3. What is ISO ?
International Organization for Standardization
Non-governmental organization in 1946, delegates
from 25 countries met in London and decided new
international organization
Objective :
To facilitate the international coordination and
unification of industrial standard
9. 1
Scope
-
QMS
udkvkyfaqmifrnfh
Quality Management System Requirement
vkyfief;a&G;cs,fjcif;
1.1 General
an organization
a) Consistently provide product that meets customer and
regulatory requirements, and
vdktyfcsufESifh
pnf;rsOf;vkyfxHk;vkyfenf;
vdktyfcsufudk
pOfqufrjywf
xkwfukef
axmufyHhay;jcif;
pGrf;&nfudk jyo&ef vdktyfonf/
(Customer)
b) Enhance customer satisfaction through QMS processes for
continual improvement
azmufonfrsm;
wdk;wufap&ef&nf&G,f&rnf/
auseyfrI
11. ISO 9000:2005, Quality management systems — Fundamentals and
vocabulary
ISO 9000:2005 pHcsdefrDpDrHcefU cGJa&;pepfrsm; tajccHpnf;rsOf;
rsm;ESifh a0g[m&
3 Terms and definitions
Throughout the text of this International Standard, wherever the term
“product” occurs, it can also mean “service”.
3. tac:ta0:rsm;ESifh t"dyÜm,fowfrSwfcsufrsm;
tjynfjynfqdkkif&m pHEIef;qdkif&m jy|mef;rlt&]]xkwfukef}}qdkaom
pum; &yfonf]]0efaqmifrI}}[lí vnf; t"dyÜm,foufa&mufNyD; jzpfonf/
13. Clause 4.1 General Requirement
1. Determine process need
(vkyfief;pOfrsm;owfrSwfj
2. Determine sequence & interaction of processes
(vkyfief;pOftwGif; qifhuJjzpfpOfESifh
tjyeftvSeftudsK;oufa&mufrI)
Purchasing
Storage
Sales & Marketing
14. General Requirement Cont’
3. Determine criteria & method
(tcsuftvufrsm;? enf;vrf;rsm; qkH;jzwfay;jcif;)
4. Ability of resources & information
(t&if;tjrpfrsm; ESifh owif;tcsuftvufrsm;)
5. Monitor , measure, analysis
(MuD;MuyfrIjyKjcif;? wdkif;wmjcif;? pDppfcGJjcm;rIrsm;j
6. Implementation action to achieve planned result & continual
improvement
( pDrHcsuf&vm'f
ESihf pOfqufrjywf wdk;wufrIudk
taumiftxnfazmf aqmif&Gufjcif;)
15. Training, Documentation, Implementation, Audit
Requirement
• Training
• Documentation
Purpose
• Knowledge &
Awareness
• For Evidence
Benefit
• Staff
Confidence
• Traceability
• Implementation
• Apply system
actual
• Internal Audit
• External Audit
• Surveillance
Audit
• Make sure the
system
• Can do
systematically
with un-fail
• Continual
Improvement
16. Clause 4.2 Documentation Requirement
4.2.1 General
(a,bl,s)
4.2.2 Quality Manual
(pHcsdefrDukrÜPDvufpJG)
4.2.3 Control of Document
(pm&Gufpmwrf;xdef;odrf;rI)
4.2.4 Control of Record
(rSwfwrf;xdef;odrf;rI)
17. QMS rSwfwrf;rSwf&m
a)
rsm;wGif yg0if&rnfht&mrsm;rSm –
Documented statements of a quality policy and quality objectives,
pHcsdefrD rl0g' ESifh OD;wnfcsufrsm; ygaom pm&Gufpmwrf;
azmfjycsufrsm;/
b) A quality manual, pHcsdefrD
ukrÜPDvufpGJ
c) Documented procedures and records required by this International
Standard, and
pm&Gufpmwrf; vkyfief;pOfESifh EdkifiHwum tqifhrD rSwfwrf;
xdef;odrf;rI
d) Documents, including records, determined by the organization to be
necessary to ensure the effective planning, operation and control of its
processes.
