February 26, 2018

Lisa Carnahan

National Institute of Standards and Technology

100 Bureau Drive, Stop 2100

Gaithersburg, MD 20899

Transmitted electronically to sp2000-02@nist.gov

Re: NIST Special Publication 2000–02: Conformity Assessment Considerations for Federal Agencies

Dear Ms. Carnahan,

As the leading trade association representing the manufacturers of electrical and medical imaging equipment, 

the National Electrical Manufacturers Association (NEMA) provides the attached comments in response to the 

December 27, 2017, solicitation of public comments on the Draft NIST Special Publication 2000–02:

Conformity Assessment Considerations for Federal Agencies.

NEMA represents nearly 350 electrical equipment and medical imaging manufacturers that make safe, reliable, 

and efficient electrical and medical imaging products and systems. Our combined industries account for 

360,000 American jobs in more than 7,000 facilities covering every state. Our industry produces $106 billion 

shipments of electrical equipment and medical imaging technologies per year with $36 billion exports.

Attached please find a matrix of comments. We are open to discussing these comments further and providing 

additional details at your request. Our Member companies count on your careful consideration and we look 

forward to outcomes that meet their expectations.

If you have any questions on these comments, please contact Craig Updyke at 703-841-3294 or 

craig.updyke@nema.org or Joel Solis at 703-841-3267 or joel.solis@nema.org.

Sincerely,

Kyle Pitsor

Vice President, Government Relations 

Attachment

National Electrical Manufacturers Association

1300 North 17th Street, Suite 900 - Rosslyn, VA 22209
National Electrical Manufacturers Association

1300 North 17th Street, Suite 900 - Rosslyn, VA 22209

 Matrix of NEMA Comments on “Conformity Assessment Considerations for Federal Agencies DRAFT, December 2017”

Line Section Item Category Subject And Comment Proposal

10, 11 Executive 

Summary

Paragraph General Both producer and economic operators (i.e., any

professional in the supply chain whose activity does 

not affect the safety properties of a product) should 

have been included in the list since both have strong 

incentives, like the threat of private liability claims 

related to nonconformity products, to verify 

compliance with relevant standards.

The primary goal of conformity assessment is to give purchasers, producers and 

economic operators, and users confidence that the products and services meet 

appropriate requirements.

101-103 Introduction, 

Audience

Sentence General Although the language here is intended to be both 

general and inclusive, it fails to throw sufficient 

light on the federal interest in compliance and 

enforcement. 

Federal participants in the process include conformity assessment program 

owners, subject matter experts, regulators, agency counsel and levels of 

management within a Federal agency, including parties responsible for 

surveillance and enforcement.

113-115 Introduction, 

Audience

Paragraph General To be consistent with Section “Addressing 

international obligations, equivalency or 

recognition”, line 1252-1253, knowledge of U.S. 

trading partners conformity assessment programs 

that may be relevant should be identified early in 

the process. 

For each specific conformity assessment program, it is also important to have a 

contextual knowledge of the agency mission and regulation governing the 

conformity assessment program, specific markets and sectors in the U.S., U.S. 

trading partners’ conformity assessment procedures and international economies, 

and the current state of conformity assessment programs within the scope of 

interest.

159-161 Introduction, 

Federal Policy 

Context of this 

Document

Paragraph General To be consistent with Section 2. Lines 344-345, 

need to expand on reference to the “private sector”.

To reduce unnecessary burden and make more productive use of Federal 

resources, the NIST guidance suggests that each agency coordinate its 

conformity assessment activities with those of other appropriate government 

agencies and with those of the private and private sector (including Federal, state, 

local and tribal).

361 Elements of a 

Conformity 

Assessment 

Program

Sentence General Typographical error. levering leveraging

379-381 Section 2, 

Objectives and 

Goals

Paragraph General To be consistent with lines 226-227, suggest 

rephrasing the term “conformity assessment 

standards”.

There is variation of the conformity assessment terms used in legislation, and at 

times not consistent with the nomenclature used in conformity assessment

standards related to conformity assessment topics.

410-411 Section 2, 

Elements of a 

Conformity 

Assessment 

Sentence General To be consistent with Footnote 4 and line 727, 

NIST should encourage program owners to seek out 

private sector technical standards developers as a 

source for providing conformity assessment 

Federal program owners should also consider using conformity assessment 

organizations, and experts in the private sector and private sector technical 

standards developers to gain insight into these concepts.
National Electrical Manufacturers Association

1300 North 17th Street, Suite 900 - Rosslyn, VA 22209

Program, E concepts.

428-433 Section 2, 

Elements of a 

Conformity 

Assessment 

Program, E

Paragraph General Sentence is difficult to follow. To improve 

readability, suggest providing the numerous 

examples in bullet form.

Examples of objects of conformity include:

 motorcycle helmets (products) that meet the U.S. Department of 

Transportation Federal Motor Vehicle Safety Standard 21811; 

 financial, insurance, genealogy, investigators and others (organizations) 

meeting the U. S. National Technical Information Service requirements 

for the safe and secure use, access, storage and management of the 

Limited Access Death Master File; and 

 contracting professionals (persons) meeting the Federal Acquisition in 

Contacting Program requirements for Federal Government contracting 

and procurement activities.

442 Section 2, 

Elements of a 

Conformity 

Assessment 

Program, E

Sentence General Recommend striking last line as it repeats what is 

said in line 439-440, “Testing is usually performed 

on a sample of the product and produces definitive 

results in a test report.”

Testing is considered to produce definitive results in a test report.

