Contoh Soalan Audit Iso 9001

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Inilah pembahasan selengkapnya mengenai contoh soal pelatihan iso 9001 2015. Admin blog Berbagi Contoh Soal 2019 juga mengumpulkan gambar-gambar lainnya terkait contoh soal pelatihan iso 9001 2015 dibawah ini. Inilah contoh soalan internal audit dan hal lain yang berhubungan erat dengan contoh soalan internal audit serta aspek K3 secara umum di Indonesia. UNE-EN ISO / IEC 17025 dan Audit Internal Laboratorium. Nota kursus audit dalaman Penemuan audit lepas MS ISO 9001:2015. Klausa 9.2: Audit Dalaman Audit dilaksanakan secara terancang berdasarkan kelulusan pengurusan Data-data pelanggan Audit susulan Standard IS09001Ð015, 1900:2014 Senarai semak KEMENTERIAN KESEJAHTERAAN BANDAR, PE-RUMAHAN DAN KERAJAAN TEMPATAN. Contoh soalan audit iso. Penerapan sistem mutu untuk pengujian laboratorium dan ISO 17025 kalibrasi, pelatihan, audit internal. Setifikasi ISO 9001. Jul 13, 2013 25 SIRI² ISO 9000 ISO 9000 Sistem Pengurusan Kualiti - Asas dan Perbendaharaan Kata ISO 9001 ISO 9004 ISO 19011 Garis panduan untuk Audit bagi Sistem Pengurusan Kualiti dan/atau Alam Sekitar Sistem Pengurusan Kualiti - Keperluan² Sistem Pengurusan Kualiti - Garis panduan untuk penambahbaikan dalam perlaksanaan 26.

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Internal Audit, ISO 9001:2015 clause 9.2, Audit program, audit frequency, audit method, auditors competency,audit scope and reporting, audit planning, Pretesh Biswas, APB Consultant.

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KURSUS AUDIT KUALITI DALAMAN

1

KURSUS AUDIT KUALITI DALAMANMS ISO 9001:2008olehMuhamad Bustaman b. Abdul Manaf

(Pensyarah Cemerlang DG 54) Institut Aminuddin Baki, KPM0199890524/mbustaman@iab.edu.mymbustaman@iab.edu.my

1Pengenalan Tajuk Kursus. Ini diikuti dengan pengenalan diri pengubal modul yang guru bagi kursus ini.Taklimat KursusPengenalan DiriJadual Kursus dan Kandungan KursusPeraturan Semasa Berkursusm bustaman/IAB/KPM/102

m bustaman/IAB/KPM/103BIODATA FASILITATOR MUHAMAD BUSTAMAN BIN HAJI ABDUL MANAFPensyarah Cemerlang DG 54, Instutut Aminuddin Baki, KPM

A. Pengalaman: Pengurus kursus Pengurusan Strategik dan Pengurusan Kualiti di Institut Aminuddin Baki semenjak 1995.1. Buku: 1. Pengurusan Kualiti dalam pendidikan 2. Perancangan Strategik

B. Latihan Profesionalisme dalam bidang Pengurusan Strategik dan Pengurusan Kualiti:

Latihan Luar Negara: i. Strategic Management & Leadership Skills: World Trade Institute, New York, USA (1996)Quality (TQM) in Education: SEAMEO Innotech, Manila (1998)Strategic Planning in Education: University of York, England (2000- 2004) iv. Strategy Performance Measurement Systems: U of Adelaide, Australia (2005)

C. Mempunyai sijil profesional Juruaudit (Lead Auditor) ISO 9000 sejak 1997 dan Sijil Kejurulatihan MS ISO 9000 dari MAMPU. Berpengalaman menjadi juruaudit bersama dengan MAMPU serta memberi konsultasi dalam pembinaan dokumen kualiti dan Audit Kualiti Dalaman .

D. Bidang kepakaran lain: Change Management, Benchmarking, Balanced Scorecard (KPI), Strategic Leadership Skills, Leadership Coaching, Strategic Thinking Skills & Personal Balanced Scorecard.

E. Ahli panel Sistem Star Rating KPM 2008 & Ketua Pasukan 2010.F. Timbalan Wakil Pengurusan Ssitem Pengurusan Kualiti MS ISO 9000 IAB.

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m bustaman/IAB/KPM/105

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m bustaman/IAB/KPM/109OBJEKTIF UTAMA

Untuk melengkapkan peserta dengan pengetahuan dan kemahiran yang diperlukan untuk melaksanakan audit kualiti dalaman ke atas pelaksanaan sistem pengurusan kualiti MS ISO 9001:2008 dengan berasaskan Standard Management System Auditing ISO 19011:2002.

9hak milik MBAM IAB KPM m bustaman/IAB/KPM/1010

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m bustaman/IAB/KPM/1013TOPIK YANG DILIPUTI

Bahagian 1: Pengenalan Pengurusan Kualiti , Standard Sistem Kualiti MS ISO 9001:2008 & faedah kepada organisasiModel Sistem PengurusanAmalan 8 prinsip kualiti dalam kerja seharian

m bustaman/IAB/KPM/1014TOPIK YANG DILIPUTI

Bahagian 2: Keperluan Standard MS ISO 9001:2008.

Bahagian 3: Dokumentasi Sistem Pengurusan Kualiti (SPK).Struktur DokumentasiKawalan Dokumentasi SPK

m bustaman/IAB/KPM/1015TOPIK YANG DILIPUTI

Bahagian 4: Pengenalan Audit

Definisi dan Jenis AuditPrinsip AuditTanggungjawab JuruauditKelayakan JuruauditGaris Panduan ISO 19011

m bustaman/IAB/KPM/1016TOPIK YANG DILIPUTI

Bahagian 5: Proses Audit Kualiti DalamanFasa 1: Perancangan AuditFasa 2: Pelaksanaan AuditFasa 3: Pelaporan Audit

Bahagian Amali:1. Amali Audit2. Amali Pelaporan

m bustaman/IAB/KPM/1017Jadual Kursus

Hari Pertama: Selasa8.00 8.30 : Taklimat8.30- 10.00: Pengenalan Kursus dan Bahagian 110.00-10.30: Kudapan pagi10.30 12.45: Sambungan Bahagian 12.15 - 4.45:Bahagian 2-Std ISO 9001:2008

m bustaman/IAB/KPM/1018Jadual Kursus

Hari Kedua: Rabu 8.15 - 10.00: Bhg: 2 & 3- Std & Dokumentasi10.00-10.30: Kudapan pagi10.30 12.45: Bhg: 2 & 3- Std & Dokumentasi12.45-2.15:Makan tengahari & rehat2.15 - 4.45:Bhg 4: Pengenalan Audit & Perancangan audit

m bustaman/IAB/KPM/1019Jadual Kursus

Hari Ketiga: Khamis8.15 - 10.00: Bhg 5: Perancangan audit dan pelaksanaan audit.10.00-10.30: Kudapan pagi10.30 12.45: Bhg 5: Pelaksanaan dan pelaporan Audit1.00-2.00:Makan tengahari & rehat2.00 - 4.30 ptg:Amali Pelaksanaan Audit4.30 ptg dan seterusnya: persiapan pelaporan audit.

m bustaman/IAB/KPM/1020Jadual Kursus

Hari Keempat: Jumaat

8.30- 10.00: Amali Latihan Pelaporan Audit10.00-10.30: Kudapan pagi10.30 12.15: Rumusan, Peperiksaan Audit, Penilaian Kursus & Penutupan Kursus

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Bahagian 1

Definisi KualitiPengenalan Pengurusan Kualiti & Standard Sistem Kualiti ISO 9001:20088 prinsip kualitiModel Sistem Pengurusan KualitiFaedah Melaksanakan MS ISO 9000

m bustaman/IAB/KPM/1022Apakah itu Kualiti?1. Fit for purpose (Juran).

2. Quality is conformance to requirements(Philip Crosby)3. Keupayaan sesuatu barang/perkhidmatan yang mempunyai ciri-ciri kemampuan untuk memenuhi sesuatu kehendak. (Shewhart)

m bustaman/IAB/KPM/1023Definisi Kualiti ISO 9000 darjah dimana sekumpulan sifat produk atau perkhidmatan yang wujud memenuhi keperluan-keperluan (3.1.1)Sifat (3.5.1) bermaksud ciri-ciri yang mebezakan sesuatu samada sedia wujud yang atau diberikan, kualitatif atau kuantitatif atau jumlah yang banyak dan terdapat banyak kelas sifat seperti fizikal, deria, kelakuan,batas waktu, ergonomic dan fungsian. Keperluan (3.1.2) adalah amalan yang biasa digunakan oleh syarikat, pelanggannya dan atau pihak yang berminat.

APA ITU KUALITI Keupayaan sesuatu produk atau perkhidmatan memenuhi kepuasan pelanggan (pihak berkepentingan)24Hak Milik MBAM@IAB KPM 09

mbam IAB KPM09Pengertian Kualiti : lima pendekatan

Menyamakan kualiti sebagai keunggulan atau kecemerlangan. Dengan itu kualiti tidak dapat ditentukan tetapi boleh dirasai atau dinikmati hanya melalui pengalaman. Misalnya, kenyataan yang berbunyi Saya tahu kualiti bila saya melihatnya/merasainya.

Hak Milik MBAM@IAB KPM 0925

Pengertian Kualiti : pendekatan 2

Berdasarkan kepada keluaran, kualiti dilihat sebagai mempunyai ciri-ciri tertentu yang boleh diukur. Ciri-ciri ini adalah ketahanan, boleh diharap, rupa bentuk dan keselamatan. Pendekatan ini membawa implikasi bahawa semakin banyak ciri ini dirangkumi dalam satu keluaran, kos pengeluaran akan meningkat.

26Hak Milik MBAM@IAB KPM 09

Pengertian Kualiti: pendekatan 3Berdasarkan pandangan pengguna quality lies in the eye of the beholder. Tiap-tiap pengguna mempunyai kehendak yang berbeza-beza dan mana-mana keluaran atau perkhidmatan yang memenuhi kehendak ini akan dianggap sebagai berkualiti.

