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Certification requirements for SME's - Automotive

As I mentioned before, there is no clear link with the small business regarding the implementation of IATF or the supply of parts to the OEM customer.However, in order for new businesses to obtain an IATF certificate, there is a right called ‘’letter of conformance.’’  I share the details of this below from IATF Rules 5.

5.14 Letter of conformance The purpose of the letter of conformance is to confirm that processes exist that satisfy the requirements of IATF 16949 and these "Rules" and where the client is not able to achieve IATF 16949 certification because of:

a) a new site without twelve ( 12) months of internal or external performance data for the automotive production and/or service parts in the scope of certification

b) an existing site that can demonstrate it is 

5.14.4 Eligible for certificationOnce the client has twelve ( 12) months performance data for the new site or if the client on an active bid list receives a contract from the customer requiring IATF 16949 certification, the certification process shall proceed by the same certification body with an initial audit (stage 1 readiness review and stage 2) with a maximum reduction of 50% possible in audit days for the stage 2 audit (see section 5.2 and 5.4 g).The 50% reduction applies only to the initial audit and only if the initial audit starts before the expiration date of the letter of conformance. The reduction shall not be applied to the subsequent surveillance audit cycle.A member of the audit team that performed the initial audit for the letter of conformance should be assigned to participate in the initial audit and each surveillance audit of the three (3) year audit cycle.The stage 2 audit shall start before the expiration date of the letter of conformance. lf the timing is exceeded, the client shall start over with an initial certification audit (stage 1 readiness review and stage 2) and no reduction shall be applied.

Standard approach/Framework for meeting all Quality clauses

APQP meetings should be held with team participation for both product design and development, as well as process design and development. 

There is no standard application, it is made according to customer-specific requirements. My recommendation is to use AIAG's APQP and PPAP manuals which are Ford, GM, Chrysler and most of automotive customer project management requirements. 

You can organize meetings according to the requests in the clauses 8.1-8.2-8.3 of the   IATF 16949: 2016 standard and the project management phases in these manuals.

For more information feel free to visit the following:

• What are the five core tools of IATF 16949? https://advisera.com/16949academy/blog/2017/08/23/what-are-the-five-core-tools-of-iatf-16949/

• ISO 9001 Defining the procedures

  Unfortunately, I do not believe that there is a best way to precisely define what procedures should be implemented in organizations. Organizations are complex adaptive systems, even if we could define the best set of procedures at a moment in time, sooner or later that set would become obsolete due to the changes in the system and in the context.

  We will always be guessing what the best set is. What I can give you is a list of topics that should be considered when thinking what procedures are needed or not. Consider that procedure may be useful or needed because of:

  • Complexity of tasks – complex tasks are more prone to errors and mistakes;
  • Staff rotation – if staff rotation is high, people have not much experience and a procedure that someone can use as guide in case of doubt is very useful;
  • Staff training – if staff training is very poor;
  • Performance – if performance results show a bad performance perhaps procedures can help people in their work;
  • Complaints – a particular case of performance;
  • Risk analysis - 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
  • Requirement – if a law, or a standard, or a contract requires a procedure.
     

  You can find more information about documents and records below:

  • List of mandatory documents required by ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-90012015/
  • How to structure quality management system documentation - https://advisera.com/9001academy/knowledgebase/how-to-structure-quality-management-system-documentation/
  • New approach to document and record control in ISO 9001:2015 - https://advisera.com/9001academy/blog/2015/06/30/new-approach-to-document-and-record-control-in-iso-90012015/
  • Free online training ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
  • Book - Managing ISO Documentation: A Plain English Guide - https://advisera.com/books/managing-iso-documentation-plain-english-guide/

• 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/