Are you 9001 2015 Ready?

Are You ISO 9001 2015 Ready?

If you are preparing for a 9001 2015 audit or pre audit, here are some interesting facts with pre-audit that will prove useful.

First, since a quality manual is no longer required, the auditor will ask to see a Process Map (not a flow chart), instead of a quality manual.
Each individual process needs at least one stated goal. Make sure your processes are labeled clearly.
Minimize the number of processes, maximize their worth.
Be sure you have listed your internal and external influences. What were the determinants in choosing them?

Define how the company is doing toward meeting that goal for the process. Clearly show progress (like with an attached excel sheet) on each process. Vintara's QMS has built in spreadsheets! Use them.
Be sure to define the Scope of the QMS and be sure to identify the scope clearly (just make sure SCOPE is in large letters as your header).
Process based audits, internal and external that are being audited will need to be navigated by the owner of the process. Saying "That’s the quality manager’s area” is no longer an acceptable response during audits.
Documentation of risk and risk levels and/or numerical scores will be of the utmost importance. Simple charts showing risk scores is preferred.
Risks should be compiled not only for individual processes, but all of them listed on one chart in order of severity for the whole of the processes.
Be sure you have listed your internal and external influences. What were the determinants in choosing them?