ISO 9001:2000 Certification 
In 1996, VRI was the first contract manufacturer in Rhode Island
to complete formal ISO 9002 certification. After a rigorous
six-month period of preparation and training, we received our
certification from NTSCS (National Technical Systems Certifications
Service). Following the original certification, we were required
to recertify every 6 months. This year, after satisfactorily
passing the new standards and requirements for ISO9001:2000,
we received the ISO9001:2000 certification. This new status
began in June of 2003. At VRI, improvements in the documents,
formal manuals and processes are an ongoing effort with enhancements
and changes incorporated on a regular basis.
ISO 9001:2000 requirements govern nearly all functions at VRI
including the following important factors along with many others:
quality assurance, material procurement, employee training,
production documentation, test records, and handling of discrepant
material. We have found that ISO 9001:2000 is more than a requirement,
it causes good business practices.
>Click
on image to view our ISO Certificate (ADOBE PDF Format)
FDA Compliance and Registration
In 1997, VRI passed a formal inspection conducted by the Food
and Drug Administration (FDA) of the US Department of Health
and Human Services. We were “found to be in compliance
with the applicable requirements of the Federal Food, Drug
and Cosmetic Act and implementing regulations.” This
initial inspection and approval enabled VRI to manufacture
an Enteral Feeding Pump, and has since extended to several
subsequent medical fabrication jobs including our most recent,
a portable heart monitor.
Raytheon Vender Qualification
Earlier this year Raytheon conducted a comprehensive Vender
“Supplier Quality System Survey” at VRI. This
survey addressed sixteen Quality Assurance processes. Raytheon
surveys of this type reflect a pass down of the requirements
of Mil-Q-9858 for Quality Assurance and Mil-I-45208 for Inspection
of Workmanship. The survey in effect “harmonizes”
our ISO 9001:2000 Quality Assurance Plan with the requirements
of the US military specifications. The survey identified nine
minor discrepancies, which have been resolved with the Raytheon
inspector and corrective actions taken. A reaudit is planned
and discussions between our QA Manager and Raytheon assure
confidence that we will become a fully qualified vender by
the end of the year.
ANSI/J 001B Soldering and ESD
Training
Earlier this year fourteen Assembly Technicians and
Management personnel completed a formal course in soldering
workmanship and ESD training. Qualified instructors from Raytheon
conducted this training. Each of the VRI technicians (and
managers as well) was certified for up to ANSI/J 001B, Level
3 workmanship. Level 3 is required to satisfy full military
specification level contracts.
Mil-Q-9858 Quality for
Military Hardware
Mil-Q-9858 is the toughest Military specification dealing
with quality. It covers all aspects of electronic assembly
for items that will be used in military combat systems. While
VRI is not formally qualified to this specification, we have,
harmonized our ISO 9001:2000 requirements with applicable
portions of Mil-Q-9858 that are contract requirements for
Raytheon, as noted above in the section discussing vender
qualification.
Mil-I-45208 Magnified Inspections
Visual inspections of manual workmanship, surface mount component
placement and reflow integrity, and automated solder connection
quality are conducted to applicable sections of Mil-I-45208.
A Vision Stereo Dynascope viewer adjustable from six to forty
power magnification with side looking prism for under component
visibility is used for these inspections.
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