AMERICAN COUNCIL OF INDEPENDENT LABORATORIES

1875 I Street NW ▪ Suite 500 ▪ Washington, DC 20006 ▪ TEL 202.887.5872 ▪ FAX 202.887.0021 ▪ www.acil.org ▪ info@acil.org

February 26, 2018

Ms. Lisa Carnahan and Ms. Amy Phelps

Standards Coordination Office

National Institute of Standards and Technology

100 Bureau Drive

Gaithersburg, MD 20899

Re: NIST’s “Draft Conformity Assessment Considerations for Federal Agencies” (Special Publication 2000-02) 

and ‘‘Draft ABC’s of Conformity Assessment’’ (Special Publication 2000-01)

Dear Lisa and Amy,

The American Council of Independent Laboratories (ACIL), founded in 1937, is the trade association 

representing independent, commercial scientific and testing laboratories. Its members are professional 

services firms engaged in testing, product certification (including medical devices), consulting, and research 

and development, including several internationally accredited organizations and their laboratory partners. 

Affiliated membership is available to manufacturer’s laboratories, consultants, and suppliers to the industry.

ACIL commends and thanks NIST for the transparency and outreach to stakeholders that have been employed 

in this effort. From the NIST Workshop for Developing Conformity Assessment Guidance in early 2017, the 

publishing and opportunity to comment on these drafts, and all of the formal and informal encouragement 

and communication in soliciting stakeholder engagement along the way, ACIL views NIST’s approach as a best 

practice of government engaging stakeholders to develop meaningful guidance.

ACIL believes addressing and incorporating the feedback below will enhance what is already a thoughtful pair 

of guidance documents for Federal Agencies. We commend NIST for taking on this difficult task of 

establishing a tool that can be leveraged for facilitating public-private engagement and strengthen confidence 

in the United States’ conformity assessment programs, which in turn strengthens our position for 

international trade.

Respectfully,

Richard Bright

Chief Operating Officer

American Council of Independent Laboratories (ACIL)

rbright@acil.org

Enhancing Public Health and Safety

Through Quality Testing and Engineering
AMERICAN COUNCIL OF INDEPENDENT LABORATORIES

1875 I Street NW ▪ Suite 500 ▪ Washington, DC 20006 ▪ TEL 202.887.5872 ▪ FAX 202.887.0021 ▪ www.acil.org ▪ info@acil.org

See Attachment – ACIL Concerns
Page 1 of 4

AMERICAN COUNCIL OF INDEPENDENT LABORATORIES

1875 I Street NW ▪ Suite 500 ▪ Washington, DC 20006 ▪ TEL 202.887.5872 ▪ FAX 202.887.0021 ▪ www.acil.org ▪ info@acil.org

ACIL Concerns Regarding

NIST Draft Conformity Assessment Publications

Given the interrelationship between the two documents, ACIL is submitting this combined

response for both NIST’s “Draft Conformity Assessment Considerations for Federal 

Agencies” (Special Publication 2000-02) and ‘‘Draft ABC’s of Conformity Assessment’’

(Special Publication 2000-01).

Clarify the intended usage and interrelationship of the two documents, 

better define the expectations for and definition of conformity 

assessment, eliminate redundancy, and guide agencies to decisions:

ACIL suggests that the “ABCs” document act as a primer for those agency personnel not 

familiar with conformity assessment. The aim is to help them understand the concepts 

before attempting to use to “Considerations” document as guide for developing a 

conformity assessment program.

With that aim in mind, the ABCs document should provide an accurate description of what 

conformity assessment is and is not. Conformity assessment is not a guarantee or a control 

– it is a demonstration that creates an incentive for compliance. The document(s) should 

not wrongly imply that conformity assessment guarantees or ensures compliance.

The core content of the Considerations document begins on line 826 with Defining the 

Conformity Assessment Model. We recommend reorganizing the document to begin with 

the definition of the model. Prior to line 826, much of the text is a regurgitation of the ABC’s of 

conformity assessment. We suggest referencing to the ABCs document to eliminate 

redundancy, reduce the size of the Considerations document, and create a better 

interrelationship between the two.

The Considerations document also ends prematurely. It doesn’t offer conclusions to help 

agencies make their choices. This is a missed opportunity because the conclusion could be 

developed into a checklist or set of guiding questions for agencies to use when determining 

the appropriate conformity assessment system to develop. Without this, an agency 

considering a conformity assessment program would have a lot of information, but not the 

steps to guide them to decisions.
Page 2 of 4

AMERICAN COUNCIL OF INDEPENDENT LABORATORIES

1875 I Street NW ▪ Suite 500 ▪ Washington, DC 20006 ▪ TEL 202.887.5872 ▪ FAX 202.887.0021 ▪ www.acil.org ▪ info@acil.org

Remove and avoid unnecessary bias regarding supplier’s declaration of 

conformity (SDoC), government laboratories and public versus private 

sector solutions:

The ABCs document should not be used to promote one method of conformity assessment 

over another (e.g. debating the merits of SDoC/first-party versus second-party or thirdparty). The purpose of discussing the types of conformity assessment is to reinforce the 

principle that there are different avenues/types, the reason for which is because they 

deliver different levels of assurance and are applied based on what is needed to manage 

risks and instill the necessary level of confidence.

The Considerations document would be a more appropriate place to identify the types of 

questions agencies should consider when selecting methods of conformity (see above 

comment about developing a conclusion to the Considerations document). However, again, 

this should not be about debating the merits of one method over another, but about guiding 

agencies to apply some criteria/considerations that are helpful to evaluate when making 

those decisions.

