CI Medical is the only ISO 9001:2015 certified pad printing company in the U.S. catering exclusively to the marking needs of the medical device industry. An ISO quality system:
- Provides a framework for consistently handling and processing of customer product
- Provides integrity of lot controls when receiving, processing and shipping customer product
- Provides product lot traceability
Ensures strict compliance with handling and processing specifications dictated by customer
What is the ISO?
ISO stands for the International Organization for Standardization. It is an independent, non-governmental international organization that establishes guidelines, requirements and specifications for products, services and systems to ensure quality, safety and efficiency. It also works to align these standards with regulatory agencies and bodies throughout the world.
What is ISO 9001?
ISO 9001 is the International Standard that promotes and defines the criteria for the development, implementation and effectiveness of a quality management systems for companies, businesses and organizations.
What Is ISO 9001:2015?
ISO standards are reviewed every five years and revised if needed. ISO 9001:2015 is the new version of the standard that replaced the ISO 9001:2008.
The most noticeable change to the standard is its new structure. ISO 9001:2015 now follows the same overall structure as other ISO management system standards, making it easier for anyone using multiple management systems. Another major difference is the focus on risk-based thinking. While this has always been part of the standard, the new version gives it increased prominence.
CI Medical’s ISO 9001:2015 Certification
Our ISO 9001:2015 certification means we follow the specific quality requirements that allow us to demonstrate our ability to consistently provide products and services that meet statutory and regulatory requirements. The ISO 9001:2015 requirements also help us focus on and improve customer satisfaction.
CI Medical is the only ISO 9001:2015 certified, pad printing company in the U.S. catering exclusively to the marking needs of the medical device industry.