Hak Milik MBAM@IAB KPM 0927

Berdasarkan kepada nilai, kualiti dilihat dari segi kos dan harga. Keluaran atau perkhidmatan yang berkualiti dilihat dari segi keperluan memenuhi kehendak pengguna dengan harga yang boleh diterima oleh mereka.

Hak Milik MBAM@IAB KPM 0928Pengertian Kualiti : pendekatan 4

Berdasarkan kepada pandangan sektor pembuatan, kualiti diertikan sebagai memenuhi kehendak atau spesifikasi yang telah ditentukan.

29Hak Milik MBAM@IAB KPM 09Pengertian Kualiti : pendekatan 3

Bagi sektor swasta, daya persaingan akan ditentukan oleh kehendak dan cita rasa pengguna. Dalam konteks perkhidmatan awam, kualiti diertikan sebagai dapat memenuhi yang menerima perkhidmatan

Hak Milik MBAM@IAB KPM 0930Pengertian Kualiti : pendekatan 5

m bustaman/IAB/KPM/1031Kesimpulan: DefinisiThe experts and gurus have various definitions. But they all add up to the same thing: Meeting the customers requirement

Hak Milik MBAM@IAB KPM 0932

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Quality Process Measuresm bustaman/IAB/KPM/1034INPUTOUTPUT

PROSESPDCA@ OUTCOME1. Kecekapan3. Kepastian kualiti4. Inovasi5. Quality of work life2. Keberkesanan6. Produktiviti7. Budgetability7 Kriteria Prestasi (Sink & Tuttle Model, 1989)

m bustaman/IAB/KPM/1035SEJARAH MENGENAI ISOISO atau International Organisation For Standardisation- organisasi antarabangsa bukan kerajaan dengan keahlian lebih 170 buah negara.In 1946, delegates from 25 countries met in London and decided to create a new international organization, of which the object would be 'to facilitate the international coordination and unification of industrial standards'. Badan ISO, rasmi beroperasi 23 February 1947, in Geneva, Switzerland

m bustaman/IAB/KPM/1036Latarbelakang ISOBecause 'International Organization for Standardization' would have different acronyms in different languages ('IOS' in English, 'OIN' in French for Organisation internationale de normalisation), its founders decided to give it also a short, all-purpose name. They choose 'ISO', derived from the Greek isos, meaning 'equal'. Whatever the country, whatever the language, the short form of the organization's name is always ISO.

m bustaman/IAB/KPM/1037INTERNATIONAL ORGANISATION FOR STANDARDISATION (IOS)

1. Tujuan: untuk mempromosi pembangunan standard .... untuk memajukan kerjasama di kalangan negara ahli dalam bidang saintifik, ekonomi dan teknologi2. Fungsi Utama IOSMenghasilkan siri standard yang boleh diguna pakai dalam semua jenis industri/perkhidmatan di pelbagai negaraJenis standard: simbol, kod, sukatan, saiz dan kelajuan.

m bustaman/IAB/KPM/1038Apa itu ISO 9000? ISO 9000, adalah satu standard bertulis yang menetapkan dan menerangkan elemen keperluan asas yang perlu ada dalam SISTEM KUALITI bagi memastikan perkhidmatan diberikan oleh sesebuah organisasi dapat memenuhi kehendak pelanggan.

m bustaman/IAB/KPM/1039ISOSistem Pengurusan Kualiti : Berasaskan dokumentasi. Document what you do, do what you document and prove itBukan standard atau perkhidmatan: Konsep pencegahanBerasaskan kepada prinsip kepastian kualiti : Konsep kualiti yang universal dan dikenal pasti melalui pengiktirafan oleh pihak ketiga

m bustaman/IAB/KPM/1040ISO...1.Say what you do- mendokumenkan prosedur pelaksanaan proses kerja yang memberi kesan kepada kualiti produk atau perkhidmatan.2.Do what you say- melaksanakan aktiviti kerja sebagaimana dinyatakan dalam prosedur3.Record what is done- senggara rekod aktiviti sebagai bukti pematuhan kepada apa yang didokumenkan.4.Improve, based on results-perbandingan antara apa yang sebenarnya dilakukan dengan apa yang dirancang. Maklumat tersebut boleh membantu sebarang kekurangan kepada sistem kualiti

m bustaman/IAB/KPM/1041Versi Standard Standard Pertama: 1987Standard Kedua:1994 (IAB bermula- dengan MAMPU)Standard Ketiga:2000 (MOODY INT)Standard keempat: 2008- versi terkini

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m bustaman/IAB/KPM/1043 PRINSIP ASAS ISO 9000Prinsip Pertama:ISO 9000 adalah standard bagi sistem kualiti.Prinsip Kedua:ISO 9000 berasaskan kepada dokumentasiPrinsip Ketiga:ISO 9000 menekankan pencegahanPrinsip Keempat:ISO 9000 adalah satu standard universal.

m bustaman/IAB/KPM/1044EMPAT STANDARD MS ISO 9000:2008 1. MS ISO 9000:2008 QMS Fundamentals and Vocabulary2. MS ISO 9001:2008 QMS Requirements3. MS ISO 9004:2008 QMS Guidance for Performance Improvement4. MS ISO 19011: Guidelines on Quality and Environmental Auditing

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BENGKELBincangkan faedah-faedah penggunaan standard dalam meningkatkan prestasi kerja organisasi? Masa : 10 minitm bustaman/IAB/KPM/1046m bustaman/IAB/KPM/1047Why Standards Matter?Standards make an enormous and positive contribution to most aspects of our lives.

Standards ensure desirable characteristics of products and services such as quality, environmental friendliness, safety, reliability, efficiency and interchangeability - and at an economical cost.When products and services meet our expectations, we tend to take this for granted and be unaware of the role of standards. However, when standards are absent, we soon notice. We soon care when products turn out to be of poor quality, do not fit, are incompatible with equipment that we already have, are unreliable or dangerous. When products, systems, machinery and devices work well and safely, it is often because they meet standards. And the organization responsible for many thousands of the standards which benefit the world is ISO.

When standards are absent, we soon notice.

m bustaman/IAB/KPM/1048Standard merangkumi bidang berikut

Manufacturing, processing, servicing, printing, forestry, electronics, steel, computing, legal services, financial services, accounting, trucking, banking, retailing, drilling, recycling, aerospace, construction, exploration, textiles, pharmaceuticals, oil and gas, pulp dan paper, petrochemicals publisching, shipping, energy, telecommunications, plastics, metals, research, health care, hospitality, utilities, pest control, aviation, machine tools, food processing, agriculture, government, education, recreation, fabrication, sanitation, software development, consumer products, transportation, design, instumentation, tourism, communications, biotechnology, chemicals, engineering, farming, entertainment, horticulture, consulting, insurance, and so on.

m bustaman/IAB/KPM/1049What standards doISO standards:make the development, manufacturing and supply of products and services more efficient, safer and cleaner facilitate trade between countries and make it fairer provide governments with a technical base for health, safety and environmental legislation, and conformity assessment share technological advances and good management practice disseminate innovation safeguard consumers, and users in general, of products and services make life simpler by providing solutions to common problems

m bustaman/IAB/KPM/1050Examples of the benefits standards provideStandardization of screw threads helps to keep chairs, children's bicycles and aircraft together and solves the repair and maintenance problems caused by a lack of standardization that were once a major headache for manufacturers and product users. Standards establishing an international consensus on terminology make technology transfer easier and safer. They are an important stage in the advancement of new technologies and dissemination of innovation.Without the standardized dimensions of freight containers, international trade would be slower and more expensive.

m bustaman/IAB/KPM/1051Examples of the benefits standards provideWithout the standardization of telephone and banking cards, life would be more complicated. A lack of standardization may even affect the quality of life itself: for the disabled, for example, when they are barred access to consumer products, public transport and buildings because the dimensions of wheel-chairs and entrances are not standardized.Standardized symbols provide danger warnings and information across linguistic frontiers. Consensus on grades of various materials gives a common reference for suppliers and clients in business dealings.m bustaman/IAB/KPM/1052Examples of the benefits standards provideConsensus on grades of various materials gives a common reference for suppliers and clients in business dealings.Agreement on a sufficient number of variations of a product to meet most current applications allows economies of scale with cost benefits for both producers and consumers. An example is the standardization of paper sizes.Standardization of performance or safety requirements of diverse equipment makes sure that users' needs are met while allowing individual manufacturers the freedom to design their own solution on how to meet those needs. Standardized computer protocols allow products from different vendors to 'talk' to each other. Standardized documents speed up the transit of goods, or identify sensitive or dangerous cargoes that may be handled by people speaking different languages.

m bustaman/IAB/KPM/1053Examples of the benefits standards provideStandardization of connections and interfaces of all types ensures the compatibility of equipment of diverse origins and the interoperability of different technologies. Agreement on test methods allows meaningful comparisons of products, or plays an important part in controlling pollution - whether by noise, vibration or emissions. Safety standards for machinery protect people at work, at play, at sea... and at the dentist's.Without the international agreement contained in ISO standards on metric quantities and units, shopping and trade would be haphazard, science would be unscientific and technological development would be handicapped.

m bustaman/IAB/KPM/1054Take 5!

Contoh Soalan Audit Iso 9001 Audit

54hak milik MBAM IAB KPM m bustaman/IAB/KPM/1055Dalam Standard versi 2008, ia berlandaskan kepada amalan lapan prinsip kualiti8 PRINSIPKUALITI

m bustaman/IAB/KPM/1056Prinsip Pertama: Bermatlamatkan PelangganOrganisasi bergantung kepada pelanggan mereka. Oleh itu organisasi hendaklah memahami keperluan pelanggan yang sedia ada dan pada masa akan datang, memenuhi keperluan pelanggan dan berusaha untuk melebihi jangkaan pelanggan.

