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Cláusula 8.5.2
La alta dirección dio instrucciones de que todos los procesos estén dentro del alcance de la norma para la empresa, sólo que una de las cláusulas (8.5.2) aplica solamente para una parte de un proceso. ¿Ésto debe quedar definido dentro del alcance?¿ Hay algún problema con ello? -
Implementación ISO 9001
Aplicando la ISO por ejemplo se certifican todas las etapas de fabricación de un producto?, o se puede certificar sólo alguna de las etapas de fabricación del mismo? es algo que me genera un poco de duda -
Certification and compliance
"My name is XXXX and I am starting a company which manufactures (suspends chemical compound into a suspension) and distributes the product as a research chemical. My main question is what certifications should I look at acquiring to make my business fully compliant. I am based in Australia, however would like to offer international shipping." -
Certification scope
"Our organization consist of 18 branches across the country. Only 8 of them ISO certified. Should I put all 18 branches under the scope or only 8 ISO certified branches?" -
Continual improvement vs step change improvement
What is the difference between continual improvement and step change improvement in the risk management. -
Design, validation versus verification
"Can you please tell me Why are the verification and validation important elements of the system design?" -
QMS scope narrowed to one department
We are a Department within an organization. The organization's employees may exceed 1000 in the organization. -
Quality objectives and risks
"After I have finished SWOT analysis, I entered all the points to the risk and opportunities matrix (probability*severity), and then -based on the results- I put quality objectives to deal conveniently with the SWOT' outputs. My question is, Is it needed to determine new risks that may threaten these quality objectives??" -
Nonconforming output and nonconformity
" What is the difference between nonconforming output and nonconformity?