ISO13485 is an internationally accepted standard for Quality Management in the medical device industry. Basically it defines requirements for a company to safeguard the consistent quality of the devices it manufactures. Companies that have implemented a Quality Management System according to ISO13485 have procedures in place for a.o.:

  • Inspection of incoming goods
  • Avoid contamination during manufacturing
  • Identification of products that do not conform to requirements
  • Recording of customer feedback
  • Internal audits
  • Training of staff
  • and many more

The quality management system is audited and approved by a 3rd party, the so-called Notified Body. The company receives an ISO13485 certificate as proof.

The main purpose of a quality management system for your company is to have control over your processes, so both you and your customers trust that the products are of consistently high quality.

QasE3D has a created a convenient table of ISO13485 containing the requirements (chapters 4 – 8). Very useful to link each requirement to the documentation in your QMS, as a kind of index. Use the form below to get the table in your desired format (DOCX, XLSX, HTML, PDF, XML). Don’t forget to purchase the full standard from ISO.

ISO13485 Table preview