Medical Devices- Quality Management System (ISO-13485:2016)
ISO 13485 is an international standard, published in 2016, that represents the requirements for a comprehensive “MANAGEMENT SYSTEM FOR THE DESIGN AND MANUFACTURE OF MEDICAL DEVICES”. The primary objective of the standard is to facilitate harmonized quality management system requirements for regulatory purposes within the medical device sector.
ISO 13485 follows the process approach that ISO 9001:2015 establishes and compliance take the form of updates. ISO 13485 provides a basis to effectively manage legal and regulatory requirements compliance as these are invoked by the USA FDA and equally EU CE medical device directives and equally other countries with due care.
Need of ISO 13485: 2016 Certification (Medical Devices- Quality Management System )
ISO 13485 requires that we monitor organizations through on site assessment of an organization’s regulatory requirements and legal obligations. Bench-marking of ISO 13485 provides recommendation, and thus granting a certificate confirms that the organization’s management system meet its regulatory requirement and legal obligations with due care. This means that certification of a management systems carries impartiality and competence to fulfill accreditation requirement whether regulatory requirement legal obligation or contractual agreement with due care.
Benefits of ISO 13485: 2016 Certification
Ensure compliance with the requirements of the standard and more
Streamline your processes, increasing efficiency resulting in significant time and cost savings
Gain a competitive edge with our independent, globally recognized third party certification
Benefit from using a single source for all your testing and certification needs
Take advantage of our wealth of international experience, expertise and global presence in the medical devices market
Facilitate planning, control, monitoring, preventive and corrective actions, auditing and review activities to ensure both that the policy is complied with and that the environmental management system remains appropriate
Be capable of adapting to changing circumstances
