Standard Prof Madya Dr

MS ISO 9001:2015 Nik Rosmawati Nik Husain

Pengurus Kualiti MS ISO 9001:2015

Kursus Audit Dalaman, PPSP, 2021

5 April 2021
 ISO = Applies to
Focus on
International Quality any International Tells you Guidance on
meeting the
Organization Managemen organization ly what must controlling
requirement
for t System (manufacturi recognized be done but necessary
s of
Standardizat standard ng and & accepted not how activities
customer
ion service)
 7.
Relationship 1. Customer
managemen focus
t

7 Quality 6. Evidence-
based decision 2. Leadership

Management making

Principles 5.
Improvemen
t
3.
Engagement
of people

4. Process
approach
 Quality Management Principles 1
Customer Focus
a) Statement
The primary focus of quality management is to meet customer requirements
and to strive to exceed customer expectations.

b) Rationale
Sustained success is achieved when an organization attracts and retains the
confidence of customers and other interested parties on whom it depends.
Every aspect of customer interaction provides an opportunity to create more
value for the customer.
Understanding current and future needs of customers and other interested
parties contributes to sustained success of an organization.
 Quality Management Principles 2
Leadership (Visi, misi)
a) Statement
Leaders at all levels establish unity of purpose and direction and create
conditions in which people are engaged in achieving the quality objectives of
the organization.

b) Rationale
Creation of unity of purpose and the direction and engagement of people
enable an organization to align its strategies, policies, processes and
resources to achieve its objectives.
 Quality Management Principles 3
Engagement of People

a) Statement
Competent, empowered and engaged people throughout the organization are
essential to enhance the organization’s capability to create and deliver value.

b) Rationale
In order to manage an organization effectively and efficiently, it is important to
respect and involve all people at all levels. Recognition, empowerment and
enhancement of competence facilitate the engagement of people in achieving the
organization’s quality objectives.
 Quality Management Principles 4
Process Approach

a) Statement
Consistent and predictable results are achieved more effectively and efficiently
when activities are understood and managed as interrelated processes that
function as a coherent system.

b) Rationale
The quality management system is composed of interrelated processes.
Understanding how results are produced by this system enables an the
organization to optimize the system and its performance.
 Quality Management Principles 5
Improvement

a) Statement
Successful organizations have an ongoing focus on improvement.

b) Rationale
Improvement is essential for an organization to maintain current levels of
performance, to react to changes in its internal and external conditions and to
create new opportunities.
 Quality Management Principles 6
Evidence-based Decision Making

a) Statement
Decisions based on the analysis and evaluation of data and information are more
likely to produce desired results.

b) Rationale
Decision-making can be a complex process, and it always involves some
uncertainty. It often involves multiple types and sources of inputs, as well as their
interpretation, which can be subjective. It is important to understand cause and
effect relationships and potential unintended consequences. Facts, evidence and
data analysis lead to greater objectivity and confidence in decision making.
 Quality Management Principles 7
Relationship Management
a) Statement
For sustained success, organizations manage their relationships with
interested parties, such as providers.

b) Rationale
Relevant interested parties influence the performance of an organization.
Sustained success is more likely to be achieved when an organization
manages relationships with all of its interested parties to optimize their impact
on its performance. Relationship management with its provider and partner
networks is often of particular importance.
Process Approach
 Quality Management System (4)

Organization
and its context
(4) Support &
Operation Customer
(7,8) satisfaction
Plan Do

Plan-Do-Check- Customers
Planning Leadership Performance
Results
of the QMS
Act (PDCA cycle) requirements
(6) (5) evaluation
(9)

Products and
Act Check services

Needs and
expectations of
relevant Improvement
interested (10)
parties (4)

Note: Numbers in brackets refer to the clauses in this International Standard.

 Plan-Do-Check-Act (PDCA cycle)
Plan:
➢ establish the objectives of the system and its processes,

➢ resources needed to deliver result in accordance with

customer’s requirements and the organization’s policies,

➢ identify and address risks and opportunities;

Do: implement what was planned

 Plan-Do-Check-Act (PDCA cycle)

Check:
➢monitor and (where applicable) measure processes and
the resulting products and services against policies,
objectives, requirements and planned activities

