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Help Please!

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by IanMcelhoney, Jul 2, 2021.

  1. IanMcelhoney

    IanMcelhoney New Member

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    I own my own IT company and i am short of a QA professional at present! Due to Covid etc
    Im working on my own to make sure we are up to the mark.

    We due to be audited by the ISO to enable us to maintain our ISO9001 accreditation in three months’ time. What steps would you take to ensure that our physical and digital inventory records were in good order and that our process documentation is up to date and the processes are being complied with?

    Please help!
     
  2. RoxaneB

    RoxaneB Moderator Staff Member

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    Welcome, IanMcelhoney.

    One is not audited by "the ISO." Presuming you're referencing a certification body.

    Answers here can be varied and diverse as there are numerous options out there for organizations to pursue. So, let's flip it around...what is your current process for maintaining physical and digital inventory records? Is it working for you? If not, why?
     
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  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Although it's common to consider records are in order and process documentation is "up to date", and this is frequently the focus of the CB auditor, you will have to demonstrate those aspects of the surveillance audit (it is a regular surveillance audit?) which are going to be scheduled. I'd suggest this:

    Approach your CB point of contact and explain you have to prepare for your audit.
    Ask them for the surveillance audit schedule
    Review that and amass the relevant records and process documents
    Assure yourself you understand what your QMS commits you to and that you can talk to that.
    Ensure you have no "holes" in your system, such as zero internal audits or Management reviews being performed.
    Since you have lost a key member of staff (QA?) then you have had a change and that should be reflected in your review - plus what you are doing about it.
    Consider, as the chief stakeholder, the need for you to become far more familiar with the use of the QMS.
     
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  4. tony s

    tony s Well-Known Member

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    Don't work on your own. Involve everybody. Sit down with your people and check whether:
    • the expected outputs of each process, from business development to project closure, are met;
    • the set performance targets, relevant to the expected outputs of the processes, are achieved;
    • the plan of actions to achieve the set targets are implemented;
    • the risks/opportunities affecting your organization and processes were identified and controls are in place to address them;
    • the activities specified in your documented procedures/policies are evidently in place; revise the procedures if the actual practices are not reflected in the procedures;
    • the forms mentioned in your documented procedures are being accomplished as specified;
    • there are concerns from the clients, including regulatory bodies, that your organization need to address; etc.
    The above are just some of the things that your organization need to have satisfactory results. There are other things that you need to ensure are happening in your organization such as planning for your organization, internal audits and management reviews. Remember that, as the top management of the organization, you are the one accountable to your system (see ISO 9001 clause 5.1.1a). Responsibilities may be delegated to your people, like your QA person, but not accountability.
     
  5. Lennart Ljungh

    Lennart Ljungh Member

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    It's always a good idea to have a look in the standard. I also think that the cost of an exxperienced consultant is a very good investment.
     
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