Faedah UtamaPemahaman menyeluruh organisasi terhadap keperluan dan jangkaan pelanggan dan stakeholder Matlamat dan sasaran prestasi yang ditetapkan mestilah berkaitan dengan memenuhi keperluan pelanggan.Peningkatan prestasi organisasi (perubahan) mestilah berasaskan untuk memenuhi keperluan pelanggan.Memastikan sumber manusia mempunyai pengetahuan dan kemahiran yang diperlukan untuk memenuhi keperluan pelanggan.

Hak Milik MBAM@IAB KPM 0957

m bustaman/IAB/KPM/1058Prinsip Kedua: Kepimpinan

Ketua organisasi (PIHAK PENGURUSAN) bertanggungjawab: mewujudkan halatuju dan matlamat organisasi dengan jelas. mewujudkan dan mengekalkan persekitaran dalaman yang sesuai untuk stafnya supaya mereka dapat terlibat sepenuhnya dalam mencapai objektif-objektif organisasi yang telah ditetapkan bersama.Faedah UtamaStaf akan lebih faham dan bermotivasi ke arah pencapaian objektif dan matlamat.Aktiviti akan dinilai, diperkemas dan dilaksanakan dengan cara yang lebih bersatu.Kepimpinan melalui teladan, menggalakkan penambahbaikan yang berterusan.

m bustaman/IAB/KPM/1059Prinsip Ketiga: Penglibatan Staf(kerja berpasukan)Staf atau pekerja di semua peringkat adalah merupakan tunggak sesebuah organisasi dan penglibatan mereka sepenuhnya membolehkan keupayaan mereka digunakan untuk faedah-faedah organisasi.Faedah UtamaPekerja yang bermotivasi, komited dan terlibat.Pekerja merasakan lebih bertanggungjawab atas prestasi masing-masing.Pekerja lebih seronok untuk terlibat dan menyumbang kepada penambahbaikan.

m bustaman/IAB/KPM/1060Prinsip Keempat: Pendekatan ProsesHasil yang dikehendaki dapat diperolehi dengan lebih efisien apabila sumber-sumber dan aktiviti yang berkaitan diurus sebagai suatu proses.Faedah UtamaKeupayaan mengurangkan kos dan memendekkan cycle times melalui penggunaan sumber-sumber.Hasil yang bertambah baik, konsisten dan boleh jangka.Membolehkan peluang-peluang penambahbaikan diberi keutamaan dan fokus.

m bustaman/IAB/KPM/1061Prinsip Kelima: Pendekatan Sistem Untuk Pengurusan Dengan mengenal pasti, memahami dan menguruskan sesuatu sistem untuk proses-proses yang berhubung kait bagi sesuatu objektif, ia dapat menambahkan kecekapan dan keberkesanan sesebuah organisasi.Faedah UtamaMemperkemaskan proses-proses yang akan menyumbang kepada hasil yang diperlukan.Keupayaan untuk fokus kepada usaha proses-prosesMemberikan keyakinan kepada pihak yang berkepentingan terhadap keberkesanan dan kecekapan organisasi.

m bustaman/IAB/KPM/1062Prinsip Keenam: Peningkatan Berterusan Peningkatan berterusan hendaklah dijadikan sebagai objektif tetap sesuatu organisasi.Faedah UtamaPeningkatan kelebihan persaingan boleh menyumbang kepada penambahbaikan keupayaan organisasi.Keupayaan bertindak balas dengan cekap kepada peluang-peluang.

m bustaman/IAB/KPM/1063Prinsip Ketujuh: Pendekatan Berfakta Dalam Membuat KeputusanKeputusan yang efektif dibuat berdasarkan analisa sesuatu data/maklumat.Faedah UtamaKeputusan yang lebih jelasKeupayaan untuk mempamerkan keberkesanan keputusan yang lalu melalui rujukan kepada fakta-fakta sejarah.Keupayaan untuk mengkaji semula dan merangsang ke arah penyemakan semula keputusan dan pandangan.

m bustaman/IAB/KPM/1064Prinsip Kelapan: Hubungan yang Saling Bermanfaat Dengan Pembekal Sesuatu organisasi dan pembekal-pembekalnya adalah saling bergantung antara satu sama lain dan hubungan yang saling bermanfaat dapat mempertingkatkan keupayaan yang menguntungkan kedua-dua pihak.Faedah UtamaMeningkatkan keupayaan untuk mewujudkan nilai bagi kedua-dua pihakFleksibel dan pantas bertindak ke atas maklum balas bersama terhadap pasaran yang berubah-ubah.Mengoptimumkan kos dan sumber-sumber.

m bustaman/IAB/KPM/1065Rehat!

65hak milik MBAM IAB KPM m bustaman/IAB/KPM/1066 KEPERLUAN-KEPERLUAN SISTEM PENGURUSAN KUALITI STANDARD MS ISO 9001: 2008

Bahagian 2Mbustaman-IAB-KPM67Std MS ISO 9001: 2008 SPKStandard yang menjadi asas bagi.Keperluan yang mesti dipatuhi Keperluan asas bagi membentuk sistem kualitiPersijilan. Asas penilaian oleh badan persijilan.Standard yang menjelaskan keperluan SPK bagi tujuan menilai kemampuan organisasi memenuhi kehendak pelanggan.Standard adalah anjal

m bustaman/IAB/KPM/1068Penambahbaikan Berterusan Sistem Pengurusan Kualiti (PDCA)PELANGGAN&STAKE-HOLDERS

KEPERLUAN

TANGGUNGJAWABPENGURUSAN ATASAN (5.0)PENGURUSANSUMBER (6.0)PENGUKURAN,ANALISIS & PENAMBAHBAIKAN (8.0)PENZAHIRAN PRODUK(7.0)(Product Realization)PELANGGAN&STAKE-HOLDERS

BERPUAS-HATI

PRODUKINPUTOUTPUTAktiviti Penambahan NilaiAliran informasi4.0Model Proses Sistem Pengurusan

Mbustaman-IAB-KPM69Keperluan MS ISO 9001:2008 dibahagikan kepada lima seksyen:Seksyen 4Sistem Pengurusan Kualiti Pemahaman mengenai proses dan dokumentasi Seksyen 5Tanggungjawab PengurusanPengurusan dan isu pentadbiran Seksyen 6Pengurusan sumberMengenai sumber kewangan, manusia, peralatan dan persekitaran kerja Seksyen 7Proses penyampaian perkhidmatan.Keperluan proses dan proses yang diperlukan bagi mengubah input kepada produk Seksyen 8

Pengukuran, Analisis dan PenambahbaikanMengenai isu seperti pengukuran produk/perkhidmatan, pemantauan sistem dan proses penambahbaikan. hak milik muhd bustaman/IAB/KPMmbustamanIABKPM70Struktur Kandungan Standard Terbahagi Kepada 8 Para0. Pengenalan

1. Skop

2. Rujukan Nomatif3.Terminologi dan definisi4.Sistem pengurusan kualiti

0.1 Am0.2 Pendekatan proses0.3 Hubung kait dengan ISO 9004.0.4. Kompatibiliti dengan sistem pengurusan lain

1.1 Am1.2 Applikasihak milik muhd bustaman/IAB/KPMmbustamanIABKPM71Clause 4.1Quality Management System (General Requirements)

Organization shall establish, document, implement, maintain and continually improve quality management system. Steps required are:

-Identify processes for QMS;

-Determine sequence and interaction of these processes;

-Determine criteria and methods for effective operation and control;

-Ensure availability of information to support effective operation and monitoring of processes;

-Measure, monitor, analyze processes and implement action to achieve planned result and continual improvement.hak milik muhd bustaman/IAB/KPMmbustamanIABKPM724.2Documentation Requirements

4.2.1General documentation requirements

Extent of QMS dependent upon:(a)Size and type of organization(b)Complexity and interaction of processes(c)Competence of personnel

QMS shall include :(a)Documented procedures required by the standard(b)Documentation required by organization for ensuring effective operation and control of its processeshak milik muhd bustaman/IAB/KPMmbustamanIABKPM73Clause 4.2.2Quality Manual shall include :

-Scope of quality management system (including justification for any exclusions);

-Description of sequence and interaction of processes in the QMS;

-Documented procedures or reference

hak milik muhd bustaman/IAB/KPMmbustamanIABKPM74Clause 4.2.3Control of documents

Quality records considered as documents but different requirementsspecified for quality records.

Control of documents required by the quality management system

Control shall cover :

-approved prior to issue

-reviewed, updated as necessary and reapproved

-current revision status of documents identified

-relevant versions of applicable documents at all points of use

- legible, readily identifiable and retrievable

- documents of external origin given identification and distribution controlled

- obsolete documents to prevent unintended use and suitably identified if retained

hak milik muhd bustaman/IAB/KPMmbustamanIABKPM75Clause 4.2.4Control of Quality records

Control shall cover records required by the quality management system;

Records maintained to provide evidence of conformance and effective operation of the quality management system;

Requirements include : identification, storage, retrieval, protection, retention time and disposition

hak milik muhd bustaman/IAB/KPMmbustamanIABKPM76Clause 5Management Responsibility

Clause 5.1 Management Commitment

Top management shall provide evidence of commitment by :

-Communicating importance of meeting customer and legal/regulatory requirements

-Establishing quality policy and objectives

-Conducting management reviews

-Ensuring availability of necessary resourceshak milik muhd bustaman/IAB/KPMmbustamanIABKPM77Clause 5.2 Customer focus

Top management shall ensure customer needs and expectations are determined and converted into requirements and fulfilled with aim of achieving customer satisfaction

hak milik muhd bustaman/IAB/KPMmbustamanIABKPM78Clause 5.3 Quality Policy

Top management shall ensure that the quality policy:

-Is appropriate to the purpose of the organization-Includes commitment to meeting requirements and continual improvement-Provides framework for establishing and reviewing quality objectives-Is communicated and understood at relevant levels in the organization-Is reviewed for continuing suitability

Quality policy shall be controlled

hak milik muhd bustaman/IAB/KPMmbustamanIABKPM79Clause 5.4Planning

Clause 5.4.1Quality objectives

Top management shall ensure that quality objectives:-are established at relevant functions and levels-are measurable and consistent with QP (including commitment to continual improvement)-include objectives needed to meet requirements of product

hak milik muhd bustaman/IAB/KPMmbustamanIABKPM80Clause 5.4.2Quality Planning

-Top management shall ensure that resources needed to achieve quality objectives are identified and planned-Output of planning shall be documentedhak milik muhd bustaman/IAB/KPMmbustamanIABKPM81Clause 5.4.2 (Coned)Quality Planning shall include :

(1)Processes of the QMS (considering permissible exclusions)

(2)Resources needed

(3)Continual improvement of the QMS

Change shall be conducted in a controlled manner and system integrity shall be maintained during this process

hak milik muhd bustaman/IAB/KPMmbustamanIABKPM82Clause 5.5.1Responsibility, Authority and Communication

Functions and interrelations within the organization, including responsibilities and authorities, shall be defined and communicated.

hak milik muhd bustaman/IAB/KPMmbustamanIABKPM83Clause 5.5.2Management Representative

Shall be appointed by top management;

Allows for more than one managementrepresentative;

Responsibility enhanced to include reporting on needs for improvement and promoting awareness of customer requirements throughout the organization.

hak milik muhd bustaman/IAB/KPMmbustamanIABKPM84Clause 5.5.3 Internal Communication

Now requirement to ensure adequate communication between various levels/functions regarding processes of QMS and their effectiveness

hak milik muhd bustaman/IAB/KPMmbustamanIABKPM85Clause 5.6Management Review

Top management shall review QMS at planned intervals.

