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  • Changes in ISO 9001:2015

     I believe that there will be changes to the QMS system next year, is there any information that a person could get regarding the changes to 2015.
  • Nonconformities of outsource partners

     We have two Outsourced Process which we are responsible.We have a contract with both of them. [ with specific terms and regulations- e.g. about environment protection, waste legislation, economic factors, etc. ] During our control on both of them, if we suspect a problem:
  • Work instructions for outsource partners

    We need to give ‘Work Instructions’ to our outsource process.
  • Developing Quality Manual

     How do i develop a quality manual for my organisation?
  • Preparation for recertification

     I have a pertinent questions I would wish you look through for me for possible way out and if there are materials I can use for such purpose.
  • SOP and Quality Manual

     The procedures for various functions are split up into multiple documents. Can we simply put them into 1 document and refer to it as our SOP manual? I assume the Quality Manual would then refer to the SOP manual for ISO referencing?
  • Internal records vs QMS

     I have some questions about some internal documents that my company uses on a daily basis that doesn't seem to be required by ISO 9001:2008. There are multiple logs and check sheets that the owner likes to have to easily see different things, without having to do a lot of research there is just a log. I was once told that if it affects the product then it needs to be a quality form, but if these
  • Auditing odd shifts according to IAF MD 5 Section 3.5

     Can you please give your valued interpretation of IAF MD 5 Section 3.5 when the scope and control of processes are same thru 24 hours and the shifts are rotating in a continuous or batch chemical plants?
  • Difference between Quality Policy and Quality Objectives

     Could you please explain the difference between Quality policy and Quality objectives for me.
  • Design and Development in polyclinic

     We have a polyclinic with lab- x ray- and and day surgery; do we consider design and development 7.3 standard as a design for service or it it is just for the product. if yes how are we going to cover it?