Quality Management System
Waqar International Surgical Instruments maintains a robust Quality Management System (QMS) to ensure that our products consistently meet or exceed the highest standards of quality and regulatory requirements. Our QMS encompasses every aspect of our operations, from product design and development to manufacturing, distribution, and customer service. Through meticulous documentation, rigorous testing, and continuous process improvement, we strive to enhance the safety, reliability, and performance of our instruments. Our QMS is designed to promote transparency, accountability, and compliance with relevant regulations and standards, ultimately fostering trust and confidence among our customers and stakeholders. At Waqar International Surgical Instruments, quality is not just a priority; it's an integral part of our culture and a cornerstone of our commitment to excellence in healthcare.
BS EN ISO 9001:2015
Waqar International Surgical Instruments maintains a robust Quality Management System (QMS) to ensure that our products consistently meet or exceed the highest standards of quality and regulatory requirements. Our QMS encompasses every aspect of our operations, from product design and development to manufacturing, distribution, and customer service. Through meticulous documentation, rigorous testing, and continuous process improvement, we strive to enhance the safety, reliability, and performance of our instruments. Our QMS is designed to promote transparency, accountability, and compliance with relevant regulations and standards, ultimately fostering trust and confidence among our customers and stakeholders. At Waqar International Surgical Instruments, quality is not just a priority; it's an integral part of our culture and a cornerstone of our commitment to excellence in healthcare.
BS EN ISO 13485:2016
BS EN ISO 13485:2016 is an international standard specifically tailored for Quality Management Systems (QMS) in the medical device industry. It outlines requirements for organizations involved in the design, development, production, installation, and servicing of medical devices and related services. ISO 13485 emphasizes the importance of maintaining a comprehensive and effective quality management system to ensure the safety, reliability, and regulatory compliance of medical devices.
For Waqar International Surgical Instruments, achieving certification to BS EN ISO 13485:2016 demonstrates our commitment to upholding the highest standards of quality and regulatory compliance in the medical device industry. It signifies that our organization has implemented robust processes and procedures to consistently meet customer and regulatory requirements throughout the entire lifecycle of our medical devices, from design and development to manufacturing, distribution, and post-market surveillance. Certification to ISO 13485 provides assurance to our customers, regulatory authorities, and stakeholders that we prioritize patient safety, product quality, and continuous improvement in everything we do.
EC Declaration of Conformity
The EC Declaration of Conformity is a document issued by the manufacturer or their authorized representative declaring that a product meets all the relevant requirements of applicable European Union (EU) directives and regulations. It is a legal requirement for certain products before they can be placed on the market in the European Economic Area (EEA).
For Waqar International Surgical Instruments, the EC Declaration of Conformity serves as a formal statement affirming that our medical devices comply with the essential requirements and standards set forth by the relevant EU directives, such as the Medical Devices Directive (MDD) or the In Vitro Diagnostic Medical Devices Directive (IVDD), depending on the type of product. This declaration is based on the manufacturer's conformity assessment procedures, which may involve testing, documentation review, and quality management system assessment.
By issuing the EC Declaration of Conformity, we declare our commitment to ensuring the safety, performance, and regulatory compliance of our medical devices in accordance with EU legislation. This document provides assurance to regulatory authorities, customers, and end-users that our products meet the necessary standards and requirements for sale and distribution within the EEA.