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With the new ISO 13485:2003, developed for the Medical Device industry, ISO 9000:2008
and the current TS 16949 Quality System Standard, companies are not just looking
at documenting their process, but focusing on the process approach to activities
and their related resources.
Our ISO consulting philosophy states that in order for a client to understand the
total benefits of the Quality System, the entire organization needs to be involved.
We understand that every organization is unique in its own right and with our focus
on the client organization; we are able to tailor a program to their needs so that
all efforts fit within the ISO Quality Management Principles (For the full text
of the ISO Quality Management Principles go to:
http://www.iso.ch/iso/en/ISOOnline.openerpage):
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Brighton will identify and develop the Business Plan/Quality
Manual to ensure goals and objectives are defined according to the correct ISO Standard
for your business.
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We perform a review of the processes, procedures and work instructions in all functional
areas, as required to prepare the documentation necessary to achieve compliance
with the correct ISO Standard, as well as provide employee training on the new business/quality
system. Management reviews are established and implemented to complete the final
phase, which would be an internal audit of the Quality System performed by Brighton
prior to the third party ISO registration audit.
Brighton is proud to state that all of our ISO clients have received their certification
from the registrar after the FIRST registration audit.