Certified quality

In addition to functionality, quality is the most important asset in our highly sensitive industry. We guarantee that you can completely rely on Gsell to deliver it. Our quality management system ensures this pledge through streamlined, efficient and cost-effective processes. In that respect, we meet all the relevant regulatory requirements (e.g. ISO 13485, 21 CFR 820) and ensure that only products with guaranteed quality leave our factory.

Our quality management system is regularly inspected by customers and the various certification bodies. We see this as an opportunity to continuously improve our QA activities.

Quality is also a key aspect of our employees’ DNA. Our quality management system supports the team in everything they do. In-depth education and ongoing advanced training keep quality awareness high and expand our expertise.

‘Guaranteed quality is in our corporate DNA’

QUALIFICATION AND VALIDATION

We qualify our production equipment and validate the necessary processes with you. We will be happy to advise you on situations where there are no specifications. Reliable, streamlined and affordable processes are always our focus. IQ, OQ and PQ are just as much a part of this process as FMEA and other risk assessments.

QUALITY ASSURANCE

Our measuring equipment portfolio is extensive – from simple gages to state-of-the-art computer-controlled measuring devices with tactile and visual measuring systems. QA also includes monitoring systems for ‘invisible’ risks such as contamination. Bioburden, TOC and cytotoxicity are periodically monitored.

VISUAL INSPECTION AND OTHER TEST PROCEDURES

Each product repeatedly undergoes visual inspections during production. This is the only way to identify and sort out even the smallest material inclusions or surface deviations. A functional test is the best guarantee of quality and safe use during surgery, especially when it comes to instruments. We carry out specific functional tests during the QA process for you on request. Industrial CT scans, for example, enable additional deep insights into the product – and complete dimensional control.

Management

Process.Net – process management

QBD.Net – document management

Qualify.Net – training management

Change.Net – change management

Monitoring

QAM.Net – audit and inspection management

SRM.Net – supplier management

Risk.Net – risk management (FMEA)

REM.Net – deviation and CAPA management

AuditTrail.Net – audit trail and records management

Assurance

Process.Net – process management

QBD.Net – document management

Compact.Net – inspection planning and quality inspection (SPC, LIMS)

PMM.Net – test equipment management

PMS.Net – preventive maintenance

APE.Net – automatic test data logging

Change.Net – change management

Analysis

QDrive.Net – quality center

Success.Net – key figure management

JobControll.net – task and escalation management

Downloads

SQS Certificate

IQNet Certificate