Purpose of review : To ensure its continuing suitability, adequacyand effectiveness

Review inputs shall cover current performance and improvementopportunities related to :

-result of audits

-customer feedback

-process performance and product conformance

-status of corrective and preventive actions

-follow-up actions from earlier management reviews

-changes affecting QMShak milik muhd bustaman/IAB/KPMmbustamanIABKPM86Review output shall include actionsrelated to :

-Improvement of QMS and processes

-Improvement of product related to customer requirements

-Resource needs

Records of reviews shall be maintained

hak milik muhd bustaman/IAB/KPMmbustamanIABKPM87Clause 6Resource Management

Clause 6.1Provision of resources

Provision of resources : Resources needed to implement and improve processes of QMS and to address customer satisfaction shall be determined and provided in a timely manner.hak milik muhd bustaman/IAB/KPMmbustamanIABKPM88Clause 6.2 Human Resources

Personnel assigned responsibilities shall be competent on the basis of applicable education, training, skills and experience.

Training, awareness and competency shall include:

-Identify competency needs for personnel

- Provide training to satisfy needs

-Evaluate effectiveness of training

-Awareness relating to relevance and importance of activities and contribution to achievement of quality objectives

Maintaining records of education training, qualification & experience

hak milik muhd bustaman/IAB/KPMmbustamanIABKPM89Clause 6.3 Infrastructure

Identify, provide & maintain facilities needed to achieve conformity of product.

This shall cover:

- Workspace and associated facilities

- Equipment, hardware and software

-Supporting services

hak milik muhd bustaman/IAB/KPMmbustamanIABKPM90Clause 6.4Work Environment

-Identify and manage the human and physical factors of the work environment

Contoh Soalan Audit Iso 9001 Adalah

- Specific reference to health & safety conditions, work methods, work ethics & ambient working conditions have been removed

m bustaman/IAB/KPM/1091Rehat!

91hak milik MBAM IAB KPM hak milik muhd bustaman/IAB/KPMmbustamanIABKPM92Clause 7Product realization

Clause7.1Planning of realization processes

Planning of sequence of processes and sub processes needed toachieve the product shall be documented

In planning of realization processes, the following shall bedetermined :

-quality objectives for the product;

-the need to establish processes and documentation and provide resources and facilities;

-verification and validation activities and criteria for acceptability;

records needed to provide confidence of conformityhak milik muhd bustaman/IAB/KPMmbustamanIABKPM93Clause 7.2Customer-related processes

Customer related processes involve :

-Determination of requirements related to the product (7.2.1)

-Review of requirement related to the product(7.2.2)

-Customer communication (7.2.3)

hak milik muhd bustaman/IAB/KPMmbustamanIABKPM94Clause 7.2.1Determination of requirements related to the product

Identification of customer requirements shall include :

-Customer requirements for product including those for availability, delivery and support;

-Product requirements not specified but necessary for intended/specified use;

- Regulatory and legal requirementshak milik muhd bustaman/IAB/KPMmbustamanIABKPM95Clause 7.2.2Review of requirements related to the product

Before commitment to supply, organization shall ensure:

-Product requirements are defined

-Where no documented statement of requirement, confirm requirement before acceptance

-Conflicting/ambiguous requirements resolved

-Ability to meet requirements

Results of review and follow-up actions shall be recorded

Revision to requirements shall result in amendment to relevant documentation and communicated to personnel in organization.hak milik muhd bustaman/IAB/KPMmbustamanIABKPM96Clause 7.2.3Customer Communication

Communication to customer relating to following shall be identified and implemented :

-product information

-enquiry /contract/ order handling

-customer feedback, including complaints

hak milik muhd bustaman/IAB/KPMmbustamanIABKPM97Clause 7.3Design and development

Covers :

-Design and development planning

-Design and development inputs

-Design and development outputs

-Design and development review

-Design and development verification

-Design and development validation

-Control of changeshak milik muhd bustaman/IAB/KPMmbustamanIABKPM98Clause 7.3.1Design and development planning

-stages of the design/development process

-required review, verification and validation activities appropriate to the stage

-responsibilities & authorities for design / development planning

Interfaces between different groups shall be effectively managed.

Planning output shall be updatedhak milik muhd bustaman/IAB/KPMmbustamanIABKPM99Clause 7.3.2Design and development inputs

Product requirements shall be defined and documented, including :

-Functional and performance requirements

-Applicable regulatory/legal requirements

-Information derived from previous similar designs

- Other requirements essential for design/ development.

Requirement shall be reviewed for adequacy. Incomplete, ambiguous or conflicting requirements shall be resolved.hak milik muhd bustaman/IAB/KPMmbustamanIABKPM100Clause 7.3.3Design and development output

Outputs of design/development process shall be documented.

Design/development output shall :

-Meet design/development input requirements

-Provide information for production/service operations

-Contain or reference product acceptance criteria

-Define characteristics of product essential for safe and proper use.

Design/development documents approved prior to release

hak milik muhd bustaman/IAB/KPMmbustamanIABKPM101Clause 7.3.4Design and development review

Review shall be conducted at suitable stages to:

-Evaluate capability to fulfil requirements

-Identify problems and propose follow-up action

Participants shall include personnel relevant to the stage being reviewed

Result of review and follow-up actions shall be recordedhak milik muhd bustaman/IAB/KPMmbustamanIABKPM102Clause 7.3.5Design and development verification

-Verification shall be performed to ensure output meets input requirements

-Results of verification and subsequent follow - up action shall be recodedhak milik muhd bustaman/IAB/KPMmbustamanIABKPM103Clause 7.3.6Design and development validation

-Design validation shall be carried out to confirm resultant product/service capable of meeting requirements of intended use

-Partial validation may be done if full validation not practical prior to delivery of product or implementation of service

-Results of validation and follow-up action shall be recorded

hak milik muhd bustaman/IAB/KPMmbustamanIABKPM104Clause 7.3.7Control of changes

-Design/development changes shall be identified, documented and controlled

-Evaluation of effects of changes on components parts and delivered products required.

-Changes shall be verified, validated and approved before implementation

Results of review and follow-up actions shall be recordedhak milik muhd bustaman/IAB/KPMmbustamanIABKPM105Clause 7.4 - Purchasing

7.4.1Purchasing Process

7.4.2Purchasing information

7.4.3Verification of purchased product

hak milik muhd bustaman/IAB/KPMmbustamanIABKPM106Clause 7.4.1Purchasing Process

-Purchasing processes shall be controlled to ensure purchased product conforms to organization requirements

-Type and extent of control dependent on effect on delivered product

-Evaluation and selection of suppliers shall be carried out

-Criteria for selection and periodic evaluation shall be defined

Results of evaluations and follow-up actions shall be recorded

hak milik muhd bustaman/IAB/KPMmbustamanIABKPM107Clause 7.4.2Purchasing Information

Purchasing documents shall contain information describing product ordered, including :

-Requirements for approval or qualification of product

-Quality management systems requirements

-Adequacy of specified requirement in documents shall be ensured prior to release

hak milik muhd bustaman/IAB/KPMmbustamanIABKPM108Clause 7.4.3Verification of purchased Product

-Activities necessary for verification of purchased product shall be determined and implemented

-Supplier shall be informed through purchasing information of intended verification by organization or customer at suppliers premises

hak milik muhd bustaman/IAB/KPMmbustamanIABKPM109Clause 7.5Production and service operations

Production and service operation covers :

-Control of production and service provision (7.5.1)

-Validation of processes for production and service provision (7.5.2)

-Identification and traceability (7.5.3)

-Customer property (7.5.4)

-Preservation of product (7.5.5)hak milik muhd bustaman/IAB/KPMmbustamanIABKPM110Clause 7.5.1Control of production and service operation

Production/service operations controlled through :

-Availability of information that specifies characteristics of product

-Availability of work instruction, where necessary

-Use and maintenance of suitable equipment

-Availability and use of suitable measuring and monitoring devices

-Implementation of monitoring activities

-Defined processes for release, delivery and applicable post-delivery activitieshak milik muhd bustaman/IAB/KPMmbustamanIABKPM111Clause 7.5.2Validation of processes for production and service provision

Production/service processes where output is not verified by subsequent measurement or monitoring shall be validated.

Validation shall demonstrate ability of process to achieve planned results.

