QMS UNDERSTANDING & IMPLEMENTING ISO 9001 2015.pptx

Abdul Rashid bin Mokthar (Cikgu)
Penceramah
QTC Management Consultant Sdn Bhd
27 FEB 2023
DD PLASTIC SDN BHD
UNDERSTANDING & IMPLEMENTING
ISO 9001:2015

COURSE AGENDA
DAY 1
• 9.00 - 10.00 am : Introduction to Quality
• 10.00 - 10.15 am : Tea Break
10.15 - 1.00 pm : Understanding Context Of
Organization
: Leadership
: Planning
• 1.00 - 2.00 pm : Lunch
• 2.00 - 3.30 pm : Support
• : Operation
• 3.30 - 3.45 pm : Tea Break
• 3.45 - 5.00 pm : Performance Eva & Improvement

WHAT IS QUALITY ?
Customer requirements
As manufactured
As delivered
Quality gap
“Quality is meeting customer
requirements”

WHAT DO CUSTOMERS
LOOK FOR
High Reliability
Low cost
Good Performance
Good maintainability
Good appearance
High safety
On-time delivery

WHY SATISFIED CUSTOMERS?
• Buy more often
• Buy more (range)
• Pay more (less price sensitive)
• Recommend more
 Free advertising
 Referred customers are best
• Stay longer
Make companies more
profitable

RESPONSIBILITY FOR
QUALITY
Quality is everyone’s business
• Clearly establishes customer needs
• Design as what customer want
• Careful plans how to meet customer requirement
• Control the production/ service provision and all other
relevant activities in accordance the plan
• Deliver to the customer on time
• Analyse the satisfaction of customer

INTERACTION OF PROCESSES
Inquiry
Tender
Installation
Handover
Document Control
Record Control
Internal Audit Corrective
Action
Maintenance
Calibration
Packaging
Quality,
Efficacy
and Safe
Product
Design and
development
Customer
Complaint

WHAT IS ISO 9001
• ISO = International Organization for
Standardization
• Quality Management System standard
• Applies to any organization
(manufacturing and service)
• Internationally recognized & accepted
• Tells you what must be done but
not how
• Guidance on controlling necessary
activities
• Focus on meeting the requirements
of customer

ISO 9001:2015
Quality Management
Systems

ISO 9001 IS CHANGING?
• ISO Standards are reviewed for suitability and
effectiveness every 5-7 years. Depending upon user
input, some revisions are more or less substantial than
others.
1987
1994
2000
2008 2015

Deming’s
wheel
(P.D.C.A.)
ISO
9000
PLAN DO
ACT CHECK Continuous
Improvement
CONTINUOUS IMPROVEMENT ?

THE ISO 9001 ENVIRONMENT
Auditors
Certification Body
Accreditation Agency
Consultant
Customer
Service
Company
Product
Company
Assure
Assure
Technical
Training
Registers
Registers
Certify
Accredits
Accredits
Assist
Assist
Train
Asses Asses

ISO 9001:2008 ISO 9001:2015
QMP 1 : Customer focus QMP 1 : Customer Focus
QMP 2 : Leadership QMP 2 : Leadership
QMP 3 : Involvement of
people
QMP 3 : Engagement of
People
QMP 4 : Process Approach QMP 4 : Process Approach
QMP 5 : System approach
to Management
QMP 5 : Improvement
QMP 6 : continual
Improvement
QMP 6 : Evidence-Based
Decision Making
QMP 7 : Factual Approach
Decision Making
QMP 7 : Relationship
Management
QMP 8 : Mutual beneficial
Supplier relationship

1 Scope
2 Normative references
3 Terms and definitions
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 policy
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
STRUCTURE OF
ISO 9001:2015 (1/3)

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 requirements 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 service provision
8.6 Release of products and services
8.7 Control of non conforming process outputs, products
and services
STRUCTURE OF
ISO 9001:2015 (2/3)

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
STRUCTURE OF
ISO 9001:2015 (3/3)

CLAUSE 4: CONTEXT OF
THE ORGANISATION

4.1 UNDERSTANDING THE
ORGANIZATION AND ITS CONTEXT
• Shall determine internal and external issues that
are relevant to its purpose and its strategic
direction.
• Shall monitor and review information relating to
internal and external issues.

