ISO 17025 Certified Calibration Laboratory Has Moved Facilities

[gard2372]

If a Cal Lab certified to ISO 17025 has moved facilities is there a requirement in the standard to recertify through the registrar or notify the registrar that the lab has moved to another facility? I know A2LA has this requirement, but I'm not sure is 17025 requires the same thing.

The lab is however recertifying with a new registrar in a few months, but what about all tools calibrated over the last few months?


I'm not worried about the certification of the lab, I'm more concerned about risk.

Namely:

1- The lab moved, and if they notified their customers of the move shouldn't their customers and the lab themselves require a recertifiction for the new lab facility?

2- If not, what are the risks associated with the move if no recertification has been done?

 

[AndyN]

Just a point or two of clarification for the people who might respond.......

Is the lab. accredited to ISO/IEC 17025 by an ILAC accreditation body?

There may be some labs which are certified by registrars, but this isn't as valid as being accredited:mg:

To get the most benefit, we have to use the correct terminology and avoid confusing less knowledgable Covers....

 

[BradM]

Just a point or two of clarification for the people who might respond.......

Is the lab. accredited to ISO/IEC 17025 by an ILAC accreditation body?

There may be some labs which are certified by registrars, but this isn't as valid as being accredited:mg:

To get the most benefit, we have to use the correct terminology and avoid confusing less knowledgable Covers....

Andy, are labs certified to 17025? I thought they were just accredited (just under 17025; not 9001). Can you educate me?

 

[AndyN]

Andy, are labs certified to 17025? I thought they were just accredited (just under 17025; not 9001). Can you educate me?

In the current early stages of development of laboratory implementation of ISO/IEC 17025, there's a lot of mis-understanding about. The most effective recognition of a lab is accreditation, as you know. The most credible is accreditaion which is offered by an accreditation body which subscribes and is recognized under the ILAC arrangements.

There are however opportunties for other organizations to offer a variety of external recognitions - indeed one I know of offers lab accreditation and doesn't even visit the lab. to verify their processes.:mg: Some labs are still ISO 9001 registered, even though this isn't really appropriate anymore.

 

[Mr Niceguy]

There is no actual requirement to suspend 17025 accreditation when moving facilities perhaps because 'moving' is hard to define.

I know from our own relocation experience that at least several months ahead the lab must inform its accreditation body, who will then propose the options. Our AB did not at any time impose a single option. There was some negotiation. In our case (we are a testing lab) the options were:

1) suspend all accredited test/calibration claims on last normal working day at old location and agree with the AB a re-assessment date after some suitable bedding-in period, say 3 months.

2) Maintain accreditation but carry out testing/calibration performance checks, agreed in advance with the AB, just before and just after the relocation (clause 5.5.9). Immediately in the new location the lab does a full internal audit of accommodation/environmental conditions and audits the two sets of testing/calibration performance checks. The AB carries out a full assessment within about 4 weeks in the new location, paying particular attention to the lab's recent internal audits.

Our AB agreed the second option (maintaining accreditation), but it knew that all equipment relocation was over 2-3 working days. It would have been temporarary suspension if the move was in bits and pieces over several weeks.

If accreditation of the testing/calibration lab was temporarily suspended a customer would have to ask them what their strategy was in order to judge the risks, in others words, some kind of customer audit of their audits until accreditation was re-confirmed by an AB.

 

[Hershal]

Andy, are labs certified to 17025? I thought they were just accredited (just under 17025; not 9001). Can you educate me?

There actually is a reason........

Labs and inspection agencies, registrars, product certification bodies, and personnel certification bodies all get accredited.....the Standards are a bit various, but for this forum, labs get accredited under ISO/IEC 17025, and inspection agencies under ISO/IEC 17020.....

The accredited registrars then can register another organization to ISO 9001.....

Certification applies to products and to personnel, not to organizations.....

So, what then is the big difference between registration and accreditation?

Both review procedures and manuals and records, and interview people.....on the quality side, the auditor may/may not have the same or similar background to the organization.....

Accreditation then picks up and brings in technical assessors, proficient in that discipline/field.....the organization being assessed must then prove to those assessors that it actually knows what it is doing, known in this world as "competence".....also, depending on a few variables, the methods employed for "Assurance of Quality" (ISO/IEC 17025 Clause 5.9.1 for labs) are reviewed in depth.....

Hope this helps.

 

[Hershal]

Oh, as to the original question.....check with your accrediting body.....they will let you know whether re-assessment is required......