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ISO 9001 - Expert Advice Community

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  • Major vs Minor nonconformity

    Could you please let me know what is the difference between major and minor nonconformity?

    Could you please provide any practice tests/incidences to rule out any nonconformity present in the scenario?

  • Clause 8.3. applicability

    Would ISO 9001 clause 8.3 'Design and development of products and services' be applicable to a scientific research lab, which has an R&D department to design Standard Operating Procedures for use in-house to produce scientific data?

  • ISO 9001 for international quality mark

    I have a start-up business. One of my products is exclusive to my company as we have designed it. So if I need to take an international quality mark or a legal stamp for that, what should it be? Is ISO standard for the product or for the organization?

  • ISO 9001 and calibration

    If my company has passed ISO 9001:2015 check, can I do calibration and make report for customer?

    Does my company need calibration Lab or not?

  • Procedure for determining context of the organization

    Clause 4.1 says there shall be a determination of external and internal issues (the context of the organization). Is the procedure for determining the context of the organization is non-mandatory?

  • Needs and expectations of interested parties

    I am looking for the needs and expectations of interested parties as per the ISO 9001:2015 standard.

  • Outsourced Process

    I would like some guidance on how to draft an Outsourced process according to ISO 9001:2015.

  • Risk and opportunity assessment

    What is the best time interval to assess/re-assess the risk and opportunity?
    Do I need to have operational and strategic risk and opportunity assessments separately?

  • Management review after audit

    When should a management review meeting be held after conducting an internal audit?

  • ISO representative responsabilities

    Is it the responsibility of an ISO representative to develop work procedures for each department in an organization?

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