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KLAUSUL ISO 9001:2015

1. Lingkup 7.4 Komunikasi 8.5.5 Kegiatan Pasca Pengiriman


2. Referensi Normatif 7.5 Informasi Terdokumentasi 8.5.6 Pengendalian Perubahan (R)
3. Istilah & Definisi 7.5.1 Umum 8.6 Pelepasan Produk dan Jasa (R)
4. Konteks Organisasi (5) 7.5.2 Membuat & Memperbarui 8.7 Pengendalian Hasil Tidak Sesuai (R)
4.1 Memahami Organisasi dan Konteksnya 7.5.3 Pengendalian Informasi Terdokumentasi 9. Evaluasi Kinerja (10)
4.2 Memahami Kebutuhan dan Ekspektasi Pihak- (R) 9.1 Pemantauan, Pengukuran, Analisa dan Evaluasi
pihak yang Berkepentingan 8. Operasi (27) 9.1.1 Umum (R)
4.3 Menetapkan Ruang Lingkup Sistem Manajemen 8.1 Perencanaan dan Pengendalian Operasional 9.1.2 Kepuasan Pelanggan
Mutu (M) 8.2 Persyaratan Produk dan Jasa 9.1.3 Analisa dan Evaluasi
4.4 Sistem Manajemen Mutu dan Prosesnya 8.2.1 Komunikasi Pelanggan 9.2 Audit Internal (R)
5. Kepemimpinan (8) 8.2.2 Penentuan Persyaratan Terkait Produk 9.3 Tinjauan Manajemen
5.1 Kepemimpinan dan Komitmen dan Jasa 9.3.1 Umum
5.1.1 Umum 8.2.3 Tinjauan Persyaratan yang Terkait 9.3.2 Masukan Tinjauan Manajemen
5.1.2 Fokus Pelanggan dengan Produk dan Jasa (R) 9.3.3 Keluaran Tinjauan Manajemen (R)
5.2 Kebijakan 8.2.4 Perubahan Persyaratan Produk dan Jasa 10. Peningkatan (4)
5.2.1 Menetapkan Kebijakan Mutu 8.3 Desain dan Pengembangan Produk dan Jasa 10.1 Umum
5.2.2 Mengkomunikasikan Kebijakan Mutu (M) 8.3.1 Umum 10.2 Ketidaksesuaian dan Tindakan Perbaikan (R)
5.3 Peran, Tanggungjawab, & Wewenang Organisasi 8.3.2 Perencanaan Desain dan Pengembangan 10.3 Peningkatan Berkesinambungan
6. Perencanaan (4) 8.3.3 Masukan Desain dan Pengembangan (R)
6.1 Tindakan untuk Menetapkan Resiko & Peluang 8.3.4 Pengendalian Desain dan
6.2 Sasaran Mutu & Perencanaan untuk Mencapai Pengembangan (R)
Sasaran Mutu (M) 8.3.5 Keluaran Desain dan Pengembangan (R)
6.3 Perencanaan Perubahan 8.3.6 Perubahan Desain dan Pengembangan Total : 76 klausul
7. Pendukung (15) (R)
7.1 Sumber Daya 8.4 Pengendalian Penyedia Eksternal Proses, Produk
7.1.1 Umum dan Jasa
7.1.2 Personil 8.4.1 Umum (R)
7.1.3 Infrastruktur 8.4.2 Jenis dan Lingkup Pengendalian
7.1.4 Lingkungan untuk Melaksanakan Proses 8.4.3 Informasi untuk Penyedia Eksternal
7.1.5 Pemantauan dan Pengukuran Sumber 8.5 Penyedian Produksi & Jasa
Daya 8.5.1 Pengendalian Penyediaan Produksi dan
7.1.5.1 Umum (R) Jasa
7.1.5.2 Pengukuran Mampu Telusur (R) 8.5.2 Identifiaksi dan Mampu Telusur (R)
7.1.6 Pengetahuan Organisasi 8.5.3 Properti Milik Pelanggan maupun
7.2 Kompetensi (R) Penyedia Eksternal (R)
7.3 Kesadaran 8.5.4 Pemeliharaan
KLAUSUL ISO 9001:2015

1. Scope 7.4 Communication 8.7 Control of nonconforming outputs


2. Normative references 7.5 Documented information 9. Performance evaluation
3. Terms and definitions 7.5.1 General 9.1 Monitoring, measurement, analysis and evaluation
4. Context of the organization 7.5.2 Creating and updating 9.1.1 General
4.1 Understanding the organization and its context 7.5.3 Control of documented information 9.1.2 Customer satisfaction
4.2 Understanding the needs and expectations of 8. Operation 9.1.3 Analysis and evaluation
interested parties 8.1 Operational planning and control 9.2 Internal audit
4.3 Determining the scope of the quality management 8.2 Requirements for products and services 9.3 Management review
system 8.2.1 Customer communication 9.3.1 General
4.4 Quality management system and its processes 8.2.2 Determining the requirements related to 9.3.2 Management review inputs
5. Leadership products and services 9.3.3 Management review outputs
5.1 Leadership and commitment 8.2.3 Review of requirements related to 10. Improvement
5.1.1 General products and services 10.1 General
5.1.2 Customer focus 8.2.4 Changes to requirements for products 10.2 Nonconformity and corrective action
5.2 Policy and services 10.3 Continual improvement
5.2.1 Establishing the quality policy 8.3 Design and development of products and services
5.2.2 Communicating the quality policy 8.3.1 General
5.3 Organizational roles, responsibilities and 8.3.2 Design and development planning
authorities 8.3.3 Design and development inputs
6. Planning 8.3.4 Design and development controls
6.1 Actions to address risks and opportunities 8.3.5 Design and development outputs
6.2 Quality objectives and planning to achieve them 8.3.6 Design and development changes
6.3 Planning of changes 8.4 Control of externally provided processes, products
7. Support and services
7.1 Resources 8.4.1 General
7.1.1 General 8.4.2 Type and extent of control
7.1.2 People 8.4.3 Information for external providers
7.1.3 Infrastructure 8.5 Production and service provision
7.1.4 Environment for the operation of 8.5.1 Control of production and service
processes provision
7.1.5 Monitoring and measuring resources 8.5.2 Identification and traceability
7.1.5.1 General 8.5.3 Property belonging to customers or
7.1.5.2 Measurement Traceability external providers
7.1.6 Organizational knowledge 8.5.4 Preservation
7.2 Competence 8.5.5 Post-delivery activitiesControl of changes
7.3 Awareness 8.6 Release of products and services

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