Introduction to ISO 13485 Certification in Iraq

ISO 13485 certification in Iraq. Factocert. Consultations, implementation, documentation, training, auditing, and registration of ISO 13485 are provided by the best ISO 13485 Consultants in Baghdad, Mosul, Basra, and Erbil. Our company offers CE Mark Certification, Halal Certification ISO certification in Iraq.

ISO 13485 Certification in Iraq

According to ISO, ISO 13485 Certification in Iraq is a quality management system requirement for organizations that provide medical devices and related services in compliance with legal and regulatory requirements. The standard also applies to the organizations involved in one or more life-cycle stages, including production, storage, packaging, designing and developing, servicing, and installing medical devices ISO 9001 certification in Iraq.

What is the process for getting ISO 13485 certification in Iraq? — Our practical implementation steps:

Our method/steps are easy, unique, time-bound, and result-oriented.

Gap Analysis:​

  • Interact with departments and examine operating procedures, documentation, and practices in different departments.
  • Analyzing your organization’s ISO requirements and identifying any shortcomings.
  • Planning for implementation and generating a gap report


  • We are educating the public about ISO standards.
  • Organize and conduct formal training sessions.
  • There is also training for running management review meetings, including internal audits, documentation training, and mock audits.


  • Processes, procedures, and results of an organization are manifested in documentation.
  • From start to finish, support for ISO-compliant documentation preparation.

Internal Audit & MRM:

  • Internal Audit (IA) as a tool is a cross-departmental audit to ensure zero loopholes in your organization’s system.
  • An organization’s top management reviews its performance and ensures it meets the standard requirements.

Final Audit and Certification:

  • Factocert — Your Certification is our responsibility!
  • Our 100% success track record ensures your certification is successful.

Why should you get ISO 13485 certification in Iraq?

ISO 13485 Certification in Iraq has proven beneficial for organizations of all sizes. Nonetheless, the benefits cannot be overstated, but they can help organizations to expand domestically and internationally and reap the rewards ISO 14001 certification in Saudi Arabia.

  • Recognized internationally: ISO 13485-certified companies receive international accreditation, which will help reach the global market as several regulators have adopted the standard.
  • Confidence among your customers: Certification against ISO 13485 demonstrates your organization’s commitment to quality and documents to your customers that your organization truly considers quality a severe aspect.
  • Credibility and brand image: ISO 13485-certified companies follow international standards in their processes. Certification will also be an essential branding tool for the company’s marketing.
  • Improve performance: Implementing a standard framework in your organization will catalyze overall performance improvement in products and services, improve relationships with your suppliers, business partners, and clients, and produce tangible results.

ISO 13485 Certification in Iraq Requirements

ISO 13485 Certification in Iraq consists of eight sections; the first three provide an introduction, and the remaining five provide requirements.

Documentation requirements and Quality Management systems are discussed in Section 4.

Section 5: Demonstrates top management commitment to providing directions and responsibility

Section 6: This section covers resources, including human resources, buildings, infrastructure, and the working environment.

Section 7: Design and development, product requirement review, and controlling the equipment to monitor and measure the product or service. This section does not apply to companies that do not design any product.

Section 8: The last section includes assessing customer satisfaction, internal audits, dealing with non-conforming products, and corrective and preventive actions.

Why Factocert for ISO Certification in Iraq

We provide the best ISO consultants in Iraq, Who are very knowledgeable and provide the best solution. And to know how to get ISO certification in the . Kindly reach us at ISO Certification consultants work according to ISO standards and help organizations implement ISO certification in with proper documentation.

For more information visit: ISO 13485 certification in Iraq

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