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Transcript of Interpretation and documentation iso 9001
British Standard Institution Learning Academy
ISO 9001:2015 INTERPRETATION & DOCUMENTATION
COURSE
8-9 Oktober 15
Dewi AlmitrasariLead Auditor & Trainer
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Benefits to you!
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3
Welcome!
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4
Delegate Introductions
Introductions
Dewi Almitra Sari
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5
Course Aim
To gain an understanding of effective quality management, by using a systematic framework to:A) Consistently provide products or
service that meet requirementsB) Enhance customer satisfaction
C) Develop effectiveness of documentation system
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Learning Objectives
Have the skills to develop documentation : • process mapping• documented information
such as procedure and supporting document
……QMS shall establishing the documented information for
the effectiveness (Clause 7.5, ISO FDIS 9001:2015)
• The history and development of ISO/FDIS 9001
• What is a Quality Management System (QMS)
• The benefits of a QMS
• The terms and definitions used
• Key concepts, principles and structure
• The main requirements of ISO/FDIS 9001:2015 and how to implement
KNOWLEDGE SKILLS
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Solution & Result...
01/05/2023
1 2 3 4
Overview Knowledge Identification
Documentation
The Need for Quality
Management System
Understanding the
requirements of the
standard is your essential starting point to working
with a management
system.
Develop your expertise to identify the
document and other to
comply the requirement
Discover how you
can develop the documentation
system
training journey to excellence... (2 days course)
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8
• Principle of QMS• Terminology
(Workshop 1)• Concept of Quality
Closing
Module 1
Module 3ISO 9001 - General
Introduction Training Agenda 2 days Course
Module 2Overview
• Historical of ISO 9001• ISO 9000, ISO 9001 &
ISO 9004
Module 4Interpretation &
Documentation of Context Organisation
• Interested Party• Scope• Process Mapping (Workshop 2)
Module 7Interpretation &
Documentation of Resources
• People• Infrastructure• Process Environment• Monitoring & Measurement• Knowledge Management)• Competence• Awareness• Documented Information(Workshop 4
Module 5Interpretation &
Documentation of Leadership
• Commitment• Quality Policy• Role & Responsibility
Module 8Interpretation &
Documentation of Operation
• Planning and provision of services ((Workshop 5)
• Control of external providers• Release & Control of Non Conforming
Module 9Interpretation &
Documentation of Performance Evaluation
• Customer Satisfaction• Internal Audit• Management Review
Module 10Interpretation &
Documentation of Improvement
• Improvement• Nonconformity & Corrective action• Continual Improvement)
Module 6Interpretation &
Documentation of Planning
• Risk Management
(Workshop 3)• Quality Objective• Management of Change
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Time Table08 October 201508.00 Opening & Introduction 08.20 Module 1 : Concept of Quality09.00 Module 2 : QMS Overview & Workshop 109.40 Module 3 : QMS Historical10.00 Break10.15 Module 4 : Context Organisation & Workshop 212.00 Ishoma13.00 Module 5 : Leadership14.00 Module 6 : Planning and workshop 315.00 Break15.15 Continued with module 616.30 End of Day 1 course
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10
Time Table09 October 201508.00 Review of day 1 materi08.15 Module 7 : Resources and workshop 410.00 Break10.15 Continued with module 711.00 Module 8 : Operation12.00 Ishoma13.00 Continued with module 8 and workshop 515.00 Break15.15 Module 9 : performance Evaluation16.00 Module 10 : Improvement16.30 End of course
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11
Course Structure
Course Format:• Activities• Classroom discussions
Materials:• Delegate workbook• Loan copy of ISO 9001
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12
British Standard Institution Overview
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13
Who is BSI?
