FOR IMMEDIATE RELEASE: July, 7, 2006
CMSI ADDS TO THEIR CURRENT ISO 13485:2003 REGISTRATION BY ACHIEVING ISO 9001:2008 REGISTRATION
"Contract Manufacturing Solutions, Inc. is one of a select few firms in their industry to have taken this step. Compliance represents a COMMITMENT on our behalf to take our company far beyond the organizational standards of our competitors and to surpass our partner’s expectations for a quality organization," said Edwin Aguilera, President for Contract Manufacturing Solutions, Inc.
The certification is a program of the International Organization for Standardization, founded in 1946 to develop common manufacturing, trade and communications standards. The ISO standards provide a framework for an organization’s structure, management and operational systems and procedures, which together will ensure consistency, efficiency, and continuous improvement of services. ISO also helps identify weakness in processes and the root causes of problems so that continuous improvements can be made.
In today's global marketplace, medical device companies are utilizing ISO 13485:2003 as a platform to build their business management system. For many companies, registration to ISO 13485 is a key to securing and maintaining global business.
What is ISO 13485?
ISO 13485 is an international standard, recognized throughout the world for establishing a business management system specific to the medical device industry. Borrowing the structure of ISO 9001:2000, ISO 13485 is applicable to organizations that manufacture private label medical devices, in vitro diagnostic medical devices, and medical components.
Created by the International Organization for Standardization, ISO 13485:2003 is based on eight quality management principles: customer focus, leadership, involvement of people, process approach, system approach to management, continual improvement, fact based decision-making and mutually beneficial supplier relationships. When fully adopted, these principles have been proven to enhance organizational performance.
Benefits of Registration to ISO 13485:2003
Provides international recognition for US manufacturers
in compliance with the FDA Quality System Regulations
(21 CFR 820).
• Enables your organization to become more cost-effective.
Improves internal communications, efficiency and
resilience to change.
Improves product and process quality and provides a basis for meeting regulatory requirements.
Requires your organization to monitor and improve key business and customer satisfaction measures.
Certification to ISO 13485 satisfies a significant portion of the EU Directive requirements for marketing medical devices in Europe.
About CMSIContract Manufacturing Solutions, Inc. is a leading contract manufacturing facility of cutting edge technologies, instrumentation, and other services. Contract Manufacturing Solutions, Inc. provides full build-to-print solutions for manufacturing, research and development, assembly, and testing of instrumentation and other products. CMSI also provides solutions such as product design, product development, FDA 510K compliance and submission, quality systems support, R&D Support, 3D Modeling (ProE, SolidWorks, and AutoCad), in-house service support, and other services. Contract Manufacturing Solutions, Inc., better known as CMSI, has built its organization around the foundation of Building Products Today for a Healthier Tomorrow. The company is based in Weston Florida. For more information, please visit www.cmfgsolutions.com or call 954.424.9813.
Contract Manufacturing Solutions, Inc. enjoys an established track record of excellence with their customers. Their expressions of satisfaction and encouragement are numerous, and they intend to continue making advances and growth in the marketplace with more unique and effective products, services, and solutions.
Media Contact InformationContract Manufacturing Solutions, Inc.
1880 North Commerce Parkway
Weston, FL 33326