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ISO 9001 - Expert Advice Community

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  • Relationship between ISO 22301 And ISO 9001

    Are there any similarities between the two standards? In other words, if I already implemented ISO 22301 will that help me if I am looking to implement ISO 9001?
  • Help on knowledge management implementation

    We have a new unit in my office and am in charge of the responsibility of knowledge management. It will entail succession planning, knowledge retention, creating a policy plan for knowledge management.

  • Clauses 8 & 10

    I kindly wanted to ask how exactly we can implement clauses 10 and 8 (improvement and operation) in Health industries like hospitals, and what are the procedures that should be taken to implement these clauses.

  • 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?

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