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  • Applicable ISO 9001 clauses for implementation in a software company

    I am working with a company who develops no hardware, only ML based software. What are the mandatory clauses of ISO 9001 that apply to them if they need to go for a certification? No manufacturing, no plants, only software. What is the best approach for them?

  • SWOT analysis and management structure in ISO 9001

    I want to understand the frame/process that is followed in creating an ISO management documentation - are you able to provide a structure. Also I liked that a SWOT analysis is carried out.  Is a SWOT always carried out?

  • Clause 8.5.4 Preservation

    Can you please clarify what this clause means? what is required? how can I demonstrate compliance? 8.5.4 Preservation The organization shall preserve the outputs during production and service provision, to the extent necessary to ensure conformity to requirements. NOTE: Preservation can include identification, handling, contamination control, packaging, storage, transmission or transportation, and protection.

  • Needs and Expectations of Interested Parties

    What are examples of needs and expectations of: - Investors - Regional Offices - Management - Contractors - Consultants - Ministry / Government - Society - Competitors - Media - Suppliers - Regulators - NGO - Employees - Workers - Outsource - Association - MOPH?

  • Internal Audit

    This is my first time doing an internal audit on "sales and marketing". I feel like our company doesn't have a sales and marketing department. How should I go about doing an internal audit for a department that doesn't get used?

  • How to drive opportunity reports by IQA team

    Can you share with me about how to drive opportunity reports by IQA team, how to start?

  • ISO 9001 Surveillance audit

    The company that we were certified through may not be able to do our surveillance audit.  Is a surveillance audit required and if we choose a different company to do our audit, do we have to go through an entirely new certification?

  • 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?
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