xda&mufaom pDrHudef;rsm;? vkyfief;wm0ef tqifhrsm;ESifh
,if;vkyfief;pOfrsm; tay: xdef;csKyfrI? uGyfuJrIudk aocsmap&ef
tzGJUtpnf; qHk;jzwfrIrsm;udk rSwfom; xm;aom rSwfwrf;rsm;/
18. NOTE: 2 The extent of the quality management system
documentation can differ from one organization
to another due to
a) The size of organization and type of activities,
b) The complexity of processes and their interactions, and
c) The competence of personnel.
Main Objective of Quality Management documentation
1. Communication of information
2. Evidence of conformity
3. Knowledge sharing
20. 4.2.3 Control of documents
Documents required by the quality management system
shall be controlled.
QMS
က က က က
က က က က
documents
(က က က က )
က က က က
က က က က က က က က က က က က က က
က က က က က က က ကက က က က က က
Document Control Center
Document Control 4.2.3
Record Control
4.2.4
က က က က
က က က
21. Record Control
4.2.4
Quality Record Registration
Records are a special type of document and shall be
controlled according to the requirements given in 4.2.4.
QMS
xda&mufaomvkyfief;pOfrsm;
vdktyfcsuftwGuf pHcsdefrDaMumif; oufao jyK&ef
rSwfwrf;xdef;odrf;jcif;rsm;udk
xdef;csKyfuGyfuJ&rnf/
eg: Records of Management Review (5.6.1)
Records of education, training , skills and experience of human
23. 5.1 Management Commitment
Top Management to show evidence of commitments
QMS development
Implementation
Customer Requirement
Quality Policy
Quality Objective
Continual Improvement
(azmufonfrsm;vdktyfcsu
(pHcsdefrDrl0g'wnfaqm
(pHcsdefrDOD;wnfcsufw
(pDrHcefU cJGrIjyefvnf
Management Review
Ability of Resources
(t&if;tjrpfrsm;&&SdEdk
24. 5.2 Customer Focus
- Customer requirement are determined
(azmufonfrsm;vdktyfcsufrsm;q
kH;jzwfay;jcif;)h
- To increase customer satisfaction
(azmufonfrsm; pdwfauseyfrIudkwdk;wufapjcif;)
Clause 7.2.1 - Determination of Requirements Related to the Product
Cluase 8.2.1 – Customer Satisfaction
25. 5.3 Quality Policy က က က က ကက က က က
က က က က
က က က
* Appropriate to the purpose of the organization
(tzGJ htpnf;&nf&G,fcsufESifhqDavQmfrI&Sdjcif
* Commitment to QMS requirements and continual
improvement
(QMS vdktyfcsufESifhudkufnDapjcif;ESifhpOfqufrjy
* Communication and understanding in the organization
(tzGJ htpnf;wGif;qufoG,frIESifh em;vnfEdkifpGrf
* Establishing and reviewing Quality Objective
(pHcsdefrD&nf&G,fcsufrsm;csrSwfay;jcif;ESihfjy
* Review
(Quality Policy udkjyefvnfokHH;oyfjcif;)
26. Quality Policy
It is the policy XYZ Co. Ltd to provide a Transportation service that
fully meets with their clients’ satisfaction.
To achieve this, the company is committed to :
1. Fully understanding and conforming to the agreed requirements of
the client
2. Always delivering the right result first time
3. Comply with the requirement of ISO 9001:2008
4. Establishing Quality Objectives that are monitored & regularly
reviewed by senior management at management review meeting.
Etc……..
