The document provides information about an ISO 9001:2015 Quality Management System (QMS) awareness training for PT. Global Teknologi Teraindo. It discusses key aspects of ISO 9001 including an overview of quality management systems, the benefits of implementing ISO 9001, and the requirements of the standard. It also provides context about ISO 9001 revisions and the new 2015 version. The trainer, Harry Eko, will cover topics such as quality definitions, customer satisfaction, ISO 9001 requirements, continual improvement concepts, and tips for getting started with implementation.
ISO 9001:2015 sets out the criteria for a quality management system and is the only standard in the family that can be certified to (although this is not a requirement). It can be used by any organization, large or small, regardless of its field of activity. In fact, there are over one million companies and organizations in over 170 countries certified to ISO 9001.
NDC Management is a legal compliance consultancy. We have ISO certification specialists, helps you to develop ISO standards in your organization to meet quality management system
ISO 9001:2015 and how it can bring benefits to organisations in any sector and of any size. We take an overview based on some case studys from ISO.org.
These standards are guidelines on how to document the processes in specific industries. The goal is consistency and a set of complete, easy to follow instructions. ISO 9000 is a set of five guideline standards that define the requirements for an effective quality management system.
ISO 9001 ultimate guide to the core quality management standard.pdfFaiz Alkhawlani
This document describes the ultimate goals to quality control in medical laboratory and provide guidance for the accurately diagnosis of patients specimens ordered by the medical doctors
Are you thinking about establishing a Quality Management System in your business?
Not sure about how to get started or the next steps?
BSI presents the basics of ISO 9001: defining the need for a Quality Management System (QMS), staying ahead of common major and minor conformities, and the journey to certification to continual improvement.
With the next revision to ISO 9001 coming out next year, now is the time to plan for establishing a QMS. In this presentation, you can learn:
• What is ISO 9001?
• How is ISO 9001 important to Small and Medium Enterprises?
• What steps are involved in creating a successful QMS?
• What are the benefits of ISO 9001?
• Why certification?
• How to achieve continual improvement with training, tools, and technology
To enroll in a FREE recording of this presentation, sign up in the BSI Learning Marketplace here: http://tinyurl.com/kxvqfo6
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With the next revision to ISO 9001 coming out next year, now is the time to plan for establishing a QMS. In this presentation, you can learn:
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Awarenes ISO 9001 HE 10-11agt2023 for PT. Global Teknologi Teraindo.pdf
1. AWARENESS TRAINING
ISO 9001:2015
SISTEM MANAJEMEN KUALITAS
( QUALITY MANAGEMENT SYSTEM - QMS)
Harry Eko, ST., M.Kom(cand)
ICT Senior Consultant
ISO 27001:2022 Trainer, Implementator,
Lead Auditor
ISO 9001:2015 Trainer and Implementator
Klien : PT. Global Teknologi Teraindo
Business : Insurance ( Asuransi )
Lokasi : Gedung Cyber I, Jl. Kuningan Barat
Raya No.8, RT.1/RW.3, West
Kuningan, Mampang Prapatan, South
Jakarta City, Jakarta 12710
Tanggal : 10-11 Agustus 2023
2. “ ….TIDAK ADA YANG ABADI MELAINKAN PERUBAHAN
ITU SENDIRI… “
Perubahan adalah suatu kepastian yang harus dihadapi setiap organisasi.
Mampukah mereka bertahan dalam arus perubahan, ataukah ikut tergerus
didalamnya.
Dengan penerapan metode dan tools yang tepat, banyak
organisasi mampu menunjukkan eksistensinya di era persaingan
yang semakin ketat ini.
ISO 9001:2015
3. What is ISO 9001?
ISO 9001 is a standard that sets out the requirements for
a quality management system. It helps businesses and
organizations to be more efficient and improve customer
satisfaction.
A new version of the standard, ISO 9001:2015, has just been
launched, replacing the previous version (ISO 9001:2008).
