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Updating ISO 9001 and ISO 13485
we are manufacturer of medical devices product i.e syringes etc, what type of update need our quality manual as per iso 9001-2008? iso 13485-2016 or ISO 9001-2015? -
Documentación opcional
He recibido esta pregunta: en la nueva certificación ISO 9001 por que se dice documentos obligatorios y opcionales? Mi respuesta La nueva versión de la norma tiene algunos documentos y registros obligatorios que se necesitan para cumplir con la ISO 9001. El resto de la documentación es opcional, como el procedimiento para determinar el contexto de la organización y las partes interesadas u otra clase de documentos que pueden ser útiles en la implementación y especialmente en el posterior mantenimiento del SGC Para más información vea "Lista de documentos obligatorios requeridos por la ISO 9001:2015": https://advisera.com/9001academy/pt-br/kit-de-documentacao-da-iso-9001/nowledgebase/lista-de-documentos-obligatorios-requeridos-por-la-iso-90012015/ -
Documenting Design History File
What is the difference between a design and development file AND a design history file (DHF)? -
Surveillance audit and transition
Hi, I have a 2 concerned. In less than 3 months we will having a 4th Surveillance Audit for this year and are new MR have no back ground in any kind of ISO. -
Bureaucratic burden of ISO 9001
The more documentation we have the more it’s not going to be effective because one: who would read it and use it; two: no value added; three: it’ll just be sitting in the repository and will only come out during an internal audit etc. -
Writing quality objectives and plans for achieving them
How should a quality objective and planning document be written? -
Determining the scope in nonprofit organization
I work for a alcohol and drug rehabilitation centre. We are a not for profit organisation and our funding bodies determine the services that we must provide and the KPIs associated with it. In terms of interested parties (Context of the organisation) my CEO believes that basically the funding bodies are the only interested parties and feels that Suppliers, contractors, cients, employees etc. are not considered interested parties relevant to the QMS. I believe they are because our employees deliver a service to our clients and their needs are proper training, proper communication, resources such as electronic QMS management programs etc. Our suppliers have a direct input on our QMS for example if our IT systems are not running smoothly it causes time delays, loss of information etc. These are just examples. Could you please assist with clarity on who we have to consider as "interested parties". -
Defining scope and repercussions
Hello, -
Metodologías aplicación cláusula 4
Quisiera mayor información acerca de metodologías o herramientas que ayuden a determinar el alcance del sistema de gestión de calidad referente al apartado 4.3 de la norma. -
Auditor de certificación
Para poder realizar auditorias de certificación a otras empresas que requisitos requiere mi empresa y mi personal.