For once, negligence towards quality and standards can be ignored or forgiven in any other field, but not in the medical field and case of medicines as well.Hence, to control and monitor the safety, quality, and standards of the medical devices industry and medical equipment, ISO 13485 standardization and certification were developed.

‘One slight glitch in these devices can prove fatal for someone’s life’

ISO 13485 is based on ISO 9001 and is a management system standard, designed to be used by organizations involved in the design, production, installation, and servicing of medical instruments and related services.

The organization which seeks this certification has to implement an ISO 13485 Quality Management System which should pass a third-party Medical Device Single Audit Program. And the organization must get re-certified every three years to maintain its ISO 13485 certification status.

This certification does not depend on the size of the organization and does not define the product quality, rather it is a process-based standard that the organization can use to control the processes and the end product should meet the desired result.

Below are the key benefits of implementing ISO 13485 quality management system:

1. Improve Company’scredibility and image –
   QMS based on standards can prove to be a vital marketing tool.
   Certification to these standards shows clients and customers that the company takes quality seriously, thus creating faith.
   Even many countries have made it mandatory for suppliers to show compliance with these standards.
2. Helps in improving processes –
   If a company develops processes based on these standards,then it helps them to identify and eliminate waste within and between processes, avoid rework, reduce errors, and provide greater efficiency and cost savings.
3. Improved decision making –
   When decisions are made based on facts and data, then those decisions are better aligned with the strategic goals of the company.
   This is what ISO 13485 emphasizes. It regards the use of evidence-based decision-making.
   It also helps to provide increased insight into the health of the process and any improvements made based on the data.

Creating a culture of continual improvement –
ISO 13485 is based on the concept of continual improvement.
When an organization adopts this culture, the management and the staff will always be on the lookout for improvements.
By establishing a systematic process for reducing problems, everyone will spend more time in delivering quality products and services than cleaning up the mistakes.

4. Better Employee Engagement –
   When employees are asked to provide their inputs for the continuous improvement of the management system, they feel involved and important, which will not only help in providing better insights but will help the employees to understand their roles better, which will increase efficiency and productivity.

Thus, companies that have achieved certification, not only can show proof to their potential clients that they comply with best practices, but can also enjoy better control over the processes and continual improvement.

Takeaways:

• It gets pretty hard for organizations to plan and implement ISO 13485 standards on their own
• To assist and help them, service providers like ISO-UAE are present.
• ISO-UAE provides online and offline consultancy and assists the organizations with the complete ISO 13485 process, right from documentation, implementation, training to preparing for the audits.
• ISO-UAE shows a sure-shot path towards the ISO 13485 certification to the companies!

For More Information Contact [email protected]

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