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Quality Assurance

Exceeding Standards and Ensuring Regulatory Compliance for Unmatched Excellence in Every Part.​

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ISO 9001 | ISO 13485 | AS9100 | DDTC/ITAR Registered

Stratasys Direct's top industry certifications and Quality Management System ensure the highest manufacturing standards.

Standard 6 Point Inspection Free | Stratasys Direct

Standard 6 Point Inspection

By default, we utilize a 6-point inspection for all projects, while also offering comprehensive inspection services such as Geometric Dimensioning and Tolerancing (GD&T).

Traceability for your manufactured parts | Stratasys Direct

Material & Part Traceability

We can trace parts back to the machine/build and the settings they were created with. Traceability from order acceptance to shipping. Records retained for 11 years.

Custom Workflows | Stratasys Direct

Custom Workflow

We adhere to standard processes but can customize workflows to meet additional customer requirements, inspections, or specific steps.

Low defect Fate Additive Manufacturing | Stratasys Direct

Low Defect Rate

Perfection is ideal, our performance is exceptionally close with a defect rate of less than 1%.

ISO 9001 | ISO 13485 | AS9100 Certifications

Stratasys Direct's ISO 9001 certification reflects our dedication to a robust quality management system that meets customer expectations and regulatory standards. In addition, our ISO 13485 certification, achieved in October 2024, emphasizes our focus on the medical device industry, ensuring the design, production, and delivery of products that adhere to strict safety, risk management, and traceability requirements. Coupled with our AS9100 certification for aerospace standards, these certifications demonstrate our commitment to delivering high-quality, reliable solutions across industries.

Minneapolis, MN

ISO 9001 | AS9100 Certification

Belton, TX

ISO 9001 | AS9100 Certification

Phoenix, AZ

ISO 9001 Certification

Tucson, AZ

ISO 9001 | AS9100 Certification

Tucson, AZ

ISO 13485 Certification

ISO 9001 | AS9100 Certification

ISO 9001 | AS9100 Certification

ISO 9001 Certification

ISO 9001 | AS9100 Certification

Quality Assurance & Security | Stratasys Direct

Security & Quality You Can Count On

At Stratasys Direct, quality assurance is a commitment to excellence. With ISO 9001, AS9100, and the newly achieved ISO 13485 certifications, we ensure strict compliance with regulatory standards across aerospace and medical industries. Our certified systems provide robust process controls and traceability, guaranteeing high-quality parts. Additionally, our ITAR registration, DIBNET compliance, and SPRS score of 110 ensure secure operations, while our adherence to NIST 800-171 guidelines safeguards sensitive information. We prioritize delivering precise, high-performance parts within project parameters.

Quality Assurance and Compliance Documentation

Is a document confirming the quality and composition of a product, including specifications like purity, concentration, and physical properties. It serves as a quality assurance document, issued after testing and analysis, to ensure compliance with standards and specifications.

Is issued by a manufacturer, supplier, or third party to confirm a product meets regulatory, technical, or contractual standards. It serves as proof of compliance through testing, inspection, and verification, including details like product ID, description, test results, and authorized signatures. CoCs are often mandatory to ensure products meet quality, safety, and regulatory requirements.

Is a secure communication network used by the United States Department of Defense (DoD) to exchange sensitive information with its contractors and suppliers. It ensures that communication channels are protected and compliant with cybersecurity standards to safeguard classified and sensitive data shared within the defense industrial base.

NIST 800-171: The National Institute of Standards and Technology (NIST) Special Publication 800-171 provides guidelines for protecting Controlled Unclassified Information (CUI) in non-federal information systems and organizations. It outlines security requirements that federal contractors and subcontractors must adhere to when handling CUI to ensure the confidentiality, integrity, and availability of this information.

Is a standardized process in the automotive industry to ensure that components and systems meet the required quality standards before they are used in production. This process involves thorough documentation, testing, and approval of parts by both suppliers and manufacturers to ensure consistency and reliability in automotive manufacturing.

RoHS known as the Restriction of Hazardous Substances Directive, is an EU regulation limiting the use of certain hazardous materials in electrical and electronic equipment to protect human health and the environment. Similarly, REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) ensures the safe use of chemicals in manufacturing. We review compliance requests on a job-by-job or part-by-part basis. By surveying our supply chain, we ensure that jobs requiring REACH or RoHS compliance meet the necessary standards, and we notify customers if any job does not comply.

The Supplier Performance Risk System (SPRS) is a tool used by the United States Department of Defense (DoD) to assess the performance and risk of its contractors and suppliers. An SPRS score of 110 indicates a high level of performance and minimal risk, demonstrating that the supplier consistently meets or exceeds contractual requirements and complies with DoD standards and regulations.

