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  • Sistema de gestión

    Primeramente debe contar con el apoyo de la dirección de la organización, que será clave durante el proceso de implementación de ISO 9001:2015, también para proporcionar los recursos necesarios.

    Más tarde le recomiendo llevar a cabo  un análisis GAP o de brecha, que le va a ayudar a identificar aquellos requisitos que ya cumple y los que le debe aún cumplir. Aquí puede llevar a cabo el análisis de forma gratuita: https://advisera.com/9001academy/iso-9001-gap-analysis-tool/

    Es muy importante que usted conozca cada una de las cláusulas para poder llevar a cabo el proyecto de implementación de ISO 9001, y para dar respuesta a esos requisitos con los que su organización debe cumplir . En este white paper puede encontrar información resumida sobre cada una de ellas - Clause by clause explanation of ISO 9001: https://info.advisera.com/9001academy/free-download/clause-by-clause-explanation-of-iso-90012015

    Más adelante, puede escribir un plan de proyecto en el que de signa responsabilidades, define la documentación que va a escribirse, los plazos etc. En este enlace puede descargarse una plantilla - Plan de Proyecto para la implementación de ISO 9001:https://info.advisera.com/9001academy/es/descarga-gratuita/plan-de-proyecto-para-la-implementacion-de-iso-9001-ms-word

    Luego ya podría empezar con la implementación de la norma: la definición de la política de calidad, los objetivos de calidad y planes para llevarlos a cabo, el contexto de la organización y sus partes interesadas, el alcance del SGC, etc...hasta llegar a la auditoría interna y la revisión por la dirección, que sería el paso previo para certificarse. En este enlace puede descargarse un checklist para la implementación de la norma - Projectect checklist for ISO 9001:2015: https://info.advisera.com/9001academy/free-download/project-checklist-for-iso-9001-2015-implementation

    Estos materiales pueden ayudarle con la implementación de ISO 9001:2015:
    - Libro – Discover ISO 9001:2015 through practical examples: https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
    - Formación gratuita en línea – Fundamentos de ISO 9001:2015 : https://advisera.com/es/formacion/curso-fundamentos-iso-9001/

  • Free Calculator - Duration of ISO 27001/ISO 22301 Implementation

    1. A quick question on your calculator..
    Q. Number of physical locations.. We have 5 employees who all work remotely. We don't have a physical office. So is this 5 physical locations?

    For certification purposes, you need to consider at least one of your remote places as the organizations' Head Quarters (e.g., the CEO place), and the others can be considered out of the scope and treated as remote locations. Considering that, you can inform a single location in the calculator.

    2. another question on the calculator. One of the question asks, will a project manager be assigned (or something along those lines), I ticked 'yes' as I am assigned as PM and I am a Prince2 practitioner. Does this assume a full time employee? I am part time, therefore I wonder if the calculation would be longer if it took that into account?

    The calculator considers an effort of one day per week (or 8h per week) for the person in the role of project manager

    Other people that will need to be involved:

    • Sponsor of the project (e.g. the CEO) - ca 4 hours per month - for approving main documents and resolving conflicts
    • Head of IT department - ca 2 man/days per month - for reviewing the documents and coordinating the IT side of the implementation
    • Heads of the departments - ca 5 man/days during the whole implementation - for participating in the risk assessment, reviewing the documents and coordinating the implementation in their departments

  • ISO 17025 : 2017 transition stage

    If you are referring to the changes the laboratory need to make or has made to transition from ISO 17025:2005 to ISO 17025:2017; yes the laboratory should perform a gap assessment, look at the risks of not meeting the requirements, decide on what is required and record actions /changes to take place. The accreditation body would have a guideline and perhaps even a transition checklist for the laboratory to use. This may be requested of you before the assessment. Remember however that in terms of accreditation, transitional changes are requirements, not merely improvements.

    I recommend you contact your accreditation body for more information on specific transitional guidelines or requirements

    The following article may be of assistance:  ISO/IEC 17025:2005 vs. ISO/IEC 17025:2017 revision: What has changed? At https://advisera.com/17025academy/blog/2019/11/13/iso-17025-2017-vs-iso-17025-2005-key-changes-infographic/. You can also download the free whitepaper Checklist of mandatory documents required by ISO 17025:2017 at https://info.advisera.com/17025academy/free-download/checklist-of-mandatory-documents-required-by-iso-17025.

    The folloing ISO 17025 toolkit preview may also be of value - Addressing Risks and Opportunities Procedure at https://advisera.com/17025academy/documentation/addressing-risks-and-opportunities-procedure/

  • Application of ISO 22301 certification

    ISO management standards cannot be applied to products, only to the process that supports them (in case of ISO 22301, the continuity of the processes that are involved in the delivery of the product).

