The Quality Management System of Boedeker Plastics is certified to both ISO 9001:2015 and ISO 13485:2016 (for medical devices).
Demonstrating our commitment to product quality and customer service, Boedeker Plastics is certified under ISO 9001:2015, a comprehensive internal Quality Assurance System. We received our latest BSI Certificate of Registration to ISO 9001:2015 (number FM 503948) on June 18, 2018 (originally registered on July 20, 2006.) The current expiration date of our ISO 9001:2015 certification is July 19, 2021.
The ISO 9000 series of standards represent an international consensus on what good management practices will result in a consistently acceptable product to the client.
Boedeker Plastics ISO 9001:2015 Certificate of Registration
Demonstrating our commitment to product quality and customer service, Boedeker Plastics is certified under ISO 13485:2016, a comprehensive Quality Management System for medical device manufacturing. In short, ISO 13485:2016 is the medical industry's equivalent of ISO 9001:2015. We received our latest BSI Certificate of Registration to ISO 13485:2016 (number FM 503949) on June 18, 2015 (originally registered on July 20, 2006.) The current expiration date of our ISO 13485:2016 certification is July 19, 2021.
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
The primary objective of ISO 13485:2016 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.
Boedeker Plastics ISO 13485:2016 Certificate of Registration
If you have additional questions concerning Boedeker Plastics’ position on quality with reference to any of the plastic materials that you purchase from our company, please contact us by phone at 361-594-2941 or by e-mail to firstname.lastname@example.org.