When ordering 3D printed parts for regulated industries—aerospace, medical, defense, or automotive—the certifications held by a service bureau determine whether they can legally and practically serve your project.

This guide explains the certifications most relevant to 3D printing services: what each one covers, who issues it, why customers in specific industries require it, and which bureaus in our directory hold it.

• Quality Management Systems: ISO 9001, AS9100D, ISO 13485, IATF 16949
• Regulatory & Compliance: ITAR, NADCAP, FDA Registration
• Industry Standards: ASTM F42, ISO/ASTM 52900
• References: Official sources for each certification body

What it covers: ISO 9001 is the international standard for quality management systems (QMS). It specifies requirements for processes that consistently provide products and services meeting customer and regulatory requirements, with a focus on continuous improvement.

Who issues it: Issued by the International Organization for Standardization (ISO) and audited by accredited third-party certification bodies. The current version is ISO 9001:2015.

Why customers care: ISO 9001 certification is the baseline quality signal for professional manufacturing services. It demonstrates that a bureau has documented processes, management oversight, and corrective action procedures. Most regulated industries require it as a minimum; aerospace and medical work requires more specific standards built on top of it.

Industries requiring it: Consumer products, industrial, automotive prototyping, general manufacturing.

Bureaus in our directory with ISO 9001:

• Xometry
• Protolabs
• Shapeways
• Hubs (formerly 3D Hubs)
• Sculpteo
• JLC3DP
• Materialise
• Stratasys Direct
• Fictiv
• i.materialise
• FIT AG
• Wenext
• 3D Systems On Demand
• Objective3D
• Imaginarium
• SyBridge Technologies
• Quickparts
• Carbon
• AddUp
• Protolabs Japan
• Divide By Zero Technologies
• Objectify Technologies
• Immensa Technology Labs
• Omni3D

What it covers: AS9100D is the aerospace and defense industry’s quality management standard. It extends ISO 9001:2015 with aerospace-specific requirements including product and process risk management, first article inspection (FAI), configuration management, customer-directed sources, and key characteristics. The “D” revision is current as of 2016.

Who issues it: Developed by the International Aerospace Quality Group (IAQG) and published by SAE International. Certification audits are performed by accredited registrars within the OASIS (Online Aerospace Supplier Information System) database.

Why customers care: AS9100D certification is required—not optional—by most aerospace OEMs and Tier 1 suppliers for production parts and many development programs. Boeing, Airbus, Lockheed Martin, and their supply chains typically require suppliers to appear in the OASIS database with current AS9100D registration. For 3D printed metal parts going into flight hardware, this is a hard requirement.

Industries requiring it: Aerospace, defense, space.

Bureaus in our directory with AS9100D or AS9100:

• Xometry (AS9100D)
• Protolabs (AS9100D)
• Materialise (AS9100)
• Stratasys Direct (AS9100D)
• FIT AG (AS9100)
• 3D Systems On Demand (AS9100)
• SyBridge Technologies (AS9100D)
• AddUp (AS9100D)

What it covers: ISO 13485 specifies quality management system requirements specific to the medical device industry. It covers design and development controls, risk management integration (linking to ISO 14971), validation of manufacturing processes, complaint handling, and post-market surveillance requirements. The current version is ISO 13485:2016.

Who issues it: Published by ISO and audited by accredited third-party certification bodies. Unlike AS9100, ISO 13485 is a standalone standard rather than an extension of ISO 9001, though the two share structural similarities.

Why customers care: Regulatory bodies in many markets—including Health Canada and the EU under the Medical Device Regulation (MDR)—accept or require ISO 13485 as evidence of QMS compliance. In the US, FDA 21 CFR Part 820 (the Quality System Regulation) is aligned with ISO 13485:2016. For 3D printed surgical guides, patient-specific implants, or regulated dental devices, your supplier must hold this certification.

Industries requiring it: Medical devices, dental, in-vitro diagnostics.

Bureaus in our directory with ISO 13485:

• Xometry
• Protolabs
• Materialise
• Stratasys Direct
• 3D Systems On Demand
• Carbon
• AddUp

What it covers: IATF 16949 is the automotive sector’s quality management standard, replacing the former ISO/TS 16949. It extends ISO 9001:2015 with automotive-specific requirements for defect prevention, reduction of variation, waste reduction in the supply chain, and support for OEM-specific requirements (Customer Specific Requirements, or CSRs). The current version is IATF 16949:2016.

Who issues it: Developed by the International Automotive Task Force (IATF), a group of automotive OEMs and their trade associations. Certification is performed by IATF-recognized third-party auditing organizations.

Why customers care: Most automotive OEMs (Ford, GM, Stellantis, BMW, Toyota, Volkswagen Group) require IATF 16949 certification for production parts suppliers. For 3D printed production or near-production parts destined for automotive assemblies, this certification is typically mandatory. Prototype work may be performed by non-certified suppliers, but production validation and beyond usually require it.

Industries requiring it: Automotive (production parts and direct suppliers).

No bureaus in our current directory list IATF 16949. Check directly with bureaus for automotive production work, or browse the bureau directory for providers with automotive experience.

What it covers: ITAR is a set of US government regulations (22 CFR Parts 120–130) that controls the export and import of defense-related articles and services listed on the US Munitions List (USML). For manufacturing services, ITAR registration with the Directorate of Defense Trade Controls (DDTC) is required to manufacture, export, or provide services for ITAR-controlled items. Registered facilities must restrict access to ITAR-controlled technical data and hardware to US persons only.

Who issues it: The US Department of State, Directorate of Defense Trade Controls (DDTC). Registration is not a certification in the quality sense—it is a legal requirement for doing business with defense programs.