Signed by
Managing Director
11 December 2010
Document : Quality Policy Issue: 01 Date :11.12.2010 Page 1 of 1
27. 5.4 Planning က က က က က က က က က
က က က က က က က က ကက က က က
က က က
5.4.1 Quality Objectives
(pHcsdefrD&nfrSef;csufrsm;csrSwfjcif;)
• To meet requirement for products/services
• (xkwfukefvdktyfcsufeSifhudkufnD&rnf)
• To establish functions and levels within the organization
• (XmewGif;vkyfaqmifcsufrsm;ESifhtqifhwkdif;ü Q.obj
udkcsrSwffay;&rnf)
• To be measurable and consistent
• (Q.obj
udkwdkif;wmEdkif&rnfh&nfrSef;csuftwdkif;wowffrwf
5.4.2 QMS Planning (BudKwifpDrHudef;rsm;csrSwfjcif;)
wnf;&Sd&rnf)
• To carry out requirement in 4.1 & Q.Objective
• (pDrHudef;csrSwf&mü 4.1. utaxGaxGvdktyfcsufrsm;
ESifh Q.obj twdkif; csrSwffay;&rnf)
• To maintain integrity of the QMS when changes to QMS
28. 5.5.1 Responsibility and Authority အအအအအအအအအအအအအအအ
TOP MANAGEMENT :
* TO DEFINE AND COMMUNICATE WITHIN THE ORGANIZATION
Managing Director
General
Manager
Production Manager
Maintenance
Manager
Organization chart
Factory
Manager
Store
Manager
Finance
Manager
Accountant
40. Ensure the person who aware the importance of their activities and
how they contribute to QMS
0efxrf;yk*¾dKvfwpfOD;onf
ol
vkyfaqmifcsufrsm;
ta&;ygyHkudk
owdjyKrdapjcif;? pHcsdefrD &nfrSef;csuf (Quality
Objective)udk
&&Sdap&efolonf
rnfuJhodkU
Maintain record of education, training, skills and experience Clause 4.2.4
tusdK;jyKae yHkudk odap&rnf/
wm0ef xrf;aqmifolrsm; ynma&;? avhusifhrI?
udk,fydkift&nftcsif;ESifh vkyfief; tawGUtBuHK
rsm;udk
rSwfwrf;rsm;jzifh
oifhawmfovdk
xddef;odrf; xm;&rnf/
41. 6.3 Infrastructure - ကကကကကကကကကကကကကကကကကက
The organization
Determine, provide and maintain the infrastructure
pHcsdefrD xkwfukefvdktyfcsufrsm; &&Sd&eftwGuf
vkyfief;cGiftwGif; vdktyfcsuf rsm;udk tzGJUtpnf; rsm;
uaxmufyHhay;jcif;? xdef;odrf;ay;jcif;? qkH;jzwfay;jcif;wdkU
1. Building, workplace and associated utilities
jyKvkyf&rnf/
taqmuftOD; vkyfief;cGifae&m (Workspace) ESifhqufEG,faeaom tok
2. Process equipments (both hardware & software)
vkyfief;pOfokH;
ypönf;rsm;/
3. Supporting services (transporting, communication or information system.
0efxrf;rsm;twGuf Transportation
qufoG,frIpepfrsm;ESifh owif;tcsuf
&&SdrIpepfrsm;/
42. 6.4 Work Environment - ကကကကကကကကကကကကကကကကကကကက
The organization
Determine, maintain the work environment
tzGJUtpnf;onf
pHcsdefrD
xkwfukef&&Sd&ef
vkyfief;cGif
ywf0ef;usifudk
qHk;jzwf
ay;jcif;?
uGyfuJay;jcif; wkdYudk jyKvkyf&rnf/
rSwfcsuf/ /
vkyfief;cGif
ywf0ef;usifqdkonfrSm
vkyfom;rsm; ½kyfydkif;qdkif&m? ywf0ef;usifqdkif&m
ESifh
tjcm;aomtcsufrsm;
(qlnHjcif;?
tylcsdef?
pdkxdkif;jcif;?
