Regulatory Documents - ISO

Regulatory Documents > ISO

ISO certificates

Orfit Industries has two ISO certificates, both certified by Lloyd's Register Quality Assurance.

 

ISO 9001:2008

Orfit Industries was one of the first companies in Belgium to obtain certification for the new 2008 version of this standard.

 

ISO 13485:2003

The EC Directive 93/42/EC requires that companies manufacturing medical devices, are certified according to this ISO standard.

 

The quality policy of ISO is to comply with requirements and continually improve the effectiveness of the quality management system.

 

ISO 9001:2008 and ISO 13485:2003 certificate

Instruction video's

  • Thermoplastic Masks
  • The AIO solution