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IATF 16949:2016

 IATF 16949:2016.

Getting to the heart of why IATF 16949 is important

 

As stated above, IATF 16949:2016 is the global technical specification and quality management standard for the automotive industry based on ISO 9001:2015. It is designed to be used in conjunction with ISO 9001:2015, and contains supplemental requirements specific to the automotive industry rather than being a stand-alone QMS.

IATF 16949:2016 brings together standards from across Europe and the U.S., outlining everything you need to know about achieving best practice when designing, developing, manufacturing, installing, or servicing automotive products. It is intended to be used by organizations of any size or industry, and can be used by any company. As an international standard, it is recognized as the basis for any company to create a system to ensure customer satisfaction and improvement, and as such, many companies demand this as the minimum requirement for an organization to be a supplier.

Because you are auditing your processes, as well as having a certification body audit them, your customers themselves do not need to audit your company. It is because of this that IATF 16949 has become a necessity for many companies to compete in the market.





 CURSO DE

SENSIBILIZACION E INTERPRETACION

DE LA ESPECIFICACION TÉCNICA

 IATF 16949:2016.

ANTECEDENTE

PARA ACREDITAR EL CURSO DE FORMACION

DE AUDITORES INTERNOS EN 
IATF 16949:2016







 






Why is IATF 16949 a good idea for your organization?

 


The benefits of IATF 16949 cannot be overstated; companies large and small have used this standard to great effect, discovering and securing tremendous cost and efficiency savings. Here are just a few of these benefits:

 

Improve your image and credibility – When customers see that you are certified by a recognized certification body, they will understand that you have implemented a system that is focused on meeting customer requirements and improvement. This improves their trust that you will deliver what you have promised.

Qualify to supply the automotive industry – This is one of the main drives for companies to get certified against IATF 16949. In order to get big customers from the automotive industry, you have to demonstrate that you are able to provide high-quality products with no defects, and an IATF 16949 certificate will prove it.

Improve customer satisfaction – One of the key principles of the IATF 16949 QMS is the focus on improving customer satisfaction by identifying and meeting customer requirements and needs. By improving satisfaction, you improve repeat customer business.

Fully integrated processes – By using the process approach of IATF 16949, you not only look at the individual processes in your organization, but also at the interactions of those processes. By doing this, you can more easily find areas for improvement and resource savings within your organization.

Use evidence-based decision making – Ensuring that you are making decisions based on good evidence is a key to the success of an IATF 16949 QMS. By ensuring that your decisions are based on good evidence, you can better target resources to the best effect to correct problems and improve your organizational efficiency and effectiveness.

Create a culture of continual improvement – With continual improvement as the main output of the QMS, you can attain ever-increasing gains in savings of time, money, and other resources. By making this the culture of your company, you can focus your workforce on improving the processes they are directly responsible for.

Engage your people – Who better than the people working within a process to help find the best solutions for improving that process? By focusing your workforce on not only managing, but also improving the processes, they will be more engaged in the outcome of the organization.

 





What does IATF 16949 actually look like?

The IATF 16949 structure is split into 11 sections. The first three are introductory, with the last seven containing the requirements for the Quality Management System. Here is what the seven main sections are about:

Section 4: Context of the organization – This section requires the organization to determine its context in terms of the Quality Management System, including interested parties and their needs and expectations. It also defines the requirements for determining the scope of the QMS, as well as general QMS requirements.

Section 5: Leadership – This clause of the standard requires top management to demonstrate leadership and commitment to the QMS, along with defining corporate responsibility and the quality policy. The top management must also assign process owners along with other roles and responsibilities.

Section 6: Planning
 – The section on planning defines requirements for addressing risks and opportunities and the requirements for risk analysis. This clause also includes requirements for preventive actions, contingency plans, and quality objectives and plans to achieve them.

Section 7: Support – In this clause you can find requirements for the resources and supporting processes needed for an effective QMS. It defines requirements for people, infrastructure, work environment, monitoring and measuring resources, organizational knowledge, competence, awareness, communication, and documented information.

Section 8: Operation – The product requirements deal with all aspects of the planning and creation of the product or service. This section includes requirements on planning, product requirements review, design, purchasing, creating the product or service, and controlling the equipment used to monitor and measure the product or service. IATF 16949 allows for requirements in clause 8.3, regarding design and development of products, to be excluded if they are not applicable to the company.

