About ISO 13485:2016 (MDQMS)

ISO 13485:2016 specifies requirements for a quality management system which requires a business to demonstrate its ability for providing medical devices as well as related services that continuously meet customer as well as applicable regulatory requirements. These organizations can be involved in a single or multiple stages of the life-cycle, which includes the design and development, production, storage and

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distribution, installation as well as the servicing of a medical device, and design and development. It can also relate to the provision of associated activities (e.g. technical support). ISO 13485:2016 can also be preferred by the suppliers or any external party that is engaged in providing the products, including quality management system associated services to such organizations.

Requirements of ISO 13485:2016 are applicable to organizations irrespective of their size, their type except where clearly stated. In a case where the requirements are stated, applying to medical devices, the requirements apply explicitly to the associated services as supplied by the organization.

The processes required by ISO 13485:2016 which are applicable to any 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, the regulatory requirements allow for exclusions of the design and development controls, which can be utilized as a justification for their elimination from the quality management system. These regulatory requirements can make available different approaches that are required to be addressed in the quality management system. It is the obligation of the business organization to make sure that the claims of conformity to ISO 13485:2016 show any exclusion of design as well as the development controls.

Role of Skymoon in ISO 13485:2016 medical devices quality management systems.

SKymoon has a well experienced assessment , implementation as well as an audit team for managing the medical devices and their quality. Skymoon provides consultancy service in the form of assessment, implementation, and audit of ISO 13485:2016 and provides certification.

Benefits of ISO 13485:2016 ( MDQMS )

  • Promotes agreement of regulatory requirements for the manufacturers of the medical devices on a global scale.
  • ISO 13485 is a quality system standard for organizations that are engaged in the design and development, production, storage as well as the distribution, along with the installation and the servicing of a medical device. Each and every requirement of the ISO 13485 is specific to organizations engaged in the production of the medical devices, irrespective of the type or size of the business.
  • Companies that achieve ISO 13485 certification can have the opportunity to have the benefits of an increased number of customers who have significant reason to place their trust and purchase products having high quality.
  • ISO 13485 will benefit customers, suppliers, management, and especially the employees and other stakeholders.
  • Quick and effective communication, suggestions, review and recognition on the efforts made, results obtained, and work to be done
  • Continuous assessment, improvement, and re-registration of systems..
  • ISO 13485 compliant management systems adopt a risk management approach which comprises an assessment for identifying & estimating the risk, utilizing risk controls as well as the techniques used for eliminating hazardous situations across the product realization.
  • Assures the customers that the product is in compliance with all the important and required product & service-oriented technical standards & regulations.

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