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Throughout
IMcNAIR
015 001
001 001
1
UK
IMcNAIR
141 130
130 146
2
UK
IMcNAIR
016 002
002 002
6
1
2
Foreword
Paragraph/
Figure/Table
Type of
comment2
Date:2015-03-03
Document:
Comments
Project:
Proposed change
Observations of the
secretariat
ge
Present draft is against ISO 9001:2008 & IAEA GS-R-3
both of which are being significantly revised in parallel for
publication 2015/16.
Comment on this version but at CD stage
translate in the later thinking and formats
of revised versions.
19443 WD version is
agreed to be based on
ISO 9001:2008 ed with
enclosure showing
ISO9001:2015
compliance matrix
ge
Add the relationship to NSQ 100 Guidance and how it is
to be applied.
In addition to text, consider adding as
Appendix.
ISO 19443 guidance
will be proposed as
per ISO 9100 (once
ISO 19443 is issued)
ge
Guidance needed on what is special about nuclear safety Add from NSQ Sect B:
culture.
NOTE 1
The main differences of nuclear safety
culture compared with general corporate
culture touch on the concept of core
hazards and the potential large effects
associated with the dispersion of
radioactive substances. It is this fact that
makes nuclear power different and that
demands a set of organizational values
that place nuclear safety as the top priority
of an organization.
NOTE 2
Safety Culture has two general
components:
1. Necessary framework within an
organization and responsibility of the
management hierarchy,
Agree to add
NOTE 1
The main differences
of nuclear safety
culture compared with
general corporate
culture touch on the
concept of core
hazards and the
potential large effects
associated with the
dispersion of
radioactive
substances. It is this
fact that makes
nuclear power different
and that demands a
set of organizational
values that place
MB = Member body / NC = National Committee (enter the ISO 3166 two-letter country code, e.g. CN for China; comments from the ISO/CS editing unit are identified by **)
Type of comment:
ge = general
te = technical ed = editorial
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Date:2015-03-03
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Comments
Project:
Proposed change
2. Attitude of staff at all levels in
responding to and benefiting from the
framework.
US pshaw
143 132
132 148
General
I am not clear that the definition of nuclear safety culture
and reference to nuclear safety culture, nuclear safety
aspects (4.2.2 5.3.3, quality management and importance
to safety) is achieving the correct emphasis when the
reader is not the licensee. Eg an organisational change in
a supplier of hardware would not consider any
organisational change having an impact on nuclear safety
management. Similarly top management of a supplier of
hardware would not see how to embed nuclear safety
objectives into their quality management. Many
references to safety are more directed at OHSAS
In quality the risk management in organisational change,
is consideration of the organisations ability to continue to
deliver the product or service to customer requirements.
5.1g -- develop and improve its safety culture ?
4.1.1 nuclear safety culture does this sit correctly, a
safety culture within an organisation is OHSAS, a culture
of ensuring the product being manufactured/installed
correctly and does not contribute to a nuclear incident is
a different culture.
Observations of the
secretariat
nuclear safety as the
top priority of an
organization.
NOTE 2
Safety Culture has two
general components:
1. Necessary
framework within an
organization and
responsibility of the
management
hierarchy,
2. Attitude of staff at all
levels in responding to
and benefiting from the
framework.
The adoption of a quality management
See notes 1 & 2 above
system aids an organization in the
understanding and application of quality
management principles for Nuclear
purposes. These principles are necessary
to achieve the safe, reliable, and efficient
utilization of nuclear energy, and
management and processing of
radioactive materials.
The design and implementation of an
organization's quality management system
is influenced by:
(a) the hazards associated with doing the
work or using the results of the work
(b) the consequences of malfunction or
failure of the item, or inappropriate use of
the results of services provided
(c) the probability of the occurrence of the
postulated consequences
(d) the design and fabrication complexity
or uniqueness of the item, or difficulty to
perform services
1
2
MB = Member body / NC = National Committee (enter the ISO 3166 two-letter country code, e.g. CN for China; comments from the ISO/CS editing unit are identified by **)
Type of comment:
ge = general
te = technical ed = editorial
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Project:
Proposed change
Observations of the
secretariat
(e) the need for special controls and
oversight of processes, equipment, and
performance
(f) the degree to which functional
compliance can be demonstrated by
inspection, test, or performance
verification
(g) the quality history and degree of
standardization of items and services
(h) the difficulty of repair, replacement, or
replication of the items and services
Additional factors that can aid in this
process of gradation:
a) its organizational environment, changes
in that environment, and the risks
associated with that
environment,
b) its varying needs,
c) its particular objectives,
d) the products it provides,
e) the processes it employs,
f) its size and organizational structure.
It is not the intent of this document to
imply uniformity in the structure of quality
management systems or uniformity of
documentation, .
PVe 142
131 131
147
General
Ge
The current structure is not in line with "Annex SL" - the
rules governing the development of all ISO management
standards and therefore also not in line with the structure
of ISO 9001:2015. As this is not a QMS standard there
might still be a possibility not being obliged to align.
US 144
133 133
N/A
ge
Withhold this standard from reaching Committee Draft
status until IAEA provides formal input and completes its
1
2
Suggest a thorough gap analysis with
ISO/DIS 9001:2014 and integrate already
those items with significant gaps
See #1 above
19443 WD version is
agreed to be based on
ISO 9001:2008 ed with
enclosure showing
ISO9001:2015
compliance matrix
IAEA to be invited for
comments on ISO
MB = Member body / NC = National Committee (enter the ISO 3166 two-letter country code, e.g. CN for China; comments from the ISO/CS editing unit are identified by **)
Type of comment:
ge = general
te = technical ed = editorial
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149
Date:2015-03-03
Comments
Project:
Proposed change
work on GSR Part II.
US 145
134 134
150
NA
JAP 146
135 135
151
Trough out
Trough out
ge
In general this draft lacks detail needed for a high
risk/highly regulated/high consequence of failure industry
such as the nuclear industry.
ge
It is recommended that the structure of paragraphs shall
To be discussed.
be upgraded in accordance with ISO 9001:2015 whose
structure is aligned with the ISO/IEC Directives Annex SL
when ISO/WD19443 will be suggested as Committee
Draft.
Because Type A MSS shall follow ISO/IEC Directives
Annex SL. (We recognize ISO/WD19443 is Type A MSS.)
When upgrading as mentioned, the comparison between
ISO 9001:2008 and 2015 shall be proceeded as follows:
1) ”-Y” and “+X” shall be clarified.
2) Necessary requirements as nuclear MSS in “Y” shall be
remained.
3) The differences between “X” and “Z” shall be
compared, evaluated and integrated.
4) Guideline shall be prepared. (See comment for 4.1.1.)
ISO/WD19443
:2015
+X
+
+Z
Observations of the
secretariat
19443 CD version
ISO 9001:2008
1
2
Document:
Suggest a thorough comparison with
AS9100, the Aerospace Standard and
the family of aerospace quality related
standards (see comment on
references below).
ISO 19443 guidance
will be proposed as
per ISO 9100 (once
ISO 19443 is issued)
19443 WD version is
agreed to be based on
ISO 9001:2008 ed with
enclosure showing
ISO9001:2015
compliance matrix
<<< Guideline”ISO/TS 9002” may be
prepared.
<<< Guideline shall be
prepared.
MB = Member body / NC = National Committee (enter the ISO 3166 two-letter country code, e.g. CN for China; comments from the ISO/CS editing unit are identified by **)
Type of comment:
ge = general
te = technical ed = editorial
(Nuclear sector)
-Y
Page 4 of 53
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0.1
Paragraph/
Figure/Table
0.1
Type of
comment2
te
Date:2015-03-03
Document:
Comments
In addition, the qualification of the
suppliers by the Licensee or a customer doesn't take only
into consideration the QMS but includes as well others
areas of assessment (technical capability and capacity,
safety, environment, radioprotection, socio-economic
aspects...)
We consider this precision as mandatory in order to
prevent future potential misunderstanding in case a
company, whose the QMS is ISO certified, would not be
qualified by the licensee or a customer because it doesn't
fulfil complementary and specifics requirements set up by
them.
Proposed change
§0.1:
Project:
Observations of the
secretariat
Add:
Add
Note 1: The
certification according
to this standard may
"Note 1: In addition to certification
be considered as a
according to this standard, criteria for
criteria for supplier
supplier qualification can also consider the qualification but
occupational safety, technical capability
supplier qualification
and capacity, environment, sociomay also consider
economic aspects…"
other criteria like the
occupational safety,
"Note 2: The certification according to this security, technical
standard may be considered as a criteria capability and
capacity, environment,
for supplier qualification but supplier
socio-economic
qualification can also consider other
aspects…"
criteria like the occupational safety,
technical capability and capacity,
environment, socio-economic aspects…" Note 2: It is reminded
that according to the
existing national
regulations, the
Licensee may entirely
or partially undertake
the qualification of the
Supplier throughout
the supply chain
"
JAP 028
010 006
006
0.3
ge
It is necessary to add a description of the relationship
between this document and ISO 9001.
US 024
0.3
ge
This adds no value as written. It is not clear without
1
2
See revised WD
Delete this section.
See revised WD
MB = Member body / NC = National Committee (enter the ISO 3166 two-letter country code, e.g. CN for China; comments from the ISO/CS editing unit are identified by **)
Type of comment:
ge = general
te = technical ed = editorial
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006 007
007
Date:2015-03-03
Document:
Comments
Project:
Proposed change
Observations of the
secretariat
discussing IAEA, 9001, 9000. It also discusses future
editions of STDs that should not be mentioned. Delete
the Section.
US 025
007 008
008
0.3
ed
…other, but the last one can also be used independently.
US 026
008 009
009
0.3
te
2nd para. – “This document specifies requirements for a
This whole document seems to be an ISO See revised WD
quality management system…”, given the lead-in material themed document – that is customer
(i.e., 0.1) this seems odd phrasing/at odds with this.
satisfaction, with a thin vainer of Nuclear
placed over it. The things related to
nuclear – such as safety are an afterthought.
The material in the document initially
speaks of “guidance” type phrasing BUT
then frequently uses the words
requirements.
Requirements are necessary.
Fr
0.3
Te
Despite the application of the norm
project is not mandatory, we feel as necessary to pay
careful attention in the potential consequences of the
application of the norm to the whole supply chain. Indeed,
the number of suppliers being potentially significant, the
norm's requirements must be adapted considering the
equipments and the requested level of quality.
As per example, for suppliers of nuclear equipements
close to their standard equipments (diesel generator,
HVAC system, instrumentation, civil works...) or products
manufactured according normalized standards (plates,
1
2
0.3
ISO 9004 and this document are quality
management system standards which
have been designed to complement each
other, but this document can be used
independently. It is crucial to recognize
that because of the safety aspects of
nuclear activities other documents, such
GS-R-3 and NQA-1 need to be
incorporated into nuclear quality
management system.
See revised WD
0.3 Relationship with ISO 9004 and NQSA See revised WD
guidelines
ISO 9004 and this standard arequality
management system standards which
have been designed to complement each
other, but the last one can also be used
independently.
This standard specifies requirements for a
quality management system that can be
used for internal application by
MB = Member body / NC = National Committee (enter the ISO 3166 two-letter country code, e.g. CN for China; comments from the ISO/CS editing unit are identified by **)
Type of comment:
ge = general
te = technical ed = editorial
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US 027
009 011
011
0.4
Fr
1.1
1
2
Paragraph/
Figure/Table
1.1
Type of
comment2
Date:2015-03-03
Document:
Comments
Project:
Proposed change
Observations of the
secretariat
pipes, bars...), nuclear sector represents a little part of
their turnover. As a consequence, these suppliers may
have a limited interest in the certification and the costs
and certification requirements might lead some of them
(especially SMEs) to exit the nuclear market.
As for ISO 9100 guidelines, NQSA guidelines are
suggested to be promoted at ISO level to support ISO
19443
organizations, or for certification, or for
contractual purposes. It focuses on the
effectiveness of the quality management
system in meeting customer, and nuclear
safety requirements.
The revised edition of ISO 9004 and
NQSA guidelines will provide guidance to
management for achieving sustained
success for any organization in a complex,
demanding, and ever changing,
environment. ISO 9004 provides a wider
focus on quality management than ISO
9001; it addresses the needs and
expectations of all interested parties and
their satisfaction, by the systematic and
continual improvement of the
organization’s performance. However, ISO
9004 and NQSA guidelines are not
intended for certification, regulatory or
contractual use.
ge
Delete the mentions of NSQ docs. These are not
reviewed or approved by national/international bodies
responsible for the subject comparisons. The U.S. and
IAEA have taken exceptions to the comparisons.
Delete this section.
See revised WD
Te
We consider that is necessary to
restrain the field of application of this standard to
specific sectors of activity. It would be pertinent to
exclude the sector of site activities (site services and
O&M activities). These activities generally involve more
local suppliers and are covered by licensee's contractual
requirements integrating already IAEA requirements
plus specific requirements adapted to plants and context
We suggest to add at the end of the last
paragraph the following note :
"Note : the scope of this standard is
mainly dedicted to design, procurement,
manufacturing, assembly, site erection
and commissionning of equipment"
See revised WD
An other alternative would be to delete
the word "services" in the first sentence
MB = Member body / NC = National Committee (enter the ISO 3166 two-letter country code, e.g. CN for China; comments from the ISO/CS editing unit are identified by **)
Type of comment:
ge = general
te = technical ed = editorial
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Comments
Project:
Proposed change
Observations of the
secretariat
different between each licensee.
of §1.1 ("This document, intended for any
organization which supplies product or
services within.."
Te
Customer or Licensee have requirements and some of
them can complete or decline requirements that
contains regulatory requirements (ex: EDF's GQAS,
specific requirement of EDF's CCTG asking to have
documents writen, verified and approved for release by
different people for documents). Addtional quality
requirements may prevail over the ISO standards
requirements. The project of standard does not plan
adaptation of the QMS (quality management system) to
the customer requirements. It is widely insufficient and
risky for the Licensee or the customer (the contractual
requirements taking back those of the Licensee).
We suggest to replace the last paragraph See revised WD
by :
The requirements specified in this
standard do not supersede the applicable
contractual and statutory or regulatory
requirements.
Should there be a conflict, statutory or
regulatory requirements shall take
precedence.
Fr
1.1
US 031
013 013
013
1.1
te
Last para. – “It is emphasized that the requirements
specified in this document are complementary (not
alternative) to contractual and applicable statutory and
regulatory requirements.”
Given this phrasing – why is this
document necessary IF “… contractual
and applicable statutory and regulatory
requirements.”, then reference the
document(s) – such as NQA-1.
Suggest rewording.
US 032
014 014
014
1.1, 1.2
te
Although this STD is intended for use on all products ad
services within the nuclear industry, it may be more suited
for non-complex, of-the-shelf, and low safety significance
items/services (rather than complex, engineered items
and structures).
Edit scope to limit it to non-complex, offSee revised WD
the-shelf, and low safety significance
items/services, while strengthening the
requirement that contractual requirements
address industry requirements for
complex/high safety significance.
US 033
1.1, 1.2
te
In its current form, the ISO draft will not be acceptable for
There needs to be some type of footnote
1
2
1.1
See revised WD
See revised WD
MB = Member body / NC = National Committee (enter the ISO 3166 two-letter country code, e.g. CN for China; comments from the ISO/CS editing unit are identified by **)
Type of comment:
ge = general
te = technical ed = editorial
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015 015
015
UK
IMcNAIR
149 138
137 016
3
2
Comments
Document:
Project:
Proposed change
compliance with U.S. nuclear safety rules.
It needs some type of footnote or scope section that
serves to send the reader to NQA-1 for safety related
items that must meet 10 CFR 830 and 10 CFR 50
(perhaps also the Parts 70/71, etc.).
or scope section that serves to send the
reader to NQA-1 and ANS-3.2 for safety
related items that must meet 10 CFR 830
and 10 CFR 50 (perhaps also the Parts
70/71, etc.). The WG should pause and
review AS9100 against the draft to
compare how that high hazard/risk
industry addresses quality requirements.
In line with revisions to ISO 9001 / IAEA GS-R-3, take
account of revisions to other standards eg ISO
9000:2015. Also Nuclear Vocabulary in ISO 921:1997
(being revised into ISO 12749-Parts) and IAEA Safety
Glossary :2007
At CD stage translate in the later thinking
and formats of revised versions.
Observations of the
secretariat
Delete “for undated
….” sentence
See revised WD
To be addressed when
the ISO 19443 will
consider the
ISO9001:2015 ed
UK
IMcNAIR
150 139
138 018
4
JAP 034
017 017
019
3- TERMS AND
DEFINITIONS
GOST R
3.
1
2
ge
Date:2015-03-03
3.2
Classification
ge
Specific nuclear reference should be given
Add ref to IAEA SSG-30 Safety
Classification of Structures, Systems and
Components in Nuclear Power Plants.
2014
3.10
ed
Clarify the meaning.
te
It is necessary to add a definition for the concept of "key
aspects of safety culture" as used in paragraph 4.1.1. and Key aspects of safety culture
The result of any activity. Product may
include service.
OK for defining
classification as per
IAEA definition SG
See revised WD
See revised WD
MB = Member body / NC = National Committee (enter the ISO 3166 two-letter country code, e.g. CN for China; comments from the ISO/CS editing unit are identified by **)
Type of comment:
ge = general
te = technical ed = editorial
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Comments
5.1., in accordance with Ref. [4, 2.11] .
155 144
144 020
Fr
Date:2015-03-03
3
3
Te
The project of norm is written in rather general
requirements which don't stick to the IAEA requirements.
the wording lacks precision and clarity, especially in the
definitions of terms used which take a very precise
signification in the frame of an ISO norm. We suggest to
use some formulations closer to the GSR-3 and to the
vocabulary and philosophy of ISO9001.Vocabulary is not
coherent with regard to the ISO 9001/9000: the project
contains different definitions about several terms (product,
supplier, ...). It may create some confusion when
companies are certified both with 9001 and 19443.
Equivalent definitions would allow a better understanding
of the actors. In such a case, il would be better to give the
additional precisions of the GSR-3 in notes.
Project:
Proposed change
Observations of the
secretariat
Key aspects of safety culture include:
Safety is integrated into all
activities,
Safety is a clearly recognized
value,
Leadership for safety is clear,
Accountability for safety is clear,
Safety is learning driven.
Product -> stick to ISO 9000 -> to be
deleted from ISO WD
Supplier : ISO organisation or person that
provides a product
See revised WD
See revised WD
Note: An all-inclusive term used in place of
any of the following: vendor, seller,
contractor (first rank supplier of the
licensee), subcontractor, fabricator,
consultant, and their sub tier level.
See comment above
Classification: A methodology to
UK IMcNAIR 150 139
determine the status of an item or an
138 018
activity, with regard to its impact or not, on
& revised WD
nuclear safety (IFS, see 3.76.), and/or
performance, and/or quality of a product.
Fr
1
2
3
3
Definitions: word "activity" is not defined in the ISO
Activity: a Task which contributes to
9001/9000: we propose the following definition: activity:
OK
See revised WD
MB = Member body / NC = National Committee (enter the ISO 3166 two-letter country code, e.g. CN for China; comments from the ISO/CS editing unit are identified by **)
Type of comment:
ge = general
te = technical ed = editorial
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Date:2015-03-03
Document:
Comments
Project:
Proposed change
Observations of the
secretariat
"element of a process in the sense of the standard NF EN the realization of the product.
ISO 9000 edition 2005, which contributes to the
realization of a product."
US 035
018 018
023
3.14
te
The reference to “licensee” is incomplete as all nuclear
facilities are not licensed.
Add the term, “owner”.
US 036
019 019
024
3.15
te
Surveillance
The definition of surveillance should be
See revised WD
deleted and the term assessment should
be used – because of its broader usability.
See revised WD
Assessment - A review, evaluation,
inspection, test, check, surveillance, or
audit to determine and document whether
items, processes, systems, or services
meet specified requirements and perform
effectively.
IT 140
129 129
145
1
2
Definitions:
1) Definitions:
We propose the following definitions which take account
also the IAEA Safety Glossary:
3.15 Surveillance - The act of monitoring or observing to
ensure that an item or activity is in compliance with
specified requirements and continue to function or are
capable of performing their functions when called upon to
do so.
3.16 Inspections - An examination, observation,
measurement or test undertaken to assess structures,
systems and components and materials, as well as
operational activities, technical processes, organizational
processes, procedures and personnel competence.
Normally are performed by independent personnel in
accordance with the standard UNI CEI EN ISO/IEC
17020.
3.15 Surveillance - The act of monitoring
or observing to ensure that an item or
activity is in compliance with specified
requirements and continue to function or
are capable of performing their functions
when called upon to do so.
3.15 see revised WD
3.16 Inspections - An examination,
observation, measurement or test
3.16 is already defined
undertaken to assess structures, systems in ISO:9000
and components and materials, as well as
operational activities, technical processes,
organizational processes, procedures and
personnel competence. Normally are
performed by independent personnel in
accordance with the standard UNI CEI EN
ISO/IEC 17020.
MB = Member body / NC = National Committee (enter the ISO 3166 two-letter country code, e.g. CN for China; comments from the ISO/CS editing unit are identified by **)
Type of comment:
ge = general
te = technical ed = editorial
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te
GOST R 1
Date:2015-03-03
Document:
Comments
Lack of certain services related to the operation and
decommissioning, contrary to the General (1.1.)
and Applications (1.2.), according to which this
document is including those for all organizations
providing services to the nuclear industry.
Project:
Proposed change
Аctivity
Observations of the
secretariat
See revised WD
A Task which during design, development,
procurement, manufacturing, construction,
assembly, inspection, testing, handling,
transportation, storage, cleaning,
preservation, site erection, commissioning,
maintenance and related services
(including those associated with the
operation and decommissioning of items
and facilities)
within the nuclear industry, directly
influences quality or performance of the
product (see 3.10).
US 037
020 020
025
3.2
IT 038
021 021
026
3.2, 3.6, 4.1.2
US 039
3.3
1
2
te
te
Classification scheme must address existing schemes.
Add- “Classification shall use ANS-58.14,
ANS-58.16, US Code of Federal
Regulations Part 830, or equivalent to
determine safety status.”
1) Requirement 3.2, 3.6, 4.1.2 :
It is proposed to indicate methods and standard
references on classification of “Important For Safety-IFS”
structures, systems and components, as follows:
“The characteristics of the IFS are identified in the safety
analysis that assigns a specific quality class, according to
the US NRC Regulatory Guide 1.26, and a specific
seismic class to each IFS. This allocation unequivocally
identifies the technical standards of reference to be used
for the design and construction of IFS.”
of “Important For Safety-IFS” structures,
See revised WD
systems and components, as follows:
“The characteristics of the IFS are
identified in the safety analysis that
assigns a specific quality class, according
to the US NRC Regulatory Guide 1.26,
and a specific seismic class to each IFS.
This allocation unequivocally identifies the
technical standards of reference to be
used for the design and construction of
IFS.”
Revise first sentence so that it refers to : safety function
Revise first sentence to: A structure,
See revised WD
No modification
MB = Member body / NC = National Committee (enter the ISO 3166 two-letter country code, e.g. CN for China; comments from the ISO/CS editing unit are identified by **)
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te = technical ed = editorial
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Comments
022 022
027
Project:
Proposed change
Observations of the
secretariat
system, or component, or part thereof, that decided
affects its safety function that was not
designed and manufactured in accordance
with the requirements of this document.
US 040
023 023
028
3.3
te
No mention of commercial grade services
Add a definition for Commercial Grade
Service
US 041
024 024
029
3.6
te
Malfunctions or failures that could lead to undue hazards
can only be determined by acceptable PSA methods
Revise first sentence to: “….could lead to See revised WD
undue radiation hazards as determined by
appropriate fault-tree-event tree methods.”
US 042
025 025
030
3.xx
te
Section 3 needs to add an item to cover special treatment Add: “3.xx Special Treatment A process See 7.4.1
of SSCs to enable them to verifiably perform selected
administered to SSCs so as to incorporate
functions under challenges that go beyond commercial
specific IFS (see 3.6) attributes”
grade capability
US 043
026 026
031
4
te
The standard uses several places “May” word under
“Note” and requirement paragraphs.
1
2
new
See ISO WD 19443 §
7.3
Recommend to review and change to
Overall proposal to be
“shall”. Also there are too many notes are done for next meeting
used in this section.
MB = Member body / NC = National Committee (enter the ISO 3166 two-letter country code, e.g. CN for China; comments from the ISO/CS editing unit are identified by **)
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te = technical ed = editorial
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IT 044
027 027
032
PVe 045
028 028
033
1
2
Paragraph/
Figure/Table
Type of
comment2
4.1
4.1
te
Date:2015-03-03
Document:
Comments
Project:
Proposed change
Observations of the
secretariat
1) Requirement 4.1:
It doesn’t emphasize the IAEA requirement of
independence of the personnel controlling on the design
and construction, not included in ISO 9001.
We propose to add in the 4.1.3 “Grading the application of
quality requirements”:
the personnel involved in inspections and surveillance on
classified items or activities must be other than those who
carried out the work
to add in the 4.1.3 “Grading the application See 7.5.1.3
of quality requirements”:
the personnel involved in inspections and
surveillance on classified items or
activities must be other than those who
carried out the work
Upgrade to 2015 version
The organization shall establish,
implement, maintain and continually
improve a quality management system,
including the processes needed and their
interactions, in accordance with the
requirements of this International
Standard. The organization shall
determine the processes needed for the
quality management system and their
application throughout the organization
and shall determine:
a) the inputs required and the outputs
expected from these processes;
b) the sequence and interaction of these
processes;
c) the criteria, methods, including
measurements and related performance
indicators needed to ensure the effective
operation, and control of these processes;
d) the resources needed and ensure their
availability;
e) the assignment of the responsibilities
and authorities for these processes;
f) the risks and opportunities in
accordance with the requirements of ???,
and plan and implement
the appropriate actions to address them;
See #1 above
19443 WD version is
agreed to be based on
ISO 9001:2008 ed with
enclosure showing
ISO9001:2015
compliance matrix
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Comments
Project:
Proposed change
Observations of the
secretariat
g) the methods for monitoring, measuring,
as appropriate, and evaluation of
processes and, if needed, the changes to
processes to ensure that they achieve
intended results;
h) opportunities for improvement of the
processes and the quality management
system.
UK
IMcNAIR
154 143
142 034
7
4.1
JAP 064
049 029
035
ge
Outsourcing may be misunderstood as only referring to
Add note that outsourcing includes any
organizations other than that covered by the QMS.
activities not addressed by the parent
Separate parts of the same organizational body may have QMS, regardless of who undertakes it.
separate QMS or be located in different locations.
To be further referred
into the guidance
4.1.1
ge
Some useful guidelines included NSQ-100 should be
added. Such guidelines are nuclear safety culture,
Classification and Grading Approach.
ISO 19443 guidances
will be proposed as
per ISO 9100 (once
ISO 19443 is issued)
JAP 065
050 030
036
4.1.1
ge
There may be some cases that some requirements in this
document are not practical for lower tier suppliers. A
description should be added to allow use of such lower
suppliers if purchasers take actions to assure the quality
of products supplies by such suppliers.
See 7.4.1 (commercial
grade item)
UK
IMcNAIR
046 029
031 037
4.1.1
Nuclear safety
culture
ed
Throughout text the omission of the word nuclear can
confuse those not always working in the nuclear sector.
1
2
4.1
General
requirement
4th para and
Note 2
Insert nuclear in front of safety culture
each time it appears
Ok for replacing all
MB = Member body / NC = National Committee (enter the ISO 3166 two-letter country code, e.g. CN for China; comments from the ISO/CS editing unit are identified by **)
Type of comment:
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Project:
Proposed change
Observations of the
secretariat
8
US 047
030 032
038
4.1.1
te
“The organization shall promote and support a strong
safety culture by…”
IF the document incorporates the clearer
(such as recommended in this review)
language on requirements than this
section will make sense and become
usable. Additionally, to recognize that the
concept of Nuclear safety culture needs to
be more pronounced within the document
(i.e., ISO 9004 is not sufficient to sustain a
Nuclear Safety culture or requirements) in
order for this paragraph to fully
functionally.
Comment to be
clarified and to be
resubmitted for next
meeting
As written it is fine IF the full concept of
Nuclear safety and QA is understood and
applied – not the
Fr
1
2
4.1.1
4.1.1
Te
The required "strong safety culture" can have important
impacts according to its understanding by the different
actors (certification bodies or regulatory bodies)
particularly for suppliers which are less involved in the
nuclear domain.
Licensees or main suppliers can elaborate methods that
can be used by their sub- contractors.
We suggest to have a less strict requirement, more
adapted to suppliers concerned by it and closer to the
following proposal:
"Each supplier in the supply chain of subcontractors
applies the policy concerning protection of the interests
elaborated by the Licensee and makes sure that the
various actors have understood the associated risks and
stakes to the activities they are responsible for."
The organization shall:
- promote the safety culture by
encouraging a common understanding of
the key aspects of safety culture within the
organization,
- shall support as appropriate the safety
culture by:
i- providing the means by which the
organization supports individuals and
teams in carrying out their tasks safely
and successfully, taking into account the
interaction between individuals,
technology and the organization,
ii- reinforcing an appropriate learning and
questioning attitude at all the different
levels of the organization,
iii- providing the means by which the
organization continually seeks to develop
and improve its safety culture.
See revised WD (New
proposal)
Keep the formal
paragraph for
guidance purpose
MB = Member body / NC = National Committee (enter the ISO 3166 two-letter country code, e.g. CN for China; comments from the ISO/CS editing unit are identified by **)
Type of comment:
ge = general
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Comments
Project:
Proposed change
Observations of the
secretariat
Methods to promote and support the
safety culture can be described in some
guides or be part of applicable contractual
requirments (Licensee or a main supplier
(of first level)).
JAP 066
051 033
039
4.1.2
tc
Submittal is Not only classification.
The classification shall be submitted to the
customer for acceptance.

See ISO WD 3.2
The policy for and results of
classification shall be submitted to the
customer for acceptance.
JAP 067
052 034
040
4.1.2
tc
Submittal is Not only to customer.
UK
IMcNAIR
017 016
016 017
10
4.2.1.2
ge
Submission to customer. May need to be submitted to
level of organization above the customer that is
determining the safety case or even Licensee.
Add note to relate to customer chain up to See WD
Licensee.
UK
IMcNAIR
048 031
035 041
9
4.1.2
Classification of
items and
services
ed
Reference given 3.9 not understood – Ref 3.9 is Nuclear
Safety
Expand on safety function – IAEA Safety
Glossary defines as :
safety function
1
2
2
The classification shall be accepted in the
necessary level.
See WD
See WD
Reference deleted
A specific purpose that must be
accomplished for safety.
MB = Member body / NC = National Committee (enter the ISO 3166 two-letter country code, e.g. CN for China; comments from the ISO/CS editing unit are identified by **)
Type of comment:
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Date:2015-03-03
Document:
Comments
Project:
Proposed change
Observations of the
secretariat
commonly condensed into a succinct
expression of three main safety functions
for nuclear power plants:
(a) Control of reactivity;
(b) Cooling of radioactive material;
(c) Confinement of radioactive material.
US 049
032 036
042
4.1.2
te
The basis for safety importance (including for para 3.9)
can only be established through appropriate fault treeevent tree methods
Add to 2nd para: “…as determined by
Appropriate methods
appropriate fault tree-event tree methods.” added in classification
definition
See revised WD
GOST R
148 137
139 043
4.1.2.
te
Present formulation of the requirements contained in the
first paragraph contrary to the requirements of Russian
legislation, according to which safety classes of elements
of nuclear power plants are assigned project developers
reactor installation and project developers nuclear power
plant.
“Taking into account the degree of
influence of product on nuclear safety
Fr
4.1.2
There is a risk of confusion between the
word classification (responsibility of the supplier) and the
classification in the sense of safety class (Licensee
responsibility).
This notion does not have to question the safety class of
the equipment which constitute an input data from the
customer towards the organization, nor even the technical
reference table choosen by the manufacturer or the
Licensee which can integrate additional elements
resulting from the technique feedback of the customer or
Replace the first sentence by:
See revised WD
Taking into account the complexity, Each
organization involved in the supply chain
shall break down the product classification
safety class in order to identify items or
activities important for safety or impacting
the performance of the product important
for the final quality of structures, systems
or components.
1
2
See revised WD
the product complexity, each organization
involved in the supply chain shall consider
break down the product classification in
order to identify items and activities
important for safety (see 3.6) or important
for the final quality of the structures,
According to the definition (3.2.) classification does not
depend on the complexity of the product , but depends on systems or components ”
its impact on nuclear safety
4.1.2
Te
MB = Member body / NC = National Committee (enter the ISO 3166 two-letter country code, e.g. CN for China; comments from the ISO/CS editing unit are identified by **)
Type of comment:
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Comments
Proposed change
Project:
Observations of the
secretariat
Licensee. Classification only allows an identification of the
activities important for safety.
In addition, classification is not specialy based on
complexity, so we suggest to delete this term.
It should be careful that the method used for the analysis
of the consequences is not too strong and remain an
industrial and reasonable practice for the organization.
Exiting guidelines can introduce a good practices (see
§0.3)
(risk analysis according to the NPE french order is an
example to avoid in this requirement).
UK
IMcNAIR
050 033
037 044
11
1
2
4.1.3
Grading the
application of
quality
requirements
1
ge
Grading should be based on more than complexity.
Reword to incorporate IAEA Safety
See revised WD 4.1.2.
Glossary wording:
“For a system of control, such as a
regulatory system or a safety system, a
process or method in which the stringency
of the control measures and conditions to
be applied is commensurate, to the extent
practicable, with the likelihood and
possible consequences of, and the level of
risk associated with, a loss of control.
An example of a graded approach in
general would be a structured method by
means of which the stringency of
application of requirements is varied in
accordance with the circumstances, the
regulatory systems used, the management
systems used, etc. For example, a method
in which:
(1) The significance and complexity of a
product or service, activity or controls are
determined;
(2) The potential impacts of the product or
service on health, safety, security, the
environment, economical aspects and the
achieving of quality and the organization’s
objectives are determined;
(3) The consequences if a product fails or
if a service is carried out incorrectly are
MB = Member body / NC = National Committee (enter the ISO 3166 two-letter country code, e.g. CN for China; comments from the ISO/CS editing unit are identified by **)
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Date:2015-03-03
Comments
Guidance needed on nuclear grading approach
Document:
Project:
Proposed change
Observations of the
secretariat
taken into account.
2. An application of safety requirements
that is commensurate with the
characteristics of the practice or source
and with the magnitude and likelihood of
the exposures.”
Add ref to IAEA TECDOC 1740 :2014 Use
of a Graded Approach in the Application of
the Management System Requirements
for Facilities and Activities
US 051
034 038
045
4.1.3
te
The grading of some items or activities would be based
on special treatment requirements
Add: “….including consideration of special See § 4.1.2
treatment requirements.”
US 052
035 039
046
4.1.3
te/ed
“For classified items or activities, the associated quality
management level….”
4.1.3. Grading the application of quality
requirements
US pshaw
053 036
040 047
4.1.3
1
2
See revised WD
For classification, or grading, of items or
activities, the associated quality
management level, inspection and
surveillance levels and documentation
requirements shall identify the activities
and items to which it applies consistent
with their importance.
1
te
Quality management level -what does this mean? This
would only attract thniking of ISO 9001 and the level is
addressd. Grading is to consider all the requirements
applicable to the assurance/confirmation of quality
---the associated product quality
assurance including inspection and
surveillance levels and documentation
including records requirements shall be
determined in accordance with the
classification of the item or service.
See revised WD
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te = technical ed = editorial
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Fr
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Subclause
Paragraph/
Figure/Table
4.1.3
4.1.3
Type of
comment2
Te
Date:2015-03-03
Document:
Comments
Project:
Proposed change
Observations of the
secretariat
It would be necessary to define some principles about this
graded approach. The requirements of the customer
cannot be increased without its agreement (and/or the
Licensee's agreement).
Within the supply chain of subcontract
ors, most of
the suppliers are only concerned by a limited number of
elements or activities and do not need to take into
account a so complex approach.
Exiting guidelines can introduce a good practices (see
§0.3) with limitations about items close to commercial
grades or components
Further to classification (§4.1.2) of For
classified items or activities, the
associated quality management levels,
inspection and surveillance levels and
documentation requirements shall be
graded in accordance with the
classification of the item or activity.
See revised WD
See revised WD
ISO 19443 guidances
will be proposed as
per ISO 9100 (once
ISO 19443 is issued)
UK
IMcNAIR
054 037
041 048
12
4.1.4
Risk approach
ed
1st part relating to safety culture not understood. Needs
clarification.
Discuss and reword
US 055
038 042
049
4.1.4
te
Application of the risk approach requires use of PSA
methods from standards such as ASME/ANS RA-S-2008
Add: “…as determined by application of
See revised WD
PSA methods such as ASME/ANS RA-S.”
PVe 056
039 043
050
4.1.4/7.1.2
te
Upgrade to ISO 9001 2015 version
6.1 Actions to address risks and
See revised WD
opportunities
6.1.1 When planning for the quality
management system, the organization
shall consider the issues referred to in 4.1
and the requirements referred to in 5 (!
Aspects of nuclear safety) and determine
the risks and opportunities that need to be
identified and addressed throughout the
product realisation including the supply
1
2
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Comments
Project:
Proposed change
Observations of the
secretariat
chain to:
a) give assurance that the quality
management system can achieve its
intended result(s);
b) prevent, or reduce, undesired effects;
c) achieve continual improvement.
6.1.2 Risk criteria are to be established
(eg likelihood, consequences, risk
acceptance, …)
6.1.3 Consistent with the nuclear safety
culture and the deployment of a graded
approach the organization shall plan:
a) actions to address these risks and
opportunities;
b) how to: integrate and implement the
actions into its quality management
system processes (see ??) and evaluate
the effectiveness of these actions.
Actions taken to address risks and
opportunities shall be proportionate to the
potential impact on the conformity of
products and services.
Integrate also the current § 7.
IT 057
040 044
051
4.1:
US 058
041 045
4.1a/1.2
1
2
1) Requirement 4.1:
It is proposed to include in an explicit manner the IAEA
requirement regarding the need of Integrated
Management System as follows:
“The organization shall establish, document, implement,
maintain and continually improve a management system
that integrates safety, health, environmental, security,
quality and economic elements to ensure that safety is
properly taken into account in all the activities of an
organization”. [Ref. IAEA GS-R-3, requirements 1.1, 1.8,
2.1]
te
“The organization shall establish,
document, implement, maintain and
continually improve a management
system that integrates safety, health,
environmental, security, quality and
economic elements to ensure that safety
is properly taken into account in all the
activities of an organization”. [Ref. IAEA
GS-R-3, requirements 1.1, 1.8, 2.1]
This material seems to be at odds with each other AND
This whole document seems to be an ISO
seems to add to the whole air of inconsistency – guidance themed document – that is customer
MB = Member body / NC = National Committee (enter the ISO 3166 two-letter country code, e.g. CN for China; comments from the ISO/CS editing unit are identified by **)
Type of comment:
ge = general
te = technical ed = editorial
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052
Date:2015-03-03
Comments
or requirements, or; clarity with regard to other
documents, difference to Management expectations
and/or min-of-the-min.
Document:
Project:
Proposed change
Observations of the
secretariat
satisfaction, with a thin vainer of Nuclear
placed over it. The things related to
nuclear – such as safety are an afterthought.
The material in the document initially
speaks of “guidance” type phrasing BUT
then frequently uses the words
requirements.
Requirements are necessary.
UK
IMcNAIR
059 042
046 053
13
4.2
Documentation
requirements
4.2.1
ge
In a global supply chain the language used in
documentation is significant. The need for translation to
be controlled is necessary.
Add wording from NQA Sect A guidance:
For some contracts or projects, the
documentation must be in a language
different from the organization language.
For the working documents used within
the organization for the contract or project
and submitted to this requirement, it is
suggested to identify the cases where the
translation in both languages (organization
language and contractual or project
language) may be necessary to ensure
correct implementation of relevant quality
requirements and therefore to propose to
workers bilingual documents as:
- manufacturing documents (e.g. welding
procedures),
- inspection documents and records,
- ….
Add :
Where translation is
required the
completeness and
accuracy of the
translation shall be
ensured
See revised WD
Add
Where such translation is required the
supplier shall include systems to use
qualified and experienced translators and
to verify such translations. (See 6.2.2)
JAP 068
053 047
054
1
2
4.2.1
tc
Requirements for documented procedures should be
prescribed. Items to be specified in the documented
procedure should be prescribed, such as responsibility,
processes, input and output of processes, forms, etc.
Change 4.2.1 c) as follows: documented
procedures and records necessary for
ensuring that requirements of this
document are met.
See revised WD for
4.2.1 c)
MB = Member body / NC = National Committee (enter the ISO 3166 two-letter country code, e.g. CN for China; comments from the ISO/CS editing unit are identified by **)
Type of comment:
ge = general
te = technical ed = editorial
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number
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Date:2015-03-03
Type of
comment2
Document:
Comments
Proposed change
And add this § in Note 1:
Project:
Observations of the
secretariat
For the note: already
addressed by ISO
9000 Series
To be further checked
in the guidelines
Documentation procedures required by
this document shall include or reference
the information in detail necessary for the
organization to accomplish the work
performed. The information shall include
scope, responsibility, processes, input and
output and forms as appropriate. The level Add ISO TR
of detail in documented procedures shall
10013:2001 in
be determined based upon complexity and Bibliography
significance of the activity, work
environment, and worker proficiency and
capability (education, training, experience)
JAP 069
054 048
055
4.2.1
tc
More processes should be in a form of documented
procedure.
UK
IMcNAIR
018 043
049 056
14
4.2.1
& 4.2.2
ge
4.2.2 2nd para recognises the potential need for Quality
Program / Plan
PVe 060
044 050
057
4.2.2
te
Eliminate
1
2
See revised WD
Change ‘may’ to ‘shall’
See revised WD
Only use ‘quality manual & plan’ (defined
in ISO 9000:2005 Cl 3.7.4 &.5)–
Vocabulary does not use ‘quality program’
Not reported
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ge = general
te = technical ed = editorial
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Date:2015-03-03
Document:
Comments
Project:
Proposed change
Observations of the
secretariat
US 061
045 051
058
4.2.2
b)
te
The clause does not address work processes that are
documented.
Revise the sentence to, “…quality
management system and other work
processes, or reference…”
See revised WD
US 063
048 056
065
4.2.2
new
te
The clause does not require: a description of how the
standard is met; describe what other standards are used
for implementation; describe interfaces for those who
manage, perform and assess work; licensee/owner review
and approval of the QMS for all direct contractors
performing design, construction, procurement, operations
services;
Add a new paragraph :
d) “describe how the requirements of this
standard are satisfied”;
e) describe what other standards are used
for implementation;
f) describe interfaces for those who
manage, perform and assess work;
g) licensee/owner review and approval of
the QMS for all direct contractors
performing design, construction,
procurement, operations services;
i) describe how QMS requirements for
direct contractors performing design,
construction, procurement, operations
services flow down to subcontractors and
suppliers.
See section 7
“However, the organizational,
documentary and technical provisions to
meet the specific additional requirements
…”
See revised WD
GOST R
151 140
141 059
4.2.2.
ed
The term «specific requirements» is not defined in part 3
Terms and definitions. Furthermore at par. 1.1 (This
document includes the standard reference [2] quality
management system requirements and specifies
additional nuclear industry definitions, requirements …)
was applied
Add:
d) a description of how
the requirements of
this standard are
satisfied
See revised WD
term «additional requirements».
1
2
MB = Member body / NC = National Committee (enter the ISO 3166 two-letter country code, e.g. CN for China; comments from the ISO/CS editing unit are identified by **)
Type of comment:
ge = general
te = technical ed = editorial
Page 25 of 53
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MB/
NC1
Fr
Clause/
Subclause
Paragraph/
Figure/Table
4.2.3
or
7.4.2.2
IT 062
046 052
060
1
2
Line
number
4.2.3, 4.2.4:
4.2.3
Type of
comment2
Te
Date:2015-03-03
Document:
Comments
Project:
Proposed change
Observations of the
secretariat
There is no mention about checking or verification by
independent person nor about approbation, anymore as in
the previous version. (to be check in GSR3)
§ 7.4.2.2. raises only a review of the documents and not
an independent verification of them.
The review of the procurement documents by another
staff than those who wrote the documents seems
inappropriate in particular for a small structure or supplier.
Is it necessary to have a review ?
7.4.2.2. Procurement document review
verification
The organization shall ensure by a review
verification of the procurement document,
the adequacy of specified purchase
requirements prior to their communication
to the supplier
Specific to French law.
Not reported
1) Requirement 4.2.3, 4.2.4:
We propose to specify ways and time of storage of
documents and records, taking into account the
provisions of the IAEA and ASME, as follows:
4.2.3 Control of documents – The organization must
prevent any possible damage to the documentation due to
natural causes (fire, water, air, earthquakes, rodents,
insects) and the actions of visitors without admission
rights.
Access to locations where records are retained should be
controlled.
The organization must identify the documents that may be
necessary in emergency conditions and store them at a
location away from the facility.
In order to storage of documents and records, electronic
duplication is accepted if the files produced are comply to
the current legislation.
[IAEA GS-G-3.1, requirements 5.40, 5.46, 5.48, 5.49 and
Appendix I, II, III].
4.2.3 Control of records – The organization must
classify records as permanent and non-permanent.
4.2.3 Control of documents – The
organization must prevent any possible
To be put in the
damage to the documentation due to
guidelines
natural causes (fire, water, air,
earthquakes, rodents, insects) and the
actions of visitors without admission rights.
Access to locations where records are
retained should be controlled.
The organization must identify the
documents that may be necessary in
emergency conditions and store them at a
location away from the facility.
In order to storage of documents and
records, electronic duplication is accepted
if the files produced are comply to the
current legislation.
[IAEA GS-G-3.1, requirements 5.40, 5.46,
5.48, 5.49 and Appendix I, II, III].
4.2.3 Control of records – The
organization must classify records as
permanent and non-permanent.
Permanent records are those relevant to
To be put in the
guidelines
The procurement document review
verification shall be performed by
competent personnel, other than those
who issued the procurement document,
and recorded (see 4.2.4).
MB = Member body / NC = National Committee (enter the ISO 3166 two-letter country code, e.g. CN for China; comments from the ISO/CS editing unit are identified by **)
Type of comment:
ge = general
te = technical ed = editorial
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number
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Type of
comment2
Date:2015-03-03
Document:
Comments
the safe operation, maintenance,
replacement, modification of any
component, to determine the causes of an
accident or malfunction, which contain the
data-base for the execution of the
"inservice inspections." (ref. ASME NQA1)
Missed an important requirement
“Individuals dealing with issuance,
verification and approval of documents
shall be authorized with regard to their
competencies. Changes to documents
shall be reviewed and recorded and shall
be subject to the same level of approval
as the documents themselves.”
4.2.3.
JAP 070
055 053
062
4.2.4
tc
Add authentication requirements.
JAP 071
056 054
063
4.2.4
tc
Add a requirement that records shall be traceable to the
activities or products
1
2
Proposed change
Permanent records are those relevant to the safe
operation, maintenance, replacement, modification of any
component, to determine the causes of an accident or
malfunction, which contain the data-base for the
execution of the "inservice inspections." (ref. ASME NQA1)
GOST R
153 142
143 061
te
Project:
GS-R-3 (5.13.)
The organization shall establish a
documented procedure to define the
controls and responsibilities needed for
the identification, storage, protection,
retrieval, authentication, retention and
disposition of records.
Records shall be traceable to associated
products and activities.
Observations of the
secretariat
See revised WD
See revised WD
See §7.5.3
MB = Member body / NC = National Committee (enter the ISO 3166 two-letter country code, e.g. CN for China; comments from the ISO/CS editing unit are identified by **)
Type of comment:
ge = general
te = technical ed = editorial
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NC1
Line
number
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Paragraph/
Figure/Table
Type of
comment2
Date:2015-03-03
Document:
Comments
Project:
Proposed change
Observations of the
secretariat
UK
IMcNAIR
019 047
055 064
15
4.2.4
ge
Additional need to provide copies of records in
accordance with customer requirements and generally at
the same time as release for use.
Develop wording
See §8.2.4
PVe 072
057 057
066
5.1
te
Add a § on leadership
See IAEA GS-R-3 or ISO 9001:2015 § 5
Add :
“… demonstrate its
leadership for
safety….”
“… ensuring safety as
the primary
consideration in all
decision making.”
“Managers at all levels
…”
See revised WD
(to match with GSR p2
Requirement 2 & 3)
US 073
058 058
067
5.1
te
“Top management shall provide evidence of its
commitment to the development and implementation of
the quality management system and continually improving
its effectiveness by:”
Senior management establishes overall
expectations for effective implementation
of the quality management system and is
responsible for obtaining the desired end
result.
US 074
059 059
5.5.2
te
Suggest this wording is more appropriate and consistent
with other standards.
d) the organizational freedom and
See revised WD
unrestricted access to top management to
1
2
See revised WD
MB = Member body / NC = National Committee (enter the ISO 3166 two-letter country code, e.g. CN for China; comments from the ISO/CS editing unit are identified by **)
Type of comment:
ge = general
te = technical ed = editorial
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NC1
Line
number
Clause/
Subclause
Paragraph/
Figure/Table
Type of
comment2
Date:2015-03-03
Document:
Comments
068
Proposed change
resolve quality management issues.
UK
IMcNAIR
075 060
060 069
16
5.5.4
Communication
with external
parties including
regulatory bodies
Fr
5.5.4
IT 076
061 061
070
5.6.1
US 077
062 062
071
5.6.1
1
2
Project:
5.5.4
new
Observations of the
secretariat
Add
“… and unrestricted
access to top
management…”
ed
As the organization may be in one country, the supplier in Insert ‘Operator / Licensee’ in front of
another and the final Operator / Licensee in another it is
national
important that the regulatory authority that authorises /
licences the facility is the one whose requirements are
addressed.
See revised WD
Te
According to the projects, the Licensee is responsible for
relations with regulatory bodies. The relations between
supplier (organization) and regulatory bodies are then
managed by the contract (concerning §5.5.4 and §7.2.3.)
Add
“…And contractual
requirements.”
te
When applicable, according to the national
authorities’ requirements and/or
contractual requirements with regards to
the nuclear safety related product issues,
the organization shall ensure that
appropriate procedures are defined in
liaison with the customer to address
communication from external parties
and/or regulatory bodies, .
Se revised WD
1) Requirement 5.6.1:
Aims to indicate the frequency of review as follow:
The top management must carried out the management
review at least annually.
[Rif. ISO/TS 29001, par. 5.6.1.1; regulations of
certification bodies].
The top management must carried out the To be put in the
management review at least annually.
guidelines
[Rif. ISO/TS 29001, par. 5.6.1.1;
regulations of certification bodies].
Managers are not required to assess their management
processes.
Add a requirement “Managers shall
See §8.2.3 in revised
assess their processes to identify and
WD
correct problems that hinder the
organization from achieving its objectives”.
MB = Member body / NC = National Committee (enter the ISO 3166 two-letter country code, e.g. CN for China; comments from the ISO/CS editing unit are identified by **)
Type of comment:
ge = general
te = technical ed = editorial
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NC1
Line
number
Clause/
Subclause
Fr
5.6.2
US pshaw
078 063
063 072
6.2.1
GOST R
156 145
145 073
6.2.2
Paragraph/
Figure/Table
5.6.2
Type of
comment2
Te
ed, te
Date:2015-03-03
Document:
Comments
Project:
Proposed change
Observations of the
secretariat
There is a real difficulty for the organization to know the
When available, lessons learned from
technical feedback from experience of other organization, other organizations shall be also taken
except when it is planned in the contract by meetings of
into account.
sharing, generaly under the responsibility of the Licensee.
(Concern § 5.6.2. but also this point covers § 8.5.3.
(Return of the other bodies)).
See revised WD and
§8.5.3
Is it a realistic expectation for a supplier to train their
personnel in eventual consequences of a malfunction or
error in their product realisation activities for every
“nuclear related “ contract they receive.
See revised WD
To comply with a logical sequence necessary swap the
two penultimate paragraph.
Furthermore, necessary to add clarification to ensure that
the requirements of the superiority of nuclear safety over
other aspects according to 5.3.8. " f " and similarly as in
7.3.2. “а.
“The organization shall designate
activities, as a minimum impacting on
nuclear safety aspects, that require
qualification of personnel and the
minimum requirements/competence for
such personnel.
See revised WD
A documented procedure shall be defined
for qualification and competence of such
personnel.”
UK
IMcNAIR
079 064
064 074
17
1
2
6.2.2
Competence
qualification
training and
awareness
e
ed
Ref to 4.2.4 about records should apply to all of a-e.
Recommend that ref to a-e be moved into See revised WD
more general comment against 6.2.2
MB = Member body / NC = National Committee (enter the ISO 3166 two-letter country code, e.g. CN for China; comments from the ISO/CS editing unit are identified by **)
Type of comment:
ge = general
te = technical ed = editorial
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US 080
065 065
075
6.2.2
US pshaw
081 066
066 076
6.2.2
UK
IMcNAIR
082 067
067 077
18
6.4
Work
environment
PVe 083
068 068
078
7
1
2
f)
Type of
comment2
te
Date:2015-03-03
Comments
No mention of continuing training.
Document:
Project:
Proposed change
Observations of the
secretariat
Revise f) to: “ Personnel shall be provided See revised WD
continuing training to maintain their job
proficiency and assess the adequacy of
the personnel … competence”
A documented procedure shall be defined See revised WD
for qualification and the initial assessment
and ongoing confirmation of competence
Note
ed
Radiologic is not a proper word
Replace with radiological
See revised WD
ge
Add a § on control of outsources processes
The organization shall ensure that
outsourced processes are controlled .
Refer to § 8.4.1/8.4.2/8.4.3 of ISO
9001:2015
See § 4.1
MB = Member body / NC = National Committee (enter the ISO 3166 two-letter country code, e.g. CN for China; comments from the ISO/CS editing unit are identified by **)
Type of comment:
ge = general
te = technical ed = editorial
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number
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Type of
comment2
ge
Comments
Document:
Project:
Proposed change
Observations of the
secretariat
UK
IMcNAIR
020 069
069 079
25
7
IT 084
070 070
080
7.1 a)
US 085
071 071
081
7.1.2
te
The concept of risk management needs expansion.
Suggest the following from AS9100:
To be considered for
Those requirements identified by the
the guidelines
customer, or determined by the
organization, which have high risks to
being achieved, thus requiring their
inclusion in the risk management process.
Factors of special requirements include
product or process complexity, past
experience and product or process
maturity. Examples of special
requirements include performance
requirements imposed by the customer
that are at the limit of the industry’s
capability, or requirements determined by
the organization to be at the limit of its
technical or process capabilities.
US 086
072 072
082
7.1.2
te
Suggest using all five bullets in AS9100C
a) assignment of responsibilities for risk
management,
1
2
7th para
Date:2015-03-03
Auditors should be able to demonstrate that they meet an Insert "Auditors shall be certificated, to an
appropriate standard (more than just guidance given in
applicable grade, by IRCA or equivalent
ISO19011:2011)
body and demonstrate competence in the
nuclear application.”
1) Requirement 7.1 a):
to add to the sixth and seventh point:
- “when contractually required, and when
We propose to add to the sixth and seventh point:
- “when contractually required, and when required by law required by law ……….”
……….”
Add “
and legally”
see revised WD
See revised WD
Additionally, it is important to take account of the evolving b) definition of risk criteria (e.g., likelihood,
MB = Member body / NC = National Committee (enter the ISO 3166 two-letter country code, e.g. CN for China; comments from the ISO/CS editing unit are identified by **)
Type of comment:
ge = general
te = technical ed = editorial
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NC1
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number
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Paragraph/
Figure/Table
Type of
comment2
Date:2015-03-03
Document:
Comments
use of probabilistic safety analyses to implement fault
tree-event tree methods in nuclear facilities in a way not
necessarily practiced in aerospace industry.
Project:
Proposed change
Observations of the
secretariat
consequences, risk acceptance) which
could require use of probabilistic models in
a PSA,
c) identification, assessment and
communication of risks throughout product
realization including consideration of
interactions between items of varied
classification,
d) identification, implementation and
management of actions to mitigate risks
that exceed the defined risk
acceptance criteria, and
e) acceptance of risks remaining after
implementation of mitigating actions.
Fr
7.1.2
7.1.2
Te
The risk management is possible only for manufacturers
of higher ranks, well involved in nuclear domain.
The organization shall develop a risk
management method,assess the risks
related to the achievement of applicable
requirements
The organization shall assess the risks
related to the achievement of applicable
requirements
JAP 113
101 073
083
7.1.3
tc
A provision should be added to consider the configuration
management requirements provided by the customer
See revised WD
and statement :
“as appropriate to the
organization and the
product”
Add:
“The configuration
management process
shall taking into
account customer
requirements”
See revised WD
US 087
073 074
084
1
2
7.1.3
te
Suggest using term “audit” instead of “assessment” to
consistent with other standards.
e) configuration audit.
Not reported
Assessment is more
flexible than audit (ex:
auditors
qualification…)
MB = Member body / NC = National Committee (enter the ISO 3166 two-letter country code, e.g. CN for China; comments from the ISO/CS editing unit are identified by **)
Type of comment:
ge = general
te = technical ed = editorial
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Line
number
GOST R
157 146
146 085
Clause/
Subclause
Paragraph/
Figure/Table
7.2.1
Type of
comment2
7.2.1/
ed
NOTE 2
Date:2015-03-03
Document:
Comments
Project:
Proposed change
Because the notion "nuclear safety aspects" is used in
paragraphs 1.2, 4.2.2, 5.3, 7.2.1, 7.2.3, it seems
appropriate to delete Note 2 in paragraph 7.2.1 and add
the appropriate definition in Chapter 3.
Observations of the
secretariat
Nuclear safety aspects
definition not reported
And eliminate Note 2
See revised WD
UK
IMcNAIR
088 074
075 086
19
7.2.1
Determination of
requirements
related to the
product
Bullet point in ed
front of NOTE
1
Challenge ‘associated quality management system level’ . Replace with ‘associated quality grade
There should only be one.
requirements’
If quality grading has been applied then there may be
varying quality grade requirements defined
US 089
075 076
087
7.2.1
c)
Does not address safety function.
US pshaw
090 076
077 088
7.2.1 c
1
2
te
See revised WD
Add to the sentence: “statutory and
Not reported :
regulatory requirements, including nuclear Safety function is
safety function and aspects….”
included in Safety
Aspects
Nuclear safety aspects applicable to the product--. need a The identification of any detail, process,
definition to better convey and direct the supplier
or aspect/ element of the product which
could directly compromise operational
nuclear integrity as a consequence of a
malfunction .
See revised WD
MB = Member body / NC = National Committee (enter the ISO 3166 two-letter country code, e.g. CN for China; comments from the ISO/CS editing unit are identified by **)
Type of comment:
ge = general
te = technical ed = editorial
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number
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Paragraph/
Figure/Table
Type of
comment2
US pshaw
091 077
078 089
7.2.1d
UK
IMcNAIR
092 078
079 090
20
7.2.2
Review of
requirements
related to the
product
Para before
deletd NOTE
US pshaw
093 079
080 091
7.2.2
Last para
GOST R
158 147
147 092
7.2.3
7.2.3./
b)
1
2
ge
te
Date:2015-03-03
Document:
Comments
Project:
Proposed change
Observations of the
secretariat
Use of levels is not appropriate and consistent with the
graded approach to establish the overall requirements to
assure and demonstrate achievement of product integrity
in accordance with the product specification.
Reword –the associated quality
assurance requirements, including
surveillance, inspections and
documentation
See revised WD
When requirements are changed then a re-review should
be undertaken to identify effects.
Insert additional sentence (as comment)
See revised WD
--changed byb the customer or the
organisation----
See revised WD
Customer communication in relation of approval of
“requirements specifications for design” should be
included according to Ref. [4, 5.98].
“b) enquiries, contracts, requirements
See revised WD
specifications for design or order handling,
including amendments,..”
MB = Member body / NC = National Committee (enter the ISO 3166 two-letter country code, e.g. CN for China; comments from the ISO/CS editing unit are identified by **)
Type of comment:
ge = general
te = technical ed = editorial
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NC1
Line
number
GOST R
159 148
148 093
Clause/
Subclause
Paragraph/
Figure/Table
7.3.1
7.3.1
Type of
comment2
te
Date:2015-03-03
Comments
Document:
Project:
Proposed change
Observations of the
secretariat
Where applicable, the design and development should be The organization shall plan and control the Add
accomplished in compliance with Ref. [4, 5.84 - 5.140].
design and development of product and
“Note: For further
where applicable in compliance with
information see
reference [4, 5.84 - 5.140].
reference [4] § 5.84 5.140”
See revised WD
UK
IMcNAIR
094 080
081 094
21
7.3.1
Design and
development
planning
After c
ge
Need to identify where topics, such as design reviews and Insert additional sentence (as comment) – Not reported
safety case submissions along with authority to proceed
cross reference to 7.3.4
beyond design, fit into the plan.
US 095
081 082
095
7.3.1
new
te
Does not describe design output documents, design
interfaces, or engineering /science principles.
1
2
Add d) “design output (drawings,
specifications, calculations, etc.).”
e) “design interfaces shall be identified
and controlled.”
f) “design shall be based on sound
See revised WD
Add “documented” for
design output
For design interfaces
add identification and
MB = Member body / NC = National Committee (enter the ISO 3166 two-letter country code, e.g. CN for China; comments from the ISO/CS editing unit are identified by **)
Type of comment:
ge = general
te = technical ed = editorial
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NC1
Line
number
Clause/
Subclause
Paragraph/
Figure/Table
Type of
comment2
Date:2015-03-03
Document:
Comments
Project:
Proposed change
engineering/science principles and
appropriate standards.”
JAP 114
102 083
096
7.3.2
GOST R
160 149
149 097
7.3.3
JAP 115
103 084
098
7.3.3
IT 096
082 085
099
7.3.5
1
2
tc
7.3.3./
Inputs shall be documented to the level of detail to assure
Inputs shall be specified to the level of
independent verification.
detail necessary to permit the design and
development activities to be carried out in
a correct manner and to provide a
consistent basis for making decisions,
accomplishing design and development
verification measures, and evaluating
design and development changes.
ed
NOTE 1
It is necessary to format Note 1 according to the
requirements of 1.1
tc
NOTE 1 Information for production and
service provision shall at least include as
appropriate, details for the manufacturing,
construction, assembly, inspection,
testing, handling, transportation, storage,
cleaning, preservation, site erection,
commissioning, and maintenance of the
product.
Software used for design shall be control.
Requirements for control of such software should be
added.
1) Requirement 7.3.5:
It applies extensively the principle of independence. It
doesn’t indicate that the degree of independence must be
graduated as a function of safety and quality of the
Observations of the
secretariat
control
See revised WD
See revised WD
Remove note1
add “such as
drawings, part lists,
specifications,
configuration
management
provisions …” in b)
Not reported
See §7.3.1
“For activities relevant to safety and the
quality of the product, design verification
shall be performed by any competent
person or group, clearly indicated and
See revised WD
MB = Member body / NC = National Committee (enter the ISO 3166 two-letter country code, e.g. CN for China; comments from the ISO/CS editing unit are identified by **)
Type of comment:
ge = general
te = technical ed = editorial
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NC1
Line
number
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Figure/Table
Type of
comment2
Date:2015-03-03
Document:
Comments
product. We propose to add to the third item:
“For activities relevant to safety and the quality of the
product, design verification shall be performed by any
competent person or group, clearly indicated and other
than those who performed the original design of the
product or participated to related design activities.” [IAEA
GS-G-3.5, requirements 5.115, 5.118].
Project:
Proposed change
Observations of the
secretariat
other than those who performed the
original design of the product or
participated to related design activities.”
[IAEA GS-G-3.5, requirements 5.115,
5.118].
JAP 116
104 086
100
7.3.5
tc
Prescribe when the verification has to be finished.
See revised WD
JAP 117
105 087
101
7.3.5
tc
Add exception of duplicate verification for design which
has been once verified.
Not reported
Re-verification is not
needed unless
different input (change
management)
JAP 118
106 088
102
7.3.5
tc
Prescribe the options for verification method.
Not reported because
addressed in detail in
the codes
JAP 119
107 089
103
7.3.5
tc
Add requirements of items to be described on the test
records.
Not reported
1
2
MB = Member body / NC = National Committee (enter the ISO 3166 two-letter country code, e.g. CN for China; comments from the ISO/CS editing unit are identified by **)
Type of comment:
ge = general
te = technical ed = editorial
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NC1
US 097
083 090
104
Line
number
Clause/
Subclause
Paragraph/
Figure/Table
7.3.5
Type of
comment2
ed
Date:2015-03-03
Comments
The new requirement is awkwardly phrased.
Document:
Project:
Proposed change
Revise to: “Design verification shall be
performed by any competent person or
group clearly indicated and other than
those
Observations of the
secretariat
See revised WD
who performed the original design of the
product or participated to related design
activities.
Fr
7.3.5
US 098
084 091
105
7.3.6
7.3.5
Te
te
Design verification shall be performed by
any competent person or group, clearly
indicated and other than those who
performed the original design of the
product or participated to related design
activities.
Design validation must be complete prior to the item being Revise to: “Wherever practicable,
used for its safety function.
validation shall be completed prior to the
delivery of the product. However,
validation shall be completed prior to use
of the item for its intended safety function.
. or implementation of
the product. Records of the results of
validation and any necessary actions shall
be maintained (see 4.2.4).”
See revised WD
add
“Where the validation
is not complete, the
organization shall
identify, control the
invalidated aspects
and inform the
customer prior to
delivery”
See revised WD
US 099
085 092
106
1
2
7.3.7
te
Design validation must be complete prior to the item being Revise to: “Design and development
used for its safety function.
changes shall be identified, justified, and
records maintained. The changes shall be
reviewed, verified and validated, as
appropriate, and approved to the same
level as the initial design and/or
development before implementation, or
use of the item for its intended safety
function. The review of design and
development changes shall include
evaluation of the effect of the changes on
See revised WD
ADD: Where the
change compromises
the validation, the
organization shall
identify, control the
invalidated aspects
and inform the
customer in a timely
MB = Member body / NC = National Committee (enter the ISO 3166 two-letter country code, e.g. CN for China; comments from the ISO/CS editing unit are identified by **)
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number
US 100
086 093
107
Clause/
Subclause
7.3.8
Paragraph/
Figure/Table
Type of
comment2
te
Date:2015-03-03
Document:
Comments
Unit testing is typically performed by the developer or
someone very close to the code. This requirement
conflicts the requirement of who is allowed to perform a
verification task (this assumes that everyone agrees that
one aspect of verification is testing).
Ger 001
087 094
108
7.4.1
JAP 120
108 095
109
7.4.1
tc
Add requirements of methods and frequency for supplier
evaluation, based on the expectation of Nuclear industry.
JAP 121
109 096
110
7.4.1
tc
Add requirements for inclusion of sub-supplier evaluation
commensurate with importance to the final product
quality, based on the expectation of Nuclear industry.
US 101
088 097
7.4.1b
te
The standard requires necessary actions in case of
commercial grade items suppliers but not requirements
1
2
Project:
Proposed change
Observations of the
secretariat
constituent parts and product already
delivered. Records of the results of the
review of changes and any necessary
actions shall be maintained (see 4.2.4).”
manner.
Rewrite to state that a testing strategy
shall be developed to assure that product
meets requirements and is accepted prior
to use.
Add reference to
§7.3.5 & §7.3.6
See revised WD
Add the following note:
Note: The experience of a supplier shall
be appreciated in the supplier evaluation
and selection.
Describe the necessary actions.
MB = Member body / NC = National Committee (enter the ISO 3166 two-letter country code, e.g. CN for China; comments from the ISO/CS editing unit are identified by **)
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111
Date:2015-03-03
Document:
Comments
Project:
Proposed change
are included in the standard. (what are the necessary
actions?)
US 102
089 098
112
7.4.1d
The standard requires to maintain a register (list) of
approved suppliers but does not require a process to
ensure that approved suppliers will continue to provide
acceptable items and services.
Require a process to ensure that
approved suppliers will continue to provide
acceptable items and services.
IT 103
090 099
113
7.4.2.1
1) Requirement 7.4.2.1:
We propose to add:
“Content of the procurement documents doesn’t foresee
the communication and training of external companies
personnel to ensure that safety is not compromised during
the performance of assigned tasks and that the risks are
minimized.” [IAEA GS-G-3.5, requirements 5.79 - 5.81].
“Content of the procurement documents
doesn’t foresee the communication and
training of external companies personnel
to ensure that safety is not compromised
during the performance of assigned tasks
and that the risks are minimized.” [IAEA
GS-G-3.5, requirements 5.79 - 5.81].
US pshaw
104 091
100 114
7.4.2.1 c
Quality management system requirements are/will be
Change to quality assurance
reference tom 9001 The graded approach should identify requirements. These collectively
quality assurance requirements which in addition to a
quality management system would include documents for
approval, inspection requirements, surveillance and
records..
JAP 122
110 101
115
7.4.3
1
2
Observations of the
secretariat
te
tc
Add requirements for exclusion of CFSI
MB = Member body / NC = National Committee (enter the ISO 3166 two-letter country code, e.g. CN for China; comments from the ISO/CS editing unit are identified by **)
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JAP 123
111 102
116
7.4.3
UK
IMcNAIR
105 092
103 117
22
7.4.3
Verification of
purchased
product
Order of paras ed
Addition of NSQ 100 to ISO 9001 leaves disjointed logic
Reorder paras as follows:
The organization shall establish and
implement the …..
The organization, the customer, licensee,
third party organizations, regulatory
bodies, and/or their
respective representatives, …..
In line with the classification requirements,
verification activity shall be planned,
documented and recorded
(4.2.4), in particular, to ensure that the
sources of classified items used are
traceable without ambiguity.
NOTE……………
Where the organization or its customer
intends to perform……
US 106
093 104
118
7.5.
new
te
No requirement to work to standards, controls, etc.
Add: “ Work shall be performed consistent
with technical standards, administrative
controls, hazards controls adopted to meet
regulatory and contract requirements.”
JAP 124
112 105
7.5.1
tc
Add requirements for use of materials having limited life.
1
2
tc
Date:2015-03-03
Observations of the
secretariat
Add requirements for control of supplier nonconformance.
MB = Member body / NC = National Committee (enter the ISO 3166 two-letter country code, e.g. CN for China; comments from the ISO/CS editing unit are identified by **)
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Project:
Proposed change
Observations of the
secretariat
119
UK
IMcNAIR
107 094
106 120
23
7.5.1 Control of
production and
service provision
IT 108
095 107
121
7.5.1.3
US 109
096 108
122
7.5.1.3
2nd last bullet ed
point
te
Not all nations use regulations to define regulatory
prerequisites.
Reword to ‘regulatory’
1) Requirement 7.5.1.3:
Independence of personnel engaged in control is planned
just to IFS items and activities, but not also to those
important for quality (see 4.1.2. “Classification of items
and activities” and 4.1.3 “Grading the application of quality
requirements”).
We propose to modify the second item as follows:
“The methods used for inspection and surveillance shall
be defined and planned. For items and activities important
for safety (see 3.6) or important for the final quality of the
structures, systems or components, they shall be
performed by competent personnel other than those who
carried out the work.”
“The methods used for inspection and
surveillance shall be defined and planned.
For items and activities important for
safety (see 3.6) or important for the final
quality of the structures, systems or
components, they shall be performed by
competent personnel other than those
who carried out the work.”
The proposed requirement lacks testing and acceptance
criteria.
Revise to: “The organization shall ensure
the provisions for inspection, testing and
surveillance activities are defined using
established acceptance and performance
criteria. have been taken into account.
The methods used for inspection and
surveillance shall be defined and planned.
For IFS items and activities, activities, they
1
2
MB = Member body / NC = National Committee (enter the ISO 3166 two-letter country code, e.g. CN for China; comments from the ISO/CS editing unit are identified by **)
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Proposed change
Observations of the
secretariat
shall be performed by competent
personnel other than those who carried
out the work. Equipment used for
inspections and tests shall be calibrated
and maintained.”
US 110
097 109
123
7.5.1.3
Ger 002
098 110
124
7.5.2 a
US 111
099 111
125
7.5.3
te
Need to insure that inspection and surveillance personnel Add sentence to that end.
have organizational independence from those
accomplishing the work.
a)
te
defined criteria for review and approval of the
processes…
The proposed text is lacking a purpose.
Add « ….including regulatory
requirements »
Revise to: “IFS items or activities shall be
identified to ensure their proper use. are
the subject to identification. The
associated documentation shall be clearly
identified and linked to the products
without ambiguity.
IT 112
100 112
126
1
2
7.6
1) Requirement 7.6:
There is a mistake in “note”: reference [3] should be
replaced with reference [9] that is the UNI CEI EN
ISO/IEC 17025.
Consideration should be given to introduce a requirement
that internal/ external laboratories must operate in
accordance with that standard.
(eg. the specifications of the main customers in the Oil &
Gas field require it already. The feeling is that you are
(eg. the specifications of the main
customers in the Oil & Gas field require it
already. The feeling is that you are going
in this direction at the regulatory level and
that, in a few years, the accreditation of
laboratories will become a mandatory
requirement).
MB = Member body / NC = National Committee (enter the ISO 3166 two-letter country code, e.g. CN for China; comments from the ISO/CS editing unit are identified by **)
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Project:
Proposed change
Observations of the
secretariat
going in this direction at the regulatory level and that, in a
few years, the accreditation of laboratories will become a
mandatory requirement).
IT 125
113 113
127
8.2.2
UK
IMcNAIR
126 114
114 128
24
8.2.2
US 127
115 115
129
8.2.2
1) Requirement 8.2.2:
Aims to indicate the frequency of internal audit as follow:
The organization must be performed the internal audit at
least annually. [Ref. NCA-3859.1, ISO/TS 29001 - par.
8.2.2.1, regulations of certification bodies].
4th para
The organization must be performed the
internal audit at least annually. [Ref. NCA3859.1, ISO/TS 29001 - par. 8.2.2.1,
regulations of certification bodies].
ed
Should not use undefined terminology ‘quality assurance Delete to read ‘specific quality plans’
programs’
te
The proposed text is lacking a full purpose.
The sentence on independence is lacking.
Add: “Independent audits shall measure
the adequacy of work performance and
promote improvement.”
Add: “Auditors shall be independent of the
audited activity and have sufficient
authority and freedom from line
management.”
US pshaw
128 116
116 130
1
2
8.2.2
Qualifications do not necessarily confirm competence
Change qualification to competence
throughout
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US pshaw
129 117
117 131
8.2.3
Emphasis the manufacturing processes
---quality management systems processes
and manufacturing/product realisation
processes
IT 130
118 118
132
8.2.4
1) Requirement 8.2.4:
We propose to specify:
- The “final acceptance inspection” must be carried out by
different personnel from those that have performed or
directly have supervised the product realization (shop
inspectors). [Ref. ISO/TS 29001 - par. 8.2.4.2].
- The “final acceptance inspection” must be carried out by
qualified personnel and, if required certified. [Ref. ASME
NQA-1].
- The “final acceptance inspection” must
be carried out by different personnel from
those that have performed or directly have
supervised the product realization (shop
inspectors). [Ref. ISO/TS 29001 - par.
8.2.4.2].
- The “final acceptance inspection” must
be carried out by qualified personnel and,
if required certified. [Ref. ASME NQA-1].
GOST R
161 150
150 133
8.2.4.
Considering nuclear safety aspects the organization shall
specify all necessary documentation in contracts and
other procurement documents in accordance with Ref [4;
5.35, 5.36].
“The organization shall ensure that all
documents required to accompany the
product are present at delivery
consequently they are to be stipulated in
procurement documents.”
Ger 003
119 119
134
8.3
1
2
te
Observations of the
secretariat
Add:
“Subsequent material handling shall not
interfere any rood cause analysis”
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US 131
120 120
135
8.3
UK
IMcNAIR
132 121
121 136
26
8.3 Control of
nonconforming
product
GOST R
162 151
151 137
8.4
Type of
comment2
3rd para
Date:2015-03-03
Document:
Comments
Proposed change
te
Correction is missing from the list. Reporting is not
optional. Causal analysis is missing.
Revise: “Products and processes that do
not conform to the specified requirements
shall be timely identified, segregated,
controlled, corrected, recorded and
reported to an appropriate level of
management within the organization.”
The Where applicable, nonconformity shall
be reported in a timely manner in
compliance with the customer
requirements. The cause(s) of
nonconformances shall be identified to
correct it and prevent recurrence.
ge
Reporting should meet regulatory requirements
Insert “regulatory and 2 in front of
“customer”
te
According to Ref. [4; 3.8 (b)]:
“3.8.The process of assessing how the expectations of
interested parties are satisfied should involve several
steps:
(a)…;
(b)Selection of the approach to, and methodology for, the
assessment;…”,
it would be reasonable to add appropriate paragraph.
1
2
Project:
Observations of the
secretariat
The organization shall determine, collect
and analyse appropriate data to
demonstrate the suitability and
effectiveness of the quality management
system and to evaluate where continual
improvement of the effectiveness of the
quality management system can be made.
This shall include data generated as a
result of monitoring and measurement and
from other relevant sources.
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Project:
Proposed change
Observations of the
secretariat
The organization shall select or develop
and approve appropriate techniques of
analysis of data and effectiveness of
management system.
The analysis of data shall provide
information relating to: …
te
The requirement is lacking a method.
Add: “ Review item characteristics,
process implementation and other quality
related information to identify items,
services and processes needing
improvement”
8.5.2
te
A requirement explicitly to identify nonconformances is
lacking.
Add: “The organization shall identify,
control and correct items, services and
processes that do not meet requirements.”
PVe 135
124 124
140
8.5.3
te
Eliminate
Fr
8.5.3
Te
Same comment than about feedback from other
organizations in §5.6.2
Add after F11" feedback from other
organizations" :
"when available"
US 136
125 125
Appendix
ge
Suggest considering adding references to aid
organizations in the nuclear supply chain such as those
#
US 133
122 122
138
8.5.1
US 134
123 123
139
1
2
new
8.5.3
Std. #
Type
Title
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141
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Figure/Table
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comment2
Date:2015-03-03
Comments
provided in AS9100.
Document:
Project:
Proposed change
Observations of the
secretariat
1.
AS9100C
REQ
Quality Management Systems Requirements for Aviation, Space and
Defense Organizations
2.
AS9101E
REQ
Quality Management Systems
Audit Requirements for Aviation, Space,
and Defense Organizations
3.
AS9102A
REQ
Aerospace First Article Inspection
Requirement
4.
AS9103A
REQ
Aerospace Series - Quality
Management Systems - Variation
Management of Key Characteristics
5.
AS9104A
REG
Requirements for Aerospace
Quality Management System
Certification/Registrations Programs
6.
ARP9107
GUD
Direct Delivery Authorization
Guidance for Aerospace Companies
7.
AS9110
REG
Quality Maintenance Systems –
Aerospace – Requirements for
Maintenance Organizations
8.
ARP9114
GUD
Direct Ship Guidance for
Aerospace Companies
9.
AS9115
REG
Quality Management Systems Requirements for Aviation, Space and
Defense Organizations - Deliverable
Software
10.
REG
1
2
AS9116
Aerospace Series – Notification
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Document:
Project:
Proposed change
Observations of the
secretariat
of Change (NOC) Requirements
11.
AS9120
REG
Quality Management Systems –
Requirements for Aviation, Space and
Defense Distributors
12.
AS9131
REG
Aerospace Series – Quality
Management Systems – Nonconformance
Data Definition and Documentation
13.
AS9132A
REG
Data Matrix Quality
Requirements for Parts Marking
14.
AS9133
REG
Qualification Procedure for
Aerospace Standard Parts
15.
ARP9134
GUD
Supply Chain Risk Management
Guidelines
16.
ARP9137
GUD
Guidance for the Application of
AQAP 2110 (NATO QA Req.) within a
9100 Quality Management System
17.
ARP9162
GUD
Aerospace Operator SelfVerification Programs
18.
AS13000
GUD
Problem Solving Requirements
for Suppliers
IT 137
126 126
142
Appendix 1
1) Appendix 1:
The table does not include the correlation with IAEA
requirements.
Comparison with UNI EN ISO 9001:2015
1) The numbers of the paragraphs and the sequence of
arguments correspond to those of the "old" ISO
9001:2008 (also Standard NSQ-100 is based on these
1
2
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Comments
Proposed change
Project:
Observations of the
secretariat
numbers and sequence).
Standard ISO 9001:2015 is conformed, instead, to the
decided by ISO new structure for all standards related
management systems.
Therefore, the pattern of the standard is “obsolete” and
should be upgraded to new ISO 9001: 2015. This action
should imply to evaluate also an adjustment to ISO
9001:2015 new requirements, such as for example:

Quality Manual* and six
Procedures required by
Standard 9001:2008 will not be
obligatory.
ISO/WD 19443 introduces new procedures, such as the
procedure to qualify the auditors (prg. 8.2.2).
In addition in this paragraph the standards are not
determined to qualify and/or to retrain the auditors (for
example, to see NQA-1, Req. 2, 303).
(*) In reference to prg. 4.2.2, documents such as the
“Quality Plans” (to see ISO 10005?) can be used to give
evidence about compliance to standard’s requirements. It
seems that there are some contradictions in this prg.

IT 138
127 127
143
1
2
Bibliography:
Preventive actions (prg. 8.5.3)
could be “redundant”, because
they are replaced by means of
risk analysis evaluation (prg.
7.1.1 and prg. 7.1.2).
1) Bibliography:
ASME is listed but is not mentioned in the text of the
document.
The standard UNI CEI EN ISO/IEC 17020 is not listed as
MB = Member body / NC = National Committee (enter the ISO 3166 two-letter country code, e.g. CN for China; comments from the ISO/CS editing unit are identified by **)
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Document:
Proposed change
Project:
Observations of the
secretariat
a reference for inspection activities.
The standard UNI/ TR 11510 “Nuclear installations Particular requirements for the application of ISO
9001:2008 in the nuclear field” is not listed.
MB/NC
139 128
128 144
Clause/
Paragraph/
Subclause
Figure/
Table
Type of
comment
Comments
Proposed change
Observations of the
secretariat
C:\Users\gcu\Documents\comments\WD 19443\Collated.doc: Collation successful
Collation of files was successful. Number of collated files : 1
SELECTED
(number of files): 1 .
FILES IN THIS GROUP(number of files): 1.
PASSED TEST
(number of files): 1.
FAILED TEST
(number of files): 0.
CCT - Version 3.0/2013-01.
1
2
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Document:
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Project:
Observations of the
secretariat
MB = Member body / NC = National Committee (enter the ISO 3166 two-letter country code, e.g. CN for China; comments from the ISO/CS editing unit are identified by **)
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