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ISO 9001 Pregunta

A las auditorias de primera parte también se les llama comúnmente auditorías internas. Para ser auditor interno debe de contar con los conocimientos necesarios para poder auditar todos los requisitos de la norma, y para ello es recomendable contar con un certificado que lo acredite. Puede ver nuestro curso gratuito en línea de auditor interno - Cursi de auditor interno ISO 9001:2015: https://advisera.com/es/formacion/curso-auditor-interno-iso-9001/

Las auditorias de segunda y tercera parte son las denominas auditorías externas. En el caso de las auditorías de segunda parte se desarrollan por el interés de una organización hacia un tercero, normalmente son las realizadas a los proveedores, subcontratistas y franquiciados. Mientras que las auditorias de tercera parte sonl levadas a cabopor organizaciones auditoras independientes y externas a la organización, que proporcionan la certificación de que el sistema cumple con la norma estándar de referencia. 

En el caso de las auditorías externas debe de contar con un certificado que acredite su formación como auditor externo, y además contar con la experiencia necesaria en el área de auditoría. Es decir, en el caso de las auditorias de tercera parte llevadas a cabo por un organismo de certificación debe de contar no sólo con el certificado sino con una experiencia de al menos 2 años con el sistemas de gestión que vaya a auditar. 

En este enlace puede acceder a nuestro curso de auditor líder en ISO 9001:2015 - ISO 9001 lead auditor course: https://advisera.com/training/iso-9001-lead-auditor-course/

Estos materiales pueden ayudarle para saber cómo llegar a ser auditor: 

- How to become an ISO 9001 lead auditor: https://advisera.com/9001academy/blog/2020/04/10/how-to-become-an-iso-9001-lead-auditor/

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

ISO 9001 Managing Knowledge

Hi, Dear Iciar, many thanks for your very good site and relevant guides.
I am the QA/QC manager of a big dairy producing company in Iran and we have implemented QMS for more than 14 years.
How can I manage the knowledge in our organization?
Could you please send me some examples?

ISO 9001 Pregunta

Debe primeramente identificar los riesgos y luego evaluar su importancia para saber si deben tomarse acciones o no para mitigar dichos riesgos. La norma no especifica ninguna metodología para llevar a cabo tal evaluación, luego corresponde a la organización decidir cómo hacerlo. Puede emplear un método cuantitativo basado en determinados criterios para evaluar el riesgo, por ejemplo, la probabilidad de ocurrencia y el impacto del riesgo en la empresa, pudiendo entonces clasificar los riegos en bajo/medio/alto nivel de importancia o significancia.

Para más información sobre riesgos en ISO 9001:2015, vea los siguientes materiales:

- How to identify risk significance in ISO 9001:2015: https://advisera.com/9001academy/blog/2019/01/14/how-to-identify-risk-significance-in-iso-90012015/

- 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/

- Webinar gratuito - Cómo implementar la gestión de riesgos en ISO 9001:2015:  https://advisera.com/9001academy/es/webinar/how-to-implement-risk-management-in-iso-90012015-free-webinar/

- Curso gratuito en línea - Fundamentos de la norma ISo 9001:2015:  https://advisera.com/es/formacion/curso-fundamentos-iso-9001/

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

ISO 9001 Pregunta

La frecuencia para la evaluación de los proveedores debe ser determinada por las necesidades de la organización, ya que la norma no establece ningún método específco. 

La norma ISO 9001:2015 requiere que evaluemos a los proveedores que inciden directamente en la calidad de nuestro producto o servicio. Por ello es crucial llevar a cabo una evaluación inicial para que pueda entrar a formar parte de nuestra lista de proveedores aceptados, y posteriormente llevar a cabo un seguimiento que incluye una reevaluación de los mismos. Las evidencias relacionadas con la re-evaluación o seguimiento de nuestros proveedores puede incluir información documentada del análisis de no conformidades, incidencias, cumplimiento de proveedores, relacionados con las actividades de los proveedores.

Respecto a los criterios, de nuevo es algo que debe ser decidido por la organización, y son una serie de elementos necesarios para poder evaluar los proveedores, como por ejemplo los relacionados con los costes, el cumplimiento con una norma, la calidad y el plazo de entrega, estabilidad financiera, etc. Una vez tenemos los criterios podemos evaluar los proveedores y clasificarlos, por ejemplo utilizando una puntuación segun cumplan con los criterios seleccionados.

