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  • ISO 9001 List of Documents needed for ISO Surveillance Audit

    What list of documents do I have to have ready for a remote ISO surveillance audit?

  • ISO 9001 Project Phase

    How do you deal with the ISO 9001 project phase, in the implementation stage where the organization decides to change the organization structure?

  • ISO 9001 design and development

    How to fulfill the 9001 clause 8.3 the design validation - the company is fabricating big engineering equipment, no prototype, so how does he do the design validation?

  • Corrective and preventive action

    I just want to increase my knowledge regarding corrective and preventive action as per standard for mass production: for example, there is 1 lakhs total quantity rejected but after the rework, they found 100 defective pieces and then all quantities are ok in inspection, how can we have to write CAPA for same.

  • Roles and responsibilities of QMS coordinator

    As a coordinator for QMS 9001:2015, what is my roles & responsibility?

  • ISO 9001 Paper procedures

    I am trying to eliminate all our paperwork instructions and procedures in binders in the plant, because they are a mess and not up to date. Question: Can you please tell me if these paper procedures require a MASTER INDEX, or MASTER RECORDS LOG of some sort to verify quickly if the latest document is on the floor or not?  It seems to me that this would be mandatory, or at the least very prudent. 

    Your Thoughts please?

  • OBS recommendations

    During an internal audit, I found a lot of gaps and some of them did not meet QMS requirements and some of them require implementing new procedures from process owner. All findings not critically and I completed audit with 1-NC, 17-OBS (observations), and few OFI. The report was prepared with recommendations for each OBS and OFI. Also, I gave a time period for reply to OBS and inform them OBS can become NC.

  • Implementing QMS in a small factory

    How much time will it take to implement QMS in one small factory?

  • Becoming a better-accredited auditor

    How can I become a better-accredited auditor?

  • Sistema de gestión

    Necesito saber cómo crear mi sistema de gestión para mi empresa.
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