➢report the results

Act: take actions to improve performance, as necessary

 Structure of ISO 9001:2015

1 Scope
2 Normative references
3 Terms and definitions
4 Context of the organization
5 Leadership
6 Planning for the QMS
7 Support
8 Operation
9 Performance evaluation
10 Improvement
 4 6 7 8 9
5
Context of Planning Support Operation Performance and 10
Leadership
organization Evaluation Improvement
7.1 Resources 8.1
6.1
5.1 Operational planning and 9.1
4.1 Actions to 7.1.2 People
Leadership and control Monitoring,
Understanding address risks 10.1
commitment measurement,
context and 7.1.3 Infrastructure 8.2 General
analysis and
opportunities Requirement for products
7.1.4 Environment for evaluation
5.2 & services
4.2 the operation of 9.1.2
Policy 6.2 processes 10.2
Interested parties 8.3 Customer
Quality Nonconformit
objectives and Design & Development satisfaction y and
5.3 7.1.5 Monitoring and
planning measuring resources corrective
4.3 Organizational 8.4 9.1.3 action
Scope roles, Control of externally Analysis and
responsibilities and provided process, product, evaluation
6.3 7.1.6 Organizational services
authorities Planning of knowledge
4.4 10.3
changes 8.5 9.2 Continual
QMS
Production and Service Internal audit improvement
7.2 Competence
Provision
9.3
7.3 Awareness 8.6 Management
Release of Products and review
Services
7.4 Communication
8.7
7.5 Documented
Control of nonconforming
information
outputs
 Clause 4: Context of organization
18
• Interested parties (Appendix 14) that are relevant to the PPSP quality
management system (QMS), requirements of the interested parties, and 4: Context of
the relevant external and internal issues are listed in the Risk organization
Management Procedure (PPSP/QMS/RM).
• The interested parties, their requirements, and the relevant external
and internal issues are determined from the regular workshop and 4.1
discussion among the core program in the PPSP. PPSP shall review this Understanding
context
organization context when indicated or at least every 3 years.
• 4.2
• The Quality Plan, required support, interaction and evaluation for our Interested parties
quality process is address in the Macro Process Map of PPSP (Appendix
1a). The Macro Process Map of Research Management in PPSP is
explained in the Appendix 1b. The delivery of undergraduate is 4.3
explained in the Appendix 2a for old curriculum and Appendix 2b for Scope
new curriculum. Whereas, Appendix 3 explained the Process Map for PG
program (M.Med). 4.4
QMS
 Design and
development of
education
programme

Macro Process Map of PPSP

http://isokesihatan.kk.usm.my/images/ppsp/Appendix_1a.jpg
Provision of
education
services

Process Map: Delivery of MD Program (New Curriculum), PPSP

https://medic.usm.my/iso/images/ppsp/Appendix_2b.jpg
 Research
management
processes

Macro Process Map of Research Management, PPSP

https://medic.usm.my/iso/images/ppsp/Appendix_1b.jpg
SCOPE
4
Context of
organization

4.1
Understanding
context

4.2
Interested parties

4.3
Scope

4.4
QMS
 4.4 Quality management system and its processes
The organization shall establish, implement, maintain and continually improve a quality management
system, including the processes needed and their interactions, in accordance with the requirements of this
International Standard.

4: Context of
organization

4.1
Understanding
context

4.2
Interested parties

4.3
ISO/TC 176/SC 2/N1266

Scope

4.4
QMS

23
TERMS AND DEFINITION

PRODUCT -
SERVICES - Delivery of
Curriculum, journal
teaching and learning,
publication, graduated
management of
students,
research
commercialization
 5: Leadership
5.1
Leadership and commitment
LEADERSHIP
5.2
(Klausa 5) Policy

5.3
Organizational roles, responsibilities and
authorities

25
 Klausa 5: Leadership

1. Carta organisasi PPSP, jab, unit 5

2. Quality Management Committee (QMC) – PPSP and Leadership
departments/units
5.1
3. Customer focus - On-line customer feedback, e-aduan, Feedbacks, Leadership and
Information in website commitment
4. Quality Policy: School of Medical Sciences will strive to be a centre of
academic excellence by providing the highest standards of medical 5.2
education and research activity and will continually improve the Policy
effectiveness of the quality management
5. Communicating the quality policy – MRM, meeting minutes, ISO 5.3
website Organizational
roles,
6. Organizational roles, responsibilities and authorities - job descriptions responsibilities and
of staffs, QMC, delegations of works
authorities
Leadership and commitment for the quality
management process (5.1)
5
PPSP Dean EXCO Leadership

5.1
Leadership and
PPSP Management Committee commitment

5.2
Policy
PPSP MS ISO9001:2015 Quality 5.3
Working Committee Organizational
roles,
responsibilities and
authorities
Departmental committee
QUALITY POLICY (5.2)

