Sistem Manajemen Mutu

Quality Management System

• A quality management system (QMS) is a formalized system that
documents processes, procedures, and responsibilities for achieving
quality policies and objectives.
• A QMS helps coordinate and direct an organization’s activities to
meet customer and regulatory requirements and improve its
effectiveness and efficiency on a continuous basis.   (ASQ, 2018)
ISO 9000:2015 (QMS fundamental & vocabulary)
2.2.2. Quality Management System
• A QMS comprises activities by which the organization identifies its
objectives and determines the processes and resources required to
achieve desired results.
• The QMS manages the interacting processes and resources required
to provide value and realize results for relevant interested parties.
• The QMS enables top management to optimize the use of resources
considering the long and short term consequences of their decision.
• A QMS provides the means to identify actions to address intended
and unintended consequences in providing products and services.
ISO-9001:2015
Where we have been and where we are going
 ISO 9001:2015 7.Contents
Support
1. Scope
• Resources
2. Normative references - Organizational knowledge
3. Terms and definitions • Competence
• Awareness
4. Context of the organization • Communication
• Understanding the organization and its context • Documented information
• Understanding the needs and expectations of
interested parties 8. Operation
• Determining the scope Of QMS • Operational planning and control
• Requirements for products and services
• Quality management system and its processes • Design and development of products and
5. Leadership services
• Leadership and commitment • Control of externally provided processes,
• Quality Policy products and services
• Production and service provision
• Organizational roles, responsibilities and
- Post Delivery, Control of change
authorities • Release of products and services
6. Planning • Control of nonconforming outputs
• Actions to address risks and opportunities
9. Performance evaluation
• Quality objectives and planning to achieve • Monitoring, measurement, analysis and
them evaluation
• Planning of changes • Internal audit
• Management review
10. Improvement
• General
• Nonconformity and corrective action
• Continual improvement

Black: core MS requirements Red: new MS requirements

Green: ISO 9001 specific
 Structure of ISO 9001:2015
PLAN DO CHECK ACT

4 Context of 9 Performance
5 Leadership 6 Planning 7 Support 8 Operation 10 Improvement
(C) Nigel H Croft evaluation
organization
2014 - All rights
reserved Understanding
Leadership
Actions to
Operation
Monitoring,
Nonconformity
of the address risk measurement,
and Resources planning and and corrective
organization and analysis and
commitment control action
and its context opportunity evaluation

Needs & Determination of

Expectations of Quality requirements for
Quality policy Competence Internal audit Continual
interested objectives products/
services improvement
parties

Roles,
responsibilities Planning of Design and Management
Scope of the Awareness
and changes development review
QMS
authorities

Control of
externally provided
QMS and its Communication
products and
Processes
services

Production &
Documented
service
information
provision

Release of
products and
services

Control of
Nonconforming
(Slide Courtesy of Alan Daniels; Boeing) process outputs,
products and
services
 4.1 , 4.2, 4.3
(C) Nigel H Croft 10 Continual improvement
Establish context,
2014 - All rights define relevant
reserved interested parties &
scope of QMS

5 Leadership
• Customer focus
• Quality Policy
• Roles &
responsibilities

4.4 QMS - General

&
Process Approach
6 Planning 9
• Risks/Opportuniti P• Monitoring,
Customers & es er measurement,
other relevant • Objectives •
fo Customer Sat Customer
interested parties • Change planning r• Data analysis Satisfaction
m• Internal Audit
•
an Management
ce review
ev
al
ua
ti
Products &
Requirements Inputs 8 Operations
o
n
Outputs services

• • Knowledge management
Resources 7 Support
• • Competence
Infrastructure processes
• • Awareness
Process environment
• • Communication
Monitoring/measuring devices
• Document control
 Section 4 – Context of the Organisation
4.1 Understanding the • this is a new clause and
organisation and its context
provides a key insight
4.2 Understanding the needs into the organisation
and expectations of
interested parties
What constitutes the
4.3 Determining the scope of organisation’s quality
the quality management management system.
system
4.4 Quality management
system and its processes