4. Whatisaqualitymanagementsystem?
• A quality management system is a way of defining how an
organization can meet the requirements of its customers and
other stakeholders affected by its work.
• ISO 9001 is based on the idea of continual improvement.
• It doesn’t specify what the objectives relating to “quality” or “meeting
customer needs” should be, but requires organizations to define
these objectives themselves and continually improve their processes
in order to reach them.
5. WhoisISO9001for?
• ISO 9001 is suitable for organizations of all types, sizes and sectors.
• In fact, one of the key improvements of the newly revised ISO
9001:2015 was to make it more applicable and accessible to all types
of enterprises.
• Smaller companies that do not have staff dedicated to quality can still
enjoy the benefits of implementing the standard – ISO has many
resources to assist them.
6. Whatbenefitswillitbringtomy
businessororganization?
Implementing a quality management system will help you:
• Assess the overall context of your organization to define who is
affected by your work and what they expect from you. This will
enable you to clearly state your objectives and identify new
business opportunities.
• Put your customers first, making sure you consistently meet their
needs and enhance their satisfaction. This can lead to repeat
custom, new clients and increased business for your organization.
7. ISO9001:benefits
• Work in a more efficient way as all your processes will be aligned
and understood by everyone in the business or organization. This
increases productivity and efficiency, bringing internal costs down.
• Meet the necessary statutory and regulatory requirements.
• Expand into new markets, as some sectors and clients require
ISO 9001 before doing business.
• Identify and address the risks associated with your organization
8. MENGAPA PERLU MUTU?
Tuntutan Pasar
Semakin
Meningkat
Tingkat Persaingan
Semakin Tinggi
Kepuasan
Pelanggan Survive
Hanya Organisasi / Bidang Usaha Yang Memperhatikan
Mutu Yang Dapat Bertahan Hidup dan Memenangkan
Persaingan
9. DEFINISI MUTU
❖Sesuai dengan kegunaan
(Fitness for Use – J. M Juran)
❖Memenuhi persyaratan pelanggan
(Conform to Customer Requirement – Phillip B.
Crosby)
❖Memenuhi harapan pelanggan
(Meeting Customer Expectations – A. V.
Feigenbaum)
❖Kepuasan pelanggan
(Customer Satisfaction – K. Ishikawa)
10. TINGKAT KEPUASAN PELANGGAN
Customer Satisfaction,
Pelanggan puas sesuai harapannya
B
E
T
T
E
R
Delight Customer,
Pelanggan puas karena
mendapatkan lebih dari harapannya.
Advocate Customer,
Pelanggan merekomendasikan kita
kepada orang lain.
Loyal Customer,
Pelanggan sangat bergantung kepada kita.
12. Should I be certified to ISO 9001?
• Certification - when an independent certification body audits your
practices against the requirements of the standard – is not a
requirement of ISO 9001, but is a way of showing stakeholders that
you have implemented the standard properly.
• For some companies, third- party certification may be a
requirement. For example, some governments or public bodies may
only contract suppliers that have been certified to ISO 9001.
• ISO does not perform certification. For more information about the
certification process, see www.iso.org and the publication ISO
9001:2015 – How to use it.
13. How do I get started with ISO 9001:2015?
Key tips
Tip 1 – Define your objectives. Why do you want to implement the standard?
Tip 2 – Ensure senior management is on board. It is crucial that everyone is
supportive of the initiative and its objectives. The publications Reaping the
benefits of ISO 9001 and ISO 9001: Debunking the myths may help with this.
Tip 3 – Identify your organization’s key processes for meeting your objectives
and customers’ needs. Within each of these processes, ensure you understand
your customers’ requirements and can guarantee that these are met. This will
form the basis of your quality management system.
14. Examples of success with ISO 9001
ISO 9001 is used successfully all over the world. In 2013 alone, over
one million certificates to the standard were issued across 187
countries, and many other companies and organizations have used the
standard without seeking certification.
