ISO 13485 - Medical Technology

Prioritization of quality and safety is one of the reasons for our success. Another is a close cooperation with the customer, in order to adjust certification services according to customer needs. In this way we achieve results with the certification of companies with the most diverse conditions.

The ISO 13485 enables you to bring products, services and processes which are of high quality. The management system also facilitates the process of continual improvement, safer products / services and more satisfied customers.

Why certify your company?

Benefits of certification:

  • Fewer misunderstandings, corrections and complaints
  • Management is working systematically with the development and improvement
  • Prevention initiatives instead of corrective actions
  • The staff becomes involved in quality work
  • The need for second party audits and "client audits" decreases
  • Your company meets the frequent customer requirement certificate
  • Your company and its products are gaining more confidence

The benefits of a certification can be seen immediately in the business in the form of

  • Higher productivity
  • Better precision in control of operations
  • Lower costs
  • A better understanding of the big picture among staff
  • Increased competitiveness
  • More power to focus on the important things

Nordic Certification Scandinavia AB fulfills the requirements of ISO 17021 management systems.

The ISO 13485 is well established and accepted by the market worldwide. Certification also means responsible behavior towards customers, staff and shareholders. ISO 13485 is a way to ensure and maintain the quality management system.

In our audits from Nordic Certification, we examine the following

We put an extra emphasis on that the management system generates a commercial and financial value for the company.

We also review

  • Management responsibility and commitment
  • Target outcome of the goals
  • Customer feedback
  • Internal audits
  • Analysis of collected information
  • Improvements, corrective and preventive actions

Specific focus areas planned for the audit may include the marketing and sales process, design and development, production, logistics process, purchasing process, document and records and, where applicable, measurement and test equipment.

Results of our audits

Our audit results will give you opportunities to improve the business and economic value of your business. We also want to demonstrate the strengths and weaknesses of your business and give you opportunities to improve the business further. Our audits show, of course, if you follow the requirements of the standard according to your descriptions how business is conducted and how you apply your processes.

We at Nordic Certification attaches particular importance to that the management system generates a commercial and financial value to your business.