91ÖÆƬ³§

We partner with our customers to solve their challenges, and we incorporate the latest innovations and technologies in our solutions and how we work together, making our global quality and regulatory systems unmatched.

You can be confident that each 91ÖÆƬ³§ manufacturing facility maintains its own comprehensive Quality Management System—integrating quality control, monitoring and management at the source of production. Our quality systems are based upon, and in compliance with, International Organization for Standardization requirements (ISO)—and where applicable, United States Food and Drug Administration regulations (FDA).

91ÖÆƬ³§'s One Entity Harmonization Initiative

Six Sigma and Lean Methodologies
These principles have been integrated across the systems/business practices of 91ÖÆƬ³§; the merged combination of these tools provide a layered science approach to supporting all aspects of our business.

Statistical Process Control (WinSPC)
By leveraging a combination of statistical process monitoring systems and controls, the 91ÖÆƬ³§ team is standardizing related best practices worldwide. We apply data-based informed decision-making team dynamics to help accelerate learning, sharing and the realization of improvements across the company. These statistical process monitoring applications supplement Active Risk Management at the production source.

Business Continuity Plan (BCP)
Each worldwide 91ÖÆƬ³§ site has a BCP, which includes the use of other 91ÖÆƬ³§ facilities with like capabilities and validated processes.

91ÖÆƬ³§ Business System (TBS)

The 91ÖÆƬ³§ Business System is designed to drive continuous improvement for customers, employees, and stakeholders. It's comprised of two key components:

1. Lean Management System - seeks to create a culture of problem solvers capable of identifying performance gaps, leading to root cause and effective countermeasures
2. Production System - applies Lean tools and practices to root causes identified to drive step change improvements in safety, quality, delivery, and cost

Regulatory Compliance Registrations/Certifications
The applicable regulatory registrations/certifications of each 91ÖÆƬ³§ location are aligned with its respective scope of services. You can view a list by location here.Ìý

• ISO 13485
• ISO 14001
• ISO 9001
• AS9100
• CMDCAS – Canadian Medical Devices Conformity Assessment System
• PAL – Japanese Pharmaceutical Affairs Law Article 13-3
• FMA – Japan Foreign Manufacturer Accreditation
• Nadcap – Special Process Accreditations