ISO 13485 Requirements

Some of the specific requirements of ISO 13485 are discussed below. The focus is on the differences between ISO 9001 and ISO 13485. Please check the standard for the exact language and requirements.The standard emphasizes the exact differences within the text of the publication.

In ISO 13485 there is a change in emphasis from “improving” the effectiveness of the quality system to “maintaining” the effectiveness and on meeting customer and regulatory requirements versus increasing customer satisfaction. There is more documentation required in ISO 13485 also. The additional required documentation includes:

  • Those documents required by regulation
  • Responsibility and authority
  • Training procedure, if required
  • Maintenance requirements
  • Health, cleanliness, clothing
  • Environmental conditions
  • Control of contaminated product
  • Risk management
  • Customer requirements
  • Design and development
  • Purchasing process including traceability records and records of verification
  • Reference materials and reference measurement procedures
  • Labeling and packaging
  • Installation and verification
  • Sterilization process validation
  • Identification and validation
  • Preserving product including shelf life
  • Monitoring, measurement and measuring devices
  • Sterilization records, servicing records, batch records, validation

Differences in research and development activities:

  • Determine design transfer activities
  • Document design planning outputs
  • Include risk management in input
  • Approve inputs
  • Document design outputs
  • Include specialist as needed in design review
  • Complete validation before delivery
  • Include clinical trial as required

Added programs to consider:

  • Clinical evaluation
  • Risk management
  • Clinical trials
  • Cleanliness of product and contamination control
  • Requirements for implantable devices
  • Communication of advisory notices