Date:2020-12-16
ge
This is a common position of the German Member of ISO and the German National Committee of IEC.
1. noted
DE 1292
Whole document
ge
Please clarify the role of the customer in the definitions. The difference must be especially clear, as in some languages “client” and “customer” is the same term.
Is the customer a participant in the market or can also be an authority?
Does the customer order a proficiency testing scheme to be provided or is it the participant of a scheme?
Specify differences between customer, participant and client.
Replace “customer” in the document with “participant”, were possible, and check if the definition of “customer” for the remaiming instances of the word “customer” is still applicable.
2. Partially agreed: "client" imported from PROC33 and cannot be changed. A note added to "customer" to clarify it also means client. WG checked client/customer/participant, not always necessary to have a contract for the latter. See new wording.
ILAC 1017
All
ge
It would simplify significantly for the reader, and for translation, if the document uses the abbreviation PT consistently.
Implement the abbreviation PT in running text where appropriate.
3. Agreed.
AR 0004
AR submitted identical comments in ISO and IEC.
Along of the CD we can see the term “client” (for common elements) and “customer” for specific text of the ISO/IEC 17043.
For Spanish speaker:
the client is who pays for the product or service
the customer is who use or receive the product or service
Clarify the use of client and customer.
4. See 2.
ge
Germany does not approve the current CD. Considering the number of comments and the immaturity of the current CD1, Germany supports the circulation of a 2nd CD.
5. Agreed.
US 0006
Ge- Title
There has been no justification for the extension of scope of the document. The current title “Conformity assessment — General requirements for proficiency testing” adequately covers what should be addressed in this document. In addition, the scope indicates the document is beyond just competence of proficiency testing providers “This International Standard specifies general requirements for the competence of providers of proficiency testing schemes and for the development and operation of proficiency testing schemes.”
6. An extension of scope of revision was requested, to include the update of the title. See CD ballot results, the change of title approved by members. The scope of the document did not change. See 55.
NEN 1243
general
ge
The standard is also for sampling and inspection, but these subjects aren't addressed explicitly in the technical requirements. The technical requirements are just focussed on the laboratory activities.
Address sampling and inspection at all the technical requirements (instead of only at the definitions, some clauses and in Annex A).
7. WG agrees in principle to open up the terminology to include other types of CA activities, beyond test and calibration as currently stated. For changes, see new wording in relevant clauses and Annex A.
ILAC 1244
General
te
In line with the VIM definition of a measurement result and in line with ISO 17025:2017, PT providers shall request from the participants the measured value and its associated measurement uncertainty, and evaluate the participant’s performance using an appropriate performance score such as z, ζ, En.
PT providers should also evaluate the participant’s performance in estimating their measurement uncertainty.
ISO/IEC 17043 shall state that: “PT providers shall request from the participants the measured value and its associated measurement uncertainty, and evaluate the participant’s performance using an appropriate performance score such as z, ζ, En.”
ISO/IEC 17043 shall also state that: “PT providers should evaluate the participant’s performance in estimating their measurement uncertainty.”
Where relevant in this standard clarify the term “results” by phrasing it as “results, including their associated measurement uncertainties”.
8. Partially agreed, WG checked wording and considered to add "where appropriate", if it makes sense.
JP1 1239
ed
Japanese comments identical in ISO and IEC.
Annex A and Annex B are informative, however, the word “(informative)” is dropped off from the item on the table of contents.
Furthermore, the line feeds between the title (Annex X) and content (title of the annex) are excessive for these items.
Correct as follows:
9. Agreed.
GR 1241
Improve grammar
26
Forward
te
ISO 13528 is under revision so should this document be aligned with the 2015 edition
Consideration be given to align this with the next revision of ISO 13528
11. Consider development stage at the end of the revision of 17043.
US 1248
US comments identical in ISO and IEC.
The concept of “quality” as currently defined is not useful and is actually confusing in this standard. “Quality” is the degree to which requirements are fulfilled and can mean ANY level of fulfilment. The intent of ISO/IEC 17043 is to establish requirements for competence, consistency and impartiality that will be COMPLETELY fulfilled in order to provide confidence in the proficiency testing provider.
Change “quality” to “competence, consistency and impartiality”
12. Partially agreed, but instead used the word "validity" where it refers to a scheme, see new wording in the relevant clauses.
CZ 1249
Introduction
te
Following comments of the CZ NC are identical to the ones sent to ISO/CASCO.
More general wording will be suitable, what about inspection accreditation bodies…
…for other interested parties, such as regulators,
laboratory
13. Agreed.
FI 1250
The standard is related to proficiency testing and the Introduction starts with interlaboratory comparisons. Thereafter, throughout the document either “interlaboratory comparison” OR “proficiency testing” is used when referring both.
To revise the Introduction (and the document) to better aim to one or another.
One suggestion is to have a chapter in the Introduction where both these terms are described and then summarized “hereafter we use term XXX to describe these both”.
14. Not agreed, this is the correct term to be used here.
CA1 1251
Same comments made in ISO and IEC.
PROPOSE AN ADDITIONAL USE OF PROFICIENCY TESTING BY PARTICIPANTS (arguably the most important use!)
Performance on proficiency testing test items may be the first indicator of a quality error within the participant’s repertoire of tests.
Having error free performance on proficiency testing does not ensure that regular testing is always error free, but performance errors on proficiency testing may signal a previously undetected testing weakness.
In most laboratories for every PT sample they get to test, they may test 100s or 1000s of regular samples. So PT is unlikely to pick up ALL errors.
But if PT DOES pick up an error, it means with high probability it is being made in non-PT samples as well.
Add following text to Introduction:
Performance on proficiency testing test items may be the first indicator of a quality error within the participant’s repertoire of tests.
15. Agreed, see new wording 1st paragraph in the introduction.
AU 1252
Page 4
Introduction is limited by language to only inter-laboratory comparisons. Proficiency testing is a useful tool for many types of tests, evaluations and examinations such as medical imaging, troubleshooting, crime scene investigation, software evaluations, etc.
Be more inclusive of the potential participants of PT schemes.
Subsequently consider the wording used in the definition of Proficiency Testing.
Suggest wording for opening line and change to point a):
Proficiency testing schemes are widely used for a number of purposes and their use is increasing internationally. Typical purposes for proficiency testing include:
a) evaluation of the performance of participants for specific tests, evaluations, examinations or measurements and monitoring participants' continuing performance;
16. Partially agreed, WG added it's not only restricted to "Interlaboratory comparisons",, added a note in definitions. For a), see new wording.
AU 1253
Page 4
Introduction
ge
As with ISO/IEC 17025:2017, acknowledge the use of risk assessment as one of the objectives and the association with ISO 9001.
Suggested wording adopted from ISO/IEC 17025:2017:
This document has been developed with the objective of promoting confidence in the operation of proficiency testing providers. This document contains requirements for providers to enable them to demonstrate they operate competently, and are able to generate valid results. Providers that conform to this document will also operate generally in accordance with the principles of ISO 9001.
This document requires proficiency testing providers to plan and implement actions to address risks and opportunities. Addressing both risks and opportunities establishes a basis for increasing the effectiveness of the management system, achieving improved results and preventing negative effects. The provider is responsible for deciding which risks and opportunities need to be addressed.
17. Partially agreed, see new wording.
GR 1254
Introduction
ge
Align with ISO/IEC 17025 by including a paragraph for using a risk based approach
Insert the second paragraph of the introduction of ISO/IEC 17025:2017 and replace the word “laboratory” with “PT provider”, i.e. “This document requires the PT provider to plan and implement actions to address risks and opportunities. Addressing both risks and opportunities establishes a basis for increasing the effectiveness of the management system, achieving improved results and preventing negative effects. The PT provider is responsible for deciding which risks and opportunities need to be addressed”.
18. See 17.
Introduction
ge
As with ISO/IEC 17025:2017, acknowledge the use of risk assessment as one of the objectives and the association with ISO 9001.
Suggested wording adopted from ISO/IEC 17025:2017:
“This document has been developed with the objective of promoting confidence in the operation of proficiency testing providers. This document contains requirements for proficiency testing providers to enable them to demonstrate they operate competently, and are able to generate valid results. Proficiency testing providers that conform to this document will also operate generally in accordance with the principles of ISO 9001.
This document requires proficiency testing providers to plan and implement actions to address risks and opportunities. Addressing both risks and opportunities establishes a basis for increasing the effectiveness of the management system, achieving improved results and preventing negative effects. The proficiency testing provider is responsible for deciding which risks and opportunities need to be addressed.”
19. Same as 17.
Te
ISO has many specific documents that describes tools and gives guidance concerning interlaboratory trials or interlaboratory schemes , such as
ISO/TS 20612:2007(Water quality) ISO22117:2019, (food sector), ISO/TS 12828-3 (fire gas analysis).
it could be feasible and useful to mention them so that users take into consideration that 17043 could be complementary to that specific ones
Add a new paragraph to the Introduction :
This document has general requirements for the competence of organizations that provide proficiency testing in a generic way , Other ISO documents in specific sectors related to proficiency testing can be used in addition , or complementary to ISO 17043, such as:
ISO/TS 20612:2007, ISO 22117:2019, ISO/TS 12828-3.
20. Disagree, cannot state all documents.
DE 1257
The proficiency testing provider should be addressed
As interlaboratory comparisons are widely used and their use is increasingly stipulated the demonstration of technical competence for proficiency providers is a basic requirement to ensure the quality of PT schemes. Typical interlaboratory comparisons include:
21. See 17.
“determination of performance” should be replaced by “evaluation of performance”
22. The text says already "evaluation".
ILAC 1259
More general wording will be suitable, what about inspection accreditation bodies…
“…for other interested parties, such as regulators,
laboratory
23. Agreed.
ILAC 1260
Introduction
a)
te
Terms such as tests, measurements etc. are used throughout the document but not in any consistent form. Indeed calibrations is missing in this bullet but is often used in other parts of the document. The term ‘examination’ could equally be added since this is used in the area of laboratory medicine and indeed is the term used in ISO 15189.
Modify text to “…specific tests, evaluations, examinations, measurements or calibrations ….”
And add a note: “the term ‘measurement’ is used throughout the rest of this document to imply equally, unless otherwise qualified, to any activity leading to a reported proficiency testing result, whether quantitative, qualitative or interpretative.”
Apply throughout the document
ILAC 1261
“…performance of laboratories …” PT applies wider than just laboratories i.e. will also cover inspection bodies, biobanks and reference material producers. It can also cover individuals/organisations performing pre- and post-analytical activities.
Add a note: “the term laboratories is used in this document to cover all organizations that are performing sampling, testing, calibrations and examinations, for example testing laboratories, calibration laboratories, inspection bodies, biobanks, etc.”
25. Partially agreed, see new wording.
UK 1262
Introduction
a)
te
Terms such as tests, measurements etc. are used throughout the document but not in any consistent form. Indeed, calibrations is missing in this bullet but is often used in other parts of the document. The term ‘examination’ could equally be added since this is used in the area of laboratory medicine and indeed is the term used in ISO 15189.
Modify text to “…specific tests, examinations, measurements or calibrations …”
And add a note: “the term ‘measurement’ is used throughout the rest of this document to imply equally, unless otherwise qualified, to any activity leading to a reported proficiency testing result, whether quantitative, qualitative or interpretative.”
Consider if ‘measurement’ needs to be included in the definition in section 3
26. See 24.
“…performance of laboratories …” PT applies wider than just laboratories i.e. will also cover inspection bodies, biobanks and reference material producers. It can also cover individuals/organisations performing pre- and post-analytical activities.
Add a note: the term laboratories is used in this document to cover all organizations that are performing sampling, testing, calibrations and examinations, for example testing laboratories, calibration laboratories, inspection bodies, biobanks, etc.
27. Same as 25.
ge
It is agreed that one of the purposes of PT is to identify ‘problems’ in a laboratory, it is not clear what the role of PT is the initiation of actions for improvement.
Clarity required. Propose to delete “and initiation of actions for improvement”.
28. Agreed, see new wording for introduction.
ILAC 1266
Introduction
b)
ge
It is agreed that one of the purposes of PT is to identify ‘problems’ in a laboratory, it is not clear what the role of PT is the initiation of actions for improvement.
Clarity required
Introduction
b)
ed
Simply text by just using the term ‘measurement’ – see previous comment and suggested note. Also inconsistent use of ‘procedures’ or ‘methods’ – suggest harmonising on ‘measurement procedures’
“… comparability of
test or
UK 1268
Introduction
b)
ed
Simply test by just using the term ‘measurement’ – see previous comment and suggested note. Also, inconsistent use of ‘procedures’ or ‘methods’ – suggest harmonising on ‘measurement procedures’ (used in VIM)
“… comparability of
test or
measurement
methods
procedures;”
And consider adding definition of ‘measurement’ to section 3 to indicate coverage of the term
31. See revision to definition 3.4 (interlaboratory comparison
UK 1269
Improve wording
b) identification of problems in laboratories and initiation of actions for improvement which, for example, may be related to the adequacy of measurement procedures, effectiveness of staff training and supervision, or calibration of equipment;
32. See 28.
“… comparability of
test or
te
Add an additional bullet after c) to address pre-analytical and post-analytical aspects
“d) Evaluation of pre-analytical and post-analytical aspects of the measurement cycle, i.e. specific procedures carried out before or after the analytical phase, such as sampling or the interpretation of measurement results”
34. Not agreed. These are common terms only in medical applications. The concerns are already addressed in other ways (sampling, inspection, use of validated measurement procedures.
UK 1265
Te
Add an additional bullet after c) to address pre-analytical and post-analytical aspects
d) Evaluation of pre-analytical and post-analytical aspects of the measurement cycle, i.e. specific procedures carried out before or after the analytical phase, such as sampling or the interpretation of measurement results
35. Same as 34.
Introduction
d)
te
Not limited to just lab customers (and suggest avoiding use of term ‘customers’
Change to d) provision of additional confidence to end users of measurement results
36. Agreed.
ILAC 1272
Introduction
e)
ge
Is the role of PT the identification of interlaboratory differences, or to identify laboratory differences?
e) Identification of
ge
Is the role of PT the identification of interlaboratory differences, or to identify laboratory differences?
Proposal for amended text: “e) identification of differences between the results reported by participating laboratories.”
38. Partially agreed, see 37.
DE 1273
g) validation of measurement uncertainty claims
39. Agreed.
UK 1274
UK 1275
GR 1276
“International Bureau of Weights and Measurements “ should be replaced by “International Bureau of Weights and Measures”
42. Agreed.
ZA 1247
Intro j)
Clarity required. Proposal for clarification: “because laboratory competence is assumed to be a prerequisite in these applications”.
43. Agreed, new text accepted.
ILAC 1277
Introduction
j)
ed
International Bureau of Weights and Measurement (BIPM) – incorrect spelling of the acronym
BIPM stands officially for Bureau International des Poids et Mesures, as it appears on the website bipm.org even when the pages are in English. If it has to be translated, the website displays ‘The BIPM’ and in rare place the “International Bureau of Weights and Measures” (BIPM)
44. Agreed.
DE 1278
Introduction
j)
ed
The BIPM is the International Bureau of Weights and measures. See e.g. https://www.bipm.org/utils/common/documents/official/legal-status-BIPM.pdf
…on behalf of the International Bureau of Weights and Measures (BIPM)…
45. Agreed.
ILAC 1279
Page 4
Introduction is limited by language to only inter-laboratory comparisons. Proficiency testing is a useful tool for many types of tests, evaluations and examinations such as medical imaging, troubleshooting, crime scene investigation, software evaluations, etc.
Be more inclusive of the potential participants of PT schemes.
Subsequently consider the wording used in the definition of Proficiency Testing.
“
Interlaboratory comparisons
Proficiency testing schemes are widely used for a number of purposes and their use is increasing internationally. Typical purposes for proficiency testing include:
a) evaluation of the performance of
laboratories
laboratories’
IT 01 1280
ge
The document includes a general clause dealing with risks and opportunities (8.5), in alignment with ISO/IEC 17025:2017.
We suggest to add a note explaining that the organization is responsible to decide which risks and opportunities need to be addressed.
Add the following new paragraph, e.g. after current 4th par:
“This document requires proficiency testing providers to plan and implement actions to address risks and opportunities. Addressing both risks and opportunities establishes a basis for increasing the effectiveness of the management system, achieving improved results and preventing negative effects. The PTP is responsible for deciding which risks and opportunities need to be addressed.”
