TÜV SÜD MIDDLE EAST L.L.

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 ISO 9001:2015

Quality Management System

Requirements

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

Ice Breaking Workshop

Lets Introduce
Ourselves

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 THE ISO 9000 FAMILY
ISO 9000 : Quality Management Systems-
Fundamentals & Vocabulary

ISO 9001 : Quality Management Systems-

Requirements

ISO 9004 : Quality Management Systems-

Guidelines for performance
Improvement

ISO 19011 : Guidelines on AUDITING Quality

Management and/or Environmental
Management Systems

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

HISTORY OF CHANGES IN THE QMS STANDARD

TÜV
TUVSÜD
SUDMiddle
ME East LLC, FDIS_ISO
Rev.No.9001:2015_TRG_UAE_2015
00 Rev. Date: 17.11.15 10-08-2015
5D1S2
 ANNEX SL – APPENDIX 2

WHAT IS ANNEX SL – APPENDIX 2?

Annex SL – Appendix 2 is a framework for all

ISO Management system standards providing:

• High level structure (HLS)

• Identical sub-clause titles

• Identical text

• Common terms and core definitions.

TÜV
TUVSÜD
SUDMiddle
ME East LLC, FDIS_ISO
Rev.No.9001:2015_TRG_UAE_2015
00 Rev. Date: 17.11.15 10-08-2015
6D1S2
ANNEX SL FRAMEWORK

NEW HIGH LEVEL STRUCTURE OF

MANAGEMENT SYSTEM

1. Scope
2. Normative References
3. Terms and Definitions
4. Context of the Organization
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance Evaluation
10. Improvement

TÜV
TUVSÜD
SUDMiddle
ME East LLC, FDIS_ISO
Rev.No.9001:2015_TRG_UAE_2015
00 Rev. Date: 17.11.15 10-08-2015
7D1S2
 INTRODUCTION
Quality Management System(QMS) – Adoption of QMS
by an organization is a strategic decision in order to
 Improve overall performance
 Provide a sound basis for sustainable development
initiatives
the ability to consistently provide products and services
meeting customer and applicable statutory and regulatory
requirements

Potential facilitating opportunities to enhance customer satisfaction

Benefits of QMS
implementation addressing risks and opportunities associated with its context
and objectives;
the ability to demonstrate conformity to specified quality
management system requirements

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 INTRODUCTION
Quality Management Principles - This standard is based on
quality management principles described in ISO 9000.

Customer Focus

Leadership

Engagement of people
Quality
Management Process approach
Principles
Improvement

Evidence-based decision making

Relationship management

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 INTRODUCTION
Quality Management Principles
1. Customer Focus – Primary focus is to meet customer requirements and
strive to exceed customer expectations

increased customer value

increased customer satisfaction

1. improved customer loyalty

Customer enhanced repeat business

Focus – Key
Benefits enhanced reputation of the organization

expanded customer base

increased revenue and market share

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 INTRODUCTION
Quality Management Principles
2. Leadership – Leaders at all levels establish unity of purpose and
direction and create conditions in which people are engaged in achieving
the organization’s quality objectives

increased effectiveness and efficiency in meeting the

organization’s quality objectives

2. better coordination of the organization’s processes

Leadership –
Key Benefits improved communication between levels and functions
of the organization
development and improvement of the capability of the
organization and its people to deliver desired results

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 INTRODUCTION
Quality Management Principles
3. Engagement of people – Competent, empowered and engaged people
at all levels throughout the organization are essential to enhance the
organization’s capability to create and deliver value

improved understanding of the organization’s

quality objectives by people in the organization and
increased motivation to achieve them

enhanced involvement of people in improvement

3. activities

Engagement enhanced personal development, initiatives and

creativity
of People –
Key Benefits enhanced people satisfaction

enhanced trust and collaboration throughout the

organization
increased attention to shared values and culture
throughout the organization
TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015
 INTRODUCTION
Quality Management Principles
4. Process Approach – 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

enhanced ability to focus effort on key processes and

opportunities for improvement

consistent and predictable outcomes through a system of

4. aligned processes
Process
approach – optimized performance through effective process
management, efficient use of resources and reduced
Key Benefits cross-functional barriers

enabling the organization to provide confidence to

interested parties related to its consistency, effectiveness
and efficiency

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 INTRODUCTION
Quality Management Principles
5. Improvement – Successful organizations have an ongoing focus on
improvement

improved process performance, organizational

capability and customer satisfaction

enhanced focus on root cause investigation and

determination, followed by prevention and corrective
actions
5.
enhanced ability to anticipate and react to internal and
Improvement– external risks and opportunities
Key Benefits
enhanced consideration of both incremental and
breakthrough improvement

improved use of learning for improvement

enhanced drive for innovation

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 INTRODUCTION
Quality Management Principles
6. Evidence-based decision making – Decisions based on the analysis
and evaluation of data and information are more likely to produce desired
results

improved decision making processes

improved assessment of process performance and

6. ability to achieve objectives

Evidence based
decision making– improved operational effectiveness and efficiency
Key Benefits
increased ability to review, challenge and change
opinions and decisions

increased ability to demonstrate the effectiveness of

past decisions

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 INTRODUCTION
Quality Management Principles
7. Relationship management – For sustained success, organizations
manage their relationships with interested parties, such as providers

enhanced performance of the organization and its

interested parties through responding to the
opportunities and constraints related to each interested
party

7. common understanding of objectives and values

Relationship among interested parties
management –
Key Benefits increased capability to create value for interested
parties by sharing resources and competence and
managing quality related risks

a well-managed supply chain that provides a stable

flow of products and services

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 INTRODUCTION
Process approach- It involves management of process and
their interactions using PDCA approach with an overall focus on
RISK BASED THINKING

understanding and consistency in meeting

requirements
the consideration of processes in terms of added
Process value
Approach
enables – the achievement of effective process performance

improvement of processes based on evaluation of

data and information

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 INTRODUCTION
Process approach-
Starting End
point point

