197) ISO Food Safety System Certification (FSSC 22000, version 4) for the following cluster - category I, Production food packaging and packaging material (EA-0197) ISO 13485:2003 ISO 13485:2016 Medical Devices - Quality Management Systems - Requirements for regulatory purposes for the scopes: - Non-active medical devices - General non-active, non-implantable medical devices - Non-active implants - Devices for wound care - Non-active dental devices and accessories - Non-active medical devices other than specified above - Active (non-implantable) medical devices - General active medical devices Dutch Accreditation Council RvA Page 3 5

4 Institute Quality & Control Ltd. - Devices for imaging - Monitoring devices - Devices for radiation therapy and thermotherapy - Active (non-implantable) medical devices other than specified above - In Vitro Diagnostic Medical Devices - Reagents and reagent products, calibrators and control materials for: Clinical Chemistry Immunochemistry (Immunology) Haemotology/Haemostasis/Immunohematology Microbiology Infectious Immunology Histology/Cytology Genetic Testing - In Vitro Diagnostic Instruments and stware - IVD Medical Devices other than specified above ISO Environmental management system certification according to ISO 14001:2015, for the scopes: IAF code NACE code (rev. 2) Description activities 1 part Section A 01, 02 Agriculture 3 Section C Food products, beverages and tobacco 12 Section C 20 (minus Chemicals, chemical products and fibres (except radioactive materials) part 20.13) 14 Section C 22 Rubber and plastic products 18 part Section C 28 Machinery and equipment 19 part Section C 26, 27 (minus 26.1, 27.9) Electrical and optical equipment (includes domestic appliances) 19 part Section C 33.13, 33.14, 95.1, 95.21, Electrical and optical equipment: repair electrical and optical equipment, domestic appliances etc. 24 Section E 38.3 Recycling 25 Section D 35.1 Electricity supply 29 part Section G 45 Wholesale and retail trade and repair motor vehicles, motor cycles 29 part Section G 46, 47 Wholesale and retail trade (except motor vehicles and motorcycles) 31 part Section H 53, Section J 60, 61 Post and telecommunication 31 part Section H Transport and storage 33 Section J 62, 63 Information technology 34 Section M 71, 74.1, 74.2 Engineering services 35 part Section M 72 Research and development 35 part Section N Pressional services: administrative and supportive services 35 part Section S 96 Pressional services: personal services 35 part Section M 69, 70, 73, 74.3, 74.9, 75 Other pressional services n.e.c. 38 Section Q 86, 87 Health and social work Dutch Accreditation Council RvA Page 4 5

5 Institute Quality & Control Ltd. 39 part Section E 37, 38, 39 (minus 38.12, 38.22, 38.3) Other social services: sewage and refuse disposal and sanitation (except "recycling" and "hazardous waste containing radioactive components") Dutch Accreditation Council RvA Page 5 5