Validation shall include, as applicable :

-qualification of processes

-qualification of equipment and personnel

-use of defined methods and procedures

- requirements for records

-revalidation, when applicable

hak milik muhd bustaman/IAB/KPMmbustamanIABKPM112Clause 7.5.3Identification and Traceability

-Where appropriate, product shall be identified at all stages of production/service operations

-Status of product with respect to measurement and monitoring requirements

-Control and record unique identification of product if traceability required.hak milik muhd bustaman/IAB/KPMmbustamanIABKPM113Clause 7.5.4Customer property

-Care shall be exercised with customer property when under organizations control or being used by it

-Customer property provided for use or for incorporation into product shall be identified, verified, protected and maintained.

-Record and report to customer if lost, damaged or unsuitable for use.

May include intellectual property

hak milik muhd bustaman/IAB/KPMmbustamanIABKPM114Clause 7.5.5Preservation of Product

Conformity to customer requirement shall be preserved during internal processing and delivery to intended destination

It shall include : identification, handling, packaging, storage and protection.

Applicable to parts or components of product or elements of service

hak milik muhd bustaman/IAB/KPMmbustamanIABKPM115Clause 7.6Control of Measuring and Monitoring Devices

-Measurements to be made and measuring and monitoring device required shall be identified;

- M & M devices shall be used and controlled in a manner that ensure measurements are consistent with measurement requirements;

-Software shall be validated before use;

-Calibration at specified intervals or before use, with traceability to national/international standards;

-Safeguard against adjustments;

-Provide protection from damage/deterioration during handling, maintenance and storage;

-Record results of calibration;

Assess validity of previous results when equipment is found to be out of calibration and take appropriate action

m bustaman/IAB/KPM/10116Rehat!

116hak milik MBAM IAB KPM hak milik muhd bustaman/IAB/KPMmbustamanIABKPM117Clause 8Measurement, analysis and improvement

Measurement, analysis and improvement covers:

-General (8.1)

-Measurement and monitoring (8.2)

-Control of non-conforming (8.3)

-Analysis of data (8.4)

-Improvement (8.5)hak milik muhd bustaman/IAB/KPMmbustamanIABKPM118Clause 8.1General

-Define, plan and implement measuring and monitoring activities to assure conformity and achieve improvement;

-Includes determination of need for and use of applicable methodologies including statistical techniques

hak milik muhd bustaman/IAB/KPMmbustamanIABKPM119Clause 8.2Measuring and Monitoring

Measuring and monitoring covers :

-Customer satisfaction (8.2.1)

-Internal audit (8.2.2)

-Processes (8.2.3)

-Product (8.2.4)

hak milik muhd bustaman/IAB/KPMmbustamanIABKPM120Clause 8.2.1Customer satisfaction

-Monitor information on customer satisfaction / dissatisfaction;

-Methods for obtaining and utilizing suchinformation shall be determined.

hak milik muhd bustaman/IAB/KPMmbustamanIABKPM121Clause 8.2.2Internal Audits

Periodic internal audits to determine if QMS- Conforms to requirements of this international standard- Has been effectively implemented and maintained;

Audits planned based on (i) status and importance of activities and (ii) results of previous audits;

Audit scope, frequency and methodologies shall be defined

Audits performed by personnel other then those who performed work being audited;

Procedure covering responsibilities and requirements, ensuring independence, recording results and reporting to management ; timely corrective action required;

Follow-up to include verification of CA and reporting resultshak milik muhd bustaman/IAB/KPMmbustamanIABKPM122Clause 8.2.3Measurement and Monitoring of Processes

Suitable methods shall be applied for measurement and monitoring of realization processes necessary to meet customer requirements;

Methods shall confirm continuing ability of each process to satisfy intended purpose

hak milik muhd bustaman/IAB/KPMmbustamanIABKPM123Clause 8.2.4Measurement and Monitoring of Product

Product/service characteristics shall be measured and monitored measurement and monitoring shall be carried out at various stages;

Evidence of conformance with acceptance criteria shall be recorded;

Authority responsible for release of product/ service shall be indicated in records;

Product shall not be released until all specified activities have been satisfactorily completed unless otherwise approved by customer hak milik muhd bustaman/IAB/KPMmbustamanIABKPM124Clause 8.3 Control of nonconforming product

Non-conforming product/service shall be identified and controlled to prevent unintended use or delivery;

Non-conforming product shall be corrected and reverified;

Appropriate action to be taken if non-conforming product/service is detected after delivering or use has started;

Proposed rectification of non-conforming product shall be reported to customers, end-user, regulatory body or other body for concession

hak milik muhd bustaman/IAB/KPMmbustamanIABKPM125Clause 8.4 Analysis of data

-Collect and analyze appropriate data

-Data analysis to be used for determining suitability and effectiveness of QMS and for identifying areas for improvement

-Data to be analyzed may include those from measuring and monitoring activities

Data analysis to provide information on :

-Customer satisfaction/dissatisfaction ;

-Conformance to customer requirements ;

-Characteristics of processes/products services;

-suppliers

hak milik muhd bustaman/IAB/KPMmbustamanIABKPM126Clause 8.5 - Improvement

Improvement covers :

-Continual improvement (8.5.1)

-Corrective Action(8.5.2)

-Preventive Action(8.5.3)

hak milik muhd bustaman/IAB/KPMmbustamanIABKPM127Clause 8.5.1Continual improvement

Processes necessary for continual improvement of QMS shall be planned and managed

Continual improvement shall be facilitated through use of:

(1)Quality Policy(2)Quality Objectives(3)Audit Result(4)Analysis of data(5)Correction/Preventive Action(6)Management Reviewhak milik muhd bustaman/IAB/KPMmbustamanIABKPM128Clause 8.5 2 Corrective Action.

-To eliminate causes of non-conformance to prevent recurrence

-Shall be appropriate to the magnitude and impact of problems

Procedure to cover :

-Identification of non-conformities (including customer complaints)

-Determination of causes of non-conformities

-Evaluation of need for actions to prevent recurrence

-Determine and implement corrective action needed

Review of corrective action taken

hak milik muhd bustaman/IAB/KPMmbustamanIABKPM129Clause 8.5.3Preventive Action

-To eliminate causes of potential non-conformities to prevent occurrence

-Shall be appropriate to the magnitude and impact of problems encountered

Procedure to cover :

-Identification of potential non-conformities-Determine of potential causes-Determination of preventive action needed-Implementation of preventive actionsReview of preventive action taken

m bustaman/IAB/KPM/10130Rehat!

130hak milik MBAM IAB KPM m bustaman/IAB/KPM/10131

AUDIT KUALITI DALAMANBahagian 4Pengenalan Audit

131hak milik MBAM IAB KPM m bustaman/IAB/KPM/1013211Definisi Audit Kualiti Proses yang sistematik, berkecuali dan didokumenkan untuk mendapatkan bukti audit dan menilaikannya secara objektif dalam menentukan kriteria audit telah dipenuhi.(ISO 19011:2002, page 1)

132hak milik MBAM IAB KPM Penjelasan: definisi1. Kriteria audit (3.2):Set dasar, prosedur atau keperluan yang digunakan sebagai rujukan.Set of policies, procedures or requirements2. Bukti Audit (3.3) Keputusan penilaian yang dibuat ke atas bukti yang telah diperolehi dengan kriteria audit. Penemuan boleh menyatakan keakuran terhadap kriteria audit, atau peluang untuk penambahbaikanm bustaman/IAB/KPM/10133m bustaman/IAB/KPM/1013416Audit Kualiti Bermakna:Mesti Sistematik (bukan rambang tetapi terperinci)

Mesti Bebas (tidak dilakukan oleh mereka yang berkepentingan)

Mesti menentukan sama ada aktiviti-aktiviti kualiti telah memenuhi keperluan planned arrangements (termasuk aktiviti-aktiviti dalam Quality Std ISO 9004)

134hak milik MBAM IAB KPM m bustaman/IAB/KPM/1013506/21/9817@ Hakcipta Terpelihara HMAAudit Kualiti Bermakna:Mesti meliputi related results iaitu memeriksa hasil setelah aktiviti-aktiviti kualiti dilaksanakan (dengan memeriksa rekod, produk, proses, membuat keputusan dll)

Mesti menentukan compliance with planned arrangements iaitu dasar dan prosedur umum seperti kontrak, pelan, spesifikasi, lukisan/lakaran, prosedur khusus dan arahan.

135hak milik MBAM IAB KPM m bustaman/IAB/KPM/1013618Audit Kualiti Bermakna:Mesti menentukan sama ada arrangements diimplementasikan dengan berkesan. Keberkesanan diukur melalui:sama ada aktiviti telah dilakukan dengan betulMenepati sasaranJadual ditepati dll

Mesti menentukan sama ada planned arrangements adalah sesuai untuk mencapai objektif iaitu sama ada peruntukan yang dibuat oleh pembekal dapat memenuhi objektif organisasinya (objektif kualiti)

136hak milik MBAM IAB KPM m bustaman/IAB/KPM/1013719Audit Kualiti Bermakna:Audit Sistem Kualiti melibatkan pemeriksaan sesuatu produktetapi bukan untuk mengesahkannya (certify)

Audit Sistem Kualiti juga melibatkan pemeriksaan sesuatu operasi dan rekod-rekod operasi untuk mempastikan rekod-rekod itu menggambarkan operasi yang lalu.

137hak milik MBAM IAB KPM SAMBUNGAN : Kesimpulan MAKNA AUDITIa adalah aktiviti pengumpulan maklumat untuk membolehkan tindakan pembetulan dan penambahbaikan dapat dikesan secara objektif.Ia dilaksanakan secara terancang/sistematikDilaksanakan olek mereka yang terlatihBerdasarkan std & kriteria yang ditetapkanMelaporkan dengan tepat, benar dan lengkap.m bustaman/IAB/KPM/10138m bustaman/IAB/KPM/1013915Jenis Audit1. Audit Luaran (External Audit) = Audit Persijilan/pihak ketiga2. Audit Dalaman (Internal Audit) = Audit pertama International Register of Certified Auditors (IRCA) menggunakan :Assessment = AuditAssessors = Auditors

139hak milik MBAM IAB KPM 140FLOW CHART OF IQA: ISO 19011

140As management tools, IQA should be done properly based on PDCA (plan, do, check and action) principle m bustaman/IAB/KPM/1014106/21/9828Tujuan PengauditanAudit dilaksanakan untuk: mencari fakta, bukan kecacatanmengelak daripada deterioration dalam standardKegunaan audit dapat dilihat apabila ianya diasaskan kepada standard yang perlu dipatuhi oleh sesebuah organisasi (contohnya standard ISO 9000)

141hak milik MBAM IAB KPM Tujuan Audit Dalaman (AD)Untuk mengumpul bukti objektif mengenai tahap keakuran pelaksanaan, kecekapan dan keberkesanan sistem pengurusan kualiti (SPK) organisasi (MS ISO 9000) dan mengesan peluang penambahbaikan (inovasi) SPK dan prestasi organisasi.m bustaman/IAB/KPM/10142Mbustaman-IAB-KPM143Audit memberi maklumat tentang:1. Adakah sistem berjalan baik?

