Ukrainian Certification Agency, certification authority accredited by National Accreditation Agency of Ukraine (NAAU), provides certification services for quality management systems for compliance with the requirements of various standards such as: ISO 13485: 2003 (DSTU EN ISO 13485:2015) “Medical devices. Quality management system. Regulatory requirements.”

Certification of quality management systems in accordance with ISO 13485

Accreditation Certificate No. 8О110

The main activity areas of Ukrainian Certification Agency in providing services on quality management system certification for compliance with the requirements of ISO 13485 are the following economic sectors:

• inactive medical devices,
• active non-implantable medical devices,
• active implantable medical devices,
• medical devices for in vitro laboratory diagnostics,
• sterilization methods for medical devices,
• devices with special substances/technologies applied.

ISO 13485 specifies requirements for the quality management system when an organization needs to demonstrate its ability to provide medical devices and related services that constantly meet customer demands and applicable regulatory requirements.

Due to changes in the legislation in the field of medical devices, the need to introduce QMS in accordance with DSTU EN ISO 13485 has become a new requirement faced by national producers. This standard can be applied by organizations engaged in the design, development, manufacture, installation, maintenance of medical devices.

Certification is carried out by evaluating the QMS documentation and carrying out an audit at production areas. Following the audit, a QMS certificate is issued for the period of 3 years.

Organizations in which the requirements of ISO 13485 are applicable:

Implementation of the ISO 13485 requirements is mostly appropriate in the following organisations:

• organizations producing medical equipment and devices under a private brand and wishing to independently locate their products in the EU markets,
• organizations specializing in the design of medical equipment only,
• organizations developing software for medical equipment,
• organizations producing components for medical equipment.

Advantages of ISO 13485 certification:

• Possibility of unimpeded trade and recognition in the countries of the world by all organizations that are part of the global supply chain of medical devices
• Higher commercial value of the products due to greater consumer confidence
• Improved image and brand of the companies demonstrating adherence to the requirements of international standards, best practices and product quality, and compliance with applicable legislative and regulatory requirements
• Opportunity to organize the company’s business processes in line with the high requirements of international and European standards
• Increase in sales volume, improved position in the existing markets and access to new sales markets
• Building of customer trust
• Competitive advantages in the struggle for favorable contracts and orders under equal conditions
• Systematic and proactive approach to identifying risks, developing and implementing control measures
• ISO 13485 is in harmony with other international standards and management system specifications, such as ISO 9001, GMP and others, which makes it possible to build an effective management system.

To obtain the ISO 13485 certificate at Ukrainian Certification Agency you need to:

1. Prepare an application and file a package of documents to the authority.
2. Sign the contract for certification and make a payment.
3. Undergo a certification audit.
   – Audit of the 1st stage (preliminary assessment)
   – Audit of the 2nd stage (final inspection / on-site audit);
   – Analysis of the results of verification and documentation of certification.
4. Obtain a certificate.

Rights and obligations of the applicant

The form of registration of complaints and appeals