ANAB Expands to Offer Testing and Calibration Laboratory Accreditation

Sidney Vianna

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From the ANAB website:

The ANSI-ASQ National Accreditation Board (ANAB) has acquired Assured Calibration and Laboratory Accreditation Select Services, LLC (ACLASS), expanding ANAB conformity assessment services to include accreditation of testing and calibration laboratories. The ACLASS acquisition complements the management systems business of ANAB.

The added expertise of ACLASS allows ANAB to further its mission to be a value-added, cost-effective provider of accreditation of conformity assessment services. The expansion of services puts ANAB in a position to increase the recognition of accreditation nationally and worldwide.
 
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Sidney Vianna

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Registrars be afraid, be very afraid....

And now that ANAB is in the Laboratory Accreditation Business, it will prohibit the issuance of non-accredited statements of conformance to ISO 17025. Check their latest Heads Up: 113. Accredited CBs and ISO/IEC 17025

CB's might lose their accreditation. For issuing non-accredited statements of conformity to standards such as ISO 17025 and ISO 15189.
 

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Hershal

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Re: ANAB Expands to Offer Lab Accreditation

WOHA guys.....let's not panic here.........

ACLASS to my knowledge is still a signatory to the APLAC (Asia Pacific Laboratory Accreditation Cooperation) MRA (Mutual Recognition Arrnagement).....that means that they MUST abide by rules defined by APLAC and ILAC (International Laboratory Accreditation Cooperation).....or risk losing the internation recognition.....those rules by the way are available at no cost on the APLAC website and the ILAC website.....

http://www.aplac.org

http://www.ilac.org
 

Sidney Vianna

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Re: ANAB Expands to Offer Lab Accreditation

that means that they MUST abide by rules defined by APLAC and ILAC (International Laboratory Accreditation Cooperation).....or risk losing the internation recognition
Hershal, what rules are relevant to this situation? I don't follow the connection between my previous post and this. Could you please clarify?
 

Hershal

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Re: ANAB Expands to Offer Lab Accreditation

I will try. ISO/IEC 17011 is very clear, and is referenced in the ILAC-IAF release. The ANSI-ANAB announcement contains only one new statement, and that is that they will conform to the international requirements that laboratory ABs have had to comply with for years, both under 17011 and its predecessor Guide 58.

As an example, if a CAB (using the current language) issues an accreditation to ISO/IEC 17025, no MRA signatory AB will accept that accreditation, and will in fact very likely write a corrective action to the laboratory.....this is and has been standard practice since the MRA inception.

APLAC puts a range of documents on its website such as the MR and PR series documents, for example PR 008.

Hope this helps.
 

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Re: ANAB Expands to Offer Lab Accreditation

I will try. ISO/IEC 17011 is very clear, and is referenced in the ILAC-IAF release. The ANSI-ANAB announcement contains only one new statement, and that is that they will conform to the international requirements that laboratory ABs have had to comply with for years, both under 17011 and its predecessor Guide 58.

As an example, if a CAB (using the current language) issues an accreditation to ISO/IEC 17025, no MRA signatory AB will accept that accreditation, and will in fact very likely write a corrective action to the laboratory.....this is and has been standard practice since the MRA inception.

APLAC puts a range of documents on its website such as the MR and PR series documents, for example PR 008.

Hope this helps.
It is as clear as mud. The ISO/IEC 17011 paragraph 4.3.6, referred to in ANAB's HU states:
4.3.6 - The accreditation body shall not offer or provide any service that affects its impartiality, such as :
a) those conformity assessment services that CABs perform, or
b) consultancy.
The accreditation body’s activities shall not be presented as linked with consultancy. Nothing shall be said or implied that would suggest that accreditation would be simpler, easier, faster or less expensive if any specified person(s) or consultancy were used.
So, now we have a case where an Accreditation Body decided to expand it's activities as a Laboratory Accreditation Body, and by doing so, created a conflict with CABs that want to issue statements of conformity to ISO 17025. And decides that, in order to mitigate the conflict, it will enforce a rule that prohibits the accredited CAB's to issue non accredited statements of conformity, or lose it's accreditation.
The above paragraph of ISO 17011 places the restriction on the AB's, not the CAB's. It seems to me that there is a reversal of responsibilities here.
For a Lab. Accreditation Body not to accept statements of conformity issued by non-accredited organizations is totally understandable. But the threat of revocation of accreditation for non-accredited certification is a totally different measure.
 

