ISO Management System

Transkripsi

1 Training and consulting SINTEGRAL Consulting ISO Management System Phone (021) Fax (021) Grand Wijaya Center Blok H 9 Jl. Wijaya II, Jakarta Selatan info@sintegral.com Presentasi ISO /Nov15 1

2 Training and consulting SINTEGRAL Services Training and consulting for: Quality Management System ISO 9000 Environmental Management System ISO Food Safety Management System ISO and HACCP Management System for Occupational and Safety OHSAS Information Security Management System ISO Cosmetics Good Manufacturing Practices (GMP) ISO Automotive Quality Management ISO/TS

3 Training and consulting To maintain our clients, we provide focus group discussion through mailing list such as Quality Club with members Visit Quality Club Presentasi ISO /Nov15 3

4 Training and consulting Quality Systems: s Strategy for the future ISO 9001:2015 Presentasi ISO /Nov15 4

5 Training and consulting International Organization for Standardization Organisasi Standardisasi Internasional (non governmental) yang beranggotakan 140 Dewan Standardisasi di i Nasional Sejak 1947 ISO telah menerbitkan standar internasional Adopsi standar ISO bersifat sukarela (voluntary) 5

6 Training and consulting ISO 9001:2015 Quality Management Standard -> Menghasilkan Barang dan jasa yang Berkualitas -> Customer satisfaction Bukan standar produk Bersifat umum (Generic) Berlaku bagi semua jenis organisasi Sejarah ISO > ISO 9001: > ISO 9001: > ISO 9001: > ISO 9001:2008 Manufacturing, Service, Institution...Big or small, Public or private, Geograpchical and socio-economic differences 2015-> ISO 9001:2015 6

7 Training and consulting Benefits of Quality System ISO 9000 Improving the company s image and credibility in international markets which is essential for success in export business Enhancement of customer satisfaction Improvement of your organization s performance and productivity Creating quality awareness and more work satisfaction among personnel Reducing scrap, rework and customer complaints 7

8 Training and consulting Struktur ISO 9001: Ruang Lingkup 2. Standar Acuan 3. Istilah dan Definisi 4. Konteks Organisasi 4.1 Memahami Organisasi dan Konteks Organisasi 4.2 Memahami Kebutuhan dan Harapan Pihak yang Berkepentingan 4.3 Menetapkan Ruang Lingkup Sistem Manajemen Mutu Sistem Manajemen Mutu dan Proses 5. Kepemimpinan (Leadership) 5.1 Kepemimpinan p dan Komitmen 5.2 Kebijakan Mutu 5.3 Peran Organisasi, Tanggung Jawab dan Wewenang 6. Perencanaan Sistem Manajemen Mutu 6.1 Penanganan Risiko dan Peluang 6.2 Sasaran Mutu dan Rencana Pencapaian 6.3 Perubahan Yang Terencana 8

9 Training and consulting Struktur ISO 9001: Pendukung 7.1 Sumberdaya 7.2 Kompetensi 7.3 Pelatihan 7.4 Komunikasi 75I 7.5 Informasi yang Terdokumentasi 8. Operasi 8.1 Perencanaan dan Pengendalian Operasional 8.2 Penetapan Persyaratan Produk dan Jasa 8.3 Desain dan Pengembangan Produk dan Jasa 84Pengendalian 8.4 Produk & Jasa yang disediakan Pihak Eksternal 8.5 Produksi dan Penyediaan Jasa 8.6 Merilis Produk dan Jasa 8.7 Pengendalian Proses, Produk dan Jasa yang Tidak Sesuai 9

10 Training and consulting Struktur ISO 9001: Evaluasi Kinerja 9.1 Pemantauan, Pengukuran, Analisis dan Evaluasi 9.2 Audit Internal 9.3 Management Review 10. Perbaikan 10.1 Umum 10.2 Ketidaksesusaian dan Tindakan Koreksi 10.3 Perbaikan Berkelanjutan 10

