ISO 13485 is the quality
management system standard for medical devices. This standard applies the
ISO 9001:2000 process
approach to quality, and replaces ISO 13485:1996 and ISO 13488:1996.
ISO 13485:2003 provides an effective base model for compliance with the EU CE
marking Medical Devices Directives (Annex II, V, VI) and Health Canada CMDCAS*
(class II, III & IV devices) requirements. ISO 13485:2003 is also
considered to be fully compatible with the FDA QSR.
Note: National/regional
regulations may allow design of devices to be excluded from the assessment
activity of lower risk devices.
ISO 13485
requires
A process approach,
supported by procedures for quality
Focus on the customer, not
just customer satisfaction
Continual improvement, not
just corrective/preventive action
QualityAdvantage
provides proven, proprietary
implementation and training support to assure that your
organization meets applicable ISO 13485 requirements promptly and
effectively.
A certified ISO
13485 Quality Management System will
Assure you meet all customer
quality requirements
Improve your
organization's competitiveness
Eliminate waste
Reduce risk
Control process variation
QualityAdvantage
ISO 13485 QMS
Implementation Support
is loaded with advantages for your organization.
We offer choices... you decide just how
much support you need.
Basic Support provides a
process-based, documented, implemented, audited Quality Management System
(QMS), acknowledging all ISO 13485 quality requirements, ready for
certification.
Full Supportprovides everything in
Basic Support,
plus we will train and mentor an Internal Quality
Audit team for your organization.
QualityAdvantage will witness your
certification audit, if you choose.
Everything we
provide meets one or more ISO 13485 requirements,
including
a quality manual unique
to your organization, acknowledging all ISO 13485
requirements (no "gap assessment" required)
documentation and implementation
support for your value-added
quality management system
development of a simple, effective document and
record control system
training of an Internal
Quality Audit Team, if you choose
a mentored, full system audit of
the new quality management system (no registrar
"preliminary assessment" required)
corrective/preventive
action support from the full system audit
recommendation for an
economical, effective registrar, if you choose
our witness of your
registration audit, if you choose
We take the time necessary to custom fit all
applicable ISO 13485
requirements to your organization. No “consultant” is as willing and
able as QualityAdvantage
to take the time to build a QMS to both reduce your
costs and "pass the audit," guaranteed!
At QualityAdvantage,we always offer No-Nonsense
Pricing,
all expenses included.
"Consultants" normally charge more than we do, and provide
less than we do.
QualityAdvantage
is
a smaller business... dollar-for-dollar, we provide more support!
We welcome comparison!
QualityAdvantageproven, proprietary implementation and
training methods assure your organization meets all ISO 13485 requirements in
minimal time and at lowest cost.
Your organization
is very busy...
everyone wears more than one hat.
Time to implement a quality management system is often
limited.We take less time to get you certified.
Quality system implementation is a "team sport..." however, if your
organization does not have the time, we can deliver a turn-key system,
guaranteed to get you certified.
Our methods never include one-size-fits-all,
“cookie-cutter” approaches.
ISO 13485 quality systems requires process
approaches, customer focus, and continual improvement. You cannot get
that from a cookie cutter.
Most importantly, our quality management systems improve your bottom line.
“Cookie cutter” approaches do not work, and only add cost.
Warning!!
We have seen so-called "Quality System kits" or
"ISO 13485 Quality Kits" offered online. These products do not
provide a QMS that will "pass" an ISO 13485 certification audit.
More importantly, these kits do not reduce quality costs. There
is no one-size-fits-all solution!
When we leave, the quality management
system is yours, not ours.
We provide all the knowledge and
experience your organization needs to effectively manage and improve your
certified QMS in the future. When we are finished, your organization
owns your ISO 13485 quality management system.
QualityAdvantage
is our association of experienced, creative, enthusiastic quality professionals
committed to
building and improving quality systems while
permanently reducing quality costs.
This is what we do... we would welcome the opportunity to work with you!
Your name
Your company
What you need
Your e-mail address
Your phone
Thank-you! We will contact you as soon as
possible.