tvif;a&mifESifh
&moDOwk)wdkY
jzpfygonf/
45. 7.1 Planning Cont’
1. Quality Objective & requirement of product
pHcsdefrD&nf&G,fcsufrsm; ESifh
xkwfukeftwGuf vdktyfcsufrsm;
2.To establish processes and document, to provide resources for
product
vkyfief;pOfrsm;ESifh pm&Gufpmwrf;rsm;
csrSwfwnfaqmufay;jcif;? xkwfukef&&Sd&ef
vkdtyf aom t&if;tjrpf rsm;udk yHhydk;ay;jcif;/
46. 7.1 Planning Cont’
3.Verification, validation, monitoring, measurement, inspection
and test activities and the criteria for product acceptance
xkwfukef
rSefuefrIppfaq;ay;jcif;?
xdef;odrf;rIay;jcif;?
wdkif;wmjcif;?
jyKvkyfjcif;?
oufwrf;?
ppfaq;rIrsm;
prf;oyfrIvkyfief;rsm;
vkyfaqmifay;jcif;ESifh xkwfukefudk vufcHtwnf jyK&ef
4.Record need to provide evidence of product Clause 4.2.4
vdktyfaom tcsuftvufrsm;wdkUvdktyfygonf /
xkwfukef
vdktyfaom
&v'frsm;ESifh
vkyfief;pOfod&SdaMumif;
oufaojy&ef
xdef;odrf;jcif;udkvnf; jyKvkyf&ygrnf/
rSwfwrf;
47. 7.2 Customer Related Processes
(0,f,loHk;pGJolESifh
qufEG,faomvkyfief;pOfrsm;)
7.2.1 Determination of Requirements
(vdktyfcsufrsm;udk qkH;jzwfay;jcif;)
7.2.2 Review of Requirement
(vdktyfcsufrsm;udk
jyefvnfoHk;oyfjcif;)
7.2.3 Customer Communication
(oHk;pGJolESifhqufoG,fjcif;)
48. 7.2.1 Determination of requirements related to
the product
အ အ အ determine အ
အ အ အ အ အ အ
The organization shallအ အ အ အ အ
အ အ အ အ အ အ အ အ အ
အ အ အ အ အ အ အ အ
a) Customer requirementsအ အ အandအ
အ အ အ အ အ delivery အ post-delivery activities,
အ အ အ အ အ အ အ
(u) azmufonfrsm; vdktyfcsufrsm;? xkwfukefypönf;
ydkYaqmifay;jcif;ESifh
aemufqufwGJ
vkyfief;aqmifwmrsm;/
b) Not stated customer requirements but necessary for specified or
intended use, where known,
(c) rSefuefpGm oHk;pGJrIESifh oHk;pGJ&rnfh
ae&mwdkYudk azmfjyay;&ef vdktyfygonf/
49. 7.2.1 Cont’
c) Statutory and regulatory requirements of the product, and
(*)
xkwfukefESifhqdkifaomod&Sd&rnfhw&m;0ifp
nf;rsOf;pnf;urf;csufrsm;/
d) Any additional necessary requirements by the organization.
(C) tjcm;aom
xyfrHaygif;xnfh&ef
rSwfcsuf/ (Post delivery) qdkonfrSm tmrcHrIESifh
vdktyfaomtcsufrsm;udk tzGJUtpnf;rS qHk;jzwf
tmrcHwdk;csJUay;jcif; pmcsKyft& xdef;odrf;rI
ay;&rnf/
0efaqmifrIay;jcif; (Maintenance service)?
tydk0efaqmifrI ay;jcif;? (Supplementary service)?
wkdY yg0ifonf/
50. Clause 7.2.2 Review of requirements related to the product
က က က က
က က က ကက က က က က
က က က က ကက က က က က က က က ကက က က က က က က
က က က က က က က က က က က က က က
The product review with the organization's commitment to supply the customer
(e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes
to contracts or orders) shall ensure that
tzGJUtpnf;onf xkwfukef vdktyfcsufrsm;udk jyefvnf oHk;oyf&rnf/
pm;oHk;ol odk hxkwfukef ydkYaqmifay;jcif; tay: tzGJtpnf;rS
OD;pm;ay;rSl hjzifh oHk;oyfcsufrsm; csrSwf&rnf/ (Oyrm wif'gay;jcif;?
