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  • Effectiveness of the Quality Management System?

    Who should be the best authority to annually judge a company's QMS as being effective? 

    My perception is that the certification body assessor should be the only judge, due to conflicts of interests within company structures such as, an internal auditor recording the effectiveness at the end of a completed annual audit schedule could be seen as conflicting, or a statement of effectiveness recorded at the end of annual management review minutes by internal management, could also be seen as conflicting against the audit protocols of not conducting assessments of processes that employees are engaged in.

    For example: Should a Managing Director who is also responsible for Supply Chain Managenment conclude that the QMS is deemed as effective.?

    Could an external assessor find conflict in the organisation's self effectiveness methodology of the QMS questionable in the above examples.?

  • ISO 9001 Strategic risk assessment

    Does ISO9001:2015 require risk assessment for change requests, non-conformances, complaints etc. or only the top-level risk assessment for the strategic business risks and opportunities? Do you have a form example for nonconformance risk assessment?

  • Clause 4 procedure and department Quality objective

    1. Is clause 4. is in need of documentation or a procedure? Especially the internal and external issues? Do I need to create a procedure for this? 

    2. Is each department is in need to create their department Quality objective or not? are they require to create their department quality objective?

  • Quality management system

    What is quality income and quality cost?

  • indicators


    I need your feedback to know the effectiveness and efficiency indicators usually used to measure and evaluate the design and development process (development of plastic injection molds)

    thank you in advance

    Best regards

  • Process vs internal audit

    What's the difference between process audit and internal audit?
  • Quality audit in manufacturing company

    I want help on the types of quality audits that can be carried out on a manufacturing company?

  • ISO 9001 Questions

    Thanks to the support by clarifying me bellow questions:

    1/Example of determining the requirements for products and services, meaning what features the product or service will have in the organization;
    2/Example of the scope of QMS and its evidence in any organization ;
    3/ Example of process design/service in any organization ;
    4/ Example of  establishment and documenting the criteria for suppliers selection in any organization ;
    5/Example of  establishment and documenting the criteria Production and service provision in any organization 

  • ISO 9001 Engineering drawing

    Where can I find the guide on archiving engineering drawing?

  • ISO 9001 Warehouses

    What is the specific ISO covering the warehouses?

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