ISO/IEC WD 17007 Guidelines for drafting standards and specified requirements for conformity assessment applications

1
??????????????????????????????????????????????????
??????????????

• ISO/IEC WD 17007 Guidelines for drafting
  standards and specified requirements for
  conformity assessment applications
• ?????? ??????
• ????????????????????????????

2
??????????
ISO/IEC Guide71994-Guidelines for drafting
of standards suitable for use for conformity
assessment
CASCO ????????????????????????? 3 ?.?. 48
The New Work Item Proposal (NP) ISO/IEC 17007
??????????????? CASCO ??????????????????????????
????? Guide 7 ????? 7 ?.?.48
3
?????????????? NP
???????????? 1 2 3 4 5
?????????????? 1 0 5 8 4
??????????????? 1 0 15 32 20
18
68
- ???????????????????????????????????????????
68 - ??????????????????, ??????,???????????,?????
?????? 64 - ????????????????????????????
66 - ?????????????????????????????????????
67 - ??????????????????????????????????????
70 Tatal score 335
1. ??????????????????? ?????????????????????? 2
. ?????????????????????????????? WG 27
????? 13 ??????
P-members (20) 18 Average points 18.6 ?????
18.6 gt 15 5 x 3
4
CASCO WG27 Drafting requirements for use in
conformity assessment applications
?????????????? 4 ??.?.49 ??????????? 30
?.?.49 ???
??????????? 23-24 ??.?.50 ? ????????????????????
? ?????????????????????????????????? ??????
Mr.W. Cunningham SCC (Canada) ?????? ABNT
(Brazil) AENOR (Spain) ANSI (USA) BSI
(United Kingdom) DIN (Germany) ICONTEC
(Columbia) IRAM (Argentina) ISIRI
(Iran) AS(Australia) SABS (South
Africa) SAC (China) TISI (Thailand)
ON (Austria) ??????????? JSA (Japan) Liaisons
IEC ILAC
5
????
????????????

• ????????????????????????????????
  ?????????????????? ???? ???????
  ????????????????????????????????? ??????????????
  ?????? ISO ??? IEC ???????????? 7
  ??????????????????
• ????????????? ?????????????????????
• ?????????????????? ?????????????????????
• ???????????? ????????????
• ??????????????????????????????

6
?????????????????
0. ????
1. ??????? 2.?????????????
3.????????????????? 4.???????
5.????????????????????? 6.???????
7
1.???????
?????????? ????????????????????????????? ????????
??????????????????? ???????????
?????????????????????????????????
????????? (????????????) ?????????
?????????????? ???????????????????????????????????
??? 1 ???????? 2 ??????????? 3
8
2. ?????????????
ISO/IEC 17000 2004 Conformity assessment
Vocabulary and general principles
3. ???????
??????? ISO/IEC 17000 2004 ???????
????????????
9
4. ??????? (Principles)
????????????????? 5 ???

• ?????????????? (general)
• ?????????????????????????????????????????????
  Separation
• of technical requirements and conformity
  assessments aspects.
• ???????????????????????????????? Flexibility
  towards conformity
• Assessment activities.
• ??????????????????????????????????????
  Functional approach
• to conformity Assessment
• ??????????????????????????????????? (
  comparability)

10
4. ???????
4.1 ?????????????? ??????????
????????????????????????????????????? 4.2
????????????????????????????????????????????????
????????? ????????????????? ???? ???????
????????? ?????????? ?????????? ?
????????????????????????????????????????????
???????????????????????????????????????????
???????? ??????????????????????????????????
???? ??????????????????????????????????????
???????????????????????? ?????????
??????????????????????????????????????????????????
???????????????????? ??????????????????????
??????????????????
11
4.3 ????????????????????????????????
????????????????????????????????????????
??? ??????????????????????????????????/???????????
?????? ??????????????? ??????????????????????
?????? ???????????????????????????
?????????????????????? ???????????????????????
????????????????????????????? ????
?????????????????????????????????????????? ???????
??????????? 1 ???????? 2 ??????????? 3
12
4.4 ??????????????????????????????????????
????????????????? ?????? selection
??????????? determination ??????????
review and attestation ?????????????????????

????????? ????????????? surveillance
(??????????)
4.5 ???????????????????????????????????
(????????????)
13
5. ?????????????????????
5.1 ??????????????????????????
?????????????????????????????????????
?????????????????????????????????????
??????????? ???????????????????????????????
????????????????????????????????????????
???????????????????????? ?????????????
(??????????) ???????????????? ?????????????
14
Table1-Overview of conformity assessment
activities
Conformity use for use for use for Relating to Relating to Relating to    
assessment first Secon Third selection and review and surveillance Result ISO/IEC
activities party d party party determination attestation     Standards
Supplier's Y ?   Y Y Y Declaration ISO/IEC 17050
declaration                
Certification of     Y Y Y Y Certificate ISO/IEC Guide 65
products                
Certification of                
management     Y Y Y Y Certificate ISO/IEC 17021
systems                
Certification of     Y Y Y Y Certificate ISO/IEC 17024
persons                
Inspection Y Y Y Y Y   Inspection ISO/IEC 17020
              report  
Testing Y Y Y Y Y   Test report ISO/IEC 17025
15
5.1.1 ?????????????????????????????????????
????????????????? ????????????????????????????
????????????????? (preferred)
??????????????????? (less preferred)
???????????????????????????? ???? ???????
??????? ??????? ?????????? ??????
???????????????????????????
16
5.1.2 ???????????????????????????????????????
??????????????????????????????????????????????
?????????????????? ????????????????????????
?????????????
????? ???????? ????????????????
?????????????????????????????????????????????????
???????? ???????????????????????
???????????????????????
17
5.1.3 ???????????????????????????????
??????????????????????????????? Type
evaluation (ISO/IEC Guide 67 2004)
????????????????? (ISO/IEC Guide 28 2004)
??????????????????????????????(ISO 19011 2002)
??????????????????????????????????????????
?????? (ISO/IEC Guide 53 2005)
18
5.1.4 ?????????????????????????????????
?????????????????????????????????????????????
???/???? ??????????????
?????????????????????????? ISO/IEC 17030
2003 General requirements for third-party
marks of
conformity ISO/IEC Guide 23 1982 Methods of
indicating conformity with
standards for third-party certification systems
ISO/IEC Guide 27 1983 Guidelines for
corrective actions to be taken by a
certification body in the event of misuse of
its mark of conformity
19
5.1.5 ????????????????????????
?????????????????????????????????????
???????? ???????????????????????????(??
ISO/IEC 170212006) ????????????????????????????
??????????????????? ???????????????
20
5.2 ?????????????????????????????????
?????????????????????????????
????????????? ?????????

• ???????????? ??????????????????????????????
  ?????? ??????????? ISO IEC ??? WTO
• ????????????????????????????????????????????
  ??? ???????
• ISO/IEC 17011 2004
• ISO/IEC 17040 2005

21
5.3 ????????????????????????????????????
?????????????????????

• ??????????????????????????????????????????????
  ? ?????????
• ?????????????????????? WTO ???????????????????
  ?? ???????????? ISO/IEC Guide 68 2002
  Arrangements for the recognition and
  acceptance of conformity assessment
  results (MRAs)

22
5.4 ???????????????????????????????????????

• ????????????????????????????????????????????????
  ?? 1 ??????????????? 2 ??????????????? 3
• ????????????????????????????????????????????
  
• ?????????????????????????????

23
6.??????? (Parking lot)

• Specification of requirements and test methods
  for products, processes and systems
• ???????????????? (????????????)

24
?
?????????