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ISO 13485 Certification

ISO 13485 Certification

About ISO 13485 Standard

ISO 13485 is a globally recognized standard that specifically provides requirements to implement the quality of medical devices and equipment. This standard guides the manufacturers or suppliers of the medical devices to deliver high-quality products and services. It also provides effective measures to identify the risks in the services of the medical equipment.

ISO 13485 Certification establishes the high-level performance of the organization that provides effective services in delivering well-designed medical devices and equipment. As it is a globally recognized certification for medical devices, it helps improve the profit and productivity of your business.

IAS is a top-searching certification body for providing management system certification on various ISO standards. We also provide product certification and lead auditor and internal auditor training courses. Our professionally trained, real-time auditors effectively audit the organization as per the trend of the local market.

Is it necessary to attain ISO 13485 Certification?

ISO 13485 offers a systematic framework to improve the manufacturing process of medical devices such as design, components, and installation and so on. This standard contains similar requirements as ISO 9001. So, it is easy and effortless to implement it in your organization.

ISO 13485 Certification is a trademark of the organization that provides high-quality medical devices and equipment. It impresses customers to trust in your products. You can also enhance the reputation of your organization by implementing the ISO 13485 Certification for medical devices.

The organization with ISO 13485 Certification ensures effective improvement in the Quality Management System (QMS). This certification offers directives, regulations as well as responsibilities to develop quality products. It demonstrates employees’ safety and the overall performance of the organization. Moreover, the ISO 13485 Certification is an excellent way to achieve betterment in design, development, production, storage, distribution, and installation.

 Benefits of ISO 13485 Certification

  • ISO 13485 Certification establishes the robust performance of medical devices and equipment
  • Guides manufacturers with directives, regulations, and responsibilities for medical products
  • Ensures global recognition
  • Reduces the operational risks and controls the management system
  • Enhances the reputation and as well as creates new business opportunities
  • Also, it ensures customer trust and employees’ safety

 IAS Certification Procedure

IAS offers ISO 13485 certification services in various countries throughout the world. Some of the countries that IAS has branches and representatives are Thailand, India, Philippines, Bangladesh, Oman, Singapore, Malaysia, Indonesia, Oman, Saudi Arabia, UAE, Qatar, and Kuwait. 

The process and procedures to attain ISO 13485 Certification by IAS as follows,
  • Call us to have a free discussion about the specific details of the required Certification
  • Complete the IAS process certification application form and send it to us.
  • The organizations have to implement the ISO requirements in all sectors of their business.
  • Also, you have to maintain the documented information containing the process or method used to implement each requirement.
The audit process has two stages.
  1. Stage1: Readiness audit
  2. Stage 2: Effectiveness audit
  • IAS will issue an audit report with non-conformities (if any).
  • The organizations have to work on those non-conformities and clear them.
  • Finally, IAS will release the certificate.
  • IAS also conducts a surveillance audit for the next two years to validate the certificate.
Want to achieve ISO 13485 Certification? Then IAS is a great choice for you.
For detailed information about the certification process and auditing procedure, just dial to the below-mentioned numbers.