ISO 13485:2016 Quality Policy Requirements

#1
Our company is currently in the process of MDSAP certification and on review of our current Quality Policy I've noticed that it talks about the QMS intending to comply with relevant ISO and international regulatory requirements and specifically lists these. For example ISO 13485, 93/42/EEC, US FDA QSR 21 CFR 820 etc. However, the ISO 13485 standard does not appear to specifically require this. Under section 5.3 Quality Policy the standard states: "b) includes a commitment to comply with requirements and to maintain the effectiveness of the quality management system;". In order to comply with this clause does anyone know if companies need to list the standards and regualtions it complies with in order to meet Section 5.3 of the standard? Does the "requirements" part of this clause mean that standards and regulations should be identified?
 
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indubioush

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#2
There is no requirement that the quality policy specifically list applicable standards. I have never listed standards, but you could if you wanted to. However, you should list the regulations and standards in your quality manual because this clarifies the scope of your quality system.
 

myusoffice

First Time Right...
#3
The scope of your quality management system should include and specifically state all applicable regulatory requirements and quality system management standard being applied. This is normally documented in Quality Manual.

Quality Policy doesn't require to state applicable regulatory requirements. Hope this helps
 
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