Sources of Inputs Outputs Receivers of

Input Activities Input

Predecessor Matter, Matter, Subsequent

processes- Energy, Energy, processes-
providers Customers-
Informati Informati
internal and internal and
on – on –
external external,
material, product,
(customer, interested
resources, service
interested parties
requireme decision
parties)
nts

Possible controls & checkpoints

to monitor and measure
performance

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 INTRODUCTION
PDCA Cycle-

Support &
Operation
(7,8)

Planning Leadership Performance

Evaluation
(6) (5) (9)

Improvement
(10)

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

INTRODUCTION

PDCA Cycle
TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015
 INTRODUCTION

Plan:
establish the objectives of the system and its
processes, and the resources needed to deliver
results in accordance with customers’ requirements
and the organization’s policies

PDCA Do: implement what was planned

Check: monitor and (where applicable) measure

processes and the resulting products and services
against policies, objectives and requirements and
report the results
Act: take actions to improve performance, as
necessary

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 Quality Management Systems –
Requirements
1.0 SCOPE
This Standard specifies the requirements for QMS where
an organization-
Needs to demonstrate its ability to consistently
provide products and services meeting customer as
well as statutory and regulatory requirements.

Organization
Aims to enhance customer satisfaction through
effective application of the system, including
processes for improvement of the system & assurance
of conformity to customer & applicable statutory and
regulatory requirements.

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 2.0 NORMATIVE REFERENCE

2.0 NORMATIVE REFERENCE

ISO FDIS 9000:2015 – Quality Management Systems,

Fundamentals and Vocabulary

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 3.0 TERMS & DEFINITIONS
3.0 TERMS & DEFINITIONS – Differences in Terminology
between ISO 9001:2008 and ISO 9001:2015
ISO 9001:2008 • ISO 9001:2015

Products • Products and services

Exclusions • Not Used (term non-applicablity is used)

• Not used (Similar responsibilities and authorities
Management Representative are assigned but no requirement for a single
management representative)
Documentation, quality
manual, documented • Documented information
procedures, records
Work environment • Environment for the operation of processes
Monitoring and measuring
• Monitoring and measuring resources
equipment
Purchased product • Externally provided products and services

Supplier • External provider

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 3.0 TERMS & DEFINITIONS
3.0 TERMS & DEFINITIONS
Quality – degree to which a set of inherent characteristics
of an object fulfils requirements

Example-1: Manufacturing Unit

Dimensional Tolerance : +/-0.5mm
-0.5 -0.4 -0.3 -0.2 -0.1 0.0 +0.1 +0.2 +0.3 +0.4 +0.5

Example-2:Service Industry-Banking
Quality Parameters
• Response Time
• Behavior of Employee
• Easy Deposit & Withdrawal
• Interest Rate

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 3.0 TERMS & DEFINITIONS
Organization – person or group of people that has its own functions
with responsibilities, authorities and relationships to achieve its
objectives
The concept of organization includes, but is not limited to – sole-trader,
company, corporation, firm, enterprise, authority, partnership, charity or
institution, or part or combination thereof, whether incorporated or not,
public or private.

Requirement – need or expectation that is stated, generally implied or

obligatory

Statutory requirement – obligatory requirement specified by a

legislative body

Regulatory requirement – obligatory requirement specified by an

authority mandated by a legislative body

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

3.0 TERMS & DEFINITIONS

Context of the organization

combination of internal and external issues that can have an effect on
an organization’s approach to developing and achieving its objectives

Interested party (preferred term) / stakeholder (admitted

term) – person or organization that can affect, be affected by, or
perceive themselves to be affected by a decision or activity

EXAMPLE : Customers, owners, people in an organization, providers,

bankers, regulators, unions, partners or society that can include
competitors or opposing pressure groups

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

3.0 TERMS & DEFINITIONS
Management System – set of interrelated or interacting elements
of an organization to establish policies and objectives and processes to
achieve those objectives

Top Management – person or group of people who directs and

controls an organization at the highest level

Policy – intentions and direction of an organization as formally

expressed by its top management

Objective – result to be achieved

Product – Output of an organization that can be produced without
any transaction taking place between the organization and the
customer

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 3.0 TERMS & DEFINITIONS
Risk – effect of uncertainty

 An effect is a deviation from the expected — positive or negative.

 Uncertainty is the state, even partial, of efficiency of information related

to, understanding or knowledge of, an event, its consequence, or
likelihood

 Risk is often characterized by reference to potential events and

consequences, or a combination of these

 Risk is often expressed in terms of a combination of the consequences

of an event (including changes in circumstances) and the associated
likelihood of occurrence

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 3.0 TERMS & DEFINITIONS

Competence – ability to apply knowledge and skills to achieve

intended results

Documented information – information required to be controlled

and maintained by an organization and the medium on which it is
contained
 Documented information can be in any format and media and from any
source.

