Management System (QMS) certification to meet new customer
Do you need EU
What is ISO
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.
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
National/regional regulations may allow design of devices to
be excluded from the assessment activity of lower risk
approach, supported by procedures for quality
Focus on the
customer, not just customer satisfaction
improvement, not just corrective/preventive action
What we do?
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
ISO 13485 QMS Implementation Support is loaded with advantages
for your organization.
We offer choices... you decide just how much support you need.
provides a process-based, documented, implemented, audited
Quality Management System (QMS), acknowledging all ISO 13485
quality requirements, ready for certification.
Full Support provides
everything in Basic Support, plus we will train and mentor
an Internal Quality Audit team for your organization.
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)
and implementation support for your value
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
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
to take the time to build a QMS to both reduce your costs and
"pass the audit," guaranteed!
we always offer No-Nonsense Pricing, all expenses included.
"Consultants" normally charge more than we do, and provide less
than we do. ISO
is a smaller business... dollar-for-dollar, we provide more
support! We welcome comparison!
proven, 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
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.
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
is our association of experienced, creative, enthusiastic
quality professionals committed to building and improving
quality systems while permanently reducing quality costs.