ISO 13485:2016:2013 (Medical Devices Quality Management Systems)

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. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

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.

The processes required by ISO 13485:2016 that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system by monitoring, maintaining, and controlling the processes

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. 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.

KVQA Asssessment understands all these issues and can perform the necessary assessment /Improvement to help you achieve ISO 13485:2016 Certification.

   controls in the work environment to ensure product safety

  focus on risk management activities and design transfer activities during product development

  specific requirements for inspection and traceability for implantable devices

   specific requirements for documentation and validation of processes for sterile medical devices

  specific requirements for verification of the effectiveness of corrective and preventive actions

KVQA Asssesment understands all these issues and can perform the necessary assessment /Improvement to help you achieve ISO 13485:2012 Certification.

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