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 |