05/01/2023
• Leading Global Standards Creation Body: British, European, ISO, Public, Private
• The UK National Standards Body: The source of British Standards
• Specialist Focus on Standards Creation, Training and Certification
• Global Network: 72,000 clients in 150 countries worldwide including governments, global brands and
SME’s
• Experienced: The world’s first National Standards Body established in 1901 and a founding member of
ISO
• Thought Leaders: Shaped the world’s most adopted standards, incl. ISO 9001, ISO 14001, OHSAS
18001
• Trusted: We’re a Royal Charter Company, reinvesting profits back into our business to improve our
clients’ experience
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BSI’s end-to-end solutions make excellence a habit
R i s k M a n a g e m e n t S t a n d a r d sS u s t a i n a b i l i t y S t a n d a r d s
O p e r a t i o n a l P e r f o r m a n c e S t a n d a r d s
Together with >10,000 independent experts,
BSI leads in the development and
maintenance of global standards
• Public Standards - PAS• British Standards - BS• European Standards -
EN• ISO Standards
Shape
We share our standards and
guidance documents in many formats,
from paper to PDF or organization-wide
licenses
• Online Standards Portal
• Network Licenses
Share
Our tutors transfer the knowledge and
skills needed to embed excellence
• In-Company Training• Public Training• Internal & Lead Auditor Training
• Self Assessment tools
• Gap Analysis
Embed
Our assessors give you proven ways to measure, improve
and confidently promote your organization
• Management Systems Certification
• Gap Analysis• Verification Services• Supplier Certification• 2nd Party Assessment
• Self Assessment Tools
• Product Certification• Kitemark & CE
marking
Assess
We support you with the knowledge and business tools you need to continually
improve
• Entropy™ Software • BSI Excellerator™
Report• Supply Chain
Solutions• Six Sigma Training • Business Improver
Training
Support
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15
Standardisasi
Sertifikasi
Accreditation Body
Certification Body
Organization
Accredits
International Accreditation ForumCertified once, accepted everywhere
UK
USA
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16
BSI Standards – World StandardsSince 1901 BSI has worked with industry to build consensus and develop standards of
excellenceYear British
StandardISO Standard
1987 BS 5750 ISO 9001 (Quality Management)
1992 BS 7750 ISO 14001 (Environmental Management)
1995 BS 7799 ISO/IEC 27001 (Information Security)
1996 BS 8800 OHSAS 18001 / AS/NZS 4801 (Occupational Health & Safety)
2000 BS 8600 ISO 10002 (Customer Satisfaction)
2002 BS 15000 ISO/IEC 20000 (IT Service Management)
2002 TS 16949 ISO/TS 16949 (Automotive)
2009 BS 16001 ISO 50001 (Energy Management)
2009 BS 5750 (based) AS 9100 (Aerospace)
2012 BS 25999 ISO 22301 (Business Continuity)
2012 BS 8901 ISO 20121 (Sustainable Events)
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Concept of Quality
1
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1818
MUTU
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Quality Management /
Manajemen Mutu
Quality Assurance /
Jaminan MutuQuality Control/ Kendali Mutu
Quality ? Mutu ?
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Apa itu Mutu?
• Memenuhi dan melebihi harapan dan kebutuhan pelanggan, dan peningkatan berkelanjutan
William Edwards
Deming (1900-1993)
• Mutu berarti kesesuaian terhadap persyaratan
Philip Bayard Crosby (1926-
2001):
• Mutu berarti kesesuaian dengan penggunaan
Joseph Moses Juran (1904 –
2008)
• Mutu berarti kepuasan pelangganKaoru Ishikawa (1915 – 1989)
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21
Evolusi Sistem Manajemen Mutu
Non Quality Culture
Quality Inspection
Quality Control
Time
Q Performance
ZERO DEFECT
ZERO DEFECT CONTINUOSLY
ZERO DEFECT CONTINUOSLY & CUSTOMERS SATISFCATION Quality
Assurance
CUSTOMERS SATISFCATION CONSISTENTLYQUALITY
MANAGEMENT
(ISO 9001:2008)
ZERO DEFECT CONTINUOSLY & INTERESTED PARTIES SATISFCATION
(ISO 9001:2015)SUSTANAIBILITY
COMPLIANCE
PERFORMANC E
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22
comprehensive portfolios ensure your corporate reputation remains secure
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Key terms and definitionsBS EN ISO 9000
BSI British Standards
Qualitymanagement
systems – Fundamental
sand
vocabulary
Management ?“Coordinated activities to direct and
control an organization”
Quality Management ?“Management with regard to quality”
Quality Management System ?
“Management system with regard to quality”
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Workshop 1a
15 minutesClick here to
start
Terms and Definitions
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Sistem manajemen
Integrasi dari keseluruhan sistem manajemen yang meliputi struktur organisasi, rencana kegiatan,
tanggung jawab, prosedur, proses dan sumber daya untuk pengembangan, penerapan, pencapaian dan
pemeliharaan kebijakan atau arah perusahaan/organisasi.
VISI
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VISI & MISI
Plan Do
CheckAction
KEBIJAKAN
SASARAN/TARGET
STRATEGI
SISTEM DOKUMENTASI
PENERAPAN
PROGRAM
PEMANTAUAN, EVALUASI & TINDAK
LANJUT
Kemana tujuan kita ?
Uraian dari visi & misi ?
Indikator pencapaian visi & misi ?
Rencana Manajemen Mutu
Metode pencapaian sasaran : prosedur, juklak, juknis, form dll
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Mengapa kita perlu sistem ?
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Integrasi = Keterkaitan
TUJUAN
• SASARAN MUTU• PROSES
• DOKUMENTASI
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Personel• Tg. Jawab&wewenang• Kompetensi/Kualifikasi
• Pelatihan• Record
• Ketersediaan
Peralatan• Kebutuhan
• Ketersediaan• Kemampuan• Pemeliharaan
• KondisiPROSES
Kondisi lingkunganPenetapan
Pengelolaan
Material• Spesifikasi
• Ketersediaan• Penyimpanan
• Pengadaan
Informasi/Metode• Kebutuhan• Spesifikasi
• Akurat• Analisa
• Komunikasi• Ketersediaan
VISI
HARAPAN CUSTOME
RKEBIJAKAN &
SASARAN, PROGRAM
PLAN DO
ACTION CHECK
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30
Pengukuran efektifitas sistem manajemen mutu
Sasaran mutu organisasi
Hasil pencapaian
% 100 75 50 25 0
Peningkatan
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Management Principle
2
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32
Key concepts : Management Principles
Customer Focus Leadership Engagemen
t of PeopleProcess
ApproachImproveme
nt
Evidence- based
Decision Making
Relationship
Management
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33
“Organisasi tergantung pada pelanggan”
“Persyaratan Pelanggan”
Menetapkan harapan pelanggan sekarang dan akan datang”
Prinsip 1:Customer Focus / “Fokus Pelanggan”
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34
Prinsip 2:Leadership /
Kepemimpinan
Pemimpin harus menetapkan keseragaman tujuan dan arah organisasi.