Documented information can refer to

 the management system including related processes
 information created in order for the organization to operate
(documentation)
 evidence of results achieved (records)

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

4 CONTEXT OF THE ORGANIZATION

4.0 Context of the

organization
4.1 Understanding the organization & its
context
4.2 Understanding the needs and
expectations of interested parties
4.3 Determining the scope of the quality
management system
4.4 Quality management system and its
processes

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 4 CONTEXT OF THE ORGANIZATION

4.1 Understanding the organization and its context

• Internal Issues
Determine • External Issues

• relevant to purpose &

strategic direction
Issues • may affect ability to
achieve intended results

Monitor and • information about these

issues
Review

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 4 CONTEXT OF THE ORGANIZATION

4.1 Understanding the organization and its context

• positive factors / conditions

Issues - Consider • negative factors / conditions

• Legal,
• Technological,
• Competitive, Market,
External Context • Cultural, Social &
– consider issues Economic
• International, National,
Regional & Local

• Values, Culture
Internal Context – • Knowledge & Performance
consider issues

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 4 CONTEXT OF THE ORGANIZATION
4.2 Understanding the needs and expectations of
interested parties – Organization’s ability to consistently provide
products & services meeting customer & applicable statutory & regulatory
requirements may be affected hence -

• Interested parties relevant to its

QMS
Determine • Requirements of these Interested
parties relevant to its QMS

• information about these interested

Monitor and parties and their relevant
requirements
Review
Interested Parties: Customers, End Users, Shareholders, Board Members, Suppliers,
Distributors, anyone involved in supply-chain, regulators.

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

4 CONTEXT OF THE ORGANIZATION

NEEDS AND EXPECTATION OF

INTERESTED PARTIES
INTERESTED PARTIES
Customer; distributors, Quality, price, & delivery of products and
retailers services

End-user Product performance/ease of

use/reliability/safety/ maintainability

Owner/shareholder Profitability/return on investment/growth in

market value of organization

Management Increased growth, sales & profitability/efficiency

& effectiveness of operations

Employees Good work environment/job

security/health/safety/ training/ promotion,
recognition and reward

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

4 CONTEXT OF THE ORGANIZATION

NEEDS AND EXPECTATION OF

INTERESTED PARTIES
INTERESTED PARTIES
External providers of product Increase scope and volume of
and services (suppliers; purchases/long-term contractual
partners)
arrangements/information on future
requirements.

Supplier’s source Product/service feedback; insight on future

(manufacturer) needs and technical support.

Regulatory Bodies Compliance with applicable requirements

and industry standards/submission of
reports.

Government & Community Environmental protection/Ethical

behavior/growth in business and taxes to
build infrastructure to support community
services, activities and institutions.

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 4 CONTEXT OF THE ORGANIZATION
4.3 Determining the scope of the quality management
system – Determine the boundaries and applicability of QMS for
establishing the scope.

Determining the
scope - Consider
the
the external and requirements of
the products
internal issues relevant
and services of
(referred to in interested
the organization
4.1) parties (referred
to in 4.2)

Note- Apply all requirements of this standard within the scope of QMS. Only in cases where
meeting the requirement is impossible (and where the absence of meeting the requirement does
not adversely impact the organization’s ability to supply conforming products and services) is it
permissible not to apply it.

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 4 CONTEXT OF THE ORGANIZATION
4.3 Determining the scope of the quality management
system

Scope

- Shall provide
- Shall be - Shall state
justification for
maintained as types of
inapplicability of
documented products &
any requirement
information services
of this standard

Conformity to ISO 9001:2015 can be claimed if inapplicability of any of

the requirements do not affect organization’s ability/responsibility in
ensuring conformity to product & services / customer satisfaction

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 4 CONTEXT OF THE ORGANIZATION
4.4 Quality management system and its processes

• determine
4.4.1 processes & their
interactions

• maintain and
4.4.2 retain documented
information

Note: Clause 4.4 of IS may be referenced to clause 4.1, 8.1 and 8.2.3 of ISO
9001:2008

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 4 CONTEXT OF THE ORGANIZATION
4.4.1 Establish, Implement, maintain and continually improve QMS including processes
needed and their interactions as per this standard. Determine processes needed for
QMS and their application throughout the organization

Determine inputs and outputs

Determine sequence and interactions

Determine and apply criteria (incl. monitoring, measurement & KPI’s) to

ensure effective operation and control of these processes

Determine resources needed. Ensure availability of resources.

Assign responsibilities and authorities

Address risk and opportunities

Evaluate these processes and implement changes needed to get

intended results

Improve the processes and the Quality Management System

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

4 CONTEXT OF THE ORGANIZATION

• Maintain documented
information to support
operation of its
processes

4.4.2 • Retain documented

information to have
confidence of effective
implementation as
planned

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

5 LEADERSHIP

5 Leadership

5.3
5.1
5.2 Organizational roles,
Leadership and
responsibilities and
commitment Policy
authorities

5.1.1 5.2.1
General Establishing the
Quality Policy

5.2.2
5.1.2
Communicating the
Customer Focus Quality Policy

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 5 LEADERSHIP
5.1 Leadership & Commitment
5.1.1 General: Top Management shall demonstrate leadership and
commitment with respect to quality management system by-

 taking accountability for the effectiveness of QMS

 ensuring that quality policy and objectives are established & are
compatible with context and strategic direction of the organization

 ensuring the integration of QMS requirements into the organization’s

business process

 promoting the use of process approach and risk based thinking

 ensuring availability of resources

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 5 LEADERSHIP
5.1 Leadership & Commitment
5.1.1 General: Top Management shall demonstrate leadership and
commitment with respect to quality management system by-
 communicating the importance of effective quality management in
conformance with QMS requirements

ensuring achievement of intended results by the QMS

 engaging, directing and supporting persons to contribute towards

effectiveness of QMS

 promoting improvement

 supporting other managers to demonstrate leadership in their areas

“Business” is interpreted as core activities to the purpose of organization’s existence

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 5 LEADERSHIP
5.1 Leadership & Commitment
5.1.2 Customer Focus: Top Management shall demonstrate leadership
and commitment with respect to customer focus by ensuring that-

 customer, applicable statutory and regulatory requirements are

determined, understood and consistently met

the risks and opportunities detrimental to conformity of products and

services with the ability to enhance customer satisfaction are determined
and addressed

 the focus on enhancing customer satisfaction is maintained

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 5 LEADERSHIP
5.2 Policy
5.2.1 Establishing the Quality Policy – Top Management shall
establish, implement and maintain a quality policy within the organization