480-481 Section 2, 

Elements of a 

Conformity 

Assessment 

Program, E

Sentence General Introduce a new term “certification system” that is 

only used once. Suggest replacing with 

“certification program” to keep consistency with 

rest of document, as in line 526, 529, 978, 999, ect.

certification programs

For example, inspection is often used in the surveillance activities of certification

systems program.

737-738 Section 2, 

Requirements 

and 

Specifications, 

B 

Sentence General Wording errors. A test method that prevents innovated innovative technology from demonstrating 

conformity may impede the innovation from being in entering the market. 

743-745 Section 2, 

Requirements 

and 

Specifications, 

C

Sentence General Wording error? Most often the evidence is provided through testing, inspection, or audit for 

conformity to the requirements or standards selected to instantiate substantiate

the requirements.

760-761 Section 2, 

Requirements 

and 

Specifications, 

D

Sentence General The sentence “Flawed test data...or the 

environment” is misplaced and should be move to 

the last sentence of the paragraph, following line 

764 which discusses “good test data”.

Flawed test data can result in the entry into the market of defective products 

capable of causing serious injury or harm to the user or the environment.

766-767 Section 2, 

Requirements 

and 

Specifications, 

D

Sentence General The use of the word “and” should be replaced with 

“in”. This is a good opportunity to introduce the 

audience to the term “professional judgement”, see 

Glossary term “inspection”, since the sentence is 

dealing with ambiguity in reaching a determination 

on conformity. 

Ambiguous requirements and in standards or ambiguity in the test, inspection or 

audit method will require the use of professional judgement and eventually 

require attention.
National Electrical Manufacturers Association

1300 North 17th Street, Suite 900 - Rosslyn, VA 22209

812-813 Section 2, 

Requirements 

and 

Specifications, 

D

Sentence General Subject of the sentence is inconsistent with lines 

779-781 which states that the subject of this 

paragraph was to be “3) and understanding of the 

concept of risk.” “Understanding” conveys a less 

extensive treatment than “determining.” Suggest 

replacing “determining risk” with “understanding 

the risk”.

In general, determining understanding the risk involves analyzing the severity of 

the consequences of non-conformity, and the likelihood of products or services 

being non-conformant.

876 Section 2, 

Conformity 

Assessment 

Roles, 

Activities and 

Policies, A

Sentence General Wording error. Too little resource and Without sufficient resources, the agency could become a 

bottle-neck in the ability of the program to meet demand.

1035 Section 2, 

Conformity

Assessment 

Roles, 

Activities and 

Policies, A

Sentence General Wording, suggest replacing “product” with 

“produce”.

Organizations performing testing, inspection, and audit activities should apply 

the test methods, etc. consistently and product produce the same results for the 

same object of conformity.

1146-

1147

Section 2, 

Conformity 

Assessment 

Roles, 

Activities and 

Policies, B

Sentence Policies to protect confidential or proprietary 

information should extend to personnel, 

manufacturing locations and suppliers. Suggest 

revising lines 1146-1147

Policies should support the confidentiality of a product under development, and

the confidentiality of a product not yet publicly announced, and the 

confidentiality of personnel, manufacturing locations and suppliers.

1195 Section 2, 

Conformity 

Assessment 

Roles, 

Activities and 

Policies, B

Sentence General Wording, suggest replacing “make” with “maker.” consider requiring the decision maker of the appeal to be higher in the 

organizational hierarchy

1193-

1196

Section 2, 

Conformity 

Assessment 

Roles, 

Activities and 

Policies, B

Sentence According to ISO/IEC 17065, “[t]he certification 

body shall only grant authority to make a 

certification decision, or any decision in the 

handling of complaints and appeals, to an

individual or group that is impartial with respect to 

the product(s).” So when it comes to appeals, the 

concern is with objectivity which can be more 

appropriately addressed by ensuring the 

impartiality of the individual or group, rather than 

on one’s position in the organizational hierarchy, a 

An appeals process to manage when the supplier or conformity assessment 

organization does not agree with the decision of the conformity assessment 

program. The program owner should consider requiring the decision maker of the 

appeal to be higher in the organizational hierarchy than an individual or group 

that is impartial with respect to the decision maker of the approval; and
National Electrical Manufacturers Association

1300 North 17th Street, Suite 900 - Rosslyn, VA 22209

term that has been defined in the Glossary.

1239-124

4

Section 2, 

Conformity 

Assessment 

Roles, 

Activities and 

Policies, B

Paragraph Expand this section to reference additional means 

for displaying a mark or label on a product to be 

consistent with FCC’s Electronic Labeling 

Guidance. 

Policies should exist when a mark or label is required. Not all Federal agency 

conformity assessment programs require a mark or label on the product, or 

displayed on the product’s integrated (non-removable) display screen, or 

alternatively on the package. Approval marks and labels are a resource need to 

both the program owner who must manage and enforce the use of the mark or 

label, and the supplier who must manage and display the mark or label. The 

symbols used in connection with the certification mark or label should be capable 

of being interpreted without further definition.

1353-135

6

Section 2, 

Operations and 

Improvement, 

A

Paragraph Suggest that when a Federal agency decides to 

actively engage in voluntary consensus standards 

activities, that the procedures provide guidance on 

how to comply with antitrust law when attending 

these types of meetings.

Federal agency programs should consider developing procedures for program 

engagement in specification development activities or voluntary consensus 

standards activities (if appropriate). These procedures may address the nature of 

engagement relationships such as monitoring standard development activities, 

active participation, possible leadership roles in these activities, etc. If the 

nature of the engagement relationship is active participation in standard 

development activity, the procedures should include guidance on how to comply 

with antitrust law when attending these types of meetings.