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ISO 9001 - Expert Advice Community

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  • Create a Performance Mindset

    What best leadership efforts and approach to strategy can you recommend for a business to create a performance mindset?

  • Design exclusion

    We are a subcontractor and we are doing a part of design and construction. However, we are not authorised to approve or validate our drawings of what we produce. So we are depending consultant for the validation part. We always exclude the design part since we are not authorized. what to do? Please advise!
  • Process map according to ISO standard

    I am responsible for process management in the company. Since I will be modeling many processes in the near future, I would also like to create a process map. I would like to create this based on the ISO standard. Can you send me information material on this topic on how I can best set up a process map or general process modeling in an ISO-compliant manner?

  • IMS Standards

    If I use the term "Management Representative" in my Quality Management System (QMS) documentation, is it still considered valid?

  • ISO 9001 - Quality Objectives and Processes

    So far, I have one question on quality objectives.  We’ve identified 14 processes in our process map – am I required to have quality objectives for each process?  6.2.1 says that we “shall establish quality objectives at relevant functions, levels, and processes” – it does not say all processes.  Can I interpret that as our organization can choose which of the 14 processes we want to establish quality objectives for?

  • Integrated checklist for ISO 9001:2015 and ISO 14001:2015

    Can you help me come up with the checklist for an internal audit for the quality department in a manufacturing company? I am a management trainee and was recently trained to be an internal auditor for those two standards.

  • ISO 9001 - Control Chart in Monitoring Variation

    How is the control chart in monitoring variation in laboratory analysis work?

  • ISO 9001 and Gap Analysis and Internal Audit

    A) As far as getting help, I need to understand better the stage 1 audit (what is being done exactly (checklist with each clause and the mention whether it is present or not in the auditee organization? How to re-use the checklist for stage 2 - a bit septic of generic/standard checklist) and eventually discussed with auditee (Past management reviews and audits some people say) to assess readiness for stage 2.

    B) I also was very interested with your discussion on the gap analysis vs internal audit and the different perspectives of each. Is the checklist the same? With additional column in the case of internal audit to write what is actually being found and observed. Is this right?

    C) I was also interested in the different ways to organize an internal audit: department by department, process by process or clause by clause. I am wondering when it is best to choose which anda whether there is such a thing a department x clause and process x clause matrices.

  • Internal Audit

    Greetings!

    Let me know how we can plan and counduct internal audit. What's steps are mandatory for internal audit. 

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