Harus menciptakan kesadaran semua orang untuk ikut serta terlibat mencapai
sasaran
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35
• Setiap orang di setiap level adalah bagian penting dari organisasi.
• Keterlibatan penuh dari karyawan sangat menguntungkan bagi organisasi.
Prinsip Ke-3 Engagement of
people
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Hasil yang diinginkan dapat dicapai lebih efisien bila sumber daya dan kegiatan yang terkait dikelola sebagai
suatu proses.
Identifikasi, pemahaman dan pengelolaan suatu sistem dari proses-proses yang saling berhubungan untuk mencapai sasaran yang ditetapkan meningkatkan
efektifitas dan efisiensi organisasi.
Prinsip Ke-4 Pendekatan
proses
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37
Key concepts : Process Approach• A Coherent System:
• Understanding
requirements
Intended results Consistent,
predictable resultsMeeting requirementsCustomer satisfaction
Activities understoodand managed asinterrelated processes
Processes adding valueProcesses providing effective performanceImprovements (through evaluation) of data/informationPDCA (process) methodology (Fig. 2)
(Interactions)
(Outputs)(Inputs)
Process
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38
Peningkatan berkelanjutan haruslah menjadi sasaran tetap dari organisasi
Prinsip Ke-5 Peningkatan
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39
Pengukuran efektifitas sistem manajemen mutu
Sasaran mutu organisasi
Hasil pencapaian
% 100 75 50 25 0
Peningkatan
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40
Keputusan yang efektif adalah yang berdasarkan pada analisa terhadap data dan
informasi.
Prinsip Ke 6Pendekatan Fakta/bukti untuk
keputusan
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41
Organisasi dan pemasoknya selalu tergantung satu sama lain dan hubungan yang saling menguntungkan meningkatkan kemampuan dari kedua belah pihak untuk menghasilkan nilai tambah yang lebih besar.
Prinsip Ke-7 Relationship Management
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42
Workshop 1b
15 minutesClick here to
start
Quality Management Principle
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ISO 9000 Family
3
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44
ISO 9001 – History
BS 5750: Part 1 : 1987ISO 9001 – 1987EN 29001 - 1987
British StandardQuality systemsPart 1. Specification for design/development,production, installation and servicing
BSI
BS 5750: Part 2 : 1987ISO 9002 – 1987EN 29002 - 1987
British StandardQuality systemsPart 1. Specification for productionand installation
BS 5750: Part 3 : 1987ISO 9003 – 1987EN 29003 - 1987
British StandardQuality systemsPart 1. Specification for final inspectionand test
BSID & DPellentesque mollis
felis dolor, quis aliquet sapien
dapibus tempus lectus. Nulla sed posuere velit, ut gravida nibh.
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45
ISO Standards for Quality Management
BS EN ISO 9004
BSI British Standards
Managing for the
sustainedsuccess of anorganization
—A quality
managementapproach
BS EN ISO 9000
BSI British Standards
Qualitymanagemen
tsystems –
Fundamentals
andvocabulary
BS EN ISO 9001
BSI Standards Publication
QualityManageme
ntsystems –
Requirements
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Evolusi Seri ISO 9000
Sejarah perubahan ISO 9001:
1st edition :ISO 9001:1987ISO 9002:1987ISO 9003:1987
2nd edition :ISO 9001:1994ISO 9002:1994ISO 9003:1994
3rd edition :ISO 9001:2000
4th edition :ISO 9001:2008
BS 5750 Part 2:1979
5th edition :ISO 9001:2015
BS EN ISO 9004 BSI British
Standards
Managing for the sustained success of
anorganization — A
qualitymanagement
approach
BS EN ISO 9000 BSI British
Standards
Quality managementsystems –
Fundamentalsand vocabulary
BS EN ISO 9001
BSI Standards Publication
Quality Management systems – Requirements
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47
Accredited Certification
Accreditation Body
Certification Body
Organization
Accredits BSI, or esteemed
competitor
UKAS, or equivalent local national body
Personnel Certification Body
eg IRCA
AuditorUser
Audits
Certificates
Training Course, Tutor,
Training Body
Accredits
Trains
International Accreditation ForumCertified once, accepted everywhere Establishe
sMultilateral Recognition Arrangements
Mandatory Documents
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48
Nama Perusahaan dan alamat
Ruang Lingkup aktifitas
Badan sertifikasi dan lembaga yang
mengakreditasi
Tanggal penerbitan dan masa berlakuk
sertifikat
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49
Receive Manual & Procedure
Stage 1Audit
CorrectiveActions
Pre-Audit
CorrectiveAction
Stage 2Audit
CorrectiveActions
Follow-up audit
6-monthlySurveillance
Audit
CorrectiveActions
Follow-up audit
3 year
major
Y
Renewal Certification Process
CERTIFICATION PROCESS – ISO 9001
Min. 3 weeks before audit
OPTIONAL
majormajor
Max.3
months
N
Y Y
Max.3
months
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50
Clause of ISO 9001:2015
05/01/2023
1
2
3
4
5
6
7
8
9
10
Scope
Normative references
Terms and definitions
Context of the organization
Leadership
Planning
Support
Operation
Performance evaluation
Improvement
1
2
3
4
5
6
7
8
9
10
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51
1) Scope
2) Normative references
3) Terms and definitions
cites ISO 9000:2015 Quality Management Systems – Fundamentals and vocabulary as indispensable for its application
this particular Management System Standard (MSS) is addressed, and this includes the ‘intended result(s)’ of the application of this Standard. These have already in the main been addressed through the promotion of the process approach, namely:• Consistent provision of products and services that meet
customer and applicable statutory and regulatory requirements (legal requirements)
• ‘Intended outcome’ is that which is ‘intended’ as a result of the application of the standard, or process etc.