There are several other examples of public sector bias and bias toward particular methods

of conformity assessment. ACIL strongly requests the following bias be amended:

The testing sections of the documents present a bias to government/university labs for 

testing, when private sector laboratories provide more abundant and often more costeffective capabilities; in most cases, private sector labs assessed as to their competency 

by an accrediting body. This should be changed to provide a neutral description of 

laboratories instead of predominantly highlighting government laboratories. By doing 

so, NIST would reinforce the directive and spirit of Office of Management and Budget 

(OMB) Circular A-119, which points agencies to rely on private sector standards and 

conformity assessment activities in lieu of government-unique standards/programs 

unless it is impractical or otherwise inconsistent with the law.

Within section 3.3 of the ABCs document is an example of the bias in the document ACIL 

is identifying with the first choice in the list of labs are all government or government 

supported labs (highlighted in bold italics). The “also” list is clearly delegated to second 

class citizenship.

“Testing can be performed by first, second, or third parties as well as by laboratories 

differing widely in size, legal status, purpose, range of testing services offered and 

technical competence. They may be government regulatory laboratories, 

government research laboratories, or government supported laboratories. They 

can also be college/university laboratories, private sector laboratories, 
Page 3 of 4

AMERICAN COUNCIL OF INDEPENDENT LABORATORIES

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laboratories affiliated with or owned by industrial firms or industry associations, or 

manufacturers' in-house laboratories."

The blanket statement “reliance upon SDoC is considered a ‘trade-friendly’ approach to 

conformity assessment.” is inaccurate. SDoC should not be highlighted as a preferred 

solution, but equally balanced with descriptions of 2nd and 3rd party conformity 

assessment. Here is our desired change:

• SDoC, 2nd party or 3rd party is dependent upon what regulators have 

determined is needed and/or what markets demand by way of confidence. 

Fundamentally, conformity assessment is designed to overcome confidence 

concerns to bring objects of conformity assessment to market.

• When SDoC is enough to satisfy confidence needs, there is not a market for thirdparty to provide services; conversely, where greater confidence is needed, SDoC

does not solve that issue.

Lines 607 through 610 of the ABCs document should be revised to take into account 

recognition by others means than peer evaluation. While organizations such as 

International Laboratory Accreditation Cooperation (ILAC) use this process, others, 

such as the North American Laboratory Accreditation Cooperation (NACLA) use paid 

assessors to conduct evaluations but also meets the requirements of ISO/IEC 17011. 

Again, the language should be balanced to represent that there are different solutions 

that provide different levels of benefit and costs that should be chosen based on the 

risks they are intended to mitigate.

We encourage NIST to balance the appropriate use of the example of the OSHA NRTL 

program (e.g. ABCs document Page 18). While it is an example of saving costs by 

leveraging third party certification, it does not leverage private sector capabilities for 

third party accreditation, instead it is performing its own first party evaluations of its 

certifiers.

Throughout both documents, the language used is predominantly product focused. This 

excludes that conformity assessment methods and approaches can be used to provide 

confidence for services, processes and systems as well. These can collectively be 

generalized and defined (in the ABCs document) as the “object of conformity 

assessment”. Since product is intuitive, the definition could benefit from the inclusion of 

an example for system and personnel certification.
Page 4 of 4

AMERICAN COUNCIL OF INDEPENDENT LABORATORIES

1875 I Street NW ▪ Suite 500 ▪ Washington, DC 20006 ▪ TEL 202.887.5872 ▪ FAX 202.887.0021 ▪ www.acil.org ▪ info@acil.org

Correct deviations from international norms, out of date references, and 

incomplete descriptions of aspects of conformity assessment:

Language within both documents deviates from international norms. Consideration should 

be given to consistently using ISO principles. For example: the “Government” callout in 

ABCs visual (page 10) as something equally defined as 1st party, 2nd party, 3rd party, etc. 

is not aligned with ISO principles. We agree government has a unique role as a regulator, 

which could be called out in a different fashion (e.g. a general sentence as opposed to its 

own unique “box”).

In figure 2 on Page 10 of the ABCs document, there are out of date terms and standards 

used: The term “registrars” is no longer used, and has been replaced with “Management 

Systems Certification Bodies”. Their corresponding standard is now ISO/IEC 17021-1. This 

table is missing Personnel Certification Bodies / ISO/IEC 17024. The box with ISO/IEC 

17065 should be labeled “Product Certification Bodies”.

In the ABCs document, Section 3.2, Inspection, should reference ISO/IEC 17020, which 

defines requirements for the operation of various types of bodies performing inspection. 

The broad definition of inspection in the standard allows great flexibility in application 

from systems to services and raw material to finished products.

In Section 3.4 of the ABC’s document, Product Certification should be established as its own 

subsection on Page 13. The way it is currently written, Management Systems and 

Personnel appear to be a subset of product, which is incorrect. Similarly, Lines 321 

through 341 on Page 15 are applicable to management systems and personnel certification 

as well. We suggest moving these to the beginning of 3.4 to follow definition of certification 

as per ISO 17000 and include examples from other program besides product certification 

in the last bullets (lines 436-441).

In the ABCs document, Line 444, the term “registration” is no longer used. This should be 

removed or made to be in past tense.

Throughout both documents, to prevent out of date references, when referencing ISO and 

IEC standards, it’s suggested to remove the dates from the standards as they are revised on 

a periodic basis (typically every five years).

In the ABCs document, Page 18, Figure 3 should be updated to include other standards such 

as 17021-1 and 17024. The bottom of the pyramid should also list facilities and systems.

In the ABC’s document, Section 5 should include examples and information on IAF/ILAC 

and regional co-operations such as IAAC and NACLA.