ISO 13485:2016 – Medical Devices:Quality Management System

We deal in ISO 13485:2016 Certification of various Accreditation Bodies. Get in touch with the CCL Business Advisors to help you out procure the best ISO 13485:2016 certification easily.

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  • ISO 13485:2016: This Certification demonstrate its ability to provide medical devices and related services meeting customer and applicable regulatory requirements.
  • Getting ISO 13485 certificate means that your Organization has taken all the precautionary measures to work well with the medical devices’ safety processes.
  • ISO 13485 certification is a symbol of trust for your customers and it enhances the image of your organization in the business market and your service domain.

What is ISO 13485:2016 Certification?

The ISO 13485:2016 is the only accepted and widely used Quality Management Standard for Companies and Organizations of any size in the medical devices industry. ISO 13485:2016 was last reviewed and confirmed in 2020. Therefore, this version remains current by the International Organization for Standardization (ISO), an International Agency composed of the National Standards Bodies of more than 160 countries.


BELOW ARE SOME OF THE ATTRIBUTES OF ISO 13485:2016

What are the requirements for ISO 13485:2016?

  • ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
  • Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.
  • If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system.

Note: It is the responsibility of the organization to ensure that claims of conformity to ISO 13485:2016 reflect any exclusion of design and development controls.

Documents Required

Documents Required for processing ISO 13485 will differ from one organization to another. However, for your understanding we have listed below the common required documents:

  • Registration Certificate
  • Office Address Proof
  • Scope of the work
  • GST Certificate
  • Cancelled Cheque
  • Bills raised/Invoice paid
  • Basic KYC of Director/Partner/Prop.

What are the Benefits of ISO 13485:2016?

ISO 13485:2016 Certification (Medical Devices: Quality Management Standard) has many benefits:

  • It improves resource efficiency and cut down the cost
  • ISO 13485 widens the access to global market substantially
  • Meets regulatory requirements as part of legal obligation
  • Assurance that quality control of devices is being measured
  • Increase stakeholder and customer trust with ISO 13485
  • Quality management system improvements to such organizations.

The CCL Business Advisors can guide you through step-by-step procedure in understanding how ISO 13485:2016 can be beneficial for your organization and how you can get ISO 13485 for your business in medical devices and legal obligation in addition to growth enhancement.

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