Appropriate to the purpose & context

of the organization supporting its
strategic direction

Provides a framework for setting

quality objectives
Quality
Policy Includes a commitment to satisfy
applicable requirement

Includes a commitment to continual

improvement of QMS

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 5 LEADERSHIP
5.2 Policy
5.2.2 Communicating the Quality Policy –

Shall be available and maintained as

documented information

Quality Shall be communicated, understood and

applied within the organization
Policy

Shall be available to relevant interested

parties, as appropriate

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 5 LEADERSHIP

5.3 Organizational roles, responsibilities and authorities –

Top management shall ensure that responsibilities and authorities at
relevant roles are assigned, communicated and understood within the
organization

 ensuring that quality management systems conforms to the

requirements of this International Standard

Top ensuring that the processes are delivering their intended outputs
Management
shall
reporting to top management on the performance of QMS including
assign opportunities for improvement
responsibility
and authority
ensuring the promotion of customer focus throughout the organization
for
ensuring integrity of QMS in case of any changes (planned and
implemented) in QMS

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

6 PLANNING

6 Planning

6.1
6.2
Actions to address 6.3
Quality Objectives
risks and Planning of Changes
and planning to
opportunities
achieve them

6.1.1 6.2.1
Determine Risk & Establish Quality
Opportunities (R&A) Objectives

6.1.2 6.2.2
Plan for actions to Plan for achieving
address R&A Quality Objectives

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 6 PLANNING
6.1 Actions to address risks and opportunities
6.1.1 When planning for QMS, consider the issues referred to in
 4.1 (understanding organization and its context) and
 4.2 (understanding the need and expectation of interested parties)
and determine risk and opportunities that need to be addressed to -

 give assurance that the quality management system can

achieve its intended result(s)

enhance desirable effects

prevent, or reduce, undesired effects

achieve improvement

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

6 PLANNING
6.1 Actions to address risks and opportunities
6.1.2 The organization shall plan (a) & (b)

6.1.2 Plan

(a) Plan the actions to address risks (b)Plan on methods

and opportunities as mentioned in how to-
6.1.1

1. integrate and implement 2. evaluate the

the actions into its QMS effectiveness of these
processes actions

Actions to address Risks and Opportunities shall be proportionate to potential impact

on conformity to products and services

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

6 PLANNING
6.1.2

Addressing •
•
avoiding risks
taking risks
Risks – • eliminating the risk sources
• changing the likelihood / consequences
may include • sharing the risk
• retaining risk by informed decision

• adoption of new practices

• launching new products
Opportunities • opening new markets
– •
•
addressing new clients
building partnerships
• using new technology
may include • possibilities to address organization’s
or its customers’ needs

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

6 PLANNING

6.2 Quality Objectives and Planning to achieve them

6.2.1 Establish Quality Objectives at relevant –
Functions, Levels and Process needed for QMS
be consistent with the quality policy

be measurable

take into account applicable requirements

Quality be relevant to conformity of products and services

Objectives and to enhancement of customer satisfaction

be monitored

be communicated

be updated as appropriate

Maintain DOCUMENTED INFORMATION on quality objectives

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

6 PLANNING

6.2 Quality Objectives and Planning to achieve them

6.2.2 When planning on how to achieve the Quality Objectives, the
organization shall determine

what will be done

what resources will be required

Quality
Objectives / who will be responsible
achievement
programs
when it will be completed

how the results will be evaluated

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

6 PLANNING

6.3 Planning of Changes

When organization determines need for changes to QMS, the changes
shall be carried out in a planned manner

the purpose of the changes and their potential

consequences

the integrity of the quality management system

Changes in
QMS - Consider the availability of resources

the allocation or reallocation of responsibilities and

authorities.

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

7 SUPPORT
7 Support

7.1 7.2 7.3 7.4 7.5

Resources Competence Awareness Communication Documented
Information

7.1.1
General 7.5.1
General
7.1.2
People
7.5.2
7.1.3 Creating and
Infrastructure Updating

7.1.4
7.5.3
Environment for operation of processes
Control of
Documented
7.1.5 Information
Monitoring and Measuring Resources

7.1.6 7.1.5.1 7.1.5.2

Organizational Knowledge General Measurement traceability

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 7 SUPPORT

7.1 Resources

• Determine and provide resources for

establishment, implementation, maintenance
7.1.1 and continual improvement of QMS
• Consider capabilities, constrains of internal
General resources
• Consider the need from external providers

7.1.2 • Determine and provide persons necessary for

•  Effective Implementation of its QMS
People •  Operation and Control of its processes

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 7 SUPPORT

7.1 Resources

• Determine, provide and maintain the

infrastructure -
• for operation of its processes
• to achieve conformity of products and
7.1.3 services

Infrastructure • Infrastructure can include-

• buildings and associated utilities
• equipment, including hardware and software
• transportation resources
• information and communication technology

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 7 SUPPORT
7.1 Resources

• Determine, provide and maintain the

environment -
• for operation of its processes
• to achieve conformity of products and
services
7.1.4
Environment for • A suitable Environment can be a
combination of Human and Physical
Operation of Factors such as
Processes • social – nondiscriminatory, calm, non-
confrontational
• psychological – stress-reducing, burnout
prevention, emotionally protective
• physical- temperature, heat, humidity, light,
airflow, hygiene, noise

Above factors can differ substantially depending upon products and services provided

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 7 SUPPORT
7.1 Resources
7.1.5 Monitoring and Measuring Resources

• Determine and provide resources to

ensure valid & reliable results when using
monitoring and measuring

• Ensure that resources provided are

7.1.5.1 • suitable for specific type of monitoring and
measuring
General • are maintained to ensure their continuing
fitness