• ‘Expected outcome’ is that which is ‘expected’ by interested parties
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52
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Context of OrganisationClause 4 - ISO 9001:2015
4
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54
Clause 4: Context of the Organization (1)Understanding the organization and its context
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55
Understand the ‘Context of your Organization’
Intended result(s) of QMS
Requirements of these
interested parties
Purpose and
strategic direction
Boundaries and
applicability (Scope)
External and
internal issues
Interested parties
relevant to the QMS
Organization
Products and
services
Applicability
Determine:
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56
Clause 4: Context of the Organization (2)4.2. Understanding the needs and expectations of interested parties
CitizensCustomers
DistributorsShareholders
InvestorsOwners
InsurersGovernment
RegulatorsRecovery service
suppliers
The OrganizationManagement• Top Management• Those accountable
for Quality policy and implementation
Those who implement and maintain the QMS• Those who maintain
QMS and risk procedures
Other StaffContractors
CompetitorsMediaCommentatorsTrade groupsNeighborsPressure groupsEmergency servicesOther response agenciesTransport servicesStaff dependents
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57
Clause 4: Context of the Organization (3)
• 4.3. Determining the scope of the QMS
• 4.4. QMS and its Processes
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Organisasi harus:
• mengidentifikasi proses-proses yang diperlukan• menetapkan tahapan dan interaksi dari proses-proses• menetapkan kriteria dan metoda untuk menjamin operasi dan
pengendalian• menjamin ketersediaan dari sumber daya dan informasi • memonitor, mengukur dan menganalisa proses-proses• menerapkan tindakan yang dibutuhkan untuk mencapai hasil yang
direncanakan dan peningkatan berkesinambungan.
Peta Proses
• 4.4. QMS and its Processes
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59
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60
Key concepts : Process
With what?(resources)
Outputs? (what,to whom)
What results?(monitoring, measurements, performance indicators)
Inputs? (what, from whom)
How done?(criteria, methods/controlsdocumentation)
With who?(responsibilities,authorities)
PROCESS
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61
Key concepts Process Approach• A Coherent System:
• Understanding
requirements
Intended results Consistent,
predictable resultsMeeting requirementsCustomer satisfaction
Activities understoodand managed asinterrelated processes
Processes adding valueProcesses providing effective performanceImprovements (through evaluation) of data/informationPDCA (process) methodology (Fig. 2)
(Interactions)
(Outputs)(Inputs)
Process
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62
Representation of the structure of this International Standard in the PDCA cycle
Leadership (5)
Support and Operation
( 7,8)
Improvement (10)
Planning (6)Performance evaluation
(9)
Plan Do
CheckAct
Quality Management System (4)
Organization and its context
(4)
Customer requirement
s
Needs and expectations of relevant interested parties (4)
Customer satisfaction
Products and
services
Results of the QMS
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63
Contoh Generik Business ProcessCalon Mahasiswa
Bagian Administrasi dan Akademik Kemahasiswaan
Pendidikan & Pengajaran
Workshop Laboratorium
Perpustakaan
Lulusan,Industri, Masyarakat
Penelitian dan Pengabdian Pada
Masyarakat
FungsiPenjaminan
Mutu
FungsiMIS
FungsiPerbaikan dan
Perawatan
FungsiPublikasi
Bg Umum, Administrasi
dan keuangan
Business process mapping sebagai peta aliran fungsi untuk menjelaskan interaksi antar fungsi dan menjadi fondasi dalam menetapkan key performance indikator yang efektif
dengan berlandaskan kaidah “next process is our customer” dan kaidah “quality built by every proceses within organization”
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Contoh Generik Context Diagram
Prosedur Proses
Belajar Mengajar
PEN-01
Prosedur Proses
Belajar Mengajar
PEN-01
Prosedur Bimbingan dan Administrasi Tugas Akhir
PEN-04
Prosedur Bimbingan dan Administrasi Tugas Akhir
PEN-04Prosedur Pelaksanaan
dan Evaluasi Ujian Semester
PEN-03
Prosedur Pelaksanaandan Evaluasi Ujian
Semester
PEN-03
Perpustakaan Laboratorium Workshop
Bagian Akademikdan AdministrasiKemahasiwaan
Unit MISUPT Perbaikandan Perawatan
Unit Publikasi
Bg Umum, Administrasi
dan keuangan
P3M
Review dan Improvement
Process
Context Diagram adalah menjadi landasan penyusunan prosedur yang efektif.Prosedur yang efektif adalah prosedur yang dibangun bukan berdasarkan klausul ISO tapi sebuah prosedur yang disusun dari nature of business proses organisasi yang disempurnakan untuk memastikan compliance
dengan ISO Requirement.
