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www.AdvaMed.org

Bringing innovation to patient care worldwide

February 26, 2018

Lisa Carnahan

Amy Phelps

National Institute of Standards and Technology 

100 Bureau Drive, Stop 2100

Gaithersburg, MD 20899

RE: NIST Special Publication 2000–01: ABC’s of Conformity Assessment 

Dear Lisa and Amy: 

The Advanced Medical Technology Association (AdvaMed) is the world’s largest association 

representing manufacturers of medical devices, diagnostic products, and medical technology. 

AdvaMed’s member companies range from the largest to the smallest medical product 

innovators and manufacturers, with nearly 70 percent of our members generating less than 

$100 million in annual sales. AdvaMed's member companies produce innovations that are 

transforming health care through earlier disease detection, less invasive procedures, and more 

effective treatments.

We support the use by federal agencies of international voluntary consensus standards to meet 

regulatory requirements, which will further efforts to harmonize global medical technology 

regulations. Using international voluntary consensus standards to meet regulatory 

requirements has many benefits, including introducing efficiencies for both the regulators and 

the medical device industry. Use of international voluntary consensus standards for regulatory 

purposes helps minimize unnecessary costs and delays in patient access to innovative new 

devices. 

We applaud the National Institute of Standards and Technology (NIST) for issuance of this

Special Publication, which we believe will be a helpful resource for users of conformity 

assessment, including medical device manufacturers. We also appreciate the extensive 

outreach that NIST engaged in to gather feedback prior to issuing the document in the Federal 

Register. In the interest of making this already helpful document as useful as possible, we 

offer technical edits in the form of specific line edits below. 

Thank you for the opportunity to submit these comments. Please do not hesitate to contact me 

at jwolszon@advamed.org or 202-434-7230 if you have any questions. 

Sincerely, 

 /s/

Jamie Wolszon 

Associate Vice President

Technology and Regulatory Affairs
AdvaMed Comments on NIST Special Publication 2000–01: ABC’s of Conformity Assessment Page 2 of 7

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194-96 1

The agreement requires that conformity 

assessment procedures not be "prepared, adopted 

and applied with a view to, or with the effect of, 

creating unnecessary obstacles to international 

trade.”

The document appears to have inadvertently 

omitted the word “not” in citing the 

Agreement on Technical Barriers to Trade.

204 2

The quality and national or international recognition 

of standards used in a conformity assessment 

program have significant impact on the validity of 

the program, the value of the information conveyed 

and the program's cost.

We believe that the quality and national or 

international recognition of the standard 

plays an important role in conferring these 

benefits.

224 2

Standards are vital tools of industry and commerce 

promoting an understanding between purchasers,

and sellers, and regulatory authorities. Standards 

enable and enabling mutually beneficial 

commercial transactions.

Standards also promote understanding for 

regulatory authorities. We note, for 

instance, FDA’s use of FDA-recognized 

standards in the 510(k) review process.

232 3

Standards used in conformity assessment should 

be clearly and concisely written, readily 

understood, precise, and technically credible, and 

contain, only unambiguous requirements for 

objective verification.

We would recommend that this document 

consider the possibility of conformity 

assessment for risk-based standards. Riskbased standards, by their very nature, are 

not necessarily unambiguous requirements 

for objective verification. However, many 

such risk-based standards are very 

important to the medical device industry. 
AdvaMed Comments on NIST Special Publication 2000–01: ABC’s of Conformity Assessment Page 3 of 7

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275 Figure 2

Replace “N/A” with “Not Determined” 

Provide a footnote to chapter 3.1 regarding 

supplier’s declaration of conformity (SDOC) 

explaining that: ISO 17050 requires that an SDOC 

must be based on evidence. This evidence may 

originate from a test and test report of a third-party 

laboratory. Alternatively, this evidence may 

originate from a manufacturer’s laboratory that may 

be accredited to ISO 17025, and supported by a 

quality management system certified by an 

accredited registrar to ISO 9001.

We note that ISO 17050 requires that an 

SDOC must be based on evidence. This 

evidence may originate from a test and test 

report of a third-party laboratory. 

Alternatively, this evidence may originate 

from a manufacturer’s laboratory that may 

be accredited to ISO 17025, and supported 

by a quality management system certified by 

an accredited registrar to ISO 9001. We 

propose adding text accordingly. 

315-340 3.2

Inspection is defined in ISO/IEC 17000:2004 (ISO 

170000, 2004) as the "examination of a product, 

process, service, or installation or their design and 

determination of its conformity with specific 

requirements, or on the basis of professional 

judgement, with general requirements. The body 

performing inspection needs to be impartial from 

the subject of inspection. The requirements for 

impartiality are outlined in ISO 17020.

We believe the requirement for impartiality 

of the inspection body according to ISO 

17020 should be added.
AdvaMed Comments on NIST Special Publication 2000–01: ABC’s of Conformity Assessment Page 4 of 7

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356 3.3

Testing laboratories conduct tests and develop 

data by performing measurements. Measurements 

are defined by ISO/IEC GUIDE 99 (2.1) as: 

“process of experimentally obtaining one or more 

values that can reasonably be attributed to a 

quantity.”

