Detailed Information about ISO 13485 Certification in Ethiopia
ISO 13485 Certification in Ethiopia

Detailed Information about ISO 13485 Certification in Ethiopia

ISO 13485 Certification in Ethiopia, is an International Standard for Quality Management System which is principally concerned with the design and manufacture, and manufacturing of medical devices. The ISO 13485 certification is a valuable certification that was created to safeguard customers and professionals in hospitals, clinics, and other medical establishments. Maintaining your products by this ISO 13485 standard will help in building a solid business.

Quality Management System (QMS) for medical products, devices, and services provides a solid base for manufacturers to meet the requirements and obligations and also demonstrate their dedication to quality and safety.

Why need ISO 13485 certification in Ethiopia?

In Ethiopia, If any company is interested in getting an ISO 13485 Certificate, it is essential to demonstrate the ability of their medical equipment or related products that continuously comply with applicable regulations, and it is necessary to verify the capability and dependability of their product.

Since you are an ISO 13485 Certified organization, the design, production, and distribution of medical devices that conform in line with the Quality Management System proves that your product meets the highest standards and your consumers can believe in your product. This will enhance your company’s image.

Advantages of ISO 13485 Certification in Ethiopia

  • Enhancing Competitiveness in the Marketplace: ISO 13485 Certification is an internationally recognized standard. it is a great tool for business leaders to expand their operations into different countries and increase their performance. Reducing the chance of causing harm or issues can automatically improve the results and assist potential customers to build confidence in the company.
  • Helping products stay on the market with no issues: ISO 13485 certification in Ethiopia,is an entire framework that helps the representatives of the company to recognize and resolve issues swiftly. It’s also beneficial since it can assist to establish and sustain an environment of personal accountability within an organization.
  • Lower Risk of Failure: 13485 certifications in Ethiopia, will help you to identify the areas where something has gone wrong and avoid any future problems. The status of an ISO 13485 Certified organization will assist in establishing trust and confidence that the manufacturing processes of devices are controlled and can be used safely.

Steps lead towards ISO 13485 certification in Ethiopia

Optional initial audit:Inspection of your site voluntarily and management documentation review, assessing your level of readiness for complete phase I & II auditing.

Audit: Stage I

The assessment of eligibility to be certified is made through the results of an audit on-site Quality management documentation analysis and a business analysis.

Audit: Stage II

Evaluation on-site of the quality management systems for excellence in areas of application and effectiveness.


A formal confirmation of the authenticity of the quality control system, and confirming your compliance with the quality standards.

First-time applicants greatly benefit from undergoing the initial audit. The process is quick and efficient preparation for your official  ISO 13485 audit procedure. You receive a written report that you can immediately use to make adjustments to your procedures before starting with the mandatory audits.

Transfer of Certification Applications for Transfer of Certification is being considered, as requested in Certification Renewal.

To get ISO 13485 Certification in Ethiopia Factocert services are provided using an approach based on the Principle that requires the audit team as well as product experts to be followed by an independent audit for the final decision.

Why should you select Factocert to obtain ISO 13485 certification in Ethiopia?

Factocert is a company that assists businesses to acquire ISO certifications such as ISO 45001, ISO 9001, ISO 14001, ISO 2200, ISO 27001, ISO 22301, ISO 13485 CE MARK, and Halal certification using an innovative and easy process. Factocert is comprised of a team of highly skilled and experienced professionals that are recognized for their technical expertise across many different industries sectors.Factocert offers the most effective ISO 13485 consultation in Ethiopia which assists customers in getting accredited at a low cost within the market.

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