pmcsKyfESifh ukefrSmMum;csuf (order) rsm; pmcsKyfwGif
ajymif;vJrIrsm; vufcHay;jcif;wkdY jzpfonf/
a) Product requirements are defined,
xkwfukef vdktyfcsuf csrSwfay;jcif;?
b) Contract or order requirements differing from those previously expressed are
resolved, and
51. Clause 7.2.2 Cont’ ……
c) The organization has the ability to meet the defined requirements.
tzGJUtpnf; pGrf;aqmif&nfonf owfrSwfxm;aom vdktyfcsuf
ESifh udkufnD&rnf/
Records of the results of the review and actions arising from the
review shall be maintained (see 4.2.4).
oHk;oyfjcif;rS xGufay:vmaom vkyfaqmifrIrsm; &v'f (record)
udk pm&Gufpmwrf; rsm; ESifh odrf;qnf;xm;&rnf/ Clause 4.2.4
52. Clause 7.2.3 Customer Communication
က က က က က က ကက က က က က က
က က က က က က
က က က က က က
The organization shall determine and implement effective arrangements for
communicating with customers in relation to
tzGJUtpnf;onf (Customer) ESifh qufoG,f&eftwGuf xda&mufaom
tpDtpOfrsm;
qHk;jzwfay;jcif;
ESihf
jznfhpGufay;jcif;wdkYudk
atmufygtcsuf tvufrsm; t& jyKvkyf&rnf/
a) Product information,
xkwfukefqdkif&m tcsuftvuffrsm;/
b) Enquiries, contracts or order handling, including amendments, and
pHkprf;rSKrsm;? pmcsKyfrsm;? tvkyfvufcHwm0ef,lrI
53. Clause 7.2.3 Cont’………..
c) Customer feedback, including customer complaints
azmufonfrsm;rauseyfrI wkdUjzpfonf/
54. 7.3 Design and Development
7.3.1 D & D Planning
7.3.2 D & D Inputs
7.3.3 D & D Outputs
55. 7.3.4 D & D Review
7.3.5 D & D Verification
7.3.6 D & D Validation
7.3.7 D & D Changes
60. 7.4.1 Purchasing Process Cont…
The type and extent of control applied to the supplier and the
purchased product shall be dependent upon the effect of the
purchased product on subsequent product realization or the
final product.
tzGJUtpnf;onf
0,f,lrnfhypönf;
ukefypönf;wifoGif;ol
rSefuefap&ef
ESifh
0,f,lonfhukefypönf;trsKd;tpm;wdkYudk
tzGJUtpnf;rS
xdef;csKyfxm;EkdifrIonf ukefypönf; xkwfvkyfpOf ESifh
aemufqHk;
ukefacsmxGufcsdef
txd
61. 7.4.2 Purchasing Information
Requirements of Information
1. Approval of (product, procedures, processes and
equipment)
2. Qualification of personnel
(u) Quality Management System
3. ypönf;0,f,lcGifh vkyfief;pOfftqifhqifh
vkyfxHk;vkyfenf;ESifhwkdif;wmrnfh ypönf;rsm;
vdktyfcsufrsm;/
(c) pDppf0,f,lEkdifpGrf;&Sdonfh t&nftcsif;&Sdol
vdktyfcsuf/
(*) QMS t&nftaoG;xdef;csKyfrI pepfudk vdktyfygonf/
62. 0,f,lonfhypönf;
rSefuefrIppfaq;jcif;
The organization
1. Establish & Implement
Inspection
tzGJUtpnf;onf
0,f,lrnfhypönf;
vdktyfcsufESifh
jynfhrSD&ef oGm;a&mufpHkprf; ppfaq;jcif; ESifh
tjcm;vdktyfaom vkyfaqmifcsufrsm;udk csrSwftaumiftxnf
azmf&rnf/
2. State intended verification arrangements and method of product
release in the purchasing information.