• Retain documented information as evidence

of fitness for purpose

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 7 SUPPORT
7.1 Resources
7.1.5 Monitoring and Measuring Resources

• Calibrated / verified at specified intervals,

prior to use against measurement
7.1.5.2 std(traceable to international/national std). If
no such std exist, basis of calibration shall be
Measurement maintained as documented information
Traceability – • Identified with their status

• Safeguarded from adjustments, damage,

When measurement deterioration (may invalidate calibration
traceability is a status)
requirement,
equipment shall be>> • Determine validity of previous measurement
results is affected when equipment is unfit to
use. TAKE ACTIONS

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 7 SUPPORT
7.1 Resources

• Knowledge shall be maintained

7.1.6 • In case of changing needs & trends – additional
knowledge and update shall be ensured
Organizational
Knowledge –
• Note-1: Organizational knowledge-specific to
organization. Gained by experience and it is
Determine information used / shared to achieve
necessary organizational objectives
knowledge for
operation of • Note-2: Organizational knowledge is based on
processes and to
achieve conformity • 1. Internal sources-intellectual property,
of products and experience, lessons learnt, sharing undocumented
knowledge, results of improvements
services
• 2. External sources – standards, academia,
conferences, customers, external providers

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 7 SUPPORT

7.2 Competence – Organization shall

• determine the necessary competence of person(s) doing work under

a its control that affects the performance and effectiveness of QMS

• ensure that these persons are competent on the basis of appropriate

b education, training, or experience

• where applicable, take actions to acquire the necessary competence,

c and evaluate the effectiveness of the actions taken

• retain appropriate documented information as evidence of

d competence

Actions may be – trainings, mentoring, re-assignment of employed persons, hiring or

contracting

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 7 SUPPORT

7.3 Awareness – organization shall ensure that persons

doing work under the organization’s control are aware of

the quality policy

relevant quality objectives

Awareness their contribution to the effectiveness of the quality

management system, including the benefits of
improved performance

the implications of not conforming with the quality

management system requirements

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 7 SUPPORT

7.4 Communication – organization shall determine internal

and external communications relevant to the QMS

on what it will communicate

when to communicate

Communication with whom to communicate

how to communicate

who communicates

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 7 SUPPORT
7.5 Documented Information
7.5.1 General – organization’s quality management system shall
include

required by this International Standard

Documented
Information
determined by the organization as being necessary for the
effectiveness of the QMS

The extent of documented information for a quality management system can

differ from one organization to another due to –

- the size of - the competence

organization and its - the complexity of of persons
type of activities, processes and their
processes, products interactions
and services

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 7 SUPPORT
7.5 Documented Information
7.5.2 Creating and updating – when creating and updating,
organization shall ensure-
identification and description
(e.g. a title, date, author, or reference number)

format (e.g. language, software version, graphics)

Creating and
and
Updating
media (e.g. paper, electronic)

review and approval for suitability and adequacy.

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 7 SUPPORT
7.5 Documented Information
7.5.3 Control of Documented Information
7.5.3.1 – documented information required by the QMS and this
international standard shall be controlled to ensure-

it is available and suitable for use, where and when it is

needed
7.5.3.1
Controls to
ensure
it is adequately protected (e.g. from loss of
confidentiality, improper use, or loss of integrity)..

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 7 SUPPORT
7.5 Documented Information
7.5.3 Control of Documented Information
7.5.3.2 – for control of documented information organization shall
address the following activities, as applicable-

distribution, access, retrieval and use

storage and preservation, including preservation of

7.5.3.2 legibility
Address the
activities for-
Control of changes

retention and disposition

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 7 SUPPORT
7.5 Documented Information
7.5.3 Control of Documented Information
7.5.3.2
Documented information of external origin determined by the
organization to be necessary for the planning and operation of the QMS
shall be identified as appropriate, and be controlled

Documented information retained as evidence of conformity shall be

protected from unintended alterations.

NOTE: Access can imply a decision regarding the permission to view

the documented information only, or the permission and authority to view
and change the documented information

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 8 OPERATION

8.0 Operation

8.1 8.3 Design &

Operation 8.2 8.6 Release of
Requirement D of P&S 8.5 Production and 8.7 Control of non
al 8.4 control of Product &
for Product service Provision Services conforming outputs
planning externally
and &Services
8.3.1 provided P&S
control General
8.5.1 Control of P&S
8.2.1 8.3.2 Provision
Customer Planning
Communicatio 8.4.1
n General
8.3.3 8.5.2 Identification and
Inputs Traceability

8.2.2 8.3.4 8.4.2 Type & 8.5.3 Property belonging to

determining Controls Extent of customer and external providers
requirements Control
8.3.5
Output
s 8.5.4 Preservation
8.4.3
8.2.3 reviewing Information for
requirements 8.3.6 external
Changes 8.5.5 Post Delivery
Providers
Activities

8.2.4 changes 8.5.6 Control of Changes

to
requirements

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 8 OPERATION
8.1 Operational Planning and Control

Plan Processes
Organization needed to meet the
Implement requirements for
shall-
provision of products and
Control services (4.4)

Implement the actions as determined in

clause 6

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 8 OPERATION
8.1 Operational Planning and Control

• Determine the requirements for products and services

a

Process
• Establish criteria for
b acceptance of products and services

• Determine the resources needed to achieve conformity to

the product and service requirements;
c

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 8 OPERATION
8.1 Operational Planning and Control
• Implement the Controls of processes in accordance with
criteria
d
to have confidence that processes have
been carried out as planned
• Determine and keep
Documented Information
e to demonstrate the conformity of products
and services to their requirements

