PH LC 2/Appendix 2

Danh mc ti liu bt buc v ti liu khuyn khch

p dng i vi t chc nh gi s ph hp

List of mandatory and voluntary documents for CABs

TT
No

Tn ti liu

K hiu

Name of document

Code

T chc nh gi s ph
hp (CAB)
PTN
Lab

TCG
IB

TCCN
CB

I. Ti liu bt buc p dng

Mandatory document
Chun mc cng nhn
Accreditation criteria
1.

2.

Yu cu chung v nng lc ca phng th nghim

v hiu chun

ISO/IEC

General requirements for competence of testing and 17025:2005

calibration laboratory
Chun mc chung cho cc hot ng ca t chc
tin hnh gim nh
General criteria for operation of various type of
bodies performing inspection

ISO/IEC

3.
4.

nh gi s ph hp Yu cu cho t chc nh
gi v chng nhn h thng qun l

ISO/IEC
Conformity assessment Requirements for bodies 17022:2006
providing audit and certification of management
systemts
Yu cu chung cho t chc tin hnh nh gi v
chng nhn h thng cht lng (C hiu lc n
15 thng 9 nm 2008)
General Requirements for Bodies Operating
Assessment and Certification/Registration of
Quality Systems (Valid untill 15 September 2008)
6.

Hng dn p dng ISO/IEC Huide 62, ban hnh

ln 4
LAF Guidance on the Application of ISO/IEC Guide

17020:2006

Chun mc chung cng nhn phng xt nghim y t

ISO/IEC
Medical laboratories Particular
15189:2007
requirements for quality and competence

5.

ISO/IEC
Guide

62:1996

IAF
GD2:2005

IAF
GD5:2006

62:1996 issue 4

7.

Hng dn p dng ISO/IEC Guide 65, ban hnh

ln 2
IAF Guidance on the Application of ISO/IEC Guide
65:1996 issue 2.

Ghi
ch
Note

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8.

Tn ti liu

K hiu

Name of document

Code

nh gi s ph hp Cc c s ca chng nhn
sn phm
Conformity Assessment-Fundamentals of Product

ISO/IEC
Guide

T chc nh gi s ph
hp (CAB)
PTN
Lab

TCG
IB

TCCN
CB

67:2004

Certification
9.

nh gi s ph hp Hng dn v mt phng
thc chng nhn sn phm ca bn th ba
Conformity Assessment-Guidance on the third-party
certification system for Products
nh gi s ph hp Hng dn s dng h thng
qun l cht lng trong cc t chc chng nhn

10.

sn phm
Conformity Assessment-Guidance on the use of an
organizations quality management systems in
product certification

11.

H thng qun l an ton thc phm Yu cu i

vi cc c quan tin hnh nh gi v chng nhn
h thng qun l an ton thc phm
Requirements for bodies providing audit and
certification of food safety management systems

12.

13.

Tha thun tha nhn ln nhau (MLA) ca PAC

Multilateral Recognition Arrangement (MLA)
Tha thun tha nhn ln nhau ca IAF/ILAC trong
vic hng dn p dng ISO /IEC 17011
IAF/ILAC Multilateral Mutual Recognition
Arrangement: Application of ISO/IEC 17011

ISO/IEC
Guide

28:2004

ISO/IEC
Guide
53:2005

ISO/TS
22003:2004

PAC-MLA001

IAF/ILAC
A5:03/2011

IAF
ML2:2011

14.

Nguyn l chung trong vic s dng du IAF MLA

General Principals on Use of the IAF MLA Mark

15.

Hng dn cng nhn xun quc gia

Guidance on Cross Frontier Accreditation

IAF GD
3:2003

16.

Chng nhn cc t chc c nhiu a im da trn

vic chn mu
Certification of Multiple Sites based on Sampling

IAF MD
1:2007

17.

Chuyn giao chng nhn h thng qun l c cng

nhn gia cc t chc chng nhn
Transfer of Accredited Certification of Management
Systems

IAF MD
2:2007

18.

