Assign topic to the user
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.
Answer:
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?”
For more on internal audit checklists see the article: Developing an internal audit checklist for AS9100 Rev D, https://advisera.com/9100academy/knowledgebase/developing-an-internal-audit-checklist-for-as9100-rev-d/
Hello Everyone,
I’m seeking your advice.
I'm currently working on an AS9100 certification project for an aircraft manufacturing startup. The company is focused on the design and development of light aircraft and is presently in the design phase. They plan to manufacture and test their first aircraft in 2026.
During the initial audit, would it be possible for the company to exclude the following clauses?
Clause 8.5: Production and Service Provision
Clause 8.6: Release of Products and Services
Clause 8.7: Control of Nonconforming Outputs
This is a question best asked of your certification body as they will have some better insight into what they can and cannot accept for their own internal rules, however, generally these clauses are not possible to exclude from the QMS. Unless your QMS scope is design only, and you never will build anything, the certification body will need to have something to audit if build and test is part of your scope.
I do understand that you are not yet using these processes as you are still in the design phase, but I believe the certification body will expect you to at least have the plans in place on what will be done for these clauses for your initial build, including having the procedures (clause 8.7 procedure is mandatory) and have identified the format of the required records for these processes. You may not have used them yet, so you will not have records created yet, but having them in their initial stages will be needed.
Of course, it will be understood that these processes are expected to be updated and improved as you begin to use them, but having them in place will be necessary to include build and test in your QMS scope.
You can learn a bit more from this related ISO 9001 article: Understanding product & service provision in ISO 9001, http://advisera.com/9001academy/blog/2014/10/07/understanding-product-service-provision-iso-9001/
Comment as guest or Sign in
Aug 09, 2024