4.1 UNDERSTANDING THE
ORGANIZATION AND ITS CONTEXT
External Issues:
(International/
National/ Regional/
Local):
 Legal
 Technology
 Competitive
 Market
 Cultural
 Social
 Economic
environment
Internal Issues:
 Values, culture
 Knowledge
 People
 Processes, systems
Organization
Intended
Outcomes
of the QMS
Monitor and review
Organization’ purpose Strategic direction

4.2 - UNDERSTANDING THE
NEEDS AND EXPECTATIONS OF
INTERESTED PARTIES
To consistently provide products and services that meet
customer and statutory and regulatory requirements, the
organization shall determine:
• Shall determine the interested parties that are relevant
to the quality management system.
• Shall determine the requirements of these interested
parties that are relevant to the QMS.
• Shall monitor and review the information about these
interested parties.

4.2 UNDERSTANDING THE NEEDS
AND EXPECTATIONS OF
INTERESTED PARTIES
Customers
Communities
Suppliers
Regulators
NGOs
Investors
Employees
Needs
and
expectations
(Requirements)
Monitor and
review
Relevant
statutory &
regulatory
requirements
3.06 : Interested parties

4.3 DETERMINING THE SCOPE
In determining the scope of the QMS, the organization shall
determine the boundaries and applicability of the QMS to
establish the scope. Shall consider:
• External and internal issues (referred to 4.1)
• Relevant requirements of interested parties (referred
to 4.2)
• Its products and services
The scope shall be available stating the:
- Product and services covered by the QMS
- Justification where the requirement cannot be applied

4.4 QUALITY MANAGEMENT
SYSTEM AND ITS PROCESSES
The new standard further promote the process approach beyond the
existing requirements in ISO 9001:2008. The organization shall determine
the processes needed for the QMS and determine:
• The inputs and outputs of the processes
• The sequence and interaction of these processes
• The criteria, methods, including measurements and related
performance indicator
• The resources needed
• The assignment of the responsibilities and authorities
• The risks and opportunities
• The method for monitoring, measuring and evaluation
• Opportunities for improvement

5.1 LEADERSHIP AND
COMMITMENT
Demonstrate leadership and commitment through :
Accountable for QMS effectiveness
Ensure Quality policy & objectives
compatible with strategic direction
Integrate QMS requirements into core
business process
Provide resources Communicate
Ensure achieve intended outcomes
Direct and support other persons
Promote continual improvement
Support other relevant management
roles to demonstrate their leadership

5.1.2 CUSTOMER FOCUS
Top management to demonstrate leadership and
commitment with respect to customer focus by ensuring
that :
• Customer requirements and applicable statutory and
regulatory are determined and met
• The risks and opportunities to satisfy are determined
and addressed.
• The focus on enhancing customer satisfaction is
maintained.

5.2 QUALITY POLICY
• 5.2.1 Top management shall establish Quality policy that:
– Appropriate to the purpose and context of the organization
– Provide a framework for setting and reviewing the quality
objectives.
– Includes a commitment to satisfy applicable requirements.
– Include a commitment to continual improvement
 5.2.2 The Policy shall:
 Be available as documented information
 Be communicated, understood and applied within the organization
 Be available to interested parties as appropriate.

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 and authority
for:
a) Ensuring that QMS conforms to the requirements
b) Ensuring the processes are delivering their intended outputs
c) Reporting the performance, including recommendation for
improvement
d) Ensuring the promotion of customer focus
e) Ensuring the integrity are maintain

- 6.1.1 When planning of QMS, shall consider the issues
referred to 4.1 and 4.2 and determine the risks and
opportunities that need to be addressed to:
 Ensure the QMS can achieve its intended outcome
 Prevent or reduce undesired effects
 Achieve continual improvement
- 6.1.2 The organization shall plan:
 Action to address these risk and opportunities
 How integrate the action into QMS and evaluate the effectiveness
6.1 ACTION TO ADDRESS RISK
AND OPPORTUNITIES

Risk assessment
Communication
and
consultation
Monitoring
and
review
Establishing the context
Risk analysis
Risk evaluation
Risk treatment
Risk identification
RISK MANAGEMENT PROCESS

