ISO 13485: Medical Devices QMS

ISO 13485 is an international standard for a medical device system for an organization to develop and demonstrate a quality management system that consistently meets customer and applicable for regulatory requirements. The safety and quality of the public cannot be kept at risk. In order to demonstrate continual improvement and maintain the new adoption of the technology in devices is accepted to upgrade the organization with new medical devices. ISO 13485 standard is an effective solution to meet the comprehensive approach to a QMS is ad hoc. It places a more significant focus on regulatory compliance of the standard with less flexibility in the process of the organization.


ISO 13485:2016 introduces some changes from ISO 13485:2012. The major focus of ISO 13485:2016 Certification is a host of subtle, yet detailed, changes requiring more thorough documentation and records on risk management, the work environment, design control, and regulatory requirements to get fulfilled by the compliance of the standard.


Also Check —>> ISO 13485 Certification in Dubai

As a global standard, the quality of medical devices cannot be negotiated as the reports produced in the concern of public health are accepted worldwide. ISO 13485 is mandatory in various countries and exporting generally requires Certification to safeguard from further risks and ease the process of transportation of medical devices. Medical devices according to FDA or as per EU Regulations are divide into various Categories based on Product Risks ex. CLASS I (Devices with low-moderate risk to the consumer requires general control; Class II (Devices with moderate-high risk requires special controls); Class III( Device with high risk supporting life or sustaining life). ISO 13485 Certification is applicable to every organization regardless of size and class of the devices.ISO 13485 Certification ensures that the Quality Manual, Control of Documents, and Control of Records, all of which are required documents to be thoroughly achieved. This certification is a valuable credential to keep all the professionals, dealers, suppliers, and customers safe in clinics, hospitals, and other medical institutions dealing in medical devices. The primary objective of ISO 13485 is to facilitate harmonized medical devices with several enhancements in QMS. The standard is designed and developed to assist organizations in focusing their management system practices on strengthening risk management approach and provide the customer with trusted products and services they can rely on upon without any recalls defects or errors in the results.

Importance of ISO 13485 in your Medical Devices

ISO 13485 standard is based on the ISO 9001 process similar HLS model approach. ISO 13485 Certification is a management systems standard specifically developed for the manufacture, supply, maintain of medical devices. Its primary objective is to facilitate harmonized medical device regulatory requirements, complying with the guidelines of the standard. Adoption of ISO 13485 helps to retain the quality with the latest technology and techniques to maintain the quality of all types of medical devices with managing the risk involved in them. This standard helps to deliver and consistently meet customer requirements, helps in reducing the operational cost by improvement in operational efficiencies. Organization gaining ISO 13485 certificate can have their own independent verification with improvement in the market value and business credentials globally. Certifications also help in winning new markets in regulated sectors.

How to achieve ISO 13485 Certification for an organization?

Now getting ISO 13485 Certification is just a cup of tea. Get ISO 13485 certifications with these simple steps.

Step 1 Internal audit Stage by Consultants –(Verification and Implementation of Legal requirements and documentations for the conformity of the standard with an organization)

Step 2 External audit by notified body –(Review of internal audit report provided by the Organization & Certificate issuance to an organization)The validity for ISO Certifications is for 3 years and requires to undertake Surveillance Audit yearly and Re-Certification after the expiry or completion of Certification. Gaining an ISO Certificate clearly states your organization’s value and is concerned about public health.

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