Getting ISO 13485 Certified in San Luis, Arizona (AZ)
The health sector of any country widely relies upon the manufacture of the state of art medical devices. Therefore, it is simply out of question for any manufacturer to compromise on the quality of the medical devices that they produce. This is where ISO 13485 comes in handy. Medical devices can be machines or instruments, vitro reagents or implants, that medical institutions use in the prevention, diagnosis, or treatment of various medical conditions or ailments.
The ISO 13485 standard is internationally accepted and it stipulates the requirements for the quality management systems that are applicable to the medical devices industry. It includes companies that develop and scheme, manufacture, and service providers for the maintenance and installation of medical devices. It also includes the manufacturers of medical device materials and integrands.
Organizations that operate in the medical devices industry should adhere to strict practices throughout the entire lifecycle of the medical device product. The primary objective of ISO 13485 is to allow synchronized quality management system guidelines within the health industry. This standard was published for the first time in 1996 but the most recently improved version was published in 2016. The revised standard is more proactive to the latest quality management practices and also highly responsive to the challenges in modern technology. The latest version also puts more emphasis on accelerated regulatory requirements as well as risk management for enterprises within the medical supply chain industry.
You stand to benefit in several ways if your organization complies with the ISO 13485 standard. It can open for you doors in the international and domestic business. Some of these benefits include:
Access to Market Expansion
The national regulatory authorities prefer manufacturers who possess a 3rd party certification for management systems in marketing medical products in their respective countries. Investing in these quality management systems increases the chances in the respective countries that require the same. It also facilitates entry into these particular markets.
When you are ISO 13485 certified, your firm demonstrates commitment and trust to quality. It is a time-consuming procedure especially in explaining the specifics and demonstrating how effective the quality management system is effortless. It takes little time to earn the confidence and credibility of customers. It will also help you to save on costs through the minimization of product failures during the inception stage.
Based on the universally accepted standard and consistency of process controls, the certified management system of your company assists you to improve your products and services radically. It can encourage harmonious relationships with your customers, suppliers, and partners while giving your brand a competitive edge in the marketplace.
ISO 13485 is a replacement for the earlier documents such as EN 46002 and 46001. The main predecessors of ISO 13585 are the 2003 and 1996 versions of ISO 13488. ISO 13485 certifications last up to three to four years until there is a publication of the other versions. Companies normally take approximately five to seven months to implement the standard from the beginning to the end of the process. However, it can vary depending on various factors like complexity of the operations, geographical location, the size of the business. IQC The ISO Pros will walk with you through the implementation of ISO 13485 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: