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  • ISO9001 Scope

    Is clause 4.3 intended to determine the scope of the organisation, i.e. in relation to its products and service lines and extent of operations; or the scope of the organisational processes that should be captured by the quality system, i.e. only those that may have a direct effect on customer satisfaction, that should therefore fall 'in scope'?
  • Exclusiones de las cláusulas 8.3 y 7.1.5

    He recibido esta pregunta: Estoy implementando ISO 9001 en una empresa que distribuye y vende válvulas y equipos de medición a industrias Oil & gas en toda latinoamérica. Los equipos son comprados previamente a otra companía. Mi pregunta es si debo excluir de mi SGC los requisitos 8.3 Diseño y Desarrollo y 7.1.5 Recursos de seguimiento y medición, ya que vendemos productos terminados Mi respuesta: Como la empresa no posee ningún proceso de diseño y desarrollo dentro del alcance del SGC, entonces puedes excluir la cláusula 8.3 del alcance de la organización. A la hora de excluir cláusulas de la norma, necesitas documentar dichas exclusiones en la documentación sobre el alcance del SGC y proporcionar justificaciones de las exclusiones. Interpreto por otro lado, que la companía además no hace seguimiento y medición de los equipos en sus procesos por lo que también podrías excluir la cláusula 7.1.5 del alcance. Para más información puedes ver "Qué cláusulas pueden ser excluidas en ISO 9001:2015" (en inglés): https://advisera.com/9001academy/blog/2015/07/07/what-clauses-can-be-excluded-in-iso-90012015/2015/ Estos materiales pueden ayudarte con respecto a la implementación de ISO 9001: - Libro"Preparación para el proyecto de implementación ISO: una guía en un lenguaje sencillo": https://advisera.com/books/preparacion-para-el-proyecto-de-implementacion-iso-una-guia-en-un-lenguaje-sencillo/ - Curso gratuito en línea: Curso de fundamentos ISO 9001 https://advisera.com/es/formacion/curso-fundamentos-iso-9001/ - Conformio (Herramienta en línea para ISO 9001): https://advisera.com/conformio/
  • Continual vs step change improvement process

    "What is the difference between continual improvement process and step change improvement process."
  • Audit scope

    "Hello. Can you advise as to the best way to conduct internal audits under the new standard do you audit each department based on all the clauses on the new standard or just risk based thinking. The risk and mitigations etc. Your guidance will be appreciated."
  • Re-write the quality manual

    "We currently have 2008 and at the very beginning stage of 2015, I know it says you don't need a quality manual, but I don't know how else document anything for our audit in February and do I need to re-write the full manual to align with the 2015 standard as the definitions are different, some the same but in different sections."
  • Exclusions

    "Hi. If a company only provides services and does not make products can you still exempt clauses? In the 2008 version we excluded 7.3 design & development."
  • Customer visit and customer satisfaction

    "I suppose to standardize organization of customer visit. I got suggestions that it should be SOP or flowchart and recently just guideline as the lowest level off documents. I went through some articles looking for answer I found that customer visit is integral part of customer satisfaction and communication and process of organization of the visit should be part of customer satisfaction procedure. Am I right ?"
  • Maintaining organizational knowledge

    Hello, how organizational knowledge can be maintained, can you please help me understand this?
  • Information Security Policy

    How can I audit the Information Security Policy at the company where I work?