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.

Pointed automotive checking fixture close to the white frame of a car in production

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
Hands holding one black 3D-printed part with copies of the same part on a white table

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. 

Prototyping quality control

Woman inspecting a part under a magnifying glass in the Materialise production area

Visual inspection

A Materialise quality team member holding a caliper to measure a 3D-printed part

Tolerances

Manufacturing quality assurance

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

Process and change control

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

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

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

The quality assurance you need

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

Talk to our team