PROGRAM KONSULTANSI

ISO 9001:2008 BERSAMA MBAS RABU, 4 FEB 2015

BAHAGIAN 1: Kesedaran Kepada

Pelaksanaan MS ISO 9001:2008

Che Azlan Taib

Universiti Utara Malaysia

What is ISO & ISO 9000 ?

ISO Perkataaan ISO bukanlah singkatan (akronim) untuk

International Standardization Organization…. Tetapi

adalah International Organisation for Standardisation

(yang mana seharusnya menjadi IOS). Sebenarnya

perkataan ‘ISO’ diambil dari perkataan Greek ‘isos’ yang

bermaksud ‘sama’ atau ‘setanding’ (equal). Dari

perkataan ‘sama/setanding’ kepada ‘standard’, perkataan

‘ISO’ dipilih sebagai nama gelaran untuk organisasi

tersebut.

Dibentuk tahun 1947, terdiri daripada Jawatankuasa

Teknikal dan Kumpulan Kerja (Working Group) bagi tujuan

membentu sesuatu standard.

ISO 9000 Satu set standard antarabangsa ( merangkumi koleksi

standard-standard antarabangsa, Spesifikasi Teknikal,

laporan Teknikal, Handbook) bagi pengurusan kualiti dan

pemastian kualiti.

Ia menetapkan dan menerangkan elemen-elemen asas

yang perlu ada dalam sistem kualiti bagi

memastikan perkhidmatan yang diberikan dapat memenuhi

kehendak pelanggan.

Keseluruhan terdapat lebih kurang 25 dokumen (termasuk

dokumen baharu ataupun yang dikemaskini).

ISO Technical Committee (TC) 176 (ISO/TC 176) dan

jawatankuasa kecil bertanggungjawab membangun

sesuatu standard.

• If you don’t already have a quality management system (QMS), you can use this ISO 9001 standard to establish one.

• And once you’ve established your organization’s QMS, you can use it to demonstrate that your organization is capable of meeting customer requirements, enhancing customer satisfaction, and continually improving both its products and services and its practices and processes.

• According to ISO 9001, your QMS must meet every requirement if you wish to claim that it complies with this ISO standard. Every requirement is both generic and mandatory and may only be excluded if it cannot be applied.

• You may exclude or ignore a requirement only if doing so does not compromise your organization's ability or responsibility to ensure that its products and services are in compliance and only if you can justify and explain why you cannot apply it. In short, if a requirement can be applied it must be applied.

• However, how you choose to meet ISO's requirements, and to what extent, will depend on and be influenced by many factors.

• ISO 9001 is designed to be used for certification purposes.

• Once you’ve established a QMS that meets ISO's requirements and deals with your organization’s business process, you can ask a registrar (certification body) to audit your system.

• If you pass the audit, your registrar will issue an official certificate that states that your organization's QMS meets ISO's requirements.

• While ISO 9001 is designed to be used for certification purposes, you don’t have to become certified.

• You can be in compliance without being formally certified by an accredited certification body (registrar).

• You can self-audit your QMS and then announce to the world that it complies with the ISO 9001 standard (assuming that it actually does).

• Of course, your compliance claim may have more credibility in the marketplace if an independent certification body agrees with your assessment.

ISO membership falls into three categories:

Full member – is a national body designated by its respective country as the ‘most representative of standardization’. Most nations are represented by full members.

Correspondent member – a nation that does not have a standardization body.

Subscriber member – a small nation with a very small economy.

Only full members may participate in the development of standards.

ISO keeps correspondent and subscriber members informed about activities.

Semua standard yang diisu perlu dikaji semula setiap 5 tahun untuk menentukan samada standard akan dikekal/dipinda/dibatal. Mesti diadaptasi tidak lebih daripada 3 tahun selepas diterbitkan revisi baharu.

