ISO 9001 : 2015

What is ISO 9001:2015?

• The ISO 9001:2015 standard is based on Seven
Quality Management Principles:
a) Customer focus
b) Leadership
c) Engagement of People
d) The Process Approach
e) Improvement
f) Evidence-based Decisions
g) Relationship management
• A well-designed and well-implemented quality
management system can and should eliminate

• Ineffectiveness
• Inefficiencies
• Problems
• Errors
• Inconsistencies
• Malicious practices
• Uncertainties
• Bad culture
 4. Context of The Organization
4.1 Understanding the organization
and its context
-internal and external issues
4.2 Understanding the needs and
expectations of interested parties
-who are your customers?
-what are their requirements?
4.3 Determining the scope of the
Quality Management System
-Internal Standard
-Goal? Customer Satisfaction
4.4 Quality Management System and
its processes
-PDCA
4.1 Memahami organisasi dan
konteksnya
-masalah internal dan external
4.2 Memahami kebutuhan dan
harapan pihak yang berkepentingan
-siapa customer anda?
-apa saja persyaratan mereka?
4.3 Menentukan lingkup sistem
manajemen mutu
-Standar Internal
-tujuan? Kepuasan Pelanggan
4.4 Sistem manajemen mutu dan
proses-prosesnya
-PDCA
 5. LEADERSHIP
5.1 Leadership and commitment
-Management demonstrates
leadership and commitment
by taking accountability and
communicating to the staff.
Everything must be clear and
understood.
5.2 Policy
-Quality policy
-available
5.3 Organizational roles,
responsibilities, and
authorities
5.1 Kepemimpinan dan
komitmen
-manajemen menunjukkan
kepemimpinan dan
komitmen dengan
mengambil akuntabilitas dan
berkomunikasi dengan staff
5.2 Kebijakan
-Kebijakan mutu
-tersedia
5.3 Peran organisasi, tanggung
jawab dan kewenangan
 6. Planning
6.1 Action to address risks 6.1 Tindakan terhadap
and opportunities risiko dan peluang
-Evidence-Based Vs Risk- -Evidence-based Vs
Based Risk-Based
6.2 Quality objectives and 6.2 Sasaran mutu dan
planning to achieve them perencanaan untuk
-must be documented mencapainya
6.3 Planning of changes -harus terdokumentasi
-want to change? Plan it! 6.3 Perencanaan perubahan
-Risk-Based thinking
 7. Support
7.1 Resources
-7.1.1 (a) focus on existing internal
resources
-7.1.4 ensuring physically and
emotionally protective environment
7.2 Competence
-ensure the persons are competent
based on education, training, or
experience
7.3 Awareness
-employees must be aware of the
QMS requirements and the
consequences for not conforming
7.4 Communication
-must determine the way to
communicate
7.5 Documented Information
7.1 Sumber Daya
-7.1.1 (a) mengutamakan sumber daya
internal yang ada
-7.1.4 menjamin lingkungan kerja yang
melindungi fisik dan psikis pekerja
7.2 Kompetensi
-memastikan karyawan yang kompeten
Berdasarkan pendidikan, pelatihan, atau
Pengalaman
7.3 Kesadaran
-karyawan harus mengetahui persyaratan
Sistem Manajemen Mutu dan akibat dari
Ketidaksesuaian
7.4 Komunikasi
-harus menentukan sarana komunikasi
7.5 Informasi yang terdokumentasi
 8. Operation
8.1 Operational planning and control
-keep all the documented
information
-why?
8.2 Requirements for products and
services
-communicate with the
customers and understand their
requirements
8.3 Design and development of
products and services
-based on the input from the
customers
8.1 perencanaan dan pengendalian
operasional
-simpan semua dokumen
Informasi
-mengapa?
8.2 Persyaratan untuk produk dan
jasa
-berkomunikasi dengan
pelanggan dan mengerti
kemauan mereka
8.3 Desain dan pengembangan
produk dan jasa
-berdasarkan input dari
pelanggan
 8. Operation
8.4 Control of externally provided
processes, products, and
services
-should control (evaluate) all
the providers
8.5 Production and service
provision
-how to appoint a
provider/supplier?
8.6 Release of products and
services
8.7 Control of non-conforming
outputs
8.4 Pengendalian proses, produk,
dan jasa yang disediakan dari
luar (eksternal)
-harus kontrol (evaluasi)
semua penyedia
8.5 Penyediaan produksi dan
layanan
-bagaimana cara memilih
penyedia/supplier?
8.6 Rilis produk dan layanan
8.7 Pengendalian
ketidaksesuaian output
 9. Performance Evaluation
9.1Monitoring, 9.1Pengawasan,
measurement, analysis, pengukuran, analisa,
and evaluation dan evaluasi
- CHECK - CHECK
9.2 Internal Audit 9.2 Audit Internal
9.3 Management Review 9.3 Tinjauan Ulang
Manajemen
 10. Improvement
10.1 General 10.1 Gambaran umum
10.2 Non-conformity and 10.2 Ketidaksesuaian dan
corrective action tindakan korektif
10.3 Continual 10.3 Peningkatan
improvement berkelanjutan
-Continual -Peningkatan
improvement Vs Berkelanjutan Vs terobosan
Breakthroughs -PDCA yang memungkinkan
-feasible PDCA
SEKIAN DAN TERIMAKASIH