2. Adakah prosedur dan dokumen yang di rujuk adalah yang terkini dan berkesan?Mbustaman-IAB-KPM144

145ROLES OF IQAAs a powerful tool to measure the effectiveness of quality management system

Evaluates organisations compliance with QMS in all aspects related production and quality control

Detects any shortcomings in the implementation of QMS

Recommend the necessary corrective and preventive actions

145The key roles of the internal quality audit: is a powerful tool for the company to measure the effectiveness of the quality management system.is a good management tool that can be used to review processes and identify any weaknesses in all aspect of GMP requirements, risks and areas of improvement.is used to assess if a process is working, if things are being done the way they are supposed to be done. However at the same time it is an excellent way of measuring the effectiveness of companys procedures.audits are also used to check any previously identified non-conformances or business changes. A good opportunity to assess how effective the changes have been done.

146BENEFITS OF IQATells you the health of a quality system

Identify the root of a problem and plan for corrective and preventive actions with timeline

Achieve better allocation of resources

Able to avoid potentially big problem

Learn what an auditors look for

Continuous improvement

146Tells you the health of the quality system : It serves as a benchmark of current performance against which future improvements are compared. An audit will show the existing system and practices. It enables the organisation to achieve consistent performance throughout the various departments or sites. Identify root of the problem and plan for corrective and preventive actions (CAPA) with timeline: Avoiding of potentially big problems. Minimise the chances of if we have known it earlier.. Better allocation of resources. Redesignation of job functions and management of resources. Able to avoid potentially big problems (continuous improvement principle). Having a structured internal audit program helps to identify, avoid and/or minimise problems. It also serves as a mean for future improvement.Learn what an auditor looks for : Standard or expectations are communicated during the audit. In addition, ideas and solutions to problems can be shared between the auditors and auitees. A qualified auditor should be able to explain the rationale behind the requirements. Each audit is an opportunity to learn about the quality system of a company as well as the various approaches in meeting the GMP expectations. You will finally know whether you comply: Compliance brings many benefits in terms of companys reputation, productivity and resources management.

Limitations of auditIt can neither help in prioritizing changes nor in allocating resources.Audit cannot mobilize people to take action.Audit cannot generate better data than the measures used to gather those.An audit, by itself cannot improve performance.An audit should not be used for wrongful purposes. It should not be used for personal indictment and to justify improve actions.147148Prinsip AuditKelakuan beretika asas kepada profesionalisme kepercayaan, integriti, kerahsiaan, dan kebijaksanaanKewajaran Penyampaian kewajipan untuk melaporkan yang benar & tepatBerkecuali asas kepada keadilan dan kebenaran kesimpulan auditPendekatan berasaskan bukti kaedah yang rasional untuk menghasilkan kesimpulan audit yang boleh dipercayai

148F Audit guidance: auditing should be seen as a positive process not as a fault finding exercise. audits need to be documented, it is important to remember that you are auditing against the Quality Management System and therefore audits should be constructed against policy and procedures, which have been developed by the company. prior to the audit date, auditor reviews the appropriate quality system documentation, records of completed corrective and preventive actions, and past audit findings for the activities to be audited, and then develops a checklist covering the quality system elements and activities to be audited. during an audit you need to see evidence that the processes are being done in accordance to the procedures and policies. Evidence should be recorded against each section being audited. Recording of evidence needs to have a description of the documentation signed, number, date and any other information that will assist in identifying that document.

149Keperibadian Juruaudit (ISO 19011)Berfikiran terbuka dan matangMempunyai pertimbangan yang baikMempunyai kemahiran analisis/teknikal dan berpendirian tetapBersikap realistik dan mempunyai kemahiran sosialBerkemahiran kemunikasiPersonaliti positif: peramah, tolong menolong, bersopan, merendah diri & jujur)

149When being audited internally, auditee should honest, open and cooperative and inform any deficiencies and difficulties during implementing all SOPs.If done by external auditor, only answer the questions and if needed only show the relative document needed. And dont blame otherm bustaman/IAB/KPM/10150Ciri-Ciri Personaliti Negatif JuruauditSuka berdebatMudah membuat keputusan tanpa usul periksa (bukti)AgresifPemalasCuaiTidak konsisten dengan keputusan yang dibuatSikap tahu semuanyaMENCARI KESALAHANm bustaman/IAB/KPM/10151Rehat!

151hak milik MBAM IAB KPM mbamIABKPM2011152BAHAGIAN 5: AKTIVITI AUDIT

Contoh Soalan Audit Iso 9001 Pdf

mbamIAB11153OVERVIEW OF AUDIT ACTIVITESPlanning and scheduling auditConducting document reviewConducting auditPrepare audit reportConducting follow-upPreparing for on-site activities

153Audit program procedure should address the following:Planning and scheduling auditAssuring the competence of auditors and audit team leaderSelecting appropriate audit team and assigning their roles and responsibilitiesConducting auditConducting audit follow-up, if applicableMaintaining audit program records Monitoring the performance and effectiveness of the audit program Reporting to top management on the overall achievements of the internal audit program

Mbustaman-IAB-KPM15406/21/98401. Program AuditProgram disediakan oleh Wakil PengurusanProgram audit dalaman: 2 kaliProgram audit luar: 1kali (Badan Persijilan)Program audit mendefinisikan lokasi, tarikh audit dan mengenalpasti auditor.

audit

Mbustaman-IAB-KPM15506/21/9841Merancang PengauditanMenjadi tanggungjawab Wakil Pengurusan & Ketua juruaudit merancang dan mengelolaPasukan audit dipilih daripada mereka yang berkelayakan.Mengumpulkan maklumat untuk merancang yang berkaitan dengan skop, termasuk maklumat juruaudit untuk penyusunan ahli pasukan dan proses yang akan diaudit.Memeriksa dokumen sistem kualiti untuk perancangan audit

Mbustaman-IAB-KPM15606/21/9842Merancang Pelan PengauditanPelan audit adalah gambaran mengenai aktiviti dan penyusunan audit.Ia merangkumi maklumat pelaksanaan audit seperti:1. proses/aktiviti yang akan diaudit2. Tarikh, masa pengauditan3. Kriteria audit4. Nama juruaudit dan auditi5. Masa untuk mesyuarat pembukaan & penutupan

MasaPasukan Audit & KetuaMasaJuruauditm bustaman/IAB/KPM/10157TarikhKetua JuruauditJuruauditKriteria AuditSkop AuditCONTOH PELAN AUDIT158AUDIT DOCUMENTATION Audit report is an

official document to report the audit findings Audit plan

should be sent to auditee prior to audit activityfindings from the last audit should be also mentioned Audit note should include

an audit questionnaireall records and comments during the audit

158Audit documentation does not need to be complicated, normally there are 3 kind of documents : The audit plan, The audit plan is sent to the department being audited a few days prior, it should include the date of the audit, the planned time, duration, auditors names, location (if relevant) and the policies and procedures that will be used during the audit. It should also mention any non-conformances that were found during last audit.The audit notes, The notes are the auditor's questions that will be asked during the audit. It should include references to particular policies and procedures and what will be asked during the audit. The same document should be used to record the findings and any comments during the audit.The audit report.The audit report is the official document used to report the findings of the audit. This document should include details of the audit, date, auditors names, policies and procedures and findings against them. It should include if it passed audit and any non-conformances or observations found. If non-conformance are found a date should be established for completion of corrective actions. The audit report is normally signed by the auditor and the department manager.

hak milik muhd bustaman/IAB/KPMmbustamanIABKPM159JADUAL AUDITJadual Audit Jan 20, 2011 8:00 8:30 Persediaan Auditor 8:30 9:00 Mesyuarat Pembukaan 9:00 9:30 Kawalan Dokumen 9:3010:30 Komitmen Pengurusan Atasan 10:3011:30 Pengurusan Pelanggan 11:3012:30 Pengurusan kursus-jabatan Inovasi 12:30 2:30 Rehat 2:30 4:30 Pengurusan Latihan 4:30 5:00 Mesyuarat penutup

Penyediaan Senarai SemakAlat bantuan untuk memandu, memberi peringatan mengenai maklumat yang perlu diperolehi dan fakta yang perlu disahkan.Panduan mengenai soalan yang akan ditanya dan keberkesanan proses temubual.Kaedah popular dalam menyediakan soalan:a. menukar kenyataan dalam standard atau prosedur menjadi soalanb. meringkaskan kenyataan tersebutc. ayat peringatan

m bustaman/IAB/KPM/10160contoh Catatkan maklumat pelanggan dalam borang maklumbalas dengan betul dan lengkapKenyataan ini akan ditukar seperti berikut: Apakah maklumat pelanggan yang dicatatkan dalam Borang Maklumbalas?Atau,Catatkan maklumat pelanggan dalam Borang Maklumbalas dengan betul dan lengkap.Jika diringkaskan, ia akan ditulis seperti berikut:Maklumat pelanggan- Borang Maklumbalas.Atau,catatkan maklumat pelanggan dalam Borang Maklumbalas dengan betul dan lengkap.Jika ditulis sebagai peringatan:Semak maklumat pelanggan dalam Borang Maklumbalas.m bustaman/IAB/KPM/10161m bustaman/IAB/KPM/10162Bahagian di auditTarikh:Muka surat: /JuruauditRujukan (Klausa) Perkara yang diauditCatatan Penemuan AuditSENARAI SEMAK163

EXAMPLE OF AN AUDIT CHECKLIST

164INTERNAL: AUDIT QUESTIONAIRES

Area audited : ______________________ Date: __________________

Question

Response

1. Does the company have a work instruction to operate the machine?

2. How is the machine being cleaned and maintained?

3. Are personnel trained to use the machine?

4.How often is the equipment being calibrated and cleaned?