Protokol ISO

Bengkel (1) - ‘Ke Arah Perlaksanaan MS ISO 9000’

Penyediaan Dokumen

Bengkel (II)

Pindaan Prosedur Kualiti

Bengkel (III)

Kerja-kerja Pembetulan Prosedur Kualiti

‘Soft Launch’ Perlaksanaan MS ISO 9000

Kursus Audit Dalaman

‘Quality Assurance Auditor Training’

Latihan Kepada Kakitangan

Pembetulan Audit Kualiti Dalaman

Tindakan Pembetulan Hasil Audit Kualiti Dalaman

Adequacy Audit Oleh SIRIM

Compliance Audit Oleh SIRIM / Certified Body

Pengiktirafan Sijil MS ISO 9000 oleh SIRIM

Aktiviti

Tarikh

Bagaimana ??

• Latihan ISO 9000

• Lead Assessor

• Audit Dalaman

• Latihan ISO 9000

• Lead Assessor **

• Pendedahan Elemen ISO 9000

Pengurus Kualiti

Ketua Bahagian

Semua Staf

1

2

3

Perlu Memahami Business Process??

Kenapa ISO ??? TQM, ISO 9000 dan Daya

Saing Organisasi

ISO – Sistem Pengurusan Kualiti

“Sistem pengurusan untuk mengarah & mengawal organisasi dalam perkara yang berkaitan dengan kualiti”

...ISO 9000:2005

Sistem lazimnya merujuk kepada dokumentasi

Manual Kualiti Prosedur Kualiti/Manual Prosedur

Kerja Arahan Kerja/SOP Garis Panduan/Fail Meja Rekod Undang-Undang/Peraturan/Akta

Tujuan Utama

• Keyakinan & jaminan kepada pelanggan; keperluan dipenuhi secara konsisten.

• Jaminan kepada pengurusan atasan; perkhidmatan disedia & disampaikan mengikut perancangan keperluan yang ditetapkan.

• Fokus kepada pencapaian & peningkatan Kepuasan Pelanggan secara berterusan.

KEPERLUAN UNTUK KUALITI

PELANGGAN KEPASTIAN KUALITI (KUALITI

ASSURANCE)

SISTEM KUALITI Berasaskan ISO 9000

OUTPUT PROSES INPUT

DOKUMENTASI

• Manual Kualiti

• Prosedur • Arahan Kerja • Dokumen Sokongan • Tanggungjawab • Pihak berkuasa Kawalan Kawalan Verifikasi

• Perlaksanaan SPK ISO 9001 bersifat “sukarela”.

• Tertakluk kepada saranan Kerajaan Malaysia melalui Surat Pekeliling Kemajuan Pentadbiran Awam Bil.2 Tahun 2002.

• Tiada format khusus bagi tujuan penyediaan dokumen mengikut Standard ISO 9001:2008.

• Dinilai oleh Badan Profesional bagi tentukan keakuran SPK organisasi kepada Standard ISO 9001.

1. CB 01 SIRIM QAS International Sdn.Bhd. 2. CB 02 Intertek Certification International Sdn.Bhd. (formerly known as

Moody International Certification (M) Sdn.Bhd.) 3. CB 03 CI International Certification Sdn. Bhd. 4. CB 04 SGS (Malaysia) Sdn. Bhd. 5. CB 05 TUV NORD (Malaysia) Sdn. Bhd. 6. CB 06 Lloyd's Register of Shipping (M) Bhd. 7. CB 07 Independent European Certification (M) Sdn. Bhd. 8. CB 08 AJA EQS Certification (M) Sdn. Bhd. 9. CB 10 Bureau Veritas Certification (Malaysia) Sdn. Bhd. 10. CB 11 BM Trada (Malaysia) Sdn.Bhd. 11. CB 12 NQA Certification Services (M) Sdn. Bhd. 12. CB 13 CARE Certification International (M) Sdn. Bhd. 13. CB 14 AGM Certification Sdn. Bhd. 14. CB 15 KGS Certification Sdn. Bhd. 15. CB 16 BSI Services Sdn. Bhd. 16. CB 17 NIOSH Certification Sdn. Bhd. 17. CB 18 DQS Certification (M) Sdn. Bhd.

