| Expert
Resource specializes in all of these standards. Our consultants
provide comprehensive services including document development,
training, implementation and consulting. |
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ISO Management Systems Standards
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ISO 9000 |
The general Quality
Management System (QMS) by which most others are based |
ISO 13485
ISO 15189
ISO 14971 |
International Medical
Devices QMS, Medical Laboratories, Medical Risk Management |
| CMDCAS, CMDR |
Canadian Medical Devices
QMS |
| Medical Devices CE Mark 510(k) |
Technical File Standards
for In-Vitro Diagnostics (IVD) and other Medical Devices, European
Union, and FDA |
| AS9100, AS9110, AS9003,
AS9120, AC7004 |
International Aerospace
QMS |
| Nadcap |
Aerospace and Defense
Contractor Accreditation Program |
| MedAccred | Medical Device Contractor Accreditation Program |
| ISO 14001 |
Environmental Management
System |
| IATF 16949 |
International Automotive
QMS |
| Automotive Processes |
PPAP, APQP, MSA, FMEA, SPC, CQI-9 |
| ISO 17025, AC7006 |
Inspection and
Calibration Laboratories QMS |
| TL 9000 |
Telecommunications QMS |
| OHSAS 18001 |
Health and Safety MS |
| ISO 22301 | Business Continuity Management System (BCM) | | ISO/IEC 27001 | Information Security Management (ISMS) |
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ISO Management Systems
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ISO
Management Systems standards establish internationally recognized best
practices for the management of an organization. When implemented, they
result in a solid foundation for process management and continuous
improvement.
ISO Management Systems are typically audited by a 3rd Party Registrar to
ensure international recognition of your
management system. Hundreds of thousands of organizations around the
world are registered to the general quality management system (QMS) ISO
9000.
Other than the ISO 14001
environmental management system, most other management systems are
derivatives of ISO 9000 with specific industry requirements. Such
industries include automotive, aerospace, telecommunications, health
care, medical devices, software development, manufacturing, and service
industries.
Learn more about our ISO Consulting methodology and step-by-step
implementation. 
read more |
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Our Approach: Focus and
Guarantee |
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| ER's approach to
Management Systems consulting is very comprehensive, flexible, and
affordable. Our consultants maintain a 100% success rate of
attaining registration upon first attempt. ER also offers a compliance
guarantee! Expert Resource guarantees that your
documentation prepared by ER will pass the final audit, regardless of
which registrar you choose to audit your management system. Beware of
consultants who only guarantee based on the registrar they choose for
you. |
ER’s clients take only 6 months or less to achieve registration.
This means that your organization will realize benefits quickly. In
some cases, we have been as fast as 2 months.
ER is a full service provider of consulting, training, document
preparation and project implementation (in English and Spanish). While
most projects are provided as a comprehensive program, a la carte
training and consulting services are also available.
We've re-thought the typical approaches to consulting and avoid the
pitfalls that can be associated with such an important organizational
change. Expert Resource uses a proven methodology to implementation
while customizing the project for each client. ER focuses on your
strategic goals, needs and company culture to create the right
implementation approach.
Unlike most consultants who provide generic documentation templates,
with ER your management system will reflect the way you do business.
Typical consulting companies provide compliant templates that result in
documentation that does not truly represent your organization. ER
focuses on creating complete, customized and compliant
documentation by interviewing your internal process owners. These key
employees take ownership as the authors while ER becomes your
expert resource. Your business disruption is reduced because your
employees rely on ER to write the documentation and provide an
efficient, effective management system.
Our main emphasis is to help your organization create a management
system that is more than just compliant, but rather providing multiple
benefits as well. Creating a management system that is a tangible
benefit to your company is more difficult than just compliance. ER is
unique in that we are continuous improvement experts with well-rounded
backgrounds. If you want to do it right, you’ll seek assistance
from experts that re-think the way typical consulting and training is
provided. |
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