Quality Assurance

Carmo's certified scope, verbatim from the certificate, is "" The QMS spans the full value chain on a single Danish site — design and development, tooling, injection moulding in ISO Class 8 production cells, downstream assembly and inspection in two fully validated ISO Class 8 cleanrooms, printing, packaging, and traceability documentation.

Yes — and longer than most. Carmo has run a certified quality management system since 1993, and certified to ISO 13485 since 2013. The current certificate below names the issuing body and its accreditation:

The certified scope, verbatim from the certificate: "" That covers Carmo's injection moulded components for both medical and technical applications. Two boundaries are worth knowing for medical-OEM regulatory planning: sterile and implantable medical devices are outside the certified scope, and rapid-iteration prototyping via Carmo Print Moulding sits outside the certified scope (the QMS engages at validation builds onward — see /en/services/rapid-prototyping/).

A component supplier. Carmo manufactures injection moulded components and assemblies that you — the medical-device OEM — incorporate into finished medical devices. Legal manufacturer responsibility under MDR (Regulation (EU) 2017/745) rests with you. Carmo's certified ISO 13485 QMS provides documentation, component-level traceability, and audit support for your MDR work, but Carmo does not make advisory notices, perform design validation activities on medical devices, or carry out installation or servicing — those rest with the legal manufacturer.

Two stages, both anchored on ISO 14644-1:2015 airborne-particle measurement. Injection moulding takes place in production cells classified as ISO Class 8 clean zones — shielded environments with HEPA particle filtration, pressure monitoring, and routine particle-count monitoring at 0.5, 1.0, and 5.0 µm size bands. Downstream assembly, inspection, printing, and packaging move into two fully validated ISO Class 8 cleanrooms at the same Danish site. Routine internal monitoring is complemented by recurring external verification by a specialist; bioburden monitoring is performed as a separate environmental control and not mixed into the ISO 14644 classification.

Component-level traceability is part of the standard documentation set under the certified ISO 13485 QMS: batch records, in-process controls, post-production inspection data, and material-lot traceability are maintained for components shipped from Carmo's cleanroom operation. Documentation depth is sized for medical-OEM supplier qualification and customer audit. Customer property protections also apply — your materials, drawings, and design data are not shared with others without written permission and do not leave Carmo's premises without explicit approval.

Yes. Carmo's certified ISO 13485 scope reads verbatim: "" Design and development are inside that certified scope, not adjacent to it. Supplier-qualification documents, on-site audits, and questionnaires are part of the routine engagement model from the design phase onward, served from the same QMS records that govern volume production. The QMS has been continuously certified since 2013; contact [email protected] to scope a specific audit.

Although Carmo is not a legal manufacturer of medical devices, control of non-conforming products — before and after delivery — plus rework activities apply to Carmo as a component supplier and are handled through the QMS's improvement process. Non-conforming components are identified, segregated, and processed per the documented procedure, with corrective and preventive action recorded under the certified ISO 13485 QMS. Management review covers improvement-process outcomes twice per year, alongside the company risk assessment and quality policy review.