http://www.standardsmalaysia.gov.my/accreditation-of-certification-bodies-acb-/directory-of-acb

Siapa Menilai Badan Pensijilan (Badan Akreditasi)

Melalui Audit :

• Audit Dokumentasi (sekurang-kurangnya 3 bulan selepas perlaksanaan SPK ISO 9001)

• Audit Permatuhan (Audit Proserdur / Prosess/Aktiviti).

Mesti buktikan SPK ISO 9001 telah dilaksana & ketakakuran audit dokumentasi telah diambil tindakan

Persijilan

Melalui Audit –sepanjang tempoh sah persijilan – 3 tahun.

• Audit Pengawasan-“Surveliance Audit”(1 tahun).

• Audit Penilaian Semula-“Re-assessment Audit”(3 tahun).

Mesti buktikan SPK ISO9001 telah dilaksana & dikekalkan dengan akur & berkesan.

Penilaian Berterusan Badan Persijilan

Penggantungan/ Penarikan Semula/ Pembatalan Persijilan

Untuk respon & ambil tindakan ke atas ketidakakuran yang dilaporkan.

Untuk kekal pelaksanaan SPK berdasarkan keperluan Standard ISO 9001.

Pembayaran perkhidmatan Badan Persijilan Salahguna persijilan & logo Badan Persijilan /

Akreditasi.

Gagal memenuhi keperluan yang ditetapkan oleh Badan Persijilan, semasa audit pengawasan / audit penilaian semula:

• The purpose of this standard is to help organizations to meet all customer needs and expectations and to comply with all relevant regulatory and statutory requirements.

• Any organization can achieve these important objectives if it establishes a quality management system (QMS) and if it continually tries to improve the suitability, adequacy, and effectiveness of this system.

• A quality management system (QMS) is a set of interrelated or interacting elements that organizations use to formulate quality policies and quality objectives and to establish the processes that are needed to ensure that these policies are followed and these objectives are achieved.

TQM, ISO 9000 dan Daya Saing Organisasi

• MS ISO 9000 ada susulan kepada pengurusan kualiti secara menyeluruh dalam revolusi kualiti yang berterusan;

• Pelaksanaan MS ISO 9000 akan membolehkan organisasi meneruskan usahanya ke arah meningkatkan lagi kualiti perkhidmatan yang diberi;

• Pencapaian MS ISO 9000 akan merupakan satu pengiktirafan bagi setiap ORGANISASI serta meningkatkan imejnya di kalangan agensi-agensi sektor awam.

• Pelaksanaan MS ISO 9000 akan membolehkan organisasi mengintegrasikan tanggungjawab pengurusan, struktur organisasi, proses, prosedur dan sumber-sumber yang ada padanya;

• Pencapaian MS ISO 9000 akan memberi kepercayaan kepada kakitangan organisasi apabila mereka memberi perkhidmatan kepada pelanggan

• Mengelakkan penyelesaian masalah dan pengurusan organisasi yang berbentuk 'fire-fighting‘.

• Tugas dan tanggungjawab setiap pegawai adalah jelas.

Malaysia and Competitiveness

COUNTRIES 2013 2012

RANK VALUE RANK VALUE

Singapore 1 89.86 1 95.92

Malaysia 2 83.15 2 84.22

Thailand 3 72.97 3 69.00

Philippines 4 63.15 5 59.27

Indonesia 5 61.81 4 59.50

COMPETITIVENESS RANKINGS BY

ASEAN REGION

Pendekatan TQM

Pengurusan Kualiti Menyeluruh melibatkan penglibatan komitmen kakitangan daripada pelbagai peringkat dalam organisasi bagi mengeluarkan produk yang berkualiti.

