ISO 13485 AND ITS APPLICATION IN THE HEALTH SECTOR

ISO 13485 and its application in the Healthcare Sector

The medical devices industry with its wide and diverse range of products ranging from bandages, gloves, heart valves, software, to the manufacture of cutting-edge devices has a sustained growth worldwide, and it is a sector with a growth perspective of up to 828 million dollars. Hence the importance of ISO 13485 in this sector.

There are many companies dedicated to the manufacture of medical devices and there are also companies that provide services such as updating, maintenance, refurbishment, training, use and commissioning of devices. Therefore, different points of compliance, quality, local and international legal requirements must be met.

Despite being in full growth and power in the economic scene also has to worry about the issues of upgrades. All companies determine different strategies to comply with the requirements of the industry and customers.

WHAT IS BEHIND MEDICAL DEVICES?

All people have made use of these devices. Nowadays there are many laws and standards that help you to improve your company’s activities, which also allow you to grow and maintain your position in the market.

Many companies have taken the initiative to implement a quality management system that allows them to standardize their activities, increase productivity, reduce unnecessary costs and ensure the quality of processes and products, so they decide to become certified under the ISO 9001 quality standard.

Other companies or organizations determine that they prefer a more specific or specialized standard such as ISO 13485 which, although its main objective is to harmonize regulatory requirements between the quality management system and medical devices, it also excludes certain quality requirements that are not suitable for the specific subject of medical devices.

ISO 13485 not only facilitates your entry into international markets, but also allows you to reduce costs, control your supply chain, increase efficiency and demonstrate that you are producing safer medical devices and medical devices.

ISO 13485 AND ITS APPLICATION IN THE HEALTH SECTOR

ADVANTAGES OF IMPLEMENTING YOUR MANAGEMENT SYSTEM with ISO 13485

The advantages of implementing your quality management system range from internal activities that are also reflected externally and can generate confidence with your customers and make you stand out from your competition.

Having your management system implemented and certified opens the door to real and exponential growth and allows you to reach different markets.

Not all companies have the vision to grow and go out into the world, because they have the idea that implementing and certifying a management system is an expense that will not allow them to continue serving their customers and their immediate needs, but it is only an investment with benefits, which even drives to participate in tenders and generate better income.

Companies involved in health issues must be the most committed to the field itself, in addition to all the changes, the vanguard, the demands and trends.

POINTS TO CONSIDER

At these points you can now go into the specific issues of the ISO 9001 standard which indicates in its point 7.2 that your organization must:

Determine the necessary competence of persons who perform, under its control, work that affects the performance and effectiveness of the quality management system.
Ensure that personnel are competent, based on appropriate education, training or experience.
Where applicable, take action to acquire the necessary competence and evaluate the effectiveness of actions taken.
Retain appropriate documented information as evidence of competence.

As for ISO 13485 it is commonly used for local regulations as part of the approval points for medical devices and medical devices. Together ISO 9001 and ISO 13485 are certifiable standards that help companies in the healthcare sector to comply with internationally required quality and safety.

At QAlliance we have highly qualified personnel to provide you with a personalized service and help you achieve your certification in ISO 9001, ISO 13485 or your integral system, contact us!

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