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ISO 9001 - Expert Advice Community

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  • Opportunities - examples

    "I would like to get some clarity on what exactly the standard requires on 6.1. Actions to address risks and opportunities. I have identified the risks as well as actions to address them for our organisation, however I'm not sure what the opportunities and actions to address them refers to. Can you please give me examples of any industry or company?”
  • ISO 9000 variants

    "Can you please explain ISO Scope and purpose of 9000 variants?”
  • Supervision of parts inspector

    "I am the Plant Manager at our business and I would like to inquire if ISO standards will allow for a final parts inspector to fall under the supervision of the Plant Manager instead of the Quality Manager as long as we change our organizational chart to show this pattern.”
  • Nonconformity about quality policy

    "Requirement of the standard: ISO 9001:2015, Cl. 5.2.1 Establishing the quality policy Top management shall establish, implement and maintain a quality policy that:
  • Scope proposal

    "Proposed (or something along these lines): Design, Development, Manufacturing and Sales of Specialty Chemical Products. Processing and Sales of Technical Grade and Food Grade Ferrous Sulfate.”
  • Design and development or customer support?

    "I am looking at the design and development requirements of the standard which, if I read it right relates to the D&D of products rather than services. I am clear about the inputs required, the controls needed and the outputs if a product is being made from scratch. However, if a company receives a request from a customer for one of their ready-made products to carry out a cleaning operation and the only thing the company does is to test samples submitted by the customer to determine which of their existing products is suitable to clean it properly is the testing and recommendation regarded as D&D? This would appear to be little more than assisting the customer buy the right product rather than D&D a new product?
  • Internal audit purpose

    "OK, so I need to clarify. ISO 9001 is a quality management system. What is actually checked at audit? Is it: that the processes identified in the documentation actually happen or are the processes themselves checked to ensure that they actually are the right processes in the first place. For example, if I build something and I implement a QMS, when I am audited do you check that the product I am making actually gets built to a specific standard or do you check that I am tracking this for myself and noting where there are any changes that need to be made. I am slightly confused as to what the ISO 9001 audit actually entails and welcome your response.”
  • Audit checklist

    We are already ISO 9001:2015 certified but I am always looking for newly developed checklists, any type of audit questions in the form of a data bank so an auditor can pick and choose audit questions. As the 9001:2015 continues to mature I will be on the prowl for new things.
  • Design and development is for more than the new

    "What does design, and development apply to is just a new product or service?”
  • Company profile

    "I need to know where I can place our company profile in terms of ISO standard, should it be under policy”