47. Addressed, see 17 and 18 and revised Introduction.
ILAC 1281
ge
The introduction part includes the role of interlaboratory comparisons for determining the performance of laboratory as described in a) to g) and with reference materials as described in i) in addition to role with NMI as described in j)
I would suggest to include also the role related to determination of the performance of inspection bodies where relevant to reflect ILAC policy in P9 and this standard clause 6.1.2
To add the role of interlaboratory comparisons in determination of the performance of inspection bodies where relevant.
48. Partially agreed, see new wording.
UK 1282
Confusing reference to laboratory competence
Proficiency testing involves the use of interlaboratory comparisons for the determination of laboratory performance, as listed in a) to g) above. Proficiency testing does not usually address h), i) and j)
because laboratory competence is assumed in these applications, but these applications can be used to provide independent demonstrations of laboratory competence.
The requirements of this document can be applied to many of the technical planning and operational activities for h), i) and j).
49. Partially agreed, see 43.
ILAC 1283
ge
Clarity required
Reference to ISO 13528:xxx
Omit xxx, since the introduction doesn’t contain effective requirements there is no need to refer to a specific version of ISO 13528
51. Agreed, see new wording.
ILAC 1285
te
ISO 13528 has replaced the need to include an informative Annex B. Suggest make reference to 13528 in the introduction and remove Annex B.
In all references to Annex B replace with ISO 13528.
Delete Annex B and replace:
“Revisions in Annex B on statistical methods are intended to conform to terminology and accepted practices in ISO 13528:XXX, Statistical methods for use in proficiency testing by interlaboratory comparisons.”
With:
“Further guidance on statistical methods for use in proficiency testing is provided in ISO 13528. While the approaches outlined in ISO 13528 satisfy the relevant requirements of this document, there might be alternate ways to achieve compliance to this document.”
52. Partially agreed, see new Annex B.
TICC 1286
Introductory Paragraph Starting with “The need for ongoing…”
The concept of “quality” as currently defined is not useful and is actually confusing in this standard. “Quality” is the degree to which requirements are fulfilled and can mean ANY level of fulfilment. The intent of ISO/IEC 17043 is to establish requirements for competence, consistency and impartiality that will be COMPLETELY fulfilled in order to provide confidence in the proficiency testing provider
Change “quality” to “competence, consistency and impartiality”
53. Agreed.
ZA 1291
Title
te
Approve the proposal to amend the title of ISO/IEC 17043 to include “Conformity assessment”.
54. Noted.
FR 0019
Same comments submitted in ISO and IEC.
Consistent operation” is an issue or an objective for the entire organization of the PT provider (structure, resource, management), not only for the process corresponding to PT schemes
Replace the end of the 1st sentence as follows:
“… general requirements for the competence, impartiality and consistent operation of proficiency testing providers”
55. Changes to Clause 1 are out of the scope of revision, see NWIP.
ZA 0963
1 Scope
ed
Remove the word ‘all’, this document includes examples of the differences between PT Schemes and their modus operandi.
This document specifies general requirements for the competence and impartiality of proficiency testing providers and consistent operation of
all
proficiency testing schemes.
56. Changes to Clause 1 are out of the scope of revision, see NWIP
DE 0962
can
use these requirements in confirming or recognizing the competence of proficiency testing providers.
57. Changes to Clause 1 are out of the scope of revision, see NWIP.
UK 1289
“…can use these requirements to confirm or recognise the….”
58. Changes to Clause 1 are out of the scope of revision, see NWIP.
ILAC 0964
1 Scope
ed
Remove the word ‘all’, this document includes examples of the differences between PT Schemes and their modus operandi.
“…consistent operation of
ge
Better not to add the year of issuance of 17000 to be same as others e.g. 17025 and avoid to use old edition in case of any updates.
Same in all the cases where there is a date…e.g. in 3.14
“ISO/IEC 17000
3.14 – “[ISO/IEC Guide 99
, definition 2.41, modified — Note 7 to entry has been deleted.]]”
60. Agreed,
CN 0021
02
Te
In this part, only the ones as the supplementary requirements to this document.
To relocate 17000 & Guide99 to Bibliography
To add ISO/IEC 17025
61. Partially agreed, 17000 and VIM need to stay normative, 17025 added.
IT 04 0022
03
4.02.1
8.9.2.i)
te/ed
We noticed that (sub)clause 4.2.1 makes use of term “client” without any specific definition in the document.
The customer can coincide or not with the participant (ie a third party not participating in the PT) then some clarification are needed.
We recommend to:
1. Use term “customer” (already defined in 3.3) instead of “client” in (sub)clause 4.2.1.
2. Clarify in the relevant definition(s) (i.e. clause 3.3) that the "customer" can be the participant or a third party not directly participating in the PT.
3. Modify (sub)clause 8.9.2, i) (i.e. management review requirements) that a feedbacks can be also from participants not only from customers.
62. WG agreed adding a note to the definition of "customer" to explain that in this document it means "customer". It agreed not to ask a deviation from PROC33 to CPC. It checked the use of client/participant throughout the text, for "participant" the is not always necessary to have a contract, as compared to the client/customer.
CA3 1240
Definitions
GE
The term “competence to conduct” is potentially problematic in the sense that there are no formal training programs that educate or certify that an organization is competent to conduct.
Canada proposes to add a definition of “competence” consistent with the definitions in ISO 15189 and aligned with other standards: 17025, 9000 and 9001.
This definition is also consistent with Webster Dictionary
Add new definition:
63. Disagree. No need for a specific “competence” definition.
EQALM
3
FI 0023
03
ed
Clause 3 Terms and definitions, difficult to read as not in alphabetical order
The whole Clause 3 into alphabetical order
65. ISO rules, agreed to put in alphabetical order
FR 0024
Te
The term “consensus value” is not understood by every readers so I propose to introduce the definition of the ISO 13528
After 3.1, add the following term:
3.2 consensus value
value derived from a collection of results in an interlaboratory comparison
[Source ISO 13528, xxx]
Sort it.
67. Agreed.
ILAC 0026
03
All
ed
Having the definitions in an alphabetical order is not very logical.
However, if the definitions are to be listed alphabetically, then they need to be sorted out since currently they are not.
Improve clarity by listing the definitions in a logical order i.e. ILC first, PT second and then so on as appropriate. That way terms will be been defined prior to them be used in a subsequent definition.
Otherwise, sort them alphabetically.
03
All
ed
Terms do not appear in any particular order (not wholly alphabetical)
List in alphabetical order or improve clarity by listing the definitions in a logical order i.e. ILC first, PT second and then so on as appropriate. That way terms will be been defined prior to them be used in a subsequent definition.
69. See 65
Ge
1. To encourage the reference to the terminological databases of ISO and IEC.
2. To save the length of the wording.
3. To avoid some potential conflicts with the terms in development of other international documents, say VIM.
4. To keep consistence with 17025 & 17034.
To delete some terms & definitions that are not directly related to PT.
70. Partially agreed, but no terms proposed for deletion. See new wording.
GR 0029
03.01
te
Typically terms defined in the document and included in other definitions are in italics followed by the definition clause in parentheses
Replace “proficiency test item” with “proficiency test item (3.8)”. Scan clause 3 for several other such occurrences
71. ISO rules, cross references italicized.
NEN 0030
03.01
te
Consensus value should be added to definitions (for definition see ISO 13528 3.11)
Add definition of ISO 13528:
consensus value
value derived from a collection of results in an interlaboratory comparison
Note 1 to entry: The phrase ‘consensus value’ is typically used to describe estimates of location and dispersion derived from participant results in a proficiency test round, but may also be used to refer to values derived from results of a specified subset of such results or, for example, from a number of expert laboratories.
72. Agreed, same as 66.
SE 0033
73. Noted.
SE 0034
03.02 & 7.2
Te
By the definition, it seems great responsibility is vested in the role of coordinator. However, in chapter 7 there is no reference to any duties, authorities or responsibilities pertaining to this function.
If no duties, authorities or responsibilities pertain to the coordinator role, remove definition and the requirement for specification in the report.
74. Agree, role of coordinator has been diminished. “coordinator” replaced by PTP. Document checked and remaining occurrences changed or deleted.
SE 0035
03.03
Te
It is confusing that we refer to clients in 4.2, but choose to only define customer and participant in chapter 3.
