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ISO 9001:2008 Awareness Course
Our Partnership King Mongkut’s University & Global Group (UK)
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
What is ISO ?
Head Office – Geneva, Switzerland
ISO officially started on 23 Feb 1947
1.Customer Focused Organization
customer အာအာ အာအာအာအာအာအာအာအာအာ အာအာအာအာအာက��� အဓ�ကဥစပအရ��စ��က�� ခင�။
2. Leadership - ေ�ခင�ဆင�င���။
3. Involvement of People - အာအာအာအာအာအာအာအာအာအဖြ���႕အစည�တြ�င�ပ�ပင�ပဝင���။
4. Process Approach - လ�ပ န �စဥက#�$ ေေ�လ&လသ��သပ�� ခင�။
8 Principles of Quality Management System
5. System Approach to Management
စ(မ�ခန �႕ခ���င*နအ,-တြတြ�က�system က�� ေေ�လ&လသ��သပ�� ခင�။
6. Continual Improvement
စဥက/က�0ပ�� �����က�ေ�ကင��မနလ,2ခင�။
7. Factual Approach to Decision Making
အာအာအာအာအာအာအာအာအာအာအာအာအာအာ အာ အာအာအာအာအာအာ အာအာအာအာအာအာအာအာအာ အာ အာအာအာအာ အာအာအာအာအာ အာအာအာအာအာအာအာအာမ�နအ,#နအ3,4�ေက5သဆ��ဖြ�65က�5ခ5မ���င*န �အခ5က- လက�5က�� ေေ�လ&လသ��သပ�� ခင�။
8. Mutually Beneficial Supplier Relationships
Suppliers အာ အာအာအာအာအာအာအာအာအာအာအာအာ အာအာအာအာအာအာ အာအာ အာအာအာအာအာအာအာအာအာအာအာအာအာအာ အာ အာအာအာအာအာ အာ အာအာအာအာအာအာအာအာအာအာ အာမ5င&��လကတြက4 �လ�ပ�ေ�ဆင*တြ�င� ေစ�ဥစ8က�အက5�� ေေ�က5ဇ�မ5ရရ��လခင�။
8 Principles Cont’
(Plan-Do-Check-Act) PDCA “Plan-Do-Check-Act” (PDCA) အာအာအာအာအာအာအာအာအာအာအာ အာအာအာအာအာအာအာအာအာ အာအာ အာ အာအာအာအာအာအာအာအာအာအာအာအာအာအာအာအာနည�ပညက��လ�ပ န �စဥက�အလ���တြ�င�အသ���ပ�တြင;တြည�။
Plan (P) : အာအာအာအာအာအာအာအာအာအာအာအာအာအာအာအာအာ အာအာအာအာအာအာအာအာအာအာအာအာအာအာအာအာအာအာ အာအာအာအာအာအာအာအာအာအာအာအာအာအာ အာအာအာအာ အာအာအာအာအာအာအာ အာ အာအာအာအာအာ အာခ5မ��< သရညမ>�န �ခ5က�5၊လ�ပ န �စဥက�5က��သ���စြစ�သ�မ5၏လ��အပ65က�၊အစြဖြ�႕အစ အာအာည�၏မ�ဝBဒ ေမ5DEF��င&�� ေက��ကG (မ�� ေရ��ေ�အDင� ေအစ(အစဥက#�$ ေသ������ ခင��E။
Do (D) : ခ5မ��< DEေ�သD ေလ�ပ န ��Eစဥက� ေက��ေအကDင-ထည� ေေ�ဖြD��ေ�ဆDငရြင*က�� ခင��E။
Check (C) : လ�ပ န ��Eစဥက��F��င&�� ေက�,Jစၥည��E ေမ5DEသည� ေခ5မ��< DEေ�သD ေမ�ဝBဒ၊ ေရညမ>�န ��Eခ5က�၊ ေ လ��အပ65က� ေ���႕F��င&�� ေေ�တြသဖြည�� ခင��Eက�� ေေ�စDင&နလ�Lကည�႕စစ�ေ�ဆE� ပ(E ေမ��4 မ��E� ပ�စ� ေ ထDE� ခင��E။
Act (A) : လ�ပ န ��Eစဥက� ေလ�ပ�ေ�ဆDင���က�� ေစဥက/က�0ပ�4 �$E�က��� ေရ��ေ�အDင� ေ� ပင/င� ေေ�ဆDငရြင*က�� ခင��E။
1 Scope - QMS udkvkyfaqmifrnfh vkyfief;a&G;cs,fjcif;1.1 Generalan organizationa) Consistently provide product that meets customer and
regulatory requirements, and
(Customer) \ vdktyfcsufESifh pnf;rsOf;vkyfxHk;vkyfenf; vdktyfcsufudk pOfqufrjywf xkwfukef axmufyHhay;jcif; pGrf;&nfudk jyo&ef vdktyfonf/
b) Enhance customer satisfaction through QMS processes for continual improvement
azmufonfrsm;\ auseyfrI wdk;wufap&ef&nf&G,f&rnf/
pOfqufrjywf zGHU NzdK;wdk;wuf rIvkyfief;pOfrsm;/
Quality Management System Requirement
All Organizatio
n
ExclusionWithin Clause
7
International StandardQMS
Clause 1.2 Application
2 Normative references
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/
စစစစစစစစ စစစစစစ စစစစအရညအေ��သြ�မင��စ�မ�ခန �႕ခ���မ��စနစ�Clause 4. Quality Management System
1. Determine process need
2. Determine sequence & interaction of processes
(vkyfief;pOfrsm;owfrSwfjcif;)
(vkyfief;pOftwGif; qifhuJjzpfpOfESifh tjyeftvSeftudsK;oufa&mufrI)
Purchasing
Sales & MarketingStorage
Clause 4.1 General Requirement
3. Determine criteria & method
4. Ability of resources & information
5. Monitor , measure, analysis
6. Implementation action to achieve planned result & continual improvement
(t&if;tjrpfrsm; ESifh owif;tcsuftvufrsm;)
(MuD;MuyfrIjyKjcif;? wdkif;wmjcif;? pDppfcGJjcm;rIrsm;jyKjcif;)
( pDrHcsuf&vm'f ESihf pOfqufrjywf wdk;wufrIudk taumiftxnfazmf aqmif&Gufjcif;)
(tcsuftvufrsm;? enf;vrf;rsm; qkH;jzwfay;jcif;)
General Requirement Cont’
Requirement
• Training
• Documentation
• Implementation
