Schedule of Accreditation

issued by

United Kingdom Accreditation Service

2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

SIRIM QAS International Sdn. Bhd

Issue No: 027

0074
Accredited to
ISO/IEC 17021:2011 to
provide quality
management systems
certification

Issue date: 07 November 2016

Bangunan 4, Kompleks SIRIM

Contact: Mr P I Subramaniam

1 Persiaran Dato Menteri

Tel: 00 60 3 55167400

Peti Surat 7035

Fax: 00 60 3 55109439

40911 Shah Alam

E-Mail: parama.i_subramaniam@sirim.my

Selangor Darul Ehsan

Website: www.sirim.my

Malaysia

Locations where certification activities covered by the above Accreditation Standard are undertaken
SIRIM QAS International Sdn. Bhd.
Bangunan 4, Kompleks SIRIM
1, Persiaran Dato Menteri
Peti Surat 7035
40911 Shah Alam
Selango Darul Ehsan
Malaysia

Assessment Manager: CR

Page 1 of 7

S c he dul e of Ac c r e di ta ti on
issued by

United Kingdom Accreditation Service

2 Pine Trees , Chertsey Lane, Staines-upon-Thames , TW18 3HR, UK

0074

SIRIM QAS International Sdn. Bhd

Accredited to
ISO/IEC 17021:2011 to provide
quality management systems
certification

Issue No: 027

Issue date: 07 November 2016

DETAIL OF ACCREDITATION
ISO 9001:2008 Certification
European Co-operation for Accreditation
Scope Reference

Full/Limited
Accreditation

Extent of Scope

EA 1 Agriculture, Fishing

Limited

Growing of crops
Agriculture Service Activities
Animal Husbandry

EA 2 Mining and quarrying

Limited

Quarrying of stone, sand and clay

EA 3 Food products, beverages and tobacco

Full

EA 4 Textiles and textile products

Full

EA 5 Leather and leather products

Limited

EA 6 Wood and wood products

Full

EA 7 Pulp, paper and paper products

Full

EA 9 Printing companies

Limited

Printing and services related to printing

EA 10 Manufacture of coke and refined

petroleum products

Limited

Manufacture of refined petroleum products

and oil based lubricating oils

EA 12 Chemicals, chemical products and

fibres

Full

EA 13 Pharmaceuticals

Full

EA 14 Rubber and plastic products

Full

EA 15 Non-metallic mineral products

Full

Assessment Manager: CR

Luggage, handbags & the like of leather

and composite materials
Footwear

Page 2 of 7

S c he dul e of Ac c r e di ta ti on
issued by

United Kingdom Accreditation Service

2 Pine Trees , Chertsey Lane, Staines-upon-Thames , TW18 3HR, UK

0074

SIRIM QAS International Sdn. Bhd

Accredited to
ISO/IEC 17021:2011 to provide
quality management systems
certification

Issue No: 027

Issue date: 07 November 2016

ISO 9001:2008 Certification

European Co-operation for Accreditation
Scope Reference

Full/Limited
Accreditation

EA 16 Concrete, cement, lime, plaster etc

Full

EA 17 Basic metals and fabricated metal

products

Full

EA18 Machinery and equipment

Full

EA 19 Electrical and optical equipment

Limited

EA 20 Shipbuilding

Full

EA 21 Aerospace

Limited

Manufacture of parts and accessories for

aircraft and repair and maintenance of
aircraft

EA 22 Other transport equipment

Limited

Manufacture of Motor Vehicles, Trailers

and Semi-Trailers (NACE34).
Manufacture of Motorcycles and Bicycles
(NACE 35.4).

EA 23 Manufacturing not elsewhere

classified

Full

EA 24 Recycling

Full

EA 25 Electricity supply

Full

EA 27 Water supply

Full

EA 28 Construction

Full

Assessment Manager: CR

Extent of Scope

Electrical and optical equipment (excluding

Medical and Surgical Equipment).

