Wisconsin Medical Device Manufacturer Achieves ISO-13485:2003 Registration

Quality standards provide a framework that manufacturers can use to demonstrate their ability to provide medical devices that consistently meet customer requirements and international regulatory requirements.

Menomonee Falls, WI – ATL, a leading 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 Wisconsin-based company, ATL President Donald Dobert said.

“ATL has been FDA cGMP compliant for the manufacturing of pharmaceutical booklet labels since 1999,” he noted. “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 Registration not only demonstrates ATL’s commitment to quality but also significantly expands the company’s market reach.

“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.

ATL followed an extremely demanding process to receive its Registration, he said. 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
• 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
• IQ-OQ-PQ Validations (Installation Qualification/ Operational Qualification/ Performance Qualification), all part of ATL’s Systems Validation Protocol
• 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
• 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.

“As a result, it includes some particular requirements for medical devices but excludes some of the requirements of ISO 9001 that are not appropriate in a regulated environment.”

ATL is proud of its Registration and the role its employees played in the process, Dobert said.

“We are pleased that ATL achieved its ISO-13485 registration on the very first attempt,” he said. “ATL will now be identified around the world as one of the very few ‘registered’ holders of this demanding regulatory standard.”

Headquartered in Menomonee Falls, WI, ATL is a leading manufacturer and converter of medical devices. The company has also specialized in multi-panel and multi-lingual booklet labels for the pharmaceutical industry for over 15 years. Visit http://www.atlco.com/pharmaceuticallabels/ to learn more.