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  • Objective for certification the university

     If I understood correctly, you want examples of objectives related to ISO 22301 certification.

    Considering that, the most common benefits for organizations which seeks certification against ISO management standards are:

    • Enhanced competitive edge
    • Reduction on losses due to security incidents
    • Reduction on fines due to legal or contractual non-conformity
    • Improvement of internal organization

    To be more specific, it would be necessary to know the university context (e.g., main courses, students profile, location, etc.).

    These articles will provide you further explanation about ISO 27001 benefits (the same concept applies to ISO 22301):

  • Calculating uncertainty

    You asked

    Please help me in calculating uncertainty 

    Advisera’s ISO 17025 toolkit guides you through the implementation of ISO 17025. The  ISO 17025 document template: Evaluation of Measurement Uncertainty Procedure and related Measurement Uncertainty Checklist and Measurement Uncertainty Record are available as part of the ISO 17025 toolkit; or as separate documents; to guide you in the process.

    See the following expert advice answer on the topic, with links to available toolkits documents: https://community.advisera.com/topic/meas-of-uncert-budget-pipette/

    You also asked

    how can use uncertainty to evaluate the competence of the operators and also that the method is fit for purpose 

    A complete discussion of measurement uncertainty is outside of the scope of the toolkit. Measurement uncertainty is a statistical measure, offering a range within which there is an equal probability of the result value lying, at a particular confidence. This uncertainty estimate is a combination of all factors that affect the variability of results, on method basis; so cannot be used directly to evaluate the competence of personnel performing the method. One way of evaluating the competence of the operators, is to analyse the variation of groups of results during or after validation.

    To state that a method is fit for its intended purpose, means providing evidence that the method is sufficiently reliable, so that the method can be used with confidence for a client to make a decision; based on results provided. The performance of a method must be evaluated through validation, along with an evaluation of measurement uncertainty. Uncertainty of measurement comprises many components, over a period of time for methods that have many variables. Depending on the purpose of the method a suitably small uncertainty may have to be achieved for a method to be fit for purpose. Look to regulatory or sector guidelines on acceptable or target uncertainties.

    The ISO 170252 toolkit and available toolkit documents are available for preview or purchase at https://advisera.com/17025academy/iso-17025-documentation-toolkit/

  • ISO certification

    Here are the four essential steps to becoming an ISO-certified business.

    1-evelop your management system. Identify your core or business processes. ...2-Implement your system. Ensure procedures are being performed as they are described in your documentation. ...3-Verify that your system is effective. ...4-Register your system.

  • ISO 13485 implementation

    It is best to make a GAP analysis between your current Quality Pharmaceutical System and requirements from ISO 13485:2016. 

    For that step, the following documents can be helpful:

  • Checklist of Mandatory Documentation Required by ISO 13485:2016 https://info.advisera.com/13485academy/free-download/checklist-of-mandatory-documentation-required-by-iso-134852016

  • Clause-by-clause explanation of ISO 13485:2016 https://info.advisera.com/13485academy/free-download/clause-by-clause-explanation-of-iso-13485

  • Diagram of ISO 13485:2016 Implementation Process https://info.advisera.com/13485academy/free-download/diagram-of-iso-134852016-implementation-process

  • Project Checklist for ISO 13485:2016 Implementation https://info.advisera.com/13485academy/free-download/project-checklist-for-iso-13485-2016-implementation

    • You can schedule a free 30-minute consultation with our ISO 13485 expert who can provide you with more information on how to proceed: https://advisera.com/13485academy/free-consultation/

  • Manufacture of Hospital Beds

    Harmonized standards that can be applicable to medical devices are listed on the following link: https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices

    In that list there is one standard applicable for hospital beds: EN 60601-2-52:2010 - Medical electrical equipment — Part 2-52: Particular requirements for basic safety and essential performance of medical beds.

  • Medical device Auditor

    Medical device auditor first need to know what is auditing process and practice. Usually, this kind of knowledge gets through the education for Lead auditor for ISO 9001 and/or ISO 13485. 

    Then, medical device auditors need to have a background in manufacturing and/or designing certain types of medical devices. This is proved by CV and expert knowledge. Each medical device auditor is specified for certain types of medical devices, there is no any auditor that audits all types of medical devices. 

    Medical devices are divided into codes.

    A list of codes for the EU market that are under Medical device regulation MDR 2017/745 can be found on the following link: https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en, look for the document MDCG 2019-14 Explanatory note on MDR codes.

    For USA market, codes for medical devices can be found on the following link: https://www.fda.gov/medical-devices/classify-your-medical-device/product-code-classification-database

    Information about ISO 9001:2015 Lead Auditor Training Course you can find on following link https://advisera.com/training/iso-9001-lead-auditor-course/

  • ISO/IEC 17025:2017 & ISO/IEC 17020:2012 certification

    What dictates the accreditation cycle?