tzGJUtpnf; (odkY) tzGJUtpnf;azmufonf (Customer) rsm;u
ukefypönf;wifoGif;ol (Supplier) xkwfvkyfonfhae&modkY
t&nftaoG;ppfoGm;a&mufvkdygu
tzGJUtpnf;
onf
ppfaq;&rnfh&nf&G,fcsu?ftpDtpOfESifh
xkwfukef
65. 7.5.1 Cont’
•Ability and use of monitoring and measuring equipment
(vkyfief;cGifoHk;ypönf;rsm;udk
xdef;csKyfjcif;ESifh udkifwG,fyHk enf; pepf)
•Implementation of monitoring and measurement
(jznfhpGufvkyfaqmifay;jcif;)
•Implementation of product release, delivery and post-delivery
activities
(xkwfukefxkwfvkyfjcif;?
o,fydkYNyD;
o,fydkYjcif;ESifh
aemufvkyfaqmifrIrsm;udk
taumiftxnfazmf vkyfaqmifjcif;/)
66. 7.5.2 Validation of process production and service provision
The organization shall validate any processes for production and service
provision where the resulting output cannot be verified by subsequent
monitoring or measurement
csrSwftaumif txnfazmfxm;aom &v'f
pGrf;aqmifrI vkyfief;pOf
(Plan Result)
(Ability of Process)
udk &&Sd&ef
udk tzGJUtpnf; rS
csrSwf&rnf/
As a consequence, deficiencies become apparent only after the product is in
use or the service has been delivered.
tzGJUtpnf; xdef;csKyfjcif; ESifh udkifwG,fyHk enf;pepft&
ukefypönf;
cdkifrmrI
oufwrf;udk
wduspGm
razmfjyEkdifvQif
ukefypönf;oHk;pGJcsdef
ESifh
0efaqmifrINyD;
ajrmufcsdefwGif
aemufqufwGJ
67. 7.5.2 Validation of Process …..
The organization shall establish arrangements for these processes including,
as applicable,
a) Defined criteria for review and approval of the processes,
b) Approval of equipment and qualification of personnel,
c) Use of specific methods and procedures,
d)
(u) Requirements for records (see 4.2.4), and
e) Revalidation.
pdppfoHk;oyfjcif;twGufpHrsm;ESihfxkwfvkyfrIjzpfpOft
wnfjyKjcif;ukdowfrSwf&rnf/
(c) toHk;jyKrnfh pufypönf;ESifh t&nftcsif;jynfhrDaom
0efxrf;rsm;udk cGifhjyKaxmufcH
•
ay;jcif;/
(*) vkyfaqmifyHkenf;tqifhqifhESifh
enf;pepfrsm;udk
toHk;jyKapjcif;
(C) rSwfwrf;xdef;odrf;&eftwGufvkdtyfcsufrsm;
68. 7.5.3 Identification and Traceability
ukefypönf;cGJjcm;owfrSwfjcif;ESifhjyefvnf
pdppf&SmazGjcif;
Identify the product status
Proces
s 1
Proces
s2
Process 3
Process
4
Finish Product
Traceability
(Root cause)
Identify + Traceability = Configuration Management
tzGJUtpnf;onf
ukefypönf;xkwfvkyfpOfwGif
BuD;Muyfjcif;ESifh xdef;odrf;jcif; t& ukefypönf; tajctaeudk
cGJjcm;owfrSwf ay;&rnf/ tu,fíjyefvnfpDppf &SmazG
vdkygutzGJUtpnf;onf ukefypönf;cGJjcm;owf rSwfjcif;udk
69. 7.5.4 Customer Property
To take care customer property while it is under the organization's
control or being used by the organization.
