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ISO 9001 - Expert Advice Community

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  • ISO 9001:2015 version revision

    Is ISO9001 expiring Sept this year? I hear it's every 7 years a new version is issued. Is it ideal for organization and individuals to continue to certify for it since it will be withdrawn in a few months.
  • Timing requirements for quarantine areas and non conforming areas

    May i know in ISO standard, for quarantine area/non conforming area any requirement for timing? Example, how many day/week/month we can keep the nonconforming product?
  • Questions to be asked in an audit checklist

    You are conducting an ISO 9001:2015 audit in an injection moulding company (a process by which plastic components are manufactured). The next activity on your audit plan is the organization’s final product testing laboratory. Which questions should be asked in a checklist?
  • ISO 9001:2015 specific clauses

    I wish to know the audit clauses specific for: 1. Customers related process 2. Branding and Public relations 3. Business development
  • External audits

    Do we need to have a surveillance audit every year, or can we have just the re-certification audit at the end of the 3-year period? Is it possible to have only one audit for the 3 years – as a whole, rather than having it every year?
  • ISO 9001 & Hazard Analysis

    Can you let me know where exactly in the ISO 9001 2015 update there is a specific reference to the need for Hazard Analysis, please?
  • Nonconformity question

    During an internal process audit, I found a UV-VIS  spectrometer was found to be past due for calibration in the production area,. When questioned, the department manager said that the equipment was out of order; but there is no warning sign indicating that. As such, I was wondering if this could be recorded as a nonconformity (M/m) or an observation.
  • SOP in ISO 9001

    Imagine a financial department manager decides to write an SOP...Should this SOP get a QA code? Or a leave sheet belongs to QMS and should get QA code?
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