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ISO 9001 - Expert Advice Community

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  • What is clause 9 about?

    "Does monitoring and measuring of gages and calibration come up in clause 9? Or are they just talking about monitoring and measuring regarding something else”
  • Roles y responsabilidades

    Roles y responsabilidades. como lograr que los lideres de proceso valoren el Sistema de Gestión de calidad ISO 9001:2015? Compromiso, enfoque a procesos y definición de indicadores
  • Quality and Information Security Manager combined?

    "Quality and Information Security Manager. Is it normal or even desirable to combine these two roles? Are there good examples of where this has been done successfully?”
  • Design and nonconformities

    "(1) I was just wondering if for example, we are currently on the first article inspection of the product and after the design and product, the customer deemed that he wants to have it modified or changed since it does not meet requirements. Will that be counted as nonconformance for ISO 9001? (2) Also, for cases where we design and develop certain products and during the development, we found out that the product will not be useable and therefore, another stage of parallel development must be conducted. Will that be considered a nonconformance in the design?"
  • Internal and surveillance audits

    "My organization recently received ISO:9001-2015 certification. I'm trying to find the requirements for maintaining the certification. Specifically, frequency of internal, management and surveillance audits. Requirements for the IA and Management audit. What to expect at the surveillance audit, etc?“
  • Correction vs corrective action

    "I would like to know what is the difference between correction and corrective action.“
  • Quality and Information Security Manager

    Hi, Is it normal or even desirable to combine these two roles? Are there good examples of where this has been done successfully? Thanks, Brian.
  • EN 9100 vs ISO 9001

    "What is the fundamental difference between the EN9100 and the ISO9001 standards?”
  • Terminology of ISO 9001 - shall word

    "In the ISO 9001 standard, the expression "shall consider" is used extensively. I was wondering what implication it had in actual audits. i.e. if we "shall consider what needs to be obtained from external providers" (clause 7.1.1), in what kind of question from the auditor might this translates into? Are we required to have any proof that we did indeed consider it? I have a similar question for the following "shall" clauses: shall ensure and shall understand?”
  • Quality Manual and IMS Manual

    "Is the scope of IMS Manual fulfill the requirement of QMS, or I need to develop other document.”