ISO 13485

Registration Assessment ISO 13485

ISO 13485 is the best internationally-accepted model. ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment. While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance. Thus it is more prescriptive in nature and requires a more thoroughly documented quality management system. ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose. A medical device organization can implement to help demonstrate compliance to laws and regulations of the medical device industry. Adopting ISO 13485 provides a practical foundation for manufacturers to address the regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices. The regulatory requirements are intended to ensure that manufacturers consistently design, produce, and place onto the market, medical devices that are safe and fit for their intended purpose.

By becoming certified in the ISO 13485 standard your company will:
  • Increase the probability of making safe and effective medical devices
  • Meet regulatory requirements
  • Meet customer expectations
  • Help monitor the effectiveness of the supply chain
  • Enter any major market around the world with one audit.
  • Improved Risk Management and Design Controls to assist customers in the development and improvement of their products.
  • Improved efficiency in assisting customers obtains market clearance and approval to meet aggressive sales and marketing goals.
  • Ensure compliance with the requirements of the standard and more
  • Potentially gain entrance into international markets since certification to ISO 13485 is seen as a first step toward achieving compliance with European requirements.
ISO 13485 certification involves a two-stage audit process for certification:

Stage 1 is a preliminary, informal review of the ISO 13485, for example checking the existence and completeness of key documentation such as the organization's Medical Devices Quality Manual.

Stage 2 is a more detailed and formal compliance audit, independently testing the Quality against the requirements specified in ISO 13485. The auditors will seek evidence to confirm that the management system has been properly designed and implemented, and is in fact in operation (for example by confirming that a committee or similar management body meets regularly to oversee the ISO 13485).