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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?
  • Effectiveness of the Quality Management System?

    Who should be the best authority to annually judge a company's QMS as being effective? 

    My perception is that the certification body assessor should be the only judge, due to conflicts of interests within company structures such as, an internal auditor recording the effectiveness at the end of a completed annual audit schedule could be seen as conflicting, or a statement of effectiveness recorded at the end of annual management review minutes by internal management, could also be seen as conflicting against the audit protocols of not conducting assessments of processes that employees are engaged in.

    For example: Should a Managing Director who is also responsible for Supply Chain Managenment conclude that the QMS is deemed as effective.?

    Could an external assessor find conflict in the organisation's self effectiveness methodology of the QMS questionable in the above examples.?

  • 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?

  • Clause 4 procedure and department Quality objective

    1. Is clause 4. is in need of documentation or a procedure? Especially the internal and external issues? Do I need to create a procedure for this? 

    2. Is each department is in need to create their department Quality objective or not? are they require to create their department quality objective?

  • Quality management system

    What is quality income and quality cost?

  • indicators


    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

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