Why customers care: Defense contractors and programs involving ITAR-listed items (most defense hardware, weapons systems, spacecraft, and related technology) are legally prohibited from sharing controlled technical data with non-ITAR-registered facilities or non-US persons. If you are manufacturing parts for a US defense program, your supplier must be ITAR registered and have appropriate data handling procedures. Violations carry severe civil and criminal penalties.

Industries requiring it: US defense programs, ITAR-controlled space hardware.

Bureaus in our directory with ITAR registration:

• Xometry
• Protolabs
• Stratasys Direct
• 3D Systems On Demand
• SyBridge Technologies

What it covers: NADCAP is a global cooperative accreditation program for aerospace engineering, defense, and related industries. Unlike AS9100D (which covers the overall quality management system), NADCAP accreditation is process-specific: a supplier earns separate accreditations for each special process they perform, such as heat treatment, non-destructive testing (NDT), welding, chemical processing, or materials testing. For 3D printing services, relevant NADCAP accreditations include NDT and materials testing.

Who issues it: Managed by the Performance Review Institute (PRI), a non-profit organization. NADCAP audits are performed by industry-volunteer technical experts who assess compliance against specific process checklists.

Why customers care: Major aerospace primes (Boeing, Lockheed, Airbus, GE Aviation, Raytheon) require NADCAP accreditation for suppliers performing special processes on flight hardware. If your 3D printed parts require heat treatment (e.g., stress relief or HIP for metal parts), NDT inspection (CT scanning, dye penetrant), or specific materials testing, those processes must be NADCAP accredited for most aerospace production programs. For development and prototype work, NADCAP is less commonly required.

Industries requiring it: Aerospace (production flight hardware), defense.

Bureaus in our directory with NADCAP:

• AddUp

What it covers: US Food and Drug Administration (FDA) establishment registration is required for domestic facilities that manufacture, prepare, propagate, compound, or process medical devices distributed in the United States, as well as foreign facilities exporting devices to the US. Registration itself is an administrative requirement; it does not imply FDA approval of the facility’s processes. Registered establishments are subject to FDA inspection and must comply with the Quality System Regulation (21 CFR Part 820) or the updated Quality Management System Regulation (QMSR, 21 CFR Part 820 aligned with ISO 13485:2016).

Who issues it: US Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH). Registration is submitted through the FDA Unified Registration and Listing System (FURLS).

Why customers care: If you are manufacturing regulated medical devices (Class I, II, or III) for the US market, your manufacturing partners must be registered with the FDA. For 3D printed medical devices—including surgical guides, implants, prosthetics, and diagnostic equipment housings—both the device manufacturer and their contract manufacturers may require registration. FDA registration is distinct from ISO 13485 certification, though most serious medical device manufacturers hold both.

Industries requiring it: Medical devices, in-vitro diagnostics, dental devices for US market.

Bureaus in our directory with FDA Registration:

• Materialise

What it covers: ASTM International Committee F42 on Additive Manufacturing Technologies develops and publishes technical standards specific to additive manufacturing. F42 standards cover terminology, process categories, feedstock specifications, design guidelines, post-processing, and mechanical test methods. Key F42 standards include:

• ASTM F3001 — Standard specification for additive manufacturing titanium-6 aluminum-4 vanadium ELI (extra low interstitial) with powder bed fusion
• ASTM F3055 — Ni-base superalloy powder for powder bed fusion
• ASTM F3184 — Standard specification for additive manufacturing stainless steel
• ASTM F3187 — Standard guide for directed energy deposition
• ASTM F3049 — Standard guide for characterizing properties of metal powders used for additive manufacturing processes

Who issues it: ASTM International, a globally recognized standards development organization. F42 standards are developed by volunteer industry and academic experts, published by ASTM, and available for purchase through ASTM.

Why customers care: When specifying material properties, test methods, or process requirements for 3D printed parts, referencing ASTM F42 standards creates unambiguous technical requirements. Many aerospace and defense programs require or reference these standards in purchase orders. For metal powder bed fusion parts in critical applications, asking a bureau which ASTM F42 material specifications they meet is a practical quality check.

Industries where it applies: Aerospace, medical, defense, automotive, industrial.

What it covers: ISO/ASTM 52900 (formerly ASTM F2792) is the foundational standard for additive manufacturing terminology. It defines seven process categories used across the industry:

• Binder Jetting (BJ) — A liquid bonding agent selectively deposits to join powdered material
• Directed Energy Deposition (DED) — Focused thermal energy fuses materials as they are deposited
• Material Extrusion (MEX) — Material is selectively dispensed through a nozzle (includes FDM/FFF)
• Material Jetting (MJ) — Droplets of build material are selectively deposited
• Powder Bed Fusion (PBF) — Thermal energy selectively fuses regions of a powder bed (includes SLS, DMLS, SLM, EBM)
• Sheet Lamination (SL) — Sheets of material are bonded to form a part
• Vat Photopolymerization (VP) — Liquid photopolymer in a vat is selectively cured (includes SLA, DLP)

Who issues it: Published jointly by ISO (International Organization for Standardization) and ASTM International under a memorandum of understanding. The joint ISO/ASTM 52900 series covers terminology, round robin testing, and data formats for additive manufacturing.

Why customers care: Understanding ISO/ASTM 52900 terminology helps when communicating with service bureaus and reading technical documentation. The marketing names used by equipment manufacturers (FDM®, PolyJet™, MultiJet Fusion™) map to these standardized process categories, which is useful when comparing quotes across suppliers using different equipment brands for the same underlying process.

Industries where it applies: All industries using additive manufacturing.

The certifications and standards described on this page are maintained by the following official bodies. Always verify current certification status with your supplier directly.

Our service bureau directory lists the certifications held by each provider. Use the directory to find bureaus that match your specific certification requirements.

Not sure which certifications you need? Contact us and we can help point you in the right direction.