ISO

1. ISO
inQualityManagementSystem

2. What is ISO?
 ISO = International Standard, published by InternationalOrganization for
Standardization
 Has members from 162 countries – HQ in Geneva
 As per August 8, 2017 there are 21740 published ISO standards

3. ISO 639 – Language Codes
 ISO 3166 – Country Codes
 ISO 4217 – Currency Codes
 ISO 9001: 2008 – Quality Management Systems
 ISO 13485: 2012 – Medical Devices Quality Management Systems
 ISO 14001: 2004 – Environmental Management Systems
 ISO 16949: 2009 – Automotive Production and Relevant Service Part Organizations
 ISO 17025: 2005 –Testing and Callibration
 OHSAS 18001: 2007 – Occupational Health and Safety
 ISO 19011: 2012 – Guidelines forAuditing Management Systems
 ISO 22000: 2005 – Food Safety Management Systems
 ISO 22301:2012 – Business Continuity Management
 ISO 26000: 2010 – Social Responsibility
 ISO 27000: 2009 – InformationTechnology
 ISO 31000: 2009 – Risk Management
 ISO 50001: 2011 – Energy Management System
 ISO 55000: - Asset Management Standard
 ISO 80000-3:2006 - System and Quantities (etc. time, units)
3

4. History of ISO  FMEA – Failure Mode and EffectsAnalysis

5. Why we need
Standard?
o For GlobalTrade
as Lingua Franca
o For Company
Minimize variance & waste, increasing productivity, access to
market, premium price
o For Customer
Consistency of quality & safety
o For Government
Market protection

6. 6
PDCA ISO 9001:2008 ISO 14001:2004 ISO 18001:2007
PLAN
5.1. Komitmen Manajemen
5.2. Fokus Pelanggan
5.3. Kebijakan Kualitas
5.4. Perencanaan
5.4.1. Tujuan Kualitas
5.4.2. Perencanaan Sistem Manajemen Kualitas
4.2. Persyaratan Dokumentasi
6.1. – 6.4. Manajemen Sumber Daya Manusia
4.2. Kebijakan Lingkungan
4.3. Perencanaan
4.3.1. Aspek Lingkungan
4.3.2. Persyaratan Peraturan Perundangan
4.3.3. Tujuan, Sasaran, dan Program
4.2 Kebijakan Kesehatan dan Keselamatan Kerja
4.3. Perencanaan
4.3.1. Identifikasi Bahaya, Penilaian Risiko, dan
Penentuan Kontrol
4.3.2. Persyaratan Peraturan Perundangan
4.3.3. Tujuan, Sasaran, dan Program
DO
5.5. Tanggungjawab, Kewenangan, dan Komunikasi
6.2.2. Kompetensi, Kesadaran, dan Pelatihan
6.3. Infrastruktur
6.4. Lingkungan Kerja
7.1. Perencanaan Realisasi Produk
7.2. Proses Terkait Pelanggan
7.3. Perancangan dan Pengembangan
7.4. Pembelian
7.5. Produksi dan Pelayanan
7.6. Pengendalian Pemantauan dan Peralatan
Pengukuran
4.4.1. Sumber Daya, Peran, Tanggungjawab,
Kewenangan
4.4.2. Kompetensi, Pelatihan, dan Kesadaran
4.4.3. Komunikasi
4.4.4. Dokumentasi
4.4.5. Pengendalian Dokumen
4.4.6. Pengendalian Operasional
4.4.7. Kesiapsiagaan dan Tanggap Darurat
4.4.1. Sumber Daya, Peran, Tanggungjawab,
Akuntabilitas
4.4.2. Kompetensi, Pelatihan, dan Kesadaran
4.4.3. Komunikasi, Partisipasi, dan Konsultansi
4.4.4. Dokumentasi
4.4.5. Pengendalian Dokumen
4.4.6. Pengendalian Operasional
4.4.7. Kesiagaan dan Tanggap Darurat
CHECK
8.2.1 – 8.2.4. Pemantauan dan Pengukuran
8.3. Pengendalian Ketidaksesuaian Produk
8.4. Analisis Data
4.2.3. Pengendalian Dokumen
4.2.4. Pengendalian Catatan dan Rekaman
4.5.1. Pemantauan dan Pengukuran
4.5.2. Evaluasi Kesesuaian
4.5.3. Ketidaksesuaian, Tindakan Perbaikan, dan
Tindakan Pencegahan
4.5.4. Pengendalian Catatan atau Rekaman
4.5.5. Audit Internal
4.5.1. Pengukuran Kinerja dan Pemantauan
4.5.2. Evaluasi Kesesuaian
4.5.3. Investigasi Insiden, Ketidaksesuaian, Tindakan
Perbaikan, dan Tindakan Pencegahan
4.5.4. Pengendalian Catatan atau Rekaman
4.5.5. Audit Internal
ACTION
5.6. Peninjauan-ulang Manajemen
8.5.1. Penyempurnaan Berkesinambungan
8.5.2. Tindakan Perbaikan
4.6. Peninjauan-ulang Manajemen 4.6. Peninjauan-ulang Manajemen
Aplikasi PDCA
dengan klausul-
klausul ISO
9001, 14001,
18001

7. ISO 9001
Clause
4.2:
Understanding the Needs and Expectations of Interested Parties
Due to their effect, or potential effect, on your ability to consistently provide products and
services that meet customer and applicable legal requirements, determine:
a) interested parties that are relevant to the quality management system;
b) relevant requirements of these interested parties.
5.5. Kebijakan Kualitas
6.4. Lingkungan Kerja
8.3. Pengendalian Ketidaksesuaian Produk
8.5.1. Penyempurnaan Berkesinambungan
8.5.2.Tindakan Perbaikan
8.5.3.Tindakan Pencegahan

8. KnowYour
‘Customer’
Interested Parties Needs & Expectation
End user Good product/service, quick delivery, affordable price
Owner RoI, productivity
Workers Good wages, safe & friendly working place
Community CSR, environmental friendly product
Government Compliance to regulations
Suppliers Clear transaction

9. ISO 9001
Clause
“Do what you write
Write what you do”

10. What is a
“document”?
Any information or instructions including policy
statements, text books, procedures, specifications,
charts, posters, notices, memoranda, drawings,
regulations, standards, etc.

11. The Benefits of
ISO 9000….
www.the9000store.com

12. Dun and
Bradstreet
findings:
85% of registered firms report external benefits
 Higher perceived quality
 Greater customer demand
www.the9000store.com

13. Dun and
Bradstreet
findings:
95% report internal benefits
 Greater employee awareness
 Increased operational efficiency
 Reduced scrap expense
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14. OtherCaseStudies showed:
 30% Reduction in customer claims
 95% improvement in delivery time
 Reduced defects from 3% to 0.5%
 40% reduction in product cycle time.
 20% increase in on-time delivery
 International acceptance and recognition
 Facilitated trade in international markets
 Promoting of safety, reliability and quality in
food products.
ISO Registration resulted in:

15. Irwin
Professional
Publishing
survey results
show:
 30% Of registered companies experience
increased customer demand.
 50% Of registered companies have decreased
number of customer audits.
 69% Of registered companies have a
competitive advantage in their market.
 83% Of registered companies products have
higher perceived quality in the marketplace.
www.the9000store.com