The framework governing Quality Management Systems (QMS) is exclusively normative (ISO 9001 standard, compliance with which is voluntary). However, Environmental Management Systems (EMS) may be governed by the ISO 14001 standard or by the European EMAS Regulation1 , in addition to other multiple legislation. Occupational Risk Prevention Management Systems (OHSMS) are also covered by both laws and voluntary standards (Law 31/95, ILO-OHS-2001 and ISO 45001). For its part, ISO 13485:2016 is based on the ISO 9001 process model approach and is a management system standard developed specifically for the production of Medical Devices (MD). Its main objective is to facilitate the harmonization of regulatory requirements for DM products. The standard contains specific requirements for the manufacture, installation and maintenance of these products.

At SOUL QUALITY, we support you with the preparation and implementation of ISO standards, according to the scope determined by your institution. We are convinced that we will be your allies in the fulfillment of your objectives based on the best continuous improvement.