Para más información sobre la evaluación de proveedores en ISO 9001:2015, vea los siguientes materiales: 

- How to evaluate supplier performance according to ISO 9001:2015: https://advisera.com/9001academy/blog/2015/10/27/how-to-evaluate-supplier-performance-according-to-iso-90012015/

- Curso gratuito en línea - Fundamentos de la norma ISO 9001:2015: https://advisera.com/es/formacion/curso-fundamentos-iso-9001/

- Libro - Gestión de documentación ISo: una guía en un lenguaje sencillo: https://advisera.com/books/gestion-de-documentacion-iso-una-guia-en-un-lenguaje-sencillo/

ISO 9001 Pregunta

Los requisitos respecto a la información documentada del Sistema de Gestión de Calidad se encuentran en la cláusula 7.5.

En general, la documentación tiene que estar controlada, para que se encuentre disponible cuando sea necesaria y que esta documentación sea adecuada para su utilización. Cuando se crea o se actualiza la documentación, la organización tiene que asegurarse de que se identifica, se describe, y se revisa que tal documentación sea adecuada para poder posteriormente ser aprobada.

Así mismo, la empresa debe determinar cómo lleva a cabo distribución, el acceso, la recuperación y la utilización de dicha documentación.

Para más información sobre la publicación de documentos de la empresa vea los siguientes materiales:

- Some tips to make document control more useful for your QMS: https://advisera.com/9001academy/blog/2014/05/20/tips-make-document-control-useful-qms/

- What does external documents control mean in ISO 9001: https://advisera.com/9001academy/blog/2019/02/04/what-does-external-documents-control-mean-in-iso-9001/

- Curso gratuito en línea - Fundamentos de la norma ISO 9001:2015: https://advisera.com/es/formacion/curso-fundamentos-iso-9001/

- Libro - Gestión de documentación ISo: una guía en un lenguaje sencillo: https://advisera.com/books/gestion-de-documentacion-iso-una-guia-en-un-lenguaje-sencillo/

Do I need iso 13485 for prosthetic liner manufacturing?

Yes, the prosthetic liner is a medical device so you need to have implemented ISO 13485:2016. Also, since the prosthetic liner is custom made device, then you need to prepare all necessary documentation as stated in the Medical device regulation MDR 2017/745, in:

• EU MDR Annex 13 – Procedure for custom made devices https://advisera.com/13485academy/mdr/procedure-for-custom-made-devices/ and
• EU MDR Annex 9 – Conformity assessment based on a quality management system and assessment of the technical documentation https://advisera.com/13485academy/mdr/conformity-assessment-based-on-a-quality-management-system-and-assessment-of-the-technical-documentation/

For more information on ISO 13485, please see the following links:

• What is ISO 13485? - https://advisera.com/13485academy/what-is-iso-13485/
• Checklist of ISO 13485 implementation and certification steps - https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/
• How to get ISO 13485 certified - https://advisera.com/13485academy/iso-13485-certification/
• Clause-by-clause explanation of ISO 13485:2016 - https://info.advisera.com/13485academy/free-download/clause-by-clause-explanation-of-iso-13485
• How can ISO 13485 help with MDR compliance? - https://advisera.com/13485academy/blog/2020/03/09/how-can-iso-13485-help-with-mdr-compliance/

• ISO 9001 Internal Audit

  In a civil engineering consultancy firm, you have to design an audit program that includes both auditing headquarters and auditing construction sites where your organization is providing its services.

  After that major difference auditing a civil engineering consultancy firm is similar to any other audit. Define the objective, the scope and the criteria. Prepare, perform and report the audit. Please check this free webinar on demand - How to perform an ISO 9001:2015 internal audit - https://advisera.com/9001academy/webinar/how-to-perform-an-iso-9001-2015-internal-audit-free-webinar-on-demand/

  You can find more information below:

  • ISO 9001 Horizontal audit vs. vertical audit - https://advisera.com/9001academy/blog/2015/03/03/iso-9001-horizontal-audit-vs-vertical-audit/
  • ISO 9001 internal auditor training: Is it for me? - https://advisera.com/9001academy/blog/2015/06/02/iso-9001-internal-auditor-training-is-it-for-me/
  • Free online training ISO 9001:2015 ISO 9001:2015 Internal Auditor Course - https://advisera.com/training/iso-14001-internal-auditor-course/ nal-auditor-course/
  • Book - ISO internal audit: A plain English guide: https://advisera.com/books/iso-internal-audit-plain-english-guide/

• ISO 9001 Question

  After reading your description I made the following drawings. First:

  

  And second:

  

  1. How to apply requirements of subject clauses 8.5 & 8.6 of ISO 9001:2015 in our above-mentioned activities? 

  Answer:

  Your organization provides different kinds of services and each time a ship is serviced a different combination of services and parts may be required. So, I’m thinking about designing how each individually service should be performed with what kind of procedures, records and controls, as a kind of library of services.

