Improving Quality and enhancing patient safety through implementing a Quality Management System (QMS) helps many Life Science organizations provide high-Quality, patient-centric care. As such, Life Science organizations continue to demand more from their Suppliers with the expectation of being able to audit several elements of their QMS and verify its conformance to ISO 9001:2015 through an independent certification body.
Why ISO 9001? Because it is defined as the international standard that specifies requirements for a Quality Management System (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that 1) understand and meet Customer needs and 2) deliver products and services that consistently meet Customer requirements.
ISO 9001 brings additional benefits to organizations, including satisfied Customers, management, and Employees. Because ISO 9001 specifies the requirements for an effective Quality Management System, organizations find that using the standard helps them:
The result is effective and efficient clinical, business, and support processes that ensure high-Quality care. Now more than ever, it’s important to find the right technology Partner who can meet the requirements of ISO 9001 with an integrated business solution.
At AX for Pharma 365™, we focus on delivering faster time-to-market solutions with higher levels of Quality. We maintain competitive pricing by leveraging our QMS – which is built on five key elements of design control, process management, documentation management, corrective, and preventive actions – throughout the entire software development and delivery lifecycle.
ISO 9001 certified since 2008, we provide Customers support and expertise across all facets of their operations. We can help Pharmaceutical, Biotech, and Medical Device organizations transform and simplify their businesses with an ERP solution designed to meet the industry’s specific requirements.