MTI’s Pittsburgh facility just completed a successful ISO 9001 audit and has been recommended for ISO 9001:2015 certification. This brings both MTI’s Pittsburgh and Atlanta facilities into compliance with the most current ISO standards. As a result, MTI customers can expect greater quality management of their value added 3PL services and the highest of standards in delivering quality products and services to their clients.
In addition to ISO 9001:2015 certification, MTI has been recently certified for ISO 13485 which ensures specific quality standards for the medical device industry.
About ISO 9001:2015
ISO 9001:2015 is the most current international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. It is the most popular standard in the ISO 9000 series and the only standard in the series to which organizations can certify.
ISO 9001 is based on the plan-do-check-act methodology and provides a process-oriented approach to documenting and reviewing the structure, responsibilities, and procedures required to achieve effective quality management in an organization. Specific sections of the standard contain information on topics such as:
- Requirements for a quality management system, including documented information, planning and determining process interactions
- Responsibilities of management
- Management of resources, including human resources and an organization’s work environment
- Product realization, including the steps from design to delivery
- Measurement, analysis, and improvement of the QMS through activities like internal audits and corrective and preventive action