• Internal Audit• External
Audit• Surveillance
Audit
Purpose
• Knowledge & Awareness
• For Evidence
• Apply system actual
• Make sure the system
Benefit
• Staff Confidence
• Traceability
• Can do systematically with un-fail
• Continual Improvement
Training, Documentation, Implementation, Audit
4.2.3 Control of Document (pm&Gufpmwrf;xdef;odrf;
rI)
4.2.1 General (a,bl,s)
4.2.2 Quality Manual(pHcsdefrDukrÜPDvufpJG)
4.2.4 Control of Record(rSwfwrf;xdef;odrf;rI)
Clause 4.2 Documentation Requirement
4.2 Documentation Requirements
4.2.1 General taxGaxG The quality management system documentation shall include
QMS rSwfwrf;rSwf&m rsm;wGif yg0if&rnfht&mrsm;rSm –a) Documented statements of a quality policy and quality objectives,
pHcsdefrD rl0g' ESifh OD;wnfcsufrsm; ygaom pm&Gufpmwrf; azmfjycsufrsm;/
b) A quality manual, pHcsdefrD ukrÜPDvufpGJc) 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;/
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
Company profile
Organization Chart
Scope
Quality Policy, Quality Objective
Business Flow Chart
Authority & Responsibility
Planning
QMR Roles
Each Department Procedure
Data Analysis
Internal Quality Audit (IQA)
Management Review
Corrective Action
Preventive Action
Quality Manual
4.2.2 Quality Manual pHcsdefrD ukrÜPD vufpGJ
Document Control Center
Document Control 4.2.3
Record Control 4.2.4
4.2.3 Control of documents
Documents required by the quality management system shall be controlled.
QMS စနငရြစMင� documents (မ��4 မ�) အာအာအာအာအာအာအာအာအာအာအာအာအာအာအာအာ အာအာအာအာ အာအာအာအာအာ အာအာအာမ5က��ထ�န �သ�မ�ထရန �လ���အပJသည�။
Record Control 4.2.4
Quality Record Registration
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 resources (6.2.2)
Records of Design and Development verification (7.3.4)
Records are a special type of document and shall be controlled according to the requirements given in 4.2.4.
Clause 5. Management Responsibility
(pDrHcefUcGJrIwm0ef0wå&
m;)
QMS development
Implementation Continual Improvement
Top Management to show evidence of commitments
Customer Requirement
Quality Policy
Quality Objective
Management Review
Ability of Resources
(t&if;tjrpfrsm;&&SdEdkifpGrf;)
(pDrHcefU cJGrIjyefvnfoHk;oyfcsuf)
(pHcsdefrDrl0g'wnfaqmufjcif;)(azmufonfrsm;\vdktyfcsufrsm;)
(pHcsdefrDOD;wnfcsufwnfaqmufjcif;)
5.1 Management Commitment
- Customer requirement are determined
- To increase customer satisfaction
(azmufonfrsm;\vdktyfcsufrsm;qkH;jzwf
ay;jcif;)h
(azmufonfrsm;\ pdwfauseyfrIudkwdk;wufapjcif;)h
Clause 7.2.1 - Determination of Requirements Related to the ProductCluase 8.2.1 – Customer Satisfaction
5.2 Customer Focus
* Appropriate to the purpose of the organization
* Commitment to QMS requirements and continual improvement
* Communication and understanding in the organization
* Establishing and reviewing Quality Objective
* Review
(tzGJ htpnf;\&nf&G,fcsufESifhqDavQmfrI&Sdjcif;)h
(QMS \vdktyfcsufESifhudkufnDapjcif;ESifhpOfqufrjywfwdk;wufrItwnfjyKay;jcif;)
(tzGJ htpnf;wGif;qufoG,frIESifh em;vnfEdkifpGrf;&Sdapjcif;)h
(pHcsdefrD&nf&G,fcsufrsm;csrSwfay;jcif;ESihfjyefvnfokH;oyfjcif;)
(Quality Policy udkjyefvnfokHH;oyfjcif;)
5.3 Quality Policy အာအာအာအာအာအာအာ အာအာအာအာ စ�ခ5�,�( မ�ဝဒမ5ခ5မ���� ခင�
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 client2. Always delivering the right result first time3. Comply with the requirement of ISO 9001:20084. 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
Quality Policy
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;wowffrwfwnf;&Sd&rnf)
5.4.2 QMS Planning (BudKwifpDrHudef;rsm;csrSwfjcif;)• 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