Add definition of client or provide notes under customer and participant explaining that a client could be both a customer and a participant.
75. Partially agreed, see new wording.
ZA 0036
Confusing definitions which contain virtually similar wording
Clarify the use of customer, client and participant in the standard.
76. Agreed, see 62.
03.03
ge
Does this definition imply that to be classified as a customer there must be ‘contractual arrangement’ in place?
Clarity required
03.03
ge
Does this definition imply that to be classified as a customer there must be ‘contractual arrangement’ in place?
Clarity required
03.03
te
In the standard different terms are used “client” (4.2.1), “proficiency testing participants and customers” (5.4), “customer” (7.1) and “participant” (7.2). This is confusing. It would be good to define the participant and customer to be the same and align the language through the standard.
A number of options for clarification are suggested:
· define the participant and customer to be the same and align the language through the standard.
· Change customer to client throughout document
· Add a note: “the term ‘client’, an alternative term for ‘customer’, used in parts of this document and these terms should be regarded as having the same definition”
79. Partially agreed, see 62.
DE 0040
80. Not agreed, this is not a requirement.
NEN 0003
Whole document
ge
In 3.3, the definition of customer is redundant. There is also a definition of participant (3.6) which make more sense to use. After all, because of the ‘contractual arrangement’ in the definition of customer, the customer becomes a participant. In other words, which kind of customers are there more than participant(s)? And in the case there are other kinds of customers, maybe better use ‘interested parties’ in the standard (e.g. use ‘participants and other interested parties’ )
Please review the whole document where customer(s) or participant(s) is appropriate, with preference for participant(s).
81. Agreed, see 62.
03.03
te
Need additional information related to customer, as NOTE under definition of 3.3
Added:
NOTE: In some cases the customer may be a participant of a proficiency testing
82. Not agreed, see 62.
UK 0042
03.03
te
Some of the PROC/33 requirements use the term ‘client’ which has not been defined on ‘customer’
Add a note: the term ‘client’, an alternative term for ‘customer’, used in parts of this document and these terms should be regarded as having the same definition
Also, should be made clear that client does not mean participant where it is used in the text
83. Agreed, see 62.
Change customer to client throughout document.
84. Not agreed, see 62.
ILAC 0044
03.04
te
This definition is fine, but if there is a consensus view that one-off exercises for single participants (see Annex A) is regarded as PT then this ILC definition needs to be changed i.e. it states ‘two or more laboratories’. However, it should be noted that this is the definition in ISO/IEC 17025
To be changed if one-off exercises for single participants are to be regarded as a PT or if they are to be regarded as an ILC (i.e. not PT)
85. Disagree, “two or more laboratories” can include the PT provider laboratory. “one-off” exercises are common in calibration, inspection, and testing.
UK 0045
03.04
te
This definition is fine, but if there is a consensus view that one-off exercises for single participants (see Annex A) is regarded as PT then this ILC definition needs to be changed i.e. it states ‘two or more laboratories’. However, it should be noted that this is the definition in ISO/IEC 17025
To be changed if one-off exercises for single participants are to be regarded as a PT or if they are to be regarded as an ILC (i.e. not PT).
However, see UK comments under Annex A, the consensus view is that one off exercises for single participants are not PT.
86. See 85.
ge
Inconsistent use of Note and Note to entry in the whole text. Preferably version Note x should be used.
Revision of the whole text
88. ISO editorial policy, will be amended by ISO editors.
ILAC 0048
ge
Inconsistent use of Note and Note to entry in the whole text. Preferably version Note x should be used.
Revision of the whole text
89. ISO editorial policy, see 65.
FR 0049
03.05
Note1
Te
‘An outlier can originate from a different population or be the result of an incorrect recording or other gross error.’
In the note, one mix the possible origine of the error (incorrect recording, gross error) and the statistical consequency that this observation belongs to a different population.
Modify Note 1 to entry as follows :
An outlier can originate from an item not representative of
a different
the population, or be the result of an incorrect recording
or other gross error
FI 0050
Term participant is explained well here
The terms like “laboratory” should be replaced by “participant” throughout the whole document,
e.g. “participating laboratory” should be “participant” and “evaluation of laboratory performance” should be “evaluation of participant performance”
91. Partially agreed, see DG proposal in 62.
ZA 0051
Remove organisation and individual
03.06
te
A proficiency testing provider does not “review” the results submitted by the participant. PT providers evaluate the performance of participants by means of attributing performance score(s) to such results (performance statistics).
“laboratory, organization or individual that receives proficiency test items and submits results for
review
93. Agreed.
DE 0053
03.06
ed
This draft includes the term client. This should be explained here.
Add Note 2 to entry to describe “client”.
Note 2: In this document the term participant is synonym to client.
94. Addressed in 62.
Same comments submitted in ISO and IEC.
Include in definition of “participant” in the same level than laboratory to Inspection Bodies instead of appearing in note 1.
Many schemes used by inspections body has the component to use test itself and is necessary they demonstrate its measures are confidence.
Release Note 1 to entry.
3.6
Participant
laboratory, inspection body, organization or individual that receives proficiency test items and submits results for review by the proficiency testing provider
95. Partially agreed, see revised text.
UK 0055
03.06
Note
ed
Is this note necessary, especially if a note has been provided in the introduction explaining the wider context of users of proficiency testing
Delete note
96. Agreed.
US 0056
03.06
Note
te
This note is not necessary as an inspection body that reports results to a PTP falls into the definition.
Remove the note.
ge
The text is not helpful, inspection body is already covered in the text above
Delete note
98. Agreed.
ILAC 0058
ge
The text is not helpful, inspection body is already covered in the text above
Delete note
proficiency testing (PT)
03.07
ed
If we are going to introduce the abbreviation for proficiency testing provider etc. using ‘PT’ then that should be introduced here
Add “(PT)”
101. Agreed
UK 0061
03.07
ed
If we are going to introduce the abbreviation for proficiency testing provider etc. using ‘PT’ then that should be introduced here
Add “(PT)”
102. Agreed.
UK 0062
103. Agreed.
ES 0063
Same position submitted in ISO and IEC.
The term analysis can be very general. Include into brackets 'including testing, calibrations and inspections'
g) sampling — where samples are taken for subsequent analysis (including testing, calibration, inspections); and
104. Bullet points deleted as these details are given in Annex A.
IN 0064
te
More clarity is required in “sampling” scheme process. Therefore definition may be modified as given in ISO 13528:2015 clause 3.2 Note 1.
Existing Text:
g) sampling — where samples are taken for subsequent analysis; and
Revised Text:
g) sampling — where the objective is to evaluate the execution of sampling and samples are taken for subsequent analysis.
105. See 104.
te
“…
characteristics of …”
Note 3: the term ‘characteristic’ is used throughout this document to imply equally, unless otherwise qualified, to the reported proficiency testing result, whether quantitative, qualitative or interpretative. It is used rather than other such terms as property, measurand, analyte, etc.”
Apply throughout the document
106. Partially agreed, “characteristics” replaces “measurands” in the document. Also see 104.
UK 0066
te
“…
characteristics of …”
Note 3: the term ‘characteristic’ is used throughout this document to imply equally, unless otherwise qualified, to the reported proficiency testing result, whether quantitative, qualitative or interpretative. It is used rather than other such terms as property, measurand, analyte, etc.”
107. See 106.
ed
Missing the word “missing” ….” The requirements of ??? document cover only those EQA activities that meet the definition of proficiency testing”.
Insert “this” The requirements of this document cover only those EQA activities that meet the definition of proficiency testing.
108. Notes deleted as covered by Annex A.
GR 0068
109. See 108.
“Some
111. See 108.
“Some
112. See 108.
ed
PT Schemes are continual (i.e., intermittent at intervals) not continuous as in a steady stream.
Change “continuous” to “continual”
03.08
Te.
As a common practice, it is not recommended to use the publicly available reference materials as PTIs since the participants might get some unreasonable information then the objectives of the PT cannot be achieved.
Sample, product, artefact, reference material, piece of equipment, measurement standard, data set or other information used for proficiency testing
114. Not agreed – the term reference material does not imply publicly available RMs, All PT items should meet the VIM definition of reference material
CN 0074
Proficiency test item Proficiency testing item
115. Agreed.
NEN 0075
03.08
te
Because sampling is also applicable, 'object' (or similar) should be added.
