Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

Transcription

1 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK Derby Manor Derby Road Bournemouth Dorset BH1 3QB Contact: Mr D Riggs Tel: +44 (0) Fax: +44 (0) info@urs-certifcation.co.uk Website: SUMMARY OF ACCREDITED SCOPE provide certification of the following Management Systems Standards and related Sector Schemes as detailed in this schedule: Quality Management Systems (QMS) to ISO 9001: 2015 Medical Devices - Quality Management Systems (MD-QMS) to ISO 13485: 2016 Environmental Management Systems (EMS) ISO 14001: 2015 Information Technology Service Management Systems (ITSMS) to ISO/IEC : 2011 Food Safety Management Systems (FSMS) to ISO 22000: 2005 Business Continuity Management Systems (BCMS) to ISO 22301: 2012 Information Security Management Systems (ISMS) to ISO/IEC 27001: 2013 Health and Safety Management Systems (HSMS) to BS OHSAS 18001: 2007 and ISO 45001: 2018 Page 1 of 21

2 QMS MD-QMS EMS ITSMS FSMS BCMS ISMS HSMS Schedule of KEY LOCATION ADDRESS Derby Manor Derby Road Bournemouth Dorset BH1 2E United Kingdom Lead Office for EN :2013 Aerospace Sector Scheme F 3 Sector 6 Noida India This Certification Body has demonstrated to UKAS that it has the systems and processes in place to provide the competence and capability, including understanding of local requirements, to manage and issue accredited management in the country in which it is established and in any other country, for the standards and scopes detailed on this schedule, unless specifically detailed in the individual Management System scope table (denoted by *). Page 2 of 21

3 QUALITY MANAGEMENT SYSTEMS In accordance with ISO 9001: 2015 Certification / Limited IAF 1 Agriculture, forestry and fishing Limited Growing of crops (non animal feed); market gardening; horticulture Raising of (non diary) cattle and buffaloes Raising of swine/pigs Including HACCP in accordance with the principles of Codex Alimentarius (URS document AN 34) in association with ISO 9001for a limited scope associated with food chain related activity. IAF 3 Food products, beverages and tobacco Including HACCP in accordance with the principles of Codex Alimentarius (URS document AN 34) in association with ISO 9001 IAF 4 Textiles and textile products IAF 5 Leather and leather products IAF 6 Wood and wood products IAF 7 Pulp, paper and paper products IAF 8 Publishing companies IAF 9 Printing companies IAF 12 Chemicals, chemical products and fibres Limited Manufacture of chemicals, chemical products and fibres excluding explosives Page 3 of 21

4 QUALITY MANAGEMENT SYSTEMS In accordance with ISO 9001: 2015 Certification / Limited IAF 13 Pharmaceuticals Limited Manufacture of botanical products. Compounding, supply and delivery of medically prescribed treatment, including pharmaceutical, medical and ancillary products and services IAF 14 Rubber and plastic products IAF 15 Non-metallic mineral products IAF 16 Concrete, cement, lime, plaster etc IAF 17 Basic metals and fabricated metal products IAF 18 Machinery and equipment IAF 19 Electrical and optical equipment IAF 21 Aerospace IAF 22 Other transport equipment Limited Manufacture of motor vehicles, trailers and semi-trailers Manufacture of invalid carriages. IAF 23 Manufacturing not elsewhere classified IAF 24 Recycling Limited Recycling of non-hazardous materials Page 4 of 21

5 QUALITY MANAGEMENT SYSTEMS In accordance with ISO 9001: 2015 Certification / Limited IAF 27 Water supply Limited Water collection and treatment IAF 28 Construction IAF 29 Wholesale and retail trade; Repair of motor vehicles, motorcycles and personal and household goods Including HACCP in accordance with the principles of Codex Alimentarius (URS document AN 34) in association with ISO 9001 for a limited scope associated with food and food chain related products only IAF 30 Hotels and restaurants Including HACCP in accordance with the principles of Codex Alimentarius (URS document AN 34) in association with ISO 9001 associated with food and food chain related activities only IAF 31 Transport, storage and communication IAF 32 Financial intermediation; real estate; renting IAF 33 Information technology IAF 34 Engineering services IAF 35 Other services IAF 36 Public administration IAF 37 Education Page 5 of 21

6 QUALITY MANAGEMENT SYSTEMS In accordance with ISO 9001: 2015 Certification IAF 38 Health and social work / Limited IAF 39 Other social services Limited Library, archives, museums and other cultural activities Sporting activities Other personal service activities Activities of business and employer s membership organisations, and of professional membership organisations Travel agency, tour operator reservation service and related activities Radio broadcasting Television programming and broadcasting activities Waste collection, treatment and disposal END ISO 9001 Sector Scheme Aerospace Sector Certification Scheme EN :2013 for the certification of clients to: AS, EN or JISQ 9100 including the 2018 version AS, EN or JISQ 9110 including the 2018 version AS, EN or JISQ 9120 including the 2018 version END Page 6 of 21