• (QMS udkvdktyfíajymif;vJ&aomtcgpkpnf;xm;aom QMS udkxdef;odrf;xm;& rnf)
5.4 Planning ၾက���င-စ(အစဥက�5 ခ5မ���� ခင�
TOP MANAGEMENT : * TO DEFINE AND COMMUNICATE WITHIN THE ORGANIZATION
Managing Director
Production Manager
Maintenance Manager
Factory Manager
Store Manager
Finance Manager
Accountant
GeneralManager
Organization chart
5.5.1 Responsibility and Authority စစစစစစစစစစစစစစစစစစတဝန � င��လ�ပပ����ငခြင!င�"#
TOP MANAGEMENT :
* APPOINTS A MANAGEMENT REPRESENTATIVE WHO WILL HAS
RESPONSIBILITY AND AUTHORITY :
MANAGEMENT မ� စ�မ�ခန �႕ခြေခ�ညအေ�ရ က���ယစ'လ�ယစ( QMS စစစစ စစစစစစစစ စ စစစစစစစ အသြတက� တဝန �ညအေ�ပပအပပ�ခန �႕ထခင� �*ဖစ,ည.�။
5.5.2 Management Representative - စ�မ�ခ န �႕ခ�ညအေ��ရ က���ယစ'လ�ယစ�
(A) TO ENSURE ALL PROCESSES (QMS ESTABLISHED, IMPLEMENTED, MAINTAINED)
အာအာအာအာအာအာအာအာအာအာအာအာအာအာအာအာအာအာ အာအာ အာအာ အာအာအာအာ အာအာအာ အာအာအာအာအာအာအာအာအာ အာ အာအာအာအာအာအာအာအာအာ အာအာအာအာအာအာအာအာအာ အလ��သလ�ပ န �စဥက�5က��ေအကတြင-ထည�ေ�ဖြခင�၊ ေ� ဖြည&��Oက�� ခင�င&��ထ�န �သ�မ� ေ� ခင����႕ ပ(မက� ေေ�သခ5စ ခင�။
(B) REPORTING TO TOP MANAGEMENT (PERFORMANCE & IMPROVEMENT OF QMS)
QMS အာအာအာအာအာအာအာအာ အာအာအာအာအာ အာအာအာအာအာ အာအာအာအာ အာအာအာအာအာအာအာအာအာအာအာအာအာ ၏လ�ပ�ေ�ဆင65က�5 ေင&��အ ခသ�����က*န �လ��အပ65က�5က�� အဆင&��� မင&�� စ(မ� ခန �႕စြခ�သ�သ��႕ �င�� ပ ခင�။
(C) ENSURING AWARENESS OF CUSTOMER REQUIREMENTS THROUGH THE ORGANIZATION
အာအာအာအာ အာအာအာအာအာအာအာအာအာအာ အာအာအာအာအာအာအာအာအာ အာအာအာအာအာအာအာအာအာအာအာအာ အာအာအာ အစြဖြ�႕အစည�အတြ�င� ေေ�ဖြက; ညမ>5၏လ��အပ65က�5သ�ရ��နလည�ငရြငOမ�က�� � မ�င&���င��� ေ� ပ�လ�ပ�ေ�ပခင�။
Management Representative
TOP MANAGEMENT :TO ESTABLISH COMMUNICATION PROCESSES
Effectiveness of QMS
pDrHtkyfcsKyfolrsm;onf tzGJUtpnf;twGif; oifhavsmfaom qufoG,frI vkyfief;pOf rsm;tm; wnfaqmufay;jcif;ESifh QMS xda&mufrItwGuf qufoG,frIrsm; vkyfaqmif ay;jcif;udk aocsmrIjyK &rnf/
5.5.3 Internal Communication အာ အာအာအာအာအာအာအာအာအာအာအာအာအာလ�ပ န �တြ�င�ဆကသြက; ယမ���မ5
5.6.1Genera
l
5.6.2Review Input
5.6.3Review Output
5.6 Management Review
စ(မ�အ�ပ65�တြပ;တြRမ5၏ ေ� ပ,2ညမS�$သပ65က��
TOP MANAGEMENT
• TO REVIEW THE ORGANIZATION’S QMS , Q. POLICY, Q. OBJECTIVE
(TO ENSURE CONTINUAL SUITABILITY, ADEQUACY AND EFFECTIVENESS,
NEED FOR CHANGES)
• MANAGEMENT REVIEW RECORD TO BE MAINTAINED.
CLAUSE 4.2.4 : CONTROL OF RECORD
စ စစစစ စ စစစစစ စ�မ�အ�ပပ!#� ညပပ,ည0မ#�.�အခြေဖ�႕အစ.�၏QMS က��� �*ပပနလ3�4 ���ပပ5မ.�။QMS �.� စ စ စစစစစစစစစစစစစစစစစစ စစ စစစ စစစစစစ စစစ စစ စစစဥဆ7က"8ပပတ� တ���တက"�� င���င����ညအေ�လ#မ��ရ� �ညအေ�ၾကင�လ��ညအေ�လက�ညအေ��ထ�ညအေ�
စစစစစ စစ စစစစစစ စ စစစစစစစစစစစ စစစစစစစရက"��ရ� �ညအေ�ၾကင�က�� �*ပပနလ3�4 ���ပပ5မ.�။ စစစစစစစစစစစစစစစစစစ စ�မ�အ�ပပ!#� ညပပ,ည0မ#၏ �*ပပနလ3�4 ���ပပ,ည0မ#က��ထ�န ���မ�ထရမ.�။(CLAUSE 4.2.4) မ�တ�
စစစစစစစစစစစစစစစစတမ�မ#ထ�န ���မ�ခင�။
5.6.1 General ေအေတြထတြထလ���အပ65က�5
5.6.2 Review Input oHk;oyf&efxnfhoGif;&rnfhtcsufrsm;
• a) Result of audits
b) Customer feedback
c) Process performance & Product conformity
d) Status of preventive & corrective actions
e) follow up actions from previous management reviews
f) effect changes to QMS
g) recommendation for improvement
• pDppfjcif;vkyfief;pOf\ &v'frsm;/
• azmufonfrsm;\ wkefYjyefrIrsm;/
• vkyfaqmifrIvkyfief;pOfESifh xkwfukefrSefuef aprI/
• trSm;BudKwifumuG,fjcif;ESifh trSm;jyifqifrI tajctae/
• ,cifjyKvkyfxm;aom pDrHcefYcGJolrsm;\ okH;oyfcsufrsm;tay:vkyfaqmifxm;rIrsm;/
• QMS tay:xdcdkufEdkifaom ajymif;vJrIrsm;/
• wdk;wufrItay:axmufcHcsufay;jc
if;/
TO MANAGEMENT : TO DECIDE AND ACTION
RELATED TO
စစစစစစစ စစစစစစစစစစစစစစစစစဆ��ဖတ!#က( မ#��မ#��၊လ�ပပ�ညအေ�ဆင!#က( မ#��မ#��1. IMPROVEMENT OF EFFECTIVENESS OF QMS & ITS
PROCESSES
QMS စ စစစစစစစစစစစစစစစစစစ စ စစစစစ စစစစစ၏ ထ�ညအေ�ရက"�� င��ယစင�လ�ပပ<န �စဥဆ=���႕၏တ��တက"��2. IMPROVEMENT OF PRODUCT