5
School of Medical Sciences will strive to be Leadership

a centre of academic excellence by providing 5.1

Leadership and
the highest standards of medical education commitment

5.2
and research activity and will continually Policy
improve the effectiveness of the quality 5.3
Organizational
management roles,
responsibilities and
authorities
Organizational roles, responsibilities and authorities
(5.3)

• The Dean of PPSP is the Head of our implemented Quality 5

Management System (QMS). The Dean shall do all delegation and Leadership
authorisation where indicated and relevant with regards to
activities affecting quality. The Head of Department/units, 5.1
program chairman are responsible for reporting relevant Leadership and
information on all issues related to academic and research commitment
activities affecting quality. The Head of Department/units,
program chairman and head of academic administration share 5.2
responsibilities and design methods to divide specific Policy
responsibilities whenever the need arises. At any given time, their
basic responsibilities remain unchanged unless specifically 5.3
identified and documented. Organizational
• All staff shall also have a copy of their described job descriptions roles,
responsibilities and
and a copy of them is kept in a file in the respective departments.
authorities
 6: Planning

6.1
Actions to address risks
CLAUSE 6 and opportunities
PLANNING 6.2
Quality objectives and
planning

6.3
Planning of changes
30
 Risk-based Thinking
31
6
Risk-based thinking is essential for achieving an Planning

effective QMS 6.1

Actions to
address risks
The concept of risk-based thinking is and
opportunities
• Carrying out preventive action to eliminate potential
nonconformities 6.2
Quality
• Analyzing any nonconformities that do occur objectives and
planning
• Taking action to prevent recurrence that is appropriate for the
effects of the non conformity 6.3
Planning of
changes
Quality Objectives And Planning To Achieve Them
(6.2)
6
Planning
• QO for the respective departments/units in PPSP- 6.1
Actions to
available and monitored, reviewed by the Heads of address risks
and
Department/Uni opportunities

• Evaluation - trend analysis of the database 6.2

Quality
(undergraduate program, postgraduate program and objectives and
planning
research achievement) and based on PPSP KPI
6.3
Planning of
changes
Quality Objectives And Planning To Achieve Them
(6.2)
For undergraduate T&L activity
• To ensure at least 40% of successful undergraduate students in the professional examinations obtain good grades (B and 6
above) Planning
• To ensure at least 90% of undergraduate students in professional examinations pass their exam 6.1
Actions to
For postgraduate T&L activity
address risks
• Ratio of postgraduate student to eligible lecturers is not more than 3 to 1. and
opportunities
• At least 75% of eligible lecturers to be the main supervisor for research / dissertation to a minimum of one postgraduate
student.
6.2
• a) Percentage of international postgraduate students in course work is at least 2%. Quality
b) Percentage of international postgraduate students in mixed-mode and research-mode is at least 10%. objectives and
• At least 20% of PhD candidates submit their thesis within 7 semesters. planning
• At least 35% of MMed candidates graduate within 8 semesters.
6.3
For research activity Planning of
• At least 60% of eligible academic staff will be involved in research as Principal Investigator. changes
• At least 60% of eligible academic staff publishes paper in the indexed journal.
Planning of changes (6.3)

6
Planning
• Any variation are subjected to approval from relevant committees and endorsed by
PPSP School Board. Each Department/Unit, Program or Block will prepare their 6.1
roster/teaching schedule/time table and distributed to the clients be it student, or Actions to
address risks
lecturer or researchers. and
opportunities
• When the need for changes is necessary to the processes of the QMS to ensure that
they achieve intended results, the changes shall be carried out in a planned manner 6.2
(for example by having a check list); taking into account that the purpose, integrity, Quality
available resources, allocation/relocation of responsibilities and authorities for the objectives and
planning
change have all been considered beforehand.
• The running of QMS in PPSP is following the planned list of yearly activities as shown 6.3
in Appendix 17 (Takwim Pegurusan Kualiti MS ISO 9001:2015, PPSP). Planning of
changes
 7 : Support
7.1 Resources
7.1.2 People
7.1.3 Infrastructure
7.1.4 Environment for the operation of
processes

CLAUSE 7 7.1.5 Monitoring and measuring resources

RESOURCES
7.1.6 Organizational knowledge

7.2 Competence

7.3 Awareness

7.4 Communication

7.5 Documented information 36

Infrastructure (7.1.3)
7
Support
7.1 Resources
• Records of equipment purchased by PPSP are 7.1.2 People

kept by PPSP administration while repair and 7.1.3 Infrastructure

7.1.4 Environment for the
service records are documented and maintained operation of processes

by the respective Department/Unit Heads. 7.1.5 Monitoring and

measuring resources
Purchasing records include and adhered to 7.1.6 Organizational
specified guidelines and procedure provided knowledge

through ministerial directives and policies and 7.2 Competence

7.3 Awareness
monitored by the Bursary Office. 7.4 Communication
7.5 Documented
information
37
Competence and training (7.2)
7
Support
7.1 Resources
7.1.2 People
7.1.3 Infrastructure
Describing the process of managing human resources by 7.1.4 Environment for the
documenting: operation of processes

