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Requirements for ISO 13458 implementers
Answer:
There is no mandatory requirements for ISO 13458 implementers. If you feel confident there is no need to take a course to transition.
The following material will provide you information ISO 13458:
- Download free ISO 13485 materials - https://advisera.com/13485academy/free-downloads/
- IMPLEMENT ISO 13485 EFFORTLESSLY - https://advisera.com/13485academy/ -
Expiring soon ISO 14001 certification
Answer:
After September 15th every certification that hasn´t done the transition to the new revision of the standard will not be valid, so you will need to perform that transition before that date if you want to maintain the certificate. If you don´t need the certification for any relevant purpose (such as external provider requirement and so on) you can wait until you properly finish the implementation of the new standard instead of failing the external audit.
You can use this free ISO 14001 on-line calculator to learn how long the transition to the new revision will take: https://advisera.com/14001academy/iso-14001-duration-calculator/
To learn more about the the transition, see these materials:
- Article - 12 steps to make the transition from ISO 14001:2015 to 2015 revision: https://advisera.com/14001academy/blog/2015/09/28/12-steps-to-make-the-transition-from-iso-140012004-to-2015-revision/
- How to make the transition from ISO 9001:2008 to the 2015 revision: https://advisera.com/9001academy/blog/2015/10/06/how-to-make-the-transition-from-iso-90012008-revision-to-the-2015-revision/
Also you can download a free preview of our ISO 14001:2015 Transition toolkit, that can help you to speed up the transition to the new revision : https://advisera.com/14001academy/iso-140012015-transition-toolkit/ -
Contexto, riesgos y otras cláusulas de la norma
Tengo un Sistema de Gestión desde el año 2014, y con la transición, tengo varias dudas:
1. Todos los procesos deben realizar una matriz dofa para el numeral 4.1, o solo la hace el proceso gerencial, y luego de identificar los factores internos y externos se hace un listado de ellos y luego se sacan las estrategias o como se procede
2. Todos los procesos deben realizar una matriz de identificación de riesgos y oportunidades o solo el proceso gerencial de lo que salga de la DOFA.
3. Se debe hacer una matriz legal o no, o es solo una matriz de correlación en cuanto a los requisitos del numeral 8.2.2 y 8.5.3, o como cumplo ese requisito.
4. La empresa en la que trabajo hace distribución y envasado de GLP, gas licuado de petroleo, o cilindros de gas propano, se requiere de diseño y desarrollo, o definitivamente se puede excluir, en la versión anterior en el alcance se excluye. pero como ahora cambio, es posible excluir este numeral o definitivamen te tendríamos que hacer el diseño y desarrollo y a que se haría.
Respuesta:
1. No debe necesariamente de realizarse una matriz DOFA para cada uno de los procesos de la organización, de la misma forma tampoco hay que centrarse en el proceso gerencial sino que a la hora de realizar la matriz DOFA tiene que que tener en cuenta todas aquellas cuestiones de la organización que pueden afectar a la satisfacción del cliente y/o partes interesadas y a la entrega de la calidad del producto o servicio. Este análisis se puede llevar a cabo con las personas relevantes de la organización, que incluyen la alta y media dirección, en una reunión de tormenta de ideas. La norma requiere la documentación del contexto de la organización, por lo que es la compañía la que decide si documentarlo o no y cómo hacerlo, puede ser mediante una lista como propones. La identificación del contexto de la organización es clave para lanzar una estrategia corporativa y para detectar oportunidades de mejora.
Para saber más sobre cómo determinar el contexto de la organización, vea - Cómo identificar el contexto de la organización en ISO 9001:2015: https://advisera.com/9001academy/pt-br/kit-de-documentacao-da-iso-9001/nowledgebase/como-identificar-el-contexto-de-la-organizacion-en-iso-90012015/
2. Al igual que ocurre en la determinación del contexto de la organización la matriz DOFA debe realizarse teniendo en cuenta todos los procesos que se encuentren dentro del alcance de la organización, pero no sería necesario realizar una matriz DOFA para cada uno de los procesos.
Para saber más sobre riesgos y oportunidades en ISO 9001:2015, vea - Cómo abordar riesgos y oportunidades en ISO 9001:2015: https://advisera.com/9001academy/blog/2016/06/21/how-to-address-risks-and-opportunities-in-iso-9001/#
3. No es necesario realizar una matriz para cumplir con ambos numerales. La norma sólo requiere de forma obligatoria retener información documentada (registros) del numeral 8.5.3 sobre Registros de la Propiedad del Cliente, pero de nuevo no existe ningún requisito de cómo hacerlo. En cuanto al numeral 8.2.2, aunque la norma no requiere ningún documento obligatorio al respecto, puede crear por ejemplo, una lista de verificación de revisión de los requisitos de los clientes. Puede descargar una muestra gratuita de la plantilla que ofrecemos para cumplir con este requisito - Lista de revisión de requerimientos de clientes: https://advisera.com/9001academy/es/documentation/lista-de-revision-de-requerimientos-de-clientes/
4. Si su empresa no realiza el proceso de diseño y desarrollo de los productos que ofrece entonces puede excluirlo del alcance, justificando de manera adecuada su exclusión.
