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  • ISO 9001 & Hazard Analysis

    Can you let me know where exactly in the ISO 9001 2015 update there is a specific reference to the need for Hazard Analysis, please?
  • Nonconformity question

    During an internal process audit, I found a UV-VIS  spectrometer was found to be past due for calibration in the production area,. When questioned, the department manager said that the equipment was out of order; but there is no warning sign indicating that. As such, I was wondering if this could be recorded as a nonconformity (M/m) or an observation.
  • SOP in ISO 9001

    Imagine a financial department manager decides to write an SOP...Should this SOP get a QA code? Or a leave sheet belongs to QMS and should get QA code?
  • ISO 9001:2015 and Six Sigma

    How to apply ISO 9001:2015 and Six Sigma for a quality management system in the construction or manufacturing industry?
  • Ensuring Quality Objectives

    What suggestions can you make to ensure quality objectives can be met in the report?
  • Lista de proveedores aprobados

    Tengo una pregunta sobre los Proveedores. De acuerdo con ISO9001 se debe tener una lista de proveedores aprobados, en esta lista solo deben de estar los proveedores de materias primas, es decir, solo aquellos proveedores que surtan de productos o servicios relacionados con la manufactura directa de mi Producto Final. Por ejemplo, me dedico a manufacturar productos metálicos, en mi lista no debe aparecer mi proveedor de papelería o agua potable, pero si deben aparecer mis proveedores de metales, tornillería, remaches, cables, tratamientos térmicos, Laboratorios de pruebas, etc. que son parte del ensamble y manufactura de mi producto. Me pueden confirmar si mi interpretación del requerimiento es correcta, por favor.
  • Amend Record Keeping from home

    In need to find out how to amend my record keeping during lockdown and i am working from home.
  • Can Agile and ISO9001 work together?

    I was wondering if agile and ISO 9001 can work together, especially regarding document control? I had a discussion with company GM about Document Contorl which raised this question. I am in the process of design and implementation of ISO 9001:2015, currently my focus is Document Control. I suggested my manager that we need to have document approval and version check for documents which are within the scope of QMS. She challenged that and said this can be agaist of Agile ( as we have some document and procedure (like recruitment procedure) and some other documents on Microsoft Teams. As you know on Teams there is no document control and version check. Again asking my question, I want to know for example, is it neccessary to have a strict Document control (version check - approval) over the documents which are not directly related to products such as our Recruitment Procedure or recruitment policies? Thanks
  • IMS Integration

    Please explain to me how to confirm that the IMS is effectively integrated (is linked to the point  PAS 99 Integrated Management)?
  • QMS, Quality Manual, Quality Procedures and Quality Management Plan

    What's the difference between QMS, Quality Manual, Quality Procedures and Quality Management Plan? When do all these need to be developed? Does an ISO certified, IMS implemented organization, working as a design, construction supervision, O&M and facility management company requires to develop QMP when it already has all IMS documents?
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