11 4 Context of organization 5 Leadership Plan 6 Planning Training and consulting 7 Support Do Check Act 8 Operation 9 Performance and Evaluation 10 Improvement 4.1 Understanding context 4.2 Interested parties 4.3 Scope 4.4 QMS Actions to Resources Operational Monitoring, General measurement, address risks and planning and analysis and opportunities control evaluation People 8.2 Nonconformity Policy 6.2 Requirements for and corrective Quality objectives Customer action Infrastructure and planning satisfaction Leadership and commitment 5.3 Organizational roles, responsibilities and authorities 6.3 Planning of changes Environment for the operation of processes Monitoring and measuring resources Organizational knowledge 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information 8.3 Design and development of 8.4 Control of externally provided processes, Control of nonconforming outputs Analysis and evaluation 9.2 Internal audit 9.3 Management review 10.3 Continual improvement 11

12 Training and consulting Klausul 4.1 Organisasi harus menetapkan isu eksternal dan internal yang relevan dengan tujuan dan arah organisasi yang Context of organization Understanding context strategis. 4.2 Interested parties 4.3 Scope 4.4 QMS Konteks internal misalnya isu-isu nilai, budaya, pengetahuan dan kinerja organisasi. Konteks eksternal misalnya isu-isu yang berkaitan dengan aspek hukum, teknologi, persaingan, pasar, budaya, sosial dan ekonomi serta lingkungan, baik internasional, nasional maupun regional. Klausul 4.2 Mengidentifikasi pihak-pihak yang berkepentingan (interested parties) dan persyaratan mereka 12

13 Training and consulting 4 Context of organization Understanding context 4.2 Interested parties 4.3 Scope 4.4 QMS Klausul 4.3 Ruang lingkup sistem manajemen mutu harus didokumentasikan dengan mempertimbangkan: Isu internal dan eksternal persyaratan pihak-pihak yang berkepentingan Produk dan jasa yang dihasilkan justifikasi apabila terdapat persyaratan standar ISO 9001 yang tidak relevan Klausul 4.4 Proses-proses dalam organisasi harus diidentifikasi yang mencakup: Input dan output proses Urutan dan interaksi antarproses Sumber daya, tanggung jawab dan aspek risiko 13

14 4 Context of organization 5 Leadership Plan 6 Planning Training and consulting 7 Support Do Check Act 8 Operation 9 Performance and Evaluation 10 Improvement 4.1 Understanding context 4.2 Interested parties 4.3 Scope 4.4 QMS Actions to Resources Operational Monitoring, General measurement, address risks and planning and analysis and opportunities control evaluation People 8.2 Nonconformity Policy 6.2 Requirements for and corrective Quality objectives Customer action Infrastructure and planning satisfaction Leadership and commitment 5.3 Organizational roles, responsibilities and authorities 6.3 Planning of changes Environment for the operation of processes Monitoring and measuring resources Organizational knowledge 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information 8.3 Design and development of 8.4 Control of externally provided processes, Control of nonconforming outputs Analysis and evaluation 9.2 Internal audit 9.3 Management review 10.3 Continual improvement 14

15 5 Leadership Leadership and commitment 5.2 Policy 5.3 Organizational roles, responsibilities and authorities Training and consulting Klausull Manajemen puncak harus menunjukkan kepemimpinan & komitmen terhadap penerapan sistem manajemen mutu: bertanggung jawab penuh atas penerapan sistem manajemen memastikan kebijakan mutu dan sasaran mutu ditetapkan Memastikan sistem manajemen mutu terintegrasi ke dalam proses bisnis organisasi. mempromosikan process approach dan risk based thinking memastikan kecukupan sumberdaya guna penerapan sistem manajemen mutu mengkomunikasikan pentingnya manajemen mutu yang efektif dan pemenuhan persyaratan sistem manajemen mutu memastikan sistem manajemen mutu mencapai hasil yang diinginkan. turut serta dan memberi arahan kepada personil agar berkontribusi terhadap penerapan sistem manajemen mutu yang efektif mempromosikan improvement mendukung peran jajaran manajemen dalam memperagakan kepemimpinan mereka di area tanggung jawabnya 15

