Quality & Compliance

Structure Of Quality Systems

Our products are manufactured using the latest technology and fully automatic CNC Machine, CNC 4 and 4 xis 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.

Structure Of Quality Systems

Our products are manufactured using the latest technology and fully automatic CNC Machine, CNC 4 and 4 xis 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 finalised 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 organisation''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 organisation''s operations.

Our Quality System - 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.

InstructionsPermanent 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
  
  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.
  
  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.

• C.A.P.A 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:


• The Identification of the problem, nonconformity, or incident or the potential problem.
• An Evaluation of the magnitude of the problem and potential impact on the company.
• The development of an Investigation procedure with assignments of responsibility.
• Performing a thorough Analysis of the problem with appropriate documentation.
• Creating an Action Plan listing all the tasks that must be completed to correct and/or prevent the problem.
• The Implementation the plan.
• A thorough Follow up with verification of the completion of all tasks, and an assessment of the appropriateness and effectiveness of the actions taken.