An organization or manufacturers must compare and understand the ISO 9001 and ISO 13485 for medical devices in Saudi Arabia:
- The scope of the two quality standards is the primary difference between ISO 9001 Standard and ISO 13485 Standard.
- ISO 9001 Certification in Saudi Arabia is the international standard that provides the quality management system specifications that can be applied to any organization regardless of its product, service, or size. The ISO 13485 in Saudi Arabia is an extensive management system that specifies for manufacturing of medical devices.
- The ISO 9001in Saudi Arabia permits an organization’s management team to assign quality responsibilities even without defining the roles. Whereas ISO 13485 needs to identify the management team member to be responsible for different aspects of the QMS for an organization.
- The ISO 9001:2015 and the ISO 13485:2016 approved a more in-depth focus on resource management, specified as different building, equipment, and IT resources.
- The ISO 9001in Saudi Arabia arranges product realization as a result of effective policies and procedures. It focuses on customer requirements to measure quality and offers operating standards that support quality product realization. ISO 13485 adds more comprehensive elements to improve customer satisfaction and safety. Verification of types of equipment. Process and risk management throughout the life cycle of the products.
- ISO 9001 focuses on a process-driven approach to continuous improvement. ISO 13485 gives a coarser definition of the different improvement methods that medical device manufacturers should keep in mind to ensure that the products are safe and effective.
- Some critical differences between ISO 9001 and ISO 13485 include standards for monitoring the performance of the products and feedback from customers.
- ISO 13485 frames on ISO 9001 to provide further requirements for effective management, documentation, and measurement to provide safe medical devices.
Factocert For ISO Certification:
Factocert is the best consultancy across Saudi Arabia that believes in working towards a pragmatic approach that outlines the requirements of the ISO Certification, CE Mark, and other international standards. For more information, visit www.factocert.com or write to us at firstname.lastname@example.org.