Excellence Through Commitment, Compliance, and Quality
Pivot International’s Quality Policy:
“The Quality Policy of Pivot International is to provide the best solutions for all clients, taking consideration of interested parties’ requirements, while ensuring that Pivot International is regarded as the preferred supplier of quality custom designed, manufactured, tested and delivered product, and to establish, maintain and continually improve our Quality Management System and Policies consistent with the requirements of ISO 9001:2015, ISO 13485:2016 and FDA QSR’s.”
At Pivot International, quality is at the core of everything we do. It is deeply embedded in our operations and a promise to our partners that every design, product, and solution meets or exceeds these standards.
Pivot International and our global locations adhere to the disciplines set forth by ISO 9001:2015, ISO 13485:2016, and IEC 60601-1. We are proudly FDA Registered, UL Listed, and CSA Approved. We are compliant with WEEE, Conflict Minerals, Prop 65, REACH, and RoHS regulations.
Quality Certifications
Pivot International – ISO 9001:2015
Pivot International – ISO 13485:2016
Pivot A2E – ISO 9001:2015
Pivot DCM – ISO 9001:2015
What is ISO 9001:2015?
ISO 9001:2015 is a Quality Management System that outlines standards for an organization to effectively adhere to quality objectives, determine confirmative of those objectives, and actively improve upon the quality management system.
What is ISO 13485:2016?
ISO 13485:2016 is the International Quality Management System specifically designed for medical devices. This standard focuses on risk management by implementing a thorough decision-making process throughout the concept, design, manufacturing, and servicing of the medical device.
By adhering to these standards, Pivot holds ourselves accountable to maintain, update, and make available all necessary paperwork required for documentation. It is our commitment to our customers to strive to continuously improve our processes and products.
For further information regarding Pivot’s regulatory compliance and quality assurance, please contact [email protected].
