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 πεδία | Παρατηρήσεις |
---|---|
Occupational health and safety management systems | IAF code |
Food products, beverages and tobacco | 3 |
Publishing companies | 8 |
Chemicals, chemical products and fibres | 12 |
Rubber and plastic products | 14 |
Basic metals and fabricated metal products | 17 |
Machinery and equipment | 18 |
Electrical and optical equipment | 19 |
Other transport equipment | 22 |
Manufacturing not elsewhere classified | 23 |
Recycling | 24 |
Water supply | 27 |
Construction | 28 |
Wholesale and retail trade; repair of motor vehicles, motorcycles, personal and household goods | 29 |
Hotels and restaurants | 30 |
Transport, storage and communication | 31 |
Financial transactions, real estate, renting | 32 |
Information technology | 33 |
Engineering services | 34 |
Other services | 35 |
Education | 37 |
Health and social work | 38 |
Other social services | 39 |
ISO 45001:2018
Εγκεκριμένα τεχνικά πεδία | Παρατηρήσεις |
---|---|
IAF code | |
Mining and quarrying | 2 |
Food products, beverages and tobacco | 3 |
Textiles and textile products | 4 (only for ISO 9001:2015) |
Publishing companies | 8 |
Printing companies | 9 |
Chemicals, chemical products and fibres | 12 |
Pharmaceuticals | 13 (only for ISO 9001:2015) |
Rubber and plastic products | 14 |
Concrete, cement, lime, plaster etc. | 16 |
Basic metals and fabricated metal products | 17 |
Machinery and equipment | 18 |
Electrical and optical equipment | 19 |
Other transport equipment | 22 |
Manufacturing not elsewhere classified | 23 |
Recycling | 24 |
Water supply | 27 |
Construction | 28 |
Wholesale and retail trade; repair of motor vehicles, motorcycles, personal and household goods | 29 |
Hotels and restaurants | 30 |
Transport, storage and communication | 31 |
Financial transactions, real estate, renting | 32 |
Information technology | 33 |
Engineering services | 34 |
Other services | 35 |
Public administration | 36 |
Education | 37 |
Health and social work | 38 |
Other social services | 39 |
SN EN ISO 3834-2:2006, (ISO 3834-2:2005)
Εγκεκριμένα τεχνικά πεδία | Παρατηρήσεις |
---|---|
Quality requirements for welding, comprehensive quality requirements | Combined with a certification based on ISO 9001 (replaces EN 729-2) |
ISO 22000:2018
Εγκεκριμένα τεχνικά πεδία | Παρατηρήσεις |
---|---|
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 πεδία | Παρατηρήσεις |
---|---|
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 πεδία | Παρατηρήσεις |
---|---|
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 DEVICES | Technical 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 πεδία | Παρατηρήσεις |
---|---|
ACTIVE (NON-IMPLANTABLE) MEDICAL DEVICES | Technical scope according to IAF MD 8:2017 – Table 1.2 |
General active medical devices | Mainly 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 | |
Software | Includes 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 machinery | Together with appropriate knowledge of attributed IAF codes in the product category |
STERILISATION METHODS FOR MEDICAL DEVICES | Technical 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 πεδία | Παρατηρήσεις |
---|---|
DEVICES INCORPORATING/UTILISING SPECIFIC SUBSTANCES/TECHNOLOGIES | Technical 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 absorbed | Mainly relevant for MS of manufacturers of medical devices and/or their legal representatives |
SN EN ISO 13485:2016
Εγκεκριμένα τεχνικά πεδία | Παρατηρήσεις |
---|---|
PARTS AND SERVICES | Technical 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 |