Recognition by Performance Review Institute Registrar
BMT USA is pleased to announce our certification to ISO 9001:2015, awarded by Performance Review Institute (PRI) Registrar. This certification validates our compliance with internationally recognized quality management standards and reflects our systematic approach to stakeholder satisfaction and continuous improvement.
What ISO 9001:2015 Certification Means for Pharmaceutical Manufacturers
ISO 9001:2015 certification provides pharmaceutical and biotechnology companies with critical assurances when selecting sterilization equipment partners:
Enhanced Quality Assurance and Compliance
- Validated Quality Management System: Our ISO-certified processes ensure consistent manufacturing standards that align with GMP requirements
- Documented Procedures: Comprehensive documentation and traceability support regulatory audits and validation protocols
- Risk-Based Approach: Systematic risk management integrated throughout our operations minimizes quality issues and equipment failures
Operational Benefits
- Reliable Supply Chain: Standardized processes reduce lead time variability and improve delivery predictability
- Improved Product Consistency: Quality controls ensure sterilization equipment meets specifications batch after batch
- Enhanced Technical Support: Structured service protocols and continuous improvement methodologies optimize equipment uptime
Regulatory Alignment
- Audit Readiness: Our certified quality management system facilitates customer qualification processes and regulatory inspections
- Change Control: Formalized change management processes ensure equipment modifications are controlled and documented
- Supplier Qualification: ISO certification streamlines vendor qualification requirements for pharmaceutical manufacturers
Statement from Performance Review Institute Registrar
“BMT USA has demonstrated its commitment to world-class quality management by implementing and becoming certified to the ISO 9001:2015 standard. They have joined an elite group of organizations worldwide who have achieved certification to this globally recognized quality standard,” stated Randy Daugharthy, Director of the Registrar Program at Performance Review Institute Registrar. “PRI Registrar is proud to partner with BMT USA in this accomplishment and looks forward to continued support of their objective of quality excellence.”
Our Commitment to the Industry
This certification reinforces BMT USA’s position as a preferred supplier of sterilization equipment for the pharmaceutical, biotechnology, laboratory, and food and beverage industries throughout North America. Our ISO 9001:2015 framework enables us to:
- Deliver excellence in equipment operability, serviceability, and support
- Maintain systematic approaches to customer satisfaction
- Implement data-driven continuous improvement initiatives
- Ensure consistent quality in GMP steam sterilizers, laboratory sterilizers, pure and clean steam generators, and laboratory ovens and incubators
About Performance Review Institute Registrar
Since 1995, Performance Review Institute Registrar has served as a management systems registrar, helping organizations achieve their potential through quality systems certification. As an affiliate of SAE International, PRI Registrar operates as a not-for-profit organization committed to raising industry standards across the sectors it serves.
Contact: [email protected] | www.p-r-i.org/registrar
About BMT USA
BMT USA, located near Seattle, Washington, is a member of the MMM Group—a global leader in pharmaceutical process equipment. With subsidiaries in over 20 countries and manufacturing facilities in the USA, Germany, and the Czech Republic, the MMM Group has supplied sterile processing solutions to pharmaceutical, biotech, laboratory, and food and beverage facilities worldwide since 1954.