| MicroGroup establishes, documents, implements and maintains effectiveness of the QMS in accordance with the requirements of ISO 13485:2003 (Bethel Facility), ISO 9001/2008 (Medway Facility) and FDA QSR.
Process management is the foundation of the MicroGroup QMS. The key processes operating at MicroGroup are described in operating procedures. These documents, supplemented with the quality policy, work instructions, forms, and standards, describe in detail the functioning of the MicroGroup's QMS. Implementation of these key processes ensures that MicroGroup consistently meets the quality and performance requirements of customers in a timely, effective manner while ensuring traceability for each part.
For component and assembly manufacturing, MicroGroup evaluates and controls process risks through its quality planning and production control systems, including:
- Contract review
- Component supplier management
- Creation of product specific quality records
The MicroGroup documentation control system supports the QMS by providing controlled revisions of appropriate documents and by maintaining Product History Files and quality records.
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MicroGroup's Corrective Action and Preventive Action system provide the process for actions taken to eliminate the cause of nonconformities. Investigation is completed to determine the root cause and necessary action to prevent reoccurrence.
Measurement Capabilities:
- Gage, hand tools
- Calibrated, traceable to National Institute of Standards and Technology (NIST)
- First article inspection of purchased components
- Receiving inspection
- Job inspection
- First piece set up inspection
- In process inspection
- Final inspection
- Samples sizes developed per C=0 AQL levels and dimension tolerance
Advanced Measurement Capabilities:
- Non Contact Measurement Systems
- High Resolution Video Measurement Systems
- OGP Smartscope
- MeasurMind 3D MultiSensor Software
- Development of component specific inspection programs by trained in house quality technicians
- Starrett
- Onyx
- Optical Comparator
- Consistent measurement accuracy
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