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Submitted February 26, 2018

Subject: ANAB Response to the Request for Comments on NIST Draft Conformity Assessment Publication 

SP2000-01: ABC’s of Conformity Assessment

Because the ABC document is intended to act as an explanatory document for those with little or no knowledge of conformity assessment 

systems and the different approaches available, it should be written to inform the reader about what conformity assessment is and is not, 

and so no conclusion is drawn.

TAs currently written, the document appears to promote some methods of conformity assessment over others. The document is heavily 

focused on product certification; most of the examples and language used are product-specific. The section on product certification list 

benefits that are applicable to the internationally recognized conformity assessment model as a whole, not product certification 

exclusively. The document does not adequately describe other methods of conformity assessment available. It implies that product 

certification is the type of conformity assessment to be used when risk associated with nonconformity is high, but the internationally 

recognized third-party accreditation framework in all aspects is built to reduce the risk.

In addition, the document appears to favor SDoC without providing adequate information on consequences of its use. The information 

on SDoC should be revised to clarify that when deciding to use SDoC there has to be a legislative framework available to deal with any 

issue that arise. The document states that SDoC is a “trade-friendly” approach but this could be misleading because many countries do 

not accept SDoC. Also, there is a higher likelihood of having to repeat a conformity assessment activity such as testing under SDoC. 

Under the internationally recognized third-party model that likelihood decreases significantly.
Section-specific comments follow:

Section: Reason: Suggested Change:

General Replace references to specific version of standards, as 

these change quite frequently.

Section 1 - Introduction:

Second Paragraph

Document is dominated by product certification in 

examples and language used. The reference to “object of 

conformity assessment” should be used through the 

document anywhere where general concepts are being 

described to ensure neutral tone of the document.

Introduce the definition of “object of conformity 

assessment” as a term applicable to products, services, 

persons, and systems.

Revise the paragraph using examples and language 

general to conformity assessment and not productspecific. 

 

Lines 170-174 Provide the reader with more general examples of 

conformity assessment activity.

Conformity assessment can verify that a particular 

product, service, or system meets a given level of quality 

or safety, and provide the purchaser or user or user with 

explicit or implicit information about its characteristics, 

the consistency of those characteristics, and/or 

performance.

Conformity assessment can also increase a purchaser’s

user’s confidence, furnish useful information to a 

purchaser or user, and help to substantiate a company's 

advertising and labeling claims ...

Line 183 Provide the reader with a more general example of 

conformity assessment activity.

.....program; and the adequacy and appropriateness of the 

standards against which the object of conformity 

assessment is evaluated.

Section 2: The section does not provide the reader with full 

understanding of all types of conformity assessment 

activities. 

Revise the section to include examples of system and 

personnel certification or revise to be more generic with 

references to object of conformity assessment.

Line 260 Missing references to system. Conformity assessment examines an object of assessment 

(such as a product, process, service, system, or person) 
and evaluates whether the object meets specified 

requirements. 

161/162 Clarify that audit also produces a report.

Revise wording in brackets (such as test, inspection, or 

audit report)

A determination is made based on evidence of conformity 

(such as a test, inspection, or audit report).

Line 164 replace surveillance with ongoing oversight.

Figure 2 – line 275/276 The term “registrars” is no longer used in favor of 

“certification bodies” or, more specifically, “management 

systems certification bodies.”

Last column replace term “Registrars” with management 

systems certification bodies. 

Revise reference to ISO/IEC 17021 to ISO/IEC 17021-1.

Add section on ISO/IEC 17024 Personnel Certification 

Bodies.

ISO/IEC 17065 is for Product Certification Bodies. First 

row of the column to ready “Product Certification”. In the 

last row revise “Product Certification Bodies”.

Figure 2. Because the reader may not have any understanding of the 

type of mutual recognition arrangements that are 

applicable to the international conformity assessment 

standard, the figure should be revised to include 

references to IAF and ILAC to enhance understanding of 

the international system.

