www.inqka.uitm.edu.

my
 2

ISO 9001 : 2015 Awareness

Presented by:

Tuan Syed Abdul lllah Alyahya Syed Abd Kadir

Centre of Foundation Studies

18 July 2018
 3 PROGRAM ITINERARY

TIME ACTIVITY

8.30 – 8.55 am Registration

9.00 – 9.30 am Introduction to course objectives, background of ISO and

QMS
9.30 – 10.00 am Introduction to ISO 9001:2015

10.00 – 10.30 am Background of changes & process approach

10.30 – 10.45 am Break

10.45 – 12.45 noon Understanding ISO 9001:2015 requirements – Clauses 1- 7

12.45 – 2.00 pm LUNCH BREAK

3
 4 PROGRAM ITINERARY

TIME ACTIVITY

2.00 – 3.15 pm Understanding ISO 9001:2015 requirements – Clauses 8- 10

3.15 - 3.35 pm Closing the gap between ISO 9001:2008 & 2015 &
Incorporating the new requirements into your system

3.35 – 3.50 pm Break

3.50 – 4.30 pm Exercise on ISO 9001:2015 Standards

4.30 – 5.00 pm Q & A Session

5.00 pm End of Session

4
5
 6 Course objectives
1. To investigate the general concept of ISO 9001 :
2015 Management System
2. To prepare documents based on the
requirements of ISO 9001 :2015
3. To establish the effective QMS based on the ISO
9001:2015. ( Manual Kualiti, Risk Register, SOP,
Quality Policy, Quality Objective, Strategic
Planning, Strategic Action, Evaluation and
Improvement )
 7 BACKGROUND
• First published in 1987, ISO 9001 has consistently been
ISO’s most popular series of standards.
• Geneva Switzerland
• Malaysia is a member of ISO
• In Malaysia – Department of Standards Malaysia
• ISO 9000 – Vocabulary and fundamentals
(Terminologies)
• ISO 9001-Quality Management System
• ISO 9004- Managing for sustained success of an
organization
8 Background
 9 Process in developing IS
• There are several distinct stages when developing ISO standard; the
key ones being :

1. New work item proposal (NP)

2. Working Draft (WD)
3. Committee Drafts (CD)
4. Draft International Standard (DIS)
5. Final Draft International Standard (FDIS)
6. International Standard (IS)

The standard is published after approval of the FDIS by participating

national standards bodies.
10 ISO 9001: 2015 TIMELINE

ISO 9001:2015

*All certifications to
ISO 9001:2008 will
No longer be valid after September 2018
 11 Objectives of revision
1. Maintain relevance- Improvement
2. Enhance an organization’s ability to satisfy
customers.
3. Provide integrated approach to organizational
management and integrate with other
management systems for example ISO 14001,
ISO 18001etc.
4. Set a consistent foundation for the next 10 years.
5. Ensure the new standard reflects the needs of all
potential user group.
 12 What’s new?
1. “Risk-Based thinking” – Proactive Preventive Action
2. Increased requirement for Top Management Commitment.
3. Less emphasis on documents; Flexibility on documentation
4. Customer Satisfaction.
5. Process Approach.
6. A new common format has been developed for use in all
management system standards (MSS). For example ISO 9001
and ISO 14001.
7. Enhance requirement for competent of resources.
8. Understand the context of the organization.
9. Organizational Knowledge.
10.Mentioned both products and services
 13 Common clause titles for ISO 9001:2015
•Introduction
1. Scope
2. Normative reference
3. Terms and definitions
4. Context of the organization (Plan)
5. Leadership (Plan)
6. Planning (Plan)
7. Support (Do)
8. Operation (Do)
9. Performance evaluation (Check)
10.Improvement (Action)
14 Comparison Between 2008 vs 2015
15 ISO 9001 : 2008 Model
16 ISO 9001 : 2015 NEW PROCESS MODEL
17 The Revised Quality Principles
18 Major difference in terminology between
ISO 9001 : 2008 and ISO 9001 : 2015
 19 Structure of ISO 9001 : 2015
1. Scope
2. Normative reference
3. Terms and definition
4. Context of the 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 QMS
4.4 Quality management system and its processes

5. Leadership

5.1 Leadership and commitment

5.2 Quality Policies
5.3 Organizational roles, responsibilities and authorities

6. Planning for the QMS

6.1 Actions to address risks and opportunities

6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
 20 Structure of ISO 9001 : 2015
7. Support
7.1 Resources