7 MEDICAL DEVICES QUALITY MANAGEMENT SYSTEMS In accordance with ISO 13485: 2016 Certification IAF Mandatory Scopes of Scope Reference Technical Area 1.1 Non-active Medical Devices General non-active, non-implantable medical devices Non-active implants Devices for wound care Non-active dental devices and accessories 1.2 Active Medical Devices (Non- Implantable) General active medical devices Devices for imaging Monitoring devices Devices for radiation therapy and thermo therapy 1.3 Active Implantable Medical Devices General active implantable medical devices Page 7 of 21

8 MEDICAL DEVICES QUALITY MANAGEMENT SYSTEMS In accordance with ISO 13485: 2016 Certification IAF Mandatory Scopes of Scope Reference Technical Area 1.4 In Vitro Diagnostic Medical Devices (IVD) Reagents and reagent products, calibrators and control materials for: Clinical Chemistry Immunochemistry (immunology) Haematology /Haemostasis /Immunohematology Microbiology Infection Immunology Histology/cytology Genetic Testing In vitro diagnostic instruments and software 1.5 Sterilisation Method for Medical Devices Ethylene oxide gas (EOG) Moist heat Aseptic processing Radiation sterilisation (e.g. gamma, x-ray, electron beam) Page 8 of 21

9 MEDICAL DEVICES QUALITY MANAGEMENT SYSTEMS In accordance with ISO 13485: 2016 Certification IAF Mandatory Scopes of Scope Reference 1.6 Devices Incorporating/Utilising Specific Substances/Technologies Technical Area Medical devices incorporating medicinal substances Medical devices utilising tissues of animal origin Medical devices incorporating derivatives of human blood Medical devices utilising micromechanics Medical devices utilising nanomaterials Medical devices utilising biological active coatings and/or materials being wholly or mainly absorbed END Page 9 of 21

10 ENVIRONMENTAL MANAGEMENT SYSTEMS In accordance with ISO 14001: 2015 Certification / Limited IAF 1 Agriculture, forestry and fishing Limited Agriculture IAF 3 Food products, beverages and tobacco IAF 4 Textiles and textile products IAF 6 Wood and wood products IAF 7 Pulp, paper and paper products Limited Manufacture of paper stationery IAF 8 Publishing companies IAF 9 Printing companies IAF 12 Chemicals, chemical products and fibres IAF 13 Pharmaceuticals IAF 14 Rubber and plastic products IAF 15 Non-metallic mineral products IAF 16 Concrete, cement, lime, plaster etc IAF 17 Basic metals and fabricated metal products Page 10 of 21

11 ENVIRONMENTAL MANAGEMENT SYSTEMS In accordance with ISO 14001: 2015 Certification IAF 18 Machinery and equipment / Limited IAF 19 Electrical and optical equipment IAF 23 Manufacturing not elsewhere classified IAF 24 Recycling IAF 27 Water supply IAF 28 Construction Limited Construction excluding Construction of bridges, tunnels utility projects and high rise buildings IAF 29 Wholesale and retail trade; Repair of motor vehicles, motorcycles and personal and household goods IAF 30 Hotels and restaurants IAF 31 Transport, storage and communication Limited Land transport (excluding railways and nuclear products) Service activities incidental to water transportation IAF 33 Information technology IAF 34 Engineering services Page 11 of 21

12 ENVIRONMENTAL MANAGEMENT SYSTEMS In accordance with ISO 14001: 2015 Certification IAF 35 Other services / Limited IAF 36 Public administration IAF 37 Education IAF 38 Health and social work IAF 39 Other social services END Page 12 of 21

13 INFORMATION TECHNOLOGY SERVICE MANAGEMENT SYSTEMS In accordance with ISO : 2011 Certification Scope Standard IT Service Management ISO : 2011 END Page 13 of 21

14 FOOD SAFETY MANAGEMENT SYSTEMS In accordance with and ISO/TS 22003: 2013 (as defined in ISO/TS 22003) ISO 22000: 2005 Certification / Limited FARMING Category A - Farming of Animals ISO/TS 22003:2013 AI Farming of Animals for Meat/ Milk/ Eggs/ Honey Limited Animals Cattle, pigs only FARMING Category B - Farming of Plants ISO/TS 22003:2013 BI Farming of Plants (other than Grains and Pulses) Growing or harvesting of plants (other than grains and pulses): horticultural products (fruits, vegetables, spices, mushrooms etc) and hydrophytes for food Associated farm packing and storage BII Farming of Grains and Pulses Growing or harvesting of grains and pulses for food Associated farm packing and storage Page 14 of 21