In the second row, include appropriate references to IAF 

and ILAC mutual recognition arrangements.

Line 277/278 Clarification and linking to the introductory paragraph 

comments.

The following sections cover many conformity 

assessment activities used to determine whether an object 

of conformity meets specified requirements.

Line 294/296 SDoC is applicable to all types of conformity assessment. ISO/IEC 17050-1:2004 “Conformity assessment –

Supplier’s declaration of conformity – Part 1: General 

Requirements” (ISO 17050-1, 2004) specifies general 

requirements for a supplier’s declaration of conformity of 
an object to the specified requirements be attested, 

irrespective of the sector involved. The object of a 

declaration of conformity can be a product, process, 

management system, person or body.

Section 3.2 The section does not describe inspection as a type of 

conformity assessment activity. 

Add after line 219 - “ISO/IEC 17020 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.”

lines 320/327 Unless it is conducted under the IAF-ILAC model, there is 

no guarantee that the activity is not conducted by a first, 

second, or third party. In 3.1, 3.3, and 3.4 the focus is on 

third party.

Delete the following paragraph.

“Inspection can be performed by first, second, or third 

parties.” 

Section 3.4. Product certification is a type of certification, equivalent 

to management systems and personnel.

Identify as a subsection of section 3.4.

3.4 Certification:

3.4.1 Product Certification

3.4.2 Management Systems Certification 

3.4.3 Personnel Certification 

Lines 394 and 402 Third-party conformity assessment activities such as 

testing and inspection services are also used when risk 

associated with the object of assessment nonconformity 

elevated.

The concepts introduced in this section are applicable to 

all types of third-party conformity assessment programs 

including management systems certification, inspection, 

testing, etc. 

Replace “certification activities” with “third-party 

conformity assessment activities” in line 394.

Line 400 replace “product” with “object of conformity 

assessment”.

Move section to before section 3.2 as an introduction to 

third-party conformity assessment activities.

Lines 421 to 441 This information is applicable to all types of certification. Move to the beginning of the section 3.4. 
Section 3.4.1 “Certification bodies” is more widely used globally than 

“Registrars” and even in the United States certification 

bodies is preferred.

Information on management systems certification is 

lacking. 

Suggested revisions:

The certification of management systems is sometimes 

referred to as registration.

Management system certification is conducted by thirdparty . 

A management system is the way in which an 

organization manages the inter-related parts of its 

business in order to achieve its objectives. These 

objectives can relate to product or service quality, 

operational efficiency, environmental performance, health 

and safety in the workplace, and many more.

ISO/IEC 17021-1 contains principles and requirements 

for the competence, consistency, and impartiality of 

bodies providing audit and certification of all types of 

management systems.

The management systems certification process involves 

assessing the compliance of

documented policies and procedures with management 

system requirements according to a

specific scope. At a minimum, an annual audit of the 

implementation of the system requirements to the scope is 

conducted on a continuing basis. Certification bodies 

issue certificates and publish lists of certified

organizations and their scopes of certification.

Management system standards have been published by 

ISO relating to quality, security,
environmental, food safety, energy performance, antibribery, and other industry-specific operations. 

Such as some of the most commonly used management 

system standards are:

ISO 9001, Quality management systems – Requirements 

with Guidance for use

ISO 14001 Environmental management systems --

Requirements with guidance for use

ISO 22000, Food safety management systems -

Requirements for any organization in the food chain

ISO 27001, Information technology - Security techniques 

- Information security management systems -

Requirements

In addition, many industries and government agencies 

have used an ISO-developed management system 

standard and added industry-specific requirements (e.g., 

the International Aerospace Quality group with the AS 

9100, Quest Forum with TL 9000 program for the 

telecommunications industry, and DoE through the 

Superior Energy Performance program).

Section 3.5: The paragraph incorporates ISO/IEC 17011 and a 

description of the IAF-ILAC peer evaluation model that is 

only based on third-party oversight. 

