There are many types of guidelines and regulations, often regulated by a authority, where a company has to deal with. E.g. guidelines and regulations regarding ISO 900X, GCP, GLP or GMP, but also for medical devices and the (medical)food industry. These guidelines and regulations will in many cases stress the company to develop and maintain a quality system. However, many companies have difficulties with the interpretation of the guidelines or regulations. PQM Consultancy can help you with this interpretation.
We advise, support and train your staff in setting up and maintain a quality management system (QMS). You must think of mapping your processes, make a plan for the introduction of a QMS, preparation of procedures (e.g. SOPs, work instructions, forms, templates), training of the established procedures, maintaining the QMS (document control) and perform change management for the QMS, buildings, processes and systems.