• a procedure that defines identification of training needs, 7.1.5 Monitoring and

measuring resources
training planning,
• conducting and evaluation of training effectiveness, 7.1.6 Organizational
knowledge
• assigning responsibilities for this 7.2 Competence
Mandatory: evidence of competence 7.3 Awareness

7.4 Communication
7.5 Documented
information
38
Awareness (7.3)
7
Support
7.1 Resources
7.1.2 People
The awareness of QMS program is handled by quality
secretariat of PPSP. The awareness is raised through varieties 7.1.3 Infrastructure

of avenues such as: 7.1.4 Environment for the

operation of processes
• Departmental meeting
7.1.5 Monitoring and
• ISO courses and workshop measuring resources

• Email groups 7.1.6 Organizational

knowledge
• Publish in intranet the quality objectives of department 7.2 Competence
• Publishing internal audit and findings 7.3 Awareness
• Have quality corner in PPSP website 7.4 Communication
7.5 Documented
information
39
Communication (7.4)
7
Support
7.1 Resources

Effective internal communication is given prime importance for efficiency 7.1.2 People
of quality management in PPSP through various methods: 7.1.3 Infrastructure
• Intranet for PPSP and Health campus 7.1.4 Environment for the
operation of processes
• Various Committee and departmental meetings
• E-mails and related websites/homepage 7.1.5 Monitoring and
measuring resources
• Electronic and notice boards
• Internal surveys and feedback sessions 7.1.6 Organizational
knowledge
• WhatsApp, memo, notice
7.2 Competence
• Mailing list for the coordinators and document controllers of the
departments and units at e-mail 7.3 Awareness
• MRM 7.4 Communication
7.5 Documented
information
40
 8
Operation
8: Operation
8.1
CLAUSE 8: OPERATION
8.1
Operational planning and
Operational planning and
control
control
8.2
8.2
Requirement for products Penambahbaikkan OQ/prosedur kerja
Requirement for products
& services
& services
8.3
Curriculum review
8.3
Design & Development
Design & Development
8.4 8.5.2 Identification and traceability
8.4
Control of externally
Control of externally
provided process, product, For the undergraduate program, this is done through the preparation of various filing system for
provided process,
services product,
services
each phases from Year 1 to Year 5 including assessments and students personal file, and
8.5 Undergraduate Information system (UGIS). Each year of study will be taken care by a specific
8.5
Production and Service
Production and Service
Provision
officer in-charge in Academic Office. For the postgraduate program, this is done through various
Provision filing system including Post-Graduate Information System (PGIS), SMUP-Peng, Supervisor
8.6
8.6
Release of Products and Report and Student’s Personal File. The student will be placed under specific staff/lecturer in-
Release Services
of Products and charge based on the program that he/she enrolled. For the research management, the processes
Services include Filing System for individual research project, Database system of research project
8.7
8.7
Control of nonconforming (Research Information System, RIS) and Database System of Asset (Asset Management System,
Control ofoutputs
nonconforming AMS).
outputs
 9: Performance and
Evaluation
9.1
CLAUSE 9: Monitoring, measurement,
PERFORMANCE analysis and evaluation

EVALUATION 9.1.2
Customer satisfaction

9.1.3
Analysis and evaluation
9.2
Internal audit
9.3
Management review
42
 9
Customer satisfaction (9.1.2) Performance and
Evaluation

9.1
Monitoring,
measurement,
• …. most of the monitoring and measurement done to assess analysis and
evaluation
customer satisfaction
9.1.2
• ….. in the department/unit procedures Customer
satisfaction
• …. methods used include collection of data obtained through 9.1.3
students/customer`s feedback/ Questionnaires/client surveys Analysis and
evaluation
and e-aduan
• PPSP requires action to be taken when more than 20% of 9.2
Internal audit
customers are not satisfied with product and services. 9.3
Management
review
Analysis and evaluation (9.1.3) 9
Performance and
Evaluation

