Hello,
With regard to ISO 13485:2016 scope of certification, a device company would like to establish a QMS and be granted a QMS certificate before regulatory approval. Question: The company's manufacturing process may not be ready for audit; but its design and development processes will be. Can the company still apply for regulatory approval under a QMS where the scope covers design and development only? Once they get approval, they will then apply for the scope to expand to manufacturing. This is for Canada. Does this make sense?
With regard to ISO 13485:2016 scope of certification, a device company would like to establish a QMS and be granted a QMS certificate before regulatory approval. Question: The company's manufacturing process may not be ready for audit; but its design and development processes will be. Can the company still apply for regulatory approval under a QMS where the scope covers design and development only? Once they get approval, they will then apply for the scope to expand to manufacturing. This is for Canada. Does this make sense?