Keep maintaining and retaining of documented information

- control the planned changes

If Changes – - review consequences of unintended changes
- take actions to mitigate any adverse effects

- Ensure controls on outsourced processes

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 8 OPERATION
8.2 Requirements for Products and Services
8.2.1 Customer Communication: Communication with
customer shall include -

providing information relating to products and services

handling enquiries, contracts or orders, including changes

Customer obtaining customer feedback relating to products and

Communication services, including customer complaints

handling or controlling customer property

establishing specific requirements for contingency actions,

when relevant

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 8 OPERATION
8.2 Requirements for Products and Services
8.2.2 Determining the requirements related to products and
services
When determining the requirements for products and services to be
offered, organization shall ensure that -

(a) the requirements for the products and services are

defined, including>(1), (2)

(1) any applicable statutory and

regulatory requirements
(2) those considered necessary by the
Ensure that organization

(b) the organization can meet the claims for the products
and services it offers

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 8 OPERATION
8.2 Requirements for Products and Services
8.2.3 Review of requirements related to products and
services
8.2.3.1 Organization shall ensure that it is capable of meeting requirements
for products and services to be offered. Hence a review shall be conducted
BEFORE committing to supply. It shall include -

• requirements specified by the customer, including the requirements

for delivery and post delivery activities
a

• requirements not stated by the customer, but necessary for the

b specified or intended use, when known

• requirements specified by the organization

c

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 8 OPERATION
8.2 Requirements for Products and Services
8.2.3 Review of requirements related to products and
services
8.2.3.1
• statutory and regulatory requirements applicable to the products and
d services

• contract or order requirements differing from those previously

e expressed

 Ensure that requirements differing from previous one are defined and resolved

 When customer doesn’t provide the documented requirements, confirm

requirements before acceptance

NOTE: when formal review is impractical (e.g. internet sales) for each order, review
can cover relevant product information – catalogues, advertizing material etc.

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 8 OPERATION
8.2 Requirements for Products and Services
8.2.3 Review of requirements related to products and
services
8.2.3.2 Organization shall retain documented information on –
• Results of review


• Any new requirements for the products and services



8.2.4 Changes to requirements for products and services

IF Change of relevant documented information is amended
products / service
requirements , relevant persons are made aware of the
ensure – changed requirements

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 8 OPERATION
8.3 Design and development(DD) of products and
services
8.3.1 General- Establish, Implement and Maintain as DD process to
ensure provision of subsequent provision of products and services

8.3.2 Design and development planning – In determining

design and development stages, consider –

• the nature, duration and complexity of the DD activities

a

• the required process stages, including applicable DD reviews

b

• the required DD verification and validation activities

c

• the responsibilities and authorities involved in the DD process

d

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 8 OPERATION
8.3 Design and development(DD) of products and
services
8.3.2 Design and development planning
• the internal and external resource needs for the DD of products and
e services

• the need to control interfaces between persons involved in the DD

f process

• the need for involvement of customers and users in the DD process

g

• the requirements for subsequent provision of products and services;

h

• the level of control expected for the DD process by customers and

i other relevant interested parties

• the documented information needed to demonstrate that DD

j requirements have been met

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 8 OPERATION
8.3 Design and development(DD) of products and
services
8.3.3 Design and development inputs – determine essential
requirements for specific types of products and services to be designed
and developed

• functional and performance requirements

a

• information derived from previous similar design and development

activities;
b

• statutory and regulatory requirements

c

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 8 OPERATION
8.3 Design and development(DD) of products and
services
8.3.3 Design and development inputs – determine essential
requirements for specific types of products and services to be designed
and developed

• standards or codes of practice that the organization has committed to

d implement

• potential consequences of failure due to the nature of the products

e and services

 Inputs shall be adequate, complete and unambiguous.

 Resolve conflicting issues on DD inputs

 Retain documented information on DD inputs

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 8 OPERATION
8.3 Design and development(DD) of products and
services
8.3.4 Design and development controls – apply controls design
and development process to ensure

• the results to be achieved are defined

a

• reviews are conducted to evaluate the ability of the results of DD to

b meet requirements

• verification activities are conducted to ensure that the DD outputs

c meet the input requirements

• validation activities are conducted to ensure that the resulting

products and services meet the requirements for the specified
d application or intended use

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 8 OPERATION
8.3 Design and development(DD) of products and
services
8.3.4 Design and development controls – apply controls design
and development process to ensure

• any necessary actions are taken on problems determined during the

e reviews, or verification and validation activities

• documented information of these activities is retained

f

• Reviews, verification and validation have distinct purposes.

Note • They can be conducted separately or in any combination

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 8 OPERATION
8.3 Design and development(DD) of products and
services
8.3.5 Design and development outputs – organization shall
ensure that outputs–

• meet the input requirements

a

• are adequate for the subsequent processes for the provision of products
b and services

• include or reference monitoring and measuring requirements, as

c appropriate, and acceptance criteria

• specify the characteristics of the products and services that are essential for
d their intended purpose and their safe and proper provision

Retain documented information on DD outputs

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 8 OPERATION
8.3 Design and development(DD) of products and
services
8.3.5 Design and development changes– organization shall
identify, review and control changes made during / subsequent to DD to
an extent so that it doesn’t adversely affect conformity to requirements.

