On-site / off-site and second-party ISO audits
External Audit and Facility Access Policy
3Dresyns® is a designer and manufacturer of highly innovative proprietary 3D printing resins, additives, materials and related technologies whose value critically depends on the protection of formulations, manufacturing know-how, technical processes, trade secrets, confidential information, digital systems and proprietary development methodologies.
For this reason, 3Dresyns® does not grant customers or other private third parties any right to audit, inspect or access its facilities, manufacturing areas, laboratories, systems, processes, records or confidential operational information.
This is a fundamental condition of the Company's operating and intellectual-property protection model.
No customer audit rights
Customers do not acquire audit, inspection or facility-access rights by purchasing 3Dresyns® Products or Services.
3Dresyns® does not accept customer audits, including:
- on-site audits;
- off-site audits;
- remote audits;
- virtual audits;
- video audits;
- announced audits;
- unannounced audits;
- second-party audits;
- supplier audits;
- quality-system audits;
- process audits;
- manufacturing audits;
- laboratory audits;
- cybersecurity audits involving access to Company systems;
- live document-review audits;
- screen-sharing inspections;
- video walkthroughs of facilities;
- interviews intended to audit confidential Company operations; or
- any equivalent activity intended to provide a private third party with inspection or audit access to the Company's internal operations.
No physical access for customer audits
Customers, potential customers, suppliers, consultants, private auditors and other commercial counterparties are not permitted to access 3Dresyns® production areas, laboratories, formulation areas, raw-material storage areas, manufacturing infrastructure or other restricted operational areas for auditing or inspection purposes.
Commercial interest, customer qualification procedures, supplier approval programs, procurement policies, quality-system requirements or internal customer procedures do not create a right of physical access to 3Dresyns® facilities.
No remote access
The prohibition on external audits applies equally to remote or digital access.
3Dresyns® does not provide private external auditors with access to:
- internal information systems;
- quality-management systems;
- internal databases;
- manufacturing software;
- formulation systems;
- internal AI-assisted tools;
- development platforms;
- source code;
- network infrastructure;
- internal file structures;
- live screens;
- security systems;
- internal communications;
- non-public batch records;
- supplier databases; or
- other confidential digital infrastructure.
3Dresyns® does not permit remote-control access, live system inspection, screen-sharing audits or equivalent digital inspection methods.
Private auditors and certification bodies
The no-audit policy applies to private third parties acting on behalf of a customer or other commercial organization.
Accordingly, 3Dresyns® does not grant audit or facility-access rights to:
- customer-appointed auditors;
- external quality consultants;
- private certification bodies;
- customer certification bodies;
- customer laboratories;
- customer regulatory consultants;
- private inspection organizations;
- notified bodies acting in connection with a customer's conformity-assessment process;
- contract research organizations;
- universities acting as customer auditors;
- procurement organizations; or
- other private organizations acting for or on behalf of a customer.
The designation, accreditation, certification or regulatory function of a private organization does not by itself create a contractual right to enter or audit 3Dresyns® facilities.
Notified bodies
A notified body involved in the conformity assessment of a customer's regulated product does not automatically acquire a right of access to 3Dresyns® merely because a 3Dresyns® material has been used by that customer.
3Dresyns® does not accept contractual conditions requiring access by a customer's notified body or other private conformity-assessment organization.
If a customer's regulatory or conformity-assessment framework requires physical or remote audit access to its material supplier as an indispensable condition for the customer's intended use, the customer must determine before ordering whether the 3Dresyns® no-audit model is compatible with its regulatory strategy.
Where such private audit access is mandatory for the customer's intended regulatory pathway, 3Dresyns® may decline to participate in that supply arrangement rather than grant access to its facilities, systems or confidential processes.
Public authorities
The only exception to the Company's private no-audit and no-access policy concerns competent public authorities exercising legally binding statutory powers directly applicable to 3Dresyns®.
Where a competent public authority lawfully requires an inspection, investigation, production of records, access to premises or other regulatory cooperation, 3Dresyns® will comply with the applicable legal obligation to the extent required by law.
Such authorities may include, depending on the applicable legal matter and jurisdiction, competent:
- judicial authorities;
- law-enforcement authorities;
- tax authorities;
- Customs authorities;
- labour or occupational-safety authorities;
- environmental authorities;
- market-surveillance authorities;
- product-safety authorities;
- data-protection authorities; or
- other governmental or public regulatory authorities possessing applicable statutory inspection or enforcement powers.
Access is provided only to the extent legally required and subject to any confidentiality, procedural, security and trade-secret protections available under applicable law.
Public authority requests must have a legal basis
A request from a public institution does not automatically provide unrestricted access to all Company information.
