A partner behind every component, batch after batch, year after year.
In short: Carmo's quality management system has been certified since 1993, and to ISO 13485, the medical-device standard, since 2013, covering design, development, manufacture and assembly. Batch records and material-lot traceability are maintained for every component, and IQ/OQ/PQ validation is documented as a component moves into regulated volume production. You remain the legal manufacturer.
Carmo A/S's quality management system is certified to ISO 13485:2016 Medical devices quality management system by Bureau Veritas (accredited by DANAK), certificate no. DK020611. Scope: Design, development, manufacture and assembly of injection molded plastic components.
All Carmo plastic components are manufactured under the same QMS and procedures.
“We have integrated our quality management system into all our processes, so everything from design and project development to assembly is documented.”
Bettina Kok, VP Quality & Compliance
Every step is recorded, from raw material to shipped component:
The records stay at Carmo, open to your audit. With the goods you receive a Certificate of Conformity (CoC) and a Certificate of Analysis (CoA) where agreed.
Design and development sit inside the certified scope, so the same procedures govern your component in development and in volume:
Medical components are moulded, assembled, inspected, printed and packed in an ISO Class 8 cleanroom environment.
The cleanroom page covers what runs where, how it is monitored, and what it means for your device file.
Any component that runs for decades will raise a question sooner or later. When it does, the records and the people are on your side of the table.
The audit is a day; the partnership is decades. Carmo delivers batch after batch and stands behind every component in the field.
Evaluating suppliers? The 12 questions to ask an ISO 13485 injection moulding partner.
Send your supplier questionnaire, audit plan or the component drawing. We'll come back with what we can document for your file and propose an audit or visit slot; NDA first if you need it, and email ([email protected]) works for attachments.
Nine functional medical components in a medical-grade material: months taken out of a timeline that had already run long.
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Functional prototypes in the production material in 1–2 days, where a conventional mould tool takes up to six weeks.
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The buoyancy lock that holds the life jacket together: co-developed over two years for equipment that has to save lives.
Read the caseThe records stay at Carmo; what ships is a Certificate of Conformity (CoC), and a Certificate of Analysis (CoA) where agreed. Held at Carmo and open to your audit: batch records, in-process controls, post-production inspection data, material-lot traceability, and equipment and tool maintenance logs, maintained for every component Carmo ships under the certified ISO 13485 QMS. 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.
Through the documented procedures of the QMS, in full, even though Carmo is a component supplier and not a legal manufacturer: control of non-conforming products before and after delivery, rework, change control and CAPA all run under it. Non-conforming components are identified, segregated and processed per the documented procedure; corrective and preventive action is recorded under the certified ISO 13485 QMS. Management review covers the outcomes twice a year, together with the company risk assessment and the quality policy.
Two stages, both anchored on ISO 14644-1:2015 airborne-particle measurement. Injection moulding takes place in production cells in a classified ISO Class 8 cleanroom environment: shielded, with HEPA particle filtration 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 validated ISO Class 8 cleanrooms, where positive pressure is monitored. Routine internal monitoring is complemented by annual external verification by a specialist; bioburden monitoring and regular sample-based gloved-fingertip (finger-dab) testing are performed as separate environmental controls and not mixed into the ISO 14644 classification.
The certified scope covers design, development, manufacture and assembly of injection-moulded components (the certificate wording is on this page). The quality management system runs across the production value chain:
Yes. Carmo’s certified ISO 13485 scope reads verbatim: “Design, development, manufacture and assembly of injection molded plastic components.“ Design and development are inside that certified scope. Supplier-qualification documents, on-site audits, and questionnaires are part of the routine engagement model from the design phase onward, drawn from the same procedures and records as volume production. The QMS has been continuously certified since 2013; contact [email protected] to scope a specific audit.
Your drawings, materials and design data remain your property, so your sourcing strategy stays in your hands. Raise it in the qualification dialogue: we will say what the documentation set can support and what a realistic setup looks like for your component.
More than 80 years of continuous private ownership: one team from prototype to volume, no handover.
ISO 13485-certified quality management and an ISO Class 8 cleanroom environment: components with the documentation your audit asks for.
You bring the problem; we bring the know-how to solve it. We don’t walk away from the hard ones. Hear it from our customers.