7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented Information

8. Operation

8.1 Operational planning and control

8.2 Determination of requirement for products and services
8.3 Design and development of products and services
8.4 Control of externally provided products and services
8.5 Production and services provision
8.6 Release of products and services
8.7 Control of non conforming process outputs, products and services
 21 Structure of ISO 9001 : 2015

9. Performance evaluation

9.1 Monitoring, measurement, analysis, and evaluation

9.2 Internal audit
9.3 Management review

10. Improvement

10.1 General
10.2 Non-Conformity and corrective action
10.3 Continual improvement
22
23 ISO 9001:2015 Clause 4 :

Context of the organization

24
 25 Understanding the Organization and Its Context – 4.1

The organization shall:

• Determine internal and external issues that are relevant to
its purpose and its strategic direction (Hala Tuju Strategik).
• Monitor (memantau) and review (mengkaji semula) information
relating to internal and external issues.
i. Use SWOT Analysis
ii. Internal and external
iii. Positive and negative

Evidence : Strategic Planning, Workshop & Presentation, Training Program,

Minute of Meeting etc.
26 SWOT ANALYSIS
27 SWOT ANALYSIS

Budget/Finance Budget/Finance
Infrastructure Infrastructure
Technology Technology
Manpower – Competency Manpower – Competency
Team Work Culture Team Work Culture
Working Environment Working Environment
Communication Communication

New Technology
New Government Policy New Legislation
Social Patterns Economy Crisis
Population Profile Contractors
Location Supplier
Local Activities
 28 4.2 – Understanding the needs and expectations of interested parties

To consistently provide products and services that meet

customer and statutory (Perundangan) and regulatory
(Peraturan) requirements, the organization shall :-

a) determine the interested parties (Customer +

Stakeholders) that have relevant to the quality
management system.
b) determine the requirement of these interested parties that
are relevant to the QMS.
Monitor and review the information about these
interested parties

Evidence: Feedbacks, Minutes of Meeting, Policies etc.

 29 4.3 – Determining the Scope QMS
In determining the scope of the QMS, the organization shall determine
the boundaries and applicability of the QMS to establish the scope. It
shall consider :
a) External and internal issues (referred to in 4.1)
b) Relevant requirements of interested parties (referred to in 4.2)
c) Its products and services (Main activities)

Shall be available and be maintained as documented

information.
The scope shall be available stating the :
• Product and services covered by the QMS
• Justification where the requirement cannot be applied

Evidence: Manual Quality, Objective Quality, Strategic

Planning Etc.
 30 4.4 – Quality Management System and its Processes

The new standard further promotes the process approach beyond

the existing requirements in ISO 9001:2008.
The organization shall determine the process needed for the QMS
and shall determine :
a) The inputs and outputs of the processes
b) The sequence and interaction of these processes
c) The criteria, methods, including measurements and related performance
indicators
d) The resources needed
e) The assign of the responsibilities and authorities
f) The risks and opportunities (Clause 6.1)
g) Evaluate these processes and implement any changes to achieve
intended results.
h) Improve the processes and the QMS
 31 PROCESS APPROACH

Evidences: Vision, Mission, Strategic Planning, Management Meeting, CQI report, Research Policy etc.
32 Clause 5 : Leadership
33
34 ISO 9001 : 2015 NEW PROCESS MODEL
 35 5.1 : Leadership and Commitment
Shall demonstrate leadership and commitment through :
 36 5.1.2 : Customer Focus

Top management shall demonstrate leadership and commitment

with respect to customer focus by ensuring that :

a) Customer requirements and applicable statutory and

regulatory requirements are determined and met
b) The risks and opportunities that can affect conformity of
products and services are determined and addressed.
c) The focus on enhancing customer satisfaction is
maintained.
Evidences: Feedbacks, CQI Report, Minutes of Meeting, Quality
Objectives, etc.
 37 5.2 : Quality Policy
5.2.1 Top management shall establish a Quality policy that :

a) Is appropriate to the purpose and context of the organization

b) Provides a framework for setting the quality objectives
c) Includes a commitment to satisfy applicable requirements
d) Includes a commitment to continual improvement of QMS

5.2.2 Communicating The Quality Policy :

The Quality Policy Shall:

a) Be available and be maintained as documented information

b) Be communicated, understood and applied within the organization
c) Be available to relevant interested parties as appropriate

Evidences: Quality Policy, Quality Objectives, Minutes of Meeting, Strategic Planning,etc.

