MITA Comments RE: NIST Special Publication 2000-01: ABC's of Conformity Assessment

1 Type of comment: ge = general te = technical ed = editorial 

page 1 of 3

195 1 ed “not” is missing 

TBT agreement reads:

5.1.2 conformity assessment procedures are not

prepared, adopted or applied with a view to or 

with the effect of creating unnecessary obstacles 

to international trade.

“not prepared ...”

204 2 te It is not the standard itself, it is the quality and 

national or international recognition of the 

standard, See also lines 232 to 236

“quality and national or international recognition of 

the standard”

224 2 te The understanding is also with authorities like 

market surveillance authorities or notification 

authorities, e.g. FDA 510(k) clearance

“purchasers, sellers and market surveillance or 

notification authorities”

275 3 te The notion “N/A” for SDoC in the rows 

Arrangements and Accreditation is not justified. 

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 lab or from a 

manufacturers lab that may even be accredited to 

ISO 17025 and may be supported by a quality 

management system that may be certified by an 

accredited registrar to ISO 9001. See also lines 

286 to 288 and 294 to 301

Replace “N/A” by “Not determined” and explain in 

a footnote or link to chapter 3.1

315-340 3.2 ge The requirement for impartiality according to ISO 

17020 of the inspection body is missing

Add e.g. in line 320 after the first sentence: ”The 

body performing inspection needs to be impartial 

from the subject of inspection. The requirements 

for impartiality are laid down in ISO 17020.”

356 3.3 te Laboratories perform measurements Complement the first sentence to read:

“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. 

370-375 3.3 ge Plenty of independent additional information is 

available from EUROLAB

Consider adding References to:

• EUROLAB Policy Paper

The role of laboratories in testing, 

inspection and certification

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

?NewsId=236&CatId=4

• EUROLAB Position Paper

First-, second- and third-party testing –

how and when
MITA Comments RE: NIST Special Publication 2000-01: ABC's of Conformity Assessment

1 Type of comment: ge = general te = technical ed = editorial 

page 2 of 3

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

?FileTypeId=14

393 3.4 te Subjects of certification are not only products but 

also services, processes of providers and 

persons

After object produced add “, services offered, 

processes applied or competence of persons”

488-490 3.5 te Accreditation activities do not include tasks such 

as testing, calibration, inspection, certification, 

management systems, persons, products, 

processes and services, and validation and 

verification.

See also lines 553 to 555 where OSHA is the 

accreditor of the NRTLs

See also lines 606-607

Accreditation activities include - on a random base 

- tasks such as supervising tests, audits or 

inspections, checking calibration of laboratory test 

equipment, checking test, audit or inspection 

reports for correctness and consistency, checking 

the quality management system for adequacy and 

completeness of accredited third parties offering 

services tasks such as testing, calibration, 

inspection, certification, management systems, 

persons, products, processes and services, and 

validation and verification.

492 3.5 te Accreditors do not assess compliance of a 

conformity assessment system but of conformity 

assessment bodies.

Accreditors use the ISO/IEC standards and guides 

with the technical and specific program 

requirements to assess compliance of a 

conformity assessment body.

Accreditors neither make use of assessment 

bodies nor do they assess CA systems

One important attribute of accreditation is the use 

of competent auditors to perform assessments of 

conformity assessment bodies.

500 3.5 ge Missing is a mentioning that accreditation is 

performed on a non for profit base and a noncompetitive base. The accreditation body or 

bodies shall be governmentally recognized like 

ANSI-ASQ National Accreditation Board (ANAB). 

Put governmental agencies on top of the pyramid. 

Explicitly give reference to ANSI-ASQ National 

Accreditation Board (ANAB) in chapter 3.5 and 

that accreditation is performed on a non for profit 

base and a non-competitive base.

519-521 4 ed Sentence incomplete, there seem words missing 

in line 521 between “assessment program” and 

“the conformity assessment program owner”

Complete sentence or reword

527 4 te Add International Standards Organisations to the 

list. See lines 620-623

618-623 te According to the definitions given in lines 587 and 

601 MRA are between governments, the IECEE 

scheme is between peer assessed test labs

Replace MRA by mutual recognition 

arrangement. In case this is meant define and 

use a different abbreviation than MRA that is 

linked to mutual recognition agreements in line 

600

644-671 References ed ISO/IEC ≠ International Organization for 

Standardization. 

Replace “International Organization for 

Standardization. ISO/IEC” by “International 

Organization for Standardization/ International 

Electrotechnical Commission. ISO/IEC”

650 References ed Missing words
MITA Comments RE: NIST Special Publication 2000-01: ABC's of Conformity Assessment

1 Type of comment: ge = general te = technical ed = editorial 

page 3 of 3

(ISO 17020, 2012). International Organization for 

Standardization. ISO/IEC 17020:2012 

“Conformity Assessment – Requirements for the 

operation of various types of bodies.” 2012. “Conformity assessment — Requirements for the 

operation of various types of bodies performing 

inspection” 2012