IAF Codes

Ως φορέας πιστοποίησης, η QS Zurich AG είναι διαπιστευμένη σε μια σειρά από διεθνή πρότυπα για τους ακόλουθους κωδικούς δραστηριότητας (IAF Codes).

Ακολουθούν οι κωδικοί δραστηριοτήτων ανά πρότυπο για τους οποίους η QS Zurich AG είναι διαπιστευμένη, και έτσι μπορεί να εκδόσει πιστοποιητικά για λογαριασμό της QS Hellas Ltd.

ISO 9001:2015, ISO 14001:2015

Εγκεκριμένα τεχνικά πεδίαΠαρατηρήσεις
Occupational health and safety management systemsIAF code
Food products, beverages and tobacco3
Publishing companies8
Chemicals, chemical products and fibres12
Rubber and plastic products14
Basic metals and fabricated metal products17
Machinery and equipment18
Electrical and optical equipment19
Other transport equipment22
Manufacturing not elsewhere classified23
Recycling24
Water supply27
Construction28
Wholesale and retail trade; repair of motor vehicles, motorcycles, personal and household goods29
Hotels and restaurants30
Transport, storage and communication31
Financial transactions, real estate, renting32
Information technology33
Engineering services34
Other services35
Education37
Health and social work38
Other social services39

ISO 45001:2018

Εγκεκριμένα τεχνικά πεδίαΠαρατηρήσεις
IAF code
Mining and quarrying2
Food products, beverages and tobacco3
Textiles and textile products4 (only for ISO 9001:2015)
Publishing companies8
Printing companies9
Chemicals, chemical products and fibres12
Pharmaceuticals13 (only for ISO 9001:2015)
Rubber and plastic products14
Concrete, cement, lime, plaster etc.16
Basic metals and fabricated metal products17
Machinery and equipment18
Electrical and optical equipment19
Other transport equipment22
Manufacturing not elsewhere classified23
Recycling24
Water supply27
Construction28
Wholesale and retail trade; repair of motor vehicles, motorcycles, personal and household goods29
Hotels and restaurants30
Transport, storage and communication31
Financial transactions, real estate, renting32
Information technology33
Engineering services34
Other services35
Public administration36
Education37
Health and social work38
Other social services39

SN EN ISO 3834-2:2006, (ISO 3834-2:2005)

Εγκεκριμένα τεχνικά πεδίαΠαρατηρήσεις
Quality requirements for welding,
comprehensive quality requirements
Combined with a certification based on ISO 9001
(replaces EN 729-2)

ISO 22000:2018

Εγκεκριμένα τεχνικά πεδίαΠαρατηρήσεις
Food safety management systems
cluster/categories 2 – 6
Fulfils the requirements of ISO/TS 22003:2013 for the sectors
Food and feed processing
(C + D)
C Food manufacturing
D Animal feed production
Catering (E)E Catering
Retail, transport and storage
(F + G)
F Distribution
G Provision of transport and storage services
Auxiliary services (H + I + J)H Services
I Production of food packaging and packaging materials
J Equipment Manufacturing
(Bio) chemicals (K)K Production of chemical and biochemical products

ISO 50001:2018

Εγκεκριμένα τεχνικά πεδίαΠαρατηρήσεις
Energy management systems
– Industry
light to medium
heavy
– Mining
– Energy supply
– Buildings
– Building complexes
– Transport
– Agriculture
Fulfils the requirements of the standard
ISO 50003:2014

SN EN ISO 13485:2016

Εγκεκριμένα τεχνικά πεδίαΠαρατηρήσεις
Medical devices and
related processes
Only certification according to standard ISO 13485 without requirements of TPA, MDO, 93/42/EEC respectively regulation (EU) 2017/745
NON-ACTIVE MEDICAL DEVICESTechnical scope according to IAF MD 8:2017 – Table 1.1
Mainly relevant for MS of manufacturers of medical devices and/or their legal representatives
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, rinsing
Non-active medical devices for ingestion
Non-active implants
Non-active cardiovascular implants
Non-active orthopaedic implants
Non-active functional implants
Devices for wound care
Bandages and wound dressing
Suture material and clamps
Other medical devices for wound care
Non-active dental devices and accessories
Non-active
dental devices/equipment and instruments
Dental materials
Dental implants
Non-active medical devices other than specified in table 1.1: to be defined in advance.

SN EN ISO 13485:2016

Εγκεκριμένα τεχνικά πεδίαΠαρατηρήσεις
ACTIVE (NON-IMPLANTABLE) MEDICAL DEVICESTechnical scope according to IAF MD 8:2017 – Table 1.2
General active medical devicesMainly relevant for MS of manufacturers of medical devices and/or their legal representatives
Devices for extra-corporal circulation, infusion and hemapheresis
Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia
Devices for stimulation or inhibition
Active surgical devices
Active dental devices
Active rehabilitation devices and active prostheses


Active devices for patient positioning and transport
SoftwareIncludes products listed in the table 1.2 that incorporate/use software or are controlled by software.
Devices for imaging
Devices utilising ionising radiation
Devices utilising non-ionising radiation
Monitoring devices
Monitoring devices of non-vital physiological parameters
Monitoring devices of vital physiological parameters
Devices for radiation therapy and thermo therapy
Devices utilising non-ionising radiation
Active (non-implantable) medical devices other than specified in table 1.2:
Medical devices referencing the Directive 2006/42/EC on machineryTogether with appropriate knowledge of attributed IAF codes in the product category
STERILISATION METHODS FOR MEDICAL DEVICESTechnical scope according to IAF MD 8:2017 – Table 1.5
Mainly relevant for MS of
specialized sterilisers/contractors and/or manufacturers of medical devices and/or their legal representatives
Moist heat
Disposable new and reusable devices or part of it
Aseptic processing
Disposable new and reusable devices or parts of it

SN EN ISO 13485:2016

Εγκεκριμένα τεχνικά πεδίαΠαρατηρήσεις
DEVICES INCORPORATING/UTILISING SPECIFIC SUBSTANCES/TECHNOLOGIESTechnical scope according to IAF MD 8:2017 – Table 1.6
Mainly relevant for MS of manufacturers of medical devices and/or their legal representatives
Medical devices incorporating medicinal substances
Medical devices utilising biological active coatings and/or materials or being wholly or mainly absorbedMainly relevant for MS of manufacturers of medical devices and/or their legal representatives

SN EN ISO 13485:2016

Εγκεκριμένα τεχνικά πεδίαΠαρατηρήσεις
PARTS AND SERVICESTechnical scope according to IAF MD 8: 2017 – Table 1.7
Mainly relevant for MS of manufacturers and/or subassemblers and/or distributors of medical devices
Together with appropriate knowledge of the relevant IAF codes in the product categor
Raw materials
Raw metals, plastic, wood, ceramic
Components
Electrical components, fasteners, shaped raw materials, machined raw materials and molded plastic
Subassemblies
Electronic and mechanical subassemblies, made to drawings and/or work instructions area
Distribution services
Distributors providing storage and delivery of medical devices, not acting as a legal manufacturer for medical devices
Maintenance services
Electrical or mechanical repair services
Facility cleaning and maintenance services
Uniform cleaning and testing of ESD smocks
Transportation services
Trucking, shipping
Air transportation service in general
Other services
Consulting services related to medical devices
Packaging services