• The organization shall establish Quality objectives at relevant
function and levels.
• The Quality objectives shall:
– Be consistent with Quality policy
– Be measurable
– Take into account applicable requirements
– Be relevant to conformity of products and services and enhancement
of customer satisfaction
– Be monitored
– Be communicated
– Be update as appropriate
6.2 QUALITY OBJECTIVE AND
PLANNING TO ACHIEVE THEM

• When planning, the organization shall determine:
 What will be done
 What resources will be required
 Who will be responsible
 When it will be completed
 How the results will be evaluated
6.2 QUALITY OBJECTIVE AND

6.2 QUALITY OBJECTIVES AND

6.3 PLANNING OF CHANGES
 Where determines the need of change to the quality
management system, the change shall carried out in a
planned and systematic manner. Shall consider :
 The purpose of the change and any potential
consequences
 The integrity of the quality management system
 The availability of resources
 The allocation or reallocation of responsibilities and
authorities

7.1 RESOURCES
7.4 Communication
Support
7.5 Documented
Information
7.3 Awareness
7.1 Resources 7.2 Competence
People Infrastructure
Environment KM
Monitoring
Resources

7.1 RESOURCES
Shall determine and provide the resources to ensure
effectiveness of the QMS.
Resource considerations include:
1. Capability of and constraints on existing internal
resources
2. Need for external providers

7.1.2 PEOPLE
7.1.2 People
• Essentially not a new requirement
• Organization shall provide persons necessary for the
effective operation of the QMS, including the processes
needed - to ensure it can consistently meet customer
and applicable statutory / regulatory requirements.

7.1.3 INFRASTRUCTURE
• Shall determine, provide and maintain infrastructure for
the operation of its processes to achieve conformity of
products and services.
• Can include building, associated facilities, equipment
including hardware and software, transportation,
information and communication technology

7.1.4 ENVIRONMENT FOR THE
OPERATION OF PROCESSES
• Shall determine, provide and maintain the environment
necessary for the operation.
• Can include physical, social, psychological, environmental
and other factor (such as temperature, humidity,
ergonomic and cleanliness)

7.1.5.1 MONITORING AND
MEASURING RESOURCES
 Shall determine resources needed to ensure valid and
reliable monitoring and measuring results.
 Shall ensure the resources provided:
 Are suitable for the specific type of monitoring and measurement
activities
 Maintained to ensure continued fitness for their purpose
 Shall retain appropriate documented information of fitness
for purpose of monitoring and measuring resources.

49
TEST EQUIPMENT CALIBRATION
PROCESS FLOWCHART

7.1.5.2 MEASUREMENT
TRACEABILITY
When measurement traceability is a requirements, or is
considered by the organization to be essential part of
providing confidence in the validity of measurement results,
measurement equipment shall be:
 Calibrated or verified, or both at specified intervals or prior to use,
against measurements 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;
 Identified in order to determine their status
 Safeguarded from adjustments, damage or deterioration

7.1.6 ORGANIZATIONAL
KNOWLEDGE
• Not the same as ‘competence’ – which relates to the
knowledge of an individual.
• Requirement for organization to 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.

• Shall determine the necessary competence of person(s)
doing work under its control that affects its QMS
performance.
• Ensure these persons are competence on the basis of
appropriate education, training or experience.
• Take action to acquire the necessary competence and
evaluate the effectiveness.
• Retain appropriate documented information as evidence
of competence.
7.2 COMPETENCE

7.3 AWARENESS
This clause is separated from competence
Awareness:
• The Quality policy
• The relevant quality objective
• Their contribution to the effectiveness of QMS
• The implication of not conforming with QMS
requirements

7.4 COMMUNICATION
WHEN to
communicate?
WHAT to
communicate?
WITH WHOM
to communicate?
HOW to
communicate?
Include internal and external Communication relevant to
QMS
Internal, Customer and Interested Parties

7.5 DOCUMENTED INFORMATION
More flexible in documentation
 ‘retain documented information as evidence of….’ i.e. records
 ‘maintain documented information’ to mean documentation other
than records
Note: The extent of documented information for a quality management
system can differ from organization to another
Document
Record
Documented
information
2008
Version

QUALITY SYSTEM
DOCUMENTATION STRUCTURE
QUALITY
MANUAL
PROCEDURES
WORK INSTRUCTION
FORMS
Policies
Organization structure
System outline
How to carry out
business activities
Specific task
within the
activities
Forms
Reference
Standards
Level 1
Level 2
Level 3
Level 4

