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  • ISO 13485 queries

    Among the questions I have during the implementation of the QMS there are the following: The change control procedure does not seem to take in consideration the NBOG guidance or MDCG-13 or to advise the registrar.

    In our toolkit we do not have a change control procedure, since in the ISO 13485:2016 standard there is no requirement for the register. Change control is covered in the Management review procedure and covers all requirements from the ISO 13485:2016, point 4.1.4.

    We considered that changes in the documentation would be initiated by the person listed as the document owner. All updates and reviews must be performed in line with the frequency defined in the List of Internal Documents. All changes to the document must be made by using "Track Changes," making visible only the revisions to the previous version, and must be briefly described in the "Change History" table; if the Track changes option is unavailable, or if the changes are too numerous, then the Track changes option is not used.

    Furthermore, each document should preferably have a "Change History" table used to record every change made to the document.

    For more information about common mistakes with ISO 13485:2016 documentation control and how to avoid them, please see the following article:

    • Is there a tri-party quality agreement between sterilizer/contract manufacturer/ legal manufacturer?

    We have a Quality agreement for the subcontractor (10.7_Appendix_7_Quality agreement subcontractor). It is general, so you can specify it for your outsourced processes.

    Records retention seems always be for 2 or 5 years. I couldn’t see anything for 10 years per MDR.

    Thank you for pointing this out to us. We will correct it.

    Statistical procedure seems to be missing.

    There is no strict requirement in the ISO 13485:2016 for the documented statistical procedures. We have partially covered it in the 20_Procedure_for_Data_Analysis_Premium_EN.

  • Le domaine d'application

    Si le manuel qualité est un document faisant partie du système de management de la qualité et, si le manuel qualité inclut déjà le domaine d'application du système, aucun autre document n'est nécessaire pour le formaliser. Dans ce cas, il est important que le manuel qualité soit approuvé par le top management ou par une personne à qui le top management a conféré cette autorité.

    Les ressources suivantes peuvent fournir plus d'informations:

  • Satisfaire a un audit ISO 9001

    Un audit a un domaine d'application, des critères et un objectif. Ainsi, un audité, pour se préparer à un audit, doit vérifier si, dans le domaine d'application de l'audit, les critères sont remplis ou non: dans quelle mesure les procédures et instructions sont suivies, dans quelle mesure les enregistrements sont généré et archivé, dans quelle mesure les performances sont conformes aux specifications, la mesure dans laquelle les installations sont correctement entretenues.

    Toute situation qui ne répond pas aux critères doit être corrigée afin qu'elle soit conforme lors de l'audit. Il sera également important de préparer les audités à l'audit en se rappelant le type de questions qui peuvent être posées et de la manière dont on peut y répondre.

    Les ressources suivantes peuvent fournir plus d'informations:

  • Estudios de riesgo

    Los riesgos existen en cualquier tipo de negocio, independientemente del sector de la actividad o de su tamaño, por ello un análisis de los riesgos de una organización es crucial para su  funcionamiento. La correcta gestión del riesgo, implica que sus consecuencias sean mitigadas y  no sean tan adversas en caso de no haberse gestionado.

    ISO 9001 2015 incorpora como requisito la gestión de riesgos a través de su enfoque o pensamiento basado en riesgos, donde dla organización necesita tener en cuenta todos los riesgos para poder alcanzar los objetivos de calidad establecidos.

    Con la gestión de los riesgos obtenemos numerosos beneficios, entre ellos preveer de forma sistemática los posibles problemas que pueden existir en la organización. Una vez identtificamos los riesgos podremos determinar cómo hacer frente a sus impactos, ya sea mitigándolos o eliminándolos mediante diferentes acciones. 

    Otros beneficios que encontramos a ráiz de la gestión del riesgo, son:  aumento de la probabilidad de conseguir los objetivos de calidad, comportamiento proactivo de la organización y su dirección, incremento de la satisfacción del cliente, aumento de la eficiencia y eficacia de las operaciones, cumplimiento de la legislación, fomento de la prevención y gestión de posibles accidentes, uso eficiente de los recursos, etc. 

    Para más información sobre la importancia de los estudios de riesgo vea los siguientes materiales:

    - How to identify risk controls in ISO 9001:2015: https://advisera.com/9001academy/blog/2019/01/21/how-to-identify-risk-controls-in-iso-90012015/

    - How to address risks and opportunities in ISO 9001: https://advisera.com/9001academy/blog/2016/06/21/how-to-address-risks-and-opportunities-in-iso-9001/

    - 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/

  • La importancia de la norma ISO 9001

    La importancia de implementar la norma ISO 9001:2015 reside en los beneficios que tendrá en la organziación. Algunos de estos beneficios incluyen:

    - La mejora de su credibilidad e imagen

    - El incremento de la satisfacción del cliente

    - Una mejora en la integración de procesos a través del enfoque de procesos de ISO 9001, que implica mejoras en eficiencia y ahorro de costes. 

    - Mejora en la toma de decisiones bassada en evidencias objetivas

    - Creación de una cultura de mejora continua

    - Empleados más involucrados en la mejora de los procesos

    Así mismo, muchos concursos promovidos por los gobiernos de distintos países exigen el implantar la norma ISO 9001:2015 para acceder a contratos o fondos, o inclusive si su organziación se trata de un proveedor de empresas que ya cuentan con la norma, puede que se le exija un certificado en ISO 9001 para poder entrar a formar parte de los proveedores.

    Para más información sobre la importancia de ISO 9001:2015, vea los siguientes materiales: 

    - Seis beneficios clave de dla implementación de ISO 9001: https://advisera.com/9001academy/pt-br/kit-de-documentacao-da-iso-9001/nowledgebase/seis-beneficios-clave-de-la-implementacion-de-iso-9001/

    - 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/

  • Assets and Risks

    Please note that the approach you are using is not common (the common practice is the asset-threat-vulnerability approach, not using only asset and threat combination). The problem with your approach is that by not considering potential vulnerabilities related to the asset you can have a misunderstanding about the risk. For example, if for a certain asset the vulnerabilities aren't easy to be exploited by threats the risk will be lower.
     
    Considering that, during risk assessment, you do not need to use data classification type, only information assets (e.g., reports, databases, contracts, etc.)
     
    Regarding the number of risks, a good approach is for each asset to identify 2 or 3 threats and for each threat 2 or 3 vulnerabilities. For 50 assets this will result in a number of risks between 200 and 450 risks.
     
    This article will provide you a further explanation about risk assessment:  

  • Defining quality objectives

    Quality objectives are overall goals or targets stated by the organization in order to achieve improvement within the QMS. Quality objectives have a strategic role in carrying out the quality policy and its implementation through a quality management system and provide a means to assess whether the QMS achieves its goals.  Therefore, it is not necessary to define quality objectives each year, this really depends on the mission, a vision and strategy of your company.

    However, please differentiate a quality objectives from regular business objectives. Business objectives you can define each year, they can be depatment-specific, anything that you need fulfill you business golas.

    Standard quality objectives can be: meeting customer and regulatory requirements, achieving the improvement of the QMS and its products, and enhancing customer satisfaction. 

    In these articles, you have more information about setting good quality objectives:

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