Add 'object etc' .
03.08
te
The use of virtual PT items such as images are increasingly being used so useful to make reference in this definition
“…equipment, image, measurement standard …”
03.08
ed
If abbreviated terms are to be used throughout the document then this should be abbreviated to ‘PT item’
Add “(PT item)”
03.08
te
The use of virtual PT items such as images are increasingly being used so useful to make reference in this definition
“…equipment, image, measurement standard …”
03.08
ed
If abbreviated terms are to be used throughout the document, then this should be abbreviated to ‘PT item’
Add “(PT item)”
121. Agreed.
ILAC 0081
03.10
te
The PT provider reports the participant performance expressed as, one or more, performance scores, they do not report any measurement results.
“Single complete sequence of distribution of proficiency test items, and the evaluation and reporting of
results to the participants
03.10
ed
If abbreviated terms are to be used throughout the document then this should be abbreviated to ‘PT round’
Add “(PT round)”
03.10
ed
If abbreviated terms are to be used throughout the document, then this should be abbreviated to ‘PT round’
Add “(PT round)”
03.11
ed
If abbreviated terms are to be used throughout the document then this should be abbreviated to ‘PT scheme’
Add “(PT scheme)”
03.11
ed
If abbreviated terms are to be used throughout the document, then this should be abbreviated to ‘PT scheme’
Add “(PT scheme)”
127. Agreed.
ILAC 0087
128. See 127.
Consider revising the definition
ES 0089
03.12
1
Ge
The definition of “robust statistical method” begins exactly with the same words than the term we are trying to define.
To eliminate “robust”
ILAC 0090
03.13
te
The definition seems somewhat vague. Is the “measure of dispersion” always a standard deviation, can it be a multiple of standard deviations? The definition is incomplete and unclear.
“…results of proficiency testing and set before the proficiency testing round, based on available
information
data to predict an acceptable dispersion of measurement results
131. Partially accepted – use definition 3.4 from ISO 13528, see new wording.
DE 0091
This definition is cryptic ("measure of dispersion used") and ambiguous ("available information")
Replace "measure of dispersion used in the evaluation of results of proficiency testing, based on the available information"
by "measure of tolerable dispersion used to evaluate participants' results in proficiency testing"
132. See above 131
03.13
te
Standard deviation for proficiency assessment reflects only one of various evaluation criteria and therefore misleading. The standard is intended for all kind of proficiency testing provider. Many of them do not use z-scores for evaluation. There shall be a more neutral definition, which is suitable for all kind of proficiency testing schemes.
Add additional definition:
3.14: Performance evaluation criterion
Criterion used to evaluate the performance of a proficiency testing participant for a particular result.
Add a note: standard deviation for proficiency assessment is one of the criteria used in proficiency testing schemes (see ISO 13528)
133. See above 131
However, this note is not understandable so should be removed.
“...: The standard deviation for proficiency assessment applies...”
Remove the note
Te
What does it mean ‘differential scale’ in the note1 :The standard deviation applies only to ratio and differential scale results.
The term “differential scale” is not clear enough. Explain, replace or delete it.
135. See above 131
03.14
te
The definition for metrological traceability originates from the GUM and refers specifically to ’Calibration’. The publication of ILAC P10 recognizes the role of CRM is providing Metrological Traceability
Consider a revised definition, or if not possible that this time, then add as part of the definition reference to CRM’s as being a suitable of ensuring metrological traceability. This should be done in the definition not only in an accompanying note.
136. VIM definitions removed – VIM is normative.
ZA 0096
Definition very difficult to understand
Propose to explain the concept of metrological traceability as it is done in ISO/IEC 17025, clause 6.5.3
137. See 136.
ISO 17034 also provides metrological traceability
Note 8 to entry: Certified values of certified reference materials from reference material producers conforming to ISO 17034 provide metrological traceability.
138. See 151.
Move both documents to chapter 3.
139. ISO policy, these documents can be normatively referenced.
NEN 0097
Measurement uncertainty definition
Definition 3.15 should be before 3.14 since measurement uncertainty is used in 3.14.
140. Definitions deleted.
“… to the measurement uncertainty.”
141. Definitions have no full stop at the end, ISO editing rules.
ILAC 0099
03.14
te
The definition for metrological traceability originates from the GUM and refers specifically to ’Calibration’. The publication of ILAC P10 recognizes the role of CRM in providing Metrological Traceability
Consider a revised definition, or if not possible at this time, then add as part of the definition reference to CRM’s as being a suitable of ensuring metrological traceability.
This should be done in the definition not only in an accompanying note.
“Note 8 to entry: Certified values of certified reference materials from reference material producers conforming to ISO 17034 provide metrological traceability.”
142. See 151.
Metrological traceability cannot be guaranteed when procedures involving dissolution are involved. Note 5 to entry could usefully be strengthened.
Add into Note 5 to entry: after result ‘ for example when dissolution procedures are involved,’
143. See 151.
ge
Is it correct to have a “must” in a Note to entry
Note 3 to entry: Specification of the reference must include the
146. See 151.
ge
The sentence implies that the effort applied to the establishment of metrological traceability is proportional to its influence on the final measurement result. This leaves it up to subjective choice. Any measurand calculated from input quantities for which there is no sound metrological traceability in place, is technically invalid.
Please clarify that it is best practice to establish the metrological traceability of all input quantities, especially the input quantities that provide imported traceability to the measurement result. The metrological traceability may not be required to be established at the highest level of accuracy if the uncertainty contribution from the input quantity is small.
147. See 151
ed
Although ISO 9000:2015 has “item” as an alternative, the main term is “object”. In addition, a draft IUPAC recommendation has suggested ‘object traceability’ to distinguish the concept from ‘metrological traceability’
“...of an
03.14
notes
Te
For information, the notes in the CD VIM4 for metrological traceability are proposed to revision
Wait for the survey on CD VIM 4 and recover the changes
149. See 151
03.14
Paragraph
ge
In previous version, the description of metrological traceability to SI unit was mention. The actual draft does not include such reference.
To add the following paragraph:
NOTE 7 The ILAC considers the elements for confirming metrological traceability to be an unbroken metrological traceability chain to an international measurement standard or a national measurement standard, a documented
measurement uncertainty, a documented measurement procedure, accredited technical competence, metrological traceability to the SI, and calibration intervals (see ILAC P-10:2002).
150. See 151
ge
In line with the introductory sentence to 3 and with ISO/IEC 17025 it is not required to repeat the definitions of ISO Guide 99.
Delete 3.14 and 3.15.
ge
In the 2010 version, a Note was included mentioning a reference to ILAC P10, which seems to have disappeared now (probably linked to the revision of P10):
NOTE 7 ILAC considers the elements for confirming metrological traceability to be an unbroken metrological traceability chain to an international measurement standard or a national measurement standard, a documented measurement uncertainty, a documented measurement procedure, accredited technical competence, metrological traceability to the SI, and calibration intervals (see ILAC P-10:2002).
However, it seems useful to keep a Note on explaining metrological traceability in the same terms as ISO/IEC 17025
It would be useful to at least add the definition of metrological traceability from the ISO/IEC 17025:2017 version :
A.2.Reference to ISO/IEC 17025 Annex A :
Metrological traceability is established by considering, and then ensuring, the following:
a) the specification of the measurand (quantity to be measured);
b) a documented unbroken chain of calibrations going back to stated and appropriate references (appropriate references include national or international standards, and intrinsic standards);
c) that measurement uncertainty for each step in the traceability chain is evaluated according to agreed methods;
d) that each step of the chain is performed in accordance with appropriate methods, with the measurement results and with associated, recorded measurement uncertainties;
e) that the laboratories performing one or more steps in the chain supply evidence for their technical competence.
With regard to demonstrating metrological traceability, it would also be useful to make a reference to Annex A.3 of ISO/IEC 17025:2017 and ILAC P10 (could be in a Note as was the case in the previous version)
152. See 151
03.15
te
If this definition of choice for uncertainty of measurement, please include a further definition of a ‘non-negative parameter’.
A non-negative parameter is also not defined in the VIM.
Add a note to the definition that will make it easier to understand for the user. Proposal: “The Uncertainty of Measurement represents a range of measurement values within which the true measurement value is expected to lie, with a specified level of confidence.”