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65
Business Process
Order Processing
Logistics
LitbangPlanning
Umum
QA, MR
CP-01
CP-02
PP-01
RID-01
SP-01
SP-02
SP-03
WI-XX-01(PenerimaanMhs baru )
WI-XX-02(Pembuatan
Kartu Tanda Peserta Test)
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66
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67
<Process > < Procedure> < W.I. >
Human resource management process
Equipment control procedurePurchasing procedure
Production procedureInspection procedure
Purchasing information controlinstruction
Supplier evaluation criteriaProducts inspection criteriaPurchasing criteria
Inquiry, negotiation and comparison of price
Sales marketing process
Production management process
Design and research process
Financial management process
ISO
900
1 Q
ualit
y M
anag
emen
t Sys
tem
Structure of quality management system and documentation
Sample 1
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68
ContohMATRIKS KORESPONDENSI "DOKUMENTASI - STANDARD"
No Departemen/ Proses
Nama Dok.
No Dok.
Klausul ISO 9001Prosedu
r Regulasi …….
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LeadershipClause 5 - ISO 9001:2015
5
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70
5. Leadership
5.1. Leadership and commitment
Leadership and commitment for the
quality management
system
Customer focus
5.2. Quality policy
5.3. Organizational roles,
responsibilities and authorities
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5.1 LEADERSHIP & COMMITMENT
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72
FOKUS KE PELANGGAN
• Persyaratan pelanggan dan peraturan yang berlaku telah ditetapkan, dipahami dan dipenuhi secara konsisten
• Resiko dan peluang yang dapat berakibat pada pelayanan & produk serta kemampuan untuk untuk meningkatkan kepuasan pelanggan telah ditetapkan
• Fokus untuk meningkatkan kepuasan pelanggan selalu dipelihara/dijaga
Top manajemen harus
menjamin:
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73
5.2 Kebijakan Mutu
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74
5.3. PERANAN ORGANISASI, TANGGUNG JAWAB DAN WEWENANG
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PlanningClause 6 - ISO 9001:2015
6
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Clause 6: Planning for the QMS
Plan actions to address risks and opportunities
Determine risks and opportunities
4.1
9.2
6.1
6.1
Issues
6.1. Actions to address risks and opportunities6.2. Quality objectives and planning to achieve them6.3. Planning of changes
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77
One can “slice and dice” these multiple dimensions of risk*
PortfolioConcentration
Risk
Transaction Risk
CounterpartyRisk
Issuer Risk
Trading Risk
Gap Risk
Equity Risk
Interest Rate Risk
Currency Risk
Commodity Risk
Risks
OperationalRisk
Reputational Risk
Business and strategic risks
Market Risk
Credit Risk
“SpecificRisk”
GeneralMarket Risk
Issue Risk
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78
Threat map
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79
Business Risk Assessment Process
Identify Risk
Assessment of Risk
Assessmentof Controls
BusinessManagement
Understand and analysethe business
Assess business
risk
Assess implementedrisk control
StrategyPlanning
ImplementationMonitoring
Improvement
Focus onstrategic
issues
Prioritisingof critical
risk
Improvedinternalcontrol
Managed Business
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80
Risk context, assessment and treatmentRelevant
Issues (from
context)red = -vegreen =
+ve
Risk Identification Risk Analysis Risk
Evaluation Risk Treatment Residual risk
Neighbourhood
disruption in street
cabling
New fibre technology available
Workforce retention
Share holders:
Stock market crash
Economic – Significant
effect on profit objectives and
liquidity if share price collapses
Impact significant but likelihood unknown (high
uncertainty)
Unable to qualify as likelihood unknown
Subscribe to Economic indicators service for
horizon scanning economic conditions and
global trends
Unknown pending horizon
scan. Re-evaluate on
report receipt. Tolerate risk.
Transfer emergency funds
to holding company
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SAMPLE - LIST OF RISK ITEMS
Design Engineering Risks Procurement Risks HSE Risks Project Management Risks Organizational Risks
Terms & Conditions
Contract RisksFEED Docs in ITB Docs are not detail and incomplete additional some procentage for Bill of Quantity calculation may required.
RFQ & RFP documents are not clear such as : Scope of Supply, Data Sheet, Bill of Quantity, Specification, Test Witness, Chemical /Oil/Grease Supply, Spare Part For Commissioning & 2 Years Operations, engineering document should be supply, Fabrication Schedule, Packaging Specification, General Condition, etc are not clear.
