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ISO 9001 - Expert Advice Community

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  • Quality Manual requirements

    “We have 30 plus Directorates in organization. The consultant said that Previous Directorate manual will become Sectoral manual in 2015 version. Is it true and what will be the document's content, please advise.”
  • Evidences about organizational knowledge

    "What audit evidence can one get for clause 7.1.6 of ISO 9001:2015”
  • Organizational knowledge

    In addition to my previous question regarding ISO 9001-2015, I also want to add clause 7.1.6 Organizational Knowledge, is this clause specifically referring to the employees knowledge or the companies experience? as what is written in our Quality Manual is the companies experience.
  • Plan de auditoria de un SGC

    Quiero saber en que consiste el plan de auditoria de sistema de gestión de calidad, si fuera de una organización de productores mejor.
  • Starting a career as consultant

    "I am start building up my career in consultancy business and I am too much interested to hear from your advice for starting such business in Europe technical and financial advice.”
  • QMS Scope and Quality Manual

    "In the template Quality Manual included in our toolkit, under section 4.3 (also 4.1 & 4.2), it states that the [CEO] determines the Scope of the QMS, but does not indicate that as part of the Quality Manual. Since it is a key part of the requirement, should the determined scope be included here under sec. 4.3? or should it reference an external document with possible support information? Would a reference to the Process Map (fig. 2) suffice? or do we need a more specific documentation?”
  • Audits and sampling

    "Can a sample be selected from the areas to be audited by processes? Example: If I have 10 processes in my management system and three areas responsible for each process, that is, 30 areas, can I sample those 30 areas so I do not need to audit all?”
  • Controlling changes

    "Which ISO 9001:2015 clause will a quality system deviation and/or waiver falls under? This is a single procedure to monitor a deviation for a certain period; therefore, the normal process will not be followed due to project implementation."
  • Key performance indicators and ISO 9001

    "The company I work for is an engineering company and certified ISO 9001:2015 a year ago but the term key performance indicator is not clear. please help”
  • Evaluating opportunities

    "Any recommendations on what matrix can be used in evaluating or assessing the opportunity?”