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QMS Guidance/Training
 
An ISO certification in ISO9001, ISO13485 or AS9100 gives customers the confidence they need to do business with your organization. To become certified is a big step in the right direction for company growth while receiving a return on investment. Your customers will know that every aspect of manufacturing is controlled, that checks and balances are in place to prevent failure. Apex Consulting will:

 

  • Determine the type of certification your company requires.

  • Create a QMS that will benefit the organizations growth

  • Train personnel to the QMS

  • Work with management to get the organization certified

Interal Auditing
 
Internal auditing plays an integral part in evaluating the health of the QMS. Missing elements of the standard or procedures or not being followed can lead to NC's during a certification audit. Apex Consulting will:

 

  • Evaluate the company QM to the standard

  • Perform internal audits on the QMS

  • Create summary for each audit

  • Create NC's for any findings

  • Administer procedural changes of  any NC findings through the companies CAPA system.

  • Review with management audit findings and proposed changes.

Paperless QMS

 

A paperless QMS system helps strengthen and organize the QMS during the certification audit. Also, prevents unauthorized or uncontrolled documents from being used within the organization. Apex Consulting will:

 

  • Evaluate and organize the company QMS

  • Create an electronic signature process

  • Develop electronic paperless procedure

  • Convert procedures, forms and associated documents electronically

  • Set-up electronic training & online administration

JobBoss use for QMS

 

The JobBoss system can be used as a powerful tool for the organizations QMS. An extension to Paperless QMS service, this procedure will track electronically CAPA's, NC's,MR's Procedural changes and other vital aspects of the QMS. Generate reports and approve all operations paperless within the JBS with no other software required. Apex Consulting will:

 

  • Evaluate the organizations use of the JBS to be certain the tools required are present.

  • Create a procedure to track QMS requirements.

  • Train personnel to use the JBS to track, approve, report and generate electronic requests

  • Set-up the JBS to create requests

  • Provide the necessary forms to execute the system effectively

Risk Management
 
Risk Management is an integral part of ISO13485 for mitigating the risk of each process to be certain failure does not occur. Apex Consulting will:

 

  • Evaluate the company QM to the standard

  • Perform FMEA(Failure mode effect analysis on each critical operation of the organization.

  • Create summary of risk for each operation

  • Create NC's for any findings

  • Administer procedural changes of  any NC findings (if applicable)

  • Review with management Risk assessment findings and proposed changes.

Grant Assistance

 

A grant is beneficial to any business large or small used to fund a QMS system (ISO9001, ISO13485, AS9100),  software, or other training used to help the organization grow. Apex Consulting will:

 

  • Evaluate the type of QMS that fits the organization based on the type of work performed. 

  • Help get the grant approval

  • Develop the company's QMS based on the type of grant

  • Train personnel on new procedures

  • Close out the grant to be certain all criteria has been met

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