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  • ISO and six sigma improvement of the service quality of logistics

    With ISO 9001 an organization implements a set of practices, written or not, they represent a standard way of doing things internally. The same ISO 9001 requires determining indicators to monitor and measure performance.

    So, your organization must have some indicators about logistics performance. When your organization decides to improve performance, it may use six sigma as a methodology for improvement.

    You can find more information below:

  • Equipment qualification

    Yes, it is a different approach for the same purpose. Typically the Design and Installation Qualification (DO and IQ) activities are performed by the supplier on commissioning, with some input by the laboratory to run certain samples and develop a method. In a 17025 those first steps need to cover clause 6.4 for equipment, as well as 6.5, Metrological traceability of results. That means making sure the equipment is selected and can perform as expected and there is a way through calibrations, to provide an unbroken link for measurements, to SI units (international references).

    You are correct,

    Yes, it is a different approach for the same purpose. Typically the Design and Installation Qualification (DO and IQ) activities are performed by the supplier on commissioning, with some input by the laboratory to run certain samples and develop a method. In a 17025 those first steps need to cover clause 6.4 for equipment, as well as 6.5, Metrological traceability of results. That means making sure the equipment is selected and can perform as expected and there is a way through calibrations, to provide an unbroken link for measurements, to SI units (international reference).

    You are correct, in an average 17025 laboratory, the Operational Qualification and Performance Qualification is the same as method validation and measurement uncertainty evaluation (clause 7.2 and 7.6) and ongoing assurance, i.e. ensuring the validity of results through the use of controls and reference standards (clause 7.7).

    Certain equipment must be calibrated, and the measurement uncertainty calculated, i.e. when it is used to establish the metrological traceability and if the validity of the reported results would be affected by the measurement accuracy and uncertainty of the equipment. Remember this does not only apply to apparatus, but also to standard reference materials or objects. This is where a laboratory will use an accredited calibration laboratory or a reputable supplier of certified reference materials. Once you have such material and a certificate of analysis, and you have evaluated the performance of your method, you can perform intermediate checks using your inhouse reference material, as long as it is well characterised (have lots of data) against the certified material (CRM) traceable to an International standards. For certain sectors, e.g pharmaceutical, a CRM has to be analysed for each analysis batch to verify, for example the performance of an HPLC or GC. The risk must be managed by the laboratory, based on the type of test and the regulatory nature of the sector.

    For more information, have a look at

    Also refer to  ILAC P10:07/2020 ILAC Policy on Metrological Traceability of Measurement Results and ILAC G24:2007 Guidelines for the determination of calibration intervals of measuring instruments, available from https://ilac.org/publications-and-resources/

  • A.6.1.5 Information security in project management

    The need to consider Information security in project management separately will depend on the results of risk assessment and applicable legal requirements (e.g., laws, regulations, and contracts).
     
    For example, some projects may require the implementation of technologies not used in your organization at large, so it would not make sense to write a corporate policy. Other projects, by force of contracts, may require that all information security is under project context. In case these situations do not occur, then you can make projects refer to the corporate documents  

    For additional information, see:

  • Applying and monitoring quality management regulations

    You must start by determining what are the relevant regulations. Access them to translate them into requirements.

    You must set a frequency to monitor if any new regulations appear and if the older ones become outdated.

     

    You can find more information below:

  • Excluding clause 8.3

    You cannot exclude a clause. You can only consider a clause as non-applicable.

    Sometimes, for an organization, a clause may be applicable or not just because of the scope of the quality management system.

    So, the answer will depend on the scope. However, it seems odd to exclude the development of the software.

     

    The following material will provide you more information about non-applicability of a clause:

  • Question about ISO 27001 and ISO 27017

    Please note that ISO 27017 is a supporting standard, providing guidance and recommendations for the implementation of cloud-related controls, and it does not have the requirements for a management system.
     
    Considering that, if you are considering implementing an Information Security Management System, then you need ISO 27001 (it is enough to cover cloud security requirements, and you will only need ISO 27017 if you have specific legal requirements demanding the use of ISO 27017).
     
    Now, if you are considering only adopting specific cloud-related controls, without using the support of a management system, then you can use only ISO 27017.  

    These articles will provide you a further explanation about ISO 27001 and ISO 27017:

  • Análisis de riesgos para el Sistema de Gestión Ambiental

    Para llevar a cabo el análisis de los riesgos y oportunidades primero debemos identificar los riesgos asociados al contexto de la organización y las partes interesadas que afecten al negocio ( por ejemplo, tendencias en la tecnología, o emisiones de la industria a la atmósfera), a los aspectos ambientales de los procesos de la organización, y a las distintas fases del ciclo de vida de los productos y servicios ofrecidos por la organización.

    La norma ISO 14001 no establece una gestión formal de los riesgos por lo que la organización deberá seleccionar el método, según sus características, situación, dimensiones, contexto, etc. pudiendo consistir en un simple proceso cualitativo o en una evaluación cuantitativa completa. Puede seleccionar una serie de criterios como la frecuencia, escala de impacto, etc. Una vez a cada riesgo se le asigne un valor puede establecer aquellos riesgos más significativos con los cuales tendrá que adoptar las acciones correspondientes.

    Para más información sobre el análisis de riesgos en ISO 14001, vea los siguientes materiales:

    - Gestión de riesgos en ISO 14001:2015: qué, por qué y cómo: https://advisera.com/14001academy/es/knowledgebase/gestion-de-riesgos-en-iso-140012015-que-por-que-y-como/

    - Webinar gratuito - ISO 14001: identificación y evaluación de los aspectos ambientales: https://advisera.com/14001academy/es/webinar/iso-14001-identification-and-evaluation-of-environmental-aspects-free-webinar-on-demand/

    - Curso gratuito en línea - Fundamentos de ISO 14001:2015: https://advisera.com/training/es/course/curso-fundamentos-iso-14001/

    -  Libro – The ISO 14001:2015 Companion - https://advisera.com/books/the-iso-14001-2015-companion/
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