Memahami Standard 1

8/9/2019 Memahami Standard 1

1/19

02/15/15 1

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!


3/19

02/15/15"

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 !"!&


4/19

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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.


5/19

02/15/155

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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02/15/15

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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02/15/15

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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02/15/158

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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02/15/15=

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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02/15/1510

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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02/15/151*

&erkara ang Boleh $e'udahkan udit

Keselesaan uditor D &engangkutan

Bilik perbincangan/rehat auditor

$akanan

&engiring 4e'pat pengauditan


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02/15/1515

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


19/19

Memahami Standard 1

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