Hershal

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Re: ANAB Expands to Offer Lab Accreditation

Actually, the rule is not new at all.....it has been in place and enforced for several years.....the only part that is new is that ANSI-ANAB is going to also enforce it.....that is because they acquired ACLASS and in order to maintain the international recognition because ACLASS is an APLAC signatory body, they must enforce this rule.....

Those of us who work for laboratory ABs welcome this announcement.....we have been enforcing it for years and are happy they are now on board also.....
 

Sidney Vianna

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What rule?

The more I think about this, the more convoluted this becomes. For example, ISO 17025 states:
[FONT=Helvetica, sans-serif]Growth in the use of management systems generally has increased the need to ensure that laboratories which form part of larger organizations or offer other services can operate to a quality management system that is [/FONT]
[FONT=Helvetica, sans-serif]seen as compliant with ISO 9001 as well as with this International Standard. Care has been taken, therefore, to incorporate all those requirements of ISO 9001 that are relevant to the scope of testing and calibration [/FONT]
[FONT=Helvetica, sans-serif]services that are covered by the laboratorys management system. [/FONT]

[FONT=Helvetica, sans-serif]Testing and calibration laboratories that comply with this International Standard will therefore also operate in accordance with ISO 9001. [/FONT]

[FONT=Helvetica, sans-serif]Conformity of the quality management system within which the laboratory operates to the requirements of ISO 9001 does not of itself demonstrate the competence of the laboratory to produce technically valid data and results. Nor does demonstrated conformity to this International Standard imply conformity of the quality management system within which the laboratory operates to all the requirements of ISO 9001. [/FONT]
Not only the second paragraph of the quoted text contradicts the last sentence of the third paragraph, but imagine a situation where a calibration wants to attain "accreditation" to ISO 17025 AND certification to ISO 9001, as well. If ANAB/ACLASS were to issue an ISO 9001 certificate to the lab, they would be violating ISO/IEC 17011.

So, the lab would have to hire two separate agencies to perform audits to both ISO 17025 AND ISO 9001, even though ISO 17025 states
Testing and calibration laboratories that comply with this International Standard will therefore also operate in accordance with ISO 9001.
:frust:.

I don't think the benefactors of the ruling have really thought this one through.

And what will ANAB do with that CAB that has a related body doing laboratory accreditation?

I wouldn't be surprised if this tangled web end up in the court system...
 
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Hershal

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#9
You are right that if a lab wants/needs both 17025 and 9K, then two separate organizations are required.....that s one of the reasons we saw a few years back both L-A-B and A2LA sign agreements with registrars for a joint assessment.....I believe both have subsequently cancelled their agreements.....

Fortunately, ISO/IEC 17025:2005 is aligned with 9K to the degree it needs to be, so a 9K organization does not NEED to impose 9K on their accredited cal lab, and in fact will likely only raise their costs, since the costs get passed along (it is business after all).....

Now, in the U.S., I believe there are no ABs that also have a 9K registrar as a part of their organization, at least none with international recognition.....others without recognition I am unsure about.....but their certs would likely not be accepted anyway.....

Outside the U.S., however, many of the ABs are Government organizations and offer accreditations to labs, inspection bodies, 9K registrars, etc........

In each case, in order to achieve international recognition, there must be some significant firewalls in place.....

So, one AB can offer lab accreditation and also accreditation to a 9K registrar, and with appropriate firewalls that is acceptable.....but the accredited registrar cannot then provide accreditation to a laboratory.....only the AB can do that.....the registrar could however provide a 9K registration to the lab.....

Hope this makes it a bit more clear.
 
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