We believe it would be helpful to add the 

concept that laboratories perform 

measurements, and to provide a definition of 

measurements. 

370-375 3.3

We would recommend that NIST consider adding 

references to:

• EUROLAB Policy Paper

The role of laboratories in testing, inspection 

and certification

http://www.eurolab.org/NewsArticle.aspx?N

ewsId=236&CatId=4

• EUROLAB Position Paper

First-, second- and third-party testing –

how and when

http://www.eurolab.org/publications.aspx?Fil

eTypeId=14

We believe that these references provide 

useful, independent, additional information 

on the topic of laboratory testing. 

392-393 3.4

The goal of certification is to provide confidence to 

interested parties that objects produced, services 

offered, processes applied or competence of 

persons providing services, meet specified 

requirements.

We would propose revising to reflect that 

subjects of certification are not limited to 

products, but also may include services and 

processes of providers and persons.
AdvaMed Comments on NIST Special Publication 2000–01: ABC’s of Conformity Assessment Page 5 of 7

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488-490 3.5

Accreditation activities include, on a random basis,

tasks such as supervising tests, audits or 

inspections, checking calibration of laboratory test 

equipment, checking test, audit or inspection 

reports for correctness and consistency, and

checking the quality management system for 

adequacy. Accreditation activities also include 

checking the completeness of accredited third 

parties offering service tasks such as testing, 

calibration, inspection, certification, management 

systems, persons, products, processes and 

services, and validation and verification.

The activities described in the original text 

are activities of the conformity assessment 

bodies. We have proposed text that we 

believe reflects the activities of the 

accrediting bodies.

492 3.5

Accreditors use the ISO/IEC standards and guides 

with the technical and specific program 

requirements to assess compliance of a conformity 

assessment system body.

We propose a technical edit to reflect that 

accreditors assess compliance of conformity 

assessment bodies, not conformity 

assessment systems.

492 - 494 3.5

One important attribute of accreditation is the use 

of competent assessment bodies auditors to 

perform assessments of conformity assessment 

systems bodies.

We propose a technical edit to reflect that 

accreditors use competent auditors to 

perform assessments of conformity 

assessment bodies. 
AdvaMed Comments on NIST Special Publication 2000–01: ABC’s of Conformity Assessment Page 6 of 7

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500 3.5

Put governmental agencies on top of the pyramid. 

Explicitly reference ANSI-ASQ National 

Accreditation Board (ANAB) in chapter 3.5 and that 

accreditation is performed on a not-for-profit basis 

and a non-competitive basis.

We believe it would be helpful to add at the 

top of the pyramid the concept that an 

accreditation body or bodies shall be 

governmentally recognized like ANAB. We 

also would recommend explaining that 

accreditation is performed on a not-for-profit 

basis and a non-competitive basis. 

519-521 4

Please note, this document refers to the federal 

agency or department that develops and maintains 

the rules, policies, procedures, etc. for its 

conformity assessment program as the conformity 

assessment program owner.

We believe the word “as” was inadvertently 

omitted from this sentence. 

527 4

Many different organizations can act as a 

conformity assessment program owner such as: 

• Certification bodies; 

• Government or regulators; 

• Purchasing agencies; 

• Trade associations; and

• Consumer organizations.; and

• International standards development 

organizations.

We believe it would be helpful, and 

consistent with other parts of this document, 

to add international standards development 

organizations to this list of organizations that 

can act as a conformity assessment 

program owner. 
AdvaMed Comments on NIST Special Publication 2000–01: ABC’s of Conformity Assessment Page 7 of 7

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618-623 5

MRAs Mutual recognition arrangements can also 

be established between two or more organizations 

located in different countries to accept each other's 

conformity assessment data and/or conformity 

assessment marks or certificates of conformity. An 

example is the IEC's System for Conformity 

Testing to Standards for Safety of Electrical 

Products (the IECEE scheme), which is designed 

to promote the reciprocal recognition of test results 

among the participating countries and to simplify 

the certification of electrical products at the 

national level.

This section of the document distinguishes 

between mutual recognition agreements and 

mutual recognition arrangements. We 

believe that in this instance, given the 

example of the IECEE scheme, which is 

between peer-assessed test laboratories, 

that the latter is intended. We would 

propose clarification that mutual recognition 

arrangement is intended here. 

644-671 References

(ISO/IEC 17000, 2004). International Organization 

for Standardization/International Electrotechnical 

Commission. ISO/IEC 17000:2004 644 “Conformity 

assessment — Vocabulary and general principles”

2004.

The documents referenced in these lines are 

ISO/IEC documents. The reference section 

appears to have inadvertently omitted the 

mention of IEC. We would add IEC to these 

references. We have provided a specific 

example of how we believe the text should 

read in lines 644-645, which we would 

recommend repeating up through line 671. 

649-651 References

(ISO 17020, 2012). International Organization for 

Standardization. ISO/IEC 17020:2012 649 

“Conformity Assessment – Requirements for the 

operation of various types of bodies performing 

inspection” 2012. 

We propose revising to include the full title 

of the referenced standard.