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ISO 9001 - Expert Advice Community

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  • Auditing outsourced processes (1)

    “We are going to audit our outsourced process so which clause of ISO 9001:2015 is most applicable’”
  • Issues are not necessarily negative (1)

    "Presently we are working for the ISO certification of the Water District where i work for. One report that they are asking to us is the REGISTRY OF OPPORTUNITIES & RISKS BASED ON EXTERNAL & INTERNAL ISSUES, & INTERESTED PARTIES, and in tabular form we need to fill these in. 1.Factors 2.Description 3.Issues 4.Opportunities (+) / Risks (-) 5.Risk level (severity & likelihood) 6.Action(s) 7.Resource(s) needed 8.Responsible / Date 9.Method to monitor results My question here is that, is the "issue" necessarily mean negative factor that gives the Water District opportunities and risks?”
  • Initial steps in ISO 9001

    "We have achieved Management approval and backing to move forward with ISO 9001 certification. As early as next week we will begin in earnest. I will keep you posted on our needs as we move forward. What would you suggest as our initial step?"
  • Nonconformities and corrective action

    "As a service provider, how to we relate Procedure for Management of Nonconformities and Corrective Action? The temple sounds mainly concern with Production. How should we deal with this procedure (8.7, 10.2) and make a record for Non-conforming records (8.7, 10.2.2) and corrective action (10.2.2)?”
  • Migración a la nueva ISO 9001:2015

    Quisiera apoyo para saber que metodología debo utilizar para realizar la migración de la versión 2008 a la versión 2015. Por donde es mejor iniciar el cambio, y cómo deben realizarse los mismo.
  • Transition to ISO 9001:2015

    "I would like support to know what methodology I should use to make the migration from version 2008 to version 2015. Where it is better to initiate the change, and how they should be done”
  • Mandatory documents

    "What documents are the Obligatory, to be prepared for Internal Audit, the system is implemented and certified, but I have monitoring audit for both internal and external.”
  • Documented information

    "I'm studying ISO 9001, but I didn't find the way of document controlling. So, I’m wondering how to manage the documents in QMS. Do you have the rules about it?”
  • Internal audit requirements

    " I would like to know who can be an internal auditor in the company? My company used to have a second party who did the internal audit. But It cost us too much so my boss has changed his mind and he is going to ask one of his employee to do the internal audit. As far as I know there should at least two people in the company to do the internal audit. One person can do all department a pat form hers and the second person can audit the first one's department. Am I right?”
  • Risks and context

    "How are the internal and external issues identified in Clause 4 of ISO 9001:2015 related to the risks and opportunities also mentioned in clause 4? How are the issues defined as compared to the risks and opportunities?”