Gim st v chng nhn li da trn kt qu t nh

gi ca khch hng
Advanced Surveillance and Recertification
Procedures

IAF MD
3:2008

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19.

Tn ti liu

K hiu

Name of document

Code

p dng k thut nh gi c s tr gip ca my

tnh (CAAT) trong vic nh gi chng nhn cc
h thng qun l c cng nhn
Use of Computer Assisted Auditing Techniques
(CAAT) for Accreditation Certification of
Management Systems

T chc nh gi s ph
hp (CAB)
PTN
Lab

TCG
IB

TCCN
CB

IAF MD
4:2008

20.

Tnh ngy cng nh gi, xut bn ln 1, 2009

Duration of QMS and EMS Audits, issued 1, 2009

IAF MD
5:2009

21.

Xc nhn phm vi cng nhn t chc chng nhn h

thng qun l cht lng
QMS Scopes of Accreditation

IAF ID
1:2010

22.

Chuyn i sang ISO/IEC 17021:2011

Transition to ISO/IEC 17021:2011

IAF ID
2:2011

23.

24.

Ngh quyt IAF 2005-12: GD3 c p dng vi tt

c cc lnh vc chng nhn c cng nhn

IAF Resolution 2005-12 GD 3 is to be applied to all

fields of accredited certification
Ngh quyt IAF 2005-14: AB khng c cng nhn
cho cc t chc cung cp dch v o to

IAF Resolution 2005-14: Abs not to accredit training

course providers

25.

Ngh quyt JGA 2007-7: AB nh ch cc CAB khi

cc t chc ny ban hnh chng nhn da theo tiu
chun cng nhn
JGA Resolution 2007-7 Abs to suspend CABs issuing
certifications to accreditation standards

26.

Ngh quyt IAF 2010-09: bin dch v ph bin ti

liu v kt qu mong mun trong vic p dng cc t
chc qun l
IAF Resolution 2010-09 Translate and Promote the
expected outcomes

27.

Ngh quyt IAF 2010-10: CAB khng cung cp dch

chng nhn c cng nhn theo ISO 26000

IAF Resolution 2010-10 CABs not to offer accredited

certification to ISO 26000

28.

Phn loi lnh vc th nghim

Classification of testing/calibration fields

AGL 01

29.

Yu cu b sung lnh vc C
Supplementary requirement for accreditation in the
fields of mechanical testing

AGL 02

30.

Yu cu b sung lnh vc Ha hc
Supplementary requirement for accreditation in the
fields of chemical testing

AGL 03

31.

Yu cu b sung lnh vc Sinh hc

Supplementary requirement for accreditation in the
fields of biological testing

AGL 04

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Tn ti liu

K hiu

Name of document

Code

32.

Yu cu b sung lnh vc Xy dng

Supplementary requirement for accreditation in the
fields of construction engineering testing

AGL 05

33.

Yu cu b sung lnh vc Khng ph hy

Supplementary requirement for accreditation in the
fields of non-detructive testing

AGL 06

34.

Yu cu b sung lnh vc in
Supplementary requirement for accreditation in the
fields of electrical testing

AGL 07

35.

Yu cu b sung lnh vc o lng, hiu chun

Supplementary requirement for accreditation in the
fields of calibration and measurement

AGL 08

36.

Yu cu b sung lnh vc Dc
Supplementary requirement for accreditation in the
fields of pharmaceutical

37.

Yu cu b sung lnh vc y t
Supplementary requirement for accreditation in the
fields of medical testing

38.

Phn loi lnh vc y t

Categories of medical testing

39.

Yu cu b sung cng nhn t chc gim nh

Supplementary
requirement
for
inspection
accreditation

AGL 09

AGLM 01
AGLM 02

T chc nh gi s ph
hp (CAB)
PTN
Lab

TCG
IB

TCCN
CB

AGI 05

Cc ti liu lin quan n chnh sch v iu kin cho vic cng nhn
Documens concerning policy and condition for accreditation
40.

Qui nh chung v cng nhn

Rule of procedure governing accreditation

41.

AP 01

Th tc cng nhn phng th nghim

Accreditation procedure for laboratory

APL 01

42.

