Is our system conforming? What processes and procedures in our Quality System pertain to this requirement? How are they documented? Do they address all of the requirements of the standard for documented procedures and records? How do they relate to one another, and is the system internally consistent (i.e. These questions are answered entirely from the standard.Ģ. What am I auditing? What are the 'shalls' that must be met? What is the intent behind the requirements, and how does it apply to our situation? What other elements of the standard are pertinent - records, training, resourcing, document control, etc.

Here is MY checklist for internal audits - well, actually my process.

At my company we do have element specific checklists, but I have never liked them - the questions on them never seem to be the ones I would ask.