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internal audits

  1. A

    Purchasing - Internal Audit Questions

    Hi I am new to manufacturing, and I work at a plant with 50 employees. I am 21 years old and am a certified lead auditor for ISO 9001, ISO 14001, and ISO 45001. I am having trouble coming up with Internal Audit questions for ISO 9001 in regards to the purchasing process? Can anyone please...
  2. W

    Where to begin with an ISO 9001:2015 internal audit

    Our very small manufacturing company is new to ISO 9001:2015. We need to plan and complete our internal audit but are clueless as no one here has done this before. Do we have to audit every Section of the QMS from 4.1 to 10.3? Or can we choose a few processes/areas of our business and audit...
  3. D

    Internal audit forms or checklists for a medical/veterinary laboratory

    I am new to this forum and I am looking for some examples on internal audit forms or checklists for a medical/veterinary laboratory.
  4. G

    Audit finding - Components being transferred inter-plant

    Hi All, I recently completed a course to become an internal auditor to ISO 13485. I also took part in my first audit for the medical device company I work for (I’m in training). During this audit I found components being transferred inter plant ( from one global site to another) but the SAP...
  5. E

    Informational Internal Audits - Wear multiple hats what can and can't I audit (so I'm not auditing my own work)

    I work at a small company where I wear many hats. I'm new to quality and putting together an internal audit plan for the first time. I started off with our key processes(sales, D&D, purchasing/inventory, and production), and for each key process listed the process document(each key process has...
  6. S

    Internal Audit Checklist for Application/Software development

    I am planning to do ISMS internal audit for software/application development team in my company. Is there any checklist available.
  7. S

    Internal Audit - Risk and Opportunity (ISO 9001:2015 )

    During an internal audit we find the Auditee has identified the Issues ( risk and opportunity ) in the issue management log but the review reports were not available. Does it fall in Minor NC or observation category? Thanks. Sheela Samuel
  8. T

    What is the purpose of Internal Audits?

    Something came to mind today concerning internal auditing our quality system (certified to iso 9001: 2015). Is the purpose of internal audit to check we are working to our quality system or a combination of that and that it meets the requirements of the standard? I think it's to check we're...
  9. M

    Can I audit processes I've established but do not implement or maintain?

    There is a QMS requirement that internal audits "shall ensure objectivity and impartiality", and that "auditors shall not audit their own work". Here's the situation: Years ago, I authored procedures for purchasing & supplier control based on our input quality system standard requirements (ISO...
  10. Ed Panek

    Root Cause CAPAs from internal audit

    We recently upgraded our QMS to ISO 13485:2016. Prior to that we had an internal audit performed by a consultant. We have 5 minor non conformances relating specifically to the new 2016 standard. In our root cause analysis I would like to present the idea that we knew there was a risk in moving...
  11. K

    Student wanting Case Study about Internal Audit Report

    Hi! Im a student and i am lookig fo a case study to answer about the Internal Audit Report, I have tried google and hasn't given me a legit answer. Thank you so much for your help.
  12. R

    How far apart can you schedule separate areas or departments in your internal audit?

    How far apart can you schedule separate areas or departments in your internal audit. Could it be done different quarters? Example Audit Shipping and Receiving one quarter and Quality the next.
  13. U

    Internal auditing - Company employees or contract second party

    Dear all, we are a medium sized company and had automotive certification first time this year according to IATF 16949. Internal system audit was carried out by an external auditor. We are now considering what the best way is, doing the internal audit by our own ( we have two auditors with the...
  14. D

    Auditing Our Outsourced 2nd-3rd Party Internal Audit Company

    Hello Everyone :o) I am looking for some guidance on how I can audit an out-sourced service provider that is performing our internal auditing process for us. This company is being used to perform our internal auditing at this time. In our recent ISO surveillance audit it was brought up that...
  15. P

    ISO 19011:2018 - Risk Based Approach for planning, conducting and reporting of internal audits

    I am reviewing the new ISO 19011:2018 and seeing that a risk based approach is required for planning, conducting and reporting of internal audits. My questions is this: Our organization already takes into consideration the status and importance of each process and area, as well as results of...
  16. J

    Microsoft Teams to manage Internal Audit System?

    Hi All, Has anyone used Microsoft Teams to manage their internal audit program? I am looking for a new way to keep up with the schedule of internal audits and track when they are completed. Teams also seems like it would be useful for tracking the actions that come out of the internal audits...
  17. K

    Which clause would best fit this Nonconformance? (Supplier Related)

    Hello! I am an internal auditor to an organization that is certified to ISO 9001:2015, IATF16949:2016, and AS9100D:2016. I wont go into the specifics, but, we test some of our supplier product through the use of a spectrometer. When covering receiving inspection for all three standards...
  18. Tagin

    Does ISO 9001:2015 require a full internal audit annually?

    Does ISO 9001:2015 require a full system internal audit every year? Or, can an internal audit plan be multi-year? E.g.: Year1: Audit processes A,B,C Year2: Audit processes D,E,F,G Year3: Audit processes H,I Year4 -repeat cycle- (Of course, there likely will be also top-level items that...
  19. S

    GM/VP softgrading internal audit finding - need feedback from an audit guru!

    Hello, I need a question answered by an auditing guru- we a a contract manufacturer, that performs our QMS internal audits under AS9100D, ISO 13485:2016, ISO 9001:2015 QMS guidelines. One of the auditors noted a nonconformance finding, but our GM/VP overruled this nonconformance finding and...
  20. S

    Internal Audit Completion Memorandum

    Hello everyone, I am looking for an Internal Audit completion memorandum. Background is that I just completed the internal audit last Friday and Tuesday, we are having a regulatory inspection; so the Quality Head has asked me to write a memo writing that the internal audit has been completed...
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