Whats included in the Medical Device QMS template pack?
Pack includes quality management system templates for developing Policies, Standard Operating Procedures (SOPs) and Work Instructions for the following areas of your business: • product information, quotations and orders • product development • production and quality planning • purchasing and receiving • production • labelling, packaging, shipping and distribution • monitoring and measurement of products • monitoring and measurement of the Quality Management System • monitoring customer feedback and satisfaction management policies, planning and commitments • management review • human resources • plant, facility and equipment • information resources • measuring and monitoring devices • continual improvement These areas are specified as being essential components of a medical device quality management system by the various regulatory bodies e.g. TGA, FDA.
