ISO Standards Certification

ISO 13485 is quality management for medical devices shares many similarities and differences with ISO 9001 Certification, the leading quality management standards developed by the International Organization for standardization.   While most revised standard follows ISO 9001’s new high-level structure Annex SL Structure, but ISO 13485 does not follow HLS, even though it was released after ISO 9001 Certification standard.   Today we’re viewing some similarities between these two ISO standards, and few areas major in which ISO 13485 and ISO 9001 get differentiated from one another.   What Is ISO 13485? An ISO standard that has been specifically designed and published for the safety and quality assurance of medical devices and related industries. This has successfully implemented the rock-solid instrument to all the manufacturers or producers of Medical Device industries for achieving reliability, trust, and unbreakable commitment from their end-user and custome...

ISO 13485 is an international standard for a medical device's system for an organization to develop and demonstrate a quality management system that consistently meets customer and applicable for regulatory requirements. The safety and quality of the public cannot be kept at risk. In order to demonstrate continual improvement and maintain the new adoption of the technology in devices is accepted to upgrade the organization with new medical devices. ISO 13485 standard is an effective solution to meet the comprehensive approach to a QMS is ad hoc. It places a more significant focus on regulatory compliance of the standard with less flexibility in the process of the organization.   ISO 13485:2016 introduces some changes from ISO 13485:2012. The major focus of ISO 13485:2016 Certification is a host of subtle, yet detailed, changes requiring more thorough documentation and records on risk management, the work environment, design control, and regulatory requirements to get fulfilled ...