Pengurusan Kualiti Menyeluruh mempercayai semua kakitangan dalam organisasi adalah pelanggan. Kakitangan yang menerima proses seterusnya dianggap sebagai pelanggan.

Pengurusan Kualiti Menyeluruh atau Total Quality Management (TQM) diperkenalkan sejak tahun-tahun 1920-an lagi apabila kaedah statistik digunakan dalam pengawalan kualiti di kilang-kilang di Amerika Syarikat.

TQM memberi fokus kepada peningkatan proses dan kekuatan kemudahan dan kepakaran semua peringkat kakitangan.

TQM menggunakan teknik statistik sebagai jalan penyelesaian masalah.

Begitu juga konsep peningkatan berterusan menjadi keutamaan semua ahli organisasi. Konsep ‘self inspection’ bagi mencapai kualiti produk dan perkhidmatan yang tinggi dalam operasi mereka. Keperluan utama dalam fasa ini ialah penglibatan kakitangan dan kerja berpasukan.

• ISO standards provide solutions and achieve benefits

for almost all sectors of activity, including agriculture,

construction, mechanical engineering, manufacturing,

distribution, transport, healthcare, information and

communication technologies, the environment, energy,

safety and security, quality management, and services.

• ISO only develops standards for which there is a clear

market requirement.

• The work is carried out by experts in the subject drawn

directly from the industrial, technical and business sectors

that have identified the need for the standard, and which

subsequently put the standard to use.

• These experts may be joined by others with relevant

knowledge, such as representatives of government

agencies, testing laboratories, consumer associations and

academia, and by international governmental and

nongovernmental organizations.

In a nutshell, the ISO 9001 standard addresses

quality management and requires companies to

establish a quality management system (QMS) in

order to fulfil the following goals:

• meet customer quality requirements

• meet applicable regulatory requirements

• enhance customer satisfaction

• and, achieve continual improvement of its

performance in pursuit of these objectives through

Plan Do Check Act.

Evaluasi ISO 9001

1. 1987 version – ISO 9000:1987

• Had the same structure as the UK Standard BS 5750, with three 'models' for quality management systems, the selection of which was based on the scope of activities of the organization.

• ISO 9000:1987 was also influenced by existing U.S. and other Defence Standards ("MIL SPECS"), and so was well-suited to manufacturing. The emphasis tended to be placed on conformance with procedures rather than the overall process of management, which was likely the actual intent.

The three 'models' :

3. ISO 9003:1987 Model for quality assurance in final inspection and test covered only the final inspection of finished product, with no concern for how the product was produced.

1. ISO 9001:1987 - Model for quality assurance in design, development, production, installation, and servicing was for companies and organizations whose activities included the creation of new products.

2. ISO 9002:1987 Model for quality assurance in production, installation, and servicing had basically the same material as ISO 9001 but without covering the creation of new products.

2. 1994 version – ISO 9000:1994

• As with the first edition, the down-side was that companies tended to implement its requirements by creating shelf-loads of procedure manuals, and becoming burdened with an ISO bureaucracy.

• ISO 9000:1994 emphasized quality assurance via preventive actions, instead of just checking final product, and continued to require evidence of compliance with documented procedures.

3. Version 2000– ISO 9001:2000

o The 2000 version sought to make a radical change in thinking by actually placing the concept of process management front and center ("Process management" was the monitoring and optimizing of a company's tasks and activities, instead of just inspecting the final product).

• ISO 9001:2000 combined the three standards—9001, 9002, and 9003—into one, called 9001.

o The 2000 version also demanded involvement by upper executives in order to integrate quality into the business system and avoid delegation of quality functions to junior administrators.

o Another goal was to improve effectiveness via process performance metrics: numerical measurement of the effectiveness of tasks and activities. Expectations of continual process improvement and tracking customer satisfaction were made explicit.