NDA Template for Stratasys Direct

NDA Review

Stratasys Direct is committed to supporting you every step of the way, including the initial stages of project discussion where confidentiality is paramount. Simply send an email to nda@stratasysdirect.com if you require an NDA before proceeding further.

Upon receiving your request and queuing it, we strive to respond as soon as possible. Once your request reaches our queue, we thoroughly examine the NDA and aim to respond promptly.

 

Quality Assurance Inspection Levels | Stratasys Direct

Inspection Levels

Standard 6 Point Inspection process includes measuring X, Y, and Z dimensions, conducting a visual inspection to ensure surface finish and overall aesthetics meet standards, checking for flatness by assessing if the part rocks on a granite block, and conducting a FOD check to inspect for foreign objects or debris.

100% Inspection to drawing for part inspection involves examining each component against the engineering drawing or CAD model to ensure it meets precise specifications, including dimensional tolerances and surface finish requirements. 

First Article Inspection (FAI) rigorously evaluates the initial part from a new manufacturing process, such as 3D printing, ensuring it meets specified requirements like dimensional accuracy and material properties. By comparing it to design specifications and conducting tests, FAIs validate the manufacturing process, identify issues early, and maintain product quality.

AS9102 Reporting sets standards for documenting first article inspections in aerospace, ensuring components meet quality standards and regulatory requirements. It includes detailed documentation of inspection results to maintain consistency, traceability, and compliance across the aerospace supply chain.

Surface Profile in GD&T, a surface profile defines the allowable variation from the ideal shape of a surface. It measures how much the surface can deviate and sets precise limits to ensure it stays within a specific tolerance zone. This ensures that the surface is uniform and matches the design specifications, allowing all parts to fit and function together correctly.

Physical Property Testing - Tension Testing | Stratasys Direct

Physical Property Testing

Surface Roughness Testing involves measuring the texture of the outer surface of a part. It quantifies the irregularities and deviations from the ideal surface, providing information about the part's finish quality.

Durometer Testing measures the hardness or softness of a material, typically elastomers or flexible materials used in 3D printing. It helps assess the material's suitability for specific applications and ensures consistency in material properties.

Colorimeter is a device used to quantify the color of a surface. It's employed to ensure color accuracy and consistency across batches of printed parts, especially important for applications where color matching is critical.

Electrostatic Discharge Static Testing involves measuring the resistance of static dissipative surfaces, such as those used in electronics applications. It ensures that parts designed to dissipate static electricity meet the required resistance standards to prevent damage to sensitive electronic components.

Tensile Testing evaluates the mechanical properties of a material by subjecting it to tension. For parts it assesses the strength and elasticity of parts by pulling them until they break, providing valuable data for material characterization and quality assurance.

Flexural Testing measures the resistance of a material to bending or deformation. It evaluates the stiffness and durability of parts when subjected to bending forces, helping ensure their suitability for applications requiring resilience and structural integrity.

Torque Testing assesses the strength and performance of threaded connections, fasteners, or other parts subject to torque forces, ensuring they meet the required specifications for assembly and use.

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Inspection Equipment

At Stratasys Direct, our commitment to quality is unwavering, and we invest in specialized inspection equipment to ensure the excellence of our manufactured parts. With measurement accuracies as precise as ±0.0010" inches for single contact measurements, ±0.0019" inches for volumetric measurements, and ±0.0010" inches for laser line scan measurements, we uphold rigorous standards, ensuring the precise evaluation of part dimensions and features. Below we highlight some of our most common inspection tools. Contact us for additional information.

Borescope Inspection Equipment | Stratasys Direct

Examine the interior of object/structures without disassembly.

Colorimeter Inspection equipment | Stratasys Direct

Precise color test that matches FED and AMS standard.

Custom Pull Scale Set Inspection Equipment | Stratasys Direct

Measure pull/push forces of hardware/Fastener

Durometer Shore A & D Inspection Equipment | Stratasys Direct

Surface hardness testing.

Faro Laser Line Scanner Inspection Equipment | Stratasys Direct

3D scan for profile value.

Height Gauge Inspection Equipment | Stratasys Direct

Measure the height of an object.

Optical Comparators Inspection Equipment | Stratasys Direct

Precise detail feature inspection

Portable Faro CMM Inspection Equipment | Stratasys Direct

For precise GD&T inspection.

Instron Machine Inspection Equipment | Stratasys Direct

Tensile and flexural testing.

Profilemeter Inspection Equipment | Stratasys Direct

Surface roughness testing

Torque Gauges Inspection Equipment | Stratasys Direct

Hardware/Fastener torque strength testing.

Moisture Analyzer Inspection Equipment | Stratasys Direct

Measure the moisture content of an object.

Megohmmeter Inspection Equipment | Stratasys Direct

Measure the resistance of static dissipative surfaces.

Variety of Thread Plugs Gauge Sets Inspection Equipment | Stratasys Direct

Check the specific thread of hardware.

