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ISO 9001 - Expert Advice Community

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  • Addressing context of the organization

    Could you please inform ,how to address clause 4 context of the Organization in the Quality Manual?
  • Quality Objectives

    With Appendix 1 Quality Objectives chart, can you explain how I determine what goes in the "Process" field of the chart?
  • Risks assessment in ISO 9001:2015

    We are already ISO 9001-2008 certified company. Now want to learn to implement risk assessment, the new things in 2015 version. Need guidance for the effective tool and formats.
  • Defining context of the organization

    How to come up context of organisation?
  • Control of outsourcing partners and suppliers

    The standard talks about assessing functions which are outsourced and establishing criteria for monitoring performance of parties to whom work is outsourced . To what extent are we required to do this?
  • Managing documents

    I have things moving along right now but I am trying to coordinate the Document and Record Control Policy for my client and I am wondering how to deal with all the external documents brought into the organization by email? Also, are items such as vehicle registration slips considered external documents that should fall under the document control process?
  • How to start complying with ISO 9001

    How are we going to start to comply the requirements?
  • Evidence of ISO 9001 compliance

    How much evidence of implementation of ISO 9001 is needed prior to and audit and certification?
  • What is new in ISO 9001:2015

    What is new addition of ISO 9001:2015?
  • Interaction of processes

    Can you help me regarding interaction of processes. We have many services including: quality control of veterinary vaccines; technology transfer; provision of trainings; Optimization of vaccine production technologies & production of essential biological reagents. How can we map out process interaction?