 38 5.3 : Organizational Roles, Responsibilities & Authorities

• Top management shall ensure that the responsibilities and authorities for relevant
roles are assigned and communicated within the organization.
• Top management shall assign the responsibility (Tanggungjawab) and authority
(kuasa) for :

a) Ensuring that QMS conforms (Patuh) to the requirements

b) Ensuring the processes are delivering their intended outputs (KPI)
c) Reporting the performance of QMS and on opportunities for improvement
d) Ensuring the promotion of customer focus
e) Ensuring the integrity of QMS is maintained when changes to the QMS are
planned and implemented. (Dokumen yang lengkap dan Jelas)
Evidences: Job scope, List of Committee, Appointment letter, Strategic Planning,
etc.
39
40 Clause 6 : PLANNING
41
 42 6.1 : Action To Address Risk And Opportunities

• 6.1.1 When planning of QMS, shall consider the issues referred to in 4.1
and 4.2 and determine the risks and opportunities that need to be
addressed to :
a) Ensure the QMS can achieve its intended outcome
b) Enhance desirable effects.
c) Prevent or reduce undesired effects
d) Achieve continual improvement

• 6.1.2 The organization shall plan :

a) Action to address (menangani) these risks and opportunities
b) How to integrate and implement the action into QMS processes
c) Evaluate the effectiveness of these actions – Penilaian Keberkesanan
Evidences: Risk Management, CQI Report, Operational Excellence, Management
Meeting, Strategic Planning etc.
43 Risk Assessment Format - Sample
 44 6.2 Quality Objective and Planning to Achieve Them

6.2.1 The organization shall establish Quality objectives at relevant

functions, levels and processes.

The Quality objectives shall :

a) Be consistent with Quality policy

b) Be measurable
c) Take into account applicable requirements
d) Be relevant to conformity of products and services and
enhancement of customer satisfaction
e) Be monitored
f) Be communicated
g) Be updated as appropriate
Evidences: Quality Objectives, CQI Report, Minutes of Meeting, Website, Customer
feedbacks, etc.
 45 6.2 Quality Objective and Planning to Achieve Them

6.2.2 When planning how to achieve its Quality Objectives, the

organization shall determine :

a) What will be done – Apa yang perlu dilakukan?

b) What resources will be required – Sumber yang diperlukan?
c) Who will be responsible – PIC?
d) When it will be completed – Tarikh siap?
e) How the results will be evaluated – Proses Pengukuran?
 46 6.3 Planning of changes
Where the need of change to the quality management system is
determined, the change shall be carried out in a planned manner
(see 4.4). Shall consider :

a) The purpose of the change and any potential

consequences – Tujuan dan Potensi.
b) The integrity of the quality management system
c) The availability of resources – Keberadaan Sumber.
d) The allocation or reallocation of responsibilities and
authorities – Agihan Semula/ Perubahan Struktur.
Establish procedure to control/smooth/consistent the process.
Evidences: Minutes of meeting, Risk Management, Job Scope, Workshop
etc.
47 Clause 7 : SUPPORT

SUPPORT
48
49 Summary
 50 7.1 Resources
• The organization shall determine and provide the
resources needed for establishment, implementation,
maintenance and continual improvement of the QMS.
Resources considerations include:

a) Capability of and constraints (Kekangan) in existing

internal resources,
b) What needs to be obtained from external providers.

Evidences: Organization Chart, Job Scope, Customer Feedbacks,etc.

51 7.1.2 People

Organization shall determine and provide persons

necessary for the effective implementation of the QMS
and for the operation and control of its processes.
(Operasi dan kawalan proses)

Evidences: Job Scope, Appointment Letter, Organization Chart,

Minutes of Meeting, etc.
 52 7.1.3 Infrastructure

The organization shall determine, provide and

maintain the infrastructure necessary for the
operation of its processes and to achieve conformity
of products and services :

For Example:
Building , Equipment, Instruments, Software,
Transport, Computers etc.
 53 7.1.4 Environment for the operation of processes

The organization shall determine, provide and maintain

the environment necessary for the operation.

