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Customer feedback and organizational memory
"I was wondering if you could tell me the requirements in regard to "obtaining customer feedback". Does this need to be substantiated by documents or are verbal discussions in this regard acceptable to the standard?” -
Auditor competence
"I currently have certification for ISO 9001-2008 Lead Auditor and Internal Auditor. Do I need to take the ISO 9001-2015? Also, is there a way to integrate ISO 27001 with ISO 9001?” -
Risks and interested parties
1.Risk based - We only manufacture a bolt carrier for the assault weapons but we do buy the key and the bolt carrier group from other companies and offer our customers different stages of completion. So, on the risk-based thinking, I have included the risk to the processes and what can and will scrap the product in house. Is this OK? 2. The interested parties list is also contained in my procedure. Is this okay? -
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!”