Process Qualification and Certification

Ensuring reliable and certifiable additive manufacturing processes

In many industries, manufacturing technologies must comply with strict regulatory and quality standards. This is particularly true in sectors such as aerospace, energy, and medical devices, where components must meet rigorous requirements related to safety, traceability, and repeatability.

When adopting metal additive manufacturing, companies must demonstrate that both the manufacturing process and the final components comply with these standards. This requires a structured qualification approach that validates materials, process parameters, and production consistency.

AltForm supports manufacturers in developing qualified additive manufacturing processes based on Powder Bed Fusion and Direct Energy Deposition technologies. Through engineering expertise, material knowledge, and industrial experience, we help companies establish processes that meet certification requirements and support long-term production reliability.

Navigating certification requirements in advanced manufacturing

Standards for additive manufacturing are evolving rapidly as the technology becomes more widely adopted in regulated industries. Organizations implementing metal additive manufacturing must ensure that their processes comply with internationally recognized standards and sector-specific requirements.

These frameworks often include ISO/ASTM standards for additive manufacturing processes and materials, such as ISO/ASTM 52941 and ISO/ASTM 52942, as well as industry certifications like AS9100 for aerospace manufacturing quality systems, ISO 13485 for medical device manufacturing, and NADCAP accreditation for special aerospace processes.

In sectors such as medical technology or healthcare applications, compliance with regulatory frameworks such as FDA requirements may also be necessary.

For many manufacturers, the complexity of these requirements can represent a barrier to adoption. Establishing a qualified additive manufacturing process requires both technical expertise and a deep understanding of certification frameworks.

AltForm works alongside customers to simplify this process. Our teams help define robust process qualification strategies that align with industry standards and production objectives.

How AltForm supports you

Qualification and certification require a structured methodology that combines process engineering, testing and documentation. AltForm supports customers throughout the different phases of this process.

Process parameter validation

The first step in qualifying an additive manufacturing process involves defining stable and repeatable process parameters. Laser power, scan strategies, layer thickness and thermal control must be carefully optimized for the selected material and application. AltForm engineers develop and validate these parameters to ensure consistent material properties and reliable process behavior.

Material selection and characterization

Material performance plays a central role in certification processes. AltForm supports customers in selecting appropriate powders and evaluating their behavior within additive manufacturing processes. Material characterization may include mechanical testing, metallurgical analysis, density verification and process repeatability studies.

Process documentation and traceability

Certification frameworks require clear documentation of the manufacturing process. AltForm assists customers in defining documentation structures that track production parameters, material batches and quality inspection procedures. Establishing traceability is particularly important for industries such as aerospace and medical devices, where production records must demonstrate the consistency of every manufactured component.

Alignment with international certification frameworks

AltForm supports manufacturers in structuring their additive manufacturing processes so they can align with recognized industry standards and certification pathways. Depending on the target industry, this may involve supporting compliance with frameworks such as ISO/ASTM additive manufacturing standards, AS9100 quality management systems for aerospace, ISO 13485 medical manufacturing standards, NADCAP special process accreditation, and regulatory requirements associated with FDA medical device approval. Our teams help customers define qualification strategies that facilitate certification and enable additive manufacturing to be adopted in regulated production environments.

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