Initially started in 1996, the standard states the things required for QMS that helps companies execute and exhibit the abilities to provide high quality medical devices that reach up to customers and regulatory requirements.
ISO 13485 is the worldwide acknowledged standard by International Standards Organization for medical device Quality Management Systems. Focus to improve Consumers satisfaction with the effectual approaches of the system including the processes for improvising the system and assuring of conformity to the consumers and appropriate with the regulatory requirements.Needs to examine the ability to continuously supply product and services that meet customers and is applicable to legislation and regulatory requirements.
ISO 9001:2015 identifies pre-conditions/requirements for a Quality Management System when a firm, ISO 9001 2015 allows risk-based thinking while executing QMS, this means to recognize risk and chances in the processes to grow an efficient ISO 9001:2015 QMS with a strong customer focus. ISO 9001 provides effectual Risk assurance based QUALITY MANAGEMENT SYSTEM.QMS mainly focuses on enhancing customers satisfaction. ISO 9001 is globally known standard to describe the requirements for quality management system in all industries.
Iso 9001:2015 vs iso 13485:2016 matrix license#