Can anybody share a sample risk assessment prepared based on ISO 17025:2017?

AndyN

A problem shared...
Staff member
Super Moderator
#2
Can you help us - the risk of using a lab, or risks TO a lab? A risk assessment by a lab isn't required to meet the ISO 9001:2015 option.
 

brucefon

Quality Coordinator - Hitachi High-Tech
#6
Everything.
The 2017 edition takes time to adapt when you're so comfortable working with the 2005 standard. It's a complete reworking in the likes of 9001 from what I've read. 18 deficiencies came out of our 2-day renewal assessment to 2017. Even with 2 months to prepare it caught us by surprise. I was able to answer and fix all 18 in the 60 days but not without a lot of help from resources like Eurolab, this forum, other Cabs like ANAB, and some from ours, A2LA.
 

AndyN

A problem shared...
Staff member
Super Moderator
#7
I'm currently working with an ISO/IEC 17025 accredited lab and I don't see much difference which would make that significant of a change. Yes, the section 4 and 6 requirements are different, but the rest is basic blocking and tackling (doesn't need changing much) from what was required under 2008... I'd be interested in what the 18 deficiencies were. Was it auditor bias?
 

brucefon

Quality Coordinator - Hitachi High-Tech
#8
I would like to say half were probably assessor bias or interpretation but most were not technical in nature, rather, writing procedures that didn't exist before for many clauses related to risk this and risk that.
 

brucefon

Quality Coordinator - Hitachi High-Tech
#10
Get ready to be impartial and identify risks to impartiality, confidentiality, and everything else. Then put it in writing.
 

Top Bottom