The Marble Medical Commitment to Quality
Our entire Marble Medical team is continuously driven to improve their performance levels in terms of:
- Output quality
- Seamless interaction with our customers - worry-free customer order fulfillment - on-time deliveries as specified
- Engineering efficiencies in product design, material sourcing, and process design into the products we make, all of which minimize both direct and indirect costs for us and our customers
We are cGMP compliant for class lll medical devices and Active Pharmaceutical Ingredient applications as required.
We have ISO 9001:2001 certification as our base quality platform.
We manage all aspects of our quality process electronically through our custom-designed operating software system.
We recognize the necessity for traceability of all components in the products we make - not just the primary components. Our operating software system facilitates the tracking of each component used and each individual involved in the production of every product we make.
Stringent audit oversight consists of our own internal audit function in conjunction with our quality process; ISO registrant recertifications; regulatory agencies reviews; and customer audits.
We utilize our quality processes as a basis for continuous improvement. We are driven by our customers, our competitors, and most importantly, by our employees who recognize continuous improvement is key to our success and as a result, their livelihood.
Certifications
- FDA Registered Drug & Medical Device Contract Manufacturer - cGMP Compliant
(Number: 1053428)
- ISO 13485:2003 Certified
Certificate Number: FM 555516)
- ISO 9001:2008 Certified
(Certificate Number: FM 560032)
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