Variety of Thickness Gauges Inspection Equipment | Stratasys Direct

Measure the object’s thickness.

Variety of Protractors Inspection Equipment | Stratasys Direct

Measure the angle.

Micrometers Calipers Inspection Equipment | Stratasys Direct

Measure the linear size of an object.

Pin Gauge Set Inspection Equipment | Stratasys Direct

Measure the diameter of an object.

Variety of Radius Gauges Inspection Equipment | Stratasys Direct

Measure the radii of an object.

Variety of V & U Gauge Block Sets Inspection Equipment | Stratasys Direct

Supporting tools for a variety of measuring equipment.

Borescope Inspection Equipment | Stratasys Direct

Examine the interior of object/structures without disassembly.

Colorimeter Inspection equipment | Stratasys Direct

Precise color test that matches FED and AMS standard.

Custom Pull Scale Set Inspection Equipment | Stratasys Direct

Measure pull/push forces of hardware/Fastener

Durometer Shore A & D Inspection Equipment | Stratasys Direct

Surface hardness testing.

Faro Laser Line Scanner Inspection Equipment | Stratasys Direct

3D scan for profile value.

Height Gauge Inspection Equipment | Stratasys Direct

Measure the height of an object.

Optical Comparators Inspection Equipment | Stratasys Direct

Precise detail feature inspection

Portable Faro CMM Inspection Equipment | Stratasys Direct

For precise GD&T inspection.

Instron Machine Inspection Equipment | Stratasys Direct

Tensile and flexural testing.

Profilemeter Inspection Equipment | Stratasys Direct

Surface roughness testing

Torque Gauges Inspection Equipment | Stratasys Direct

Hardware/Fastener torque strength testing.

Moisture Analyzer Inspection Equipment | Stratasys Direct

Measure the moisture content of an object.

Megohmmeter Inspection Equipment | Stratasys Direct

Measure the resistance of static dissipative surfaces.

Variety of Thread Plugs Gauge Sets Inspection Equipment | Stratasys Direct

Check the specific thread of hardware.

Variety of Thickness Gauges Inspection Equipment | Stratasys Direct

Measure the object’s thickness.

Variety of Protractors Inspection Equipment | Stratasys Direct

Measure the angle.

Micrometers Calipers Inspection Equipment | Stratasys Direct

Measure the linear size of an object.

Pin Gauge Set Inspection Equipment | Stratasys Direct

Measure the diameter of an object.

Variety of Radius Gauges Inspection Equipment | Stratasys Direct

Measure the radii of an object.

Variety of V & U Gauge Block Sets Inspection Equipment | Stratasys Direct

Supporting tools for a variety of measuring equipment.

Stratasys Direct CAD Design Services

Design Services

Accelerate product development with our custom design services, DFM, 2D to 3D conversions, STL file repair, and advanced manufacturing tooling

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Automotive Rated Paint Sprayer AM Part Finishing | Stratasys Direct

Finishing & Assembly

Expert Finishing, Assembly, & Surface Treatment Service for Prototypes & Production Parts

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Stratasys Direct™ finishing stereolithography SLA part

Services

Discover top-tier 3D printed solutions with Stratasys Direct™. Our custom manufacturing services excel in 3D fabrication. Find high-quality custom parts manufacturing solutions using FDM, PolyJet, SLA, SAF, P3, SLS, and MJF technologies.

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Woman and Man holding very large 3d printed part at Stratasys Direct

About Stratasys Direct | On Demand 3D Printing

We help customers use 3D printing to produce designs that were previously impossible to build via conventional manufacturing methods. How can we help you?

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Stratasys Direct Contact Us

Stratasys Direct® 3D Printing Service Contact Us

Contact Stratasys Direct® for expert assistance with 3D printing, design, and finishing services. Our team is ready to support your project needs with advanced solutions. Reach out to us today!

View more
Stratasys Direct CAD Design Services

Accelerate product development with our custom design services, DFM, 2D to 3D conversions, STL file repair, and advanced manufacturing tooling

Automotive Rated Paint Sprayer AM Part Finishing | Stratasys Direct

Expert Finishing, Assembly, & Surface Treatment Service for Prototypes & Production Parts

Stratasys Direct™ finishing stereolithography SLA part

Discover top-tier 3D printed solutions with Stratasys Direct™. Our custom manufacturing services excel in 3D fabrication. Find high-quality custom parts manufacturing solutions using FDM, PolyJet, SLA, SAF, P3, SLS, and MJF technologies.

Woman and Man holding very large 3d printed part at Stratasys Direct

We help customers use 3D printing to produce designs that were previously impossible to build via conventional manufacturing methods. How can we help you?

Stratasys Direct Contact Us

Contact Stratasys Direct® for expert assistance with 3D printing, design, and finishing services. Our team is ready to support your project needs with advanced solutions. Reach out to us today!