    For further information, see:

  • Scope clause

    ISO 9001:2015 clause 4.3 is about the scope of the quality management system (QMS). Once determined the scope an organization may find that some clauses may be not applicable. For example, an organization may have two kinds of business:

    1. Manufacturing products that are sold to consumers through stores
    2. Manufacturing products according to client’s instructions and with client’s materials

    If the QMS scope is only about business 1, then clause 8.5.3 is not applicable. Please check ISO 9001:2015 Annex A.5 about applicability

    The following material will provide you more information about scope and exclusions:

  • ISO 9001 Course

    Please check this article - How to choose the most appropriate training - https://advisera.com/training/compare/ - where you can find this table:

    https://advisera.com/wp-content/uploads/2023/04/advisera-how-to-choose-apropriate-training-page-img.svg

    Where the first column sets the circumstances in which each course will most applicable. For example, the ISO 9001:2015 Foundations Course can be useful to help you implement a quality management system in your school.

    You can find detailed information about how to plan and implement a quality management system in the following links:

  • Surveillance audit

    Certification contracts are valid for three years. After the certification audits, there are yearly surveillance audits.

    Surveillance audits are mostly about checking if your management system is working as designed. So, pay special attention to your records. Are all the incidents being recorded? Measurements, complaints, corrective actions, non-conformities, internal audits, and management review, etc. Remember, if your organization had any minor non-conformity or observations during the certification audit, be sure that auditors will look into those issues with special care to confirm that actions were taken and close those nonconformities.

    Surveillance audits will take less time to perform than the original certification audit. Auditors are not so much concerned with the quality management system design, but with its maintenance. I cannot tell you what auditors will ask but I can assure you that they will start each time by looking at your key activities (such as management review, internal audit, corrective actions and complains treatment), and will then only look at some of the remaining parts within your management system.

    You can find more information below:

  • Inability of reaching the work place due to lockdown

    A laboratory needs to address the risk of the event you describe. To answer your question, I would like to pose a few more questions - what does the signature of an authorised signatory on a report mean? What are they acknowledging or committing to, with their signature? Is it a solution for the laboratory to send the signatory the reports (hardcopy or electronic) for signature, away from the laboratory ?

    How this situation is handled depends on a number of factors. You need to look at the consequence and implication of deviating; and see if a temporary or alternative arrangement can be made.  Firstly consider context depending on the sector. It will depend on the purpose  - the need of the customer (what the results are being used for) Consider if there are legislative requirements to be met for releasing of results? Can an interim result be released under the circumstances, if deemed suitable and this is included in a signed agreement ? Note that looking at the reporting step, the standard accommodates an agreement with the customer to report results in a simplified way. This does not however address the authorisation to release results.

    Secondly consider issues in terms of accreditation, i.e. claiming technical competency for the result released on a report with the accreditation mark. One must also consider that the authorised signatory (or technical signatory) is a role with associated responsibilities required by the accreditation body for testing and calibration laboratories. The accreditation body requirements must be met. What ISO 17025 requires is that the laboratory has competent, authorised personnel, that the validity of results is ensured and that results are reviewed and authorised before released. The standard does not prescribe how the laboratory must achieve this, for example for an authorised signatory to wet sign a report. Whoever performs this role is signing that they are confident that the results are valid, that the management system is in control, with all the process, controls and checks in place. To do this they need access to all the necessary information and data for the result as a well as quality control and monitoring data for internal and external quality evaluation, in order to release results. If pandemic restrictions means that the signatory is not physically in the laboratory, they may be able to sign offsite, as long as they acknowledge the responsibility, are aware of the risks and meet the extra or temporary controls in place.  This could include having and recording discussion with personnel who performed the actual tests, prior to release.  Another control could be for the authorised signatory to perform some verification checks on return to the laboratory.

     

    For further information on Ensuring the Validity of results, and reporting requirements, have a look at the ISO 17025 toolkit preview of the Quality Assurance Procedure at https://advisera.com/17025academy/documentation/quality-assurance-procedure/ and the Testing Report Procedure at https://advisera.com/17025academy/documentation/testing-report-procedure/

  • Data Protection Matrix

    You need to make an inventory of data processing, for each process you need to identify the lawful basis for data processing, the information given to the data subject, the risk for freedom and rights of the data subject, the security measure taken, and the data retention period.

    You can use our Data Mapping and DPIA Toolkit: https://advisera.com/eugdpracademy/eu-gdpr-data-mapping-dpia-toolkit/

    You can consider enrolling in our free EU GDPR Foundations Course

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