|

2653 S. Iris St.
Lakewood, CO
80227 USA
303-985-7942
|
ISO 13485 Consulting
Develop new QMS
Upgrade or optimize an existing QMS
Conduct second party audits
Assist with certification audits
Implement documentation systems |
 |
ISO
13485 consulting services
Quality Works offers ISO consulting programs, on-line and on-site, to assist you in developing and implementing
an effective Quality
Management System (QMS) that meet the requirements of ISO 13485,
Council Directive 93/42/EEC for CE
marking of medical devices, and Canadian Medical Device Regulations (MDR). Our experienced consultants provide a full range of
services such as:
-
Development and implementation of new QMS
-
Upgrade or optimization of your existing QMS to establish
compliance with additional standards
-
Conduct second party audits, including
pre-certification audits
-
Development and implementation of
documentation systems
-
Assistance in certification audits
On-line
ISO Consulting Program:
Our on-line ISO
13485 consulting program may be suitable for those companies that need
minimum disruption of their operation and would like to save
consultant's travel expenses. Our online service is very similar
to traditional on-site consulting, except most communication
between our experienced consultants and clients is by phone and
e-mail. So to use this service, you will need internet access
and an e-mail address. With on-line ISO Consulting we will:
-
Based on information
you submit, provide you with a proposal and a firm quote
similar to this example
-
Develop
an implementation plan
similar to this
example
-
Include
free of charge any of our publications needed to document your QMS
-
Assist
you in development of top level documentation: Quality Manual and second
level procedures
-
Review
your procedures and records
-
Based on the
information you provide, issue monthly reports to ensure compliance with the
plan and timely completion of your project
On-Site ISO
13485 Consulting Program
Our on-site ISO Consulting program may be added to your on-line consulting service at your discretion to enhance achieved results. In this phase we recommend:
-
Training,
such as standard overview for management
-
Auditor training
-
Pre-certification
audit to ensure readiness of the quality management system and all employees
-
Certification
audit support. Our consultants
either worked for or with different registrars and know what registrars are
looking for
Affordable ISO Consulting Service
You now have a choice, on-line or on-site.
Use our services to best suit your needs: augment your staff,
assure ISO certification, resolve quality problems, qualify your
suppliers, pass your next audit, or relieve critical resources.
Understanding that time is money, our expert consultants will
help you get back to business quickly. With Quality Works'
on-site or on-line ISO 13485 consulting services, you can bring in
expert help at a fraction of the price you would pay a full time
consulting firm.
For a free no obligation proposal and quote, please complete
our
Request for a Quote
form.
Call us today to discuss
your specific ISO management system needs!
|