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  • Internal audits scope

    "Are internal audits required on all manufacturing processes prior to the Readiness Review, or on all QMS processes, or both?”
  • Outsourced activities in ISO 9001

    I have a querry. A small Construction Company having about 20 employees.
    Entire Desgin Development and HR activities are outsourced. Now this Company proposes to go in for ISO 9001: 2015 version Certification.
    Can the Architect and HR Consultant from whom services are taken be involved for facing ISO Certification Registration checking/audit?
    Please Revert.
  • Risks and opportunties in ISO 9001

    I purchased the Risks and Opportunities procedure and registry from you on Friday, May 18th. I’m a bit confused on who should be in charge of this procedure. Should it be the President of the company or the Quality Manager?? Also, I’m a little confused about the registry. Can’t I just use the FMEA for parts that we produce for our customers? I have to do FMEA’s for all my parts anyways, wouldn’t this be acceptable for my certification audit ? (which is Thursday and Friday of this week).
  • Quality manual and interested parties

    "I have a few questions I'd like to ask regarding the new ISO 9001:2015 standard. The first, is it required to list out the interested parties within the Quality Manual? The second, is the safety manual required to be a quality document?”
  • Management representative and ISO 9001:2015

    "Is it not necessary to appoint MR for our organisation? Then who is dedicated to maintaining the QMS, please clarify. Further is it necessary to give MR a Job Description for her/his works and letter for the same position according to QMS?”
  • Stakeholders and risk assessment

    "How to make stakeholders risk assessment in ISO 9001:2015? I need an example”
  • Contracting and ISO

    "Our company is working to ISO 9001:2015, now at Stage 2. The auditor has asked us if we are a contractor? We have our own Company Name (Financial Entity) but our Employment Contracts, Pension and Payroll are paid by another company, the link being, we have the same chairman. However, HR functions Induction, Training, Holiday and Sick records, etc are carried out and managed within our company. We are not a subsidiary. Do we class ourselves, "Contractors" - Would this then be detrimental to us gaining our own ISO certification? Please could this be clarified?
  • QMS and improving performance

    "I would like to seek information on how QMS can do improvement in company, something like improvement in QMS Perspective. Please advise me on this issue.”
  • Gestión del Riesgo y Continuidad de Negocio

    Mi pregunta en especifico es si con base en la Gestión del Riesgo dentro del ámbito de la ISO 9001:2015, es exigible presentar un documento sobre la "Continuidad de Negocio", por parte de los organismos certificadores?
  • Control y codificación de documentos

    La información no obligatoria por la norma como por ejemplo los análisis foda, ¿se pueden mostrar en la auditoría de transición sin código y sin control documental? Digamos ¿como parte de una serie de minutas en donde se ha tratado el tema?