153. Not agreed, term deleted.
ILAC 0110
03.15
ge
Delete the word ‘uncertainty’ and keep only the measurement uncertainty and uncertainty of measurement. Since they are the relevant to the technical context of this standard. ‘uncertainty’ is generic and better to avoid in a technical standard and keep its always with its conjugate.
3.15
03.15
te
If this definition of choice for uncertainty of measurement, please include a further definition of a ‘non-negative parameter’.
A non-negative parameter is also not defined in the VIM.
Look for a simpler definition that can be understood by all.
Consider the definition available in an earlier version of the VIM such as
.
03.15
te
As above. Not sure that ‘uncertainty’ on its own should be included
Delete ‘uncertainty’ and ‘uncertainty of measurement’
If these terms are used in the document they should be changed to read ‘measurement uncertainty’
156. See 153
The definition of measurement uncertainty is revised
Wait for the survey on CD VIM 4 and recover the changes
157. Same as 149.
ge
The text relating to the inclusion as an uncertainty contributor in preference to applying a correction is vague and ambiguous.
Propose replacing with, “Sometimes, estimated systematic effects are not corrected for but instead are considered as measurement uncertainty contributors”.
158. See 153
ge
The text is not applicable to all scenarios. Considering a measurement uncertainty to be a range of values within which the true value is expected to lie with a specified level of confidence, changing the best estimate of the measurand does not necessarily change the range of values.
Either remove entirely or specify in which cases this would apply.
159. See 153
03.16
impartiaity
ge
In this definition reference is made to a laboratory, while it should be a proficiency testing provider
impartiality
presence of objectivity
Note 1 to entry: Objectivity means that conflicts of interest do not exist, or are resolved so as not to adversely influence subsequent activities of the proficiency testing provider.
Note 2 to entry: Other terms that are useful in conveying the element of impartiality include “freedom from conflict of interests”, “freedom from bias”, “lack of prejudice”, “neutrality”, “fairness”, “open-mindedness”, “even-handedness”, “detachment”, “balance”.
[SOURCE: ISO/IEC 17021 1:2015, 3.2, modified — The words “the certification body” have been replaced by “the proficiency testing provider” in Note 1 to entry, and the word “independence” has been deleted from the list in Note 2 to entry.]
160. Removed, as normatively referenced as suggested in comment 163.
MB 0967
Change the word “laboratory” to “proficiency testing provider”
Note 1 to entry: Objectivity means that conflicts of interest do not exist, or are resolved so as not to adversely influence subsequent activities of the proficiency testing provider.
161. See 160.
Change the word “laboratory” to “proficiency testing provider”
[SOURCE: ISO/IEC 17021 1:2015, 3.2, modified — The words “the certification body” have been replaced by “the proficiency testing provider” in Note 1 to entry, and the word “independence” has been deleted from the list in Note 2 to entry.]
162. See 160.
Delete clause. The general reference to ISO/IEC 17000:2020 is sufficient.
163. Agreed.
ILAC 0117
03.16
te
Impartiality is defined in ISO 17000. The reference should go to ISO 17000 and not 17021.
Change definition to be
“objectivity with regard to the outcome of a conformity assessment activity
Note 1 to entry: Objectivity can be understood as freedom from bias or freedom from conflicts of interest.
[ISO/IEC 17000:2020, 5.3]”
164. See 163.
03.16
te
Suggest this is replaced with the definition of ‘impartiality’ from ISO 17000
Replace with definition from ISO 17000
165. See 163.
The definition comes from ISO17025 and still mentions laboratories. Since, ISO17000 has been revised and provides with a definition of impartiality (§ 2.2.3)
Replace by the definition of ISO 17000 :
impartiality
objectivity with regard to the outcome of a conformity assessment activity
Note 1 to entry: Objectivity can be understood as freedom from bias or freedom from conflicts of interest.”
[Source ISO/IEC 17000:2020, 2.2.3]
te
A PT provider shall demonstrate impartiality in all activities. In Note 1 to enty change “laboratory” by PT Provider.
3.16 impartiality
presence of objectivity
…
[SOURCE: ISO/IEC 17021 1:2015, 3.2, modified — The words “the certification body” have been replaced by “the PT provider” in Note 1 to entry, and the word “independence” has been deleted from the list in Note 2 to entry.]
167. See 163.
03.16
[source]
ed
Reference is made to ‘the laboratory’, but should be ‘the PT provider’.
Change ‘the laboratory’ into ‘the PT provider’.
168. See 163.
change “the laboratory” to “the PT provider”
[SOURCE: ISO/IEC 17021 1:2015, 3.2, modified — The words “the certification body” have been replaced by “ PT provider”
169. See 163.
IT 02 0123
170. See 163.
Replace the word “laboratory” with “proficiency testing provider”
Objectivity means that conflicts of interest do not exist, or are resolved so as not to adversely influence subsequent activities of the proficiency testing provider
171. See 163.
te
In several instances document refers to “laboratory” when it should be “PT provider”
“Laboratory” should be replaced by “PT provider”. Scan entire document for other such replacements necessary.
172. See 163.
ge
Objectivity means that conflicts of interest do not exist, or are resolved so as not to adversely influence subsequent activities of the laboratory.
Objectivity means that conflicts of interest do not exist, or are resolved so as not to adversely influence subsequent activities for service delivery.
173. See 163.
False reference: it's not laboratory
Note 1 to entry: Objectivity means that conflicts of interest do not exist or are resolved so as not to influence subsequent activities of the proficiency testing provider adversely.
174. See 163.
Ge
The note refers the objectivity to the laboratory activities instead to the proficiency testing provider.
To change “laboratory” by “proficiency testing provider”.
175. See 163.
“… activities of the
te
The use of “laboratory” appears to be copied from ISO/IEC 17025 and does not fit well in this document.
Replace “laboratory” by “proficiency testing provider” in note 1 and the source statement.
177. See 163.
Replace the word “laboratory” with “proficiency testing provider”
The words “the certification body” have been replaced by “the proficiency provider” in Note 1 to entry, and the word “independence” has been deleted from the list in Note 2 to entry
178. See 163.
179. See 163.
te
Why has ‘independence’ been removed, it is important that the PT provider has the necessary level of independence.
Reinstate “independence”
te
Why has ‘independence’ been removed, it is important that the PT provider has the necessary level of independence.
Reinstate ‘independence’ to align with ISO 17000 definition (replace ‘conformity assessment activity’ to ‘proficiency testing provider’
181. See 163.
“… replaced by “the
182. See 163.
03.16
note1
ed
Reference is made to 'the laboratory', but should be 'the PT provider'.
Change ‘the laboratory’ into ‘the PT provider’.
183. See 163.
To change “laboratory” by “proficiency testing provider”.
185. See 163.
ed
Change “the laboratory” into “PT provider”.
186. See 163.
03.16 Note 1 and Source note
Impartiality as used in this standard applies to proficiency testing providers not laboratories.
Change “laboratory” to “proficiency testing provider”
187. See 163.
ge
In line with the introductory sentence to it is not required to repeat the definitions of ISO/IEC 17000.
Delete 3.16, 3.17, 3.18
CZ 0141
Definition does not fit for PT provider
Reformulate the definition with respect to PT provider and delete accreditation body
189. See 188.
Reference is not correct (compared to 17025)
“a conformity assessment body or accreditation body, relating to the activities of that body”
should be replaced by
“a PT provider, relating to the activities or results of that provider”
190. See 188.
03.17
ge
Remove reference to Accreditation Body. This document may be used by any PTP, not only those which are accredited. This would also better align this document with the definition in ISO 17025:2017
expression of dissatisfaction, other than appeal, by any person or organization to a proficiency testing provider, relating to the activities or results of that proficiency testing provider, where a response is expected
191. See 188.
03.17
te
Why mentioning the accreditation body while this standard is for PT-providers.
Skip 'accreditation body'.
192. See 188.
03.17
te
Conformity Body has not been defined and is not a term that may be well known to all PT providers. Amend the text to be appropriate for this document and add a note to the source explaining the change.
“… to
the proficiency testing provider, relating to
the
, where a …”
[SOURCE: …… - modified to refer to proficiency testing providers rather the original wording of conformity assessment body or accreditation body]
193. See 188.
03.17
te
Conformity Assessment Body has not been defined and is not a term that may be well known to all PT providers. Suggest amending the text to be appropriate for this document and add a note to the source explaining the change.