4. Version 9001:2008

• ISO 9001:2008 only introduced clarifications to the existing requirements of ISO 9001:2000 and some changes intended to improve consistency with ISO 14001:2004. There were no new requirements. For example, in ISO 9001:2008, a quality management system being upgraded just needs to be checked to see if it is following the clarifications introduced in the amended version.

• The ISO 9000 standard is continually revised by standing technical committees and advisory groups, who receive feedback from those professionals who are implementing the standard.

5. Latest Version ??? •DIS 2014 • DIS (Draft International Standard) - not the final version. • According to ISO, the final version of the standard will be

published in September of 2015.

• ISO 9001 was first published in 1987, updated in 1994, and again in 2000 and 2008.

• This current (rough) draft version was published in July of 2014 and is the fifth edition of the ISO 9001 standard.

• Once the final version is published, it will officially cancel and replace all previous editions.

• ISO DIS 9001 2015 is a quality management standard. It defines a set of quality management requirements. These requirements can be found in the following seven sections:

• Scope

• Normative references

• Terms and definitions

• Context

• Leadership

• Planning

• Support

• Operations

• Evaluation

• Improvement

SEJARAH PELAKSANAAN STANDARD MS ISO 9001:2008 DALAM SEKTOR AWAM

• Bermula sejak tahun 1996 melalui Pekeliling Kemajuan Pentadbiran Awam (PKPA) Bil. 2 Tahun 1996 bertajuk “Garis Panduan Bagi Melaksanakan MS ISO 9000 Dalam Perkhidmatan Awam”, bertarikh 11 Julai 1996.

– Berasaskan salah satu pensijilan berikut iaitu MS ISO 9001 atau

MS ISO 9002 atau MS ISO 9003 versi 1994.

• Selaras dengan penambahbaikan standard oleh ISO dalam tahun 2000, pelaksanaan standard MS ISO 9000 di Agensi-Agensi Sektor Awam Malaysia telah beralih kepada pensijilan MS ISO 9001:2000.

• Arahan peralihan kepada pensijilan MS ISO 9001:2000 telah dikeluarkan melalui Surat Pekeliling Kemajuan Pentadbiran Awam (SPKPA) Bil. 2 tahun 2002 bertajuk “Garis Panduan Bagi Melaksanakan MS ISO 9000:2000 Dalam Perkhidmatan Awam”, bertarikh 16 Disember 2002.

• Oktober 2008, ISO telah mengeluarkan Standard ISO 9001:2008 yang merupakan penambahbaikan kepada standard ISO 9001:2000.

• Penambahbaikan ini meliputi penerangan dan penjelasan yang lebih terperinci terhadap beberapa keperluan standard tertentu.

• Jabatan Standard Malaysia telah mengeluarkan Standard MS ISO 9001:2008 untuk diterima pakai oleh semua organisasi di Malaysia termasuk agensi-agensi Sektor Awam.

• Semua pensijilan berasaskan MS ISO 9001:2000 luput pada akhir tahun 2010.

• Agensi-Agensi Sektor Awam dikehendaki mengambil salah satu tindakan berikut:

a. Agensi yang telah mendapat pensijilan MS ISO 9001:2000, agensi berkenaan dikehendaki beralih kepada pensijilan MS ISO 9001:2008 selewat-lewatnya pada akhir tahun 2010 bagi mengekalkan status pensijilan ISO;

b. Agensi yang belum mendapat pensijilan MS ISO

9000:2000, agensi berkenaan dikehendaki untuk terus

mendapatkan pensijilan mengikut standard MS ISO

9001:2008;

• Pembentukan Standard ISO 9000 dan Model pendekatan Proses

A standard is a document that provides requirements, specifications, guidelines or characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their purpose.

ISO has published over 19 000 International Standards that can be purchased from ISO or its members

Standards What is a standard?

International Standards bring technological, economic and societal benefits.

They help to harmonize technical specifications of products and services making industry more efficient and breaking down barriers to international trade.

Conformity to International Standards helps reassure consumers that products are safe, efficient and good for the environment.

Benefits of International Standards...

