The ISO 13485:2013 Certification is used for implementation of a system that manages the quality of the devices that are manufactured in the company and ensures best quality of the products. The system ensures the manufacturers that the products they provide to the customers are of best quality and there is no chance of inducing any quality defects in the products.
When a company is granted the ISO 13485:2013 certificate, it is provided a complete set of instruction on how to ensure zero quality defects in the products as well as the manufacturing process for better quality assurance. The ISO 13485:2013 accreditation is necessary for the companies that are indulged in the manufacturing of high end medical devices so that they are able to provide the products with zero defects to the customers with better consistency.
Some of the Advantages of ISO 13485 are as follows
- Improve customer satisfaction. The ISO 13485 standard is built on a set of quality management principles, one of which is ensuring customer satisfaction. This can be achieved by assessing customer needs and expectations, and striving to meet them. Customers know what they want, and what they need, and many of them will not even entertain a supplier that isn’t certified. Beyond that, ensuring the satisfaction of your existing customers keeps them coming back, and helps you sell your services to new customers. This translates directly to increased revenue.
- Improve your processes. Using the process approach outlined in ISO 13485, it’s much easier to discover opportunities for improvements. You’ll be able to identify and eliminate waste within and between processes, reduce errors, and avoid rework—facilitating greater efficiency and cost savings.
- Improve decision-making. Another quality management principle of ISO 13485 regards the use of evidence-based decision making. When you use facts and data to drive your decisions, those decisions tend to be better aligned with the strategic goals of your company. While “gut feelings” may be appropriate in some social situations, they can spell trouble in business. An added bonus is the increased insight into the health of your processes, and any improvements that are made, once you keep track of the data.
- Create a culture of continual improvement. A third quality management principle making up the foundation of ISO 13485 is the concept of continual improvement. When adopted as the culture in your organization, management and staff will always be on the lookout for ways to improve on how things are done. By establishing systematic processes for reducing problems and mitigating their effects, everyone will spend less time cleaning up mistakes, and more time delivering quality products and services.
- Better employee engagement. When employees are asked to help look for ways to improve their own processes, not only will they often provide the best insight – they will also be much happier and more invested in the success of the company. The more your employees understand their roles in delivering quality products and services, the more engaged they are, which leads to increased efficiency and productivity.
Documents required for ISO 13485
- Incorporation Certificate of Organisation or GST Registration certificate
- Scope of working
- Copy of Invoices for any purchase or sale
- Contact Details of owner
- Any other document as required time to time.
Steps for ISO 13485 Registration
- Making an application to an accredited ISO certification body
- Providing the required documents
- Defining the certification scope
- Initial assessment to verify that the basic structure of the management system is implemented.
- Certification audit
- Surveillance audits-it includes the verification of continuous improvement, closure of nonconformities from previous audits, conformance to the standards etc.
- Re-certification after three years