T
Thukira
Hi...We are certified to ISO 13485: 2016 for service projects and products which are not included in MDD scope as per ISO certificate.
We are planning for internal audit program this year.
Give that the above scenario, is sampling on projects allowed as per ISO 13485:2016.
Example: In total of 4 service projects of different customer, can we do 2 projects for internal audit and show the same for external auditors or what standard says on this /would be best practices
In 13485, I could not refer requirements that we should cover all projects or sample projects for internal audit.
Please advise.
We are planning for internal audit program this year.
Give that the above scenario, is sampling on projects allowed as per ISO 13485:2016.
Example: In total of 4 service projects of different customer, can we do 2 projects for internal audit and show the same for external auditors or what standard says on this /would be best practices
In 13485, I could not refer requirements that we should cover all projects or sample projects for internal audit.
Please advise.