The Quality System and Quality Improvement Process is supported by each department. Adequate Standard Operating Procedures exist in the respective departmental areas to ensure that every effort is made to meet the expectation of the customer. Operations Procedures Manual is implemented. The departments are capable of meeting intended requirements as an integral part of the organization. All employees have the essential skills to perform their functions in a contributory fashion.
Instruments employed are capable of measuring process variables to the required accuracy.
Quality Control procedures are fully integrated. Quality records are maintained, as specified.