Success with ISO 9001 can take many forms. For some enterprises, it is
all about attracting new clients, while others see it as the blueprint for
internal efficiency.
15. Other standards in the 9000 family
There are many other standards in the ISO 9000 series that can help you reap
the full benefits of a quality management system and put customer satisfaction
at the heart of your business.
• ISO 9000 contains detailed explanations of the seven quality management
principles with tips on how to ensure these are reflected in the way you
work. It also contains many of the terms and definitions used in ISO 9001.
• ISO 9004 provides guidance on how to achieve sustained success with your
quality management system.
• ISO 19011 gives guidance for performing both internal and external audits
to ISO 9001. This will help ensure your quality management system delivers
on promise and will prepare you for an external audit, should you decide to
seek third-party certification.
16. Faktor yang mempengaruhi SMM
MUTU TERPADU
SISTEM MANUSIA MANAJEMEN
KOMITMEN
KESADARAN
TANGGUNG
JAWAB
KETERLIBATAN
KEBIJAKAN MUTU
SASARAN MUTU
RENCANA PENGEMBANGAN
PENYEDIAAN SUMBER
DAYA
SUPERVISI
SPESIFIKASI
STANDARD
KONSISTENSI
PERBAIKAN
SERTIFIKASI
17. KONSEP PDCA DALAM
SISTEM MANAJEMEN MUTU
Kemajuan Organisasi akan berbeda satu dengan yang lain,
tergantung dari IMPROVEMENT yang dilakukan
18. SEJARAH ISO 9001
Seri ISO 9000 Tahun 2000
• Perubahan keluarga standar
• Penekanan pada siklus
peningkatan mutu yang
berkesinambungan
• Fokus pada pelanggan
• Pendekatan proses
Seri ISO 9000
Tahun 1994
Tidak ada perubahan yang
Radikal dari Versi Tahun
1987
Seri ISO 9000
Tahun 1987
•Sistem mutu untuk” Manufakturing”
•Fokus terhadap pelanggan tersamar
•Formalitas dokumentasi
•Konsistensi mutu produk / jasa
Seri ISO 9001 versi
2008
Seri ISO 9001
versi 2015
Pemahaman Manajemen Mutu Berbasis ISO 9001:2015
19. STANDAR KLAUSUL ISO 9001:2015
(ANNEX SL” HIGH LEVEL STRUCTURE)
1.
2.
3.
4.
Scope
Normative references
Terms and definitions
Context of the organization
Understanding the organization and its
context
7. Support
• Resources
• Competence
• Awareness
• Communication
•
• Documented information
8.
9.
Operation
• Operational planning and control
Needs and expectations of
interested parties
Determining the scope
Management System
•
Performance evaluation
•
• • Monitoring, measurement,
analysis & evaluation
• Internal audit
5. Leadership
• Leadership and commitment
• Policy
• Roles, responsibility and
• Management review
10. Improvement
• Non conformity and corrective
action
• Continual Improvement
Authority
Planning
• Actions to address risks &
opportunities
• Objectives and plans to achieve them
6.
20. MODEL PROSES ISO 9001:2015
Result Of
The QMS
Leadership
(5)
Performance
Evaluation
(9)
Planning
(6)
Improvement
(10)
Support,
(7)
Operation
(8)
DO
QUALITY MANAGEMENT SYSTEM (4)
PLAN
CHECK
ACT
Organization
and its Context
(4)
Customer
Requirements
Need and Expectations
Of Relevant Interested
Parties (4)
Customer
Satisfaction
Product And
Services
21. KONSEP IMPLEMENTASI
VISI & MISI
KEBIJAKAN
MUTU
SASARAN
MUTU /
TARGET
PROGRAM
PENCAPAIAN
DESAIN BISNIS
PROSES
CEK &
EVALUASI
TINDAK
LANJUT
KONTEKS ORGANISASI
1. ISU-ISU
2. PIHAK BERKEPENTINGAN
ANALISA RESIKO
SOP/
INSTRUKSI KERJA
22. Format Prosedur Mutu
1. TUJUAN
Suatu pernyataan singkat yang menerangkan mengapa
prosedur ini diberlakukan dan apa yang harus dicapai.