16 Training and consulting 5 Leadership Leadership and commitment 5.2 Policy Klausull Fokus pelanggan dengan cara : memenuhi persyaratan pelanggan, perundang-undangan dan peraturan lain yang berlaku menetapkan risiko dan peluang yang berpengaruh terhadap kesesuaian produk dan jasa telah ditetapkan. fokus meningkatkan kepuasan pelanggan 5.3 Organizational roles, responsibilities and authorities Presentasi ISO /Nov15 16

17 Training and consulting 5 Leadership Leadership and commitment 5.2 Policy 5.3 Organizational roles, responsibilities and authorities Klausul 5.2 Manajemen puncak harus menetapkan kebijakan mutu Klausul 5.3 Manajemen puncak harus memastikan bahwa tanggung jawab dan wewenang telah ditetapkan, dikomunikasikan dan dipahami Presentasi ISO /Nov15 17

18 Plan Training and consulting Do Check Act 4 Context of organization 5 Leadership 6 Planning 7 Support 8 Operation 9 Performance and Evaluation 10 Improvement 4.1 Understanding context 4.2 Interested parties 4.3 Scope 4.4 QMS Leadership and commitment 5.2 Policy 5.3 Organizational roles, responsibilities and authorities Actions to address risks and opportunities 6.2 Quality objectives and planning 6.3 Planning of changes Resources Operational Monitoring, General planning and measurement, control analysis and evaluation People Nonconformity Infrastructure Environment for the operation of processes Monitoring and measuring resources Organizational knowledge 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information Requirements for 8.3 Design and development of 8.4 Control of externally provided processes, Control of nonconforming outputs Customer satisfaction Analysis and evaluation 9.2 Internal audit 9.3 Management review and corrective action 10.3 Continual improvement 18

19 Training and consulting 6 Planning 6.1 Actions to address risks and opportunities Objectives and planning Klausul 6.1 Risk management Klausul ini mensyaratkan organisasi mengidentifikasi risiko dan peluang, mengambil tindakan untuk mitigiasi risiko dan evaluasi tindakan yang telah diambil/ 6.3 Planning of changes Klausul 6.2 Organisasi harus menentukan sasaran mutu pada fungsi dan tingkatan yang relevan. Sasaran mutu harus terukur (SMART) Klausul l 6.3 Perubahan-perubahan harus terkontrol (change management) 19

20 4 Context of organization 5 Leadership Plan 6 Planning Training and consulting 7 Support Do Check Act 8 Operation 9 Performance and Evaluation 10 Improvement 4.1 Understanding context 4.2 Interested parties 4.3 Scope 4.4 QMS Leadership and commitment 5.2 Policy 5.3 Organizational roles, responsibilities and authorities Actions to address risks and opportunities Resources Operational Monitoring, General planning and measurement, control analysis and evaluation People Nonconformity 6.2 Requirements for and corrective Customer action Infrastructure satisfaction Objectives and planning 6.3 Planning of changes Environment for the operation of processes Monitoring and measuring resources Organizational knowledge 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information 8.3 Design and development of 8.4 Control of externally provided processes, Control of nonconforming outputs Analysis and evaluation 9.2 Internal audit 9.3 Management review 10.3 Continual improvement 20

21 Training and consulting 7 Support Klausul Resources People Infrastructure Environment for the operation of processes Monitoring and measuring resources Organizational knowledge 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information Sumber daya harus cukup tersedia untuk penerapan sistem manajemen mutu yang meliputi : internal resources external providers people monitoring and measuring resources organizational knowledge required to ensure the processes provide conforming external communication Klausul 7.2 Kompetensi personil harus ditetapkan Kompetensi berdasarkan pendidikan, pelatihan dan pengalama kerja 21

