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QUALITY MANAGEMENT

ISO 9001
ISO 13485
CERTIFIED COMPANY

Onefive GmbH is certified  ISO 9001:2008 and ISO 13485:2012.
The certifications have been accredited by DQS Medizinprodukte GmbH.

The ISO 9001:2008 certification shows that the company is committed to provide cutting edge technology and to produce it with the highest levels of quality in all phases of the product’s life.
The ISO 13485:2012 standard specifies the requirement for a Quality Management System to ensure the production of devices that strictly fulfill the regulatory requirements of medical device production.

The Quality Management System (QMS) is a well established and continuous process at Onefive. From the very beginning it has been a key part of the company’s strategy to deliver high performance products of highest quality to the photonics industry.

QUALITY MANAGEMENT SYSTEM

ISO 9001:2008 CERTIFICATE

ISO13485:2012 CERTIFICATE

GUARANTEED SPECIFICATIONS

ALL ONEFIVE LASERS ARE DESIGNED
AND BUILT FOR RELIABLE AND
MAINTENANCE-FREE 24/7 OPERATION
UNDER HARSH ENVIRONMENTS

- 24/7 operation
- Maintenance-free
- Alignment-free
- Plug & Play
- Full remote control
- Diffraction-limited beam quality
- On/Off cycles: > 10’000
- Lifetime: > 10’000 h
- Operation temperature range: 10 °C – 40 °C
- Storage temperature 10 °C – 65 °C
- Shock and vibration proof
- Dust sealed
- Passively air cooled
- Low power consumption

STRICT PRODUCTION PROCEDURES

IEC COMPLIANT PRODUCTS

IEC PROVED
INDUSTRIAL GRADE
PERFORMANCE

Shock & Vibration Test
IEC 60068-2-27:2008
IEC 60068-2-6 : 2007

Electromagnetic Compatibility
IEC 61010-1: 2010
IEC 61326-1 : 2012

Laser Radiation Safety
IEC 60825-1 : 2014