subject: Perfecting The Elements Of Quality Management System Leads To Sure Certification [print this page] In improving profit status, sales are not the only means to achieving this goal. If you have an excellent quality management system or QMS, you are sure to reap the benefits from it. In a pharmaceutical company, high standards QMS leads to a good working environment for the employees, high quality medicine for the patients and less recall in the production line.
If you are looking for ISO certification, then there is no better way to do this than to improve your QMS. QMS is more than a process, it is a philosophy. The management needs to take some time and assess, understand and really commit to QMS to make it better than before. Once you start improvements and you ask your employees to increase their standards, a sustainable organization can be attained.
There are certain elements of QMS that needs to be focused on to be able to guide you and your company in the process. The first thing is the SOP or the standard operating procedure. SOPs should be second nature to your employees, knowing it by heart. It should be reinstated in every process, methods, forms, manuals and templates.
Another important element is the documentation. Every method should be well documented so that assessment is easier. Know how to classify documents accordingly and have a working filing system as well. For certification of quality management systems, the approval of documentation is needed. There should also be a smooth transfer of documents so that the department or team needing it has access.
All sorts of deviation from the procedure should be documented and filed into the deviation reports system. These goes for all related matters such as technical, quality improvements, customer complaints and health and safety deviation. Just make sure that the deviations are still covered by the standards for the certification of quality management systems
Other essential elements are vendor selection, evaluation and certification, product complain procedure, annual product review and GMP audit and training. As for the equipments being used in the manufacturing, make sure it passes the standards of esd 20:20. It is a standard approved by ANSI.
