Quality & Regulatory
Each Tecomet, Inc. manufacturing facility maintains a comprehensive Quality Management System, integrating the control, monitoring and management of quality at the production source. These Tecomet active risk management systems are designed around helping the operator to be successful.
In order to be a leading supplier Tecomet strives for outstanding performance in all that we do. All employees are driven by the following fundamental values without compromise:
- Always listen to our customers so that we may identify their needs, and provide them with the best solution and the best value.
- Always strive to provide our customers with the latest technologies, the most innovative products with the best technical support and service in the industry.
- Always put the customer first and be responsive to their inquiries.
- Create an enjoyable, positive work environment that helps our employees grow, motivates them to take responsibility, and gives them a clear understanding that they can make a difference and rewards them for our success.
- Identify those suppliers who have the same commitment to excellence that we do and form a true partnership to ensure each other's long-term success.
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).
Tecomet regulatory registration / certifications information listed by facility location. View PDF (PDF - 63KB)
Frequently Asked Questions
Does Tecomet 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 Tecomet; the merged combination of these tools provide a layered science approach to supporting all aspects of the business.
Does Tecomet apply Statistical Process Control (SPC)?
Yes, Tecomet applies a combination of statistical process monitoring systems and controls. The Tecomet team is standardizing related best practices worldwide.
Tecomet 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 Tecomet provide any Dock to Stock service capabilities?
Yes, the worldwide Tecomet 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 Tecomet site have a Business Continuity Plan (BCP) in place?
Yes, each worldwide Tecomet site has a BCP, which includes the use of other Tecomet facilities with like capabilities and validated processes.
Does Tecomet have any Tecomet brand implants available for purchase?
No, The Tecomet Executive Management has developed an Implant policy, which has been integrated within Tecomet 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 Tecomet companies achieved?
Each Tecomet location and the applicable 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