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ISO 9001 - Expert Advice Community

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  • Cómo definir el alcance

    Actualmente trabajo en una empresa de desarrollo de software y contamos con certificación en un modelo de calidad llamado cmmi , pero éste certifica al área de desarrollo (producción) mi duda es la siguiente: si yo cuento con departamentos como finanzas, área comercial, ventas, etc. ¿puedo separar todas esas áreas y certificarlas como una empresa "interna" y que el área de desarrollo sea mi cliente??? Esto tomando en cuenta que la norma te habla de un cliente y de una organización, pero aquí todo seria interno.
  • Certification scope and international activities

    "If a certification scope covers the activities carried out by the operatives of an international business unit of a parent organisation, must I nominate the countries, or the offices within those countries, in the defined scope (I mean on the certificate)? If my processes are central, does this not then mean that the business unit, wherever its operatives function from, is entirely in scope anyway. Would naming the countries make any geographical mention in the certification scope serve as a preclusive factor rather than an inclusive factor? I’d rather carry out audits and have my certifying body audit remotely based on projects undertaken rather than visit the offices in countries in which my operatives may operate from. Other than possible legislatory variations as the business is run internationally, I don’t see that my certification scope has any real geographical aspect. Do you have any advice?”
  • Involvement of corporation

    "Our site is owned by a company in the US. If our (UK) site is aiming for certification, would management review need to involve the US directors?”
  • Certification as a requirement to sell

    "If I have an idea for a product and want to be able to sell and am required to have ISO 9001 to sell, how do I gain this prior to manufacture of the product. Do I have to manufacture without ISO, if so, how do I sell?”
  • Planning employees' succession

    "I wish to know which clause in ISO 9001-2015 standard requires succession planning of employees”
  • Context example

    "Can you provide me examples of context for valve manufacturing organization...”
  • What is needed to prepare certification audit

    "I am working in a self-financing college. Already we had ISO 9001:2008, now we are moving to ISO 9001:2015. For that, I am the overall college ISO coordinator. I have one doubt. We prepared the process flow chart for the entire system and its risk assessment. An internal audit also over. We prepared the PPT for the college. My question is, what type of report or document we need to submit to ISO for assessment?"
  • Questions from the external auditor

    "What kind of question we can expect the external auditor may ask to the quality personnel?”
  • Meaning of context determination

    "What does determining context of the organization exactly mean?”
  • Evidencing revision

    I have just taken on the role of QM for a small company that has their 2015 in July. I have 2 questions, When we are putting a new designation changing our Quality systems title in the title. old being 9001:2008 to 9001:2015. must I list a revision date ? revision level ?