• Can include physical, social, psychological, environment

and other factors such as temperature, humidity,
ergonomic and cleanliness.
Keperluan Tempat Kerja ; Meja, Kerusi, Komputer dll.
 54 7.1.5.1 Monitoring and measuring resources

The organization shall:

• Determine resources needed to ensure valid and reliable
monitoring and measuring results.
• Ensure the resources provided :
a) Are suitable for the specific type of monitoring and
measurement activities
b) Maintained to ensure their continuing fitness for their purpose

• Retain appropriate documented information of fitness for purpose

of monitoring and measuring resources.
(Simpan rekod Calibration)
 55 7.1.5.2. Measurement Traceability
When measurement traceability is a requirement, or is considered by the
organization to be an essential part of providing confidence on the validity of
measurement results, measurement equipment shall be :

a) Calibrated or verified, or both at specified intervals or prior to use,

against measurement standard traceable to international or national
measurement standard; when no such standards exist the basis used
for calibration or verification shall be retained as documented
information;
b) Identified in order to determine their status
c) Safeguarded from adjustments, damage or deterioration

Shall take appropriate action as necessary if measuring equipment is

found to be unfit.
 56 7.1.6 Organizational Knowledge

• Organization shall determine, maintain, and make

available knowledge needed for operation of its processes
and to achieve conformity of products and services.
• Need also to consider whether additional knowledge
needed to address changing needs and trends.
• Internal Sources: Regular meeting, presentation, results
of improvement etc.
• External sources : Standard, conferences, gathering
knowledge from customer or external provider
 57 7.2 Competence

The organization shall:

a) Determine the necessary competence of person (s) doing work
under its control that affects its QMS performance.
b) Ensure these persons are competent on the basis of appropriate
education, training or experience. – Sijil Kelayakan.
c) Take action to acquire the necessary competence and evaluate
the effectiveness – Feedbacks, CQI Report, Propens.
d) Retain (Rekod) appropriate documented information as evidence
of competence. Fail Peribadi.
 58 7.3 Awareness
The persons doing work under the organization’s control
shall have awareness on:

a) The quality policy; University, Faculty, etc.

b) The relevant quality objective: University, Faculty, etc.
c) Their contribution to the effectiveness of QMS
d) The implication of not conforming with QMS
requirements ( Non- Conformity and Conformity)
Evidences: Website, Notice Board, Workshop, Briefing etc.
 59 7.4 Communication
• Includes internal and external Communication relevant to QMS

Evidences: Meeting, Website, Notice Board, Workshop, Briefing, Poster, Banner, etc.
60 7.5 Documented Information
61 7.5 Documented Information
62
63 CLAUSE 8 : OPERATION
OPERATION
64
 65 8.1 Operational Planning and Control
The organization shall plan, implement and control the
processes as outlined in 4.4, needed to meet requirements for
the provision of products and services and to implement the
actions determined in 6.1 by :

a) Determining requirements for the product and services

b) Establishing criteria for the processes and for the acceptance of
products/services
c) Determining the resources needed (Sumber yang diperlukan)
d) Implementing control (Laksanakan Kawalan terhadap proses)
e) Determining, maintaining and retaining documented information.

Evidences: Strategic Planning, Objective Policy, Objective Quality, Risk Register, etc.
 66 8.2.2 Determination of requirements related to product and services

The organization shall establish, implement and maintain a

process to determine the requirements for the products and
services to be offered to potential customer.
Shall ensure :

a) Product and service requirements and applicable statutory

and regulatory requirements are defined;
b) It has the ability to meet the defined requirements and
substantiate the claims for the products and services it
offers

Evidences: Contract Agreement, Website, Profile, Feedbacks from industries,

Market Surveys (Employer & Alumni), Curriculum Review Procedure Etc.
 67 8.2.3 Determination of requirements related to products and services

The organization shall review: (Engagement with Customer)

a) Requirements specified by the customer, including the requirements for

delivery and post delivery activities
b) Requirements not stated by the customer but necessary for specified
or intended use, when known;
c) Requirements specified by the organization
d) Statutory and regulatory requirements related to the product and
service
e) Contract or order requirements differing from those previously
expressed

Evidences: Minutes of Meeting, Customer Feedbacks, Policy, Guidelines, Etc.

