We have a polyclinic with lab- x ray- and and day surgery; do we consider design and development 7.3 standard as a design for service or it it is just for the product. if yes how are we going to cover it?
If the organization strictly applies known technology, protocols, pathways, or procedures then it may exclude element 7.3 of ISO 9001 and must document appropriate justification to assure that the customer/patient/client understands.
For example: The surgeon goes to learn a new procedure or how to use a new piece of equipment used for surgical procedures. When the surgeon is trained to do this new procedure, it becomes the norm for that surgery. The surgeon is responsible for the care plan, but did not design the actual protocol used in
When the organization develops a different way to implement a pathway, protocol, or procedure then the element 7.3 applies.When the design and development element is appropriate, there should be procedures about how design is to be reviewed and approved prior to implementation. Reco rds of design reviews, verification, and validation should be available.