HSE Project Plan Implementation. High standard will impact to project cost and schedule
Project purpose and need is not well-defined
Inexperienced staff assigned
Refer To Legal Analysis on Draft of Contract from Legal Department or Refer to Analysis from Contract Engineer
Plot Plan, P&ID, One Line Diagram & Hazardous Area Change
Critical Items and Very tight Schedule that need special attentions
Risk Register and Risk Management Execution are not well done since Engineering Design Stage.
Project scope, schedule, objectives, cost, and deliverables are not clearly defined or understood
Losing critical staff at crucial time of the project
Inaccurate assumptions on technical issues in planning stage
Increase in material cost due to market forces
Environmental analysis (AMDAL) incomplete
Unreasonably high expectations from stakeholders
Insufficient time to plan
Surveys incomplete Political Situation is unstable, War, Riot, Embargo
Environmental regulation or local regulation is not Clear or Changed
Vendor or contractor delays Unanticipated project manager workload
Changes to Capacity, Materials or Specification
Economic is Unstable, Depression, Inflasion, Currency Rate is unstable, Oil Price is unstable or increase.
Construction Waste Treatment Availability
Estimating and/or scheduling errors
Internal “red tape” causes delay getting approvals, decisions
SIL, HAZID & HAZOP Study have potensial to add more materials, instrument & equipments.
Disaster, Climate, High/Low Tide and Other Nature Conditions.
Availability of project data and mapping at the beginning of the environmental study is insufficient
Unplanned work that must be accommodated
Functional units not available, overloaded
Basic Engineering Design Data & Detail Engineering Design Data are wrong.
Massive Development or Massive Construction in some country or Province that requires a lot of Cosntruction materials
New information after Environmental Document is completed may require re-evaluation or a new document (i.e. utility relocation beyond document coverage)
Lack of coordination/communication
Lack of specialized staff or Skilled MP resources are limited.
P&ID and Plot Plan Review Meeting are not so carefully done so it does not find a crucial problem
Loading & Unloading and Transportation Plan which need special attentions
New alternatives required to avoid, mitigate or minimize impact
Underestimated support resources or overly optimistic delivery schedule
Overlapping of one or more projects
Don't Consider Operability, Maintainability & Constructability
Import & Export Regulations are changed
Design changes require additional Environmental analysis
Inaccurate contract time estimates
Approval Procedure for Engineering Products is very long
Procurement Planning & Control are wrong
Unanticipated Noise, Air Quality and Waste impacts
Unresolved project conflicts not escalated in a timely manner
Project causes an unanticipated barrier to wildlife
Unanticipated escalation in right of way values or construction cost
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The FMEA Form
Identify failure modes and their effects Identify causes of the
failure modesand controls
Prioritize Determine and assess actions
A Closer Look
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Workshop 3
45 minutesClick here to
start
Risk Management
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6.2. Quality objectives and planning to achieve them
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Institusionalobjectives
progressingCurrent
Situation
Objective and Effort of the whole institution
Future Situation
Risk Analysis
Vision
Mission
Performance indicators
Risk AObjectives A
Risk BObjectives B
Risk CObjectives C
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• Planning/implementing QMS changes (6.3), • Controlling operational changes, planned and
unintentional (8.1)• Addressing unplanned changes affecting products &
services (8.5.6) • See also 7.1.6 Organizational knowledge - for
addressing changing needs and trends, with respect to knowledge
6.3. ‘Planning of Changes’
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ResourcesClause 7 - ISO 9001:2015
7
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• 7.1 – Resources• Determine and provide the necessary resources
including people, infrastructure, operational processes, and knowledge
• 7.2 – Competence• Identify and maintain competence
• 7.3 – Awareness• Make objectives known, and ensure awareness of QMS
• 7.4 – Communication• What, when, how, who, and to whom
• 7.5 – Documented information• Reflects variety of sources and need to back up
information
Clause 7: Support
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7.1. Sumber daya / Resources
7.1.2 Sumber Daya Manusia
7.1.3 Infrastruktur
7.1.4 Lingkungan Kerja
7.1.1. Organisasi harus menetapkan dan menyediakan sumber daya yang diperlukan
organisasi harus menyediakan orang-orang yang diperlukan untuk efektifitas operasi dari sistem manajemen mutu, termasuk proses yang diperlukan.
Organisasi harus menetapkan, menyediakan dan memelihara infrastruktur untuk operasi dari proses dalam mencapai kesesuaian produk dan jasa. Infrastruktur dapat mencakup: bangunan dan utilitas
terkait; peralatan termasuk
perangkat keras dan perangkat lunak;
transportasi; teknologi informasi dan
komunikasi.
Organisasi harus menetapkan, menyediakan dan memelihara lingkungan yang diperlukan untuk operasi dari proses untuk mencapai kesesuaian produk dan jasa.Lingkungan dapat mencakup fisik, sosial, psikologis, lingkungan dan faktor lainnya (seperti suhu, kelembaban, ergonomi dan kebersihan
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These need to be determined/provided to ensure valid and reliable results. Controls will include: suitable resources, maintenance, documented information, measurement traceability (if required) including: verification, calibration status, adjustment safeguards, and appropriate corrective action on equipment malfunction.