စစစစ စစစစစစ စစစစစ စ စစ စစစစစစစစစ စစစစစ စစစစစညအေ�ဖက, .�၏လ���အပပ!#က� င��အ.�ထ�တ> �န �၏တ���တက"��3. RESOURCE NEEDS
စစစစ စစစစစစစစစစအရင�အ*မစ�လ��အပပ!#က"#
5.6.3 Review output – အာအာအာအာအာအာအာ အာအာအာအာစ�ခ5�,�( မ�ဝဒမ5ခ5မ���� ခင�
Clause 6. Resource Management
t&if;tjrpfpDrHcefYcGJrSl
6.1 Provision of Resources (t&if;tNrpfaxmufyHhrIrsm;)
6.2 HumanResources(vlom;t&if; tNrpfrsm;)
6.3 Infrastructure(taNccHtaqmufttHkrsm;)
6.4 Work Environment(vkyfief;cGifygwf0ef;usiftaNct
ae)
- determine and provide the resourcestzGJUtpnf;onfvdktyfaom t&if;tjrpfrsm;udk qkH;jzwfay;jcif;? axmufyHh ay;jcif;wdkUudk jyKvkyf&rnf/
a) To implement and maintain the QMS & continual improve it effectiveness
Q.M.S \ t&nftaoG;ESifh ,if;\ xda&mufrItqufrjywfwdk;wufvmap&ef jznfhpGufay;jcif;? xdef;odrf;ay;jcif;/
b) To enhance customer satisfaction
(Customer) vdktyfcsufrsm;udk &&Sdapjcif;jzifh azmufonf \ auseyfrIrsm; wdk;yGm;vmap&ef wdkYjzpfonf/
Clause 6.1 Provision of Resources
အရင�အ မစ�ေ�ထကJT��မ�$မ5
Personal performing work affects product conformity
Staff Competency(Education, Training, Skills &
Experience)vlyk*¾dKvfwpfOD;wpfa,mufjcif;\ vkyfaqmifaomtvkyfrsm;onfxkwfukef (odkU) 0efaqmifrI\ pHcsdefrDrSefuefapa&;udk tusdK;oufa&mufrIU&Sdojzifh? ,if;0efxrf;\ynma&;? oifwef;rsm; wufa&mufjcif;? ukd,fydkift&nftcsif;ESifh vkyfief;tawGUtMuKH wdkUonf pGrf;aqmif&nf jynfh0rI &Sd&rnf/
rSwfcsuf/ /Q.M.S vkyfaqmifcsuftwGif; wm0efwpf&yfudk xrf;aqmifaom yk*¾dKvfonf wdkuf½dkufjzpfap? oG,f0dkufíjzpfap xkwfukefvdktyfcsufrsm; pHcsdefrDrSefuef apa&; tay:ü tusdK;oufa&muf Edkifonf/
6.2.1 General
6.2 Human Resources လ�သအရင�အ မစ�5
Cont…….. 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 tusdK;jyKae yHkudk odap&rnf/
Maintain record of education, training, skills and experience Clause 4.2.4
wm0ef xrf;aqmifolrsm;\ ynma&;? avhusifhrI? udk,fydkift&nftcsif;ESifh vkyfief; tawGUtBuHK rsm;udk rSwfwrf;rsm;jzifh oifhawmfovdk xddef;odrf; xm;&rnf/ (Clause 4.2.4) rSwfwrf;rsm; xddef;odrf;xm; &Sd&rnf/
Determine, provide and maintain the infrastructureThe organization
1. Building, workplace and associated utilities
2. Process equipments (both hardware & software)
3. Supporting services (transporting, communication or information system.
pHcsdefrD xkwfukefvdktyfcsufrsm; &&Sd&eftwGuf vkyfief;cGiftwGif; vdktyfcsuf rsm;udk tzGJUtpnf; rsm; uaxmufyHhay;jcif;? xdef;odrf;ay;jcif;? qkH;jzwfay;jcif;wdkU jyKvkyf&rnf/
taqmuftOD; vkyfief;cGifae&m (Workspace) ESifhqufEG,faeaom tokH;taqmifrsm;/
vkyfief;pOfokH;ypönf;rsm;/
0efxrf;rsm;twGuf Transportation
qufoG,frIpepfrsm;ESifh owif;tcsuf &&SdrIpepfrsm;/
6.3 Infrastructure - ေအ� ခခ�ေအဆက-အ��မ5
Determine, maintain the work environment
The organization
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/
6.4 Work Environment - အာအာအာအာအာအာအာအာအာအာအာ အာအာအာ အာအာအာ အာလ�ပ န ��ခင�ပ��ဝန �က5င�ေအ� ခေအန
Clause 7. Product Realization xkwfukefoabm
od&Sdem;vnfjcif;
The organization shall plan and develop
Product realization processes
Consistent with
Requirement of QMS
tzGJUtpnf;onf xkwfukefudk od&Sdem;vnf&eftwGuf pDrHudef;a&;qGJjcif;? vkyfief;pOf wdk;wufatmif vkyfaqmifjcif; jyKvkyf&rnf/ ,if;pDrHudef;a&;qGJjcif;onf tjcm;aom QMS vkyfief;pOfwdkY\ vdktyfcsufESifh tnD cdkifrmrI&Sd&rnf/
7.1 Planning of Product Realization
အာအာအာအာအာအာအာအာအာအာအာအာအာ အာအာအာအာအာအာအာ အာအာအာအာထ��# $ေ,;ဘသ�ရ��နလညမVန �စ(မ�က�န �မ5ခ5မ���� ခင�
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;/
7.1 Planning Cont’
3.Verification, validation, monitoring, measurement, inspection
and test activities and the criteria for product acceptance
xkwfukef\ rSefuefrIppfaq;ay;jcif;? oufwrf;?