Puede leer este artículo para obtener más información sobre las exclusiones en ISO 9001:2015 - Qué cláusulas pueden excluirse en ISO 9001:2015? (disponible en inglés): https://advisera.com/9001academy/blog/2015/07/07/what-clauses-can-be-excluded-in-iso-90012015/2015/#
Para saber más sobre las cláusulas de la norma puede descargar este documento - Explicación de ISO 9001:2015 cláusula a cláusula (disponible en inglés): https://info.advisera.com/9001academy/free-download/clause-by-clause-explanation-of-iso-90012015
Este curso gratuito en línea también puede ayudarle a entender cada uno de los requisitos de la norma ISO 9001:2015 - Curso de fundamentos de la norma ISO 9001:2015: https://advisera.com/es/formacion/curso-fundamentos-iso-9001/ -
School mailing list
Answer:
Not unless you are sending them marketing materials. However, if the communication is based on consent you need to provide the parents with the option to withdraw the consent. -
Keeping data in hard copy
Hi Andrei
Thanks so much for your kind help -
Monitoring and Measurement Resources and service companies
Answer:
Section 7.1.5 is about monitoring and measurement resources. Resources is a key word, not necessarily equipment or instruments.
Another important point is Section 7.1.5 deals only with the monitoring and measurement features that are used to verify the conformity of the product or the service with the requirements. Not all monitoring and measurement operations performed on the product and/or service are effectively used to determine product conformity.
How does your organization ensure that the services provided are according to requirements? The monitoring and measurement resources can be, for example, samples or visual patterns.
That being said, it is not really unusual for service organizations to conclude that they do not have monitoring and measurement r esources and therefore consider this Section to be not applicable in their QMS.
The following material will provide you information about not applicable clauses:
- ISO 9001 – What is an acceptable exclusion in Clause 7 of ISO 9001? - https://advisera.com/9001academy/blog/2015/03/24/what-is-an-acceptable-exclusion-in-clause-7-of-iso-9001/
- What clauses can be excluded in ISO 9001:2015? - https://advisera.com/9001academy/blog/2015/07/07/what-clauses-can-be-excluded-in-iso-90012015/2015/
- free online training 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/ -
Terms of service for ITIL implementation
Answer:
Basically, ITIL does not have any particular terms to be implemented. If you have enough know-how and know what ITIL is about, you can start the implementation.
If you don't have enough knowledge, there are few options:
1. Purchase official ITIL documentation, visit some of the training (starting with Foundation) and implement it. It will take long, cost a lot, but it's possible
2. Hire a consultant – should be quicker than #1, but more expensive (btw. read this free whitepaper before hiring a consultant „List of questions to ask ITIL consultant“ https://info.advisera.com/20000academy/free-download/list-of-questions-to-ask-itil-consultant
3. Purchase the documentation toolkit with extensive support options and do it by your self with our support, like https://advisera.com/20000academy/pricing
Read the free whitepaper „Implementing ISO 20000 with a consultant vs. DIY approach“ https://info.advisera.com/20000academy/free-download/implementing-iso-20000-with-a-consultant-vs-diy-approach or see this free webinar „How to use a Documentation Toolkit for the implementation of ITIL / ISO 20000“ https://advisera.com/20000academy/webinar/how-to-use-a-documentation-toolkit-for-the-implementation-of-itil-iso-20000-free-webinar-on-demand/ to find out more about your options and their characteristics, advantages, disadvantages... -
Service in ISO 20000
Answer:
Basically, a service is a service, in both standards. ISO 9001 is more generic and applicable to any industry and can be applied to both - products and services. ISO 20000 is focused on (IT) services and goes much deeper in requirements for the whole lifecycle of the service.
Learn more about ISO 9001 in the article " What is ISO 9001?" https://advisera.com/9001academy/what-is-iso-9001/ and "What is ISO 20000?" https://advisera.com/20000academy/what-is-iso-20000/ -
Documentation of control A.12.7.1
I was wondering, how can I develop a control for A.12.7.1? should it be inside a policy? Which policy?
Answer: If you have identified risks or legal requirements that justify the application of control A.12.7.1 - Information systems audit controls, which requires careful planning and agreement regarding the verification of operational systems, I suggest you to develop its implementation in the Security Procedures for IT Department template, located in folder 11 Security Controls of the ISO 27001 Documentation Toolkit you bought.
This document helps define and ensure correct and secure functioning of information and communication technology for which the responsibility lays with the IT department, and you can include the implementation of control A.12.7.1 here. -
Periodic overhaul in total productive maintenance
Answer:
Periodic overhaul is maintenance methodology to prevent a major unplanned breakdown where, based on fault or interruption history, a piece of equipment, or subsystem of the equipment, is proactively taken out of service and disassembled, repaired, parts replaced, reassembled, and then returned to service.
Overhauling a machine is fundamentally an economic decision. I don't overhaul my pickup truck engine at 100 K, although I could. The cost-benefit analysis may convince me that a new truck is warranted. The need to "overhaul" equipment is usually based on the probability the machine will catastrophically fail in a manner that will require extensive repair and the event will be costly. Timing of overhauls (when to do them) is a major factor. Summer shutdown is used for these to avoid interruptions to production output.