Quality System Documentation
The way you conduct business, both internally and externally can benefit
if the processes are controlled by Quality documentation. This way you
move towards consistently repeating the best ways and improving those
that are lacking.
AQAS will document your quality documents, including the Quality Manual
and Procedure Manual which uniquely reflects the way YOU run YOUR
business.
There are a significant number of documents required to prove the design
control phase, covering planning, input, output, verification,
validation, review, change and design transfer. These design phases
comprise quality documents covering planning, specification
requirements, test, test protocols etc. All are subject to "Document and
Data control".
The Quality Manual describes what you do in order to comply with the
related International Standard, whilst the Procedure Manual describes
how you go about your business. Included in the Procedure Manual are all
the related report formats that you will need.
Medical device manufacturer's may require ISO13485 and the European
Communities Medical Device Directives (MDD) including one or more of the
listed annexes.
Uniform Product Recall, device listing or registering, TGA compliance,
Vigilance systems, Quality Plans, Declaration of Conformity, incident
reporting and feedback are all part of the quality documented
procedures, covering the advent of both Australian and export business.
Quality systems are not an add-on to your business, they are the way you
conduct your business.
It's just a better way of doing it !
Key Benefits
* Documentation provides the basis for consistency and improvement
* Your Customers should develop increased confidence in your
capabilities
* Accredited companies are more likely to gain larger market share
* New employees more readily pick up the correct way of doing their work
* The way you conduct your business is brought under control
E-mail: sales@aqas.com.au