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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.

Qual­ity ISO 9001:2015
Med­ical Devices ISO 13485:2016
Envi­ron­ment ISO 14001:2015
Safety and health at work ISO 45001:2018
Aero­space ISO9100
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