15 FOOD SAFETY MANAGEMENT SYSTEMS In accordance with and ISO/TS 22003: 2013 (as defined in ISO/TS 22003) ISO 22000: 2005 Certification / Limited FOOD and FEED PROCESSING Category C - Food Manufacturing ISO/TS 22003:2013 CI Processing of perishable animal products Production of animal products including fish, seafood, meat, eggs, dairy and fish products CII Processing of perishable plant products Production of plant products including fruits and fresh juices, vegetable, grains, nuts and pulses CIII Processing of perishable animal and plant products (mixed products) Production of mixed animal and plant products including pizza. Lasagne, sandwich, dumpling, ready to eat meals CIV Processing of ambient stable products Production of food products from any source that are stored and sold at ambient temperature including canned foods, biscuits, snacks, oil, drinking water, beverages, pasta, flour, sugar and food grade salt. CATERING Category E - Catering ISO/TS 22003:2013 Preparation, storage and, where appropriate, delivery of food for consumption, at the place of preparation or at a satellite unit. END Page 15 of 21

16 BUSINESS CONTINUITY MANAGEMENT SYSTEMS In accordance with ISO 22301: 2012 Certification IAF 7 Pulp, paper and paper products / Limited IAF 8 Publishing companies IAF 9 Printing companies IAF 17 Basic metals and fabricated metal products IAF 18 Machinery and equipment IAF 19 Electrical and optical equipment IAF 20 Shipbuilding IAF 21 Aerospace IAF 22 Other transport equipment IAF 38 Health and social work END Page 16 of 21

17 INFORMATION SECURITY MANAGEMENT SYSTEMS In accordance with and ISO/IEC 27006: 2015 ISO/IEC 27001: 2013 Certification Scope Standard Information Security Management System Certification ISO 27001:2013 END Page 17 of 21

18 HEALTH AND SAFETY MANAGEMENT SYSTEMS In accordance with BS OHSAS 18001: 2007 (OHSAS 18001: 2007) and ISO 45001: 2018 Certification / Limited IAF 3 Food products, beverages and tobacco IAF 4 Textiles and textile products IAF 5 Leather and leather products IAF 6 Wood and wood products IAF 7 Pulp, paper and paper products IAF 8 Publishing companies IAF 9 Printing companies IAF 12 Chemicals, chemical products and fibres Limited Manufacture of chemicals, chemical products and fibres excluding explosives IAF 13 Pharmaceuticals Limited Manufacture of botanical products. Compounding, supply and delivery of medically prescribed treatment, including pharmaceutical, medical and ancillary products and services IAF 14 Rubber and plastic products IAF 15 Non-metallic mineral products Page 18 of 21

19 HEALTH AND SAFETY MANAGEMENT SYSTEMS In accordance with BS OHSAS 18001: 2007 (OHSAS 18001: 2007) and ISO 45001: 2018 Certification / Limited IAF 16 Concrete, cement, lime, plaster etc IAF 17 Basic metals and fabricated metal products IAF 18 Machinery and equipment IAF 19 Electrical and optical equipment IAF 21 Aerospace IAF 22 Other transport equipment Limited Manufacture of motor vehicles, trailers and semi-trailers Manufacture of invalid carriages IAF 23 Manufacturing not elsewhere classified IAF 24 Recycling Limited Recycling of non-hazardous materials IAF 27 Water supply Limited Water collection and treatment IAF 28 Construction IAF 29 Wholesale and retail trade; Repair of motor vehicles, motorcycles and personal and household goods Page 19 of 21

20 HEALTH AND SAFETY MANAGEMENT SYSTEMS In accordance with BS OHSAS 18001: 2007 (OHSAS 18001: 2007) and ISO 45001: 2018 Certification / Limited IAF 30 Hotels and restaurants IAF 31 Transport, storage and communication IAF 32 Financial intermediation; real estate; renting IAF 33 Information technology IAF 34 Engineering services IAF 35 Other services IAF 36 Public administration IAF 37 Education IAF 38 Health and social work Page 20 of 21

21 HEALTH AND SAFETY MANAGEMENT SYSTEMS In accordance with BS OHSAS 18001: 2007 (OHSAS 18001: 2007) and ISO 45001: 2018 Certification / Limited IAF 39 Other social services Limited Library, archives, museums and other cultural activities Sporting activities Other personal service activities Activities of business and employer s membership organisations, and of professional membership organisations Travel agency, tour operator reservation service and related activities Radio broadcasting Television programming and broadcasting activities Waste collection, treatment and disposal END Page 21 of 21