Section 9: Performance evaluation – This section includes the requirements needed to make sure that you can monitor whether your QMS is functioning well. It includes assessing customer satisfaction, internal audits, monitoring products and processes, and management review.

Section 10: Improvement – The last section of the standard defines the requirements for continual improvement of the QMS, including requirements for nonconformities and corrective actions, problem solving, and error-proofing processes.

These sections are based on a Plan-Do-Check-Act cycle, which uses these elements to implement change within the processes of the organization in order to drive and maintain improvements within the processes.



 

ISO/TS es el estándar de sistemas de gestión de la calidad automotriz; este estándar cuya versión actual es la 2009 evolucionará en una norma que publicará la IATF (International Automotive Task Force),

la cual se alinea con las especificaciones de la última versión de la norma de calidad: la ISO 9001:2015.

El nuevo estándar lleva por nombre

IATF 16949:2016.

¿Cuáles son los principales cambios?

·    El Control de Cambios

·    Se efectúan Análisis de Riesgos asociados al Sistema de Calidad.

·    Se agregan requisitos relacionados a la Responsabilidad Corporativa de la empresa.

·    Se revisan los requisitos de Trazabilidad del productos

 ACCIONES PRÁCTICAS A IMPLEMENTAR

REALIZAR UN ANÁLISIS DE RIESGOS (AMFE) para gestionar los fallos que pueden afectar a la calidad del producto (Fase de diseño y de fabricación)
 
ELABORAR ENCUESTAS DE CLIMA LABORAL, para conocer el grado en que el personal es consciente de la relevancia de sus tareas y su contribución al sistema de gestión.
 
DISPONER DE UN PLAN DE CONTINGENCIA ante emergencias del tipo: Paradas de planta, falta de mano de obra, fallos deequipos clave..etc., que garantice en todo momento el cumplimiento de los requisitos del cliente.
 
FIRMA POR PARTE DE TODO EL PERSONAL, DE UN COMPROMISO DE CONFIDENCIALIDAD , que asegure la confidencialidad de los productos y proyectos en desarrollo contratados por el cliente y de la información relacionada con el producto.
 
IMPLEMENTAR UN PLAN DE LIMPIEZA VALIDADO de las maquinaria e instalaciones de producción, de forma que se evite la contaminación cruzada.
 
Elaboración de un PROGRAMA DE PROTOTIPOS.
 
Elaborar una POLÍTICA DE PREVENCIÓN DE LA CORRUPCIÓN, UN CÓDIGO DE CONDUCTA PARA LOS EMPLEADOS Y UNA POLÍTICA DE ESCALAMIENTO ÉTICO.
 
ELABORACIÓN DE UN PLAN DE CONTROL a nivel de sistema, subsistema, componentes y/o materiales para el producto suministrado, incluyendo los relativos a los procesos de producción de materiales a granel así como piezas.
 
Elaborar ESTUDIOS ESTADÍSTICOS DE REPETITIVIDAD/REPRODUCIBILIDAD para el seguimiento del buen estado de medida de los aparatos.
 
ACREDITAR EL LABORATORIO INTERNO EN BASE AL ESTÁNDAR ISO 17025:2005 (si es externo, incluirlo como requisito, para asegurar el cumplimiento de los requisitos exigidos en la norma IATF 16949)

El nuevo estándar fue publicado en Octubre del 2016; las organizaciones que se encuentran actualmente certificadas deberán hacer la transición, teniendo como fecha límite el día 14 de Septiembre del 2018 de acuerdo al "Transition Plan To The Revised Automotive QMS" que fue publicado el día 20 de Agosto del 2016 por la IATF.

Para llevar a cabo una transición exitosa dentro de su organización, hay actividades que se deben gestionar como el Evento destinado para la Transición así como la gestión de las No-Conformidades existentes para la decisión de la Organización Certificadora de emitir o no el Certificado;

es por eso que no se recomienda que las organizaciones dejen al último momento la Transición pues si no acreditan la Auditoría destinada a ello, corren el riesgo de no hacerlo en tiempo.