22 Training and consulting 7 Support Klausul 7.3 dan Resources People Infrastructure Personil yang bekerja dibawah kendali organisasi harus memahami sistem manajemen organisasi Saluran komunikasi internal dan eksternal harus ditetapkan Environment for the operation of processes Monitoring and measuring resources Organizational 7.2 Competence Klausul 7.5. Dokumen yang beredar harus terkontrol: SOP, Working Instruction, formulir, dll. knowledge Pengendalian dokumen internal dan eksternal 7.3 Awareness 7.4 Communication 7.5 Documented information Media dokumen termasuk kertas, video, sample, foto, dll Providing people with the information they need 22

23 4 Context of organization 5 Leadership Plan 6 Planning Training and consulting 7 Support Do Check Act 8 Operation 9 Performance and Evaluation 10 Improvement 4.1 Understanding context 4.2 Interested parties 4.3 Scope 4.4 QMS Leadership and commitment 5.2 Policy 5.3 Organizational roles, responsibilities and authorities Actions to address risks and opportunities 6.2 Objectives and planning 6.3 Planning of changes 7.1 Resources People Infrastructure Environment for the operation of processes Monitoring and measuring resources Organizational knowledge 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information Operational Monitoring, General planning and measurement, control analysis and evaluation Nonconformity Requirements for 8.3 Design and development of 8.4 Control of externally provided processes, Control of nonconforming outputs Customer satisfaction Analysis and evaluation 9.2 Internal audit 9.3 Management review and corrective action 10.3 Continual improvement 23

24 Training and consulting 8 Operation Klausul 8.1 Organisasi wajib melakukan kontrol proses 8.1 Operational planning and control 8.2 Requirements for 8.3 Design and development of 8.4 Control of externally provided processes, Control of nonconforming outputs Proses termasuk proses outsourcing Klausul Customer communications; customer property, and contingency actions Klausul Menetapkan persyaratan pelanggan; termasuk peraturan perundang-undangan g dan peraturan organisasi Klausul Melakukan review terhadap persyaratan barang dan jasa untuk memastikan organisasi dapat memenuhi persyaratan yang ditetapkan atau tidak 24

25 Training and consulting 8 Operation Klausul 8.3 Proses desain dan pengembangan harus terkendali 8.1 Operational planning and control 8.2 Requirements for perencanaan desain input desain kontrol desain 8.3 Design and development of output desain perubahan desain 8.4 Control of externally provided processes, Control of nonconforming outputs Klausul 8.4 Organisasi harus memastikan bahwa barang yang dibeli sesuai dengan persyaratan yang telah ditentukan 25

26 Training and consulting 8 Operation Klausul Operational planning and control 8.2 Requirements for Organisasi harus memastikan proses produksi dan jasa berlangsung dalam kondisi terkendali Klausul Persyaratan identifikasi dan mampu telusur 8.3 Design and development of Klausul Persyaratan properti pelanggan 8.4 Control of externally provided processes, Control of nonconforming outputs Klausul Persyaratan preservasi (penyimpanan) Klausul Persyaratan proses pengiriman dan after sales Klausul Persyaratan management of change 26

27 Training and consulting 8 Operation 8.1 Operational planning and control 8.2 Requirements for 8.3 Design and development of Klausul 8.6 Peryaratan untuk rilis produk dan jasa Evidence of conformity with the acceptance criteria Traceability to the person authorizing the release Klausul 8.7 nonconforming outputs shall be controlled. 8.4 Control of externally provided processes, Control of nonconforming outputs 27

28 4 Context of organization 5 Leadership Plan 6 Planning Training and consulting 7 Support Do Check Act 8 Operation 9 Performance and Evaluation 10 Improvement 4.1 Understanding context 4.2 Interested parties 4.3 Scope 4.4 QMS Leadership and commitment 5.2 Policy 5.3 Organizational roles, responsibilities and authorities Actions to address risks and opportunities 6.2 Objectives and planning 6.3 Planning of changes 7.1 Resources People Infrastructure Environment for the operation of processes Monitoring and measuring resources Organizational knowledge 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information Operational Monitoring, General planning and measurement, control analysis and evaluation Nonconformity Requirements for 8.3 Design and development of 8.4 Control of externally provided processes, Control of nonconforming outputs Customer satisfaction Analysis and evaluation 9.2 Internal audit 9.3 Management review and corrective action 10.3 Continual improvement 28

