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ISO 9001 - Expert Advice Community

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  • Le domaine d'application

    Concernant le domaine d'application, est-ce obligatoire d'avoir une information documentée spécifique décrivant les limites du SMQ même si on a déjà mentionné le domaine d'application dans le manuel qualité?

  • Satisfaire a un audit ISO 9001

    Que faire pour satisfaire à un audit ?

  • Estudios de riesgo

    Para que sirve los estudios de riesgo y cual es el beneficio?

  • La importancia de la norma ISO 9001

    La importancia de la norma ISO 9001:2015.

  • Auditing regulatory offices

    How to audit an ISO 9001-2015 regulatory office?

  • ISO 9001 update on the requirements

    Would you please advise, if there are any updates to requirements on ISO 9001:2015?

  • Quality Management System

    All departments of our company start to create their procedures. All prepared procedures review by department heads and then approved by the company director. For the ready procedure, they give a number, rev. and an effective date. Finally, they submit to the QA department to establishing on master document register.
    My question that, what is QA/QC role in this process?
    Is it required to re-approved by the Quality manager for conformity of procedure to standard requirements? if required how to proceed?
    If not, how the Quality team be ensuring that procedure suitable for ISO 9001 standard requirements.

  • ISO 9001 KPIs for the documentation department in the pharmaceutical industry

    How can I determine ISO 9001 KPIs for the documentation department in the pharmaceutical industry?

  • Prioridades en la implementación

    Qué es lo más importante, como priorizar, como aplicar?
  • Tackling clause 8.5.1

    Hi, I am a production manager at a soap manufacturing company. How do I tackle clause 8.5 production and service provision 8.5.1 F which says [the validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement?

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