|
2653 S. Iris St.
Lakewood, CO
80227 USA
303-985-7942
|
ISO 13485 Consulting
on-site
Development of new QMS
Optimization of an existing QMS
internal and supplier audits
Assistance with certification audits
Implementation of documentation systems |
 |
ISO
13485 2003 Consulting On-site
Quality Works offers ISO 13485 on-site consulting programs to assist your
organization 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 (CMDR). Our experienced consultants provide a full range of
services such as:
-
Development and implementation of the new
ISO 13485 QMS,
-
Upgrade or optimization of your existing QMS to establish
compliance with additional standards and regulations,
-
Conducting internal and supplier audits, including
pre-certification audits,
-
Development, implementation and optimization of
documentation systems,
-
Assistance in certification audits.
When you choose Quality Works to assist you
in development of your ISO 13485 2003 quality management system, your consultant will:
-
Conduct detailed gap analysis of your
current quality management system,
-
Review your lower level procedures and records,
-
Develop your ISO 13485 project implementation plan
similar to this example,
-
Include free of charge any of Quality Works documentation needed
for your ISO 13485 quality management system,
-
Assist you in development of the top level
documentation: ISO 13485 or integrated Quality Manual and second level procedures,
-
Issue monthly progress reports to ensure compliance
with the project plan and timely completion of your ISO 13485 implementation project,
-
Provide necessary training,
-
Conduct auditor training,
-
Conduct your pre-certification audit to
ensure readiness of your quality management system and all employees for
your certification audit,
-
Provide certification audit support.
For a free, no obligation
proposal and a quote for your ISO 13485 2003 project, complete our
request for a quote or
call us today to discuss your
specific needs.
|
