NOVO Engineering’s quality management system (QMS) has been certified to ISO 13485:2003 and ISO 9001:2008 standards by accrediting body DNV GL Nemko Presafe A/S as of Q1 2015. Our QMS was developed in house so that we could tailor the procedures to the needs of a product development engineering business model.

NOVO needed a QMS with core procedures that applied to all projects, while other only to medical device and diagnostic product development efforts. The system also needed to account for the fact that we may be engaged for an entire product development lifecycle or only for a specific phase of development. Our solution is a highly-specialized QMS that is integrated into our workflow automation software to facilitate compliance.
To develop the QMS, NOVO’s quality manager defined procedure categories that correlate to the sections of ISO 13485:

  • QMS documentation requirements
  • Management responsibility
  • Resource management
  • Product realization
  • Measurement, analysis, and improvement

The quality manager worked with senior management and process owners for each procedure to develop a robust system. “Quality isn’t something one person creates and delegates,” NOVO’s quality manager says, “Quality is the output of everyone’s efforts.”

NOVO’s ISO certification and quality system have proven to be a significant benefit to our medical device startup clients. “When we engage with medical device start-ups, they may not have established their own QMS yet, but they can hit the ground running on their development by working under the design and document control of our QMS,” says NOVO’s quality manager. Later, when the client receives certification for their own QMS, we can transfer design control, risk management, SOPs, and other project documentation into their system.

NOVO will be recertified in 2017 to the new revisions of ISO 13485 and ISO 9001.

Read more about our QMS here.