Post on 01-Jun-2018
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MEMAHAMI KEPERLUANSTANDARD MS ISO 9001:2000
Disampaikan oleh
MOHD NOR USOP
Lead Auditor
IRCA
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Klausa 8
Beri perhatian lebih
kepada Klausa 8
Bezakan Correction
dengan Corrective
action (8.5.2
Corrective ction!
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Semangat MKSP 12
#ntegrasikan $K%& dengan
'esuarat pengurusan serta
'esuarat)'esuarat lain– Hasil
perbincangan/keputusanmesyuarat pengurusan danmesyuarat-mesyuarat lainmenjadi bahan input kepadaMKSP (laporan yang perlu
dibentangkan mengikut StdISO !"!#$
– %umusan Minit mesyuaratMKSP mesti ditulis mengikutStd ISO !"!&
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Semangat MKSP 22
!"#"$ Review output The output from the
management review shallinclude any decisions andactions related to
a) improvement of theeffectiveness of the qualitymanagement system and its
processes,b) improvement of product
related to customerrequirements, and
c) resource needs.
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Re%&' Kual(t(
&rosedur pengendalianrekod hendaklah
'e'atuhi peraturan+undang)undang+ arahandan dasar Kera,aan angberkaitan denganpengurusan rekod.
$enga-al rekod/ail sulit
'engikut prosedur angditetapkan (ail hi,au) %td#% *.2.*!
o rekod kaunseling
o rekod peperiksaan
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Ka)alan D&%umen 'an Re%&'
$enga-al doku'en kualitidan rekod seperti %td #%dan &K
abel 3%alinan 4erka-al 6ekodkan salinan
terka-al untuk 'enga-alpengedaranna
7oku'en usang dilabel3Batal
7oku'en luaran dika-al 4.2.3 e to ensure that
documents of externalorigin are identified andtheir distributioncontrolled
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Ka)alan D&%umen 'an Re%&'
$enga-al doku'enkualiti dan rekod
seperti %td #% dan &K &elupusan doku'en
dan rekod 'esti'engikut &ekeliling&elupusan ang sedia
ada 6ekod K9: "12 (;arta
$odal! disenggaradengan baik
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Ka)alan *emantauan
Menga)al *emantauan
'an *engu%u+ano &ersepsi &ela,ar terhadap
pensarah dan pencerapan
K< terhadap pensarah
ang 3ber'asalah
o &e'antauan/&engukuran
perlu di,alankan lebih kerap
daripada ang ditetapkan
dala' &K
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Ka)alan *emantauan
,"!"1 -&nt+&l &. *+&'u/t(&n an'
se+(/e *+&(s(&n
4he organization shall plan andcarr out production and
service provision under
controlled conditions.
Controlled conditions shall
include+ as applicablee! the i'ple'entation o
'onitoring and 'easure'ent+
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Keselamatan
1. &e'ada' api
diselenggara dan
sentiasa dala'
keadaan ang baik
(%td #% .5.5!
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Control o nonconor'ing product
36everi oleh pihakpengurusan se'ua aktiviti
organisasi ang dirancangtetapi tidak dapatdilaksanakan
8"$ -&nt+&l &. n&n/&n.&+m(ng *+&'u/t :hen nonconor'ing
product is corrected itshall be sub,ect to re)veriication tode'onstrate conor'itto the re>uire'ents.
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AUDIT ERSAMA MAMPU
Tum*uan
6ekod ? ail
&engu'pulan 'aklu'at ? nalisis &e'betulan+ &encegahan ?
&ena'bahbaikan
&ertingkatkan pengggunaan #C4 untuk
'e'bantu proses pengu'pulan dan
analisis data
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AUDIT ERSAMA MAMPU
@act or $th A
aanan baik C6/B% dikurangkanA
uditi terlalu banak bercakap lebih
banak lagi kele'ahan dikesanA
4idak boleh 'enoal auditor auditor
'arahA
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&erkara ang Boleh $e'udahkan udit
Keselesaan uditor D &engangkutan
Bilik perbincangan/rehat auditor
$akanan
&engiring 4e'pat pengauditan
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Re3u(+ements &. ISO 9001:2000Re3u(+ements &. ISO 9001:2000
4 5ual(t6 Management S6stem 7ene+al Re3u(+ements*.1 Eeneral re>uire'ents (identiication o business
processes!
*.2 Eeneral docu'entation re>uire'ents) Fualit $anual) Control o docu'ents
) Control o records
! Management Res*&ns((l(t6 7T;e Plan -lause
5.1 $anage'ent co''it'ent
5.2 Custo'er ocus
5." Fualit &olic ? Fualit b,ectives5.* &lanning
5.5 6esponsibilit+ authorit and co''unication
5. $anage'ent 6evie-
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# Res&u+/es Management 7T;e PLAN -lause/&nt(nue'
.1 &rovision o resources
.2 ;u'an resources
." #nrastructur
.* :ork 9nviron'ent
, P+&'u/tSe+(/e Real(sat(&n 7T;e DO -lause
.1 &lanning o product/service realisation
.2 Custo'er related processes
." 7esign and develop'ent.* &urchasing
.5 &roduction/service provision
. Control o 'onitoring and 'easuring devices
8 Measu+ement< Anal6s(s an' Im*+&ement 7T;e -HE-K
-lause8.1 Eeneral
8.2 $onitoring and 'easure'ent
8." Control o non)conor'ing product
8.* nalsis o data
8.5 Im*+&ement 7T;e A/t -lause
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Eight Quality Principles:Eight Quality Principles:
• Customer FocusCustomer Focus: understand, meet and strive: understand, meet and striveto meet customerto meet customer expectationexpectation
• LeadershipLeadership: established unity of purpose and direction: established unity of purpose and direction• Involvement of PeopleInvolvement of People: essence of an organisation: essence of an organisation• Process ApproachProcess Approach: activities and resources managed: activities and resources managed
as a processas a process• System Approach to ManagementSystem Approach to Management: manage interrelated: manage interrelated
process as a system process as a system• Continual improvementContinual improvement: permanent objective of the: permanent objective of the
organisationorganisation•
Factual approach to decision maingFactual approach to decision maing : effective: effectivedecision are based on data in the analysisdecision are based on data in the analysis• Mutually !eneficial supplier relationshipsMutually !eneficial supplier relationships::
interdependent and mutually relationshipinterdependent and mutually relationship
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' P%ISIP P)*+%+S,
Unit Pemodenan Tadbiran Dan Perancangan Pengurusan Malaysia
StandardMS ISO
9000:2000
STANDARD MS ISO
9001:2000
1. Tumpuan kepada pelanggan
2. Kepimpinan
3. Penglibatananggota organisasi
4. Pendekatanproses
5. Pengurusanberdasarkanpendekatan sistem
6.Penambahbaikanmenyeluruh
7. Pendekatanmembuatkeputusanberasaskan fakta
. !ubungan dgnpembekal untukfaedah bersama
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