7.1.5 Monitoring and measuring resources
Dimana pemantauan atau pengukuran yang digunakan untuk bukti kesesuaian produk dan jasa dengan persyaratan yang ditentukan, organisasi harus menentukan sumber daya yang dibutuhkan untuk memastikan kevalidan dan kehandalan dari hasil pemantauan dan pengukuran.
Organisasi harus memastikan bahwa sumber daya yang disediakan: cocok untuk jenis tertentu kegiatan pemantauan dan pengukuran yang
dilakukan; dipelihara untuk memastikan kesesuaian tujuan mereka.
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• Defined as ‘available collection of information (meaningful data – facts about an object) being a justified belief and having a high certainty to be true’.
• This can include information such as intellectual property and lessons learned.
• The requirement here is to determine, maintain and make available (extent necessary) the knowledge necessary for the operation of its processes, AND to achieve conformity of products and services.
• Knowledge necessary to address changing needs and trends will also need considering, and how to acquire or access any additional knowledge necessary.
• Sources: (Internal) learning from failure/success, capturing knowledge of experts, etc. (External) academia, standards, conferences, customers, external providers etc.
7.1.6. Organisational Knowledge
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Other supportKompetensi (7.2) Kepedulian (7.3) Komunikasi (7.4)
Organisasi harus: menentukan kompetensi yang
diperlukan untuk orang (s) yg. melakukan pekerjaan di bawah kendalinya dapat mempengaruhi kinerja mutu;
memastikan bahwa orang-orang ini kompeten atas dasar pendidikan, pelatihan, atau pengalaman;
di mana berlaku, mengambil tindakan untuk memperoleh kompetensi yang diperlukan, dan mengevaluasi efektivitas tindakan yang diambil;
menyimpan informasi terdokumentasi sebagai bukti kompetensi.
CATATAN tindakan Berlaku dapat meliputi, misalnya, penyediaan pelatihan, mentoring, atau re-assigment orang saat ini bekerja; atau mempekerjakan / mengontrak orang yang kompeten.
Orang yang melakukan pekerjaan di bawah kendali organisasi harus peduli terhadap: kebijakan mutu; sasaran mutu yang
relevan; kontribusi mereka
terhadap efektivitas SMM, termasuk manfaat dari peningkatan kinerja mutu;
implikasi ketidaksesuaian persyaratan sistem manajemen mutu
Organisasi harus menetapkan komunikasi internal dan eksternal yang relevan dengan sistem manajemen mutu termasuk: pada apa yang akan
dikomunikasikan; kapan berkomunikasi; dengan siapa
berkomunikasi; bagaimana berkomunikasi.
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7.5. Documented Information
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Pengendalian dokumenmenyetujui dokumen akan kecukupannya sebelum diterbitkan,
meninjau dan memperbaharui seperlunya dan menyetujui ulang dokumen,
memastikan perubahan dan status revisi terkini,
versi relevan dari dokumen yang berlaku tersedia di tempat pemakaian,
dapat dibaca dan mudah dikenali,
Pengendalian dokumen yang berasal dari luar
mencegah pemakaian tak disengaja dari dokumen obsolete (kadaluarsa)
7.5. Documented Information
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9805/01/202398
Pengendalian RekamanIdentifikasi rekaman
Cara penyimpanan
Cara perlindungan
Cara pengambilan
Masa retensi
Cara pembuangan rekaman.Rekaman harus terbaca, dapat dikenali dan mudah
ditemukan.
7.5. Documented Information
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Workshop 4
30 minutesClick here to
start
Documentation
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OperationalClause 8 - ISO 9001:2015
8
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Clause 8: OperationOperational planning and control
Requirements for products and services
Design and development of product‘s’ and services
Production and service provision, including
release
Control of externally provided products and services
Control of nonconforming process…
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8.1. Operational planning and control
8.1 Perencanaan dan Pengendalian Operasional
Merencanakan, menerapkan dan mengendalikan proses yang diperlukan untuk realisasi produk.
