Technimark China Facility Earns Key ISO Medical Device Certification

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.”

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RJG Training Excellence Award Presented to Technimark

Technimark’s Gary Schiller Receives RJG Training Excellence Award.
rjg-training-award

Technimark’s Gary Schiller was recently named as winner of RJG’s Training Excellence Award, a special honor that recognizes commitment to the RJG Master MolderSM Certification program. He was one of only three to receive the award.

Gary Schiller is our Master Molder III “Train the Trainer” where he provides our in-house training. Technimark currently has 6 people certified as Master Molder II, 10 people certified as Master Molder I, and we have trained 54 people in Systematic Molding. Gary will have trained 100 people in the company by the end of the first quarter of next year.

“I think it is great that Technimark has given him the opportunity and support to train the Systematic Molding and Master Molder I classes. We have heard only positive feedback on what he has been doing with close to 100 people,” said Bruce Winslow, director of Global Operations Molding & Technology. “It is going to impact us greatly in the future, building our people and creating a new processing culture.”

RJG Master Molding training has helped Technimark as a company to commit and dedicate training on systematic molding and standardizing processing methodology on a global scale. Gary received the RJG Training Excellence Award at the MAPP Benchmarking and Best Practices Conference in Indianapolis for his great work and dedication to injection molding.

RJG, an acknowledged international leader in injection molding training, technology and resources, developed the Master Molder program to bridge the gap between classroom instruction and implementation on the production floor.

The award was presented in October at the MAPP (Manufacturers Association For Plastics Processors) Benchmarking Conference in Indianapolis.

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