Understanding of quality

Your understanding of quality is critical, as it determines whether a 3D printed component satisfies your requirements. This means that there is no such thing as a single quality, but rather a number of different qualities that we need to precisely understand. Only then is it possible to meet your expectations. So, in essence, quality is relatively absolute. For us, quality does not just mean the quality of your component that we test at the end of additive manufacturing. For us, quality is much more complex, it has many dimensions, is a continuous process, a daily challenge and requires detailed knowledge of the production processes. As a result, our aim is to always produce the right quality and integrate a corresponding understanding of quality into the overall manufacturing process, which includes the manpower, the milieu, the machinery, the material, and the methodology. That’s why we certify our processes, that’s why we train our employees, and that’s why we use statistical process control technologies and invest in quality assurance and quality measurement systems, because our aim is to deliver the quality that you expect.
Manufacturing with laser melting

Quality process

Our mission is to develop and produce the perfect component for you every single time. But, perfection requires the critical assessment and continuous improvement of the current situation. That is the aim of our quality process. FMEA or 8D reports are just as much a part of our process as CIP or Kanban. We keep a constant eye on the harmonious integration of input, transformation, and output to continue to develop our quality system.
Quality process
Quality assurance

Quality assurance

No component leaves our company without a final quality test during which we meticulously compare whether and the extent to which the component properties coincide with your requirements. You decide whether we perform a simple visual inspection or examine, scan and/or measure your component in great depth, or whether we perform another analysis. We have access to a wide range of different measurement and testing technologies up to and including CT scans.
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Certificates

ISO 9001 (FIT AG)

ISO 9001 (FIT AG)

To proof the overall quality of its products and processes, FIT AG is certified according to ISO 9001 for its general quality assurance system for manufacturing and service.

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ISO 9001 (FIT Production GmbH)

FIT Production GmbH is certified according to ISO 9001 for its general quality assurance system for manufacturing and service.

The certification to ISO 9001 reflects our continuous ambition to do everything to fully satisfy our customers.

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EN 9100 (FIT Production GmbH)

FIT Production GmbH is certified according to EN 9100 for aerospace industry.

EN 9100 is a widely adopted quality management standard for the aerospace industry, technically equivalent to American JISQ 9100 und SAE AS 9100/9110/9120 standards.

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ISO 9001 (FIT Prototyping GmbH)

FIT Prototyping GmbH is certified according to ISO 9001 for its general quality assurance system for manufacturing and service.

You are welcome to get a good impression of the high level of quality assurance we are able to maintain in our company. Please don't hesitate to contact us to fix a date for an audit.

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EN ISO 13485 (FIT Production GmbH)

FIT Production GmbH is certified according to EN ISO 13485, representing the requirements of a comprehensive quality management system for the design and manufacture of medical devices such as medical implants.

It is the basis for the production of titanium blanks for the medical products and devices industry. The guidelines of the Medical Device Directive within the European Union are fully accomplished.

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Japanese Accreditation Certificate of foreign medical device manufacturer (FIT Production GmbH)

FIT Production has been certified as a foreign medical device manufacturer pursuant to Article 13-3 of the Japanese Pharmaceutical Affairs Act.

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FDA-Compliance (FIT Production GmbH)

The services and manufacturing processes for medical implants destined for the U.S. markets by FIT Production GmbH are compliant with FDA requirements (U.S. Food and Drug Administration) since 2012.

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FIT AG
Am Grohberg 1
92331 Lupburg
Germany

© Copyright • 17.11.2019 • FIT AG • All Rights reserved