Is a Laboratory Scope Necessary if...

jackerman64

Corp Quality Sys *****
All of your calibrations are sent to or performed by ISO 17025 accredited labs and no additional lab testing is performed other than pre-launch?
 

Sebastian

Trusted Information Resource
Re: Is a Lab Scope Necessary if...

7.1.5.3.2 requires laboratory scope of external laboratory, so you have to have it. I can not imagine, that there is no internal laboratory onboard and 7.1.5.3.1 does not applies at all. Please follow laboratory definition.
 

howste

Thaumaturge
Trusted Information Resource
Re: Is a Lab Scope Necessary if...

It seems to me that it's easier to just have a lab scope than it is to try to weasel out of having one.
IATF 16949 definition for Laboratory said:
Facility for inspection, test, or calibration that may include but is not limited to the following: chemical, metallurgical, dimensional, physical, electrical, or reliability testing.
Do you do any dimensional inspection? Also, even pre-launch testing performed onsite would require a lab scope.
 

joekirk

Involved In Discussions
Re: Is a Lab Scope Necessary if...

7.1.5.3.2 requires laboratory scope of external laboratory, so you have to have it. I can not imagine, that there is no internal laboratory onboard and 7.1.5.3.1 does not applies at all. Please follow laboratory definition.
In addition, you should also confirm that the laboratories lab scope actually covers or states that type of services that they are accredited too.
Example: Company is ISO17025 and their scope covers calibrating weight scales and you are using them to calibrate an x-ray diffraction machine (not part of scope).
 

amiuda

Involved In Discussions
Re: Is a Lab Scope Necessary if...

In addition, you should also confirm that the laboratories lab scope actually covers or states that type of services that they are accredited too.
Example: Company is ISO17025 and their scope covers calibrating weight scales and you are using them to calibrate an x-ray diffraction machine (not part of scope).

HI Jorkirk,
Well... for a ISO17025 accredited I believe is not necessary to ask for their lab scope:

1. Go to https://ilac.org/signatory-search/ (ILAC is the international Laboratory Accreditation entity);
2. on "Economy" select your country, and you´ll find out country entity responsible for lab acreditations;
3. access this entity and check if the lab you are using is acredited for the analysis they´re performing (so no lab scope required) !

Usually I ask for Lab scope for the labs that are not ISO17025 (ex. tests done on other sister plants).

Hope this helps.
 
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dwperron

Trusted Information Resource
Re: Is a Lab Scope Necessary if...

The new (2017) version of 17025 clears this up in Annex A. A.3.1.b):

"Scopes of accredited calibration laboratories are publically available from their respective accreditation bodies."

You need to declare what you have been accredited to do, so a scope is mandatory.
 

amiuda

Involved In Discussions
Re: Is a Lab Scope Necessary if...

The new (2017) version of 17025 clears this up in Annex A. A.3.1.b):

"Scopes of accredited calibration laboratories are publically available from their respective accreditation bodies."

You need to declare what you have been accredited to do, so a scope is mandatory.

Let's avoid confusion.
From a point of view of ISO 17025 lab, of course you need a lab scope.

Here, the question of this author is if he has calibrations done externally by a ISO 17025 if he needs to ask their lab scope.
The answer is no, is not necessary.
 
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howste

Thaumaturge
Trusted Information Resource
Is a Laboratory Scope Necessary if... All of your calibrations are sent to or performed by ISO 17025 accredited labs and no additional lab testing is performed other than pre-launch?

Let's avoid confusion.
From a point of view of ISO 17025 lab, of course you need a lab scope.

Here, the question of this author is if he has calibrations done externally by a ISO 17025 if he needs to ask their lab scope.
The answer is no, is not necessary.

I believe that the OP is actually asking about IATF 16949 clause 7.1.5.3.1:
7.1.5.3.1 said:
An organizations internal laboratory facility shall have a defined scope that includes its capability to perform the required inspection, test, or calibration services. This laboratory scope shall be included in the quality management system documentation.
I believe his question is, "if I outsource all calibration and post-launch testing to external 17025 accredited labs, do I still need an internal laboratory scope?" My answer is yes, they still need a lab scope to cover any internal inspections as well as pre-launch testing.
 
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