“… to
the proficiency testing provider, relating to
the
, where a …”
[SOURCE: … - modified to refer to proficiency testing providers rather the original wording of conformity assessment body or accreditation body]
194. See 188.
1
ge
ISO/IEC 17025:2017 has replaced “a conformity assessment body or accreditation body” with “a laboratory” (Clause 3.2). In the case of ISO/IEC 17043, the term “a proficiency testing provider” might be more suitable.
To replace “a conformity assessment body or an accreditation body” with “a proficiency testing provider (3.9)”.
195. See 188.
ed
Below the definition is a remark “[SOURCE:...”. However, the same format is not used in 3.15 and 3.16.
Harmonise Chapter 3 as appropriate.
196. See 188.
Reference is not correct (compared to subclause 3.17)
“a conformity assessment body or accreditation body, relating to the activities of that body”
should be replaced by
“a PT provider, relating to the activities or results of that provider”
198. See 188.
03.18
ge
Remove reference to Accreditation Body. This document may be used by any PTP, not only those which are accredited.
request to a Proficiency Testing for reconsideration of an adverse decision relating to a proficiency testing result
199. See 188.
03.18
te
Definition of appeal in ISO/IEC 17000 is too general for the purposes of this document
Replace current definition with “request by a participant to the PT provider for a reconsideration of the performance evaluation of the participant”
200. See 188.
03.18
te
Why mentioning the accreditation body while this standard is for PT-providers.
Skip 'accreditation body'.
201. See 188.
03.18
ed
Reference is made to 8.7 of ISO/IEC 17000; this should be 8.6
Change 8.7 into 8.6.
03.18
te
It is discussable if 'appeals' is applicable for PT-providers. Statistics to be used etc. are documented and communicated in advance.
In ISO/IEC 17000 a definition regarding to appeals is described. Appeals are related to reviews (clause 7.1 of ISO/IEC 17000) and decisions (clause 7.2), but PT-providers don't review and don't make decisions regarding to requirements; they just report the results and report the statistical outcome. An appeal (a request for reconsideration) is not relevant.
Skip 3.18 (and clause 7.15).
203. See 188.
03.18
te
The definition needs to be modified to be appropriate for this document and a note added to the source
“request by the
person or organization that provides, or that is, the object of conformity assessment to a conformity assessment body or an accreditation body for
participant, or other customer, to the proficiency testing provider for reconsideration
by that body of a decision it has made relating to that object
of the performance assessment that they have been given.”
[SOURCE …. – modified to relate to the context of this document]
204. See 188.
03.18
te
The definition needs to be modified to be appropriate for this document and a note added to the source
“request by the participant, or other customer, to the proficiency testing provider for reconsideration of the performance assessment that they have been given.”
[SOURCE …. – modified to relate to the context of this document]
205. Same as 204.
SOURCE: ISO/IEC 17000:2020, 8.6
206. Same as 202.
Te
We cannot see that a proficiency testing provider takes any decisions in the meaning used in the functional approach. If a party providing proficiency testing would take such a decision, it would do so in another capacity outside the scope of this standard.
Delete clauses.
FR 0160
04.01.1
Te
Since impartiality is one of the 3 main issues of the management system (see scope), it deserves being included in a management policy
After 4.1.1, insert a new paragraph as follows:
“4.1.2 The proficiency testing provider management shall be committed to impartiality”.
Renumbered this other sub-clauses.
208. Not agreed, this is covered in 4.1.5: proficiency testing provider shall have top management commitment to impartiality.
ILAC 0161
04.01.1 onwards
Line 1
ed
If we are introducing abbreviate terms in the definitions then they should be used throughout the document
Throughout the document change:
‘Proficiency testing’ to ‘PT’
209. Agreed.
UK 0162
04.01.1 onwards
Line 1
ed
If we are introducing abbreviate terms in the definitions, then they should be used throughout the document
Throughout the document change:
‘Proficiency testing’ to ‘PT’
210. Same as 209.
Monitoring interval is not defined.
4.1.3. The proficiency testing provider shall monitor its activities and its relationships to identify threats to its impartiality on an on-going basis. This monitoring shall include the relationships of its personnel.
211. Not agreed, this was the old PROC33 wording, monitoring is ongoing anyway.
TH 0164
Same comments in ISO and IEC.
Should adopt the requirement clause 4.1.4 of the ISO/IEC 17025:2017 for the consistency to similar scheme
The Proficiency testing provider shall identify risks to its impartiality on an on-going basis. This shall include those risks that arise from its activities, or from its relationships, or from the relationships of its personnel. However, such relationships do not necessarily present The Proficiency testing provider with a risk to impartiality.
Note A relationship that threatens the impartiality of the laboratory can be based on ownership, governance, management, personnel, shared resources, finances, contracts, marketing (including branding), and payment of a sales commission or other inducement for the referral of new customers, etc.
212. Agree, editorial, replace “body” with “proficiency testing provider”, for the rest not agreed as new mandatory wording. This is CASCO PROC 33 revised wording and has to be used. Using the term "risk" would be a deviation that needs to be requested to CPC. WG decision not to ask deviation.
ZA 0165
The proficiency testing provider shall monitor its activities and its relationships to identify threats to its impartiality on an on-going basis
213. Same as 211.
04.01.3
Ge
· Use the term risks instead of threats to unify terminology with other standards and with clause 8.5.
· Monitoring on an on-going basis
The proficiency testing provider shall monitor its activities and its relationships to identify risks to its impartiality on an on-going basis.
214. See 211 and 213.
DSM 0167
04.01.3
ge
Propose for Clause 4.1.3 to be elaborated to Clause 4.1.4 of ISO/IEC 17025:2017.
The proficiency testing provider shall identify risks to its impartiality on an on-going basis. This shall include those risks that arise from its activities, or from its relationships, or from the relationships of its personnel. However, such relationships do not necessarily present a proficiency testing provider with a risk to impartiality.
NOTE A relationship that threatens the impartiality of the laboratory can be based on ownership, governance, management, personnel, shared resources, finances, contracts, marketing (including branding), and payment of a sales commission or other inducement for the referral of new customers, etc.
215. This is CASCO PROC 33 revised wording and has to be used. Using the term "risk" would be a deviation that needs to be requested to CPC. WG decision not to ask deviation.
SSC 0168
To replace “threats” with “risks” to standardise with ISO/IEC 17025:2017.
“The proficiency testing provider shall monitor its activities and its relationships to identify risks to its impartiality. This monitoring shall include the relationships of its personnel.”
“NOTE A relationship can be based on ownership, governance, management, personnel, shared resources, finances, contracts or marketing (including branding). Such relationships do not necessary present a body with a threat to impartiality.”
216. See 215.
ed
Existing Text
Such relationships do not necessary present a body with a threat to impartiality.
Revised Text
Such relationships do not necessary present a proficiency testing provider with a threat to impartiality.
217. Agree, replace “body” in this clause.
ILAC 0170
UK 0171
ed
Such relationships do not necessary present a body with a threat to impartiality.
Such relationships do not necessarily present a body with a threat to impartiality.
221. Same as 218.
04.01.4
Te
Should adopt the requirement clause 4.1.5 of the ISO/IEC 17025:2017 for the consistency to similar scheme
If a risk to impartiality is identified, the The Proficiency testing provider shall be able to demonstrate how it eliminates or minimizes such risk.
222. See 215.
04.01.4
Ed
Refer to 17025 wording, the subject of responsibility is clearer and more verifiable.
Proposed to be amended to
If a threat to impartiality is identified, the proficiency testing provider shall be able to demonstrate how it eliminates
or minimizes such threat.
SSC 0176
To replace “threat” with “risk” to standardise with ISO/IEC 17025:2017.
“If a risk to impartiality is identified, its effect shall be eliminated or minimized so that the impartiality is not compromised.”
224. Not agreed, CASCO mandatory language
FI 0177
04.01.5
te
For PT providers that are part of a larger organization this requirement, it could be appropriate to define the “top management” to a smaller entity, e.g. Unit, Department, Center
Proposed phrasing
225. Not agreed, CASCO mandatory language
PL 0178
04.01.5
ge
Top management is mentioned in only one clause of the standard, in the other clauses there is management. Recommendation to harmonize the vocabulary.
Change “top management” into “management”.