9.1
Monitoring,
PPSP monitors, measures, analyse and evaluate the activities: measurement,
analysis and
Conformity to our objectives (as stated in 6.2) evaluation
Requirement and management control of performance of product 9.1.2
and service in all aspects of academic activities (as stated in 8.6) Customer
The degree of customer satisfaction (as stated in 9.1.2). satisfaction
The performance and effectiveness of the QMS
9.1.3
If planning has been implemented effectively Analysis and
The effectiveness of actions taken to address risks and evaluation
opportunities
The performance of external providers 9.2
Internal audit
The need for improvements to the quality management in PPSP
9.3
Management
review
44
Maklumbalas
pelanggan
• 2 jenis – e-aduan
& borang kajian
kepuasan
pelanggan
• Raw data,
analisa, tindakan,
NCP form
MANAGEMENT REVIEW (9.3) 9
Performance and
Evaluation

9.1
Monitoring,
measurement,
i. The status of actions from previous management reviews analysis and
ii. Changes in external and internal issues relevant to the Quality Management evaluation
iii. Effectiveness of actions taken to address risks and opportunities
9.1.2
iv. Information on the performance of the Quality Management, including trends in: Customer
• Customer satisfaction and feedback from relevant interested parties satisfaction
• The extent to which quality objectives have been met
• Process performance and conformity of products and services 9.1.3
Analysis and
• Nonconformities and corrective actions evaluation
• Monitoring and measurement results
• Audit results 9.2
• The performance of external providers Internal audit
v. The adequacy of resources 9.3
vi. The effectiveness of actions taken to address risks and opportunities Management
review
vii. Opportunities for improvement.
46
 10: Improvement
CLAUSE 10: 10.1
IMPROVEMENT General

10.2 Nonconformity and

corrective action

10.3
Continual improvement

47
10.2 Nonconformity And Corrective Action

• A Corrective Action Procedure (PPSP/QMS/CA) is maintained to ensure that PPSP

reacts to nonconformity (including any arising from complaints) and deal with the
10
consequences. The procedure also provides a system for reviewing, analysing, Improvement
determining the causes; and if similar nonconformities exist, or could potentially
occur, to ensure that appropriate corrective actions are taken.
10.1
• PPSP shall take action to eliminate the causes of nonconformity through: General

• Remedial action
10.2
• Performance analysis Nonconformity
• Discussion/meeting and corrective
action
• Training
• Other relevant actions 10.3
Continual
• Documented procedure is established to eliminate causes of nonconformities in improvement
order to prevent recurrence. Thus, the effectiveness of the corrective actions (CA)
taken shall be reviewed.
CONTROL OF NON-
CONFORMING
PRODUCTS/SERVICES`
(NCP) - (PPSP/QMS/NCP)

• Analisa kepuasan pelanggan

>20% tidak memuaskan
• OQ tidak tercapai
CORRECTIVE
ACTION
(PPSP/QMS/CA)
Penambahbaikan berterusan PPSP, 2021
1. Perubatan Integratif
Perlaksanakan Rekod baru PG –
2. CRL Sistem Pengurusan memantau
3. CTU Kualiti penerbitan calon
ISO9001:2015 di 6 program Mmed
4. UPKW jabatan/unit (Dr. Tuan
5. Perubatan Nuklear (En Faris, En Ismail, Noorkorina Tuan
Pn Mazira) Kub)
6. Rehab
Due siap: Jun 2021 Review Objektif
Review Internal
Issues and External Kualiti
Issues (28 dari 38)
(Dr Tg Ahmad (Dr Nik
Damitri) Rosmawati)
Rekod baru PG –
memantau penerbitan
calon program Mmed:

Maklumat
Penyeliaan,
Penyelidik Utama,
Penerbitan Setiap
Pensyarah
(PPSP/QMS/QM/L1)
MILESTONE AKTIVITI ISO 9001:2015 TAHUN 2021 (update: 16/3/2021)

Jan Feb Mac Apr Mei

Latihan Training Bengkel Pengurusan Due date submit Perbentangan
Audit Dalaman
for Trainer (TOT) Risiko, 4 Feb 21 daftar risiko, 17 Mac pengurusan risiko
2021, 30 Mei – 10
Pengurusan Risiko tahap tinggi bersama
31 Jan 2021 Kursus Lead Auditor Jun
EXCO Dekan
Review dokumen 28 mac-1 Apr
kualiti Kursus Internal
Kursus Pemantapan
Audit, 5 April
ISO, 17 Mac

Jun Jul Aug Okt

Mesyuarat dgn TM Tutup NCR, 1 Recertification Kursus Pemantapan
Audit SIRIM, awal Pengurusan Kualiti
selepas Audit Julai
August (Pengurusan Latihan)
Dalaman
MRM, Akhir Julai