nex’ quality

Quality system

Do you need to establish, upgrade or feed your quality management system?

We are able to intervene at all stages and on all issues of your quality approach:

  • To select and manage the relationship with the notified bodies or authorities;
  • To simplify and optimise your quality management system based on an inventory of the existing system and recommendations to gain flexibility in adaptability and therefore, effectiveness;
  • To ensure your account for maintenance, coordination and management of the evolution of the quality system by adapting your strategy and standards and regulatory changes;
  • To implement a QMS that meets the quality standards of the health professions (ISO 13485, 21 CFR 820, JPAL, ANVISA, GLP, GMP, CMDCAS).

Our services can also include preparation for certification audits, as well as conducting your subcontractor audits.

Nex’quality is available as one-time coaching on specific missions or as outsourced services as part of an annual contract.

Business cases

Case 1

Outsourcing quality control

Case 2

Eliminating non-compliance permanently