How To Get ISO 13485 Certification Training In India?

Author: Yogendra Pratap

In today’s competitive world, businesses must keep themselves a step ahead of their competitors to ensure that they stand at a specific position in the international marketplace. To be there, the organizations must adhere to the manufacturing standards and quality assurance. International Organization for Standardization (ISO) certification gives certifications to organizations for establishing trust and credibility among stakeholders, consumers, and other business partners. Having ISO certification ensures that the organization meets all the global standards for business. ISO is a non-governmental organization that provides certifications to organizations to check everything in the organization. The main aim of the ISO is to improve the welfare of the organization worldwide.

What Is ISO 13485 Certification?

ISO 13485 Certification demonstrates that the organization outlines the required parameters for a quality management system and consistently provides medical devices and other related services to fulfill the regulatory and customer requirements. The certification includes the inspection of design and development, storage and distribution, production, installation, and servicing of a medical device, which are all checked when an organization applies for ISO 13485 certification. An organization that provides goods as a third party or a goods supplier business can also apply for the ISO 13485 certification.

Who Can Apply For ISO 13485 Certification?

Any organization, irrespective of size, can apply for the ISO 13485 certification. An organization operating in the medical devices, either services, manufacturing, supply, etc., can surely apply for the certificate. The organizations connected with the medical equipment services can also apply for the certification.

How To Get ISO 13485 Certification Training In India?

It is mandatory in most countries to have rules and regulations for the safety of products and services provided by the business. Compliance with the regulation is necessary for all organizations to get an ISO 13485 certification. So, to make organizations more aware of the rules and regulations, gain awareness, and gain practical knowledge of the ISO 13485 certifications.

The ISO 13485 certification training in India also enables organizations to conduct internal audits. When the training is complete, the individual will be able to understand the requirements of ISO13485 and conduct internal audits effectively in their organization. The process to get an ISO 13485 certification training in India includes:

  • The ContentThe training includes the proper explanation of the purpose and structure of the ISO 13485 certification and how it is helpful for an organization.

  • Who Can AttendAny management representatives, professionals from medical device manufacturing industries, compliance managers, project team members of ISO 13485 audit, regulatory personnel, or anyone wanting to have an in-depth understanding of the ISO 13485 Process.

  • DurationThe lead auditor training is given provided to the person for a period of 3 days.

  • ApprovalThe lead auditor training for ISO 13485 certification is approved by DNV- GL Training Academy. Most often, the certificate is valid for a period of three years, and later on, the organization can go for recertification.

  • MethodologyThe ISO 13485 certification training or Lead Auditor Training course is meticulously designed with international feedback from several trainers, customers, and consultants. The course includes a high-level interaction between the participant and the trainer with live sessions of real-life examples. This knowledge can be applied by the participants in their organization to handle any similar situation.

Conclusion

It is a must for any organization to have professional training for the ISO 13485 certification. This will be helpful in all kinds of scenarios and help them tackle any situation in the organization that might be tricky and challenging to handle. So, an organization with ISO 13485 certification trained professional will surely help in the boosting the growth of the organization and will increase the sales.