ISO 13485 focuses on quality in the same way as ISO 9001, but this standard is specifically for medical products. What makes it different is more stringent demands in terms of documentation, development control, traceability, etc. This involves us working on the basis of the requirements specified by your customers, along with your ambitions for your business. We focus on the activities which help your products to maintain their performance and meet customers’ requirements. We set targets and measure relevant key indicators. We then add the other elements demanded by ISO 13485. We put on our “ISO 13485 glasses” and look at your business from an external standpoint. This allows us to see all the activities and elements which lead to the quality demanded by your customers, based on relevant statutory requirements. Essentially, the following activities are required with ISO 13485.
- Targets and action plans
- Processes and key indicators
- Customer requirements
- Controlling important activities in the production and service processes
- Non-conformance management and customer requirement feedback
- Internal audit
- Management review for analysis and decisions