SWISSFACTORY.GROUP
Certifications
Quality Management
We have implemented a comprehensive quality management system to continuously optimise our processes and production. We are certified according to ISO 9001 including the additional requirements of the international MedTech industry according to ISO 13485 and FDA registered. We obtain raw materials, components, packaging, and services from suppliers who are integrated into this quality management system.
- Complete overview of certifications (click here)
- General Management Systems
- Operational approvals
- Admissions of persons
- Type approvals
Quality | ISO 9001:2015 |
Medical Devices | ISO 13485:2016 |
Environment | ISO 14001:2015 |
Safety and health at work | ISO 45001:2018 |
EKAS Management System under the aspects of occupational safety / health protection | EKAS 6508 |
Pressure equipment acc. Rulebook 2014/68/EU | AD-2000 HP 0 |
EN 13445–4 | |
EN 13480–4 | |
EN 3834–2 | |
Load-bearing components and kits for steel structures up to EXC4 acc. to Rulebook 305/2011 EU | EN 1090–1:2009 + |
EN 1090-A1:2011 | |
EN 1090–2 | |
Welding process | ASME Code IX |
Production and repair of objects requiring a permit | SVTI regulation 501 |
Production of steel structures as well as special structures with fatigue loading without material and thickness restrictions | SIA 263/1 H1 |
Approval for the manufacture and repair of essential technical objects in nuclear power plants | KTA 1401 |
Qualification of welding procedures and preparation of welding instructions | ISO 15614 |
Bonding of rail vehicles and vehicle parts | DIN 6701–2:2015 |
Welding of rail vehicles | EN 15085–2 — CL1 |
Fusion welding of metallic materials | ISO 3834–2 |
ZFP qualifications up to Level III for dye penetrant, magnetic particle, ultrasonic and radiographic testing | EN 473 / ISO 9712 |
Welding of rail vehicles and vehicle parts | EN 15085–2 CL1 |
Welder with ID according to… | ISO 9601–1:2013 |
ISO 9606 / EN 287 | |
ASME Code IX | |
ISO 14732–142 | |
Dye penetrant, magnetic particle, ultrasonic radiographic testing | ISO 9712 / EN473 |
Approval for re-stamping of pressure equipment acc. to Rulebook 2014/68/EU | AD-2000 HP0 |
EN 12952–5 | |
EN 13445–4 | |
EN13480‑4 | |
Transfer of marks for the purpose of identification of materials on semi-finished products and components | SVTI regulation 201 |
Adhesive Practitioners | DVS-EWF 3309 |
European Adhesive Specialist | DVS-EWF 3301 |
Type approvals | Approval no. |
Pressure vessel with double jacket | IS-CH-SWISSTS-04–05-32772–016 |
PED-Z-COS-EP.5516954 | |
PED-Z-COS-EP.5517365 | |
Pressure vessel without double jacket | PED-Z-COS-EP.5516615 |
PED-Z-COS-EP.5518205 | |
PED‑Z.COS-EP.5518597 | |
PED‑Z.COS-EP.5519572 | |
Category I and II pressure vessels Module A2 | PED‑Z.COS-EP.5516388 |
Category III pressure vessels Module C2 | PED‑Z.COS-EP.5516389 |
Quality | ISO 9001:2015 |
Environment | ISO 14001:2015 |
Safety and health at work | ISO 45001:2018 |
Medizinalprodukte / Medical devices |
ISO 13485:2016 FDA registered |
Pressure equipment acc. Rulebook 2014/68/EU |
AD-2000 HP 0 EN ISO 3834–2 EN 13445–4 EN 13480–4 |
Load-bearing components and kits for steel structures up to EXC4 acc. to Rulebook 305/2011 EU |
EN 1090–1:2009 + EN 1090-A1:2011 EN 1090–2 |
Welding process | ASME Code IX |
Production and repair of objects requiring a permit | SVTI regulation 501 |
Production of steel structures as well as special structures with fatigue loading without material and thickness restrictions | SIA 263/1 H1 |
Approval for the manufacture and repair of essential technical objects in nuclear power plants | KTA 1401 |
Qualification of welding procedures and preparation of welding instructions | ISO 15614 |
Bonding of rail vehicles and vehicle parts | DIN 6701–2:2015 |
Welding of rail vehicles | EN 15085–2 — CL1 |
Fusion welding of metallic materials | ISO 3834–2 |
Welding of rail vehicles and vehicle parts | EN 15085–2 CL1 |
Welder with ID according to… |
ISO 9601–1:2013 ISO 9606 / EN 287 ASME Code IX ISO 14732–142 |
Dye penetrant, magnetic particle, ultrasonic radiographic testing | ISO 9712 / EN473 |
Approval for re-stamping of pressure equipment acc. to Rulebook 2014/68/EU |
AD-2000 HP0 EN 12952–5 EN 13445–4 EN13480‑4 |
Transfer of marks for the purpose of identification of materials on semi-finished products and components | SVTI regulation 201 |
Adhesive Practitioners | DVS-EWF 3309 |
European Adhesive Specialist | DVS-EWF 3301 |
Pressure vessel with double jacket |
IS-CH-SWISSTS-04–05-32772–016 PED-Z-COS-EP.5516954 PED-Z-COS-EP.5517365 |
Pressure vessel without double jacket |
PED-Z-COS-EP.5516615 PED-Z-COS-EP.5518205 PED‑Z.COS-EP.5518597 PED‑Z.COS-EP.5519572 |
Category I and II pressure vessels Module A2 | PED‑Z.COS-EP.5516388 |
Category III pressure vessels Module C2 | PED‑Z.COS-EP.5516389 |