CMSI's Quality System is based on ISO 13485:2003, FDA, cGMP, and ISO 9001:2008 Requirements

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ISO 13485:2003

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FDA

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cGMP

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ISO 9001:2008





Quality is not taken lightly at CMSI, it’s our close attention to quality that is one of the reasons we are a prominent contract manufacturing facility in South Florida. Our pledge to quality has enabled us to earn ISO 9001:2008 and ISO 13485:2003 certification and to request that our out-sourcing partners are also ISO certified. Upon occasion we forge a partnership with a company that does not have ISO certification, in this event we have implemented a system in which we carefully screen our affiliates to ensure their services or products meet our rigorous guidelines.

Our quality plan is the basis for a business system that certifies quality from start to finish, from order placement to order fulfillment.

CMSI's Quality Standards

• ISO 13485:2003

• FDA

• cGMP

• ISO 9001:2008


Certified ISO Quality System Auditor on staff

The manufacturing sector is an industry in which dependability is not a luxury, it’s key. To ensure the highest quality products are delivered to our customers, we have administered ISO quality Assurance and Continuous Improvement systems. Our primary goal is to maintain a robust quality system that stresses defect prevention and reduction of waste in the supply chain. Some of the important features of our Continuous Improvement systems include:


Internal Quality Audits

CMSI has an Internal Audit system established, which audits all key elements of our business quality management system on an annual basis. The system determines whether quality activities comply with planned arrangements, and it also concludes the effectiveness of the quality system. These audits are performed by a qualified ISO internal auditor.


Continuous Employee Enrichment

CMSI employees are encouraged to excel in our business culture and to be proficient in their area of expertise. Employees are not authorized to work on their own until they obtain the proper training for each process they are associated with. All employees undergo retraining and recertification when applicable.


Calibration and Preventive Maintenance Program

All equipment at CMSI is assigned it’s own Calibration and Preventive Maintenance schedule, which is evaluated by a effective system and monitored on a regular basis.


Quality & Reliability Testing

We perform in-house testing and for testing that is out of our capability, we will pre-qualify and locate the proper testing facility on your behalf, if needed.


Quality Meetings

CMSI continuously puts effort towards improving each production process within our facility. A team of employees assemble in each area of production (not necessarily their own) and they identify areas that could be improved. This enables employees to be involved with improvement programs, while increasing knowledge about processes other than their own.


We cannot stress enough the importance of a strong quality system and the impact it has on an end product. We are very proud of the system we have in place and feel you too will be impressed. To request a copy of our quality manual, please contact our Quality Department.





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