Square 1 Industries, Inc., a contract manufacturing and product design company of advanced electronic devices and printed circuit board assemblies (PCBAs), announces that they have achieved ISO 9001:2015 certification of their Quality Management System (QMS). Square 1 successfully completed its stage 2 assessment audit on January 13th, 2023 by its Notified Body, ABS Quality Evaluations.
International Organization for Standardization (ISO) 9001:2015 is the most updated standard of its kind and focuses on quality management systems and performance. It assists companies in developing a management system that aligns quality with their wider business strategy. There is a focus on risk-based thinking and accountability in all organizational processes that helps improve communications, efficiency, and implementation of continuous improvement. As part of our certification requirements, Square 1 will be subjected to annual audits of its QMS to ensure its suitability and adequacy in meeting customer, and other interested party, requirements.
For any company, the path to certification requires a substantial commitment of time and other resources. Even before the business began operating in February 2022, Square 1 management had an objective to achieve ISO 9001:2015 certification and worked many early mornings and late nights to realize this goal in such a short period of time.
As part of our continued commitment to quality and delivering value to our customers, Square 1 has planned expansions of our QMS to include ISO 13485:2016 (medical device QMS), FDA Registration & Part 820 QSR Compliance as well as alignment to EU MDR 2017/745 (EU medical device QMS) to support our customers who operate in the European medical device market.
Thank you,
Square 1