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. 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.

ISO 13485:2016

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.

How YOUR business can benefit from achieving ISO 13485 : 2016

  • Increase access to more markets worldwide with certification;
  • Outline how to review and improve processes across your organization;
  • Increase efficiency, cut costs and monitor supply chain performance ;
  • Demonstrate that you produce safer and more effective medical devices;
  • Meet regulatory requirements and customer expectations.
  • The certification of a quality management system, specifically for medical devices, to ISO 13485 proves advantageous, and in many cases essential, for medical companies which export their products to the global market.

    Risk Management

    When making medical devices there is a risk to a person's life therefore ISO 13485 requires that organization's establish documented requirements for risk management in the product realization process. Risk management includes risk assessment, risk analysis and risk reduction. Risk Assessment is identifying risks. Risk Analysis is looking at the probability and severity of all hazardous situations. Risk reduction is reduction, mitigation (labeling), elimination of risk as much as possible.

    Risk management applies to quality management system processes and most importantly it applies to the design of the device, manufacturing and supporting services. Risk management is such an important process that ISO 13485 requires risk management is done in accordance with ISO 14971. The international standard for medical device risk assessment is ISO 14971.

    Quality Certification provides the highest level of confidence in a quality assurance system and informs the world that a manufacturer is committed to quality.

    ISO 13485 is a quality management system standard specifically for the medical devices industry, which encompasses aspects of the ISO 9001 standard, plus additional industry-specific medical device requirements.

    Who is this Standard for?

    • Companies who currently manufacture private label medical devices, but want to eventually place these devices under their name on the market in the European Union;
    • Consultancies or agencies, which design, manufacture, and assemble medical and in vitro diagnostic medical devices, as well as medical component manufacturers;
    • Manufacturers of in vitro diagnostic medical devices that want to distinguish themselves, and prepare for future IVD regulatory obligations to enter the EU.

    When it comes to medical device manufacturing, patient safety greatly depends on the quality and consistency of medical products.

    ISO 13485 is intended to maintain your organization's effectiveness of processes and to ensure safe medical devices. Certification to the standard clearly demonstrates an organization's commitment to ensuring the design, development, and production of medical devices that perform safely and effectively. Gaining certification support through Dynamic Strategies¢ī provides the highest level of confidence in a quality assurance system and informs the world that a manufacturer is committed to quality.

    Like other ISO management system standards, certification to ISO 13485 is not a requirement of the standard, and organizations can reap many benefits from implementing the standard without undergoing the certification process. However, third-party certification can demonstrate to regulators that you have met the requirements of the standard. ISO does not perform certification.


    Some of the key benefits are listed below:

    • Establishes an effective quality management system;
    • Allows an organization to meet regulatory and customer requirements;
    • Increases the efficiency of its processes and reduce waste;
    • Improves staff morale;
    • Enhances focus on risk management;
    • Gains awareness of improvement opportunities;
    • Increases responsiveness to issues and non-conformities;
    • Ensures safe, quality medical devices;
    • Helps secure an organization's economic growth and corporate reputation.