internal audits

  1. C

    Internal Audit - Process Clause Matrix / Audit Checklist

    Hi All, I have a question regarding the internal audit process. Please see below background about the company I work for: Our site is certified to ISO 13485:2016 and 21 CFR 820. We have an extensive audit checklist (13485 and 21 CFR 820) which is pretty much in the form of turning every clause...
  2. CPhelan

    Internal audit - Combine similar nonconformities in one or keep separate?

    Hello, I am completing an internal audit on our QMS. There is 3/4 minor nonconformities associated with personnel not being trained on the most recent revision of documents. Should these be listed in the report as one nonconformity with detail in the report stating which documents or is it best...
  3. A

    External Auditor issue with Internal Audits

    Hi all, We recently went through a AS9100D (Aerospace Standard) surveillance audit with success- only one minor finding in purchasing. Anyway, the auditor didn't like that we didn't clearly show that we had audited to each clause of the standard in our audits even though I had the auditors...
  4. M

    Internal Audit Plan in Retail

    Hello everyone, Currently I am setting up an IA department in one of the biggest retail businesses in my country. Could anyone help me sending me IA plan and universe for retail business with working papers? Any advises would be appreciated. Thank you all in advance.
  5. W

    Internal Auditing carried out by a 3rd party - Review of previous audits

    Hi All, I have just gone through a customer CI program and one thing they have picked up on is out internal audits that are compiled by a 3rd party. The internal audit does not reference that the previous audit has been reviewed and previous actions closed. Does this need to be documented...
  6. S

    Need Assistance in Visual Inspection - Tiny electronic components

    Internal auditor wrote me up for not having a sampling plan on tiny electronic components. I am a distributor of electronic components that sell product purchased from OEMs and CMs as excess materials. 1> Is there any requirement for visual inspection of electronic components? Such as do the...
  7. D

    Management of NC after internal system audit

    Hello all, after our internal system audit we have obviously detected some NC. We have in 3 weeks time the official IATF audit and of course it's not possible at all to solve all of them. The responsible of the system is forcing the organization to close all them before the audit because this...
  8. Ashland78

    IATF 16949 - How often do we have to audit entire IATF Manual

    In the past automotive companies I have worked when auditing the Quality System, whether it was TS 16949, or VDA6.3 we did not have to audit every single element(section) annually. I have worked at a company a year now and one of my responsibilities was to develop an Internal Audit program...
  9. 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...
  10. 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...
  11. 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.
  12. 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...
  13. 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...
  14. 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.
  15. 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
  16. T

    Informational 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...
  17. 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...
  18. 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...
  19. 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.
  20. 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.
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