International Standards are strategic tools and guidelines to help companies tackle some of the most demanding challenges of modern business.

They ensure that business operations are as efficient as possible, increase productivity and help companies access new markets.

For business

Benefits include: Cost savings - International Standards help optimise operations and therefore improve the bottom line Enhanced customer satisfaction - International Standards help improve quality, enhance customer satisfaction and increase sales Access to new markets - International Standards help prevent trade barriers and open up global markets Increased market share - International Standards help increase productivity and competitive advantage Environmental benefits - International Standards help reduce negative impacts on the environment

Dr Che Azlan Taib - STML

ISO 31000 Risk management ISO 9000 Quality management ISO 26000 Social responsibility ISO 14000 Environmental management ISO 50001 Energy management ISO 3166 Country codes ISO 4217 Currency codes

Popular standards

28-01-2015 62

How does ISO develop standards?

An ISO standard is developed by a panel of experts, within a technical committee.

Once the need for a standard has been established, these experts meet to discuss and negotiate a draft standard.

As soon as a draft has been developed it is shared with ISO’s members who are asked to comment and vote on it.

If a consensus is reached the draft becomes an ISO standard, if not it goes back to the technical committee for further edits.

Key principles in standard development

ISO does not decide when to develop a new standard. Instead, ISO responds to a request from industry or other stakeholders such as consumer groups. Typically, an industry sector or group communicates the need for a standard to its national member who then contacts ISO. Contact details for national members can be found in the list of members.

1. ISO standards respond to a need in the market

ISO standards are developed by groups of experts from all over the world, that are part of larger groups called technical committees. These experts negotiate all aspects of the standard, including its scope, key definitions and content.

2. ISO standards are based on global expert opinion

3. ISO standards are developed through a multi-stakeholder process

4. ISO standards are based on a consensus

The technical committees are made up of experts from the relevant industry, but also from consumer associations, academia, NGOs and government.

• Developing ISO standards is a consensus-based approach and comments from stakeholders are taken into account.

Stages of the development of International Standards

• The first step is to confirm that a particular International Standard is needed. A new work item proposal (NP) is submitted for vote by the members of the relevant TC or SC to determine the inclusion of the work item in the programme of work. The proposal is accepted if a majority of the P-members of the TC/SC votes in favour and if at least five P-members declare their commitment to participate actively in the project. At this stage a project leader responsible for the work item is normally appointed.

1) Proposal stage

• Usually, a working group of experts, the chairman (convener) of which is the project leader, is set up by the TC/SC for the preparation of a working draft. Successive working drafts may be considered until the working group is satisfied that it has developed the best technical solution to the problem being addressed. At this stage, the draft is forwarded to the working group's parent committee for the consensus-building phase.

2) Preparatory stage

3) Committee stage

• As soon as a first committee draft is available, it is registered by the ISO Central Secretariat. It is distributed for comment and, if required, voting, by the P-members of the TC/SC. Successive committee drafts may be considered until consensus is reached on the technical content. Once consensus has been attained, the text is finalized for submission as a draft International Standard (DIS).

4) Enquiry stage

• The draft International Standard (DIS) is circulated to all ISO member bodies by the ISO Central Secretariat for voting and comment within a period of five months. It is approved for submission as a final draft International Standard (FDIS) if a two-thirds majority of the P-members of the TC/SC are in favour and not more than one-quarter of the total number of votes cast are negative. If the approval criteria are not met, the text is returned to the originating TC/SC for further study and a revised document will again be circulated for voting and comment as a draft International Standard.

5) Approval stage

6) Publication stage

• The final draft International Standard (FDIS) is circulated to all ISO member bodies by the ISO Central Secretariat for a final Yes/No vote within a period of two months. If technical comments are received during this period, they are no longer considered at this stage, but registered for consideration during a future revision of the International Standard. The text is approved as an International Standard if a two-thirds majority of the P-members of the TC/SC is in favour and not more than one-quarter of the total number of votes cast are negative. If these approval criteria are not met, the standard is referred back to the originating TC/SC for reconsideration in light of the technical reasons submitted in support of the negative votes received

• Once a final draft International Standard has been approved, only minor editorial changes, if and where necessary, are introduced into the final text. The final text is sent to the ISO Central Secretariat which publishes the International Standard.

