1. Hello and Welcome to The Quality Forum Online...Continuing in the spirit of People Helping People !
    Dismiss Notice
Dismiss Notice
You must be a registered member in order to post messages and view/download attached files in this forum.
Click here to register.

Internal Audits Prior to CB Audit

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Steven Severt, Jun 10, 2018.

  1. Steven Severt

    Steven Severt Member

    Joined:
    Jun 6, 2018
    Messages:
    13
    Likes Received:
    5
    Trophy Points:
    2
    I am currently going through the CB audits to transition to the 9001:2015 standard at our three main US facilities and one of the issues that came up at our CA facility has me a bit worried about what will happen this week at our OH facility. We had some non-conformance issues regarding our internal audit process, which admittedly had a lot of gaps. We had been without quality representatives (myself included - I'm new to the company) until about three months before the CB audit, so we didn't have much time to get familiar with the company, products, and state of the QMS. That being said, we did not complete many of the internal audits during that time to close the gap. At CA, there was an approved audit schedule with some of the audits completed, but not all. Because not all of the internal audits were completed against the 2015 standard, and thus they did not yet have the Management Review completed, they were given a non-conformance and a timetable to complete the internal audits and Management Review. I guess what baffles me about this is that the standard does not state that these items have to be completed prior to the CB audit. It only states that they must be done periodically. If our CA facility had a schedule to complete the audits and the MR, where are they in violation of the standard?
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    1,992
    Likes Received:
    1,035
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    OK, so Steve, what is the exact wording of the NC?
     
  3. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

    Joined:
    Jul 31, 2015
    Messages:
    652
    Likes Received:
    468
    Trophy Points:
    62
    Location:
    USA
    I would like to see it too.

    9.2.1 requires internal audits to provide information on whether the quality management system conforms to "the requirements of this International Standard." That would logically include, for example management review, as there are changes to the requirements. On that basis, nonconformities are being issued for not completing audits to the revised standard.
     
  4. Steven Severt

    Steven Severt Member

    Joined:
    Jun 6, 2018
    Messages:
    13
    Likes Received:
    5
    Trophy Points:
    2
    I haven’t seen the actual audit report yet, so I’m not exactly sure how it’s worded. I’ll come back when I’ve seen the actual report. At any rate, I finished all of the internal audits and management review at my facility today to prepare for the start of CB audits tomorrow. I’ll let you know how things go.
     
  5. RoxaneB

    RoxaneB Moderator Staff Member

    Joined:
    Jul 31, 2015
    Messages:
    587
    Likes Received:
    663
    Trophy Points:
    92
    Location:
    Ontario, Canada
    Without knowing the wording of the finding, it is difficult to explore potential solutions, but I will say this for Management Review - most people structure it as a formal meeting. It doesn't need to be in that format. So, for that facility - and the others - consider other ways that your organization might already be meeting the requirements of management review. Make the standard work for you not the other way around. :)
     

Share This Page