Quality Policy
We always do work for the total satisfaction of the customer with the supply of our full guaranteed quality products at most competitive prices and in time delivery services. We wish to mention that satisfaction of our valued buyers over our products is our asset in fact.
This quality policy is communicated to all employees as part of their training, with the intent of providing a clear, common understanding, directly applicable to their work. The quality policy is reviewed at least once per year for continuing suitability and adequacy.
Quality Objectives
- Only Defect-Free Product and Services shipped/provided to customers/suppliers
- Continuous Improvement in Delivery Performance through the Utilization of Capable Processes
- Maintenance/Continuation of ISO 13485 Certification
- Compliance with European Union CE
- Maintenance/Continuation Current Good Manufacturing Practice(cGMP) regulations enforced by the FDA
Quality Management
Our QMS forms the backbone of our operations, ensuring that every surgical instrument we produce undergoes rigorous scrutiny at every stage of manufacturing. From design and material selection to production and final inspection, our QMS leaves no room for compromise on quality.
Our certifications are listed below:
ISO 9001:2015
IMPLANT SURGICAL CO. has implemented a quality management system, which has been certified ISO 9001:2008. This certification ensures that the company constantly delivers products that meet all customers’ needs and regulatory requirements and requires that we commit to the improvement of the system and ongoing conformity to regulations. The system has been audited by Dynamex Certification accredited assessor and is subject to surveillance audits to ensure ongoing compliance.
ISO 13485:2016
We are proud to not only achieve recognition as an ISO 13485 certified company, but we are also 100% compliant with the quality criteria required by this medical device manufacturing standard which ensures that we meet the regulatory requirements for the quality of medical instruments, medical devices, and medical technology.
The key aspects that ISO 13485 requires but is not limited to are following:-
Promotion and awareness of regulatory requirements as a management responsibility.
Production Control / Product Identification & Traceability
Control of Non-Conforming Product
Data Analysis & Improvement
Focus on risk management activities and design control activities during product development.
Specific requirements for documentation and validation of processes for medical devices.
Specific requirements for verification of the effectiveness of corrective and preventive actions
cGMP (FDA)
cGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA).
It provides for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.
CGMP regulations assure the identity, strength, quality, and purity of drug products by requiring that manufacturers of medical devices adequately control manufacturing operations.
IMPLANT SURGICAL conducts training for supervisors and workers to ensure that they have the necessary knowledge on regular basis once a year.
EC Declaration of Conformity
This deceleration provides the assurance that products supplied by Implant Surgical Company are in conformity with the essential requirements of the European Medical Devices Directive (93/42/EEC) and are manufactured to the highest standards of craftsmanship in accordance with the relevant national and international standards.
We continue to work towards compliance with the new MDR (2017/745). The new regulation will come into force on May 25th, 2024.