Business Quality Assurance International Ltd Woodvale House, Clarinbridge, Co. Galway Management System Certification Body Registration number: 5007 is accredited by the Irish National Board (INAB) to undertake certification of management systems as detailed in the schedule bearing the above registration number in conformity with ISO/IEC 17021-1:2015 Conformity assessment - Requirements for bodies providing audit and certification of management systems - Part 1: Requirements (This certificate must be read in conjunction with the annexed schedule of accreditation) Date of award of accreditation: 30:01:2008 Date of last renewal of accreditation: 31:01:2018 Expiry date of this certificate of accreditation: 31:01:2023 This accreditation shall remain in force until further notice subject to continuing conformity with ISO/IEC 17021-1, IAF guidance and any further requirements specified by the Irish National Board. Manager: Dr Adrienne Duff Chairperson: Issued on 31 January 2018 Ms Ita Kinahan Organisations are subject to annual surveillance and are re-assessed every five years. The renewal date on this certificate confirms the latest date of renewal of accreditation. To confirm the validity of this certificate, please contact the Irish National Board at +353-1-6147000. The INAB is a signatory of the European co-operation for (EA) multilateral agreement and the International Forum (IAF) multilateral arrangement for accreditation of management systems certification. Edition 20, 31/01/2018 5007 Page 1 of 12
Schedule of (Annex to accreditation certificate) BUSINESS QUALITY ASSURANCE INTERNATIONAL LTD I.S. EN ISO/IEC 17021-1:2015 Initial Date : 23-May-2005 Expiry Date of Current 31-January-2023 Certificate of : Postal Address: Woodvale House, Clarinbridge, Co. Galway Telephone: +353 (91) 796017 Fax: +353 (91) 796434 E-mail: info@bqai.ie Contact Name: Mr Declan O' Connor Scope of : Certification of management systems for the sectors detailed in the following pages. Edition 20, 31/01/2018 5007 Page 2 of 12
Certification Standard: ISO 9001:2008, ISO 9001:2015 IAF No. NACE Code Description 3 10.31 Processing and preserving of potatoes 10.39 Other processing and preserving of fruit and vegetables 10.85 Manufacture of prepared meals and dishes 10.91 Manufacture of prepared feeds for farm animals 6 16.23 Manufacture of other builders' carpentry and joinery 16.29 Manufacture of other products of wood; manufacture of articles of cork, straw and plaiting materials 9 18.12 Printing and service activities related to printing - other printing 12 20.13 Manufacture of other inorganic basic chemicals 20.14 Manufacture of other organic basic chemicals 14 22.19 Manufacture of other rubber products 22.22 Manufacture of plastic packing goods 22.29 Manufacture of other plastic products 32.99 Other manufacturing n.e.c 33.19 Repair of other equipment 17 24.41 Precious metals production 24.33 Cold forming or folding 25.11 Manufacture of metal structures and parts of structures 25.29 Manufacture of tanks, reservoirs and containers of metal 25.5 Forging, pressing, stamping and roll forming of metal; powder metallurgy 25.91 Manufacture of steel drums and similar containers 33.11 Repair of fabricated metal products 18 33.2 Installation of communications equipment 25.73 Manufacture of tools 28.4 Manufacture of metal forming machinery and machine tools Edition 20, 31/01/2018 5007 Page 3 of 12
Certification Standard: ISO 9001:2008, ISO 9001:2015 IAF No. NACE Code Description 18 28.94 Manufacture of machinery for textile, apparel and leather production 28.96 Manufacture of plastic and rubber machinery 28.99 Manufacture of other special purpose machinery n.e.c 33.12 Repair of machinery 33.2 Installation of industrial machinery and equipment 19 26.20 Manufacture of computers and peripheral equipment 22 29.2 Manufacture of bodies (coachwork) for motor vehicles; manufacture of trailers and semi-trailers 24 38.11 38.21 38.32 39 Collection of non-hazardous waste Treatment and disposal of non-hazardous waste Recovery of sorted materials Remediation activities and other waste management services 28 43.1 Demolition and site preparation 43.21 Electrical installation 43.29 Other construction installation 43.39 Other building completion and finishing 43.99 Other specialized construction activities n.e.c. 29 45, 46, 47 Wholesale and retail trade; repair of motor vehicles and motorcycles 31 49.41 Freight transport by road 49.42 Removal services 52.10 Warehousing and storage 52.21 Service activities incidental to land transportation 79 Travel agencies, tour operators and other reservation service and related activities Edition 20, 31/01/2018 5007 Page 4 of 12
Certification Standard: ISO 9001:2008, ISO 9001:2015 IAF No. NACE Code Description 32 65.1, 65.2 Insurance and reinsurance 33 62 Computer programming, consultancy and related activities 63 Information service activities 34 71.1 Architectural and engineering activities and related technical consultancy 74.2 Photographic activities 74.90 Other professional, scientific and technical activities n.e.c. 35 63.99 Other information service activities n.e.c. 69.1 Legal activities 70.21 Public relation and communication activities 70.22 Business and other management consultancy activities 74.10 Specialised design activities 78 Employment activities 81.2 Cleaning activities 82.20 Activities call centres 82.92 Packaging activities 82.99 Other business support service activities n.e.c 85.60 Educational support activities 37 Full Education 38 86/88.9 Human health activities/other social work activities without accommodation Edition 20, 31/01/2018 5007 Page 5 of 12