Kes Malaysia - DSM

Request for new

standards

ISC approval

of NP Funding

Draft Malaysia

Std

Issue for public

comment

Review public comment

ISC Acceptance of final draft

Verification by Standards Malaysia

Approval by

MOSTI Minister

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Dr Che Azlan Taib - STML 28-01-2015 70

Dr Che Azlan Taib - STML 28-01-2015 71

72

Overview of the ISO 9000 Family of Standards

Attribute ISO 9000 Family ISO 9000 ISO 9001 ISO 9004

Purpose To assist organizations operate effective QMS.

To facilitate common understanding of the concepts and language used in the family of standards.

To provide and equitable basis for assessing the capability of organizations to meet customer and applicable regulatory requirements.

To assist organizations to satisfy the needs and expectations of all interested parties.

Intent To facilitate mutual understanding in national and international trade and help organizations achieve sustained success.

To be used in conjunction with ISO 9001 and ISO 9004

To be used for contractual and certification purposes

To assist organizations purpose continual improvement. It is not intended as a guide to meeting the requirements of ISO 9001.

73

Attribute ISO 9000 Family

ISO 9000 ISO 9001 ISO 9004

Scope The management of quality

Defines the principles and fundamental concepts and terms used in the ISO 9000 family

Defines the requirements of a QMS, the purpose of which is to enable organizations to continually satisfy their customers.

Provides guidelines for improving the performance of organizations and enabling them to satisfy all interested parties.

Appli-cability

Applies to all organizations regardless of size or complexity

Applies to all terms used in the ISO 9000 family

Applies where an organization needs to demonstrate its ability to provide products and services that meet customer and regulatory requirements and aims to enhance customer satisfaction.

Applies to organizations seeking guidance on developing QMS and improving their performance

Facts and Figures

3 standards 81 definitions 8 sections, 51 clauses, more than 250 requirements

8 sections, 64 clauses

74

Certification Time Line (Ghant Chart) (Example)

Training

Documents Development

Implementation (At Least 2 months)

Internal Audit

Management Review

Meeting

Adequacy Audit

Compliance Audit

Certified (Valid for 3 years)

Surveillance Audits (Second and Third Year)

Re-Assessment Audit (Fourth Year)

Activities

2015

Indicator:

J F M A M J J O S

Plan Actual

PRINSIP PENGURUSAN KUALITI MS ISO 9001:2008

• Prinsip pengurusan kualiti berasaskan standard MS ISO 9001:2008 adalah bersamaan dengan prinsip pengurusan kualiti berasaskan standard MS ISO 9000 iaitu berteraskan kepada lapan prinsip:

Prinsip-Prinsip Pengurusan Kualiti

Tumpuan Kepada

Pelanggan

SPK seharusnya dapat memenuhi kehendak pelanggan

dan berupaya memacu agensi untuk menyampaikan

perkhidmatan melebihi

Kepimpinan Pengurusan atasan hendaklah merancang dan

menentukan kualiti perkhidmatan agensi dan

mengamalkan pengurusan strategik dalam menetapkan

hala tuju agensi.

Penglibatan Anggota Agensi

Sumber terpenting agensi harus dilibatkan dalam usaha

meningkatkan prestasi agensi melalui program

pembangunan kompetensi dan penyediaan saluran

komunikasi yang berkesan.

Pendekatan Proses Mengenal pasti input dan proses transformasi input-input berkenaan pada output, outcome dan keberhasilan yang dikehendaki dan ditetapkan.

