Quality Registrations
- ISO 9001:2000 (Minnesota facility)
- ISO 13485:2003 (Minnesota facility)
- ISO 9001:2008 (Connecticut facility)
- ISO 13485:2003 (Connecticut facility)
- ISO 9001 : 2008 (New York facility)
Spectrum Plastics Group has been audited by our existing customers and the FDA and found to be compliant in the following:
- AS 9100
- cGMP, 21 CFR, Section 820
In addition, Spectrum Plastics Group has a full in-house metrology lab.
Clean Room Facilities
- ISO 7 - Class 10,000 - (1) Total
- ISO 8 - Class 100,000 - (7) Total
In addition, Spectrum Plastics Group has other controlled environments available for manufacturing your product according to your specifications.
Quality Methodologies and Processes
Spectrum Plastics Group utilizes the following methodologies and processes to ensure quality.
- Advanced Product Quality Planning (APQP)
- Statistical Process Control (SPC)
- Six Sigma
- Black Belts
- Green Belts
- Lean Manufacturing
- Kaizen Events
- 5S Activities
- Value Stream Mapping
- Kanban Systems