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Edition 20, 31/01/2018 5007 Page 1 of 12
Business Quality Assurance International Ltd
Woodvale House, Clarinbridge, Co. Galway
Management System Certification Body
Registration number: 5007
is accredited by the Irish National Accreditation 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 Accreditation Board.
Manager: Chairperson:
Dr Adrienne Duff Ms Ita Kinahan
Issued on 31 January 2018
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 Accreditation Board at +353-1-6147000.
The INAB is a signatory of the European co-operation for Accreditation (EA) multilateral agreement and the International
Accreditation Forum (IAF) multilateral arrangement for accreditation of management systems certification.
Edition 20, 31/01/2018 5007 Page 2 of 12
Schedule of Accreditation
(Annex to accreditation certificate)
BUSINESS QUALITY ASSURANCE INTERNATIONAL LTD
I.S. EN ISO/IEC 17021-1:2015
Reg. No. 5007
Initial Accreditation Date : 23-May-2005
Expiry Date of Current
Certificate of
Accreditation:
31-January-2023
Postal Address: Woodvale House, Clarinbridge, Co. Galway
Telephone: +353 (91) 796017
Fax: +353 (91) 796434
E-mail: [email protected]
Contact Name: Mr Declan O' Connor
Scope of Accreditation: Certification of management systems for the sectors detailed in the
following pages.
Edition 20, 31/01/2018 5007 Page 3 of 12
Scope of Accreditation
Business Quality Assurance International Ltd
Reg. No. 5007
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 4 of 12
Scope of Accreditation
Business Quality Assurance International Ltd
Reg. No. 5007
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 5 of 12
Scope of Accreditation
Business Quality Assurance International Ltd
Reg. No. 5007
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 6 of 12
Scope of Accreditation
Business Quality Assurance International Ltd
Reg. No. 5007
Certification Standard: I.S. EN ISO 13485:2012 (ISO 13485:2003)
Main
technical
areas
Technical areas Product categories covered by the technical areas
Non-active
medical
devices
General non-active,
non-implantable
medical devices
Non-active medical devices for ingestion
Sales and
distribution
of
non-active
medical
devices
General non-active,
non-implantable
medical devices
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 medical devices with measuring function
Non-active ophthalmologic devices
Non-active instruments
Contraceptive medical devices
Non-active medical devices for disinfecting, cleaning
and rinsing
Non-active devices for in vitro fertilisation (IVF) and
assisted reproductive technologies (ART)
Non-active medical devices for ingestion
Non-active implants Non-active cardiovascular implants
Non-active orthopaedic implants
Non-active functional implants
Non-active soft tissue implants
Devices for wound care Bandages and wound dressings
Suture material and clamps
Other medical devices for wound care.
Edition 20, 31/01/2018 5007 Page 7 of 12
Scope of Accreditation
Business Quality Assurance International Ltd
Reg. No. 5007
Certification Standard: I.S. EN ISO 13485:2012 (ISO 13485:2003)
Main technical
areas
Technical areas Product categories covered by the technical areas
Sales and
distribution of
active medical
devices (non-
implantable)
General active
medical devices
Respiratory devices, devices including hyperbaric
chambers for oxygen therapy, inhalation anaesthesia.
Assembly of
procedure
packs
containing
non-active
medical devices
General non-active,
non-implantable
medical devices
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 medical devices with measuring function
Non-active ophthalmologic devices
Non-active instruments
Contraceptive medical devices
Non-active medical devices for disinfecting, cleaning
and rinsing
Non-active devices for in vitro fertilisation (IVF) and
assisted reproductive technologies (ART)
Non-active medical devices for ingestion
Non-active implants Non-active cardiovascular implants
Non-active orthopaedic implants
Non-active functional implants
Non-active soft tissue implants
Devices for wound
care
Bandages and wound dressings
Suture material and clamps
Other medical devices for wound care.
Edition 20, 31/01/2018 5007 Page 8 of 12
Scope of Accreditation
Business Quality Assurance International Ltd
Reg. No. 5007
Certification Standard: I.S. EN ISO 13485:2012 (ISO 13485:2003)
Main technical
areas
Technical areas Product categories covered by the technical areas
Assembly of
procedure
packs
containing
non-active
medical devices
Non-active dental
devices and
accessories
Non-active dental devices/equipment and instruments
Dental materials
Dental implants
Non-active medical
devices other than
specified above
N/A
Edition 20, 31/01/2018 5007 Page 9 of 12
Scope of Accreditation
Business Quality Assurance International Ltd
Reg. No. 5007
Certification Standard: I.S. EN ISO 13485:2012 (ISO 13485:2003)
Main technical
areas
Technical areas Product categories covered by the technical areas
Assembly of
procedure
packs
containing
Active Medical
Devices
(Non-
Implantable)
General active
medical devices
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 for imaging Devices utilizing ionizing rays
Devices utilizing non-ionizing rays
Monitoring devices Monitoring devices of non-vital physiological
parameters
Monitoring devices of vital physiological parameters
Devices for radiation
therapy and thermo
therapy
Devices utilising ionizing radiation
Devices utilising non-ionizing radiation
Devices for hyperthermia/hypothermia
Devices for (extracorporal) shockwave therapy
(lithotripsy)
Active (non-
implantable)
medical
devices other than
specified above
N/A
Edition 20, 31/01/2018 5007 Page 10 of 12
Scope of Accreditation
Business Quality Assurance International Ltd
Reg. No. 5007
Certification Standard: I.S. EN ISO 13485:2012 (ISO 13485:2003)
Main technical
areas
Technical areas Product categories covered by the technical areas
Assembly of
procedure
packs
containing
Active
Implantable
Medical Devices
General active
implantable
medical
devices
Active implantable medical devices for stimulation /
inhibition
Active implantable medical devices delivering drugs
or other substances
Active implantable medical devices substituting or
replacing organ functions
Implantable
medical devices
other
than specified
above
n/a
Edition 20, 31/01/2018 5007 Page 11 of 12
Scope of Accreditation
Business Quality Assurance International Ltd
Reg. No. 5007
Certification Standard: I.S. EN ISO 13485:2012 (ISO 13485:2003)
Main technical
areas
Technical areas Product categories
covered by the
technical areas
Assembly of
procedure
packs
containing
In vitro
diagnostic
medical devices
(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
In Vitro Diagnostic Instruments and software n/a
IVD medical devices other than specified above n/a
In vitro
diagnostic
medical devices
(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 12 of 12
Scope of Accreditation
Business Quality Assurance International Ltd
Reg. No. 5007
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.