2. RUANG LINGKUP
Suatu pernyataan singkat yang menerangkan kegiatan
perusahaan yang dicakup dalam prosedur.
3. DEFINISI
Suatu daftar keterangan dari singkatan atau terminologi
atau istilah khusus yang digunakan dalam prosedur.
4. DOKUMEN PENDUKUNG / REFERENSI
Suatu daftar dari dokumen lain (seperti prosedur, instruksi kerja,
peraturan pemerintah, peraturan perusahaan, standar teknis,
manual book) yang berhubungan dengan prosedur.
STANDAR OPERASIONAL PROSEDUR
23. 5. RINCIAN PROSEDUR
Suatu uraian langkah demi langkah dari setiap tahapan
proses atu kegiatan.
6. CATATAN MUTU
Suatu daftar hasil kegiatan yang dituangkan dalam bentuk
dokumen yang berasal dari pemilik proses atau dari unit kerja
lain ataupun dari luar perusahaan yang disimpan oleh pemilik
Proses (dalam bentuk hardcopy maupun softcopy).
7. KRITERIA KEBERHASILAN
Suatu uraian mengenai ukuran secara kuantitatif maupun
kualitatif keberhasilan pelaksanaan prosedur dikaitkan dengan
tujuan prosedur itu sendiri.
8. CATATAN PERUBAHAN
Suatu uraian ringkas mengenai perubahan yang terjadi antara
prosedur yang berlaku dengan prosedur revisi sebelumnya.
STANDAR OPERASIONAL PROSEDUR
24. Catatan “Organization Knowledge” / Pengetahuan Organisasi
Catatan 1 :
“ Pengetahuan organisasi adalah pengetahuan
khusus untuk organisasi, umumnya diperoleh
dengan pengalaman.
Ini adalah informasi yang digunakan dan diberikan
untuk peningkatan tujuan organisasi.
Catatan 2 :
Pengetahuan organisasi dapat berdasarkan pada:
A. SUMBER INTERNAL ( kekayaan
intelektual; pengalaman, pelajaran dari
kegagalan dan keberhasilan, hasil
perbaikan dalam proses, produk dan
layanan).
B. SUMBER EKSTERNAL ( standard;
akademisi; konferensi; pertemuan ilmiah
dari pelanggan atau penyedia eksternal)
Knowledge Organisasi
Tambahan :
25. WhywasISO9001revised?
• All ISO standards are reviewed and revised regularly to make sure
they remain relevant to the marketplace.
• ISO 9001 has been updated to take into account the different
challenges that businesses now face.
• For example, increased globalization has changed the way we do
business and organizations often operate more complex supply
chains, and there are increased expectations from customers.
• ISO 9001 needs to reflect these changes in order to remain relevant.
26. Whatarethekeyimprovements?
Structure
ISO 9001:2015 now follows the same overall structure as other ISO
management system standards (High-Level Structure), making it easier
for anyone using multiple management systems.
See Annex SL of ISO/IEC Directives Part 1 (the rules for developing
ISO standards) for further information.
Focus on risk-based thinking
This has always been part of the standard, but the new version gives it
increased prominence.
More information can be found on the Website run by ISO/TC 176/SC
2, the group of experts behind the standard
(www.iso.org/tc176/sc2/public).
27. What benefits does the
new version bring?
The new version of the standard brings the user a number of benefits.
ISO 9001:2015:
• Puts greater emphasis on leadership engagement
• Helps address organizational risks and opportunities in a
structured manner
• Uses simplified language and a common structure and terms,
particularly helpful to organizations using multiple management
systems
• Addresses supply chain management more effectively
• Is more user-friendly for service and knowledge-based
organizations