xdef;odrf;rIay;jcif;? wdkif;wmjcif;? ppfaq;rIrsm;
jyKvkyfjcif;? prf;oyfrIvkyfief;rsm;
vkyfaqmifay;jcif;ESifh xkwfukefudk vufcHtwnf
jyK&ef vdktyfaom
tcsuftvufrsm;wdkUvdktyfygonf /
4.Record need to provide evidence of product Clause 4.2.4
xkwfukef\ vdktyfaom &v'frsm;ESifh
vkyfief;pOfod&SdaMumif; oufaojy&ef rSwfwrf;
xdef;odrf;jcif;udkvnf; jyKvkyf&ygrnf/
7.1 Planning Cont’
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;)
စစစစစစစစစ စစစစစစစစထ�နကနလ>@နကနလ7ည���င5 လ���အပပ!#က"#က��ဆ��ဖတ�ညအေ�ပပခင�။The organization shall determine
a) Customer requirements delivery and post-delivery activities,
(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/
7.2.1 Determination of requirements related to the product
c) Statutory and regulatory requirements of the product, and
(*) xkwfukefESifhqdkifaomod&Sd&rnfhw&m;0ifpnf;rsOf;pnf;urf;csufrsm;/
d) Any additional necessary requirements by the organization.
(C) tjcm;aom xyfrHaygif;xnfh&ef vdktyfaomtcsufrsm;udk tzGJUtpnf;rS qHk;jzwf ay;&rnf/
rSwfcsuf/ (Post delivery) qdkonfrSm tmrcHrIESifh tmrcHwdk;csJUay;jcif; pmcsKyft& xdef;odrf;rI 0efaqmifrIay;jcif; (Maintenance
service)? tydk0efaqmifrI ay;jcif;? (Supplementary service)? wkdY yg0ifonf/
7.2.1 Cont’
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
,cifu rSm,lxm;aom (order) rsm;?
pmcsKyfrsm;ajymif;vJrIrsm;udk ajz&Sif;ay;&rnf/
Clause 7.2.2 Review of requirements related to the product
အာ အာအာအာအာအာအာအာ အာအာ အာအာအာအာ အာအာအာအာအာအာအာအာအာအာအာအာအာ အာ အာအာအာအာအာအာအာအာအာအာအာ အာအာအာအာအာအာအာထ��# $န �င&��ဆက�ယမ�ေ�သလ���အပ65က�5က�� ေ� ပ,2ညမS�$သပ�� ခင�
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
Clause 7.2.2 Cont’ ……
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 (Order)rsm;ESifh rauseyfrI
wkdUjzpfonf/
Clause 7.2.3 Customer Communication အာ အာအာအာအာအာအာအာ အာအာအာအာေ�ဖြက; ည�င&��ဆကသြက; ယမ�� ခင�
c) Customer feedback, including customer complaintsazmufonfrsm;\rauseyfrI wkdUjzpfonf/
Clause 7.2.3 Cont’………..
7.3 Design and Development
7.3.1 D & D Planning
7.3.2 D & D Inputs
7.3.3 D & D Outputs
7.3.4 D & D Review
7.3.5 D & D Verification
7.3.6 D & D Validation
7.3.7 D & D Changes
7.4 Purchasing
ဝယစA 0ညအေ�ရ လ�ပပ<န �စဥဆ�
7.4.1 Purchasing Process ဝယစA 0ညအေ�ရ လ�ပပ<န �စဥဆ�
7.4.2 Purchasing information စစစစစစစ စစ စ စ စစစစ စစစစစစ စစစစစစဝယစA 0ညအေ�ရ င��ပပတ, က�ညအေ���တင�အခ#က( လက"#
7.4.3 Verification of purchase product
0,f,lonfhypönf;\ rSefuefrIppfaq;jcif;
7.4.1 Purchasing Process
Purchased Product
Purchase Requirements
Type & Extent of Control(Supplier & Purchased Product)
Final Products
7.4.1 Purchasing Process Cont…Evaluate &
Select Supplier
OrganizationRequirements
Supply Product
Establish : Criteria for selection, evaluation & re-evaluation Record : 4.2.4 tzGJUtpnf; onf ukefypönf; wifoGif;oludktuJjzwfjcif;? a&G;cs,fjcif; jyKvkyf &mwGif tzGJUtpnf;\ vdktyfcsufESifh udkufnD&rnf/ pHowfrSwfcsuf udk vnf; csrSwfxm;&rnf/
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; rSefuefap&ef
ukefypönf;wifoGif;ol ESifh
0,f,lonfhukefypönf;trsKd;tpm;wdkYudk
tzGJUtpnf;rS xdef;csKyfxm;EkdifrIonf ukefypönf;
xkwfvkyfpOf ESifh aemufqHk;
ukefacsmxGufcsdef txd
aumif;usKd;qdk;usKd;udk oufa&muf apygonf/
7.4.2 Purchasing Information
Requirements of Information
1. Approval of (product, procedures, processes and
equipment)
2. Qualification of personnel
3. Quality Management System(u) 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/
7.4.3 Verification of Purchased Product
0,f,lonfhypönf;\ rSefuefrIppfaq;jcif;
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 cGifhjyKyHkenf;vrf;rsm;udk BudKwif today; azmfjyxm;ay;&rnf/
Establish & Implement InspectionThe organization
1.
