Quality Management

AJR Specialty Products offers quality management

Quality Management

AJR Specialty Products manufactures a diverse array of medical devices and consumable products. AJR Specialty Products is a leading provider of contract manufacturing services to the medical device and consumable industries. 

We are committed to providing our customers and partners with safe and effective, quality products and services. 

AJR Specialty Products follows strict regulatory compliance and quality standards to ensure the safety of our products and services. Our documented  procedures are broad in scope and are the basis of our business activities. We strive for harmonized processes to safeguard the highest quality – from the quality of incoming materials through the design, development, manufacture, storage, handling and distribution of our products. 

At AJR Specialty Products, our quality management system is designed to ensure compliance with all applicable national and international requirements as well as to meet the expectations of our partners and customers. For us, it is an ongoing task to undertake regular quality improvements across all operations. 

AJR Specialty Products operates under the applicable governing standards and regulations, including but not limited to the following:

•FDA 21 CFR Part 820 – U.S. Quality System Regulation Good Manufacturing Practice for Medical Devices. (QSR)
•ISO 13485 – Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes. 
•ISO 9001 Quality Management System – Requirements. 

To monitor compliance with these standards, internal and third-party assessments of our quality and regulatory systems are conducted. 

At AJR Specialty Products, quality is an integral part of our day-to-day operations, our business strategy, and our business philosophy.

The basis for the lasting and successful partnerships with our partners and customers is the commitment to consistently improve the quality of our products and services.  Therefore, our quality management system is regularly reviewed during internal quality audits as well as certified by external auditors. Currently AJR Group has an ISO 13485 certificate covering 3 business units within our organization. We continuously expand the successive integration of all the AJR Group business units into our ISO certification scope.

Quality Process

The goal of AJR GROUP is to manufacture products that meet the customer requirements and highest industry standards by providing exceptional customer satisfaction, consistent quality, on-time delivery and continual improvement of the quality management system; while complying with applicable statutory and regulatory requirements.

Quality and Regulatory Compliance Units at AJR Group

Quality and Regulatory Compliance at AJR Group consists of the following areas: Quality Assurance, Quality Control, and Regulatory Affairs. Our staff of highly trained employees oversees all quality-related functions for AJR Group’s manufactured products. In addition, technicians, inspectors, coordinators and administrative personnel perform vital functions on a daily basis to assure effective implementation of our quality management system and compliance with applicable regulatory requirements.