La norma IATF 16949 , establece los requisitos particulares (SUPLEMENTOS) para la aplicación de Norma ISO 9001 para la producción en serie y piezas de recambio original en la industria del automóvil.

La norma se aplica a todos los fabricantes en el mundo dentro de la cadena de suministro automotriz - para vehículos, sus partes, componentes o sistemas, incluyendo las funciones de apoyo, ubicadas en el sitio o fuera de él (tales como los centros de diseño, las oficinas corporativas de la compañía y los centros de distribución).

LAS EXCLUSIONES PERMITIDAS NO INCLUYEN EL DISEÑO DEL PROCESO DE FABRICACIÓN.

 El OBJETIVO PRINCIPAL de IATF 16949:

Mejora continua

Énfasis en la prevención de defectos

Reducción de variación y desperdicios en la cadena de suministro.

La norma asegura que los componentes, piezas y sistemas de seguridad del automóvil cumplen los requisitos especificados por los clientes así como la reglamentación aplicable.

Impulsa la mejora continua de los productos a mejores precios, así como la investigación y desarrollo de nuevos componentes que influyen en la seguridad del propio vehículo y su entorno.











Objetivo

IATF 16949:2016 Sistemas de Gestión
del Sector Automotriz

IATF 16949:2016, es un documento innovador con una fuerte orientación al cliente y sus requisitos y expectativas.

ISO/TS 16949, fue creada por el International Automotive Task Force

(IATF) CON EL FIN DE
ARMONIZAR LAS DIFERENTES EVALUACIONES Y SISTEMAS DE CERTIFICACIÓN EN LA CADENA
DE SUMINISTRO GLOBAL DEL SECTOR AUTOMOTRIZ.

Otras actualizaciones fueron desarrolladas
(segunda edición en 2002 y tercera edición en 2009), según fue necesario, ya sea por el fortalecimiento del sector automotriz o por actualizaciones a ISO 9001. ISO/TS 16949 (junto con las publicaciones técnicas de apoyo desarrolladas por los fabricantes de equipo original [OEM, por sus siglas en inglés], y las asociaciones comerciales automotrices nacionales) introdujo un conjunto común de técnicas y métodos para el desarrollo de productos y procesos comunes para la fabricación automotriz a nivel mundial.

En preparación para la migración de ISO/TS 16949:2009 a esta Norma del SGC Automotriz,
IATF
16949:2016, se solicitó retroalimentación a organismos de certificación, auditores, proveedores y OEM
para crear la Norma IATF 16949:2016, que cancela y reemplaza a ISO/TS 16949:2009.
Esta Norma del Sistema de Gestión de la Calidad Automotriz, en adelante referida como Norma del SGC
Automotriz o IATF 16949, junto con los requisitos específicos de los clientes que sean aplicables, y los
requisitos de la Norma ISO 9001:2015, define los requisitos fundamentales del sistema de gestión de la
calidad en las ORGANIZACIONES QUE FABRICAN PIEZAS DE PRODUCCIÓN Y PIEZAS DE
SERVICIO EN LA INDUSTRIA AUTOMOTRIZ.
Como tal, esta Norma del SGC Automotriz

NO PUEDE CONSIDERARSE UNA NORMA DEL SGC POR SÍ
SOLA SINO QUE NECESITA ENTENDERSE COMO UN SUPLEMENTO DE LA NORMA ISO 9001:2015 Y UTILIZARSE JUNTO CON ESTA ÚLTIMA.




The latest revision of IATF 16949 came out in November of 2016, and as the deadline for transitioning gets closer, people are starting to become concerned about what steps they need to take to make sure they are compliant with this latest version.

It’s true that IATF 16949:2016 has brought some substantial changes with regard to concepts and methods, but it’s nothing too difficult. As long as companies take the time to properly plan for the transition, and approach the process systematically, there’s no reason why it can’t be completed before the deadline.

Timing

Starting on October 1, 2017, all new certification audits must be conducted according to the new IATF 16949:2016 and the IATF Rules 5th edition. Organizations already certified against ISO/TS 16949:2009 can make the transition for their next recertification audit. When the grace period ends on September 14, 2018, the old ISO/TS 16949:2009 certificates will no longer be valid.

