ISO Compliance for Medical devices

The opening of international markets means a great challenge for our emerging economy, this challenge must be met with a lot of responsibility, applying innovative strategies that lead to raising competitive levels.
In this sense, the customer not only buys a product or service, the customer buys quality, and the companies that compete successfully in the markets are those that have adopted quality as their main competitive variable. The globalization of economies presents great challenges for entrepreneurs, who have the opportunity to apply innovative management mechanisms, to use business tools that allow them to successfully face the increasingly difficult competition.

One of these challenges is the Free Trade Agreements, and when talking about these, one must think of a market of global dimensions, of new clients, with numerous and different requirements. Yesterday’s competitors are no longer the same and, although it is true the market has grown, the competitive forces that handle it too, are now stronger and the competition more aggressive.

Staying in this market is not a matter of chance, nor of subsidizing prices, the only way to continue competing is to create value to our products and services and take advantage of our competitive advantages. In this aspect, a quality certification, under the ISO 9001: 2008 standard , differentiates us from the competition, since it allows companies to insert themselves into this global market, since large buyers seek to ensure that their suppliers maintain the quality of their products. , make your deliveries within the agreed deadlines and have an adequate capacity to respond to your new needs. A management system is to help achieve it.
The implementation of Quality Management Systems has nowadays become an important Competitiveness tool for companies to provide or provide products or services successfully in any market, regardless of their size, item or place where they work. This through the redefinition of their strategies and management processes that meet the increasingly demanding customer requirements. Therefore, for this reason, there is a need to implement quality management systems that ensure companies operate at international quality standards.

Through the implementation of the Quality Management System the client obtains greater confidence and satisfaction of the products and services that he acquires. In turn, the organization controls its processes, increases efficiency (minimizes errors), reduces non-quality costs and obtains recognition. Meanwhile, the staff benefits from a greater knowledge of the processes, increases their morale and improves their identification with the company, in addition to developing teamwork.

It is in this context that some companies need implementation and certification :

• for export purposes,
• to demonstrate in the local market that their processes are controlled and based on international management standards,
• as required by its main clients,
• for considering these standards a management management tool aimed at improving the performance of your organization,
• interested in corporate decisions.

As a recommendation, the first thing is to learn how to efficiently manage your processes and learn to discover opportunities for improvement always with the aim of achieving your objectives and goals and, logically, satisfying the market where they operate, having this as a principle, the ISO 9001 standard is an efficient management tool that helps organizations meet the established objectives. It is also an international standard and flexible enough to adapt to any business sector and organization size.