ISO 13485 2016 is a quality management standard for medical devices. It defines a set of quality management requirements. The purpose of this quality management standard is to help both medical device suppliers and service providers to meet both customer expectations and regulatory requirements. According to ISO 13485 2016, any medical device supplier or service provider can achieve these objectives if it establishes a quality management system (QMS) and if it continually tries to improve the suitability, adequacy, and effectiveness of this system.

ISO 13485 2016 is based on the ISO 9001 2008 standard. Both standards are organized in the same way and use much the same numbering system. In addition, many of the ISO 13485 requirements are taken directly from ISO 9001 without modification. However, some ISO 9001 requirements were modified and others were excluded. And, of course, ISO 13485 2016 also includes an extensive set of requirements specifically related to medical devices.

Benefits of ISO 13485:2016:

The benefits of ISO 13485 cannot be overstated. Companies of all sizes have realized significant savings in cost and time, plus other improvements that an efficient Quality Management System naturally bring about. The following is a list of six top reasons to implement ISO 13485 in your company:

Improve your company’s credibility and image. ISO 13485 is the internally recognized gold standard for quality in the medical device industry. Certification to this standard shows clients and customers that your company takes quality very seriously, and that you have a system in place to ensure it. Your QMS can be a powerful marketing tool, and it has become a requirement in many countries for suppliers to show compliance. This translates to more opportunity.

 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.

Your advantages in working with us:

  • Security in planning and execution at an individual fixed price
  • Compact, unbureaucratic, and flexible approach
  • Fast implementation through years of audit expertise
  • Shortened audit duration and certification in 6-12 weeks

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