The organizations that are involved in the manufacturing and handling of medical devices are required to adhere to the rules and regulations as per ISO 13485 Certification. It is very much crucial for ensuring the safety of the medical devices for the end-users. This global framework provides guidelines for producers and distributors of medical products. This blog will explain all about ISO 13485, from what it is, why it is important, to its benefits, and how it can be achieved?
What is ISO 13485 and Why is it Important?
It is an international framework that sets out the criteria for implementing a Quality Management System for medical devices (QMSMD). It demonstrates the competency of the organizations in delivering the best quality and safe medical devices and relevant medical services that can fulfill the customer’s expectations as well as ensure compliance with the regulatory norms.
It is important to organizations at all stages of the product life cycle, beginning with the design, manufacture, storage, and distribution of the final product. It may be applied to relevant services of medical devices as well as related activities which are in the form of technical support- both remotely and on-site.
The key benefits of ISO 13485:
Some of the many benefits of this standard are as follows:
- It helps you improve your processes, potentially reducing costs
- More reliable management makes it possible to strengthen relations with stakeholders.
- Achieving the certification strengthens your image and gives you confidence in the eyes of customers.
- Your QMS for medical devices will ensure product quality and consistency, following strict compliance with the requirements of the standard.
- The worldwide acceptability of the standard expands the scope of the market for your business.
- It is recognized by the Global Harmonization Task Force (GHTF) as the standard for the implementation of an MDQMS model for medical industries. Additionally, it also addresses all legal and contractual requirements.
- Food and Drug Administration (FDA) requirements are also covered in this standard.
How to obtain ISO 13485 certification?
Getting ISO 13485 is no big issue in today’s upgraded systems. The important steps to become ISO Certified for your organization are as follows:
- First, you need to choose a reputable and credible ISO certification body.
- Second, create an application in the authorized form that must include all accountability issues, necessary confidentiality, and defined access rights.
- Third, the ISO certification body will review all documented reports associated with the various policies and principles that are followed within the organization. If deficiencies exist, the applicant must develop an action plan to address them within their organization.
- Fourth, the ISO certification body will conduct a physical on-site inspection to verify organizational changes consistent with existing deficiencies.
- Once the certification body has approved your management system, including your procedures and processes, you will receive the required ISO standard.
It is important to note that the International Organization for Standardization (ISO) does not certify, it simply publishes the ISO standards. An external organization carries out the certification. SIS Certifications is one of these organizations reputed to be one of the best in the world. Our vast pool of auditors is known for its in-depth audit expertise, the conformity of your management systems with the required standards, and the awarding of certificates at the end. The fluidity in our process, our integrity, and our commitment to meeting deadlines distinguish us from other certifying bodies.
To know more about us, visit:
https://www.youtube.com/c/SISCert
