ISO 13485:2016 Certification

ISO 13485 Certification

What is ISO 13485 standard?

ISO 13485 is an internationally recognized standard for a quality management system, especially for medical devices and equipment. The requirements of the ISO 13485 apply to any organization, regardless of size, that develops and provides medical devices. This standard also applies equally to the associated services that the organization provides.

ISO 13485 specifies requirements for the continual improvement of medical devices’ quality and performance. Also, it establishes that medical equipment is safe and reliable to use.

About IAS – A UQAS accredited ISO 13485 Certification body in South Africa

Integrated Assessment Services is an accredited certification body for providing process certification and product certification in South Africa.

We provide ISO 13485 Certification services in South Africa and also in various countries across the globe including African countries such as Nigeria, Morocco, Kenya, Ghana, Ethiopia, etc. Also, we offer certification services in major cities of the following countries India, Malaysia, Singapore, Italy, UK, Netherlands, Germany, France, Thailand, Bangladesh, Turkey, Egypt, Oman, Qatar, Kuwait, Brazil, Mexico, etc.

IAS is also famous for auditing and issuing product certification such as Kosher, Green, CE Marking, GOST-R, RoHS, etc.

IAS offers lead auditor training, internal auditor training, and as well as awareness and foundation training on numerous ISO management system standards.

How does the ISO 13485 Certification benefit my business?

  • The ISO 13485 Certification enhances the quality of medical devices
  • Ensures employees’ safety
  • Reduces customer compliance
  • Minimizes operational errors as well as cost
  • Improves customer satisfaction
  • Also, enhances the organization’s reputation

Ways to get ISO 13485 Certification through IAS:

IAS offers simple yet effective ways to support the organization in the implementation of the ISO 13485 Certification.

  • Find the IAS application form on our site.
  • Fill the form and send it to use.
  • Contact us to get detailed information about the ISO 13485 certification and our auditing process.
  • Implement the effective requirements of ISO 13485. You can also get help from a consultant (our auditors also act as a consultant to guide the organization in the fulfillment of the desired ISO standard).
  • Train your employees and prepare the documents such as internal audit reports, the organization’s process, and services records, etc.
  • IAS audit team will come with a plan to conduct the audit.
  • We conduct an ISO 13485 certification audit and confirm that an organization (our client) is providing safe and quality services to its customers. Finally, we issue the UQAS accredited ISO 13485 Certificate.
  • Also, IAS conducts a surveillance audit every year until the validity of the initial certification.
  • Further, we also perform a Re-certification audit for the continual improvement of your organization’s management system.

Looking for an accredited ISO 13485 Certification body in South Africa? Look no further! Here is IAS. Contact us to know more about the ISO 13485 Certification and our auditing process.

For detail discussion over phone or in-person, kindly contact our executives through Mail: or Mobile:+91 9962590571