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What is ISO 13485?

22/02/21

Jellagen has an outstanding commitment to quality control and has been ISO 13485 certified for the past 3 years.  

What is ISO 13485? 

ISO13485 is a Quality Management System (QMS) standard taken from the internationally recognized ISO 9000 quality management standard series. It is the medical device industry’s most widely used international standard for quality management. It is in place to ensure a company demonstrates its ability to provide medical devices and related products or services that consistently meet customer and applicable regulatory requirements.

What are the requirements of ISO 13485? 

Sections 1- 3  – General Admin – Including Scope, Normative References and Terms & Conditions.

Section 4: Quality Management System – This section includes the requirements for the Quality Manual, Control of Documents, and Control of Records, all of which are required documents in the QMS.

Section 5: Management Responsibility – The management responsibility requirements cover the need for top management to be involved in the implementation and maintenance of the QMS.

Section 6: Resource Management – The section on management of resources is short, but covers the necessity to control all resources, including human resources, buildings, and infrastructure and the working environment.

Section 7: Product Realization – The product requirements deal with all aspects of the planning and creation of the product or service. This section includes requirements on planning, product requirements review, design, purchasing, creating the product or service, and controlling the equipment used to monitor and measure the product or service. 

Section 8: Measurement, Analysis and Improvement – This last section includes assessing customer satisfaction, internal audits, monitoring products and processes, dealing with non-conforming product, and corrective and preventive actions. 

What does ISO 13485 mean for our customers?

The ISO 13485 certification demonstrates a strong commitment to continual improvement and gives customers confidence that we bring safe and effective products to market. Jellagen is future proofing itself with ISO13485. With this certification we can ensure that we can either manufacture our own medical devices or provide collagen to our customers to develop their own, safe in the knowledge our products are made to the highest standards.

 

If you are interested in working with Jellagen and our ‘Marine Type 0’ collagen? Please contact us, or find out more information here.