txufyg azmufonfydkifqkdifaom ypönf;rsm;udk
tzGJUtpnf; xdef;csKyfrIatmufü &SdpOf (odkY)
toHk;jyKcsdefrSm *½kwpdkuf&Sd&rnf/
The organization shall identify, verify, protect and safeguard
customer property provided for use or incorporation into the
product.
tzGJUtpnf;onf azmufonfydkifqdkifaom ypönf;rsm; udk
rdrdukefxkwfvkyfief;pOf twGuf
70. 7.5.4 Customer Property Cont’
If any customer property is lost, damaged or otherwise
found to be unsuitable for use, the organization shall
report this to the customer and maintain records (see
4.2.4).
tu,fí azmufonfydkifqkdif aom ypönf;rsm;onf
aysmufqHk;?
ysufpD;
(odkY)
rrSefrueftoHk;jyKrIudk
awGU&Sdygu
azmufonf
udk
wifjy&rnf/
rSwfwrf; xdef;odrf;xm;&rnf/ Clause 4.2.4
71. 7.5.5 Preservation of Product
xkwfukefrsm;odrf;qnf;xkyfyk
d;yHkpepf
During internal processing & delivery to the customers in order to
maintain conformity to requirements.
Preservation shall include identification, handling, packaging,
storage and protection.
Preservation apply to the constituents parts of a product.
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72. 7.6 Control of Monitoring and Measuring
Equipment
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73. 7.6 Control of Monitoring and Measuring Equipment
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• To ensure valid results, measuring equipment shall be
calibrated or verified or both at specific intervals or prior to use
against measurement standards, where no such standard
exist, the basis use for calibration or verification shall be
recorded. (see 4.2.4)
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80. pdwfauseyfrI
As one of the measurements of the performance of QMS. The
organization shall monitor information relating to customer
perception as to whether the organization has met customer
requirements. The methods for obtaining and using this information
shall be determined.
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81. 8.2.1
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NOTE: Monitoring customer perception can include obtaining input
from sources such as customer satisfaction surveys, customer data on
delivered product quality, user opinion surveys, lost business
analysis, compliments, warranty claims and dealer reports.
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82. 8.2.2
Internal
Audit
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အ အ အ အ အ အ
အ အ အ အ အ အ အ အ အ
အ အ အ အ အ အ အ အ
Internal audits to determine whether the quality
management system
a) conforms
-to the planned arrangements (see 7.1),
-to the requirements of this International Standard
-to the QMS requirements and
b) is effectively implemented and maintained.
90. 8.5 Improvement
8.5.1 Continual Improvement
The organization shall continually improve the effectiveness of QMS
through the use of the
1) Quality policy,
2) Quality objectives,
3) Audit results,
4) Analysis of data
5) Corrective and preventive actions and
6)Management review
92. Corrective Action Cont’
A documented procedure shall be established to define requirements for
a) Reviewing nonconformities (including customer complaints),
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က က က က က က က က ကက က က က က က က က က
b) Determining the causes of nonconformities,
c) Evaluating the need for action to ensure that nonconformities do not
reoccur,
d) Determining and implementing action needed,
e) Records of the results of action taken (see 4.2.4), and
f) Reviewing the effectiveness of the corrective action taken.
93. 8.5.3 Preventive Action
to eliminate the causes of potential nonconformities .
Preventive actions shall be appropriate to the effects of the
potential problems.
A
documented
procedure
shall
be
established
to
requirements for
a) Determining potential nonconformities and their causes,
b) Evaluating the need for action to prevent occurrence of
nonconformities,
c) Determining and implementing action needed,
d) Records of results of action taken (see 4.2.4), and
e) Reviewing the effectiveness of the preventive action taken.
define
94. Six Mandatory Procedures
❆ Document Control Procedure 4.2.3
❆ Record Procedure 4.2.4
❆ Internal Audit Procedure 8.2.2
❆ Control of Non-conformance Procedure 8.3
❆ Corrective Action Procedure 8.5.2
❆ Preventive Action Procedure 8.5.3
