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.