Retain Documented Information on

• design and development changes

a

• the results of reviews

b

• the authorization of the changes

c

• the actions taken to prevent adverse impacts

d

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 8 OPERATION
8.4 Control of externally provided processes, products
and services
8.4.1 General – Organization shall ensure that externally provided
processes, products and services conform to requirements

 Products and services from external provider are

intended to be used into organization's own products and
services

Determine
 Products and services from external provider are
Controls directly provided to customer on behalf of organization
WHEN
 Process or a part of process is provided by an external
provider (as decided by organization)

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 8 OPERATION
8.4 Control of externally provided processes, products
and services
8.4.1 General – Organization shall ensure that externally provided
processes, products and services conform to requirements

Evaluation

Determine & Selection

Apply CRITERIA
for Monitoring of performance

Re-evaluation

retain documented information of such activities and actions of such

evaluations

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 8 OPERATION
8.4 Control of externally provided processes, products
and services
8.4.2 Type and extent of control
Ensure that externally provided process remain under
control of QMS

Define controls on PROVIDER as well as on OUTPUT

Organization Potential impact of process, product, services

on meeting customer/statutory & regulatory
shall requirements
Consider
Effectiveness of controls applied by external
provider

Determine verification activities to ensure that

products/services meet requirements

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 8 OPERATION
8.4 Control of externally provided processes, products
and services
8.4.3 Information for external provider- organization shall
ensure the adequacy of requirements prior to communication
(a)the processes, products and services to be provided

products and services

(b) Approval methods, processes and equipment
of
Communicate the release of products and services
the
requirements (c) competence, including any required qualification of persons
for
(d) external providers’ interactions with the organization

(e) control and monitoring of the external providers’

performance

(f) verification or validation activities that the organization, or its

customer, intends to perform at the external providers’ premises

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 8 OPERATION
8.5 Production and Service Provision
8.5.1 Control of Production and Service Provision – The
organization shall implement production and service provision under
controlled conditions

the characteristics of the products, the

services, or the activities to be
(a) Availability performed
of documented
information on-
the results to be achieved

(b) availability and use of suitable monitoring and measuring

Controlled resources
Conditions
include-
(c) the implementation of monitoring and measurement activities at
appropriate stages to ensure that criteria is met, (criteria for process
controls and acceptance criteria for product and services)

(d) use of suitable infrastructure and environment for the operation

of processes

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 8 OPERATION
8.5 Production and Service Provision
8.5.1 Control of Production and Service Provision

(e) appointment of competent persons, including any required

qualification

(f) the validation, and periodic revalidation, of the ability to achieve

planned results of the processes for production and service
provision, WHERE
Controlled [the resulting output cannot be verified by subsequent monitoring or
measurement]
Conditions
include-
(g) implementation of actions to prevent human error

(h) implementation of release, delivery and post-delivery activities

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 8 OPERATION
8.5 Production and Service Provision
8.5.2 Identification and Traceability

 use suitable means to identify outputs when it is necessary to

ensure the conformity of products and services

Identification  identify the status of outputs with respect to monitoring and

and measurement requirements throughout production and service
Traceability provision

control the unique identification of the outputs when traceability is

a requirement.
Retain the documented information necessary to enable traceability

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 8 OPERATION
8.5 Production and Service Provision
8.5.3 Property belonging to customers or external
providers – The organization shall exercise care with property belonging
to Customers and External Providers under organization’s control or being
used by the organization

• Organization shall identify, verify, protect and safeguard -

Customers’ or external providers’ property provided for use or
 incorporation into products and services

• IN CASE of Lost, Damaged, unsuitable for use – Inform customer /

external provider & retain documented information16


NOTE: Customer’s / external provider’s property may include material,

components, tools and equipment, premises, intellectual property and personal
data,

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 8 OPERATION
8.5 Production and Service Provision
8.5.4 Preservation - Organization shall preserve the outputs during
production and service provision, to extent necessary to ensure
conformity to requirements

Preservation can include -

Transmission
Contaminatio and
Identification Handling Packaging Storage Protection
n control transportatio
n

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 8 OPERATION
8.5 Production and Service Provision
8.5.5 Post Delivery Activities – Organization shall meet the
requirements for post delivery activities associated with products and
services
a) statutory and regulatory requirements

b) the potential undesired consequences

associated with its products and services
Extent of Post
Delivery c) the nature, use and intended lifetime of its
Activities- products and services
Consider>
d) customer requirements

e) customer feedback.

NOTE: Post-delivery activities can include actions under warranty provisions,

contractual obligations such as maintenance services, and supplementary services
such as recycling or final disposal.

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 8 OPERATION
8.5 Production and Service Provision
8.5.6 Control of changes – Organization shall review and control
changes for production or service provision, to the extent necessary to
ensure continuing conformity with requirements.

results of the review of changes

Retain
documented person(s) authorizing the change
information on –

any necessary actions arising from the review

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 8 OPERATION
8.6 Release of Products and Services –
The organization shall implement planned arrangements, at appropriate
stages, to verify that the product and service requirements have been met.

planned arrangements have been satisfactorily completed

Products /
services cannot
be released until unless otherwise approved by a relevant authority and,
–
as applicable, by the customer`

evidence of conformity with the acceptance criteria

Retain
Documented
Information on – traceability to the person(s) authorizing the release.

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 8 OPERATION
8.7 Control of nonconforming outputs –
8.7.1 The organization shall ensure that outputs that do not conform to their
requirements are identified and controlled to prevent their unintended use or
delivery.
- Take appropriate action based on nature of nonconformity and its effect on
conformity of products and services
- This shall apply to nonconformity detected after delivery of products, during /
after provision of services.
(a) correction

(b) segregation, containment, return or suspension of

Nonconforming provision of products and services
outputs shall be
treated as – (c) informing the customer

(d) obtaining authorization for acceptance under

concession.

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 8 OPERATION
8.7 Control of nonconforming outputs –
8.7.1
Conformity to the requirements shall be verified when nonconforming
outputs are corrected

8.7.2
(a) describes the nonconformity

Retain (b) describes the actions taken

Documented
Information that
– (c) describes any concessions obtained

(d) identifies the authority deciding the action in

respect of the nonconformity.