  Each provision of service in a particular ship in a particular request will be a combination of one or more services. You only add the monitoring and control of the set of services in place. After a request for intervention your organization designs and develops a project for that particular request. If you look into each service in your library, you can draw a flowchart from start to end and you can apply clause 8.5. In that flowchart you can identify all places where there are risks of something being wrong and design a quality control plan (clause 8.6)

  2. How to develop a process flow chart for above activities? 

  Answer:

  If you try to develop a process flowchart for all activities at the same time it will become a big mess and it will not be useful. A model it is not about describing reality as it is, a model is about describing reality in a useful way. So, that is why I recommend developing a process flow chart for each service and then, develop a project flow chart about how the whole intervention will be managed and controlled.

  3. Is it necessary that all OEMs & Equipment Servicing companies ?  
  Repairers to be evaluated for their performance as per Clause 8.4 of ISO 9001:2015 which normally is extremely difficult in our case ? 

  Answer:

  It is up to each organization to determine what kind of qualification is required for its suppliers. For example, an organization may decide no qualification for a supplier of standard parts but may require more for a supplier of made to order customized parts. About evaluation of performance your organization may decide which suppliers are critical and only evaluate those suppliers.

  You can find more information below:

  • Risk-based thinking is a great way of implementing prevention and control into a quality management. ISO 9001:2015 promotes the process approach and in this free webinar on demand - The Process Approach - What it is, why it is important, and how to do it - https://advisera.com/9001academy/webinar/iso-9001-process-approach-free-webinar-on-demand/ I show how to relate processes, risks, training, documentation and control
  • Purchasing in QMS – The Process & the Information Needed to Make it Work - https://advisera.com/9001academy/blog/2014/03/18/purchasing-qms-process-information-needed-make-work/
  • Enroll for free course - ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
  • Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/ where I use the risk-based thinking in several examples.
     

• ISO 9001 Question

  QA agreement is also valid for services suppliers?

  Answer:

  Of course, it is, as long as both parties understand it, and reach an agreement about service level

  How can we efficiently and clearly accept all of the above-requested information in QAA? According to ISO 9001 2015, which sections?

  Answer:

  Before an agreement is reached there is a negotiation. Each party comes to negotiation with a proposal. Imagine that your organization will be responsible for doing those 7 points. What kind of competency requirements, procedures, records and control you would implement? That can be your starting point for the negotiation. About ISO 9001:2015, for starters consider clause 8.4.1 c) and 8.4.3, your organization is buying processes, what in previous versions of the standard was known as subcontracting or outsourcing. For other clauses I see things like these:

  – 8.4, 8.6 and 8.7
  – 8.2.1, 8.5.5 and 8.7
  – 8.5.1 h)
  – 8.2.1, 8.5.5 and 8.7
  – 8.5.6
  – 8.5.1 f) h)
  – 8.5.2

  Can we audit the supplier processes according to VDA 6.3?

  Answer:

  Again, that should be included in the QAA. Please check ISO 9001:2015 clause 8.4.3 f)

  The following material will provide you more information:

  • Purchasing in QMS – The Process & the Information Needed to Make it Work - https://advisera.com/9001academy/blog/2014/03/18/purchasing-qms-process-information-needed-make-work/
  • Enroll for free course - ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
  • Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/ where I use the risk-based thinking in several examples.
     

• ISO 9001 Identifying and Assessing Risk and Opportunity

  First, although useful, it is not mandatory to use a risk and opportunity matrix/criteria to evaluate risks and opportunities.

  I recommend using a very simple matrix for any level:

  

  Where L stands for Low, M for Medium and H for High. Severity is more for risks, for opportunities you may use Advantage.

  After using this approach for some time you can refine the matrix and include more factors if considered relevant.

  The following material will provide you more information about risks and opportunities:

  • Risk-based thinking replacing preventive action in ISO 9001:2015 – The benefits - https://advisera.com/9001academy/knowledgebase/risk-based-thinking-replacing-preventive-action-in-iso-90012015-the-benefits/
  • 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/
  • Please check this free webinar on demand - Free webinar – How to implement risk management in ISO 9001:2015 - https://advisera.com/9001academy/webinar/how-to-implement-risk-management-in-iso-90012015-free-webinar/
  • Enroll for free course - ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
  • Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/ where I use the risk-based thinking in several examples.