Commitment to Quality

  • We have over 32 years of experience developing and manufacturing high technology medical analyzers and medical devices
  • We have more than twenty client OEM partners
  • We have launched over 90 new instruments for Nova or our partners and have received more than 87 FDA 510(k) clearances
  • Characteristics are high quality, low cost, and focus on customer deadlines

Much of Nova's success can be attributed to an aggressive quality philosophy which includes the goal of manufacturing products that surpass the stated specifications. To meet this goal, Nova has established an innovative Product Line Quality Committee (PLQC) process for each client. This process establishes a cross functional quality team that includes the client. For each product we manufacture, the teams proactively address quality, operational, and cost issues. To develop truly successful long-term partnerships, we know it takes more than just designing and manufacturing good products. The PLQC is one aspect of Nova's commitment to total customer service.

 
 

Raw Data

PLQC

Monthly

(Product line Quality Commitee)

Management Review

Semi Anually

Customer Complaint Data

Manufacturing Quality Data

Failure Analysis Data

Members:

  • Technical Program Manager or Development Program Manager (Chairperson)
  • Manufacturing Manager
  • Technical Services Manager
  • Quality Assurance Representative
  • Engineering Representative
  • Strategic Partner

Charter:

  • Identify Top Problems Impacting Field Performance
  • Propose and Qualify Solutions
  • Manage Field Implementation of Solutions
  • Set Annual Quality Improvement Goals

Members:

  • President, V.P's of R&D, Manufacturing, & Technical Support

Updated On:

  • PLQC Activities
  • Progress Against Top Problems
  • Progress Against Quality Goals

Charter:

  • Resource Allocation

Regulatory Compliance

Nova is an FDA-registered manufacturer of medical products and we have never needed to conduct an FDA mandated product recall. All design processes and manufacturing procedures comply with FDA Quality System Regulations (QSR), ISO 13485:2003, and ISO 9001:2008 requirements.

ISO 13485 and ISO 9001, TUV Certified World Class Quality

Nova has been awarded ISO 13485:2003 and ISO 9001 international quality certifications, quality standards recognized by over 90 countries. As a natural evolution of Nova’s world class quality philosophy, ISO standards require that a company develop, document, and effectively implement comprehensive quality systems from research and development to manufacturing, delivery, and customer support.