ISO 13485:2016 Certification

ISO 13485 certification

What is ISO 13485 certification standard?

ISO 13485 is a specifically developed standard for quality management systems of medical devices and equipment. This international standard specifies requirements to ensure continual improvement in the quality of medical devices. It is applicable to all sizes of the organization that manufactures medical equipment. Also, the specifications of ISO 13485 apply equally to the companies that deliver associated services.

ISO 13485 Certification represents an industry’s effective QMS performance in delivering high-quality medical devices and equipment. Also, it consistently improves the products’ quality which enhances the customers’ satisfaction.

How does the organization benefit by achieving the ISO 13485 certification?

  • Improves QMS performance
  • Enhanced quality of medical devices
  • Increased business opportunities
  • Reduces operational errors
  • Customer satisfaction
  • Also, better organization’s reputation

 Why IAS?

Integrated Assessment Services is a universally recognized certification body in Morocco, accredited by UQAS for providing management system certification on popular ISO standards.

We have more than 13 years of professional experience in auditing and issuing ISO standard certifications and product certifications.

IAS has professional experts who have the best industry background experience to guide our clients in the effective implementation of the management system.

Other than Morocco, IAS also offers ISO 13485 Certification service in the major cities of various African countries including South Africa, Ghana, Nigeria, and so on. We have several branches and representatives to issue ISO Certifications in numerous countries including Malaysia, Singapore, Bangladesh, Thailand, Vietnam, Philippines, Qatar, Oman, Saudi Arabia, Italy, France, Mexico, Turkey, etc.

We are also famous for providing product certifications such as Kosher, Halal, CGMP, BRC, HALAL, CE Marking, and so on.

IAS’ ISO 13485 certification procedure: Easy process, effective services!

  • Firstly, make an enquiry through our website
  • Or fill the application form and send to [email protected]
  • Or else, contact us directly to know the auditing procedures specific to your organization
  • IAS will initiate the audit, after receiving the application
  • Basically, the auditing process of IAS has two stages such as readiness audit and effectiveness audit
  • Finally, IAS will issue the UQAS accredited certificate which is valid for 3 years
  • IAS also conducts a surveillance audit every year and re-certification audit after the validity of the initial certification is over

Feel free to contact us to know detailed information about the ISO 13485 Certification and its auditing process!

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