Chnh sch v lin kt chun

Policy for traceability

APL 02

43.

Chnh sch v TNTT/SSLP

Policy for Proficency testing/inter laboratory
comparison

APL 03

44.

Kim sot kt qu chng trnh TNTT/SSLP

Controlling the Proficiency Testing Results

APL 04

45.

Th tc nh gi cng nhn TCG

The conduct of inspection accreditation assessment

API 01

46.

Qu trnh cng nhn t chc chng nhn

CB Accreditation process

APC 01

47.

Hng dn phn loi hat ng gim nh

Categories of inspection

AGI 02

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Tn ti liu

K hiu

Name of document

Code

48.

Qui nh v phm vi cng nhn

The scope of accreditation

AGC 01

49.

C cu ph PTN
Fee structure for laboratory

AGL 10

50.

C cu ph TCG
Fee structure for IB

AGI 03

51.

Hng dn tnh ph nh gi cng nhn cc t chc

chng nhn

T chc nh gi s ph
hp (CAB)
PTN
Lab

TCG
IB

TCCN
CB

AGC 07

Fee structure for certification applicants

52.

Th tc gii quyt phn nn

Complaints

AP 02

53.

Th tc gii quyt khiu ni

Appeals

AP 03

54.

Hng dn nh gi a im
Guidance for the Accreditation of Bodies With

AGC 08

AGC 09

Multiple Locations
55.

Hng dn nh gi chng kin

Guidance for the Witnessing Arrangement

56.

Hng dn s dng logo

Guidance for use of accreditation logo and symbol

AG 01

Cc biu mu
Forms
57.

Phiu theo di chng trnh th nghim thnh tho

Labs PT list

AFL 01.01

58.

Phiu hi PTN
Questionnaire for laboratory

AFL 01.02

59.

Phiu hi PXN y t
Questionnaire for Medical laboratory

AFLM 01.01

60.

Phiu hi TCG
Questionnaire for Inspection body

AFI 10.01

61.

n ng k cng nhn
Application form

AF 11.01

AF 11.01

AF 11.01

Ph lc A - Phm vi ngh cng nhn

62.

- Th

nghim
Appendix A Accreditation scope for testing
laboratories

63.

Ph lc B - Phm vi ngh cng nhn - Hiu

chun
Appendix B Accreditation scope for calibration
laboratories

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64.

Tn ti liu

K hiu

Name of document

Code

Ph lc C - Phm vi hiu chun ni b

Appendix C Internal Calibration scope

T chc nh gi s ph
hp (CAB)
PTN
Lab

AF 11.01

AF 11.01

TCG
IB

TCCN
CB

Ph lc D - Thng tin b sung nh gi li

65.

Appendix D
assessment

Addition information for re-

Ph lc E - Gim nh
66.

Appendix E Accreditation scope for inspection

bodies

AF 11.01

Ph lc F - Chng nhn
67.

68.

Appendix F Accreditation scope for certification

bodies
Ph lc G - Phm vi ngh cng nhn
Phng Xt nghim Y t

AF 11.01

Appendix G Accreditation scope for Medical

Testing Laboratory

AF 11.01

AGL 12

AGL 17

AGL 18

AGL 19

AGL 24

II. Ti liu hng dn

Guidances
69.

Hng dn cc chng trnh th nghim thnh tho

Proficiency testing guidance
Hng dn tnh khng m bo o

70.

71.

Guide to the
measurement

expression

of

uncertainty

in

Hng dn tnh khng m bo o trong phn

tch ha hc nh lng
Guide to the expression of measurement uncertainty
in chemical test
Hng dn cc v d c lng khng m bo

72.

o trong phn tch ha hc nh lng

Examples for estimate measurement uncertainty in
chemical test

73.

Hng dn nh gi o lng
Guidance for measurement audit

Lu :
- PTN: Phng th nghim,
- PXN: Phng xt nghim,
- TCG: T chc gim nh,
- TCCN: T chc cng nhn,
- PT: Th nghim thnh tho

Ghi
ch
Note