 68 8.3 Design and development of products and services

The organization shall:

Establish, implement and maintain an appropriate D&D process

(clause 8.3.1)
Clarification of the application of D&D requirements (clause 8.3.1)
D&D planning (clause 8.3.2)
D&D inputs (clause 8.3.3)
D&D controls – new clause combinig reviews, verification & validation
(clause 8.3.4)
D&D outputs (clause 8.3.5)
D&D changes (clause 8.3.6)

Evidences: Curriculum Review Procedure, New Program, Guidelines, policy,

Etc.
69 8.4 Control of External Provision of Goods And Services
 70 8.5.1 Control of production and services provision
Shall plan and carry out production controlled conditions. Controlled conditions shall include, as
applicable :

a) Availability of documented information that defines characteristics of products and services

b) Availability of documented information that defines the activities to be performed and results
to be achieved
c) The availability and use of suitable monitoring and measuring resources
d) Monitoring and measurement activities at appropriate stages and acceptance criteria have
been met
e) The use and control of suitable infrastructure and process environment
f) The competence of person
g) Validation where resulting output cannot be verified
h) The implementation of actions to prevent human error
i) The implementation of products and services release and delivery and post-delivery activities

Evidences: Staff Qualification, Experience, Training Activities, List of Equipment, Certification, Organization
Charts, Job Scope, Etc.
 71 8.5.2 Identification and Traceability

• Where necessary to ensure conformity of products and services,

the organization shall use suitable means to identify process
outputs.
• Shall identify the status of process outputs with respect to
monitoring and measurement requirements
• Where traceability is a requirement, shall control the unique
identification of the process output and retain any documented
information necessary to maintain traceability.

Evidences: Student ID, No Permohonan, No Tender , Kod Program, Kod

Kampus etc.
 72 8.5.3 Property belonging to customers or external providers

• Used to be “customer property”

• Intent still the same, e.g.. to take care of customer’s
property while it is under the organization’s control or
being used by the organization.
• Requirement extended to cover not just customer
property but also property belonging to external
providers.
• Can include materials, components, tools, customer
premises, intellectual property and personal data.
Evidences: Policy, Guidelines, Procedure, Minutes of Meeting, etc.
 73 8.5.4 Preservation

• Shall ensure preservation of process outputs during

production and services provision, to the extent
necessary to maintain conformity to the
requirements.

• Can include identification, handling, contamination

control, packaging, storage, transmission or
transportation, and protection

Evidences: Transcript, Scroll, etc.

 74 8.5.5 Post delivery activities
• Shall meet requirements for the post delivery activities
associated with the products and services
• In determining the extent of post-delivery activities that are
required, the organization shall consider :

a) Statutory and regulatory requirements

b) The potential undesired consequences associated with its products
and services
c) The nature, use and intended lifetime of the products and services
d) Customer requirements
e) Customer feedback
 75 8.5.6 Control of changes

• The organization shall review and control changes for

production or service provision to the extent necessary to
ensure continuing conformity with requirements.
(Semakan Kurikulum)

• The organization shall retain documented information

describing the results of the review of changes, the
personnel authorizing the change, and any necessary
actions arising from the review.
Evidences: (Surat JAF, JKIKU, Senat, Tender Drawing,
Construction Drawing, Minutes of Meeting, etc.)
 76 8.6 Release of products and services

• The organization shall implement planned arrangements at

appropriate stages to verify that product and service
requirements have been met.
• The release of products and services to the customer shall not
proceed until planned arrangements have been satisfactorily
completed unless otherwise approved by a relevant authority, and
as applicable, by the customer. Documented information shall
provide evidence of conformity with acceptance criteria and
traceability to the person authorizing the release.

(Keputusan peperiksaan, Surat Konvo, Program Baru, Etc.)

 77 8.7 Control of nonconforming process outputs, products and services

• 8.7.1 The organization shall deal with nonconforming outputs in one or more of
the following ways :
a) Correction
b) Segregation, containment, return or suspension of provision of products
and services
c) Informing the customer
d) Obtaining authorization for acceptance under concession

• 8.7.2 The organization shall retain documented information that :

a) Describes the nonconformity
b) Describes the actions taken
c) Describes any concessions obtained;
d) Identifies the authority deciding the action in respect of nonconformity
78 Clause 9 :PERFORMANCE EVALUATION
79
 80 9.1 Monitoring, Measurement, Analysis & Evaluation

9.1.1 General
The organization shall determine:
a) What needs to be monitored and measured
b) The methods for monitoring, measurement, analysis and
evaluation as applicable – Valid Results
c) When the monitoring and measuring shall be performed
d) When the results from the monitoring and measurement
shall be analyzed and evaluated.
• Shall evaluate the performance and the effectiveness of the
QMS
• Shall retain appropriate documented information as evidence of
the results.
 81 9.1.2 Customer Satisfaction
• The organization shall monitor customers’ perceptions of
the degree to which their needs and expectations have
been met.
• Shall determine the methods for obtaining, monitoring
and reviewing this info.

