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Competitors as interested parties?
"How competitor can be an interested party for an organization?” -
Acciones correctivas
He recibido esta pregunta: ¿A toda acción correctiva se le tiene que realizar la técnica de análisis de causa raíz, me refiero a que si un hallazgo, se podría decir no es muy grave es necesario que se documente es técnica? Mi respuesta: El tema de las acciones correctivas es tan relevante en esta nueva norma como en la anterior versión y de hecho, el análisis de la causa raíz sigue siendo la parte más importante del proceso de la acción correctiva. En caso de haber identificado que un problema es realmente serio, más que una simple no conformidad, entonces es necesario llevar a cabo una acción correctiva para evitar que el problema vuelva a surgir de nuevo. Para ello es necesario aplicar un proceso sistemático que nos asegure que no vamos a olvidarnos de nada por el camino, y éste es el análisis de la causa raíz. En esta técnica es fundamental que no sólo tratemos de forma superficial el problema sino que hagamos un análisis más exhaustivo para encontrar la verdadera causa raíz. Si un problema es suficientemente grande como para invertir tanto tiempo como recursos en crear una acción correctiva, entonces es suficientemente importante como para garantizar que el problema se corrige de forma adecuada y se mantiene corregido. Para obtener más información puede leer los siguientes artículos (sólo disponibles en inglés): - https://advisera.com/9001academy/blog/2013/10/27/seven-steps-corrective-preventive-actions-support-continual-improvement/ - https://advisera.com/9001academy/blog/2016/09/20/how-to-proceed-once-qms-corrective-action-is-defined/ Además los siguientes recursos pueden ser de utilidad en la implantación de la norma ISO 9001:2015: - Libro "Preparación para el proyecto de implementación: Una guía en un lenguaje sencillo": https://advisera.com/books/preparacion-para-el-proyecto-de-implementacion-iso-una-guia-en-un-lenguaje-sencillo/ - Curso gratuito en línea: Curso de fundamentos ISO 9001 https://advisera.com/es/formacion/curso-fundamentos-iso-9001/ - Conformio (herramienta en línea para ISO 9001): https://advisera.com/conformio/ -
Certification of internal auditors
"Is it necessary for a trainer to be certified (IRCA?) to conduct Internal Quality Audit training in-house, considering that he has attended external IQA training and had auditing experiences?” -
Training manuals and QMS documents
"When considering what documents need to include as part of the QMS, should training manuals used in the implementation of a new database need to form part of the QMS documents? My thought is no but not sure if I am correct?” -
Quality objectives and values
"Can the "quality policy" be the "core purpose" of the company? Can the "quality objective" be the "core values" of the company?" -
Process vs department
"Regarding clause 9.1 if a department is not tracking and measuring objectives are they not complying with clause 9.1" -
QMS as a preventive system
" We have a very mature QMS. Is it correct to declare our QMS is a preventive system? Does this declaration helps us to comply with the Risk Based thinking requirement? Let me explain. Our procedures and instructions are set to perform an activity in a standardized way. This will prevent errors and will help to be consistent with our product/customer requirements every time. Therefore, our procedure/instruction are preventive tools for our company. We think the risk base thinking is covered by our QMS itself!” -
Shortning the quality manual
My client is a small company of approx. 20-25 people operating from 4 different locations. The company is a supply and service provider of firefighting and safety equipment to the marine industry. They do have a QMS today that was made several years ago, and I believe it was based on the ISO 9001:2008. However, it was never audited by a certification body. Company management now plans to take the next step and proceed with writing a revised QMS to meet the ISO 9001:2015 standard. In the current company QMS there are some sections that may not be specifically mentioned as requirements of the 2015 standard. F.inst.: Mission/Vision statement Code of Ethics and Business Conduct Quality, Safety, Health & Environment Protection Policy Job preparation (very detailed check-list of tools and spares to bring to the worksites when doing service onboard cruise vessels, one list for each product type, portable fire extinguishers, fixed fire fighting systems, breathing apparatus etc.) Emergency & Hazardous Preparedness. (Company is b ased in Florida where there are frequent hurricane threats) Many of the chapters in the current manual are very good, but in order to keep the new QMS as short as possible, should some of these chapters be taken out and perhaps be part of a separate “Operational Manual” or an Employee Handbook? The current manual is extensive in size…90 pages. It even includes employee performance reviews which perhaps should be included in the employee handbook… -
Risk based approach
"As a Consulting Engineer, I understand that for ISO 9001-2015 and also for ISO 14000-2015; Risk Analysis is a major new development. Also, the idea of Risk Analysis has been carried over into other standards such as ISO/IEC Standard 17025-2017; and other ISO standards which use the same template. With this background, my main concerns are two. 1. How to do a good job of Risk Analysis in a Test Lab setting (ISO/IEC Std. 17025-2017) in an Inspection Body setting (ISO/IEC Std. 17020-2012) and in a Product Certification Body setting (ISO/IEC Std. 17065-2012 and ISO/IEC Std. 17067-2013). 2. How do I use ISO 31000 to do Risk Analysis in the above standards. If you can kindly answer these in the webinar, I will be very grateful. Another good idea is to provide a guidance paper with a template for Risk Analysis.” -
Risks and context
"What would be the risks addressed and connect to the context of the organisation on document?” Actually no documented information required but If I want to make then what will be ?”