ISO 13485:2016 laboratory equipment

1. In what way is the laboratory equipment involve in the ISO 13485?

2. If laboratory equipment is used within a project for a medical device then does this need to be included in the QMS ?

Laboratory equipment is involved in ISO 13485 in the following situations:

• if it is used for quality control of the raw material, semi-products and finished medical device
• if it is used for the design of the medical device
• if it is used to calibrate any equipment in the production process

3. Is the ISO based on a medical device the company is trying to sell or is this for all instruments used for the development of devices?

In section 1 Scope of the ISO 13485:2016 is stated that this standard specifies requirements for a quality management system where the organizations need to demonstrate its ability to provide a medical device and related services that meet customer requirements and applicable regulatory requirements. It furthermore states that these organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation or servicing, and any other technical support activities. 

For more information on ISO 13485, please see the following link:

• What is ISO 13485 https://advisera.com/13485academy/what-is-iso-13485/