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Benefits of QMS

ISO Consulting

What is ISO?

Medical Devices & Labs

ISO 14000 Environmental MS
Expert Resource specializes in all of these standards. Our consultants provide comprehensive services including document development, training, implementation and consulting.



ISO Management Systems Standards
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
ISO 14001 Environmental Management System
ISO/TS 16949 International Automotive QMS
Automotive Processes PPAP, APQP, MSA, FMEA, SPC
ISO 17025 Inspection and Calibration Laboratories QMS
TL 9000 Telecommunications QMS
OHSAS 18001 Health and Safety MS
ISO 22301 Business Continuity Management System (BCM)
ISO 50001 Energy Management System (EnMS)



 
ISO Management Systems
ISO Management Systems
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.

So 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.
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Our Approach: Focus and Guarantee
 
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 registration. This means that your organization will realize benefits quickly. In some cases, we have been as fast as 4 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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