ISO 13485:2003 Demonstrates Adherence to Strict Quality Management Principles
Suzhou, China (June 10, 2016) – Technimark’s facility in Suzhou, China recently earned its ISO 13485:2003 certification after an extensive internal operations audit. Suzhou has been certified to ISO 13485:2003 by the certification body, SGS, for the manufacture and assembly of plastic parts used for medical devices.
According to the International Organization on Standardization (ISO), the primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
Technimark plans to obtain ISO 13485:2003 certification in all of its global operations to ensure its healthcare business is fully compliant with all regulatory quality management guidelines.
Preparation for the certification process began in 2014 when the company entered into the medical device manufacturing space in China with the construction of an ISO 146441 certified Class 8 cleanroom. As the infrastructure was developed, the current ISO 9001 quality management system was expanded to meet the additional requirements of ISO 13485, including implementation of a formal risk management program as well as other regulations unique to the medical device industry.
“The rigorous training and certification system we’ve adopted positions Technimark well to meet our customers’ need to demonstrate regulatory compliance throughout their development and manufacturing process,” said Carlos Diaz, senior vice president of Global Operations at Technimark. The Suzhou facility, which is currently being expanded, also maintains its ISO 9001:2008 certification for customers whose products do not need the specialized requirements of ISO 13485:2003.
The ISO standards for quality management systems (QMS) serve as the basis for the Good Manufacturing Practices (GMP), Good Clinical Practices (GCP) and Good Laboratory Practices (GLP) required by most government regulatory bodies as well as a foundation for compliance with the U.S. Food and Drug Administration’s 21 CFR Part 820 guideline and similar international standards for medical device manufacturers.
“To support our customers’ work to develop lifesaving medical devices, Technimark provides consistent, high-quality performance while meeting – and often exceeding – all relevant regulations,” said Mr. Diaz. “Incorporating ISO quality management process standards into all Technimark global operations mirrors our commitment to high-quality production methods and full regulatory compliance.”
