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ISO 9001 - Expert Advice Community

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  • ISO 9001:2015 clause 4 internal and external issues vs interested parties

     Can you explain ISO 9001:2015 clause 4 internal and external issues vs interested parties, please? Companies use very general terms there.

  • ISO 9001 clauses relating to Incoming Quality

    Advice me the ISO Clauses that relate to Incoming Quality.

  • Managing customer complaints

    I am working in a communication company. I have 203 customers and the registered 90 complaints regarding service issues in the whole month. I like to know is it fine as per ISO standard or not as the daily complaints % is approximately 3%

  • Context, internal and external factors and interested parties

    How to implement the analysis of the context, internal and external factors and interested parties.

  • Interpretación de requisitos de la norma

    En el apartado 0.1 la norma plantea:
    0.1 Generalidades
    Los beneficios potenciales para una organización de implementar un sistema de gestión de la calidad basado en esta Norma Internacional son:
    a) la capacidad para proporcionar regularmente productos y servicios que satisfagan los requisitos del cliente y los legales y reglamentarios aplicables.
    Mi pregunta es:
    A qué se refiere cuando expresa: "requisitos legales y reglamentarios aplicables"?
    En el apartado 8.2.2 Determinación de los requisitos para los productos y servicios se plantea:
    a) los requisitos para los productos y servicios se definen, incluyendo:
    1) cualquier requisito legal y reglamentario aplicable;A qué se refiere cuando plantea: "cualquier requisito legal y reglamentario aplicable" ?
    Agradezco por adelantado su colaboración en el esclarecimiento de mis dudas. Saludos.

  • Section 8.5.6

    Referred to section 8.5.6 (control of change) we are planning to implement " management of change procedure". we plan to use this procedure for all changes in IMS (for changes in procedures, company specification or aspects). We will do risk analysis to identify potential hazards and impacts associated with the changes. All discussed with the staff in conjunction with the change send to QA department for registration 
    is it possible to use this section for these purposes and am I correctly understand section 8.5.6?

  • IMS system

    Our company plans to use IMS. I want to clarify who shall be responsible for document registration in the system. QA specialist is responsible for Quality documentations. Who shall take responsibility for EMS and HSE documentation? 
    Could the QA department take overall responsibilities for IMS?

  • ISO 9001 Clause 8.4 implementation

    Please I need your help on how to articulate and implement the requirements of Clause 8.4

  • Excluding clauses of ISO 9001 for a law firm

    I'm working on the implementation of ISO 9001 in a law firm. What clauses of the standard can we exclude? Clause 8.3 (design and development) seems to be quite obvious; but what else could we exclude?
  • ISO 9001 and supply chain control

    Why does ISO9k not focus more on supply chain control? the existing points on supplier management pay no respect to supply chain and BCM as result of issues caused. also, control of fake/fraudulent components during the supply chain is not controlled.

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