7.5 DOCUMENTED
INFORMATION
7.5.2
Creating
&
Updating
Includes documented information of external origin
7.5.3
Control
Identification & description (e.g. title, date, author, reference
number
Format (e.g. language, software version, graphics, media)
Review and approval
Ensure available and suitable for use
Ensure adequate protection
Distribution,
access, retrieval,
use
Storage,
preservation,
legibility
Version
control
Retention &
disposition

• Company Name
• Title
• Doc number
• Effective Date
• Revision
• Signature
• Distribution list

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:
 Determining requirements for the product and services.
 Establishing criteria for the processes and for the
acceptance of product/service.
 Determining the resources needed.
 Implementing control.
 Retaining documented information.

8.2.1 CUSTOMER COMMUNICATION
 Shall determine and implement effective arrangements for
communicating with customers in relation to:
 Product or services information
 Enquiries/contract/order handling, including changes
 Obtaining customer views and perceptions, including complaints
 Handling or treatment of customer property, if applicable
 Specific requirements for contingency actions, when relevant

 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:
 Product and service requirements and applicable statutory and
regulatory requirements are defined;
 It has the ability to meet the defined requirements and substantiate
the claims for the products and services it offers.
8.2.2: DETERMINATION OF
REQUIREMENTS RELATED TO
PRODUCT AND SERVICES

 The organization shall review;
 Requirements specified by the customer, including the requirements
for delivery and post delivery activities.
 Requirements not stated by the customer but necessary for
specified or intended use, when known;
 Statutory and regulatory requirements related to the product and
service.
 Contract or order requirements differing from those previously
expressed.
8.2.3: REVIEW OF REQUIREMENTS
RELATED TO PRODUCT AND
SERVICES

8.3.1 General
The organization shall establish, implemented and is
maintaining a design and development process that is
appropriate to ensure the subsequent provision of our
products and services.

8.3.2 Design and development (D&D)
planning
In determining the stages and controls for D&D, the
organization shall consider:
a) The nature, duration and complexity of all D&D activities?
b) The required process stages, including applicable D&D reviews?
c) The required D&D verification and validation activities?
d) The responsibilities and authorities involved in the D&D process?
e) The internal and external resource needs for the D&D of products and services?
f) The need to control interfaces between persons involved in the D&D process?
g) The need for involvement of customers and users in the D&D process
h) The requirements for subsequent provision of our products and services?
i) The level of control expected for the D&D process by customers and other
relevant interested parties?
j) The documented information needed to demonstrate that all D&D requirements
have been met?

8.3.3 Design and development input
• The organization shall determine the requirements
essential for the specific types of our products and
services to be designed and developed. The organization
shall consider:
a) functional and performance requirements
b) information derived from previous similar design and
development activities
c) statutory and regulatory requirements
d) standards or codes of practice that our organization has
committed to implement
e) potential consequences of failure due to the nature of our
products & services
• inputs shall adequate for design and development purposes,
complete and unambiguous

8.3.4 Design and development controls
The organization shall apply controls to D&D process to
ensure that:
a) the results to be achieved are defined
b) reviews are conducted to evaluate the ability of the results of D&D to
meet requirements
c) verification activities are conducted to ensure that our D&D outputs meet
the input requirements
d) validation activities are conducted to ensure that our resulting products
and services meet the requirements for the specified application or
intended use
e) any necessary actions are taken on problems determined during the
reviews, or verification and validation activities
f) documented information of these activities is retained

8.3.5 Design and development outputs
The organization shall ensure that all D&D outputs:
a) meet the input requirements
b) are adequate for the subsequent processes for the provision of our
products and services
c) include or reference monitoring and measuring requirements, as
appropriate, and acceptance criteria
d) specify the characteristics of our products and services that are
essential for their intended purpose and their safe and proper
provision

8.3.6 Design and development changes
The organization shall identify, review and control all changes
made during, or subsequent to, the D&D of our products and
services, to the extent necessary to ensure that there is no
adverse impact on conformity to requirements.
The organization shall retain documented information on:
a) design and development changes
b) the authorization of all changes
c) the actions taken to prevent adverse impacts

Supplier
Associate company
Outsource
Information
from
External
provider
(8.4.3)
Select and
evaluate
(8.4.1)
Verification
activities
(8.4.2)
Documented information
Criteria
Information for external providers are now more detailed and explicit
8.4 CONTROL OF EXTERNAL
PROVISION OF GOODS AND SERVICES

8.4.1 General
• Shall ensure that externally provided processes, products
and services conform to the proposed product and service
requirements.
• Shall determine and apply criteria for the evaluation,
selection, monitoring of performance, and re-evaluation of
external providers? Is it based on their ability to provide
processes or products and services in accordance with
requirements.
• Shall retain documented information for these activities
and any necessary actions arising from these evaluations.

