I am getting ready to do an internal audit and was looking for some assistance. I've established 4 categories: 1. QMS/Management Support, 2. Purchasing/External Providers, 3. Customer Order Review, and 4. Manufacturing.
I was wondering what sections of the standard you think belong which category? (Except for Design, as we have eliminated that) and also, what might be some good questions to ask for the internal audits for each section.
Internal audits are in important part of managing the QMS but remember that you need to audit the processes that are in place and not just the standard. It is easiest to validate that the processes meet the standard requirements during your preparation, and then audit with questions against the implemented processes when you are performing the audit.
For QMS/management support the most relevant clauses are likely clause 5 (leadership), clause 6 (planning) and clause 9.3 (management review). Some good questions would include “how does the leadership team demonstrate commitment to the QMS and customer focus?”, “Do auditees know the quality policy and understand how what it means to them?”, “How does management review happen and what are the inputs reviewed?”
For Purchasing/external providers clause 8.4 (control of externally provided processes, product and services) is most relevant. Some questions could include “How do you determine the controls to apply to each supplier?”, “How are controls implemented?”, What information is provided to providers to ensure that we received what we need?”
For Customer order review clause 8.2 (Requirements for products and services) is relevant. Questions could include “How do we communicate with customers?”, “How do we determine what is required for products and services?”, “How are requirements reviewed?”, “How are changes in requirements handled?”
For Manufacturing clause 8.5 (Product and service provision), clause 8.6 (release of products and services) and clause 8.7 (control of nonconforming outputs) are most relevant. Questions could include “What controls are in place for product and service provision?”, “How wo we preserve products and services during creation?”, “What controls are in place to ensure products and services meet requirements before release?”, “How do we control nonconforming products and services?”