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ISO 9001 - Expert Advice Community

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Product: Conformio Product: ISO 27001 Documentation Toolkit Product: ISO 13485 & MDR Integrated Documentation Toolkit ISO 27001 Product: ISO 27001 & ISO 22301 Premium Documentation Toolkit ISO 9001 Risk Assessment Product: ISO 13485 Documentation Toolkit ISMS Internal Audit register of requirements Product: ISO 27001 & ISO 27017 & ISO 27018 Cloud Documentation Toolkit Product: ISO 27001/Risk Assessment Table ISO 9001:2015 ISO27001
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  • Documentation and scope

    "We are planning to implement ISO 9001 to our organization. Our organization is an IT firm where we develop web applications for customers. Our business is more than 5 years old. We are in the process of completing gap analysis checklist. We are not sure with few concepts. Can you please advice us, in general, how many documents or information we need on hand to show it to the audit firm? Also, how does organization's scope works with products and services along with international standard?”

  • Main changes in documentation

    "What are expected changes in procedures and manual as I have already certified QMS as per ISO 9001:2008.”

  • Planning changes to the QMS

    "What constitutes a “change to the QMS”? Since there are now more requirements when a “change” occurs, I’d like clarification of “changes to the QMS”. (I don’t want to create work for people just because we changed a form for example.)”

  • Organizational knowledge and processes or individuals

    "Do we have to fill up self-designed format on OK 7.1.6 for individual or for process like Production, Eng., R & D, Marketing, SCM etc etc.”

  • Cómo presentar los documentos en la auditoria

    ¿Es necesario tener todo impreso para la auditoría? ó ¿es posible que se revise, en una computadora?

  • Deadlines for acceptance of documents

    Could you be able to suggest me the decent way to set the deadline for acceptance of individual documents in the course of QMS implementation – a) in accordance with Project Tasks listed 1 to 24 or b) in accordance with Project Files 00 to 16 (in logical order)?

  • Starting off ISO 9001:2015

    Could you please kindly provide any guidance for me to start off ISO 9001:2015 project as I am a bit overwhelm with where to start the project. Our project team comprises 3 person – myself, CEO, Director and another P.A to CEO.

  • SMART and Good Quality Objectives

    "I have seen many different variations for how to interpret the “SMART” acronym. Who would be the leading authority as to which is the correct interpretation? Is it simply up to the organization to decide which variation would best fit their quality objectives? Please advise at your earliest convenience.”

  • Documented information format

    "What is the meaning of the term "Format"? Our documents will be created in MS Word, stored on our server. I don't know how to determine what the format means”

  • Documentación obligatoria en ISO 9001

    Por favor ayudarme en el plan de trabajo de la implementación DE ISO 9001:2015 e ISO 14001:2015. Necesito saber cual es la documentación total que necesito por favor
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