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New 9001 and 13485 standard
Hi! In new 9001 standard says that there is no need to have an management representative? how about in the new 13485 standards? is the new 13485:2016 is still need the MR or not -
Risk assessment methodology
How to get the risk rating considering the probability, consequence etc. for what rating mitigation plan to be provided and basis? As such standard is not give details for various parameters and rating etc.. how auditors will accept such table made a company? -
Why is top management important for QMS
How you will elaborate the importance of top management role in a QMS and reason? What shall we do if we find management do not take interest in design and QMS? what will your convincing points? -
Top management role in QMS
Whats is the importance of Top Management role in a Quality Management system? -
Auditoria de Certificación
Cuando me hagan auditoria, me preguntan por la caracterización del proceso, el mapa de proceso y el flujo grama? o con cualquiera de los tres cumplo el requisito? -
EA 35 code
I have two questions and I do not know if you can help me . -
Writing a Quality Manual
How to write water quality management system manual in mineral water factory? -
Surveillance audit
Hi! please assist me to my concerned. 1. We have upcoming surveillance audit by september 2017. and the expiration of are certificate is april 2018. what if the auditor found a 1 or 2 major NC what will be happen to are certificate. 2. How long is the compliance for the identified major NC. 3. And what if the auditor didn't satisfy for the compliance of the major NC. Thank you. -
DUDA
Buenos Dias, en el punto 7.1.2 de la ISO 9001:2015 me piden un manual de funciones. la pregunta seria el manual de funciones es lo mismo que el perfil de cargos o son dos cosas diferente? en caso de ser dos cosas diferentes ¿podría hacer una unión de esos dos para que quede como uno? -
Documenting clause 6.3
What is the best documentation to demonstrate compliance with clause 6.3 Planning of changes ISO 9001: 2015?