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  • ISO 9001 Implementing Managment Quality and Risk-based thinking

    How to implement management quality and risk-based thinking into the everyday work life of every employee within the organization?

  • ISO 9001 Evaluation of the effectiveness of training

    How to evaluate the effectiveness of Training to perform a process to a procedure? I am an internal auditor and I am trying to determine how to determine if we are meeting the requirements of 7.2c to evaluate the effectiveness of the actions taken; i.e. Training took? We are currently just having a supervisor sign off on OJT, but that does not sound like "Evidence of Effectiveness." Don't we need to be giving some kind of Quiz, or at least be defining what exactly they were trained for, and are they now competent to perform that process?

  • Structuring a table of interested parties

    I am trying to structure an interested parties table where I can capture pertinent information.  What other information can I include in the table besides columns for the interested party, their requirements, and the responsible person?

  • Design office ISO objectives

    ISO objectives for a design office

  • ISO 9001 - 10 Must have documents

    What are the 10 common documents that all departments must have?

  • ISO 9001 - Is quality manual mandatory?

    We are ISO certified on 9001:2015 standard. Just inquiring whether it is mandatory to have a quality manual or is it not. Can you please quote in which part f the standard does it state not to have one?

  • ISO 9001 Quality management in hospitals

    Kindly need your guidance for ISO-hospital, as our team working on Quality management in High-quality chain hospitals.

  • Quality Manual for ISO 13485 and ISO 9001

    I'm new in creating of Quality manual in both ISO 13485:2016 and ISO 9001:2015. May I know on how to indicate the Internal and external issue requirements in the Quality manual of ISO 9001:2015?

  • Quality Manual

    Does the standard ISO 9001:2015 require to have a quality manual?

  • Approval of records

    My company is implementing QMS and we are a bit confused about records. We will not have many, some minutes, and similar. We would just like to confirm that all records need to have: title, date, author, reference number (unique identifier)? Approval just for those we decide that need to have approval? Thank you!
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