3Dresyns® may verify the identity, competence, jurisdiction, legal basis and scope of any inspection or information request and may take appropriate measures to protect information outside the legally required scope.
Where legally appropriate, the Company may request that:
- the legal basis of the inspection be identified;
- the scope of requested access be defined;
- access be limited to information relevant to the statutory purpose;
- trade secrets and Confidential Information receive appropriate protection;
- copies or extracts be controlled where legally permitted;
- Company representatives accompany inspectors; and
- applicable procedural safeguards be respected.
No voluntary private inspections
3Dresyns® does not convert customer, supplier or private third-party audit requests into voluntary inspections of its facilities.
The Company distinguishes between:
- mandatory public-authority inspections required by applicable law; and
- private commercial or contractual audit requests.
The first category is handled according to applicable law.
The second category is not accepted under the 3Dresyns® operating model.
Customer regulatory obligations
Customers may operate under quality, regulatory, certification or supplier-control systems that impose requirements on their own organization.
A customer's own regulatory, quality-system, certification or internal supplier-control obligations do not by themselves create an audit or inspection right against 3Dresyns®.
The customer is responsible for determining before purchase whether the documentation and supplier-control model offered by 3Dresyns® is sufficient for the customer's intended application and regulatory framework.
If the customer's system requires supplier access that 3Dresyns® does not provide, the customer should not rely on the purchase of a 3Dresyns® Product as evidence that such access will later be granted.
ISO standards and customer procedures
Customer implementation of ISO standards, internal quality systems, supplier-qualification procedures or certification schemes does not automatically incorporate those procedures into the contract with 3Dresyns®.
A customer's decision that it wishes to audit suppliers does not by itself create a corresponding obligation for 3Dresyns® to accept that audit.
Where a customer requires a specific audit right as a condition of supplier approval, that requirement must be disclosed before ordering.
3Dresyns® does not accept orders on the basis of a private audit right that conflicts with this policy.
Customer purchase orders and audit clauses
Audit, inspection, facility-access, record-access or supplier-surveillance clauses contained in a customer's purchase order, procurement conditions, supplier manual, quality agreement, online procurement portal or other customer-generated document are not accepted merely because 3Dresyns® receives, processes, acknowledges or fulfils an order.
To the fullest extent permitted by applicable law, any such terms that conflict with the Company's no-audit policy are expressly rejected.
3Dresyns® does not intend to grant private audit or facility-access rights through customer standard terms.
No access through quality agreements
3Dresyns® will not enter into a customer quality agreement that requires private physical or remote audit access to Company facilities, laboratories, manufacturing processes, systems or Confidential Information.
Where a proposed quality agreement contains such a requirement, the audit provision must be removed for the commercial relationship to proceed.
Protection of intellectual property and trade secrets
3Dresyns® develops proprietary formulations, processes, manufacturing methods, AI-assisted development methodologies, workflows and technical know-how that constitute valuable Confidential Information and trade secrets.
External audit access can create risks including:
- unintended disclosure of formulations;
- exposure of raw-material identities;
- disclosure of manufacturing sequences;
- exposure of proprietary process controls;
- disclosure of supplier information;
- exposure of experimental technologies;
- disclosure of confidential customer projects;
- exposure of digital development systems;
- unauthorized reproduction of internal documentation;
- reverse engineering;
- industrial espionage; and
- loss of trade-secret protection.
The no-audit policy forms part of the reasonable measures used by 3Dresyns® to protect its Confidential Information, proprietary know-how and trade secrets.
Protection of other customers
Restricted access also protects Confidential Information belonging to other customers, partners and collaborators.
An external auditor acting for one customer must not be placed in a position where it could obtain access to:
- another customer's identity;
- another customer's confidential project;
- custom-development information;
- confidential samples;
- commercial conditions;
- production information;
- research results;
- project files; or
- other information protected by confidentiality obligations.
Physical and digital security
3Dresyns® maintains restricted physical and digital access to sensitive Company information and infrastructure.
The Company's security model is designed to reduce unauthorized access to confidential technical, commercial and operational information and to support compliance with applicable confidentiality obligations and internal security requirements.
Detailed security architecture, access-control mechanisms, network configuration and other security-sensitive information are themselves treated as restricted information and are not disclosed for customer audit purposes.
Supplier qualification without audits
3Dresyns® supports reasonable customer supplier-qualification requirements through controlled documentation rather than external access to Company facilities or internal systems.
Depending on the Product and applicable circumstances, information that may be provided includes:
- Company identification information;
- Product Technical Data Sheets;
- Safety Data Sheets;
- Instructions for Use;
- Product specifications;
- batch or lot identification;
- traceability information;
- Product-specific declarations;
- test data where applicable and available for disclosure;
- Certificates of Analysis where offered for the relevant Product;
- regulatory or Customs documentation where applicable;
- country-of-origin information where applicable;
- quality-related declarations where supported; and
- other controlled documentation that 3Dresyns® determines can be disclosed without compromising Confidential Information or proprietary know-how.
