Quality management

Certificates

certifikati, brinox

Brinox d.o.o. maintains an integrated management system certified by TÜV SÜD, which includes the requirements of international standards

  • ISO 9001
  • ISO 14001
  • ISO 45001
  • ISO 27001

The integrated management system includes the requirements of guidelines of good practice (cGxP, ISPE).
Brinox products are designed and produced in line with the requirements for factory production control following these standards:

  • EN ISO 3834-2
  • ASME BPE 2000
  • AWS D 18.1, AWS D 18.2 and SIST EN 12732 A through D
  • EN 1090-1

Brinox has obtained certificates for the production of pressure equipment according to:

  • ASME Boiler and Pressure Vessel Code
  • AD 2000-Merkblatt HP0 / EN 13445-4 / and EN ISO 3834-2
  • PED 2014/68/EU Module A2

Welding procedures are certified according to the standard ISO 15614-1.
The quality and functionality of our products are also confirmed by acknowledged certification bodies:

  • Praevena AG
  • EHEDG
  • ATEX
     

Quality control

kontrola kakovosti, brinox

Our goal are high-quality products and satisfied clients; therefore, quality control is an important part of our production process, especially as our products are highly specific.

Quality assurance in the production process is implemented in several stages, including:

  • input control,
  • intermediate controls in the production process, and
  • a final product control.

Qualifications

kvalifikacije, brinox

Qualifications are carried out in accordance with the good practice guidelines and documented evidence that the manufactured equipment, the facility or the process system is suitable/ready for the intended use and fulfils the user requirements.

The activities of the department refer to the implementation of IQ/OQ tests in the scope of FAT and SAT tests as well as the calibrations and user training after completion of SAT testing.

Professional qualifications

Strokovna usposobljenost

In our production we involve contractors with the best qualifications with welding certificates according to ISO 9606, for welding operators according to ISO 14732 and for providers of non-destructive testing according to ISO 9712.
 

The designers and constructors of process systems and equipment use 3D modelling applications and are experts for the sizing of process equipment using classical methods and FEM analysis. They are qualified for the preparation of technical documentation for the production of general equipment and pressure equipment according to various directives and the regulations PED 2014/68/EU, ASME VIII-1, AS 1210.
 

The process automation team consists of engineers with several years of experience in process management who are expert in various software tools and process management IT technologies. They also have expertise in the area of relevant regulations, recommendations and standards (GAMP 5, 21CFR11, ISA S88.01).

References
Leo Pharma
Aerie Pharmaceuticals
Pomurske mlekarne
Coca-Cola HBC
Lactalis
Teva
Alkermes
Alvogen
Mlekarna Planika
Capsugel
Sarajevksa pivara
Fresenius Kabi
Alcon
Zott
Johnson & Johnson
Meggle
Lek
Merck
Novartis
Pharmathen
Lactosan
Heineken pivovarna Union
Heineken pivovarna Laško
Dottikon
Pfizer
Žito
Bionorica
Zoetis
Lonza
GlaxoSmithKline
Grupacija Imlek
Frutarom Etol
Galderma
Sotex
PepsiCo
Mlekarna Celeia
Takeda
Mlekarna Škofja Loka
Nektar Natura
Pharmstandard
CSL Behring
Krka
Sandoz
Legal notice

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