In our company, we have a small core group supporting ISO 13485 while most of the Purchasing, Information Technology, Human Resources, etc. is shared company-wide and their involvement in ISO 13485 is very, very limited.
How do I calculate the total number of personnel for the non core-group. Just to throw out a number, the core group would be 50 while the non-core group would be 550. Now, to give total number of employees to the Registrar, the core group would be definitely 100% or a 1-to-1 match but is it okay to report a percentage, say 10% of the 550 + 55 to the registrar for them to identify the audit days?
We decided 10% as a ball-park - so my question is first, is this approach the same used else where and if not, what would be the calculation for this type of non-core group?
Thank you!
How do I calculate the total number of personnel for the non core-group. Just to throw out a number, the core group would be 50 while the non-core group would be 550. Now, to give total number of employees to the Registrar, the core group would be definitely 100% or a 1-to-1 match but is it okay to report a percentage, say 10% of the 550 + 55 to the registrar for them to identify the audit days?
We decided 10% as a ball-park - so my question is first, is this approach the same used else where and if not, what would be the calculation for this type of non-core group?
Thank you!
