Always LLC offers multiple services to help establish, maintain, or improve Quality Systems. We provide interim Quality Assurance Management, Quality System remediation projects, as well as implementation of Quality Systems for new or existing companies. We have over 20 years of implementation and management of ISO 13485 Quality Systems and we have experience from the perspective of owners, customers, and employees.
Driving Quality Systems Excellence
Our team specializes in designing ISO 13485 Quality Systems tailored to the unique needs of your business. After identifying all potential exclusions such as Installation and Servicing activities, we start with a comprehensive Quality Manual which serves as the master plan for your Quality System. With the Quality Manual approved, we then draft the entirety of the System Procedures required to achieve Quality System excellence for your business. The process can be as collaborative or autonomous as you prefer.
If you need temporary management of your Quality Assurance team, we offer interim management services to ensure continuity and compliance. Our diverse experience within medical device companies allows us to step in to oversee and maintain your quality processes. We have a strong commitment to patient safety and risk-based decision making. Having founded and owned a medical device company ourselves, we incorporate your perspective as a business owner into the risk-based decision making process.
For businesses with existing quality systems in need of improvement, we provide comprehensive remediation services. Our experts will listen to your concerns and assess your current QMS. We identify areas for enhancement, and implement effective solutions to strengthen your quality systems.
“The feedback from the auditor was that we have a really, really strong quality system, and she was very impressed with the maturity of our quality system at the age of our company. I believe truly and sincerely that credit belongs to Always LLC. ” - Chief Operating Officer of a Medical Device Manufacturer