Those organizations that need to transition from ISO/TS 16949:2009 to IATF 16949:2016 will need to pass a transition audit, including VETO approval for certification, on or before that September 14 deadline. Those companies undergoing their transition audit between July and September of 2018 will have 120 days, at a maximum, to receive a positive VETO decision after their transition audit is complete.

Transition steps

Here are the 12 steps, in order, that I recommend for any organization looking to transition to the 2016 version of the IATF 16949 standard:

1) Define the context of the organization. Consider this new requirement carefully, as it serves as the foundation of your new Quality Management System (QMS). There are no extra requirements beyond those of ISO 9001:2015, but due to the nature of the industry, IATF 16949 is known for raising the bar, so you should anticipate this clause to be looked at closely when it comes time for the certification audit.

2) List all interested parties. Technically, this is part of the same clause where you’ll find context of the organization, but because it is new, you may want to pay extra attention. Identifying all interested parties and acknowledging their expectations are important when defining the company’s strategic direction.

3) Review the scope of the QMS. Now is the time to take another look at the existing scope of your Quality Management System, because the reliability and integrity of your QMS depend on it. The new revision of the standard requires the evaluation of customer-specific obligations, and their inclusion in the scope of the QMS.

4) Demonstrate leadership. Leadership requirements in the new revision of the standard are nearly identical to those for management commitment in the last version. However, IATF 16949:2016 places even greater importance on organizational leadership, with additional requirements listed for corporate responsibility. Top management can show leadership by creating a Quality Policy and quality objectives, holding themselves accountable for the Quality Management System, and providing adequate resources to keep it running smoothly.

5) Assess risks and opportunities. The latest revision requires the assessment of risks and opportunities. The focus is on the organization’s ability to achieve the planned results, as well as other concepts like compliance obligations and context of the organization. Risk assessment should include past experiences from audits, customer complaints, product recalls, scrap and rework, and field returns and repairs. Once risks and opportunities have been assessed, plans should be made to address them.

6) Align QMS objectives with strategic direction of company. Your company’s Quality Management System cannot be in opposition to the company’s overall business strategy. Likewise, quality objectives should be aligned with the company’s other activities. The new revision requires the creation of plans for achieving the objectives, as well as the definition, establishment, and maintenance of quality objectives to meet customer requirements.

7) Control documented information. The new term “documented information” includes both procedures and records. The transition is a good time to make improvements to your existing documentation while you work on realigning your existing procedures with the new clause numbers. For more information, see: List of mandatory documents required by IATF 16949.

8) Increase operational control. IATF 16949:2016 calls for better control over processes – for example, operating criteria, and the implementation of controls over processes according to these criteria. In addition, confidentiality requirements have been increased, along with expansion of operational planning and control obligations.

9) Redefine the design and development process. The definition of your design and development process needs to be expanded to include inputs, outputs, controls, and responsibilities; as well as how changes to the design and development process will be managed – like who is authorized to make changes, who will review results of any changes, and what will be done to avoid negative impacts.

10) Control external providers. The purchasing process has been renamed “Control of externally provided processes, products and services.” The requirement basically says that you must do whatever you have to, in order to make sure your providers deliver what is expected. This can be achieved through verifying that processes, services, and products supplied by external providers comply with your requirements. To do this, you’ll have to determine what information needs to be provided to suppliers, including type and extent of any controls.

11) Evaluate QMS performance. You are required to evaluate your QMS with regards to its performance, effectiveness, and efficiency. You may already be familiar with KPIs (Key Performance Indicators) – you just need to figure out what needs to be monitored, how it should be monitored, and how often.

12) Measure and report. Measuring and reporting are assigned greater importance in the new standard, particularly when it comes to the performance evaluation mentioned previously. Likewise, management review and the internal audit process must be aligned with the new standard. Even though there’s no change to the methods of conducting these activities, some changes have been made to the requirements to be audited as part of the internal audit, as well as to the input elements for the management review.

Transitioning to the new version of the standard may seem overwhelming in the beginning, but I estimate that over the course of a year, it shouldn’t take more than an hour or two per month. These aren’t changes for the sake of changes – they do make sense, and offer a tremendous opportunity to further integrate your Quality Management System with your other business activities, and get a leg up on your competition.








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