SERVICES:

ISO Management Systems

Nadcap

Medical Devices

Lean Manufacturing

Employee Training Courses

California Training Funding

State Funding for Consulting

Federal Funding for 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

IVD & Medical Devices Technical Files 

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 US Aerospace and Defense Contractor Accreditation Program
ISO 14001 Environmental Management System
ISO/TS 16949 International Automotive QMS
Automotive Processes PPAP, APQP, MSA, FMEA, SPC
TE-9000 Automotive Tooling & Equipment Supplement QMS
ISO 17025 Inspection and Calibration Laboratories QMS

TL 9000

Telecommunications QMS

OSHAS

Health and Safety QMS

 

 

 

ISO Management Systems implement best practices for the management of your organization.  They focus on setting consistent processes for most every area of your company, ensuring a minimum of quality assurance and customer satisfaction.  These standards can be either US Domestic or International and are typically audited by 3rd party registrars.  

ER specializes in consulting, training and document development that creates a system that is of true benefit to your company, not just compliance.   read more

Nadcap is the leading worldwide cooperative program of major companies designed to manage a cost-effective consensus approach to special processes & products and provide continuous improvement within the aerospace & automotive industries. 

Expert Resource provides document development, training and consulting services to prepare a company for the Nadcap audit.     read more

 

Medical Device and Medical Laboratory 

Standards and Regulations

Medical Device manufacturers and Medical Laboratories are required to meet domestic and international standards for product quality and management systems.  ER provides comprehensive consulting, training and document development for these standards and regulations.  

ISO 13485, CMDCAS, ISO 15189, 510(k), CE Mark, In-Vitro Diagnostics, Technical Files, FDA submissions, ISO 14971, FDA resolution, GMP, QSR, CMDR, Clinical Trial, TGA, etc.      read more

 

ER provides California State Funding to offset the costs of training and consulting.  Many of our clients have 100% of their training costs reimbursed through funding opportunities.  Our clients average $1,000 of funding per employee!    read more  

 

ER works with a cadre of training companies and experts around with world.  We provide courses in hundreds of topic areas.  Just ask and we'll provide your with an expert trainer and curriculum in any subject.

In consortium with our parent company CalTraining, Inc., ER provides company-wide training needs assessments and the resources to fulfill any training courses required over a one to two year period.  Many small and large corporations depend on ER and CalTraining for all of their training needs.     read more

 

Lean Manufacturing is a systematic approach to design, manufacture and market a product of a higher quality, in a shorter time frame, at lower cost with more variety.  The Lean Manufacturing tools can be used to improve almost any business.  It is not uncommon to improve profitability by 100% to 500% over a 1 to 3-year period.

Common Lean Manufacturing Tools include Kaizen, 5S, Total Productive Maintenance (TPM), Value Stream Mapping (VSM), Standardized Work, Just In Time (JIT) Inventory, Pull Systems, Takt Timing, Cellular Manufacturing, Visual Controls, Statistical Process Control (SPC), Production Flow Smoothing, and Set-up Time Reduction.

Lean Consulting is customized to your organization's current manufacturing situation and typically includes a combination of training, hands-on preparation and hands-on consulting.   read more

 

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