    It is ISO/IEC 17011 Conformity assessment — Requirements for accreditation bodies accrediting conformity assessment bodies that specifies the restriction and criteria for an accreditation body to determine the length of the accreditation cycle. Accreditation bodies must comply with ISO/IEC 17011:2017 and establish separate accreditation schemes (containing rules and processes) within their scope. For example an ISO 17025 scheme and an ISO 17020 scheme. Each scheme has an accreditation cycle which begins at the point of achieving initial accreditation or decision after full reassessment and continues for no more than five years. The criteria is that it must be of a suitable length so that the assessment program can cover sufficient assessments of relevant locations and activities, representative of the scope of accreditation. Typically this cycle is four years or five years for ISO 17025.

    What, if any, requirements are dictated by ILAC?

    ILAC’s role is to not to dictate or regulate but to develop and harmonize the accreditation practices of member accreditation bodies. They produce policy documents and guidelines which provide criteria or interpretation of accreditation criteria, applicable during assessment. For example with reference to the requirements for an assessment of an internal audit program., in ILAC G28:07/2018 Guideline for the Formulation of Scopes of Accreditation for Inspection Bodies (ISO 17020) ILAC state “The inspection body shall ensure that all requirements of ISO 17020 are covered by the internal audit program within the accreditation re-assessment cycle”.

  • Aspects vs hazards

    "ISO 14001:2015 does not define “hazard”. It only mentions “the nature of onsite hazards (e.g. flammable liquids, storage tanks, compressed gasses)”.


    Any organization interacts with the environment. Environmental aspects are the elements of an organization’s activities or products or services that interact or can interact with the environment. Those interactions may take place under normal situations, during startup or stoppage, or during abnormal or emergency situations. Environmental aspects during abnormal or emergency situations may generate particularly significant environmental impacts, environmental consequences. The word hazards are used when significant environmental impacts, significant environmental consequences are a possible outcome.

    You can find more information about the aspects and hazards below:

     

  • Identifying scope and risks

    1.is it mandatory that i should use techniques like SWOT, PESTLE for identifying internal and external issues

    Answer:

    No, SWOT or PESTLE are not mandatory techniques for identifying internal and external issues. They can be useful, but not mandatory.

    2.In Most of the sample QMS Manual i have seen is same that is replica the doubt which i have is ,is it ok if we define the scope by our own?

    Answer:

    Yes, each organization should define its own management system scope

    3.Quality Management System (QMS) Scope of our company defines standardization of processes, QMS equips project team with documented approach that helps in maintaining the quality of work, reduction of rework and cost-effective project execution. This is what I prefer to define for my company/and is it ok?

    Answer:

    I think that it has to be improved. Organizations shall define, document and make available the scope of the QMS, referring to the Products and Services that are provided and identifying the limits of the management system. The scope should clearly describe the type of Products and Services covered by the system and provide sufficient information, preventing the transmission of erroneous or misleading information about what the organization covers in the quality management system and what it is able to provide to its customers. It must be available because it is through the scope that the organization communicates to the relevant interested parties, namely customers and potential customers, the Products and Services it makes available.    

    The following material will provide you information about the scope of a quality management system:

  • Tiempo de implementación

    Para una empresa de 200 empleados, con los recursos apropiados podría tardarse alrededor de 1 año. No obstante, la duración de la implementación de la norma va a depender de varios elementos como:

    - los recursos asignados a la implementación de la norma, tanto en términos económicos como de personal

    - la complejidad del producto o servicio a certificar, o de los procesos dentro de la organización

    - la cantidad de información documentada existente, como procedimientos, instrucciones de trabajo, etc. 

    - el número de localizaciones que tenga la empresa

    - el conocimiento sobre la norma

    Puede calcular el tiempo aproximado que le llevaría implantar la norma aquí - 9001 Implementation Duration Calculator: https://advisera.com/9001academy/iso-9001-duration-calculator/

    También le recomiendo que haga una evaluación de los requisitos con los que necesita cumplir la organización mediante un análisis GAP o de Brecha. Puede utilizar la siguiente herramienta de forma gratuita en nuestra web - Análisis de breha ISO 9001: https://advisera.com/9001academy/es/herramienta-analisis-de-brecha-iso-9001/

    Además estos materiales pueden ayudarle a calcular el tiempo que tardará en implementar la norma en su organización: 

    - Curso gratuito - Fundamentos ISO 9001:2015: https://advisera.com/es/formacion/curso-fundamentos-iso-9001/

    - Libro - Discover ISO 9001:2015 through practical examples: https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/

     
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