8.4.2 Type and extent of control
• Shall ensure that external provider do not adversely
affect organization’s ability to consistently deliver
conforming customers requirements.
• The organization shall:
a) ensure that externally provided processes remain within the
control of our QMS
b) define both the controls that it intends to apply to an external
provider and those it intends to apply to the resulting output
c) take into consideration the potential impact of the externally
provided and the effectiveness of the controls applied
d) determine the verification, or other activities, necessary to
ensure that the externally provider meet all requirements

80
Supplier Performance Assessment

8.4.3 Information for external provider
The organization shall communicate to external providers its requirements for:
a) the processes, products and services to be provided
b) the approval of:
- products and services
- methods, processes and equipment
- the release of products and services
d) competence, including any required qualification of persons
e) the external providers’ interactions with our organization
f) control and monitoring of the external providers’ performance to be applied by
our organization
g) verification or validation activities that our organization, or its customer, intends
to perform at the external providers’ premises

8.5.1 CONTROL OF PRODUCTION AND
SERVICE PROVISION
 Shall plan and carry out production under controlled conditions.
Controlled conditions shall include, as applicable:
 Availability of documented information that defines characteristics of
product or service
 Availability of documented information that defines the activities to be
performed and results to be achieved
 Monitoring and measurement activities at appropriate stages and
acceptance criteria have been met.
 The use and control of suitable infrastructure and process environment
 The availability and use of suitable monitoring and measuring resources
 The competence of person
 Validation where resulting output cannot be verified
 The implementation of product and service release and delivery and post-
delivery activities

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 requirements, shall control the unique
identification of the process output and retain any documented
information necessary to maintain traceability.

8.5.3 PROPERTY BELONGING TO
CUSTOMERS OR EXTERNAL
PROVIDERS
Used to be “customer property”.
Intent still the same, i.e. to take care of 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 material, components, tools, customer premises
and intellectual property.

8.5.4 PRESERVATION
 Shall ensure preservation of process output during
production and service provision, to the extent
necessary to maintain conformity to the requirements,
 Can include identification, handling, packaging,
storage, transmission or transportation and protection.

8.5.5 POST DELIVERY ACTIVITIES
Shalleet 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
c) The nature, use and intended lifetime of the products and
services
d) Customer requirements
e) Customer feedback

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.
The organization shall retain documented information
describing the results of the review of changes, the personnel
authorizing the change, and any necessary actions.

8.6 RELEASE OF PRODUCTS
AND SERVICES
The organization shall implement planned arrangements
at appropriate stages to verify that product and services
requirements for verification have been met.
The release of products and services to the customer shall
not proceed until planned arrangements for verification of
conformity have been completed unless otherwise
approved by a relevant authority and as applicable by the
customer. Documented information shall provide
traceability to the person authorizing.

8.7 CONTROL OF NONCONFORMING
PROCESS OUTPUTS, PRODUCTS AND
SERVICES
8.7.1 The organization shall deal with nonconforming process outputs,
products and services in one or more of the following ways:
• Correction
• Segregation, containment, return or suspension of provision of
• Informing the customer
• Obtaining authorizing for acceptance under concession
8.7.2 The organization shall retain documented information that:
• Describe the conformity
• Describe the actions taken
• Describe any concessions obtained;
• Identifies the authority deciding the action in respect of nonconformity

8.7 CONTROL OF
NONCONFORMING OUTPUTS

CLAUSE 9:
PERFORMANCE
EVALUATION

 The organization shall determine:
 What need to be monitored and measured.
 The methods for monitoring, analysis and evaluation as applicable
 When the monitoring and measuring shall be performed
 When the results from the monitoring and measurement shall be
analyzed and evaluated.
 Shall retain appropriate documented information as evidence of the
results.
 Shall evaluate the quality performance and the effectiveness of the
quality management system
9.1 MONITORING, MEASUREMENT,
ANALYSIS & EVALUATION
9.1.1 General

