Quality control is a process that is utilized to make sure a certain level of quality in a product or service. It might include whatever actions a business deems essential to offer for the control as well as verification of certain characteristics of a product or service. Usually, it involves thoroughly examining as well as testing the quality of products or the outcomes of services. The basic aim of this process is to make sure that the products or services that are provided meet specific requirements and characteristics, like being dependable, satisfactory, safe as well as fiscally sound.
Usually, quality control is confused with quality assurance. However, the two are similar, but there are a few basic differences. Quality control is concerned with examining the product or service — the result ‐ and quality assurance is concerned with examining the procedure that leads to the result. A company would use quality assurance to make sure that a product is manufactured in the correct way, thereby eliminating or reducing potential problems with the quality of the final product.
Progressive companies work on a Quality Assurance System. For medical Devices like Orthopedic Implants Quality Assurance System as per international standard – ISO 13485 is mandatory.
SIORA Surgicals has successfully implemented a Quality Assurance System at its manufacturing unit at Rai complying to ISO 13485:2016. The company relies on controlling critical manufacturing processes to minimize the production of non-conforming products and weed out any product not meeting the desired quality standard from reaching the customer.
Process validation is done for all critical processes that may impact the quality of the finished product. In addition, quality control measures are also adopted at raw material, in-process and finished product stage of the process cycle. The corrective and preventive action may be related to machine, Method or Man. It may also raise the need for imparting adequate skills or training to the worker in the production line.
The Quality Assurance System is routinely audited both by an internal team of auditors as well as by external auditors to check compliance to stipulations of international Standard ISO 13485.