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              EzQMS
  Features and Benefits

 

EzQMS provides an easy software solution to organize your current or new Quality System Documentation on your SQL Server or hosted by EzQMS. 

 

Feature:

Use your current documentation

Benefit:

Fast integration into your existing quality system saving you time and money without scrapping your current work.

 

Feature:

Use FDAISO customized compliant documentation.

Benefit:

Fast integration into your new quality system saving you time and money developing a Quality Manual, Procedures and Forms

   

Feature:

Organizes your documents for fast, easy retrieval

Benefit:

Reduces employee's current workload

 

Feature: 

Integrated Search Bar

Benefit: 

Quickly identifying related documents

 

Feature: 

Automated email notification of ECNs, CAPAs and NCRs

Benefit:

Keeps employees current on document or product changes and customer concerns

 

Feature: 

All documents become part of the ECN process for document control

Benefit:

Minimize risk of submitting an inferior product to your customer

 

Feature: 

Utilize a Matrix in EzQMS to your ISO, etc. Requirements

Benefit:

Hyperlinks to your controlled documentation and lets you see your Gaps in your objective evidence of required documentation and procedures if they exist

 

Feature: 

 Off-Site Locations

Benefit:

We can provide your off-site Sales Office, Corporate Etc. to have access to EzQMS using the Internet

 

Feature: 

EzQMS Web Hosting

Benefit:

Minimize the cost associated of maintaining a SQL Server and your IT Department for EzQMS. 

 

 

Feature: 

Pre-Installation of Purchased Quality Documentation into EzQMS

Benefit:

Have your Quality System up and Running fast with minor work left with procedures forms and work instructions

 

 

 

 


EzQMS Documentation 
        Enhancements

  
We have partnered with FDAISO and we now have a complete package that gets you up and running at the most economic price on the market.
  
Need a Quality Manual, Procedures and Forms for: ISO9001:2008, ISO13485:2003 FDA, CMDR or CE Marking?  

No Problem!  We have partnered with FDAISO and you can purchase these products from us and/or we can incorporate these documents pre-installed in EzQM or buy these documents direct and use in your current system...


    
    What we offer in
        "Documentation"


  Request Document Guidebook(s)

 


   1. ISO 9001 System™  is specifically       
      designed to meet the ISO 9001 standard.  
      Achieving ISO 9001 certification
      recogizes your company as a worldwide   
      leader in customer service...  $299.00

   2. ISO 9001 + CE Marking System™  is    
      specifically designed to meet ISO 9001    
      and CE Marking standards. Achieving      
      ISO 9001 certification recognizes your
      company as a worldwide leader in     
      customer service. CE Marking is required   
      by EU for products and services entering    
      the European marketplace...  $529.00

   3. FDA QSR System™  is specifically      
     designed to meet FDA QSR regulations 21
     CFR Part 820.  Required by FDA for      
     medical device manufacturing and     
     servicing. Also meets FDA’s 21 CFR Part 7
     (Recalls), 21 CFR Part 803 (Medical Device 
     Reporting), 21 CFR Part 806 (Corrections   
     and Removals) requirements for medical
     devices...  $499.00

   4. FDA QSR + Risk Analysis System™  is
     specifically designed to meet FDA QSR
     regulations 21 CFR Part 820 , ISO 14971
     standard for conducting FMEA’s. Required     
     by FDA for medical device manufacturing    
     and servicing. Also meets FDA’s 21 CFR
     Part 7 (Recalls), 21 CFR Part 803 (Medical
     Device Reporting), 21 CFR Part 806
     (Corrections and Removals) requirements
     for medical devices. The Risk Analysis
     section contains Procedures and      
     Spreadsheets for conducting Failure  
     Modes Effects Analysis...  $499.00

   5.FDA QSR + ISO 13485 + CE Marking + 
     CMDR System™
  is specifically 
    designed to meet FDA QSR and ISO      
    13485, ISO 14971, EN 980, Risk Analysis,   
    CE Marking, MDD 93/42/EEC standards,
    Health Canada SOR 98/282 and      
    Australian
    regulations. Also meets FDA’s 21 CFR    
    Part 7 (Recalls), 21 CFR Part 803     
    (Medical Device Reporting), 21 CFR Part     
    806 (Corrections and Removals)
    requirements for medical devices.
    CE Marking is required by EU for medical
    devices entering the European      
    marketplace. Also meets Canadian and
    Australian Medical Device Regulations.   
    Your company’s quality system will meet
    FDA and International medical device
    manufacturing and servicing Standards...       
    $629.00

   6. ISO 13485 + CE Marking System™ is  
    specifically designed to meet ISO 13485, 
    ISO 14971 , EN 980 , Risk Analysis , CE
    Marking and MDD 93/42/EEC standards      
    and regulations. CE Marking is required       
    by EU for medical devices entering the
    European marketplace. Also meets    
    Australian Medical Device Regulations.
    Your company’s quality system will meet
    international medical device       
    manufacturing and servicing standards...  
    $549.00

  7. ISO 13485 + CE Marking + CMDR
      System™
  is specifically designed to    
    meet ISO 13485, ISO 14971, EN 980,       
    Risk Analysis, CE Marking, and CMDR
    standards and regulations. CE Marking is
    required by EU for medical devices    
    entering the European marketplace. Also
    meets Canadian and Australian Medical
    Device Regulations. Your company’s
    quality system will meet international  
    medical device manufacturing and
    servicing standards...  
    $599.00

     

Copyright © 2009, EzQMS. All Rights Reserved.
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         About EzQMS

We provide Software that organizes and  enhances your ISO 9001, ISO/TS 16949(automotive), AS9100 (aerospace), ISO 14001 (environmental), ISO 17025 (laboratory), OHSAS 18001 (health and safety), ISO 13485 (medical devices),  TL9000 (telecommunications), ISO 22000/HACCP (food) Industries, FDA,
and CMDR (Health Canada).


Ez QMS incorporates easy access to your company's Quality Manual, Procedures, Corrective and Preventative Action, Work Instructions, Forms and Templates, Engineering Change Requests (Notices), Nonconformance Reports and much more.

Years of experience went into producing our Quality Management Software to ensure it provided: Ease of use / Ability to use your current forms/templates and documents which  are viewed in Microsoft Viewers / Network Capability / Documentation entered into Ez QMS is part of document control thru the ECN Process / Easy retrieval of your quality records / Email Notification to your Corrective and Preventative Action (CAPA), Non-Conforming Reports (NCR) & Engineering Change Notices (ECN). 

         Who we recommend
   
           "Consultants"

simpleQuE provides consulting, training and auditing services and
assist companies in achieving and sustaining certification to

ISO 9001, ISO/TS16949 (automotive)       AS9100 (aerospace),TL9000 (telecommunications), ISO/IEC 17025 (laboratory), ISO 14001 (environmental)    OHSAS 18001 (safety), ISO 13485             (medical), NQA-1 (nuclear), ISO 17020 (inspection)

 
simpleQuE also provide assistance and training with Internal audits and supplier audits, Problem solving, root cause analysis and corrective action Automotive core tools (FMEA, control plans, PPAP, MSA, SPC, APQP.

They are experts in the standards they  support and are certified lead auditors, third-party certification auditors, and business executives with extensive industry work experience, including EzQMS
.

          
www.simpleque.com

      
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