 The organization shall monitor customer perceptions of the
degree to which requirements have been met.
 Shall obtain information relating to customer views and
opinion of the organization and its products and services
 The methods for obtaining and using this information shall
be determined
 Can include customer satisfaction/opinion survey, customer
data on delivered products or service, market share
analysis, compliments, warranty claims and dealer reports.
9.1.2 CUSTOMER SATISFACTION

SATISFACTION
6.5 7 7.5 8 8.5 9 9.5 10
Accuracy of deliveries
Trade margin
Product development
On time delivery
Problem resolution
Treat me like a customer
Staff training
Brand promotion

 Shall analyze and evaluate appropriate data and information arising from
monitoring, measurement and other sources.
 The result of analysis shall be used to evaluate:
 Conformity of product and services
 The degree of customer satisfaction
 The performance and effectiveness of the QMS
 If planning has been implemented effectively
 The effectiveness of actions taken to address risks and
opportunities
 The performance of external providers
 The need for improvements to the quality management system
9.1.3 ANALYSIS AND
EVALUATION

PRESENTATION REPORT
Bar Graph
Radar Graph
Line Graph
Pie Graph
Demonstrate the quantities of given
Values and show relationships among
Those amounts.
To look at several different factors all
related to one item.
Plot information and track performance
To show value measured in relation to the
Whole.
RANGE (R CHART)
0
0.01
0.02
0.03
0.04
0.05
0.06
0.07
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
RANGE
R R BAR UCL-R LCL-R
Histogram Control Chart

• Shall conduct Internal Audit at planned intervals
• Organization should establish an audit programme including
frequency, method, responsibilities, planning requirement
and reporting. The programme should be based on the
results of previous audits
• Define audit criteria and scope.
• Auditor shall be impartial of the area audited
• Ensure results of audit are reported to relevant
management
• Retain documented information
9.2 INTERNAL AUDIT

9.3.2 MANAGEMENT REVIEW
INPUTS
Top management shall take into consideration:
• The status of action from previous management review
• Changes in external and internal issues that are relevant to quality
management system
• Information on quality performance:
 Customer Satisfaction
 The extent to which quality objectives have been met
 Process performance and conformity of products and services
 Nonconformities and corrective actions
 Monitoring and measurement results
 Audit results
 Process performance of external providers
• Adequacy of resources
• The effectiveness of action taken to address risk
• Opportunities for continual improvement

9.3.3 MANAGEMENT REVIEW
OUTPUTS
The output of the management review shall include
decisions and actions related to:
• Opportunities for improvement
• Any need for changes to quality management system
• Resources needs
The organization shall retained documented information as
evidence of the results of management reviews

THE MANAGEMENT REVIEW
(REPORT)
• Agenda
• Meeting Reports
• Meeting Presentations
• Action Item & Decision
List
Meeting Minutes are required.

10 IMPROVEMENT
The organization shall determine and select opportunities for
improvement and implement necessary actions to meet customer
requirements and enhance customer satisfaction. This shall include, as
appropriate:
• Improving processes to prevent nonconformities
• Improving products and services to meet known and predicted
requirements
• Improving quality management system results
Note: Improvement can be effected reactively (corrective action), incrementally
(continual improvement), by step change (breakthrough), creatively
(innovation) or by re-organizing (transformation)
10.1 GENERAL

10.2 NONCONFORMITY AND
CORRECTIVE ACTION
When nonconformity 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 by:
1) Reviewing 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
e) Make changes to the QMS

Details of Non-conformance
Root Cause:
Corrective Action :
Verification :
Verified by: _______ NCR Close Out: Yes/No
CORRECTIVE ACTION REPORT (CAR)
Correction:

10.3 CONTINUAL IMPROVEMENT
Shall continually improve the suitability, adequacy and
effectiveness of the QMS.
Shall consider the outputs of the analysis and evaluation and the
output from management review, to confirm if there are areas of
underperformance or 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.

BORANG PENILAIAN KURSUS
TAIP LINK DIBAWAH DI BROWSER TELEFON PINTAR ANDA
https://www.surveymonkey.com/r/2CCWC55
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QMS UNDERSTANDING & IMPLEMENTING ISO 9001 2015.pptx

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