ISO 13485 Certification
ISO 13485:2016 is the international quality management standard for the design and manufacture of medical devices. The current ISO 13485 standard is largely based on ISO 9001. The main differences between ISO 13485 and ISO 9001 are:
Continuous improvement is not a regulatory requirement; ISO 13485 requires the effectiveness of the QMS (Quality Management System) to be maintained.
Customer satisfaction is not a regulatory requirement, the goal being to provide safe and effective medical devices.
Certification to the ISO 13485 standard is particularly beneficial for organisations manufacturing medical devices but is also relevant to companies in the supply chain and offering service support to manufacturers.
If you export medical products and want to gain access to new markets, the standard provides a globally recognised quality system that may meet the market's requirements and save you valuable time and cost.
ISO 13485:2016 will provide you with a QMS that will:
ü Demonstrate your commitment to product quality
ü Improve quality control
ü Manage risks
ü Comply with any legal and regulatory requirements
ü Provide improved operational efficiency