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ISO 13485

ISO 13485: Medical Devices Quality Management System
ISO 13485 certificate is required for medical device manufacturers. This is also known as quality management system for medical device manufacturing. ISO 13485 certificates provide a framework to establish & maintain good practices while manufacturing medical devices. ISO 13485 certificates are also mandatory for notified CE marking.

ISO 13485 is an international standard, globally recognized for establishing quality management systems that consistently meet customer and regulatory requirements for safe and effective medical devices. The certification allows medical equipment manufacturers to meet global standards of safety in developed countries and comply with the existing legislation in those nations. The principles of ISO 13485 set out an explicit management system.

Benefits of an ISO 13485 Certification

  • Is recognized globally as the best quality practices from organizations within the medical device industry.
  • Enables you to work within many countries where it is a regulatory requirement such as CE Mark in Europe and with many organizations where it is a contractual obligation or expectation.
  • Helps create a systematic framework in which organizations monitor measure and analyze their processes and customer feedback.
  • Helps provide a framework for implementation of action ns (where necessary) to ensure achievement of planned results and to ensure maintenance of effectiveness of those processes with applicable customer, quality and regulatory requirements.
  • Can provide improved performance measurable in key metric areas such as increased sales, increased timeliness in getting products to the global marketplace, reduced costs, fewer errors, less waste, better use of time and resources and lower product failures.

Procedure for the ISO 13485 Certification

Gap Analysis: Firstly we work on the areas where the organization is at present position and how ISO standard is working and find the gap.

Implementation: Our company provides training according to ISO 13485 standard, than after review the whole process of implementation training and if it is working properly than we establish that process as system. Once we make proper system, your organization is able to work properly as per standard even in our absence.

Certification audit: The certification process proceeds in two stages. The audit team examines if the documentation of your management system already complies with the standard. Subsequently you demonstrate the practical application and effectiveness of your management system.

Issuing the certificate: After a successful certification process your company receives the certificate. It certifies compliance with the standards and operability of your management system.

Our experts will be more than happy to assist you should you have questions or require any further information on the ISO 13485 certification of your Medical Device quality management system.