Perencanaan realisasi produk harus taat azas dengan persyaratan
Menetapkan : Kriteria proses Kriteria keberterimaan produk dan
pelayanan kebutuhan sumber daya Pengendalian proses antara lain aktifitas
verifikasi, validasi, monitoring, measurement inspeksi dan test yang diperlukan spesifik teradap produk dan kriteria keberterimaan produk;
Informasi dokumen yang diperlukan termasuk rekaman diperlukan untuk menyediakan bukti bahwa proses-proses realisasi dan produk yang dihasilkan memenuhi persyaratan
Pengendalian perubahan Pengendalian “outsource”
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8.2. Requirement for product and Services
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8.2. Requirement for product and Services
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8.2. Requirement for product and Services
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8.3.5. KELUARAN DISAIN & PENGEMBANGAN
• Sesuai Masukan• Dapat diproses secara efektif
dan efesien
8.3.4. PENGENDALIAN DISAIN & PENGEMBANGAN
• Evaluasi kemampuan pemenuhan persyaratan
• VERIFIKASI (Self-checking, Pemeriksaan oleh personel/Team yang independent , Metode pembanding (Kalkulasi atau evaluasi design yang serupa), Test, simulasi atau uji coba
• VALIDASI, Memastikan sesuai dengan keinginan
• Identifikasi masalah dan tindak lanjut
8.3.3. MASUKAN DISAIN & PENGEMBANGAN
• Persyaratan Pelanggan & Pasar
• Peraturan• Disain sebelumnya• Sumber daya (material,
peralatan, Skill yang diminta, Evaluasi & pemeriksaan)
8.3.6. . PENGENDALIAN PERUBAHAN• Identifikasi• Pengendalian dokumen terkait• Informasi harus akurat & benar• Komunikasi yang efektif• Perubahan harus diverifikasi dan validasi
8.3.2. PERENCANAAN DISAIN &
PENGEMBANGAN• Tahapan proses
• tinjauan, verifikasi & validasi untuk setiap desain
• tanggung jawab & wewenang
• komunikasi dengan bagian terkait
8.3. Design & Development
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8.4. Control of externally provided products and services
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8.4. Control of externally provided products and services
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8.4. Control of externally provided products and services
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8.5.1. Pengendalian penyediaan produk dan pelayanan
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Workshop 5
30 minutesClick here to
start
Process Identification
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Organisasi harus:• identifikasi produk dengan cara sesuai diseluruh
realisasi produk , jika diperlukan• identifikasi status produk berkaitan dengan persyaratan
pengukuran dan pemantauan • mengendalikan dan merekam identifikasi khas dari
produk, bila mampu telusur dipersyaratkan
8.5.2. Identifikasi & Mampu Telusur
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harus:• diidentifikasi• diverifikasi• dilindungi dan dijaga
milik pelanggan atau provider eksternal yang hilang, rusak atau karena suatu hal tak layak pakai harus direkam dan dilaporkan
Property mencakup “intelektual property”
8.5.3. property belonging to Customers or External providers
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Preservasi kesesuaian produk selama proses internal dan penyerahan
Mencakup: identifikasi penanganan pengemasan penyimpanan perlindungan bagian-bagian yang menjadikan produk
8.5.4. Preservasi
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8.5.5. Post Delivery Activities
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8.5.6. Control of Changes
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8.6. Release of Product and Services
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8.7. Control of NonConforming Output
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Performance EvaluationClause 9 - ISO 9001:2015
9
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Clause 9 – Performance evaluation
• 9.1 – Monitoring, measurement, analysis and evaluation• What needs to be monitored and measured, how and when
• 9.2 – Internal audit • To establish whether the QMS conforms to requirements
and is effectively implemented and maintained• 9.3 – Management review
• Top management must regularly review the QMS
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Clause 9 – Performance evaluation9.1. Monitoring,
measurement, analysis and evaluation
9.1.1
9.1.2
9.1.3
(General)
(Customersatisfaction)
(Analysis andevaluation)
• What needs to be monitored and measured, how and when
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9.1.2. Customer Satisfaction
Faktor loyalitas pelanggan
BASIC
EXPECTED
DESIRED
UNANTICIPATED
Faktor Kepuasan
Standar minimun yg diterima
Nilai rata-rata (sama seperti jasa lainnya)
Apa yang diinginkan pelanggan
Melebihi apa yang
diinginkan pelanggan
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Clause 9 – Performance evaluation
9.2. Internal AuditTo establish whether the QMS conforms to requirements and is effectively implemented and maintained
At planned intervals
(status and importance)
Ensure system
conforms to planned
arrangements
Ensuresystem
conforms to ISO 9001
Effectively implement
ed and maintained
Follow-up actions
Audit criteria, scope, frequency, methods defined in documented information
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9.3. Management Review
Sistem harus ditinjau oleh top managemen :
• dalam interval yang direncanakan• untuk menjamin berlanjutnya kesesuaian, kecukupan dan
keefektivan• untuk menilai kesempatan untuk peningkatan dan• kebutuhan untuk perubahan sistem, kebijakan dan sasaran
mutu
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Management Review
Previous actions/status
External/internal issues
N/C’s, corrective actions
Monitoring/Measurement
Audit results
Customer satisfaction
External providers
Adequacy ofresources
CONSIDER:
REVIEW
Process performance
Risks andopportunities
Continual improvement (C.I)
Opportunities (C.I)
Changes to QMS
Resource needs
Doc. Information
WHAT NEEDSTO CHANGE?
! !
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ImprovementClause 10- ISO 9001:2015
10
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Clause 10: Improvement
Improvement
Nonconformity and corrective action
Continual improvement
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Improvement
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What to evaluate ?
Action
•Policy•Critical Success
Factor•Measurement
•Program
•Data collected•Responsibility
•Frequency•Method
•Corrective•Correction• Improvement
How to evaluate ?
Analyze
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Nonconformity and corrective action
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QUALITY PROBLEM•Operational Cost•Customer satisfaction Result •Non conformity•Performance•Health & Safety
CORRECTIVE ACTION •Coordination between function•Caused identification•Analysis & corrective action plan•Follow up•Implementation monitoring, efficiency and evaluation on its effectiveness
POTENTIAL
PROBLEMS
CONTINUAL IMPROVEMENT
PREVENTIVE ACTIONS•Caused identification•Analysis & preventive action plan •Implementation•Implementation monitoring, efficiency and evaluation on its effectiveness (Management Review)
Continual improvement
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Continual improvement
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Review and Final Questions
?