Revise as follows:

There are accreditation programs conducted by third 

parties for testing laboratories, inspection bodies, and 

certifiers.

Figure 3: Missing references. Include other conformity assessment standards such as 

ISO/IEC 17021-1 and ISO/IEC 17024. 

Update the bottom of the pyramid to include facilities and 

systems.
Line 502 The first sentence is incorrect as there is not place within 

accreditation for peer evaluation; the intent of 

accreditation is independent oversight.

Separate accreditation from the rest of the paragraph. 

Line 502 to 512 The paragraph appears to include peer evaluation systems 

among CABs as well as ABs. There are two systems in 

place for peer evaluation: the IAF-ILAC systems for 

accreditation bodies and some schemes where CABs peer 

evaluate one another such as the IECex scheme. The IAFILAC model is widely accepted and recognized by many 

governments and industries. 

If the intent is to describes both, the difference between 

the two should be clarified and explained in detailed as 

the two are very different from each other. 

Line 510 The reader with background in conformity assessment 

may read the reference to “organization” and not think it 

includes entities such as industry, associations, etc.

Replace reference to “organization” with “specifier” and 

link to the bullets that follow the paragraph for examples 

of a specifier. 

Line 529 ISO/IEC 17067 is specific to product certification. 

Schemes are applicable to all types of conformity 

assessment bodies and conformity assessment programs.

Remove reference to ISO 17067.

Line 539/542 Missing references. Factors to be considered include the type of conformity 

assessment activities and specific requirements to be met, 

such as testing laboratories meeting the requirements of 

ISO/IEC 17025; inspection bodies and ISO/IEC 17020; 

certification bodies and ISO/IEC 17021-1, ISO/IEC 

17024 or ISO/IEC 17065; and use of supplier declaration 

of conformity per ISO/IEC 17050 ...

Line 548 to 555. It would be best to use an example of a government 

program where third-party accredited conformity 

assessment services and international conformity 

assessment standards are used. OSHA program does not 

address either one of these points.

This approach would be in line with the NTTAA and 

OMB A119.

Include examples of a program to align with the intent of 

NTAA and OMB A119.
Section 5: This section needs to include information on IAF, ILAC, 

and regional cooperations such as IAAC. These 

cooperations play a crucial role in the overall third-party 

conformity assessment system. 

The section should include a discussion on the oversight 

of ABs, ILAC and IAF. The document should illustrate 

the difference between how ABs operate as ILAC and 

IAF members versus ABs that do not participate, as there 

is a significant difference. 

Suggested text below:

The IAF and ILAC mutual recognition agreements are 

internationally recognized forms of approval; signatories 

have demonstrated their conformance with specified 

standards and requirements. Accreditation by a signatory 

of the ILAC MRA and/or IAF MLA provides assurance 

that decisions are based on reliable results, thus 

minimizing risk.

The International Laboratory Accreditation 

Cooperation (ILAC) and the International Accreditation 

Forum (IAF) provide this international oversight. ABs 

that are signatories of the ILAC and/or IAF mutual 

recognition agreements (MLAs or MRAs) must conform 

with the requirements of ISO/IEC 17011 as applicable 

program-specific requirements, and are admitted to the

agreements for a specific capability, for example, as an 

accreditor for testing labs or for management systems 

certification bodies. Technical competence of the AB and 

conformance to the requirements is verified through 

rigorous on-site evaluation by other members of the IAF 

or ILAC community.

This evaluation provides evidence or confirmation that an 

AB operates in accordance with international 

requirements when providing oversight of accredited 

CABs. It also provides assurance that the AB understands 

the CAB’s process and can attest to the CAB’s 

competence.

Thank you for the opportunity to provide input. ANAB will gladly provide advice and reasoned input based on our relevant experience

as a global accreditation body.
Respectfully,

Natalia Larrimer

ANAB