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1. VERSI TERBARUISO 9001:2015
Anda Siap untuk Berubah ?
By: M. Shobrie H.W., SE, CFA, CLA, CPHR, CPTr.

2. Latar Belakang
PadaTahun1987QMS-ISO9000untukpertamakalitelahmenjadiStandarInternasionalyangPalingPopulerdiDunia.
Setelahmelewatimasalebihdari25tahun,ISOtechnicalcommitteeISO/TC176,QualityManagementandQualityAssurance,subcommitteeSC2,QualitySystems,merupakanyangPalingSibukuntukurusanGenerasiberikutnyadariStandardSistemManajemenMutu.

3. Revisi-revisi ISO 9001 sejak Awal
1987
1994
2000
2008
2015
R E V I S I

4. Seri Standar ISO 9000
ISO9000MenjadiStandaryang“best- seller”danPalingKonsistendiantarastandar-standarlainnya.
SecaraMantaptelahMenetapkan“PlatformandLanguage”bagiOrganisasiuntukMembahasmasalah-masalahtentangMutu.
DenganMenetapkanPersyaratankedalamISO9001,SistemManajemenMutuISOmemberikan“base-levelconfidence”bagiOrganisasiuntukMenyediakanProduk- produkYangSesuai,telahmemberikansumbangsihbesarbagiperdagangandunia.

5. Seri Terbaru ISO 9001:2015
ISO9001:2008is Requirements –
Quality Management System (QMS)
Versi Lama
ISO9004:2009is Managing for the sustained success of an organization –
A Quality Management Approach (QMA)

6. Memperhatikan ke Masa Depan
Visi dari Komite Standar ISO yang melihat jauh ke Depan

7. REVISION OF QUALITY PRINCIPLES
Prinsip Dasar Direvisi dari Delapanmenjadi Tujuh

8. 4. Process
Approach
Prinsip-prinsip Mutu
7 Prinsip DasarManajemen Mutu

9. Jadwal ReleaseISO 9001:2015

10. 6. Planning
7. Support
9. Performance Evaluation
10. Improvement
1. Scope
2. Normative References
4. Context of Organization
5. Leadership
10 Klausul ISO 9001:20153. Terms and Definition8. Operations

11. Klausul yang Diusulkan FDIS
1.Scope
2.Normative References
3.Terms and Definitions
3.01. Organization
3.02. Interested Party (preferred term)
3.03. Requirement
3.04. Management System
3.05. Top Management
3.06. Effectiveness
3.07. Policy

12. 3.08. Objective
3.09. Risk
3.10. Competence
3.11. Documented Information
3.12. Process
3.13. Performance
3.14. Outsource
3.15. Monitoring
3.16. Measurement Process
3.17. Audit Klausul yang Diusulkan FDIS

13. 3.18. Conformity
3.19. Non-conformity
3.20. Correction
3.21. Corrective Action
3.22. Continual Improvement
Klausul yang Diusulkan FDIS

14. WELCOME TO REQUIREMENTS
PERSYARATAN YG DIUSULKAN

15. Klausul 4. Context of Organization
4.1.Understanding the organization and its context
4.2. Understanding the needs and expectations of interested parties
4.3.Determining the scope of the quality management system
4.4.Quality Management System
4.4.1. General
4.4.2. Process Approach

16. Klausul 5. Leadership5.1. Leadership & Commitment5.2. Quality Policy
5.3. Organizational Roles,
Responsibilities & Authorities
5. Leadership

17. Klausul 6. Planning
6.1. Actions to address risks &
opportunities
6.2. Quality objectives & planning
To achieve them
6.3. Planning of changes
6. Planning

18. Klausul 7. Support7. Support
7.2
7.5
7.3
7.47.1
Resources
Competence
Awareness
Documented Information
Communication

19. 7.5. Documented Information
7.5
GeneralCreating andUpdating
Control
of
Documented
Information

20. Klausul 8. Operation
8.1.Operational planning and control
8.2.Determination of market needs & interactions with customers
8.3.Operational planning process
8.4.Control of external provision of goods and services
8.5.Development of goods and services
8.6.Production of goods& provision of services
8.7.Release of goods and services
8.8.Non-conforming goods and services

21. Catatan
Klausul 8 meng-coverpersyaratan pada Klausul 7 dalam Versi Lama.
Klausul 7.3 design & development dlm Versi Lama, Disederhanakan di dalam Klausul 8.5 development of goods and servicesVersi Baru.
Standard ISO Versi Baru (Versi 2015) mampu memecahkan persoalan yang berhubungan dgn masalah-masalah “design and development”.

22. Klausul 9. Performance Evaluation
9.1.9.2.
9.3.
Monitoring, Measurement , Analysis and Evaluation :
9.1.1.General, 9.1.2.Customer satisfaction, 9.1.3. Analysis and evaluation of data
Internal Audit
Management Review

23. 10.1. Nonconformity and Corrective Action
10.2. Improvement
Klausul 10. Improvement

24. HUBUNGI0878-7063-5053M.SHOBRIE@GMAIL.COM
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