Certification Standard: I.S. EN ISO 13485:2012 (ISO 13485:2003) Main technical areas Non-active medical devices Sales and distribution of non-active medical devices Technical areas General non-active, non-implantable General non-active, non-implantable Non-active implants Devices for wound care Product categories covered by the technical areas Non-active for ingestion Non-active devices for anaesthesia, emergency and intensive care Non-active devices for injection, infusion, transfusion and dialysis Non-active orthopaedic and rehabilitation devices Non-active with measuring function Non-active ophthalmologic devices Non-active instruments Contraceptive Non-active for disinfecting, cleaning and rinsing Non-active devices for in vitro fertilisation (IVF) and assisted reproductive technologies (ART) Non-active for ingestion Non-active cardiovascular implants Non-active orthopaedic implants Non-active functional implants Non-active soft tissue implants Bandages and wound dressings Suture material and clamps Other for wound care. Edition 20, 31/01/2018 5007 Page 6 of 12
Certification Standard: I.S. EN ISO 13485:2012 (ISO 13485:2003) Main technical areas Sales and distribution of active medical devices (nonimplantable) Assembly of procedure packs containing non-active Technical areas General active General non-active, non-implantable Non-active implants Devices for wound care Product categories covered by the technical areas Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia. Non-active devices for anaesthesia, emergency and intensive care Non-active devices for injection, infusion, transfusion and dialysis Non-active orthopaedic and rehabilitation devices Non-active with measuring function Non-active ophthalmologic devices Non-active instruments Contraceptive Non-active for disinfecting, cleaning and rinsing Non-active devices for in vitro fertilisation (IVF) and assisted reproductive technologies (ART) Non-active for ingestion Non-active cardiovascular implants Non-active orthopaedic implants Non-active functional implants Non-active soft tissue implants Bandages and wound dressings Suture material and clamps Other for wound care. Edition 20, 31/01/2018 5007 Page 7 of 12
Certification Standard: I.S. EN ISO 13485:2012 (ISO 13485:2003) Main technical areas Assembly of procedure packs containing non-active Technical areas Non-active dental devices and accessories Non-active medical devices other than specified above Product categories covered by the technical areas Non-active dental devices/equipment and instruments Dental materials Dental implants N/A Edition 20, 31/01/2018 5007 Page 8 of 12
Certification Standard: I.S. EN ISO 13485:2012 (ISO 13485:2003) Main technical areas Assembly of procedure packs containing Active Medical Devices (Non- Implantable) Technical areas General active Devices for imaging Monitoring devices Devices for radiation therapy and thermo therapy Active (nonimplantable) medical devices other than specified above Product categories covered by the technical areas Devices for extra-corporal circulation, infusion and haemopheresis Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia Devices for stimulation or inhibition Active surgical devices Active ophthalmologic devices Active dental devices Active devices for disinfection and sterilisation Active rehabilitation devices and active prostheses Active devices for patient positioning and transport Active devices for in vitro fertilisation (IVF) and assisted reproductive technologies (ART) Software Devices utilizing ionizing rays Devices utilizing non-ionizing rays Monitoring devices of non-vital physiological parameters Monitoring devices of vital physiological parameters Devices utilising ionizing radiation Devices utilising non-ionizing radiation Devices for hyperthermia/hypothermia Devices for (extracorporal) shockwave therapy N/A (lithotripsy) Edition 20, 31/01/2018 5007 Page 9 of 12
Certification Standard: I.S. EN ISO 13485:2012 (ISO 13485:2003) Main technical areas Assembly of procedure packs containing Active Implantable Medical Devices Technical areas General active implantable medical devices Implantable other than specified above Product categories covered by the technical areas Active implantable for stimulation / inhibition Active implantable delivering drugs or other substances Active implantable substituting or n/a replacing organ functions Edition 20, 31/01/2018 5007 Page 10 of 12
Certification Standard: I.S. EN ISO 13485:2012 (ISO 13485:2003) Main technical areas Assembly of procedure packs containing In vitro diagnostic (IVD) Technical areas Reagents and reagent products, calibrators and control materials for: Clinical chemistry Immunochemistry (immunology) Haematology/haemostasis/immunohaematology Microbiology Infectious immunology Histology/cytology Genetic testing In Vitro Diagnostic Instruments and software IVD other than specified above Product categories covered by the technical areas n/a n/a n/a In vitro diagnostic (IVD) Reagents and reagent products, calibrators and control materials for: Clinical chemistry Immunochemistry (immunology) Haematology/haemostasis/immunohaematology Microbiology Infectious immunology Histology/cytology Genetic testing n/a Note that the above scope of accreditation does not suggest that BQAI is a Notified Body. Edition 20, 31/01/2018 5007 Page 11 of 12
Certification Standard: ISO 27001:2013 IAF No. NACE Code Description 9 Printing companies 19 Electrical and optical equipment 33 Information technology 35 Other services End of scope. Edition 20, 31/01/2018 5007 Page 12 of 12