Quality Plastics and Engineering
Plastimold is an ISO 9001:2015, ISO 13485:2016 (Medical) certified and AS 9100 (Aerospace) compliant quality plastics and engineering facility. Our processes ensure that our product is delivered on time and with zero defects. Quality is embedded in our culture and starts with the professionalism of our administrative staff, to each operator, and through out the engineering department. Plastimold truly understands what it takes to manufacturing a quality part not only the first time, but every time.
ISO 9001:2015 Certified
ISO 9001:2015 is an internationally recognized standard for creating, implementing, and maintaining a Quality Management System for a company. ISO 9001 certification provides your customers reassurance that you have established a Quality Management System based on the seven quality management principles of ISO 9001. In fact, ISO 9001 is such an essential and influential standard that it is used as the basis when industry groups want to create their own industry standards.
ISO 13485:2016 Certified
Adopting ISO 13485 provides a practical foundation for manufacturers to address the EU Medical Device Directive (MDD), the EU Medical Device Regulation (MDR), and other regulations, as well as demonstrating a commitment to the safety and quality of medical devices. It a focuses on risk, clarification of management responsibilities, clarification of training responsibilities, improvement to the facility requirements, better alignment of design and development requirements to many regulations, more emphasis on control of suppliers, requirements for traceability procedures, addition of complaint handling, and enhancement of product cleanliness requirements.
AS 9100 Compliant
AS 9100 is the most recent standard for organizations that design, develop or provide aviation, space and defense products and services, including parts, components and assemblies. It standardizes quality management system requirements for companies involved with the aerospace industry and supply chain. The standard does so by building off general ISO 9001 standards for quality management systems, adding industry-specific guidelines for the safe development, production and distribution of quality aerospace parts and products.
Federal Drug Administration Registered
As a medical injection molding supplier, Plastimold is registered with the FDA and can assist with the design and manufacturing of your device. We have experience with Class I, II, and III devices and are familiar with the different regulation and compliance issues associated.
Documented Inspection Process For Accountability
Each part produced in our facility undergoes a first article inspection. Our quality plastics and engineering team will perform a first article inspection (FAI) based on our quality checklist and criteria approved by our customers. Together we will define what is acceptable as a quality part and generate a part specification. Parts are checked for dimensional accuracy, functionally, key features, and cosmetic defects. Rejected parts are quarantined, reground, and recycled. Once customer approval is received on the sample parts, the job is scheduled or immediately begins production.
Once the job is in production, in-process inspections are done at predefined intervals. Parts are randomly sampled and inspected to verify they are in compliance with the part specification. Inspection information is stored in our automated enterprise resource planning system. Any part or mold issues are noted and will be addressed during the run and again at the end of the run before the mold is stored. Good parts are shipped and bad parts are reground and recycled.