29 Training and consulting 9 Performance evaluation Monitoring, measurement, analysis and evaluation Customer satisfaction Analysis and evaluation 9.2 Internal audit 9.3 Management review Klausul Organisasi harus melakukan evaluasi terhadap kinerja sistem manajemen mutu Klausul Kepuasan pelanggan harus dimonitor Klausul Organisasi harus melakukan analisa dan evaluasi data dan informasi yang berasal dari proses pemantauan dan pengukuran. 29

30 Training and consulting 9 Performance evaluation Monitoring, measurement, analysis and evaluation Customer satisfaction Analysis and evaluation Klausul 9.2 Audit internal harus dilakukan secara berkala Program audit harus dibuat dan disahkan Audit internal harus dilaksanakan oleh auditor internal yang independen dan berkualifikasi Laporan audit harus tersedia yang berisi tindakan perbaikan 9.2 Internal audit 9.3 Management review 30

31 Training and consulting 9 Performance evaluation Monitoring, measurement, analysis and evaluation Customer satisfaction Analysis and evaluation 9.2 Internal audit 9.3 Management review Klausul 9.3 Management review Management review (tinjauan manajemen) harus dilakukan secara berkala. Agenda pembahasan management review meliputi 1. perubahan isu eksternal dan internal 2. informasi i kinerja dan efektifitas sistem manajemen mutu, 3. kepuasan pelanggan dan feedback pihak yang berkepentingan 4. tingkat pemenuhan sasaran mutu 5. ketidaksesuaian dan tindakan koreksi 6. hasil pemantauan dan pengukuran 7. hasil audit 8. kinerja proses dan kesesuaian produk dan jasa 9. kinerja external provider 10. kecukupan sumber daya 11. efektivitas tindakan yang diambil terhadap risiko dan peluang 12. peluang untuk perbaikan kinerja 13. status tindak lanjut dari management review yang lalu, 31

32 4 Context of organization 5 Leadership Plan 6 Planning Training and consulting 7 Support Do Check Act 8 Operation 9 Performance and Evaluation 10 Improvement 4.1 Understanding context 4.2 Interested parties 4.3 Scope 4.4 QMS Leadership and commitment 5.2 Policy 5.3 Organizational roles, responsibilities and authorities Actions to address risks and opportunities 6.2 Objectives and planning 6.3 Planning of changes 7.1 Resources People Infrastructure Environment for the operation of processes Monitoring and measuring resources Organizational knowledge 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information Operational Monitoring, General planning and measurement, control analysis and evaluation Nonconformity Requirements for 8.3 Design and development of 8.4 Control of externally provided processes, Control of nonconforming outputs Customer satisfaction Analysis and evaluation 9.2 Internal audit 9.3 Management review and corrective action 10.3 Continual improvement 32

33 Training and consulting 10 Improvement General 10.2 Nonconformity and corrective action Klausul 10.1 Organisasi harus mengambil tindakan improvemnet yang diperlukan guna memenuhi persyaratan pelanggan dan meningkatkan kepuasan pelanggan. CATATAN: Contoh improvement misalnya tindakan koreksi, korektif, perbaikan kontinyu, langkah perubahan (misalnya terobosan), inovasi atau re-organisasi 10.3 Continual improvement Klausul 10.2 Tindakan perbaikan harus dilakukan bila terjadi ketidaksesuaian (nonconformity) Klausul 10.3 Organisasi harus meningkatkan kesesuaian, kecukupan dan efektivitas sistem manajemen mutu secara terus-menerus (continual improvement). 33

34 Training and consulting Thank You Zulkifli Nasution SINTEGRAL Consulting 34