Connecticut Facility Awarded Two ISO Accreditations: 9001:2008 and 13485:2003
posted by Jane Burbach on April 15, 2010
On Wednesday, January 6, 2010, Dave Kelly, General Manager, Spectrum Plastics Group Connecticut facility, announced the facility has upgraded its International Quality System from ISO 9001:2000 to ISO 9001:2008. In addition, the Connecticut facility was also certified for ISO 13485:2003 at the same time. The new certificates were awarded on December 31, 2009, by UL DQS Inc, an ANAB accredited registrar.
ISO 9001:2008 is the latest revision of the ISO Quality Management System standard which has become the global benchmark for providing assurance about the ability to satisfy quality requirements and to enhance customer satisfaction in supplier-customer relationships.
ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
"Our team put in some long hours and did a great job at transforming our Quality Systems to the most current International Standards" stated Kelly. "Working with our corporate quality management team from our Minnesota facility has allowed us to implement best practices and improve our overall processes, which greatly increased the efficiency of the entire ISO qualification process," continued Kelly.
Both ISO certifications, 9001:2008 and 13485:2003, require meeting or exceeding a wide range of global quality management standards spanning manufacturing and assembly, product development, control monitoring and measuring, quality management, shipping & receiving and supplier processes, and customer satisfaction, among others. To ensure ongoing quality compliance, certified organizations also participate in follow-up audits every six months.
Spectrum Plastics Group operates production facilities located in Minnesota and Connecticut, serving a large geographical customer base. Focused on the medical device industry, Spectrum Plastic Group provides a wide range of injection molding services, including:
In addition to injection molding services, Spectrum Plastics Group operates two rapid prototyping divisions, Protogenic located in CO which serves the middle and western US and Dynacept located in NY which serves the eastern and southern US. Both divisions offer SLA (Stereo-lithography), LS (Laser Sintering), RTV Rubber Molding/ Urethane Casting, CNC Machining, LSR Prototypes and Rapid Tooling and Rapid Molding.
Spectrum Plastic Group provides seamless transition from one step to the next regarding a customer’s product development process. We make sure your product receives the required time and attention.
Spectrum Plastics Group is a contract manufacturer, providing plastic injection molded components, sub-assemblies and finished products to Medical OEMs. The Corporate Office is located at 7309 West 27th Street, Suite 2100, Minneapolis, MN 55426.
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ISO 9001:2008 is the latest revision of the ISO Quality Management System standard which has become the global benchmark for providing assurance about the ability to satisfy quality requirements and to enhance customer satisfaction in supplier-customer relationships.
ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
"Our team put in some long hours and did a great job at transforming our Quality Systems to the most current International Standards" stated Kelly. "Working with our corporate quality management team from our Minnesota facility has allowed us to implement best practices and improve our overall processes, which greatly increased the efficiency of the entire ISO qualification process," continued Kelly.
Both ISO certifications, 9001:2008 and 13485:2003, require meeting or exceeding a wide range of global quality management standards spanning manufacturing and assembly, product development, control monitoring and measuring, quality management, shipping & receiving and supplier processes, and customer satisfaction, among others. To ensure ongoing quality compliance, certified organizations also participate in follow-up audits every six months.
Spectrum Plastics Group operates production facilities located in Minnesota and Connecticut, serving a large geographical customer base. Focused on the medical device industry, Spectrum Plastic Group provides a wide range of injection molding services, including:
- Design for Manufacturability - reduce cost associated with production
- Micro-molding – precision production of parts with complex geometries weighing less than 1 gram
- Implantable Devices – extensive experience with bio-resorbable and PEEK® grade resins
- Value-added services, including assembly, medical packaging, and sterilization management
In addition to injection molding services, Spectrum Plastics Group operates two rapid prototyping divisions, Protogenic located in CO which serves the middle and western US and Dynacept located in NY which serves the eastern and southern US. Both divisions offer SLA (Stereo-lithography), LS (Laser Sintering), RTV Rubber Molding/ Urethane Casting, CNC Machining, LSR Prototypes and Rapid Tooling and Rapid Molding.
Spectrum Plastic Group provides seamless transition from one step to the next regarding a customer’s product development process. We make sure your product receives the required time and attention.
Spectrum Plastics Group is a contract manufacturer, providing plastic injection molded components, sub-assemblies and finished products to Medical OEMs. The Corporate Office is located at 7309 West 27th Street, Suite 2100, Minneapolis, MN 55426.
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