Most organizations have systems in place that are designed to assure the quality of outputs from the organization. The size of the organization, and the business sector that it operates in, may drive decisions on the degree of formality required of the Quality System.

For example, in industries where compliance with Regulatory requirements is important, a fully structured, well documented approach is needed. ISO 13485 is a harmonised standard that provides information on Quality Management Systems for Medical Devices. The FDA Quality System Regulations (QSRs) is another document that is relevant to that industry.

Other industries may have less stringent, or different, Regulatory requirements, allowing for more flexibility with respect to the extent of the formality and documentation required of the Quality System. ISO 9001 may then be an appropriate standard to consider applying.

Whatever business you are in, we can help with assessing and implementing the most appropriate system for your needs.