ISO 13485:2016 Certification

ISO 13485 Medical Devices – Quality Management System

ISO 13485, a particular international standard for quality management system in medical devices. The standard requires an organization to implement in the life cycle of a medical device, so that it fulfills the Medical Device regulatory Compliances. Also, the standard specifies the requirements of medical devices to be free from contaminants, sterilized, and maintain cleanliness in their entire life-cycle.

Moreover, the standards require the suppliers and other external parties whose give services to such organization may also undertake ISO 13485 requirements. ISO 13485 gives guidance to the organization to implement the QMS effectively in medical device manufacturing or medical service supply-chain organizations.

Moreover, the standard ISO 13485 ensures consistency in design, development, production, installation, and delivery of safe medical devices. Thus, ISO 13485 Certification ensures the organization to provide medical devices or medical services with high quality and safety. Therefore, the ISO 13485 certification is applicable to all the organizations that supply medical devices.

Major benefits of acquiring the ISO 13485 Certification:

  • Improves customer satisfaction.
  • Improve safety in using medical devices.
  • Increase in productivity, profitability and quality of products.
  • Global recognition of your business
  • Effective quality management system.
  • Better workplace improves communications between employees and their job security.
  • Good leadership practices in the organization.
  • Meets applicable statutory and regulatory requirements for your business

IAS – The most trusted ISO 13485 Certification body

IAS, a privately held corporation, is headquartered in the southern part of India. Incorporated in 2007, specialize in providing ISO management standard certification and product certification to local, national, and international organizations with UQAS accreditation.

IAS certified many successful organizations with our qualified auditors and technical expertise by auditing and assisting the quality-driven organizations in Ghana and its cities namely Accra, Tema, Tamale, Kumasi, etc.,

Also operating worldwide with 200 more qualified auditors, consultants, trainers in Asia, Europe, Middle East, Gulf, USA.

IAS provides quality and business systems auditing, consulting, and also IRCA certified training services specializing in helping the companies for their growth and development in their management systems.

We specialize in ISO 9001, ISO 22301, ISO 14001 ISO 20000, ISO 15189, ISO 17025, ISO 45001, ISO 13485, etc. Also product certification such as BRC, VAPT, Green, CE marking, HACCP, RoHS, GOST-R, etc.,

ISO 13485 certification procedure:

With the help of our IAS team of auditors and subject matter expert you can rely on us for successful certification to your organizations.

  • At first, make an enquiry or contact us by sending email info@iasiso.com.
  • download and fill application form from the website at free of cost
  • With your specified requirements, IAS initiates contract review with the organization.
  • Certification process- two stages of audit namely stage1 &2.
  • Non-conformance closure (if any found during the audit)
  • Issuance of ISO 13485 certificate with three years validity.

For further more details, please send your quotes to info@iasiso.com.

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