7.5 Production and Service
Provision
စစစစစစ စစစစစ စစစစစစစစစစစထ�တ3 �ပပ"�� င��ဝန �ညအေ�ဆင"��လ�ပပ<န �စဥဆ�
7.5.1 Control of production and service provision xkwfvkyfjcif;ESifh 0efaqmifrIudk xdef;csKyfjcif;
• Ability of product Information
owif;tcsuftvuf &&SdEkdifrIwGif xkwfukef\
vdktyfaom 0daoo vu©Pm &yfrsm; yg0if&rnf/
• Ability of work instruction
vkyfief;cGif ñTefMum;csuf (Work instruction)
&Sd&rnf/
• Use of suitable equipment
oifhavsmfaom vkyfief;oHk;ypönf;oHk;pGJjcif;
• 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,fydkYjcif;ESifh
o,fydkYNyD; aemufvkyfaqmifrIrsm;udk
taumiftxnfazmf vkyfaqmifjcif;/)
7.5.1 Cont’
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 (Plan Result) udk
&&Sd&ef pGrf;aqmifrI vkyfief;pOf (Ability of Process)
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 jzpfEkdifajc&Sdaeom csKdU,Gif; csufrsm; &SdvmEkdifonf/
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) Requirements for records (see 4.2.4), ande) Revalidation.
7.5.2 Validation of Process …..
(u)pdppfoHk;oyfjcif;twGufpHrsm;ESihfxkwfvkyfrIjzpfpOftwnfjyKjcif;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;(i) toHk;jyKoufwrf;wkd;owfrSwfay;jcif;wdkY jzpfonf/
7.5.3 Identification and Traceabilityukefypönf;cGJjcm;owfrSwfjcif;ESifhjyefvnfpdppf&SmazGjcif
;
Identify the product status
Process 1 Proces
s 2
Process 3Process
4
Traceability (Root cause)
Identify + Traceability = Configuration Management
Finish Product
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 xdef;csKyfrI jyK&rnf/ rSwfwrf; xdef;odrf;&rnf/ Clause 4.2.4
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 wGJzuftoHk;jyK&efay;xm;pOfrSm vdktyfaom pDppfcGJjcm;owfrSwfjcif; (identify)? rSefuefrI (verify)? xdef;csKyfrIESifh vkHNcHKrI (safeguard) &Sdatmif vkyf&rnf/
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
7.5.5 Preservation of Productxkwfukefrsm;odrf;qnf;xk
yfykd;yHkpepfDuring 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.
tzGJUtpnf;onf XmewGif; vkyfief;aqmifwm vkyfaqmifaepOfESifh xkwfukefudk a&muf&Sd &rnfh ae&modkY ydkYaqmifjcif;wdkYtwGuf xkwfukefudk odrf;qnf; xkyfydk;&rnf/ 4if;ü ypönf;cGJjcm;ay;jcif; (identification)? udkifwG,frI yHkpH (handling)? xkyfydk;jcif; (packaging)? odrf;qnf;jcif; (storage) ESifh umuG,fay;jcif; wdkYyg0ifonf/ xkyfydk;jcif;enf;pepff (Preservation) onf wnfwHhcdkifrm onhfxkwfukefwpfckjzpf&ef wpfpdwfwpfydkif; yg0ifonf/
7.6 Control of Monitoring and
Measuring Equipment
toHk;jyKypönf;rsm;udk BuD;Muyf?
wkdif;wmjcif;udk xdef;csKyfjcif;pepf
7.6 Control of Monitoring and Measuring Equipment toHk;jyKypönf;rsm;udk BuD;Muyf? wkdif;wmjcif;udk
xdef;csKyfjcif;pepf
• 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)cdkifrmwdusaom &v'f (valid result) &&Sd&ef wdkif;wmonfh
(equipment) rsm;udk
rSefuefrIppfaq;jcif; (calibration) (odkY) wdusrIppfaq;jcif;
(verification) (odkY) 2rsKd; pvHk;udkvkyfaqmifay;&rnf/ xdkYtjyif
wdkif;wmyHk pepf (measurement standards) pDppfjcif; (treaceability)
onf EdkifiHwum todtrSwfjyK (odkY) rdrdEdkifiHtvdkuf
wdkif;wmrI enf;pepfjzpf&rnf/ tu,fí txufyg (2)csufr&Sd ygu?
tajccHtoHk;jyK&ef (Calibration ESifh Verification) udk
rSwfwrf;xdef;odrf; xm;&rnf/ Clause 4.2.4
Thickness Measuring Devices
Customer Property for Calibration
Measuring Devices Calibration
Clause 8. Measurement, Analysis and Improvement
စစစစစ စစစ စစ စစစစစစစစစစတ��င�တစစ�ညအေ�ဆမ�� င��တ���တက�ညအေ�ကင��မနလ"��
Clause 8.1 GeneralPlan &
Implement
(Processes )Monitoring, Measurement, Analysis and
Improvement
To demonstrate
Conformity of Product Requirement
To ensure Conformity of QMS
To continually improve
Effectiveness of QMS
tzGJUtpnf;onf wdkif;wmjcif; (Measurement) ? pDppfcGJjcm;jcif; (Analysis) ESifh vkyfief;pOfrsm; wdk;wufrI jyKjcif; twGuf pDrHudef;a&;qGJjcif;? jznfhpGufjcif;wdkYudk vkyfaqmif&rnf/
xkwfukef\vkdtyfcsuftwdkif; pHcsdefrDaMumif; jyoEdkif&rnf/
(Quality Management System) pHcsdefpHnTef;rDaMumif; aocsmap&ef aqmif&Gufxm;&rnf/
QMS \ xda&mufrI tpOfwdk;wufap&efwdkYjzpfonf/
8.2 Monitoring and Measurement
စစစစစစစစ စစစစစစစညအေ�စငB�Cက.�'စ�ညအေ�ဆခင� င��တ���င�တမ��မ#
8.2.1 Customer Satisfaction - azmufonfrsm;\ 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.QMS \ vkyfaqmifcsufudk wkdif;wmjcif;wpfckjzpfaom azmufonfrsm;\ xifjrif ,lqcsuf (Customer Perception) ESifhqdkifaom owif;tcsuftvufrsm;udk tzGJUtpnf;onf BuD;Muyf uGyfuJ&rnf/ ,if;owif;tcsuftvufrsm;udk&&Sd&efESifh tokH;jyK&ef enf;vrf;rsm;udkqkH;jzwfay;&rnf/ QMS onf azmufonfrsm;\ vdktyfcsufESifhudkufnDatmif vkyfaqmifEdkifrI &Sdr&Sdudk BuD;Muyf &rnf/
8.2 (Monitoring & Measurement) uGyfuJjcif;? wdkif;wmjcif; 8.2.1 azmufonfrsm;\ pdwfauseyfrI (Customer Satisfaction)
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.
