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  • Six mandatory procedures

    What are the 6 required documented processes?
  • Device Master File Documentation & Record Control

    Hi! Please help me to my concerned. What is the meaning of DHF/Batch records. I'm not familiar to this DHF meaning. This DHF/Batch records is in the audit plan of are upcoming auditor but I did not know what is this. Thank you.
  • Transition in an engineering company

    I work at a small engineering firm that is planning our transition from ISO 9001:2008 to 9001:2015. We're having a little trouble identifying what actions we need to take to update our QMS, as the changes seem very abstract. Could you suggest some resources we might use to give us practical suggestions for how to begin our transition? For example, it seems that ISO 9001:2015 is asking us to frame our QMS in risk management. I understand what that means (I think), but I don't really know what implication that would have for our existing systems.
  • Política de calidad, objetivos e indicadores

    Podrías por favor enviarme un ejemplo de una política calidad que contenga los objetivos estratégicos y además como declinar estos objetivos en indicadores?
  • ISMS policy and ISMS framework ( global document)

    Can you please explain the contents that are needed to be included in these documents??? Are ISMS objectives defined first or RA/RT is performed first?? Can organisations have ISMS policy defined before setting ISMS objectives? Because ISMS objectives are included in Policy, I believe policy is defined post objectives and these objectives are defined post RA/RT....
  • Uncontrolled Copy and New Issues in ISO 9001 2015

    Please allow me to request for your best recommendation on:
  • Mejora continua

    Buenas, Me gustaría saber como puedo implementar la mejora continua en una empresa de obra civil, donde apenas se esta implementando un SIG
  • Documenting actions to address risks and opportunities

    Is it really required for an institution to give action plan in addressing their risks and opportunities? Although, our external auditors (for re-certification) included them for documents required in review purposes and audit plan preparation? Thank you.
  • Documenting clause 8.1

    Can you please kindly advise if we are required by the standard to maintain and retain documented information for clause 8.1? If so, can you please provide examples of documented information that should be maintained and retained.
  • What is Quality Assurance

    What is Quality assurance?