EN ISO 13485:2016: Medical devices. Quality management systems. Requirements for regulatory purposes.

What is ISO 13485:2016

ISO 13485 is Quality Management System for Medical Devices. ISO 13485 is applicable to designers, manufacturers, and distributors of medical devices. The standard contains the requirement for quality management systems, to meet customer requirement and incorporate applicable regulatory requirements within an organization’s quality management system.

Certification process

The certification process consists of 3 basic phases:
1) Elaboration of documentation
2) Putting QMS into practice
3) Certification by an accredited certification body

• Registration of the application
• Agreement for conducting a certification audit (Note: the certification audit is conducted in two stages)
• Appointing a team of auditors
• Preparing an audit plan
• Audit: verification of facts in the following stages:
  • Stage I: On-site Assessment of Certification eligibility through documentation analysis
  • Stage II: On-site evaluation of quality management system
• Elaboration of the Certification Audit Report
• Assessment of the Audit Report by the Certification Body
• Issuing the Certificate

During the three year validity period of the certificate, a surveillance audit takes place once a year. One of the following is issued depending on the surveillance findings

• Decision on confirmation of the certificate validity until the next surveillance;
• Decision on suspension of the certificate;
• Decision on withdrawal of the certificate in case of fundamental deviations from requirements of standards.

Benefits of ISO 13485 Certification:

• Guarantee of production process stability and thus steady and high quality of services and products supplied to customers;
• Meeting Regulatory Requirements,
• Simplifying the process of attestation of conformity to requirements of EU directives and corresponding Government Orders;
• Attestation of efficiency and effectiveness of the established quality management system by an independent third party;
• Optimization of costs reduction of operating costs, reduction of nonconforming products costs, raw materials, energy and other resources savings,
• Enhancing trust of public and public monitoring bodies in respect of the medical devices manufacturer.

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