business quality assurance international ltd - inab quality assurance international ltd woodvale...

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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.

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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.

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Scope of Accreditation


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

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Reg. No. 5007



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

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Reg. No. 5007



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

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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 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.

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Reg. No. 5007


Main 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



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.

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Reg. No. 5007


Main 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

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Reg. No. 5007


Main 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


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

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Reg. No. 5007


Main 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

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Reg. No. 5007


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.

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Reg. No. 5007

Certification Standard: ISO 27001:2013


9 Printing companies

19 Electrical and optical equipment

33 Information technology

35 Other services

End of scope.

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