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

9 PERFORMANCE EVALUATION
9 Performance Evaluation

9.1 Monitoring,
measurement, analysis and 9.2 Internal audit 9.3 Management
evaluation review

9.1.1 9.3.1
General General

9.1.2 9.3.2 Management

Customer Satisfaction review inputs

9.1.3 Analysis and 9.3.3 Management

evaluation review outputs

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 9 PERFORMANCE EVALUATION
9.1.1 General – The organization shall determine –
• what needs to be monitored and measured
a

• the methods for monitoring, measurement, analysis and evaluation

b needed to ensure valid results

• when the monitoring and measuring shall be performed

c

• when the results from monitoring and measurement shall be analyzed

d and evaluated

The organization shall evaluate the performance and the effectiveness of the
quality management system.

Retain appropriate documented information as evidence of results

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 9 PERFORMANCE EVALUATION
9.1.2 Customer Satisfaction – The organization shall –

 Monitor Customers’ perceptions of the degree to which their needs and

expectations have been fulfilled

 Determine the methods for obtaining, monitoring and reviewing this

information

NOTE – Examples of monitoring: Customer Surveys, customer feedback on

delivered products and services, meetings with customers, market-share analysis,
compliments, warranty claims & dealer’s report.

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 9 PERFORMANCE EVALUATION
9.1.3 Analysis and Evaluation – The organization shall analyze and
evaluate appropriate data and information arising from monitoring and
measurement. Results of analysis shall include –

• conformity of products and services

a

• the degree of customer satisfaction

b

• the performance and effectiveness of the quality management system

c

• if planning has been implemented effectively

d

• the effectiveness of actions taken to address risks and opportunities

e

• the performance of external providers

f

• the need for improvements to the quality management system

g

NOTE: Methods to analyze data can include statistical techniques

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 9 PERFORMANCE EVALUATION
9.2 Internal audit
9.2.1 – The organization shall conduct internal audits at planned intervals to
provide information on whether the quality management system–

(a) Conforms to
1. Organization’s own requirements for its quality management system
2. The requirements of this International Standard

(b) Is effectively implemented and maintained.

9.2.2 – The organization shall

• plan, establish, implement and maintain an audit programme(s)
• including the frequency, methods, responsibilities, planning requirements and
reporting.
a • Take into consideration the importance of the processes concerned, changes
affecting the organization, and the results of previous audits

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 9 PERFORMANCE EVALUATION
9.2 Internal audit
9.2.2 – The organization shall
• define the audit criteria and scope for each audit
b

• select auditors and conduct audits to ensure objectivity and the

c impartiality of the audit process

• ensure that the results of the audits are reported to relevant

d management

• take appropriate correction and corrective actions without undue

e delay

• retain documented information as evidence of the implementation

f of the audit programme and the audit results

See ISO 19011 for guidance.

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 9 PERFORMANCE EVALUATION
9.3 Management Review
9.3.1 General: Top management shall review the organization’s quality
management system, at planned intervals, to ensure its continuing
suitability, adequacy, effectiveness and alignment with the strategic
direction of the organization.

9.3.2 Management Review Inputs – Management review shall be

planned and carried out taking into consideration of –

(a) the status of actions from previous management reviews;

(b) changes in external and internal issues that are relevant to the quality
management system
(c) information on the performance and effectiveness of the quality
management system, including trends in-

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 9 PERFORMANCE EVALUATION
9.3 Management Review
9.3.2 Management Review
(c) Performance & effectiveness of QMS includes-

1
• customer satisfaction and 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
• the performance of external providers

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 9 PERFORMANCE EVALUATION
9.3 Management Review
9.3.2 Management Review Inputs – Management review shall be
planned and carried out taking into consideration of –

(d) the adequacy of resources

(e) the effectiveness of actions taken to address risks and opportunities
(f) opportunities for improvement-

9.3.3 Management review outputs – The outputs of the

management review shall include decisions and actions 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

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

10 IMPROVEMENT

10 Improvement

10.2 10.3
10.1
Nonconformity and Continual
General
corrective action Improvement

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 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 as well as to
address future needs and expectations;
b) correcting, preventing or reducing undesired effects
c) improving the performance and effectiveness of the quality management
system.

NOTE: Improvement can include correction, corrective action, continual

improvement, breakthrough change, innovation and re-organization

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 10 IMPROVEMENT
10.2 Nonconformity and Corrective Actions
10.2.1 When a nonconformity occurs, including any arising from complaints,
the organization shall

(1) Take action to control and correct it

(a) React to the
nonconformity
(2) Deal with the consequences

(b) evaluate the need for action to (1) reviewing and analyzing the nonconformity
eliminate the cause(s) of the
nonconformity 2) determining the causes of the nonconformity
so that it does not
recur or occur elsewhere 3) determining if similar nonconformities exist,
or could potentially occur

(c) implement any action needed

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 10 IMPROVEMENT
10.2 Nonconformity and Corrective Actions
10.2.1 When a nonconformity occurs, including any arising from complaints,
the organization shall
(d) review the effectiveness of any corrective action taken

(e) update risks and opportunities determined during planning, if

necessary

(f) make changes to the quality management system, if necessary

Corrective actions shall be appropriate to the effects of the nonconformities

encountered
10.2.2 Retain documented information as evidence of

(a) the nature of the nonconformities and any subsequent actions

taken
(b) the results of any corrective action

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 10 IMPROVEMENT
10.3 Continual improvement
The organization shall continually improve the
 Suitability
 Adequacy
 Effectiveness of the quality management system

The organization shall consider the

 results of analysis and evaluation
 the outputs from management review, to determine if there are needs or
opportunities that shall be addressed as part of continual improvement.

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015

 Thank You

TÜV SÜD Middle East LLC, FDIS_ISO 9001:2015_TRG_UAE_2015 10-08-2015