rSwfcsuf/ / azmufonfrsm;\xifjrif,lqcsuf (Customer Perception)
uGyfuJjcif;vkyfaqmif&mwGif? t"dut&if;tjrpfjzpfaom
azmufonfrsm;u avhvmjcif;?o,faqmifaom xkwfukef\
t&nf taoG; ESifhqdkifaom (Customer data) tcsuftvufrsm;
toHk;jyKol\xifjrifcsufavhvmjcif;?
qHk;½HI;oGm;aompD;yGm;a&;udkpDppfjcif;
(Analysis)? jynfhpHkrIjyKjcif; (Compliment) ? uwdjyKrI
ay;jcif; (Warranty claims) ESifh udk,fpm;vS,frsm; (dealer
report) \ wifjyrIwdkY yg0if&rnf/
8.2.2 Internal Audit စစစစစစစစစစစစစစစစစလ�ပပ<န �သြတင�စရင�စစ�ညအေ�ဆခင�
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.
8.2.3 Monitoring and Measurement of Processes
The organization shall apply suitable methods for monitoring and, where applicable, measurement of the QMS processes.
အဖြ���႕အစည�တြ�င�QMS အာအာအာအာအာအာအာအာ အာအာအာ အာအာအာအာအာ အာ အာအာအာအာအာအာအာ အာအာအာ အာအာအာအာလ�ပ န �စဥက#�$����င��ရန � ေင&�� ေေ�စင&နလ�Lကည&��စစ�ေ� အာ အာအာ အာအာ အာ အာအာအာအာအာအာအာအာအာအာအာအာ အာအာအာအာအာ အာအာအာအာအာအာအာအာအာအာ အာ အာအာအာအာအာအာအာအာအာအာအာအာဆရန �အတြ�က�သ����< သနည�လမ�မ5က��အသ��ပ�ရမည�။
These methods shall demonstrate the ability of the processes to achieve planned results.
Processes အာအာအာအာအာအာအာအာ အာအာအာအာအာအာအာအာအာအာ အာအာ အာအာအာအာအာအာအာအာအာအာအာအာ မ5၏�စမ�ဆင*ညမ>5သည�ခ5မ��< သ Plan results အာအာအာအာအာအာအာအာအာအာအာအာ အာအာအာအာအာ အာအာအာအာအာအာအာ အာ အာအာအာအာအာအာအာ အာအာအာအာအာ အာ အာအာမ5အ���င� ေေ�အင�� မင����ရရ��င*န �နည�လမ�မ5သ�����ေ�ဖြပ ေေ� ပထရမည�။
8.2.3 Monitoring and Measurement of Processes Cont’
When planned results are not achieved, correction and
corrective action shall be taken, as appropriate.
Plan results အာ အာအာအာအာအာအာအာအာအာအာအာအာအာအာ အာအာအာအာအာအာအာ အာအာအာအာ မ5 ေမအင�� မငJကအမ�ပင/င�ေ�ဆငရြင*က�� ခင�(CAR) ေ� ဖြင&�� ေေ�ဆငရြင*က*မည�။
8.2.4 Monitoring and Measurement of ProductThe organization shall monitor and measure the characteristics of the product to verify that product requirements have been met.
အာအာအာအာအာအာအာအာအာ အာအာအာအာအာအာအာအာ အစြဖြ�႕အစည�သည�မ�မ����႕၏ထ��# $န � (Products) အာ အာအာ အာအာအာအာအာအာအာအာ အာ အာအာအာအာအာ ေင&��သက/ $��င�ေ�သအခ5က- အာ အာအာအာ အာအာအာအာအာအာအာအာ အာ အာအာအာအာအာအာအာ အာအာအာအာအာအာအာအာအာ အာအာအာအာအာအာအာ အာ အာအာအာအာအာအာအာအာအာအာအာလက�5င&��အရေညမWတြသက�� ေေ�စင&နလ�Lကည&�Oစ�ေ�ဆမ�$မ5 ေ� ပ�လ�ပ*မည�။
This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements (see 7.1). Products အာ အာ အာအာအာအာအာအာအာအာအာအာအာအာ �F��င&�� သက/ �$င�ေ�သလ�ပ န �စဥက�5၏အဆင&နအ�4X$��င�က�� plan အာ အာအာအာ အာအာအာအာအာအာအာအာအာမ5၊အစ(အစဥက�5ဖြ
င&�� ခ5မ���ေ�ဆငရြင*က*မည�။Evidence of conformity with the acceptance criteria shall be maintained.
အာအာအာအာအာအာအာအာအာအာအာ အာအာအာအာအာအာအာ အာအာအာအာအာ အာအာအာအာအာအာအာအာအာ အာအာအာအာအာအာအာအာအာအာ အာ အာအာအာ အာအာအာအာအာအာအာအာ အာ အာအာအာအာအာအာအာ အာအာအာအာလက6�င�ေ�သစ�ခ5�,O�ညန �မ5 ေင&��ထ��# $န �၏က���ကG (မ��အရေညမWတြသက��သ�����ေ�ဖြပထရမည�။
8.2.4 Monitoring and Measurement of Product Cont’
Records shall indicate the person(s) authorizing release of product for delivery to the customer (see 4.2.4).
