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Organizational knowledge
Thanks for information and guidance that you are continuously made them available for us. -
Auditing of the new version
I was able to attend your webinar,, my audit team was there as well...I still am a bit confused about the Internal audits that need to be conducted per the new standard.. Can you elaborate for me please? -
Transition of ISO 13485 and maintaining ISO 9001
Our company is manufacturing of Customize Orthopedic shoes . As of now we are currently holding the ISO 9001:2008 and ISO 13485:2012 and have a plan to upgrade in to ISO 13485:2016 by next year. Is it possible to cancel the ISO 9001:2008 and focus to ISO 13485. what do you advice. -
Qualifications of the Management Representative
1.What if the appointed QMR has no background in ISO is she/he qualified to be QMR or not? -
Implementing ISO 9001 in hospital
I want to implement the ISO standard a in my Hospital . Can you guide me for the same . I need the standard manual , the step wise detailing for ISO certification -
Quality manual and procedures in small company
I need to write a quality manual for a small manufacturing company. I am confused by all the documents that are referred to in a Quality Manual -what should be included in a quality manual - are all the external docs required also? -
Risks assessment in ISO 9001
Hope you will be fine & in good health.