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ISO 9001 - Expert Advice Community

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Product: Conformio Product: ISO 27001 Documentation Toolkit Product: ISO 13485 & MDR Integrated Documentation Toolkit ISO 27001 Product: ISO 27001 & ISO 22301 Premium Documentation Toolkit ISO 9001 Risk Assessment Product: ISO 13485 Documentation Toolkit ISMS Internal Audit register of requirements Product: ISO 27001 & ISO 27017 & ISO 27018 Cloud Documentation Toolkit Product: ISO 27001/Risk Assessment Table ISO 9001:2015 ISO27001
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  • KPI requirements

    Are KPIs also required for the external audit for the sales department?

  • How can I tag an instrument which is not in use as per ISO norms?

    How can I tag an instrument which is not in use as per ISO norms? Some of our company instruments are not in use and are not calibrated. Can I simply mention "Not in use" in a tag and tie on the instrument?

  • ISO 9001 Certification Documentation

    I contact you to ask you some questions regarding the documentation for ISO 9001 certification. We are currently a limited liability company with a single shareholder, I am his partner and I will join the company in January 2022, at the moment for tax issues I do not copy the company but we manage all the effects in two. I specify this thing because one of the doubts we have is related to the presence or not of an organization chart. I see that there may be figures such as CEO, General Manager, Sales, administration manager. We do not have these figures formally to date. Can I appear as General Manager even if I am not in the Chamber of Commerce registration? If you need an engagement letter for certification purposes? The administration is a service that we buy partly from a professional and partly from the accountant which of the cited? do we have to put names or is it enough the role that can then be played by different people? Can we omit the organization chart or make a simplified one? RGQ in our case of coinciding with AD? Are all the chapters and sub-chapters of the manual mandatory? If someone does not belong to us or we have nothing to say, do we put n / a? For example, we do not have offices but we work either digitally from home (especially in the last year and a half) or on-site by the customer. Can we use Teams and Office 365 as a repository? Thank you in advance for your answers

  • Risk Management for Pharmaceuticals

    How to create the right Risk Management Program for Pharmaceuticals?

  • Who should Quality report to?

    Can you please advise where in the ISO9001 it states that Quality shouldn't report to Operations or who they should report to please?

  • ISO 9001 Strategic risk assessment

    Does ISO9001:2015 require risk assessment for change requests, non-conformances, complaints etc. or only the top-level risk assessment for the strategic business risks and opportunities? Do you have a form example for nonconformance risk assessment?

  • Quality management system

    What is quality income and quality cost?
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