91ÖÆƬ³§

Does 91ÖÆƬ³§ apply Six Sigma and Lean Methodologies?
Yes, the application of Six Sigma quality sciences and Lean/Human factor 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 the business.

Does 91ÖÆƬ³§ apply Statistical Process Control (SPC)?
Yes, 91ÖÆƬ³§ applies a combination of statistical process monitoring systems and controls. The 91ÖÆƬ³§ team is standardizing related best practices worldwide.

91ÖÆƬ³§ applies 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.

Does 91ÖÆƬ³§ provide any Dock to Stock service capabilities?
Yes, the worldwide 91ÖÆƬ³§ production teams are all capable of providing statistical process capability data, which will provide the scientific rationale to enable the justification to take product ship to stock and/or direct distribution.

Does each 91ÖÆƬ³§ site have a Business Continuity Plan (BCP) in place?
Yes, each worldwide 91ÖÆƬ³§ site has a BCP, which includes the use of other 91ÖÆƬ³§ facilities with like capabilities and validated processes.

Does 91ÖÆƬ³§ have any 91ÖÆƬ³§ brand implants available for purchase?
No, The 91ÖÆƬ³§ Executive Management has developed an Implant policy, which has been integrated within 91ÖÆƬ³§ systems and policies worldwide. The mention policy clarifies the Company has taken a position in conducting business within the medical device orthopedic industry of not direct brand labeling and selling any implant products to the marketplace. The company will continue to operate in a medical device industry as a contract manufacturer and full service provider of implant products and services to our Original Equipment Manufacturer customers.

What regulatory compliance registrations/certifications have the 91ÖÆƬ³§ companies achieved?
Each 91ÖÆƬ³§ sites regulatory registrations/certifications are aligned with their respective scope of services, considering;

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