QMS for Life Sciences
Elsmar Cove Forum Sponsor

What accreditation is required for Internal Laboratories?

E

ellie

#1
My company is a compounder with internal laboratories. Many managers are questioning if we must maintain our laboratory accreditation to ISO17025 or equivalent to be accredited per QS9000, third edition?
 

Stuart Andrews

Involved - Posts
#2
The way I see it is this!

If you had ISO17025 before you were/are going to be QS accredited then you must have done this for a reason. Ask yourself - what was that reason?

Even if you are ISO17025 accredited, this does not mean you will meet the requirements of lab control for QS9000 (but you probably will). You still need to meet ALL the requirements of QS9000 separately.

If one of your customers requires you to have ISO17025, they won't be impressed if you've decided to leave out ISO17025 and go for QS9000 instead.

I really think you need to keep both because QS9000 is an automotive quality management standard that gives “minimum requirements” for in-house Lab control, and I would imagine it doesn’t come close to meeting the requirements of a Lab accreditation cert. Not by a long way!!!!
 
D

D.Scott

#3
To address your managers' questions - No - there is no requirement to have accreditation to ISO17025 in order to be accredited to QS-9000. As Stuart says though, if a customer requires it - that's a different matter.
Dave
 

Stuart Andrews

Involved - Posts
#4
D.Scott, upon reading your reply I had concluded that as ellie had stated "maintain"; their company already had ISO17025. But your interpretation of the question is right, and there is no need for a QS9000 sub-contractor/supplier to have ISO17025 to become QS accredited.

I thought I'd clarify this incase ellie was confused by my first answer.

[This message has been edited by Stuart Andrews (edited 09 June 2001).]
 
Top Bottom