As an initial step, we highly recommend that manufacturers perform a thorough Gap Assessment against any new regulations (or standards, guidelines, etc.). This allows the company to develop a regulatory strategy to fulfill its obligations and ensure ongoing compliance. We offer gap analysis services to support you in this process.
QMS
Quality Management System Setup
Complete setup of your QMS to fit the scope and role of your organisation. As a minimum, this service includes the Quality Manual and major quality procedures which may be used as a foundation to develop the system further. Offer retraining to your employees to keep your QMS up to date and ensure proper document maintenance.