Compliance simplified in revised ISO 13485:2016

This is the first part of a three-part series focused on the changes between ISO 13845:2003 and ISO 13485:2016. The second and third parts of this series will be featured in upcoming issues of Today’s Medical Developments.

July 6, 2016

ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry. It has recently been revised, with the new version published in March 2016.

The new ISO 13485:2016 standard is more focused on identification of interested parties and their expectations and the implementation of a process-based system for planning, monitoring, and improvement of the overall quality management system. It requires additional emphasis on identification and monitoring of all suppliers’ processes to ensure that the overall company objectives are met. This includes industry-specific specialists responsible for raw materials, plastics processing, and precision tooling as well as suppliers to the medical device industry.

Successful suppliers know their customers’ needs and fulfill requirements because they control their processes and ensure quality. A tool for managing an organization and improving performance, it acts as a quality management system that identifies opportunities for improvement and fulfills the requirements of customers and suppliers, allowing organizations to optimize their processes while reducing costs.

For smaller organizations, survival in today’s economy relies upon ISO 13485 certification. Organizations are turning toward this certification to control the quality and effectiveness of management systems and reduce costs associated with poor quality. Some seek certification because their clients demand it or because their competitors are certified. Others become certified to grow market share and sell overseas. A company’s ISO industry-specific specialist has a monumental responsibility to know the business, both operationally and financially, to improve performance reporting.

These services are customized to meet the needs of each supplier, requiring a background in supporting clients with supplier and process assessments for improvements and audits. Clients access their expertise and global footprint to gain relevant information quickly and cost-effectively.

An ISO industry-specific specialist will provide an independent and expert assessment of a company’s management system, assuring top management that the system conforms to the requirements of the standard. The insight gained from an assessment/audit on whether the management system is suitable for achieving the desired results is important. The specialist will suggest improvements and support the decision-making process.

Lewis Yasenchak is the founder/owner of P&Y Management Resources, specializing in ISO compliance/certification, quality training, and related management issues for the plastics industry. Yasenchak can be reached at or 706.694.2977.