2008 – No direct equivalent

4.4. Sistem manajemen mutu dan prose-
prosesnya
• 4.4.1. Organisasi harus menetapkan, menerapkan, memelihara dan
terus menerus meningkatkan sistem manajemen mutu, termasuk
proses-proses yang diperlukan dan interaksinya, sesuai dengan
persyaratan dari Standar Internasional ini.
• 4.4.2. Dalam hal yang diperlukan, organisasi harus :
• Memelihara informasi terdokumentasi untuk mendukung operasional proses-
proses;
• Menyimpan informasi terdokumentasi untuk memiliki keyakinan bahwa
proses-proses yang sedang dilakukan berjalan seperti yang direncanakan
Organisasi harus menetapkan proses-proses yang diperlukan
untuk sistem manajemen mutu dan penerapannya di seluruh
organisasi, dan harus:
• Menentukan input yang diperlukan dan output yang diharapkan dari proses-proses tersebut
• Menentukan urutan dan interaksi dari proses-proses tersebut;
• Menentukan dan menerapkan kriteria dan metode (termasuk pemantauan, pengukuran
dan indikator kinerja terkait) yang diperlukan untuk memastikan operasional yang efektif,
dan pengendalian atas proses-proses tersebut;
• Menentukan sumber daya yang dibutuhkan dan memastikan ketersediaannya;
• Menentukan tanggung jawab dan wewenang untuk proses-proses tersebut;
• Menangani risiko dan peluang seperti yang ditentukan sesuai dengan persyaratan
• Mengevaluasi proses-proses dan menerapkan setiap perubahan yang diperlukan untuk
memastikan proses-proses tersebut mencapai hasil yang diinginkan;
• Meningkatkan proses-proses tersebut dan sistem manajemen mutunya.
Tugas
• Lakukan identifikasi
• Komponen-komponen standar ISO 9001:2015 yang
ada pada Standar SNARS ed 1.1 atau standar
akreditasi dari Kementerian Kesehatan tahun
2021(2)
Klausul ISO 9001:2015 SNARS 1.1 Standar akreditasi KemKes
4. Konteks 4.1. Konteks organisasi
organisasi terkait isu eksternal
dan internal
4.2. Pemahaman
organisasi thd
kebutuhan dan
harapan pihak
berkepentingan
4.3. Ruang lingkup
SMM
4.4. SMM dan
prosesnya
Klausul ISO 9001:2015 SNARS 1.1 Standar akreditasi KemKes
5. 5.1. Kepemimpinan
Kepemimpinan dan komitmen
5.2. Kebijakan mutu
5.3. Peran, tanggung
jawab dan otoritas
organisasi
Klausul ISO 9001:2015 SNARS 1.1 Standar akreditasi
KemKes
6. Perencanaan 6.1. Tindakan untuk
menangani risiko
6.2. Sasaran mutu dan
rencana untuk mencapai
6.3. Perencanaan
perubahan
Klausul ISO 9001:2015 SNARS 1.1 Standar akreditasi
KemKes
7. Pendukung 7.1. Sumber daya (SDM,
sarana, prasarana,
lingkungan)
7.2. Kompetensi
7.3. Kesadaran
(awareness)
7.4. Komunikasi
7.5. Informasi yang
terdokumentasi (dan
kendali thd informasi
terdokumentasi)
Klausul ISO 9001:2015 SNARS 1.1 Standar akreditasi KemKes
8. Operasional 8.1. Perencanaan
dan pengendalian
operasional
8.2. Persyaratan
produk dan layanan
8.3. Perencanaan/
disain produk dan
layanan
8.4. Pengendalian
produk dan layanan
8.5. Penyediaan
produk dan layanan
8.6. Pelepasan
produk dan layanan
8.7. Kendali atas
produk tidak sesuai
Klausul ISO 9001:2015 SNARS 1.1 Standar akreditasi
KemKes
9. Pengukuran 9.1. Pemantauan,
kinerja pengukuran, analisis, dan
evaluasi

9.2. Audit internal

9.3. Tinjauan manajemen

10. Perbaikan 10.1. Peningkatan

10.2. Ketidak sesuaian dan
Tindakan perbaikan