Eagle has been audited and passed the ISO 9001:2015 and ISO 13485:2016 version for our quality management system.
ISO 9001 is an international standard for an organizations quality management system for any industry. These standards help to ensure consistent products to meet customers’ specifications. Eagle first received certification in 1998. Since then there have been revisions every few years.
ISO 13485:2016 is the ISO version for the medical device industry. This version was first published in 1996.
The first ISO certification focused on quality and preventive action. Instead of just checking the final product, the product was checked continuously during the production process. ISO 9001 requires continual improvement, ISO 13485 requires only that the certified organization demonstrate the quality system is effectively implemented and maintained. These processes helps minimize waste and errors thus increasing productivity. This is still a process used today during production.
In 2000 a new ISO 9001 version was implemented, replacing ISO 9001, ISO 9002 and ISO 9003. This version required more involvement from upper management. Other requirements included: Approve documents before distribution; Provide correct version of documents at points of use; Use your records to prove that requirements have been met; and develop a procedure to control your records.
In 2008, ISO 9001:2008 was introduced. The 2008 version only introduced clarifications to the existing requirements of ISO 9001:2000 and some changes intended to improve consistency.
The newest ISO certification in ISO 9001:2015. The focus for this version of ISO is performance. This was achieved by combining the process approach with risk-based thinking, and employing the Plan-Do-Check-Act cycle at all levels in the organization. The new version has 10 clauses as opposed to the 8 in the 2008 version. They include:
Scope, Normative reference, terms and definitions, context of the organization, leadership, planning, support, operation, performance evaluation and improvement.
Continuously improving is a key ingredient in a quality management system. Eagle will constantly stay on top of ways to increase customer satisfaction. At Eagle, every employee is concerned with the quality of each product at every step of production. This extends from order entry and raw material purchasing to fabrication and QA to final test and shipping.