PRLog - Sep. 18, 2012 - WASHINGTON -- Washington, DC, September 18, 2012 – Global Pacific Manufacturing Group llc (visit us at http://www.gpacmfg.com ) has developed an ISO 13485 FDA QSR compliant quality management system in a modular format designed for rapid implementation and integration. The system consists of a complete ISO 13485 quality system crafted into 4 logical modules that can be installed in its entirety, by specific modules, or individual Standard Operating Procedures (SOP's) can be individually integrated into an existing system to address areas of non-compliance.
GPMG's ISO 13485 Modular Quality System
The GPMG modular quality system was originally developed to expedite factory relocation projects and to rapidly address quality system gaps identified during FDA QSIT preparation audits. The modularized approach also gives GPMG the ability to support the quality systems needs of start-up manufacturers and distributors who are typically faced with resource and cost challenges.
Common applications of the modularized quality system are existing manufacturers with compliance gaps, new divisions or start-ups, distributors, brand only companies outsourcing manufacturing activities, contract design facilities, and contract service providers
Potential benefits of the system include:
• implementation can follow a logical sequence
• increased control over implementation process
• simplifies project management and tracking
• providing a rapid solution for a specific need
• adaptable to varying organizational structures
• reduced time to certification and compliance
• reduced resources and costs
Global Pacific Manufacturing Group llc is a privately held global consulting company that provides engineering and manufacturing consulting services to the medical device industry.