On-site / off-site and second-party ISO audits

A second-party audit is when a customer performs an audit of a supplier to ensure that the supplier is meeting the specific requirements defined in the contract. These requirements may include special control over certain processes, traceability, documentation, records, and overall quality management. In non sensitive businesses these audits can be done on-line or even off-site by reviewing documents submitted by the supplier. Announced and unannounced audits are contemplated by ISO standards and may be performed on a supplier without first discussing the audit with the supplier or giving them prior knowledge of the inspection date.

3Dresyns is a designer and manufacturer of highly innovative proprietary 3D resins and additives, whose value depends on the protection of its formulations, manufacturing know-how, and confidential Artificial Intelligence assisted design tools. For this reason 3Dresyns does not accept nor permit any type of external audit, on-site or off-site, from customers, suppliers, notified bodies, or any other third parties. This no-audit policy is firm and non negotiable for all our products, facilities, and operations.

Our facilities have strictly restricted physical access and reinforced digital protection to prevent any potential risk of physical or electronic data breaches and to fully comply with our existing NDAs and 3Dresyns physical and digital security policies. As a raw material supplier, 3Dresyns is not legally required to be audited by its customers under ISO or medical device regulations. Instead, 3Dresyns operates under its own internal quality management and control system, aligned with key quality principles, and supports its customers with technical documentation, traceability by batch, internal test data, and professional Instructions for Use IFU when applicable, without exposing confidential information or compromising the security of its technology and facilities.

This high level of security is particularly crucial to protect both 3Dresyns and its customers, ensuring the long term continuity, confidentiality, and quality of our products without the risks associated with external inspections or audits.

For more info read 3Dresyns digital security policies. 

Rationale Behind Our No-Audit Policy

1. Protection of Intellectual Property and Trade Secrets

3Dresyns develops highly innovative, proprietary formulations, processes, and technologies that constitute the core of our competitive advantage. Allowing external audits—physical or digital—would expose sensitive information, including formulation know-how, AI-assisted design methodologies, production parameters, and protected workflows.
To eliminate any risk of industrial espionage or reverse engineering, audits of any kind are strictly prohibited.

2. Physical and Digital Security Requirements

Our facilities operate under a high-security model with restricted access to comply with our internal security protocols and the NDAs we maintain with customers, partners, and collaborators.
External audits, visits, or remote inspections inherently increase the risk of data leakage, unauthorized access, or the exposure of confidential infrastructure.

3. Regulatory Context: No Legal Requirement for Raw Material Suppliers

As a supplier of materials—not a manufacturer of medical devices or end-use regulated products—3Dresyns is not subject to mandatory external audits under ISO 9001, ISO 13485, FDA, MDR, or equivalent regulations.
Manufacturers of final devices may choose to audit their suppliers, but such audits are not a legal obligation for raw material producers and therefore not required for compliance.

4. Quality Assurance Without External Intrusion

Although we do not permit audits, 3Dresyns maintains a robust internal quality management system designed to ensure high standards of consistency, traceability, and product performance.
We provide customers with:

  • batch traceability,

  • internal test reports,

  • declarations of conformity,

  • safety and regulatory documentation,

  • technical support and guidance.

This allows us to ensure reliability and transparency without compromising security or exposing proprietary knowledge.

Conclusion

3Dresyns’ strict no-audit policy safeguards our intellectual property, protects the integrity of our production systems, ensures compliance with existing NDAs, and preserves the confidentiality essential to our customers and partners.
By maintaining full control of our physical and digital infrastructure, we guarantee the continuity, consistency, and security of our products—without the risks associated with external inspections.