Eng | Esp


Our products are manufactured using the latest technology and fully automatic CNC swiss turn, CNC 5 axis vertical machining centre, CNC 4 axis vertical machining centre, CNC 3 axis vertical machining centre, CNC turning machine etc. which ensures the quality and reliability of products through a single step of manufacturing. (i.e. the raw materials to finished products). The raw materials used in these finished products are procured from approved vendors which are finalized after stringent vendor qualification.

In order to improve existing products and identify the need for new ones, we systematically monitor and evaluate the requirements of the customers. Effective quality assurance and after-sales procedures are a fundamental part of the organization’s operations.

All personnel are obliged to comply with the jointly accepted operating principles defined in the quality system. Our management supervises compliance with these principles and is also responsible for developing the quality system. Management conducts annual monitoring of quality and environmental policy and checks whether targets have been reached. Management pays particular attention to personnel motivation and competence development. We have several procedures to ensure personnel’s continued ability to meet the challenges set by the organization’s operations.
Quality Policy

Madison Ortho is committed to meeting customer, statutory, and regulatory requirements and increasing customer satisfaction through continual improvement of its products, services, and it's Quality Management System. The organization is committed to maintaining the effectiveness of the Quality Management System by means of internal audits, management reviews and corrective action and preventive action procedures for any Quality Management System non-conformances.

(a) Basic structure and documentation

The Company’s quality system is a collection of the responsibilities and procedures according to which tasks assigned to the organization are implemented. The Quality Manual and Standard Operating Procedures (SOP), the Safety Instructions (SI) issued by the administration govern our operations. These are the quality system’s key reference material. The quality system documentation as a whole provides a comprehensive description of how we handle both quality assurance, environmental and occupational safety issues.
Our quality system consists of the following elements:

• Quality Manual
• Standard Operating Procedures
• Reference material

The ISO 13485 quality system standard is applied in all production related activities and process operations. The quality system describes the flow of the processes so that everything related to customer service, the reliability and efficiency of operations, and environmental protection is defined to meet the requirements of the standard.

We employ Corrective Action and Preventive Action (CAPA) which is a fundamental management tool that is used in every quality system. The company has strong belief that this simple step by step process for completing and documenting corrective or preventive actions results in complete, well documented investigation and solution that will satisfy regulatory requirements and form the basis for an effective continuous improvement plan for the company. The ability to correct existing problems or implementing controls to prevent potential problems is essential for continued customer satisfaction and efficient business practice.

(b) Quality system documents

(i) Quality Manual

The quality system’s main document is Quality Manual, which defines the core quality assurance elements that all of the company’s units are obliged to follow. The Quality Manual shows the structure of company quality system as well as the position of lower level documentation within the system. It also describes the processes associated with the quality system. Quality assurance is based on the quality, environmental policy and safety policy drawn up by our senior management.

(ii) Standard Operating Procedures

The Standard Operating Procedures describe our operating processes and their management in accordance with their definitions in the previously mentioned standards and Quality Manual. Standard Operating Procedures cover framework processes and core support processes. Framework processes are those operating processes that, with regard to our business concept results in key products. Support processes are implemented on the basis of either an external customer order or an internal order for framework processes.

The targets set in the Standard Operating Procedures must be in keeping with our quality policy. Taken together, the Standard Operating Procedures and Quality Manual form a comprehensive description of the quality assurance for each operating process. The Quality Manual and Standard Operating Procedures have primarily been drawn up for internal use. However, this documentation also aims to provide interest groups and customers with information on the operating methods to which we are committed.

(iii) Reference Material

The quality system’s core reference material is categorized as follows:

• Laws, statutes and regulations with direct relevance to our operations
• Permanent Regulations and Instructions
• Manuals
Permanent Regulations and Instructions; Safety Instructions; other instructions

Permanent Regulations and Instructions includes the company’s organizational structure, vision, mission, financial regulations, archiving regulations, internal inspections, procedures related to purchasing and contracts and safety instructions. References are given in this document instead of repeating content within quality documentation.
Manuals contain the general procedures and guidelines associated with our operations. Procedures for developing manuals and keeping them up-to-date are described within each manual.

(c) Evaluation and development of the quality system Our key quality assurance evaluation and development procedures are as follows:

• Internal and external audits
• Reviews of operational areas
• Management’s quality system review
• Self-evaluation

We use self-evaluation to develop our operations. Self-evaluation covers both evaluations of internal monitoring and the appropriateness of risk management. The principle of CAPA is employed as part of self- evaluation to ensure the effectiveness of our operations.
CAPA Procedures

Implementing an effective Corrective or Preventive Action (CAPA) procedure capable of satisfying quality assurance and regulatory documentation requirements is accomplished in seven basic steps:

1. The Identification of the problem, nonconformity, or incident or the potential problem, nonconformity, or

2. An Evaluation of the magnitude of the problem and potential impact on the company.

3. The development of an Investigation procedure with assignments of responsibility.

4. Performing a thorough Analysis of the problem with appropriate documentation

5. Creating an Action Plan listing all the tasks that must be completed to correct and/or prevent the

6. The Implementation the plan.

7. A thorough Follow up with verification of the completion of all tasks, and an assessment of the
    appropriateness and effectiveness of the actions taken.

Get in touch
About Madison Ortho Inc.
Product Catalog
Madison Ortho, a leading Orthopedic implants company with rapidly expanding footprints all over the world.

With in a short span of time since its launch, Madison Ortho has been able to carve out a leadership position in the countries where it has introduced its products due to its focus on satisfying the needs... More >>
Upcoming Conferences
t: (787) 7232900 e: info@madisonorthoinc.com  
Copyright © 2012 Madison Ortho Inc. All Rights Reserved.