Lifesol Medical India Private Limited becomes ISO 13485:2016 from SIS Certifications

Warmest congratulations to Lifesol Medical India Private Limited for successfully achieving UAF accredited ” ISO 13485:2016 “. By achieving this they have manifested assurance towards Quality Management for Medical Devices.

The scope of this management consists of Manufacturing and Supply of Disposable Medical Devices and Instruments.

As per the audit team, the certification has been said to be “process-oriented and engaging”. This process was conducted using collaboration and the auditing provided good results about the effectiveness of their internal systems. They appreciate the entire organization for its continuous support during the audit.

Some other standards that can be opted for by Lifesol Medical India Private Limited

Lifesol Medical India Private Limited can demonstrate its dedication to fostering a more sustainable economy with ISO 14001:2015 Certification for Environmental Management System (EMS). ISO/IEC 27701:2019, and compliance with the General Data Protection Regulation (GDPR) can assist the organization in safeguarding critical data belonging to Patients.


Additionally, ISO 22301:2019 ensures the implementation of a robust Business Continuity Management System (BCMS). Whereas ISO 37001:2016 certification enables Lifesol Medical India Private Limited to adhere to an ethical code of conduct, establishing an Anti-Bribery Management System (ABMS).

Benefits of ISO 13485:2016 for Lifesol Medical India Private Limited -

ISO 13485:2016 is globally recognized and frequently required for regulatory clearance in many countries. Compliance ensures that Lifesol Medical meets regulatory standards in several regions, simplifying international commerce and growing the company’s global reach.


The standard concentrates on building a strong quality control system. This translates to better operating efficiency, consistent product quality, and increased process control for Lifesol Medical. It entails painstaking documentation, risk assessment, and methods for ongoing improvement.


Having ISO 13485:2016 certification might provide you with a big competitive edge. It enhances Lifesol Medical’s standing and presence in the market by setting them apart from rivals who might not hold certification. Ensuring suppliers fulfil strict quality criteria is a common aspect of adhering to the standard. Better supplier performance, more dependable supply chains, and higher-quality products all result from this.

SIS CERTIFICATIONS certified that Lifesol Medical India Private Limited is accredited by both International Accreditation Services (IAS) and United Accreditation Foundation (UAF) Services. Several certifications, including but not limited to ISO 9001ISO 14001ISO 22301ISO 21001ISO 37001ISO 41001ISO 45001ISO 50001ISO 13485ISO 22000HACCPISO 27001IATF 16949CERoHSKOSHERHALALProduct Certifications, and training comes under the aegis of its services.