ISO 9001 - Expert Advice Community

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  • 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?”
  • Documentation and scope

    "We are planning to implement ISO 9001 to our organization. Our organization is an IT firm where we develop web applications for customers. Our business is more than 5 years old. We are in the process of completing gap analysis checklist. We are not sure with few concepts. Can you please advice us, in general, how many documents or information we need on hand to show it to the audit firm? Also, how does organization's scope works with products and services along with international standard?”
  • Main changes in documentation

    "What are expected changes in procedures and manual as I have already certified QMS as per ISO 9001:2008.”
  • Planning changes to the QMS

    "What constitutes a “change to the QMS”? Since there are now more requirements when a “change” occurs, I’d like clarification of “changes to the QMS”. (I don’t want to create work for people just because we changed a form for example.)”