Getting ISO 13485 Certified in Mission, Texas (TX)
When you are ISO 13485 certified, you will be able to consolidate the trust of your employees and business. It is an essential requirement for the firms that manufacture medical devices. Currently, ISO 13485 is a globally accepted standard in the medical manufacturing industry. The standard certifies that you have conformed to the regulatory requirements.
Firms in this industry have to give out proof for the implementation of quality management systems through the entire production cycle. That is why it is important to get ISO 13485 certification. If your business is located in Mission, Texas (TX), the best company to help you with this process is IQC The ISO Pros. We have a lot of experience in helping firms in this industry with ISO 13485 certification and training.
ISO 13485 makes sure that you conform to the international standards in all the phases of the life span of your medical devices. This includes sales, technical assistance, installation, manufacturing, and design. ISO 13485 also covers the other posy production elements such as distribution, storage, and the provision of associated services. To add to this, decommission and disposal of damaged/used medical devices are regulated by ISO 13485.
ISO 13485 is a standard that is based on the ISO 9001 management standard. The only difference is that it has been adapted for the manufacturing environment of medical devices. When you are certified for both of them, it will ensure the effectiveness, transparency, and competitiveness of your brand. It will bring in more trust from potential business partners.
For the manufacturers, this certification is an implication of expanded access to the market. Being in a position to work with a global network of potential business partners and clients is among the top reasons why companies need this certification. Both international and national authorities prefer medical device manufacturers who have a third-party certified and audited quality management system. When you invest in this system, it speeds access in those countries that require it. It will help your company to expand its sales and production operations.
Investing in the recognition and implementation of ISO 13485 standards can help you to save a lot of money. First, when you provide proof that you meet high-quality standards, it will take you significantly little time to find potential customers. All potential clients that purchase medical equipment need commitment and credibility to qualify for all their business partners.
Even though this ISO standard doesn’t emphasize the great need for continual improvement, it strictly points to the achievement of customer satisfaction and meeting the quality requirements. Thus, when you implement it in your company, you will get a process control that will allow further improvement and development of your company.
The latest ISO version highlights the need for risk decision management and effective risk management more. Risk management should be documented fully for all medical devices and applied during the whole life-cycle of the product. ISO 13485 proves that the risk is fully understood and documented. The other standard for medical devices risk management is ISO14971. IQC The ISO Pros will help you with the training and implementation of these standards.
IQC The ISO Pros can help you implement, train on, consult, and have your company and/or organization certified on the following ISO Certifications: