Document: N3 collated comments Project: CASCO TC304

Template for comments and secretariat observations Date:2023-05-15

NWIP in TC 304 and CIB CASCO JWG63

MB/ Line Clause/ Paragraph/ Type of Comments Proposed change Observations of the
NC1 number Subclause Figure/Table comment2 secretariat

Be- Ge - ISO 7101 is still in a first DIS and still needs to be 1. Noted
001 circulated. This vote seems to us too early.
- The proposed Annex A on competencies
contains only a limited number of knowledge
requirements, so their impact is considered limited.
The added value of this standard will therefore be
very limited and does not require an additional
standard.
DE- ge The competence criteria for QMS in the health 2. Noted
002 sector are sufficiently described in ISO/IEC 17021-
3 as required by German legal, statutory and other
requirements.
Any additional TS is not seen to add any value.
-003 IIOC All document ge IIOC maintains its opposition to the creation of 3. Noted
these ‘dash’ documents as it believes there are
already sufficient mechanisms in place to manage
the competence of auditors, not least ISO/IEC
17021-1.
U.S.- Pg 3 ed of how health systems work and how each Change word to singular 4. Noted, this is on the
002 L 36 stakeholders plays a… “stakeholders” should not form 4
be plural

ge 5. Noted
NC- Scope It is suggested to supplement the logical
003 relationship with the above two standards and the
logical relationship with ISO7101 to clarify the
positioning of this standard.
ge 6. Noted
NC- Scope Amended into Requirement on personnel’s ability
004 audit and certification for medical quality
management system

te It is not possible to require healthcare facilities to 7. Noted, related to

U.S.- 9.2 Para 3 provide all of the training required for hand hygiene “The healthcare facilities shall should provide with another document
001 requirement the training and educational resources . . . .”

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 **)
2 Type of comment: ge = general te = technical ed = editorial
Page 1 of 4
 Document: N3 collated comments Project: CASCO TC304
Template for comments and secretariat observations Date:2023-05-15
NWIP in TC 304 and CIB CASCO JWG63

MB/ Line Clause/ Paragraph/ Type of Comments Proposed change Observations of the
NC1 number Subclause Figure/Table comment2 secretariat

ID- Annex A Table of te In coloum “Knowledge and Skills” at row 12 which “Communication skills appropriate to all levels 8. Noted, this is
004 Knowledge is “Language skills appropriate to all levels within within the organization” generic requirement
and Skills the organization”. from ISO/IEC
since the communication skills are firmer than 17021-1
language skills, we propose to rephrased this
sentence become “Communication skills
appropriate to all levels within the organization”
ID- Annex A Table of te In coloum “Knowledge and Skills” at row 14 and 15 9. Noted, this is
005 Knowledge which are “presentation skills” and “Interview skills” generic requirement
and Skills we propose they not become new row but become from ISO/IEC
the part of “Audit management skills” in the last 17021-1
row.

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 **)
2 Type of comment: ge = general te = technical ed = editorial
Page 2 of 4
 Document:
Template for comments and secretariat observations Date:2023-05-15
NWIP in TC

MB/ Line Clause/ Paragraph/ Type of Comments Propo

NC1 number Subclause Figure/Table comment2

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 **)
2 Type of comment: ge = general te = technical ed = editorial
Page 3 of 4
NP ISO_