audits and auditing

  1. W

    ERP Audit Trail audit by FDA? Regular audit trail report template?

    Hi folks, I wonder if someone can give me hints for how an "audit trail report" of an ERP (Electronic Resource Planning) system should look like to fulfill the requirements of FDA Quality System audits of medical device manufacturers? We are a small start-up, have a QMS (13485:2016...
  2. M

    Who should have access to Audit trail?

    Dears, Could you help me sharing your expert perspective about this topic? Who you think should have access to view audit trail data ? do you think it´s good to share with end-user or only sys admin ?
  3. S

    Auditor requests confidential information via Email

    Hi, I've been preparing for the ISO9001:2015 Surveillance Audit. My auditor requested some documents, and he asked me to send it to him by email for the " Documents Review Stage''. I reviewed some of the documents he requested and found that certain documents would not be permissible to be...
  4. 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...
  5. Q

    Effective Auditing advice needed

    Hi everybody I tried to find a topic related to my doubt and didn't find anything, and that is the reason of my question. When auditing internally, and the scope is to verify compliance against 9001 2015. What do you do?, do you question each clause and subclause of the standard even if the...
  6. lyobovnik

    Matters being audited, independence, participation and direct responsibility

    Background: I am a QA Manager at a small business (~20 employees) that is a contract manufacturer for a very large MDM. I have completed no degree higher than a high school diploma, did not go to school for this, started at the lowest position here and basically fought to carve my path here...
  7. A

    Welcome to the MedAccred Forum!

    Welcome! This forum is intended to provide details of the MedAccred Critical Process Accreditation Program: MedAccred is an industry-managed supply chain oversight program for critical manufacturing processes that: reduces risk to patient safety assures quality products verifies compliance...
  8. nantmel

    Does 13485 auditor have a right to inspect non-CE products?

    Hi all, This is a debate that I've been having with my boss at the moment... We are an ISO13485 registered company making medical devices for the EU market predominantly. However, we also have a 510K exempt product being sold in America. We have a 13485 surveillance audit coming up, and there...
  9. R

    Auditing support and management processes

    So far, in our company internal audits, we audit areas/departments, instead of auditing processes. Probably because we have processes written as procedures, but unlike a process map, when writing, you can make a process less cross-sectional across departments. In the writing, it can focus on a...
  10. A

    Scheduled during our company's inventory activity - ISO 9001 audit question

    I have my ISO 9001 2015 upgrade audit scheduled for the first week of July My question is we are scheduled during our company's inventory activity so we will be bare bones as far as associates and there will be no manufacturing activity going on Am i wrong or is it impossible for the auditor...
  11. Q

    Is it a NC, if a clause is not declared as non applicable?

    Hello everybody Please give some input on this issue: Im in a reselling company, measurement devices are not needed nor used. I have scheduled an internal audit for the next week. we are declaring with no applicability 8.3 and 8.5.1.f, but I wonder if I should declare 7.5.1 as...
  12. A

    ISO 9001:2015 registrar Auditor requesting copies of procedure prior to audit

    All, We have our ISO 9001:2015 Upgrade audit next week. I got a call today from our auditor and he requested copies of the procedures for our key processes. I am newer in the quality world but have never sent this level of documentation to a 3rd part auditor before. I have sent him our QM...
  13. F

    It is acceptable moving remote locations staff to manufacturing plant for auditing?

    Hello, In the company where I'm working, we are experiencing a huge issue with the CB that certificates our plants of Asia perimeter, because doesn't accept as valid the certificates of another different CB that certificates our other sites and remote locations in the rest of the world...
  14. J

    VDA audit, control plan - My hair is almost gone now

    So, does everyone really include all process parameters on their control plans? We will not be doing this. We have 75% market share and we did not get that way by giving our competitors a leg up.. we have timing, temperatures and pressures that are proprietary. I can't believe a company would...
  15. M

    CB and Internal auditors most common nonconformities against AS9100D

    CB and Internal auditors, what are your most common findings for AS9100D? Let's just say a small machine shop that excludes design, or similar.
  16. K

    Tips for Auditee Training

    Hello, What tips do people have for training auditees? By this I mean, the company I am with are about to undergo a 13485 notified body audit and I would like to give training to the employees who might find themselves in front of the auditors. As an auditor, myself, I know what things I...
  17. K

    Is an annual "audit schedule" the same thing as an audit scope/ audit plan?

    Just as the title says, we have an annual audit schedule ever year that shows what processes will be audited every month. Will this satisfy the "audit plan/scope" requirements? The standards that we are currently certified to are ISO9001:2008 and TS 16949. We are working on getting our AS9100D...
  18. S

    IATF 16949 - Manufacturing and Product Audit Approach

    Hi all, In IATF 16949 the requirement state 9.2.2.3 Manufacturing process audit The organization shall audit all manufacturing processes over each three-year calender period to determine their effectiveness and efficiency using customer-specific required approaches for process audit. Where...
  19. J

    Is My AS9100 certification Auditor Normal?

    I'm in the final throes of my AS9100D certification audit, and my auditor is being less than straightforward with me. I'm hoping to compare notes to see if this is just the way it is, or if I should consider looking for a new auditor or even registrar. I've had the same auditor for 4 years, and...
  20. MrPhish

    Should Potential Customer Complaint Outcome Define Registrar NC Rating?

    I didn't see any existing thread this issue fits in, so here goes: On a recent surveillance audit, the Registrar was reviewing my listing of customer complaints that were actively being managed via my internal process (i.e. CAR had been created, root cause identified, actions being taken, and...
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