Pengurusan Yang Mengamalkan Pendekatan Sistem

Mengenal pasti dan mengurus dengan berkesan proses-proses kerja dalam organisasi yang ada hubung kait antara satu sama lain bagi mencapai objektif agensi.

Penambahbaikan Secara Berterusan

Merancang dan menambah baik secara berterusan SPK berasaskan penganalisaan pencapaian dasar dan objektif kualiti, penemuan audit, tindakan pembetulan dan pencegahan serta kajian semula pengurusan.

Pendekatan Membuat Keputusan Berasakan Fakta

Membuat keputusan dengan tepat dan betul berkaitan SPK berdasarkan penganalisisan data dan maklumat.

Hubungan Dengan Pembekal Untuk Faedah Bersama

Menwujudkan hubungan baik antara agensi dengan pembekal bagi mendatangkan kebaikan kepada kedua-dua pihak dalam mencapai objektif kualiti.

Kefahaman Asas

Klausa Standard ISO 9001:2008

Dasar Kualiti

ObjektifKualiti

Prosedur Kualiti

Rekod-rekod Kualiti

Perlantikan Jawatankuasa Kualiti MBAS

• Pengerusi

• Ahli-ahli (Ketua Bahagian)

Bidang Tugas Jawatankuasa Kualiti MBAS

– Memantau status dan kemajuan inisiatif perlaksanaan ISO 9000

– Mengenal pasti, menyelaras dan memperuntukkan sumber-sumber yang diperlukan dalam pelaksanaan sistem kualiti.

– Menentukan sistem kualiti difahami oleh semua warga dan dipatuhi di setiap proses kerja

– Membantu dan menyokong bagi melicinkan penerimaan dan pematuhan ke atas sistem kualiti

– Mengenal pasti mereka yang bertanggungjawab menyediakan manualkualiti, prosedur kualiti dan arahan kerja

Bidang Tugas Jawatankuasa Kerja / Pelaksana

• Mendefinisikan proses-proses dan prosedur-prosedur

• Membantu menyediakan prosedur

• Menyediakan maklumat berkaitan latihan dan penyediaan dokumen

• Menyediakan input kepada jadual perjalanan projek

• Memastikan bersedia untuk audit dalam

• Membentuk kumpulan kecil kerja untuk menyediakan manual, prosedur dan arahan kerja

• Menentukan struktur atau format dokumen yang akan disediakan

• Menyemak dokumen yang telah disediakan

• Menentukan dokumen tersebut mematuhi piawaian ISO 9000

• Mengenal pasti dan mendapatkan sumber-sumber yang diperlukan

Memahami maksud pensijilan ISO 9001:2008. Memahami kenapa pensijilan tersebut perlu. Memahami Dasar Kualiti, Objektif Kualiti dan skop

pensijilan. Memastikan anda telah mendokumenkan tugas-

tugas anda. Semak fail meja, carta aliran tugas dan dokumen-

dokumen yang berkaitan dengan tugas anda. Jika anda terlibat dengan prosedur kualiti ISO

9001:2008, dapatkan prosedur kualiti yang terkini.

Apa Peranan Anda

Kenalpasti langkah-langkah yang berkaitan dengan tugas anda.

Laksanakan langkah-langkah tersebut sebagaimana yang telah digariskan.

Simpan rekod-rekod yang berkaitan untuk diaudit. Menunjukkan rekod-rekod kualiti kepada pegawai

audit apabila diminta.

Rumusannya

• Komitmen Pengurusan Atasan • Penubuhan Jawatankuasa/Pasukan Pelaksana. • ProgramKesedaran&Kefahaman. • Dokumentasi&AuditDokumentasi(“stage1

audit”). • Pelaksanaan. • Audit Pematuhan/Persijilan(“stage 2 audit”). • Mengekalkan Perlaksanaan & Persijilan.

Langkah lazim untuk membangun, melaksana & mengekalkan SPK ISO9001:2008.

SEKIAN

Che Azlan Taib c.azlan@uum.edu.my

0194740666