Supplier questionnaires
3Dresyns® may, at its discretion, respond to reasonable written supplier questionnaires that can be completed using information available for external disclosure.
Completion of a questionnaire does not constitute acceptance of an audit right.
3Dresyns® may decline to answer questions requesting:
- trade secrets;
- formulations;
- raw-material identities;
- supplier identities;
- confidential manufacturing information;
- internal process parameters;
- restricted customer information;
- internal security information;
- confidential software or AI-system details;
- information protected by NDAs; or
- other non-public information that the Company determines should not be disclosed.
Document review is not an audit
Providing a TDS, SDS, IFU, declaration, Certificate of Analysis, questionnaire response or other controlled document does not grant the recipient a continuing inspection, verification or audit right over 3Dresyns®.
The recipient may use the supplied document for its legitimate supplier-assessment purposes subject to applicable confidentiality and intellectual-property restrictions.
No guarantee of customer certification
Provision of Product documentation or supplier information does not constitute a guarantee that a particular certification body, notified body, regulator, customer quality system or other organization will accept 3Dresyns® as a supplier for a particular regulated application.
The customer remains responsible for determining whether its intended use, regulatory pathway and supplier-control requirements are compatible with the 3Dresyns® no-audit model.
Medical, dental and regulated applications
Some customers may use 3Dresyns® materials in research, development or manufacturing activities associated with medical, dental or other regulated applications.
Supply of a raw material does not mean that 3Dresyns® assumes the role, regulatory obligations or quality-system responsibilities of the manufacturer of the customer's final device or end-use product.
The customer remains responsible for determining the regulatory requirements applicable to its final product and supply chain.
If the customer's regulatory pathway requires private supplier audits or notified-body access to the material supplier and no alternative supplier-control method is acceptable under that framework, the customer should determine this requirement before selecting 3Dresyns®.
No implied right arising from Product claims or documentation
Product specifications, technical documentation, biocompatibility information, testing information, conformity statements or other documentation supplied by 3Dresyns® do not create an implied right to audit the Company.
Any Product-specific claim is governed by the applicable Product documentation, test conditions and contractual framework.
Requests for facility visits
Requests to visit Company facilities for supplier qualification, procurement review, technical inspection, due diligence, customer audit or similar purposes are not accepted.
Where 3Dresyns® independently chooses to hold a commercial meeting with a customer or other visitor at a non-sensitive location, such a meeting does not constitute an audit and does not provide access to restricted operational areas or confidential systems.
Photography, recording and data collection
Unauthorized photography, video recording, audio recording, scanning, copying, data capture or electronic recording of Company facilities, documents, systems, screens, equipment or confidential information is prohibited.
Any recording required by a competent public authority is governed by the applicable legal authority and procedural requirements.
No unannounced private access
No customer, customer representative, private auditor, certification organization, notified body or other private third party has any right to arrive at 3Dresyns® facilities without prior authorization and demand access.
Unannounced private visits do not create an inspection right and access will not be granted on that basis.
Requests conflicting with this policy
If a customer informs 3Dresyns® that its procurement, regulatory, certification or quality system requires supplier audit rights inconsistent with this policy, 3Dresyns® may inform the customer that the requested condition cannot be accepted.
The customer may then determine whether the available documentation-based supplier qualification model is sufficient for its intended use.
3Dresyns® will not compromise the confidentiality of its facilities, formulations, systems or proprietary processes in order to satisfy a private customer's audit requirement.
Public inspections required by law
Nothing in this policy is intended to obstruct or prevent lawful inspections, investigations or information requirements imposed directly on 3Dresyns® by competent public authorities acting within their statutory powers.
Where such an obligation applies, 3Dresyns® will cooperate to the extent legally required while taking appropriate measures to preserve Confidential Information, trade secrets, customer confidentiality and other legally protected information.
Worldwide application
3Dresyns® supplies Products internationally and applies this private no-audit policy to customers and commercial relationships worldwide, to the fullest extent permitted by applicable law.
A customer's location, destination country, procurement system or internal quality policy does not by itself alter the Company's no-audit model.
Mandatory legal powers exercised by competent public authorities remain subject to the laws applicable in the relevant jurisdiction.
Governing principle
3Dresyns® does not grant customers, notified bodies acting for customers, certification bodies, private auditors or other private third parties physical or remote audit access to its facilities, manufacturing processes, laboratories, systems or Confidential Information. Supplier qualification is supported through controlled documentation. Access or disclosure beyond that model is provided only where a competent public authority directly requires it under applicable law.