ISO 13485 standard Integration

ISO 13485: 2016 Medical Device is the quality management system standard for medical devices. An organization that is hoping and wanted to expand its businesses to the international market can adopt ISO 13485 Certification. Basically, ISO 13485 standard is the requirement of CE Marking.

In the United States, the Food and Drug Administration (FDA) has its regulatory requirements specified in 21 CFR Part 820. Under this organizations used to design, manufacture, package, label, store, and install any medical device for human use for their safety and security. Implementation of ISO 13485 and GMP are interrelated as GMP and ISO 13485 are more or less the same and the implementation of one system can help you achieve the other.

Benefits of ISO 13485 Standard Certification

When implementing ISO 13485 standard, organizations adopt a risk-based approach to establish the QMS in all phases of their product realization. ISO 13485 standard is an international quality certification to establish design and development, production, installation, and post-market surveillance of medical devices. Ultimately, the process is based on continual improvement in all areas of the organization. Some benefits of ISO 13485 certification are:

  1. Increase Credibility of your organization
  2. Enhance Business Performance
  3. Provide customer satisfaction
  4. Demonstrate Commitment to High-Quality Medical Devices.
  5. Managing quality throughout the life-cycle of a medical device
  6. Ensures safety in medical devices
  7. Participate in international tenders
  8. A requirement of CE mark to sell medical devices in the European Union

Integrating ISO 13485 Medical Device

Integrating quality management systems for medical devices has many advantages.

For example, a medical device company may choose the ISO 13485 standard along with ISO 9001, GMP to do business in various global markets like the US, Europe, and other parts of the world. It helps you avoid developing and maintaining multiple lists of documents.

Integration of ISO 13485 standard helps the growing Indian economy to produce quality and safe products within the nation. To avoid imports of devices and use Indian-made products.

The manufacturer, trader, reseller, or any related to the supply chain of the devices can adopt ISO 13485 Certification to ensure the products they are providing or selling are 100% safe and secure for patient’s health safety.

After the outbreak of this Covid- 19 people are more cautious about their health and are aware of the certified organization and devices.

Implementation of ISO 13485 standard can help you with developing the system, which includes: Quality manual, Quality system procedures, Quality system implementation, and documentation to provide trustworthiness of their products.

Our ISO 13485 Certification process includes the following steps

  1. Understanding your existing Quality Management System
  2. Identifying Gap Analysis in the management
  3. Developing documents such as quality manual, forms, templates
  4. Providing the required training to the employees of the organization
  5. Review of SOPs (Standard Operating Procedures)
  6. Implementing a well-documented Quality Management System for Medical devices
  7. Conduct Internal Audit to find non-conformities
  8. Root cause analysis addressing non-conformities. (CAPA)
  9. Selection of CBs
  10. Conduct external audit
  11. Closing of any observations of audit findings by the certification/notification body
  12. Issuance of ISO 13485 Certification.


ISO 13485 is established to maintain documented quality d the medical devices accomplishing the standard requirements. Conducting a third-party audit helps the organization to get known by your competitors and as well customers to build brand image. This ISO 13485 standard also complies with regulatory devices of all the classes of medical devices. Integration of ISO 13485 standard helps to reduce the error and mistakes or malfunction of the medical devices as described in the description manual.

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