5. When is the last breakdown of the machine?Are there any product being affected?

IA MONITORING

Melaksanakan Auditm bustaman/IAB/KPM/10165

Mesyuarat PembukaanSesi perbincangan pembukaan di antara pasukan audit dan auditee.Pengerusi: Ketua JuruauditAgenda mesyuarat:1. Memperkenalkan juruaudit terlibat2. Penerangan mengenai tujuan/skop/kaedah auditm bustaman/IAB/KPM/10166Mesyuarat Pembukaan3. Penerangan mengenai ketidakakuran4. Pengesahan Jadual audit5. Pengesahan kerahsiaan6. Melangkapkan keperluan pentadbiran audit spt borang kehadiran, borang maklumbalas7. Penjelasan mengenai isu-isu yang mungkin timbul ketika auditm bustaman/IAB/KPM/10167Temubual AuditTemubual adalah salah satu kaedah yang penting untuk mendapatkan maklumat. Melalui proses temubual, pengumpulan maklumat berlaku dan seterusnya pengumpulan bukti objektif.m bustaman/IAB/KPM/10168Temubual AuditSoalan yang akan dikemukakan oleh Juruaudit mestilah:*Memerlukan jawapan yang boleh memberi maklumat yang dikehendaki,*Tidak mencadangkan jawapan, dan*Tidak mengandungi ayat dan implikasi yang beremosi.

m bustaman/IAB/KPM/10169Temubual AuditLazimnya, proses temubual audit mempraktikkan 3 jenis soalan yang berikut:SOALAN TERBUKA,SOALAN TERTUTUP, danSOALAN PENJELASAN. m bustaman/IAB/KPM/10170Soalan Terbaik Semasa Audit SHOW MEatauBOLEH BERIKAN SAYA...atauTolong tunjukkan..m bustaman/IAB/KPM/10171Kaedah A-LOCK (ask, listen, Observe & Check)Tanya soalan,Berhenti bercakap,Dengar jawapan yang diberikan,Minta penjelasan jika keliru/tidak fahamLangkah pemerhatian dan pemeriksaan ke atas bukti objektif,Buat catatan yang perlu,Jika sudah berpuashati, tanya soalan yang seterusnya.m bustaman/IAB/KPM/10172Persekitaran AuditFaktor elemen fizikal: keselesaan persekitaranElemen emosi: mencari keakuran bukan ketidakakuran. Jaga eye contact dan body language.Kaji pendengar yang baik:a. mendengar dengan fikiran terbukab. Gunakan bahasa badan yang betulm bustaman/IAB/KPM/10173sambunganc. menjadi pemerhati- auditi cakap lebih. Jangan menyampuk atau ganggu auditi bercakap.d. Tumpukan kepada maklumat yang ingin dicarie. elak dari terus buat kesimpulanm bustaman/IAB/KPM/10174hak milik muhd bustaman/IAB/KPMmbustamanIABKPM175THE GOLDEN RULES OF AUDITINGBe preparedRetain an open mindBe professionalDo not waste timePresent a true and fair view

Calm, Courteous, Professional, Polite & Firm

hak milik muhd bustaman/IAB/KPMmbustamanIABKPM176TAKE 5!

176hak milik muhd bustaman/IAB/KPMmbustamanIABKPM1773INTERNAL Q AUDIT - MAS 97EXTRA NOTE : AUDIT CONDUCTCOMMUNICATION SKILLSQUESTIONING SKILLSLISTENING SKILLS

1773IABhak milik muhd bustaman/IAB/KPMmbustamanIABKPM178

DEVELOP GOOD AUDITING SKILLSAvoid leading, multiple, & trick questionsListen intentlyBe observant & take noteTry to establish root cause of deficienciesActually witness & document objective evidenceAvoid giving adviceRemain calm, courteous, polite, professional & firm

hak milik muhd bustaman/IAB/KPMmbustamanIABKPM179COLLECTING EVIDENCECommunication

Communicate clearlyBe open mindedBe aware of biasesAsk question in regard to the QMSDo not make assumptionsLead auditors should rely on the audit team

hak milik muhd bustaman/IAB/KPMmbustamanIABKPM1805Questioning SkillsExplaining your need :Give reasons for asking questionsDont demand information, request it politelyDont use deception to obtain information

1805IABhak milik muhd bustaman/IAB/KPMmbustamanIABKPM1816Type of QuestionsClosed questionsProbing questionsEmotive questionsTrick questionsHypothetical questionsSystematic questionsLeading questionsMultiple questions

1816IABhak milik muhd bustaman/IAB/KPMmbustamanIABKPM1827Dont askLeading questionsEmotive questions Dont you use red reject labels ? Why dont you stamp these documents UNCONTROLLEDIn general dont ask closed questions: Do you have a procedure for controlling noncomforming product ?

1827IABhak milik muhd bustaman/IAB/KPMmbustamanIABKPM18310Requests - Sebagai tambahan kepada soalan, auditor perlu memeriksa dan mendapatkan bukti-bukti. - Jika auditee tidak memberikan kerjasama, auditor perlu meminta dengan cara yang baik untuk mendapatkan bukti.

18310IABhak milik muhd bustaman/IAB/KPMmbustamanIABKPM18411Example Requests I would like to see some results of the design verification activities you performed on project XHaving examined your audit procedures and found them satisfactory, I would now like to examine the file of audit reports

18411IABhak milik muhd bustaman/IAB/KPMmbustamanIABKPM185SOME QUESTION TO ASK THE AUDITEEAre these open ended or closed ended?Are things being done the way you documented them?Is the department manager and staff following their own procedures and work instructions?Is your system effective?Are you meeting your quality objectives?Is the quality objectives?What is your responsibility and authority?In what way does the quality policy effect what you do?What feedback do you receive about your performance?When problems arise, what do you do about them?

Iso 9001 Audit Checklist Example

hak milik muhd bustaman/IAB/KPMmbustamanIABKPM186METHODS FOR IMPROVING AUDITING SKILLSAsk question instead of giving direct orders, if you are the audit team leader.

There are two things that every person in the world appreciates...to be asked..to be thanked.

hak milik muhd bustaman/IAB/KPMmbustamanIABKPM187COLLECTING EVIDENCEWrite down the information as you conduct the audit.Keep all of your notes together.

hak milik muhd bustaman/IAB/KPMmbustamanIABKPM188COLLECTING EVIDENCEDocumentation to audit:PoliciesProceduresWork instructionsRecordsExternal documents

hak milik muhd bustaman/IAB/KPMmbustamanIABKPM1898Listening SkillsIntelligent and active listeningHearing, understanding and remembering the messageTaking part in the interactionFeedback

1898IABhak milik muhd bustaman/IAB/KPMmbustamanIABKPM1909

One of the first steps to improving listening skills is to identify factors which hinder effective listeningListening problems:Selective attentionPremature conclusionsPersonal prejudices

1909IABhak milik muhd bustaman/IAB/KPMmbustamanIABKPM19113Giving FeedbackWhen something is found that is in your opinion good, give praiseWhen problems are uncovered, dont jump to conclusionsDont indicate that there is nonconformityPoint out potential problemsIf there is evidence of nonconformity in the system then say that there is a weakness not a NC

19113IABMbustaman-IAB-KPM19206/21/9844Pengumpulan & Pengesahan Bukti ObjektifBukti objektif merujuk kepada: data supporting the existence or verify of something Std ISO 9000Terbahagi 3 kategori:Dokumen (rekod, fail, minit mesyuarat, laporan kursus) bukti ini menunjukkan perkara yang telah berlaku atau aktiviti/proses yang telah dilaksanakan mengikut prosedur.

2. Pelaksanaan ia merujuk kepada aktiviti yang dilaksanakan sebenar dan boleh diperhatikan.(present)3. Manusia tahap pengetahuan dan pemahaman yang diperlukan untuk melaksanakan prosedur pada masa depan (future)m bustaman/IAB/KPM/10193hak milik muhd bustaman/IAB/KPMmbustamanIABKPM194WHAT ARE AUDIT FINDINGS?An observation is a positive, negative, or neutral fact that is supported by objective.A nonconformity is the non-fulfillment of a requirement.An audit-finding is a written statement or conclusion describing a nonconformity. It concludes:The requirement, as it is stated In the quality standard, or regulationThe observation which provides evidence that the standard or regulation is not being met

RECORD ALL AUDIT FINDINGS!