က�န �ေ�ခ5ပစၥည�က��customer ဆ(သ��႕ လပင�ပခင�၊container အာ အာအာ အာအာ �င�� ခင�မ5အတြ�က� အာအာအာအာအာအာအာအာအာအာအာအာအာအာအာအာအာ အာအာအာအာအာအာအာအာအာအာအာ အာအာအာအာအာအာအာအာအာအာအာအာအာအာအာအာအာအာ�ဝ,YတြRလပင�ပမည&��ပ�ဂလ- မ��4 မ�ထရ��ရန �။
The release of product and delivery of service to the customer shall not proceed until the planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer.
Product လပင�ပခင�င&�� customer အာ အာအာအာ အာအာအာအာအာအာအာအာအာအာအာအာ ဆ(သ��႕ ေေ� ပပ��႕ ခင�မ5အတြ�က�အစ(အစဥက�5ဖြင&�� အာ အာအာ အာအာအာအာအာအာအာအာအာအာအာအာအာအာအာအာအာအာအာအာ အာ အာ အာအာအာ အာအာအာအာအာအာအာအာအာအာအာအာအာအာအာအာအာ ေ�ဆငရြင*က6�T� ပ(သက/ $��င*ပ�ဂလ�5၏အ�ည�� ပ�ခ5က�ရရ��ခ�&ပက co., ltd အ အာအာအာအာအာအာအာ အာအာအာအာအာ အာ အာအာအာအာအာအာအာ အာအာအာအာအာ တြ�က� မ�တြယမင�သလ�ပ�ေ�ဆင��� ေ� ဖြစ;တြည&နအ�-[0ပင� customer �F��င&�� ပ�; က�ေ�သ အက5�� အ မ��� အနည�ခင�မ5 ေ� ဖြစ�ေ�ပၚငJသည�။
8.3 Control of Nonconforming Product
To prevent its unintended use or delivery.
A documented procedure to define the controls and related
responsibilities and authorities for dealing with nonconforming
product. (u) y,fzsufxm;aom pHcsdefrrD xkwfukefrsm; pGefYypfjcif;udk vkyfaqmifjcif; (c) ,if;pHcsdefrrD xkwfukefudk toHk;jyKrvm;? xkwf,lcGifhjyKrvm;? vufcHrvm; qdkwmudk oufqdkif&m wm0ef&Sdol (odkY) azmufonfrS vufcHvQif cGifhjyKjcif; jyKEdkifonf/ (*) pHcsdefrrDaomxkwfukeffrsm;[ko,faqmiftoHk;jyKNyD;rSod&Sdygu?,if;xkwfukef\jypfcsufrsm; (odkU) jzpfEdkifacs jypfcsufrsm; udkoifhavsmfovdk ta&;,lvkyfaqmif& rnf/
tu,fí pHcsdefrrSDaom xkwfukefrsm; (Non-conformity
product) jyefvnfjyKjyif rGrf;rHNyD; ygu ,if;udk vdktyfcsuf twdkif; jynfhrD jyo&ef jyefvnfppfaq;rIrsm; jyKvkyf&rnf/
8.4 Analysis of Data Cont’- The analysis of data shall provide information relating to
Data analysis အာအာအာအာအာအာအာအာအာအာက�� ေေ�ဆငရြင*က*တြ�င� ေေ�အကJအခ5က�5ပဝင*မည�။a) Customer Satisfaction (see 8.2.1),
အာအာအာအာအာ အာအာအာအာအာအာအာအာ အာ စသ��သ�မ5၏စ���ေ�က5နပ���။(products & service)
b) Conformity to Product Requirements (see 8.2.4),
အာအာအာအာအာအာအာအာအာအာအာအာအာအာအာအာ အာအာအာအာ အာအာအာအာအာအာအာအာအာအာအာက�,Jစၥည�အတြ�က�က���ကG (မ��ရ��ေ�သလ���အပ65က�5။c) Characteristics and trends of processes and products, including
opportunities for preventive action (see 8.2.3 and 8.2.4), and
အာအာအာအာ အာအာအာအာအာ အာအာအာအာအာအာအာအာအာအာအာအာ အာအာအာအာအာအာအာအာအာအာၾက���င#တြကယမ�� ခင�မ5ဆငရြင*က*နအ,-တြတြ�က�လ��အပ�ေ�သလ�ပ န �စဥက၊�က�,Jစၥည� အာအာအာအာအာအာအာ အာအာ အာ အာအာအာအာအာအာ အာအာအာအာအာအာအာမ5င&��ပ�; က�ေ�သအခ5က- လက�5။d) Suppliers (see 7.4).
က�,Jစၥည�ပတြသင�သ�မ5။
8.5 Improvement စ စစ စစစ စစ စစစစစစစစစစတ��တက"��အသြတက�ညအေ�ဆငခြင5က!#က�
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
8.5.2 Corrective ActionTo eliminate the causes of nonconformities in order to prevent reoccurrence.
-appropriate to the effects of the nonconformities encountered.-NC အာအာ အာအာ အာအာအာအာအာအာအာအာအာအာအာအာအာ အာအာ အာအာအာအာအာအာအာအာအာအာအာအာအာအာအာအာ မ5 ေေ�နက4 နအစLက�မ� ေ� ဖြစ�ေ�ပၚ ခင�မ�ကတြကယမ�င*နအ,-တြတြ�က�မက��ကG (မ��မ5၊NC ေ� ဖြစ�ေ�ပၚရျ0
ခင� ေအၾကင�ရင�မ5က�� ေေ�ဖြထ���ေ�� ဖြရ�င�ရမည�။
Corrective Action Cont’
A documented procedure shall be established to define requirements for
a) Reviewing nonconformities (including customer complaints),
NC မက��ကG (မ��မ5က�� ေ� ပ,2ညမS�$သပ*န �။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.
8.5.3 Preventive Actionto 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 define
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.
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
Thank You!Daw Phyu Phyu Win(Managing Director)
No. 146, 1st Floor, 47th StreetBotahtaung Township
Yangon MyanmarTel: 01-9000377-9, 202401
E-mail: [email protected]@isomyanmar.com
Website: www.isomyanmar.com
