Dual ISO 9001 and ISO 13485 Certification for Company with different Product Lines

O

ontheopenroad

#11
Re: Dual ISO 9001 and ISO 13485 Certification

Also, on my quality policy, I used the phrase by maintaining and improving the effectiveness, and this sat well with both the 9001 and 13485 auditors (I had to run separate audits this time due to time constraints with the expiry of my existing certificate).
 
Elsmar Forum Sponsor
#12
Re: Dual ISO 9001 and ISO 13485 Certification

In addition to Coury:
The quality policy should in addition bear the comittment to comply with regulations.

Our ISO 9001:2008 Quality Policy already states a commitment to meet regulatory requirements, so we're good to go in that respect.
 
B

Bill Marshall

#13
Re: Dual ISO 9001 and ISO 13485 Certification for Company with different Product Line

With regards to the policy differences between 9001 and 13485, I did read an explanation of this a while ago which goes something like this :-

ISO 13485 was intended as a harmonised standard to satisfy the requirements of the medical devices directive.
Because the legislative requirements are static (necessarily so in order that they have any legal weight), continual improvement was deemed to be beyond the scope of the standard.
The standard therefore focusses on compliance with requirements, ie maintenance rather than improvement of effectiveness.

I hope my memory serves me well and that this doesn't over simplify it,

best regards from the UK
 
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