ISO 13485 is part of ISO 9001 standard which illustrates its ability to provide medical devices and consistently meet customer and applicable regulatory requirements. Organizations involved in one or more stages including design, development, production, storage, distribution, installation, or servicing of a medical device, provision of associated activities

The cost of an ISO 13485 Certificate varies in accordance with the variety required as per the goods or services dealt with by the business. The cost of ISO 13485 certification further depends upon the circumstances like the size of the business, audit requirements, and level of operations.

ISO 13485 Mandatory Requirements — Documents and Records

• Monitoring and checking equipment calibration reports.
• Documents of training, skills, experience, and eligibilities.
• Product/service specifications review records.
• Features of product to be produced and service to be presented.
• Production/service provision change control records.
• Results of internal audits.
• Results of the management review.

and more…

ISO 9001 is the international standard that gives specifications for a quality management system that can be implemented to any organization despite the industry, product or service, or company size. ISO 13485 is a comprehensive management system especially for the manufacture of medical devices.

Certease will make the certification process fasters, and simpler. But, it again depends on the size and process of the Organization.