ISO 13485:2016 Certification

About ISO 13485 Certification

Integrated Assessment Services a leading third party agency provides ISO 13485 Certification in Ghana. The certification is for medical device manufacturers who wish to demonstrate that they operate to the highest quality standards.

ISO Certificate for Medical Device

This certification is also referred to as ISO 13485 Certification Ghana. Further, other Certification such as ISO 9001 Certification or ISO 14001 Certification or ISO 45001 Certification are generally opted ISO Certificate for Medical device manufacturers. It is an international standard that specifies requirements for a quality management system (QMS) when manufacturing medical devices. Certification to ISO 13485 demonstrates that your organization can provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

ISO 13485 Certification

Who can apply for ISO 13485 Certification in Ghana

ISO 13485 Certification is appropriate for manufacturers of medical devices. The certification is also applicable to organizations that provide contract design and/or consulting services for medical device manufacturers who are not certified. Applicants must have a quality management system in place that addresses the key elements specified in ISO 13485:2016(2).

key elements of ISO 13485:2016

  • 1. Context of the organization
  • 2. Leadership
  • 3. Planning
  • 4. Support resources
  • 5. Operation
  • 6. Performance evaluation
  • 7. Improvement

The cost of ISO 13485 Certification in Ghana

The cost of ISO 13485 Certification in Ghana will depend on the size and complexity of your organization and the number of locations where you operate. Certification to ISO 9001, ISO 14001 or ISO 45001 may also be required depending on the products and services you offer.

Certification typically takes between 12 and 18 months to complete, and organizations must be able to show that they meet a range of requirements relating to their quality management, design control and risk management systems. The cost varies according to what countries are involved.

You can find more information about the cost of ISO 13485 Certification in Ghana by contacting Integrated Assessment Services. We will be happy to help you determine if this certification is right for your organization and provide a quote for the services required.

If you are interested in ISO 13485 Certification in Ghana, please contact Integrated Assessment Services. We would be happy to help you get started!

The benefits of ISO 13485 Certification in Ghana include:

There are many reasons why an organization should consider ISO Certificate for Medical Device, Some of the benefits include:

  • improved customer satisfaction as a result of consistently meeting customer and regulatory requirements;
  • improved product quality and safety as a result of having a structured, systematic approach to quality management;
  • reduced costs and improved efficiency as a result of improved process control;
  • improved market access and increased customer confidence as a result of certification to an internationally recognized standard.
  • improved customer satisfaction
  • enhanced competitive position
  • increased business opportunities.

Steps to obtain ISO 13485 Certification in ghana

  1. Assess your current QMS against the requirements of ISO 13485:2016
  2. Install a new or improved QMS that complies with the requirements of ISO 13485:2016
  3. Undergo an initial certification audit followed by subsequent surveillance audits conducted by a certification body accredited to ISO/IEC 17065
  4. Upon satisfactory completion of all requirements, the certification body will issue a certificate based on ISO 13485:2016
  5. The certification is valid for three years and requires annual surveillance audits to maintain certification.

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