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Quality Driven
Quality Policy
All employees of Roechling Medical Lancaster are committed to doing the right thing, the right way, all of the time, in order to meet or exceed our customer’s expectations.
At RML, a commitment to doing the right thing includes a commitment to comply with ISO 13485, GMP, OSHA, and other legal requirements as well as all ethical, quality, policy, procedure, and company objectives requirements, and to maintain the effectiveness of the quality management system.
Regulatory Affairs
RML is a progressive, FDA-registered medical device company with a quality system in compliance with Government Regulation 21 CFR Part 820, Quality System Regulation. We are also a certified ISO 13485:2003 company. The Total Quality Management (TQM) and Operational Excellence focus of the company provides its customers with consistently high-quality products.
All employees are given comprehensive training on the requirements of the Quality System Regulation (QSR) and all aspects of Good Manufacturing Practices (GMP) prior to their first work assignment.
Our customers are encouraged to review the RML Quality Manual and are invited to visit and conduct compliance audits. We will assist our customers with all of their regulatory requirements.
Continuous Improvements
At Roechling Medical Lancaster, we are committed to continuous improvement and embrace a number of strategies to improve quality, increase customer satisfaction (internal and external), reduce waste, reduce costs, and improve profitability. Our portfolio of tools and systems are based on principles of Operational Excellence (OpEx), a philosophy of leadership, teamwork and problem-solving that results in continuous improvement throughout the organization by focusing on the needs of the customer, empowering employees, and optimizing existing activities. These tools and systems include:
Total Quality Management
RML’s TQM strategy is focused on empowering our employees to make customer satisfaction their highest priority. Every employee is expected to do the right thing, to reduce variation, and to identify opportunities for process improvement.
Lean Manufacturing
At RML, we associate the concept of lean manufacturing optimizing processes to eliminate waste and to elevate productivity. We look beyond our own facility to consider suppliers and vendors, and we foster teamwork so our staff can distribute knowledge and feel empowered to change processes at the source.
Six Sigma
RML uses six sigma tools and techniques to reduce process variation and errors by applying quality and statistical tools. This enables us to minimize defects across design and manufacturing and, ultimately, deliver higher-quality products.
Project Management
RML adheres to a rigorous project management process to keep projects on schedule and ensure best practices and high standards are maintained throughout production. A dedicated project manager serves as the main point of contact and monitors schedules and budgets. The project manager also enforces the project’s goals.
We systematically apply the appropriate knowledge, skills, tools and techniques to ensure all project activities satisfy the requirements defined by the customer during the project kickoff. This involves managing scope, cost, and schedule to ensure all projects are delivered on time and on budget.
