ATL Earns ISO 13485

ATL, a medical device converter and manufacturer, has been registered to ISO 13485:2003. The standard, which specifies requirements for a quality management system directly related to medical device manufacturing, was a natural next step for the Menomonee Falls, Wis.-based company, according to the company’s president, Donald Dobert.

“ATL has been FDA (U.S. Food and Drug Administration) cGMP (current good manufacturing pratices) compliant for the manufacturing of pharmaceutical booklet labels since 1999,” Dobert said. “We are regulated by the CFR (Code of Federal Regulations) 21 CFR 210, 211, and 820. The CFR section that governs medical devices is 21 CFR 820. ISO 13485:2003 registration is similar in scope to 21 CFR 820.”

The ISO certification not only demonstrates ATL’s commitment to quality but also significantly expands the company’s market reach, he said.

“Achieving ISO 13485:2003 registration allows ATL to become a manufacturer of medical devices that are marketed and sold in the European Economic Community,” Dobert said, adding that ATL followed an extremely demanding process to receive its registration.

ISO 13485:2003-registered organizations must have systems in-place to comply with regulatory items such as:
• Risk management;
• Quality management;
• Documentation, document control, and control of quality records; and
• Management commitment.

Dobert said the standard also focuses on critical issues like customer focus, quality policy, training, infrastructure, work environment, planning of product realization, and purchasing (material) controls.

Other ISO-specified systems that must be in place for registration include:
* Sterilization controls and cleanliness controls for bio-burdens;
* Installation Qualification/ Operational Qualification/ Performance Qualification validations;
* Identification and traceability;
* Preservation of product;
• Control of measuring devices;
• Internal audits and measurement of process effectiveness;
• Control of non-conforming product and analysis of data; and
• Corrective action and preventive actions.

“ISO 13485 is based on the ISO 9001 format with additional requirements relating to design, special processes, environmental control, traceability, documentation records and regulatory actions,” Dobert said. “This is an outcome of the primary objective for the creation of ISO 13485, which was to facilitate standardized medical device regulatory requirements for quality management systems. ATL is proud of its registration and the role its employees played in the process. We are pleased that ATL achieved its ISO 13485 registration on the very first attempt.”