Penemuan Audit & penilaian Awal (1)Maklumat atau bukti audit yang diperolehi semasa sesi temubual, pemerhatian ke atas aktiviti atau proses dan pengesahan yang dibuat ke atas dokumen hendaklah dicatatkan atau direkodkan di dalam Senarai Semak. Maklumat atau bukti audit tersebut hendaklah dicatat atau direkod dengan jelas dan lengkap termasuk bukti yang spesifik dan objektif.m bustaman/IAB/KPM/10195Penemuan Audit & penilaian Awal (2)Catatan atau rekod ini adalah penting untuk menyediakan laporan penemuan audit dan kesimpulan audit serta hendaklah diikuti dengan penilaian awal ke atas keakuran pelaksanaan sesuatu aktiviti atau proses seperti:AKUR atau TIDAK AKURTIDAK BOLEH DISAHKANTIDAK CUKUP BUKTI

m bustaman/IAB/KPM/10196Penemuan Audit & penilaian Awal (3) PERLU RUJUK atau BERKESAN atau TIDAK BERKESANm bustaman/IAB/KPM/10197Perbincangan Pasukan (1)Perbincangan ini bertujuan untuk: Membuat penilaian semula ke atas penemuan audit dan lain-lain maklumat yang dikumpulkan oleh semua juruaudit (menilai pelan audit, kerjasama auditee, rintangan/kesusahan yang dihadapi).Persediaan untuk menyediakan laporan audit.m bustaman/IAB/KPM/10198Perbincangan Pasukan (2)Mencapai persetujuan ke atas semua laporan audit yang akan dikemukakan/dilaporkan kepada pihak yang diaudit.Tanggungjawab Ketua juruaudit menentukan klasifikasi NC (ketidakakuran)m bustaman/IAB/KPM/10199Perbincangan Pasukan (3)Keputusan yang dicapai melalui penilaian ke atas penemuan audit boleh dikategorikan kepada tiga (3) iaitu: Keakuran Ini menunjukkan bukti objektif yang diperolehi dapat membuktikan keakuran pelaksanaan kepada keperluan yang telah ditentukan.m bustaman/IAB/KPM/10200Perbincangan Pasukan (4) Ketidakakuran Ketidakakuran (nonconformance) bermaksud tidak memenuhi keperluan yang telah ditetapkan (the nonfulfillment of specified requirements) Pemerhatian/peluang penambahbaikan Komen yang dibuat ke atas sistem pengurusan kualiti untuk tujuan penambahbaikan atau perkara kurang bukti.m bustaman/IAB/KPM/10201Klasifikasi Ketidakakuran1 : Majora. Ketidakakuran yang berlaku telah menunjukan kegagalan sepenuhnya untuk memenuhi mana-mana klausa STD 9001:2008 atau kriteria audit yang lainb. tidak akur kepada keperluan SPK yang mengakibatkan kesan buruk/besar terhadap kualiti produk/perkhidmatan yang diberikan kepada pelangan dan organisasi gagal mengambil tindakan pembetulanm bustaman/IAB/KPM/10202Sambungan: majorc. Ketidakakuran yang konsisten dan berulang-ulang terhadap keperluan SPK.d. Ketidakakuran yang berlaku terhadap SPK yang boleh membawa kepada ketidakpatuhan kepada keperluan undang-undang yang berkaitan dengan kualiti produk/perkhidmatan.m bustaman/IAB/KPM/10203NC MinorNC yang terasing dan tidak konsisten dalam memenuhi keperluan yang telah ditetapkanNC yang berlaku tidak memberi kesan kepada kualiti produl/perkhidmatanNC yang tidak memberi kesan dalam memenuhi keperluan, kehendak dan jangkaan pelanggan.m bustaman/IAB/KPM/10204Kesimpulan Audit Semasa membuat kesimpulan audit, Ketua Juruaudit haruslah mengambil kira tujuan utama audit dilaksanakan. Selain daripada menilai sejauh mana keakuran kepada keperluan yang ditetapkan, audit juga adalah aktiviti untuk mengenalpasti peluang penambahbaikan. Maka, boleh kita katakan bahawa peluang penambahbaikan perlu m bustaman/IAB/KPM/10205Kesimpulan Audit diutamakan kepada pihak pengurusan auditee berbanding dengan ketidakakuran.m bustaman/IAB/KPM/10206hak milik muhd bustaman/IAB/KPMmbustamanIABKPM207COMPLETIONAll conformities are addressedAll corrective actions implementedAll corrective actions evaluated as effectiveAudit completed

Contoh Soalan Audit Iso

Mesyuarat Penutup (1)Mesyuarat ini dipengerusikan oleh Ketua Juruaudit dan dihadiri oleh pasukan audit, auditee dan pengurusan atasan organisasi yang di audit. Mesyuarat ini adalah aktiviti penutup proses audit untuk pasukan audit membuat kesimpulan ke atas audit yang telah dilaksanakan.m bustaman/IAB/KPM/10208Mesyuarat Penutup (2)Tujuan Mesyuarat Penutup diadakan adalah untuk:

Mengucapkan terima kasih kepada semua pihak yang terlibat dalam proses audit di atas sokongan dan kerjasama yang telah diberikan sepanjang proses audit.m bustaman/IAB/KPM/10209Mesyuarat Penutup (3) Menjelaskan secara ringkas mengenai proses audit yang telah dilaksanakan (cth: kaedah audit, persampelan dan laporan). Menjelaskan bahawa semua penemuan audit ankan dikekalkan kerahsiaannya. Mana-mana rekod/laporan/dokumen yang mengandungi maklumat rahsia akan dikembalikan kepada organisasi.m bustaman/IAB/KPM/10210Mesyuarat Penutup (4) Melaporkan semua penemuan audit yang merangkumi Laporan Ketidakakuran, Laporan Pemerhatian dan Laporan Peluang Penambahbaikan supaya difahami dan dipersetujui, dan disahkan oleh auditee. Biasanya ia dilaporkan oleh juruaudit yang bertanggungjawab ke atas penemuan audit atau laporan tersebut.m bustaman/IAB/KPM/10211Mesyuarat Penutup (5) Menjelaskan kaedah untuk menutup ketidakakuran yang dilaporkan dan persetujuan mengenai jangkamasa tindakan susulan (lihat Bahagian 9) Menjelaskan kesimpulan audit serta syor/cadangan bagi tujuan persijilan kepada organisasi yang diaudit. Ini adalah penting untuk memastikan organisasim bustaman/IAB/KPM/10212Mesyuarat Penutup (6) faham mengenai keputusan yang akan diambil oleh Badan Persijilan. Memastikan semua rekod audit adalah lengkap ( senarai kehadiran, pengesahan audit daripada organisasi, laporan telah ditandatangani dan lain-lain dokumen bagi tujuan pentadbiran audit).m bustaman/IAB/KPM/10213Mbustaman-IAB-KPM21406/21/9845Laporan Hasil AuditDapatan audit dibuat secara verbal semasa mengaudit.Hasil audit didokumenkan dalam bentuk laporan (conformities and nonconformities) Dilaporkan dalam Mesyuarat Penutup (closing meeting)Cadangan tindakan pembetulan dikemukakan kepada pihak pengurusan organisasi

Mbustaman-IAB-KPM21506/21/9846Audit SusulanCadangan tindakan pembetulan dikemukakan kepada auditor untuk dinilai.Auditor membuat keputusan menerima/menolak.Jika auditor menerima, teruskan untuk diimplementasi.Jika sebaliknya, buat cadangan baru.Implementasi tindakan pembetulan diperiksa sama ada melalui perhubungan atau pengauditan terus di tempat organisasi.Hendak melihat sama ada nonconformity telah dapat diatasi.

Mbustaman-IAB-KPM21606/21/9847Melengkapkan Rekod AuditAuditor perlu mengawasi pelaksanaan tindakan pembetulanLengkapkan rekod audit setelah semua tindakan pembetulan dilakukan dengan berkesan.Masa / tarikh ditentukan untuk audit pengawasan (surveillence audit)

Module 9GMP Workshop Kuala Lumpur 14-16 Nov 2005217CONCLUSIONSNobody likes to be audited..

It is a means to have continuous improvement217Especially when it involves giving your company the license to manufacture or shutdown.But, if you are prepared and have a basic quality system in place, you see it as a way for continual improvement.

Kejayaan sebenar ialahbila anda merasai kenikmatan atas hasil perubahan.

SEKIAN TERIMA KASIH

m bustaman/IAB/KPM/10219SEKIAN, TERIMA KASIH

General Requirements

• Where are the processes needed for the quality management system identified?
• Have the sequence and interaction of the processes been determined?
• What criteria and methods will be used for operation and control of the processes?

Management

• Where are the processes needed for the quality management system identified?
• Have the sequence and interaction of the processes been determined?
• What criteria and methods will be used for operation and control of the processes?
• How does management ensure that customer needs and expectations are determined, converted into requirements and fulfilled?
• Does this include customer obligations related to the product-including regulatory?
• Does the quality policy include a commitment to continual improvement?
• Does it provide a framework for establishing and reviewing objectives?
• Do the quality objectives include a commitment to continual improvement?
• Do quality objectives include those needed to meet requirements for product?
• How does the management rep promote customer awareness?
• Does the quality manual include a description of the sequence and interaction of the processes included in the quality management system?
• Does Management Review consider changes that could affect the quality system?
• Are there records of the output of management review? Do they include:
  actions to improve the quality system and its processes
  improvement of product related to customer requirements

Resources

• Can the organization demonstrate that resources are provided to address customer satisfaction?
• Are they provided in a timely manner?

Human Resources

• Has the organization evaluated the effectiveness of training provided?
• Has the organization ensured that its employees are aware of the relevance and importance of their activities and how they contribute to achievement of the quality objectives?

Planning

• Has the organization planned for realization of product?
• Does it include product quality objectives?
• Does it include the need to establish processes and documentation, provide resources and facilities specific to the product?
• Does the plan for measurement and monitoring to ensure conformity and achieve improvement identify the need for and use of statistics?

Customer Requirements

Does the identification of customer requirements include product requirements not specified by the customer, but necessary for the intended or specified use
obligations related to product, including regulatory and legal requirements

Review of product requirements

Does the organization confirm customer requirements when the customer does not provide a documented statement of requirement?

Customer Communication

Has the organization identified and implemented arrangements for communication with customers relating to:

• product information inquiries
• contracts or order handling including amendments
• customer feedback including complaints

Purchasing Control

How has the organization determined the extent of control of purchasing processes?
Is it dependent on the effect on subsequent realization processes and their output?

Customer Property

Has the organization applied the care of customer supplied property to intellectual property?

Preservation of Product

Has the organization validated any process where resulting output cannot be verified?
Does verification include:

• qualification of process
• qualification of equipment and personnel use of defined methodologies and procedures requirements
• for records revalidation

Customer Satisfaction

• Is the organization monitoring information on customer satisfaction and dissatisfaction?
• Where are the methodologies for obtaining and using this information defined?
• Has the organization analyzed appropriate data to determine:
  • suitability and effectiveness of the quality management system
  • actions to improve the quality system and its processes
  • improvement of product related to customer requirements