A Stringent Approach to Quality

Your project is in safe hands

At Materialise, quality comes first. With certifications such as ISO 9001, ISO 13485, and EN9100, as well as strict quality assurance processes and dedicated procedures for prototyping and manufacturing, you can trust that every product you get is exactly what you ordered. Discover why you can rely on our approach to quality assurance and control.

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Quality assurance

Industry-specific certifications

More than 30 years of AM experience

Two unique services to meet your needs

3D-printed maquette of Leuven's city hall

High-quality prototyping

All prototypes produced at Materialise follow our standard quality parameters for dimensional accuracy and cosmetic appearance. 


  • We conduct a basic visual inspection of surface quality against Materialise quality inspection guidelines 
  • Tolerances are guaranteed with a standard accuracy of ±0.3% on bounding box (X-Y-Z) dimensions

Explore our prototyping service

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Consistent, repeatable, reliable series production

With our manufacturing services for series parts, we have developed extensive quality and process controls to ensure that parts are consistently produced from part 1 to part 10,000 and beyond.


  • Our proven NPI process successfully carries your idea from concept to scaled production. 
  • Diligent quality, change, and process controls ensure the repeatability you need to scale up to series production. 

Explore our manufacturing service

Prototyping quality control

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Visual inspection

Our quality inspection guidelines cover any issues that arise in the following stages:

  • Data prep 
  • Labeling 
  • Printing 
  • Finishing
A Materialise quality team member holding a caliper to measure a 3D-printed part

Tolerances

We guarantee that every part we deliver will be printed with a standard accuracy of ±0.3% across the X, Y, and Z axes. We can also provide a limited dimensional inspection report for every project upon request.

Manufacturing quality assurance

A man standing on the floor of a 3D priting production facility, looking at a clipboard

Process and change control

We’re experienced with different levels of process qualification, with strict process and change control. We’ll inform you about any changes that may affect the form, fit, or function of your parts.

  • Process validation (IQ, OQ, PQ)
  • Process Flow Charts, PFMEAs, Control Plans 
  • Process Control Documents 
  • Process capability charts based on process control data 
  • Weekly change control board
A view over the shoulder of a person wearing latex gloves and using a handheld quality checking tool to assess a 3D-printed medical implant in front of a computer screen showing Materialise software

Quality control

We know that printing one part in a series of 100 is very different from printing one part 100 times. Our stringent quality controls ensure the repeatability and consistency you need in every order.

  • Visual inspection aligned with quality catalog  
  • Dimension control, including SPC sampling 
  • Weight measurement 
  • Surface roughness measurement 
  • Tensile testing acc. to ISO 527-1
A Materialise team member putting a 3D-printed part into bubble wrap for shipment next to a packing box and a laptop with the design of the part

Capabilities

Our 3D printing facilities include a number of dedicated production lines and other additions that are essential for various industries.

  • Production services, including drilling, reaming, inserts, threading, and clean room packaging 
  • 3D scanning 
  • Bagging and tagging 
  • Design and Engineering services

Which service is right for you? 

prototyping services
Manufacturing services
Our offering
Quality requirements
All quality parameters must meet the requirements listed at the beginning of the project.
All quality parameters must be repeatable across batch and repeat orders.
Tolerances
Standard accuracy ±0.3% (with a lower limit of ±0.3 mm) on the bounding box (X-Y-Z dimensions). Limited dimensional inspection report available upon request. 
A standard accuracy of ±0.3% (with a lower limit of ±0.3 mm) on all dimensions. Full dimensional inspection report.
Mechanical properties
Mechanical properties based on ranges given by material supplier data.
Statistical performance data are available based on extensive process control. Specific upper and lower limits can be defined based on statistical performance data.
Surface quality
Basic visual inspection against Materialise quality inspection guidelines.
Extensive visual inspection against Materialise quality inspection guidelines. Customer-specific defect catalogs can be defined. 
Quality documentation
N/A
First Article Inspection (FAI) report. Inspection test report (dimensional, flammability, cytotoxicity, etc.) Certificate of Conformity according to ISO 9001 / EN9100 / ISO 13485 / EASA Form 1.
Process control
No change control​: Parameter variability may cause quality differences from one order to another.
Long-term repeatability is guaranteed through our New Product Introduction (NPI) process, strict process control, and change notification. PFMEA, control plan, process flow charts, MSA, etc., are available in line with PPAP methodology.

Frequently asked questions

Inspiration

More inspiration

The quality assurance you need

Tell us about the specific requirements of your project. We’ll make sure you get them.

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