The different existing ISO can be easily implemented in traditional single unifunctional product design but becomes not implementable in our multivariable and multifunctional 3Dresyns business approach since our 3Dresyns portfolio includes online custom ordering of complex multivariable and multifunctional products.

Each of our nearly 500 unifunctional products have its basic SKU (Stock Keeping Unit) which can be converted online to up to 10 billion products and SKUs, after online optional functionalization with thousands of colors and up to 4 functional additives, among around 50 choices.

All our made to order 3D resins, including the simplest unifunctional resins, need to be tuned by us for each printer specification for optimum printing, resolution, mechanical properties and biocompatibility.

The ISO 9000 family has a limited view and applicability of predictive, interpolative, and corrective algorithmic systems based on artificial intelligence for designing billions of materials choices! Our multifunctional business approach and offering require innovative internal Quality Management Systems, which cannot be contemplated in the existing traditional univariable or fixed management systems of ISO.

3Dresyns Quality Policy
3Dresyns is committed to providing safe and functional 3D resins to fully comply with all relevant regulations. 3Dresyns is also committed to the continuous improvement of the quality of its products and services by implementing a reliable internal quality management system.

3Dresyns Quality Assurance
3Dresyns performs appropriate quality controls to ensure that each lot is produced according to the specifications of the manufacturing recipe of each product reference. 

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 they are meeting the requirements specified in the contract. These requirements may include special control over certain processes, requirements on traceability, documentation, records, etc... 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 performed on a supplier without first discussing the audit with the supplier or giving them prior knowledge of the inspection date. 

3Dresyns suppliers and customers are not allowed to visit, not to perfom any on-site / off-site second-party audits for security reasons, since our (and ours customers) confidential information, trade secrets, know how and facilities have restricted access to outsiders, to prevent any potential risk of data breaches and fully comply with our existing NDAs and security policies. This high level security is particularly crucial to protect us and our customers working in highly confidential industries. 

3Dresyns business model is an efficient multivariable & multifunctional online service, not a face-to-face public showroom or workshop, designed to give fast and reliable online solutions to existing unmet customer and market needs related to 3D printing

Production of products under ISO certification
Under contract, 3Dresyns manufactures its products under the ISO family with its partner tollers, which are ISO certified to manufacture 3Dresyns products under ISO certification.

Related links: Are medical device raw material suppliers required to be ISO 13485 certified?