The ISO 13485-2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
About ISO 13485-2016
The ISO 13485-2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
An organization need not be in an active production stage of medical equipment in order to seek the ISO 13485 certification. Compliance with this ISO standard is regarded as steps towards meeting the inline standard requirements of Global Harmonization Task Force Guidelines (GHTF).
Incorporating the certification standard lays down a pragmatic approach for medical equipment manufacturers to inculcate the Medical device directives and also will help showcase organization’s commitment to safe manufacturing practices as well as indicate the quality of the pieces of equipment thus manufactured.
The ISO 13485 continues to remain a standalone document specification however, its applications and specifications are most of the times coordinated and harmonized with ISO 9001(Link to ISO 9001 page).
However, there are some key differences between ISO 13485 and ISO 9001
Difference between ISO 13485 and ISO 9001:2015
|ISO 9001||ISO 13485|
|Continous Improvement and the use of customer feedback||Establishing Policies , Procedures and processes and demonstrating products/services as fit for required purpouse|
|Continual Improvement of the quality management system||Mitigating Risk|
|Not yet required for regulatory approval||Required to support regulatory approval in some countries|
Benefits of ISO 13485 Certification:
This ISO standard has guidelines and specifications for a Quality Management System and will surely help manufacturers produce high-quality equipment for appropriate health care as well as customer satisfaction. Irrespective of whether an organization is looking to operate locally or expand its business to the global scale, acquiring an ISO 13485 certification will help with enhancing performance, get rid of uncertainties and broaden the avenues for new market opportunities. Companies with this certification also exuberate a commitment to manufacturing quality of the highest standards to customers as well as regulators. Here we list down some of the benefits of ISO 13485 registration:
- Vastly improve the access to new markets with a certified organization
- Deploy guidelines to review and improve the wide range of processes across the organization.
- Supply chain Performance enhancement and monitoring along with cutting overhead costs and boosting efficiency
- Illustrate safer and effective medical equipment production
- Fulfill Regulatory requirements as well meeting customer demands.