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  • 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?

  • indicators

    Hello

    I need your feedback to know the effectiveness and efficiency indicators usually used to measure and evaluate the design and development process (development of plastic injection molds)

    thank you in advance

    Best regards

  • Process vs internal audit

    What's the difference between process audit and internal audit?
  • Quality audit in manufacturing company

    I want help on the types of quality audits that can be carried out on a manufacturing company?

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