Medical Device: ISO 13485

ISO 13485: Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes is designed for the medical device industry. A number of changes from the ISO 9001 foundation have been made. These change include the following:

The emphasis on continual improvement has changed to maintaining your product and system. The emphasis on customer has taken a slightly different form. More documentation is required by this standard than in the ISO 9001 standard.

This standard is available in the US through TECHSTREET. All ISO standards are available through the International Standardization Organization.

Some of the key issues addressed by ISO 13485 are

  • Regulatory focus
  • Process approach
  • Focus on “meeting customer requirements”
  • Focus on “maintaining the effectiveness of the QMS”
  • Maintenance of procedural documentation
  • Clarification of specific differences between ISO 9001 and ISO 13485

The tools provided in this website apply to this standard. To start your ISO 13485 implementation, follow the implementation suggestions. Evaluate your current system in relationship to this standard; determine what you have in place and what you need to build on. Prepare a plan of attack.

If you are currently registered to ISO 9001, some of the differences are discussed in ISO 13485 Requirements.

For introductory training or implementation assistance, please contact us.

ISO 13485 Related Standards:

  • ANSI/AAMI/ISO 14971:2000 and 14971/A1:2003 Medical Devices — Application of Risk Management to Medical Devices
  • ISO 10993 Biological Evaluation of Medical Devices
  • ISO 15189 Quality Management in the Medical Laboratory
  • ISO/TR 14969 Quality Management Systems — Medical Devices — Guidance on the Application of ISO 13485
  • ISO 11607 Packaging for terminally sterilized medical devices