226. This is CASCO PROC 33 revised wording and has to be used. Changing it would be a deviation that needs to be requested to CPC. WG decision not to ask deviation.
IN 0179
04.01.5
ed
Word “top” can be deleted in this sentence for bringing uniformity
Existing Text
The proficiency testing provider shall have top management commitment to impartiality.
Revised Text
227. See 226.
IT 03 0180
ge
WG 44 decided not to use term “top management”. Therefore, we suggest to align the text to ISO/IEC 17025.
We recommend to use “management” instead of “top management”.
228. See 226.
04.01.5
1
ge
The usage of the term “top management” has been removed in ISO/IEC 17025:2017. Suggestion to standardise with the phrasing of ISO/IEC 17025:2017 clause 4.1.2.
“The proficiency testing provider management shall be committed to impartiality.”
229. See 226.
04.02
ge
Clear statement about confidentiality of participant identity is missing in the text (Cl. 4.10.1 in valid version of 17043)
Add the relevant text
230. Agreed, clause added.
04.02
ed
The term client in the chapter should be replaced with term customer
term “client” should be “customer”
231. See 62.
04.02
ed
This clause refers to the ’client’ on 3 occasions, whilst elsewhere in the document reference is made to the ’customer’ or the ‘participant’.
There also needs to be some consistency in the uses of customer and participant. In some cases, customer is referred to as ’other customers’ to differentiate between customers and participants.
Change client to customer or participant.
232. See 62.
04.02
(3.6)
te
As discussed at the September 2020 meeting, second day, we have a common understanding that “client” under the CASCO Proc. 33 (as appearing in clause 4.2 in 17043CD) is identical to “participant” in the remaining text of the standard.
If the wording is unchangeable due to being the obligatory statement, we should place a NOTE to sub-clause 4.2 explaining that “client” is identical to “participant”(3.6).
Add NOTE to 4.2:
“NOTE “client” referred only in 4.2 is identical to “participant”(3.6) .
233. ‘See 62.
04.02
ed
This clause refers to the ’client’ on 3 occasions, whilst elsewhere in the document reference is made to the ’customer’ or the ‘participant’.
There also needs to be some consistency in the uses of customer and participant. In some cases customer is referred to as ’other customers’ to differentiate between customers and participants.
See ILAC comment to 3.3 where options for change given for consideration
234. See 62.
04.02
ge
Propose to change the word “client” to “participants” because clients that participate in a proficiency testing program are called participants
1.2.1. The proficiency testing provider shall be responsible, through legally enforceable agreements, for the management of all information obtained or created during the performance of proficiency testing. The proficiency testing provider shall inform the participant, in advance, of the information it intends to place in the public domain. Except for information that the participant makes publicly available, or when agreed between the proficiency testing provider and the all other information is considered proprietary information and shall be regarded as confidential.
1.2.2. When the proficiency testing provider is required by law or authorized by contractual arrangements to release confidential information, the participant concerned shall be notified of the information released, unless prohibited by law.
4.2.3 Information about participant information obtained from sources other than the participant (e.g., complainant or regulators) shall be confidential between the participant and the proficiency testing provider. The source of this information shall be confidential to the proficiency testing provider and shall not be shared with the participant, unless agreed by the source.
4.2.4. Personnel, including any committee members, contractors, personnel of external bodies, or persons acting on the proficiency testing provider’s behalf, shall keep confidential all information obtained or created during the performance of proficiency testing activities.
235. Not agreed, use the word client, WG decision not to change PROC 33 wording. See WG decision issue 1 (N28) and comment 62.
DE 0188
04.02
ed
The possibility to waive the confidentiality by the participant got lost by the revision.
It happened in the past, that we as PT provider were contact to ask special participants for waivering their confidentiality, as they were successful users of a certain method, which was not successful used by the asking party. In these cases we informed the participant about the question and the contact dates of the other participant and it is up to the participants to waive the confidentiality or not.
The other case is the information of the legal authority about the performance of the official control laboratories in NRLs organized by the NRLs in federal organized states in Europe. As the authority can ask directly the official control lab for the confidential data this not is quite useful in the discussion of the NRL with these authorities.
Add:
4.2.5 Participants can elect to waive confidentiality within the proficiency testing scheme, for example for the purpose of informing relevant authorities..
NOTE In most instances, the proficiency testing results can be provided to the relevant authority by the participants themselves.
236. Not agreed, this is covered in 4.2.1.
EQALM
4.2
ge
Add two notes
Note 1: For example, the use of an anonymization code ensures impartiality and confidentiality in the evaluation of results.
Note 2: The terms "proprietary" and "confidential" do not preclude publication for academic and new insights of information purposes, provided that clients cannot be identified, including by inference.
237. Partially agreed, WG accepted in principle to include the notes, see new wording. See also proposal in 241.
EQALM
4.2.1
ed
"client" should be replaced by 'participant"
The proficiency testing provider shall inform the participant, in advance, of the information it intends to place in the public domain, except for the information that the participant makes.
238. See 235.
04.02
Confidentiality
04.2.1
Ge
The committee needs to make sure that in the process of ensuring confidentiality, it doesn’t put PT/EQA programs in a box. Some organizations provide informative critiques on collated information for informative and educational purposes (continual improvement). Some organizations use PT/EQA information in a way that generates new knowledge which is published in scientific journals.
There should be text that makes it clear that the terms “proprietary” and “confidential” do no preclude publication for academic and new insights of information purposes, provided that client identifiers are
Add new:
NOTE: “all information” is defined as Information that impacts on the confidentiality of the users.
Participants can elect to waive confidentiality with the PT scheme. PT providers can use the data that cannot be identified for the purpose of education, improve and publication.
239. Not agreed, see 237 for wording.
SSC 0190
ge
The words “client” appear only in Section 4.2. Suggestion to define “client” under Section 3 Terms and definition.
Add a definition of “Client” under Section 3 Terms and definition.
240. Partially agreed, See 62.
IT 07 0191
te
Clause 4.2 does not explicitly state that the identity of participant shall be confidential.
Add the following new bullet in 4.2 or 7.1.1:
"The identity of participants in a proficiency testing scheme is confidential and known only to persons involved in the operation of the proficiency testing scheme, unless the participant waives confidentiality."
241. Agreed.
CZ 0192
04.02.1
ge
Term client is unclear in this consequence and is not mentioned in the definition. Should be user and/or participant
Clarify the text
242. See 235.
04.02.1
ed
Even if the text in section 4.2.1 is considered “fixed”, correct an inconsistency in terminology, because the term “customer” is defined in 3.3 and used throughout the text with the exception of clause 4 where “client” is used
Replace “client” with “customer”
04.02.1
ge
There is always confusion among PT Providers on what kind of document is acceptable as legally enforceable agreements. Therefore clarity may be given under Note to clause 4.2.1
Proposed Text for Note 1 under Cl 4.2.1
Note - Legally enforceable agreements are in form of agreement / contract / declaration.
244. Not agreed, current PROC 33 text is sufficient and see new notes.
ABNT 0195
04.02.1
ed
The term “client” is not used in any other part of the standard. The term “customer” is used throughout the standard. Just one term should be used.
Replace “client” by “customer”,.
The word client (or customer) is missing after “between the proficiency testing provider and the…”
4.2.1 The proficiency testing provider shall inform the customer, in advance, of the information it intends to place in the public domain. Except for information that the customer makes publicly available, or when agreed between the proficiency testing provider and the customer all other information is considered proprietary information and shall be regarded as confidential.
245. See 62.
04.02.1
1
ge
To incorporate clauses 4.10.3 and 4.10.4 in ISO/IEC 17043:2010 into this clause.
The word “client” is missing from the last sentence.
“The proficiency testing provider shall be responsible, through legally enforceable agreements, for the management of all information obtained or created during the performance of proficiency testing. The proficiency testing provider shall inform the client, in advance, of the information it intends to place in the public domain or to any interested party on request. Except for information that the client makes publicly available, or when agreed between the proficiency testing provider and the client (e.g. for the purpose of regulatory authority and/or interested party requirements), all other information is considered proprietary information and shall be regarded as confidential.”
246. Yes, client added to the text, the word was missing. On the second part on interested parties, the WG feels it's already covered and no need to modify the PROC33 text.
GR 0197
ed
Even if the text in section 4.2.1 is considered “fixed” an obvious error should be corrected (missing word “customer”)
Replace “between