Page 3 of 7

S c he dul e of Ac c r e di ta ti on
issued by

United Kingdom Accreditation Service

2 Pine Trees , Chertsey Lane, Staines-upon-Thames , TW18 3HR, UK

0074

SIRIM QAS International Sdn. Bhd

Accredited to
ISO/IEC 17021:2011 to provide
quality management systems
certification

Issue No: 027

Issue date: 07 November 2016

ISO 9001:2008 Certification

European Co-operation for Accreditation
Scope Reference

Full/Limited
Accreditation

EA 29 Wholesale and retail trade; Repair of

motor vehicles, motorcycles and personal
and household goods

Full

EA 30 Hotels and restaurants

Full

EA 31 Transport, storage and

communication

Full

EA 32 Financial intermediation; real estate;

renting

Full

EA 33 Information technology

Limited

Software consultancy & supply

Maintenance & repair of office, accounting
and computing machinery

EA 34 Engineering services

Limited

Research & development in engineering

Architectural and engineering activities and
related technical consultancy

EA 35 Other services

Full

EA 36 Public administration

Full

EA 37 Education

Full

EA 38 Health and social work

Limited

Human Health Activities

EA 39 Other Social Service

Limited

Activities of Membership organisations

Library an archive activities
Sporting Activities

Assessment Manager: CR

Extent of Scope

Page 4 of 7

S c he dul e of Ac c r e di ta ti on
issued by

United Kingdom Accreditation Service

2 Pine Trees , Chertsey Lane, Staines-upon-Thames , TW18 3HR, UK

0074

SIRIM QAS International Sdn. Bhd

Accredited to
ISO/IEC 17021:2011 to provide
quality management systems
certification

Issue No: 027

Issue date: 07 November 2016

ISO 9001:2008 Certification

European Co-operation for Accreditation
Scope Reference

Full/Limited
Accreditation

Extent of Scope
Botanical, Zoological and Nature Reserve
Activities

END

BE EN ISO 13485:2003 & ISO 13485:2012 Certification

IAF Mandatory Scopes of Accreditation
Scope Reference
Non-active Medical Devices

Technical Area

General non-active, nonimplantable medical

devices

Extent of Scope

Non-active implants

Devices for wound care

Non-active dental devices

and accessories

Assessment Manager: CR

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 instruments
Non-active medical devices
for disinfecting, cleaning,
rinsing
Non-active ophthalmologic
devices

Non-active orthopaedic
implants

Bandages and wound

dressings
Suture material and clamps
Other medical devices for
wound care

Non-active dental
devices/equipment and
instruments
Dental products
Dental implants

Page 5 of 7

S c he dul e of Ac c r e di ta ti on
issued by

United Kingdom Accreditation Service

2 Pine Trees , Chertsey Lane, Staines-upon-Thames , TW18 3HR, UK

0074

SIRIM QAS International Sdn. Bhd

Accredited to
ISO/IEC 17021:2011 to provide
quality management systems
certification

Issue No: 027

Issue date: 07 November 2016

BE EN ISO 13485:2003 & ISO 13485:2012 Certification

IAF Mandatory Scopes of Accreditation
Scope Reference

Technical Area

Extent of Scope

Non-active medical
devices other than
specified above

Active Medical Devices (Non-Implantable)

General medical devices

Monitoring devices

Sterilisation Method for Medical devices

Devices for extra-corporal

circulation, infusion and
haemopheresis
Respiratory devices
Devices for stimulation or
inhibition
Active surgical devices
Active dental devices
Active devices for
sterilisation and disinfection
Active rehabilitation devices
and prostheses
Active devices for patient
positioning and transport
Software

Monitoring devices of nonvital physiological

parameters
Monitoring devices of vital
physiological parameters

Ethylene oxide gas

(EOG)
Moist heat

Aseptic processing

Assessment Manager: CR

Page 6 of 7

S c he dul e of Ac c r e di ta ti on
issued by

United Kingdom Accreditation Service

2 Pine Trees , Chertsey Lane, Staines-upon-Thames , TW18 3HR, UK

0074

SIRIM QAS International Sdn. Bhd

Accredited to
ISO/IEC 17021:2011 to provide
quality management systems
certification

Issue No: 027

Issue date: 07 November 2016

BE EN ISO 13485:2003 & ISO 13485:2012 Certification

IAF Mandatory Scopes of Accreditation
Scope Reference

Technical Area

Extent of Scope

Radiation sterilisation
(e.g. gamma, x-ray,
electron beam)

In Vitro Diagnostic Medical Devices (IVD)

In Vitro Diagnostic
Instruments and software

END

SIRIM QAS International Sdn. Bhd is recorded as issuing UKAS accredited certificates to organisations in
the countries listed below. This list is current at the time of issue of this schedule.
Indonesia

Malaysia

Singapore

Thailand

Assessment Manager: CR

Peoples Republic of China

Republic of Korea

Page 7 of 7