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How ISO 13485:2016 certification is beneficial to customers?

Medical device industry is a fast-pace industry with innumerable technological advances. With this ever growing market, patient safety is the most important aspect which can be ensured via high quality of medical devices. It is necessary for medical device manufacturers to follow stringent regulatory requirements, since the health professionals rely on the medical devices for patient’s health and safety.


ISO (International Organization for Standardization) sets out a Quality Management System which is recognizable in major markets around the world. Conformance to ISO 13485 establishes that the manufacturer has met an objective standard of excellence which enables them to achieve customer satisfaction.

Sticking to the rules mentioned by ISO 13485 reduces the risks and failures associated with medical device manufacturing ensuring standardization of parts and components, predefined after sales service norms and reliability in the overall quality of the product.


  • Traceability: It is the ability to identify and trace the history of the product with respect to its location, distribution and application. The function of traceability in the medical device framework is to detail why, how, where and when a product has been manufactured.

In case of any defect in parts, the source and batch of the parts/components can be identified and these can be easily replaced by recalling the defected ones.


  • Customer at focus: The Quality Management System requires the manufacturer to take customer needs into account. The product is designed and developed considering the customer requirements and expectations since customer satisfaction is one of the principles stated in ISO 13485. The standard also establishes guidelines to safeguard customer property during after-sales and maintain the conformity of product during servicing, storing and distributing.


  • Continuous improvement: ISO 13485 ensures removal of non-conforming products (rejected, faulty parts) to prevent their recurrence. The management needs to define corrective and preventive actions and review all these in regularly scheduled internal Audits.

In case of any error, root cause analysis is done and internal processes are modified wherever required.


  • Data maintenance: Data is the foundation of Quality improvement. At each stage of the life-cycle of the product, documentation is prepared to keep track of all the processes and changes occurring. Product wise supplier data, design data and test results are maintained and have an open access to the Management. This enables the medical device manufacturers to maintain the performance and safety of medical devices.


Now, the US-FDA has revealed its plans to amend their Quality System Requirements to harmonize with ISO 13485:2016 standard.

Status Medical Equipments being an ISO 13485:2016 certified company is delivering reliable medical devices with exceptional quality and service standards.

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