On-site / off-site and second-party ISO audits
A second-party audit refers to an audit performed by a customer on a supplier to verify compliance with contractual requirements, which may include controls over specific processes, traceability, documentation, records, and quality management practices. In non-sensitive industries, such audits may be conducted online or off-site through document review. ISO standards contemplate both announced and unannounced audits.
3Dresyns is a designer and manufacturer of highly innovative, proprietary 3D resins and additives, whose value critically depends on the protection of its formulations, manufacturing know-how, and confidential Artificial-Intelligence-assisted design tools.
For this reason, 3Dresyns does not accept or permit any form of external audit, whether on-site, off-site, remote, announced, or unannounced, by customers, suppliers, notified bodies, or any other third parties. This no-audit policy is firm, absolute, and non-negotiable and applies to all products, facilities, processes, systems, and operations.
Our facilities operate under strict physical access controls and reinforced digital security systems to prevent any risk of physical or electronic data breaches and to fully comply with existing Non-Disclosure Agreements (NDAs) and internal security policies.
As a raw material supplier, 3Dresyns is not legally required to undergo customer audits under ISO standards, medical device regulations, or equivalent frameworks. Instead, 3Dresyns operates under its own internal quality management and control system, aligned with key quality principles.
Customers are supported through professional documentation and controlled information exchange, including batch traceability, internal testing data, declarations, and detailed Instructions for Use (IFU), where applicable, without exposing confidential information or compromising the security of our technology or facilities.
This high level of protection is essential to safeguard both 3Dresyns and its customers, ensuring long-term continuity, confidentiality, and product quality without the risks inherent to external audits or inspections.
Rationale behind our no-audit policy
1. Protection of intellectual property and trade secrets
3Dresyns develops proprietary formulations, processes, AI-assisted design methodologies, and production workflows that constitute its core competitive advantage. Allowing external audits—physical or digital—would expose sensitive information and create unacceptable risks of industrial espionage or reverse engineering.
To eliminate such risks, audits of any kind are strictly prohibited.
2. Physical and digital security requirements
Our operations follow a high-security model with restricted access to facilities, systems, and data. External audits, visits, or remote inspections inherently increase the risk of unauthorized access, data leakage, or exposure of protected infrastructure and confidential information.
3. Regulatory context: no legal audit obligation
As a supplier of raw materials—not a manufacturer of regulated end-use products such as medical devices—3Dresyns is not subject to mandatory external audits under ISO 9001, ISO 13485, FDA, MDR, or equivalent regulatory schemes.
While manufacturers of final products may choose to audit their suppliers, such audits are not a legal requirement for raw material suppliers and are therefore not required for regulatory compliance.
4. Quality assurance without external intrusion
Despite not permitting audits, 3Dresyns maintains a robust internal quality management system designed to ensure consistency, traceability, and performance.
We provide customers, where applicable, with:
- Batch and lot traceability
- Internal test reports
- Declarations of conformity
- Safety and regulatory documentation
- Technical support and guidance
This approach ensures transparency and reliability without compromising security or proprietary knowledge.
Conclusion
3Dresyns’ strict no-audit policy protects intellectual property, preserves the integrity of its production systems, ensures compliance with existing NDAs, and safeguards the confidentiality essential to customers and partners.
By retaining full control over physical and digital infrastructure, 3Dresyns guarantees continuity, consistency, and security of its products without the risks associated with external inspections or audits.