Can YOU help? --> Unanswered questions <-- (Other than Marcelo's Informational posts)

audits and auditing

  1. R

    I've been auditing for a CB for 18 years

    I've been auditing for a CB for 18 years. The ISO 9001:2015 version of the standard in my. opion is a step backwards. It. borders on being, again in my opinion, useless and not auditable.
  2. P

    Consultant Auditing Qualifications Requirements

    We are a small plastics manufacturer that has made the decision to become registered to ISO9001:2015. We have found a consultant to help us become registered. My questions are: Since the consultant is training us to do our internal audits should the consultant be a qualified auditor? does the...
  3. Q

    Audit 1 week away and no agenda from auditor yet

    We have an audit (surveillance) coming up and don't have an agenda from auditor yet. Obviously this impacts our ability to prepare. Is there any requirement regarding timing of when auditor owes us an agenda?
  4. A

    Audit purpose - case study - What is the role of SQE in such case?

    Hello, Let's imagine that we have situation when the company A is struggling with the components from Supplier. There were few different problems with Supplier (and already received some 8D reports), but this time problem concerns to NOK threaded holes. SQE already knows they are tapping these...
  5. G

    Auditor watching tech do procedure - Can tech ask questions?

    If the tech does not understand something, or cannot locate a document on the network; can the tech ask one of the bystanders for help? I know the bystanders cannot volunteer anything.
  6. N

    Is consultant prohibited in ISO9001 audit?

    Hi, Anyone knows if consultant attending audit is prohibited by any accreditation or certification body rules? I know that for IATF16949 it states clearly this prohibition. How about ISO9001 audit?
  7. N

    Is ISO14001 consultant allowed to attend ISO14001 audit?

    Hi, Anyone knows if consultant attending audit is prohibited by any accreditation or certification body rules? I know that for IATF16949 it states clearly this prohibition. How about ISO14001 audit?
  8. M

    Why have IATF rules required the CBs to audit remote supporting functions at first?

    Hi all, In clause 5.5, IATF rules (5th ed.) states that: When planning the initial stage 2 audit, the remote supporting function shall be audited prior to the site. Additional audits of remote supporting functions may be necessary based upon their demonstrated performance as seen at the...
  9. Ed Panek

    Observational Audit of Contract Manufacturer Production

    I have production for a contract manufacturer we have not used in over a year. To reduce my interference but still audit them, we have agreed to an observational audit of their production next week. This will require no QA personnel from their team to be available as I will just observe...
  10. Coury Ferguson

    Report the CB... Certification Audit (IATF 16949) not to ISO 17021

    In the event that a CB doesn't really perform a Certification Audit (IATF 16949) by the standards of 17021, what actions can you take with the CB? 1. Notify the ANAB 2. Contact the CB 3. Request a Witness Audit What actions can be taken? I really don't want to go into details. But, I am not...
  11. K

    Audit without a QA/RA Representative

    Due to some unfortunate circumstances our QA/RA manager had to leave last month. Unfortunately, we're due for an audit for ISO 13485:2016, in a few weeks and have yet to find a replacement (we're still going through interviews). The rest of the team can pick up much of the slack, but we've...
  12. eule del ayre

    IATF 16949 / ISO 9001:2015 audit criteria

    what are the criteria for ISO Audits? just in case anyone knows for certification purposes
  13. 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...
  14. 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 ?
  15. 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...
  16. 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...
  17. 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...
  18. 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...
  19. 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...
  20. 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...
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