Can include customer satisfaction/opinion surveys, customer

feedback on delivered products and services, market share
analysis, compliments, warranty claims and dealer reports.

Evidences: Minutes of meeting, Feedbacks, Seminar, Etc.

 82 9.1.3 Analysis And Evaluation
1. The organization shall analyze and evaluate appropriate
data and information arising from monitoring and
measurement.
2. The result of analysis shall be used to evaluate :
a) Conformity of products and services
b) The degree of customer satisfaction
c) The performance and effectiveness of the QMS
d) If planning has been implemented effectively
e) The effectiveness of actions taken to address risks and
opportunities
f) The performance of external providers
g) The need for improvements to the QMS

Evidences: Exam results, CGPA, AD, ANC, Feedbacks etc.

 83 9.2 Internal Audit
The organization shall conduct Internal Audit at planned intervals to ensure that the organization’s
requirements and the requirements of this standard, are met and the QMS is effectively implemented
and maintained.
The organization shall:
a) Plan, establish, implement and maintain an audit programme (s) including the frequency, methods,
responsibilities, planning requirements and reporting which shall take into consideration the
importance of the processes concerned, changes affecting the organization, and results of previous
audits.
b) Define audit criteria and scope
c) Select auditors and conduct audits objectively and impartially ( Certification, Audit Plan,
d) Ensure results of audit are reported to relevant management
e) Take appropriate correction and corrective actions
f) Retain documented information

Evidences: Results of Audit, Auditors with qualification, Audit Schedule, Audit Plan, etc.
84 9.2 Summary of Internal Audit
 85 9.3.2 Management review inputs
Top management shall take into consideration :
a) The status of actions from previous management reviews
b) Changes in external and internal issues that are relevant to QMS
c) Information on quality performance which includes:
1. Customer satisfaction & feedback from relevant interested parties
2. The extent to which quality objectives have been met
3. Process performance and conformity of products and services
4. Nonconformities and corrective actions
5. Monitoring and measurement results
6. Audit results
7. Performance of external providers
d) Adequacy of resources
e) The effectiveness of actions taken to address risks & opportunities
f) Opportunities for improvement
Evidences: Minutes of Meeting, Customer Feedbacks, Risk Register etc.
 86 9.3.3 Management Review Outputs
The output of the management review shall include
decisions (Keputusan) and actions (Tindakan) related to:
a) Opportunities for improvement
b) Any need for changes to the quality management
system
c) Resource needs
The organization shall retain documented information as
evidence of the results of management reviews.

Evidences: Minutes of meeting, Meeting Schedule, Examiner Report, Industry

Meeting, Etc.
87 Clause 10 : IMPROVEMENT
88
 89 10 - IMPROVEMENT
10.1 General
The organization shall determine and select opportunities for improvement and
implement necessary actions to meet customer requirements and enhance customer
satisfaction.
These shall include:
a) Improving products and services to meet requirements and address future
needs and expectations
b) Correcting, preventing or reducing undesired effects
c) Improving the performance and effectiveness of QMS

Note : Improvement can include correction (reactive action), corrective

action, continual improvement (incremental), breakthrough change (radical),
innovation (creative) or by re-organizing (transformation)
 90 10.2 Nonconformity and corrective action
When a nonconformity (also complaint) occurs, the organization shall :
a) React to the nonconformity, and as applicable:
1) Take action to control and correct it
2) Deal with the consequences
b) Evaluate the need for action to eliminate the causes by :
1) Reviewing & analyzing the nonconformity
2) Determining the causes of nonconformity
3) Determining if similar nonconformities exist, or could potentially occur
c) Implement action needed
d) Review the effectiveness of corrective action taken
e) Update risks & opportunities
f) Make changes to the QMS
 91 10.3 Continual improvement
The organization shall:
• Continually improve the suitability, adequacy and effectiveness of
the QMS
• Shall consider the results of analysis and evaluation, and the
outputs from management review, to determine if there are
needs/opportunities that shall be addressed as part of continual
improvement.

Where applicable, shall select and utilize applicable tools and

methodologies for investigation of the causes of
underperformance and for supporting continual improvement.
92
93
 Thank You
Institut Kualiti dan Pengembangan Ilmu (InQKA)
Universiti Teknologi MARA
Blok A, Aras 5,
Bangunan Akademik 2,
40450 Shah Alam, Selangor

Tel: +603 5543 5702/5711/5703/5713/5732

Faks: +603 5543 5721/5722
Laman Web: http://inqka.uitm.edu.my/
Emel: [email protected]
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