Quality Management Systems - Garza MD
Garza MD can help you in the development and implementation of a Quality Management System (QMS). The QMS will be compliant with ISO 9001, ISO 13485 or both. An integration with Information Security Management (ISO 27001) is also possible.
Optimization of an existing QMS is another area where Garza MD can be consulted. Involving you in every step of the process together we implement and optimize your QMS. We create practical and lean processes that make sense to your organization .
Optimization could be done by the automation of processes. Garza MD can advise on different QMS software tools and assist during implementation of these tools.
Advice and coaching for the QA department and the Management Team can be part of the support, especially in case of resistance to the QMS in the organization. As well as training for more understanding of the QMS in your entire organization.
Garza MD can perform internal audits and gap analyses to identify areas of improvement and / or shortcomings in compliance.
Together we decide how much assistance is needed.
Examples of specific areas and needs
Document control – Garza MD has extensive expertise in best practices on how to control all your documents of the design, development, production, maintenance and service lifecycle.
Design & Development – Trained as a designer, we speak the language of developers. Garza MD can motivate software and hardware developers to make quality assurance a living target and asset of the organisation. .
Production – Based upon a thorough technical background and work experience, the services of Garza MD may extend to the manufacturing processes. This includes the analysis of current ways of working, suggesting improvements and supporting the implementation of these.
QMS software validation – Software validation is often a complex and time consuming activity. Garza MD can support you in making software validation manageable by analysing your current process and simplifying it by removing unnecessary steps.