Why should you get ISO 13485 Certification for your company?

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Trying to convince top management of the worth of any project can be intimidating – particularly when the ROI isn’t directly apparent. Implementation of a Quality Management System (QMS) based on ISO 13485 Certificationis one such project, where it’s problematic to put a dollar amount on the ultimate benefits. Instead, it’s essential to recognize the potential advantages that your company will appreciate through implementing a QMS, and then aid top management get a feel for what these could be worth – and not only in terms of dollars plus cents.

Why is ISO 13485 a good idea for your company?

The advantages of ISO 13485 certification offered by several companies cannot be exaggerated. Companies of all sizes have realized noteworthy savings in cost and time, plus other improvements that an effectual Quality Management System naturally brings about. The following is a list of six top reasons to implement ISO 13485 in your company:

Improve your company’s reliability and image. ISO 13485 is the internally documented gold standardtypical for quality in the medical device industry. Certification to this standard illustrates clients and consumers that your company takes quality very seriously, and that you have a system in place to safeguard it. Your QMS can be aninfluential marketing tool, and it has become a necessity in several countries for suppliers to show obedience. This translates to more occasions.

Improve customer satisfaction – The ISO 13485 standard is erected on a set of quality management principles, one of which is making sure customer gratification. This can be accomplished by assessing customer requirements and expectations, and determined to meet them. Consumers know what they need, and when they need it, and several of them will not even use a supplier that isn’t certified. Beyond that, making sure the gratification of your prevailing customers keeps them coming back, and assists you sell your services to new customers. This translates straight to amplified revenue.

Improve your processes – Using the procedure approach outlined in ISO 13485, it’s much easier to realize opportunities for improvements. You will be capable to recognize and eradicate waste within and between procedures, decrease errors, and evade rework—facilitating greater competence and cost savings.

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