ISO 9001-2015 Simple Any For MGMT E

PDT- Awareness 9001 v 1
What is the quality?
Degree to which a set of

inherent characteristics
of an object fulfils
requirements
ISO 9000:2015

Quality management
Coordinated activities to direct and

control an organization with regard
to quality
IS0 9000-2015

Quality management
principles

Customer focus
The primary focus of quality management is to meet
customer requirements and to strive to exceed customer
expectations.
Key benefits
— increased customer value;
— increased customer satisfaction;
— improved customer loyalty;
— enhanced repeat business;
— enhanced reputation of the organization;
— expanded customer base;
— increased revenue and market share.
Customer focus
Possible actions
— recognize direct and indirect customers as those who receive value
from the organization;
— understand customers’ current and future needs and expectations;
— link the organization’s objectives to customer needs and
expectations;
— communicate customer needs and expectations throughout the
organization;
— plan, design, develop, produce, deliver and support products and
services to meet customer needs and expectations;
— measure and monitor customer satisfaction and take appropriate
actions;
— determine and take actions on interested parties’ needs and
expectations that can affect customer satisfaction;
— actively manage relationships with customers to achieve sustained
success.
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
Key benefits
— increased effectiveness and efficiency in meeting the
organization’s quality objectives;
— better coordination of the organization’s processes;
— 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.
• Effective leadership doesn't depend on charisma
• Defining leadership
– ''the process whereby one individual influences other
group members towards the attainment of defined
group, or organizational goals"
(Barron & Greenberg, 1990)
– "Leadership is the process in which leaders and
followers interact in a way that enables the leader to
influence the actions of the followers in a non-
coercive way towards the achievement of certain
aims and objectives".
(Rollinson, 2008).

Leadership
Possible actions
— communicate the organization’s mission, vision, strategy,
policies and processes throughout the organization;
— create and sustain shared values, fairness and ethical models
for behaviour at all levels of the organization;
— establish a culture of trust and integrity;
— encourage an organization-wide commitment to quality;
— ensure that leaders at all levels are positive examples to people
in the organization;
— provide people with the required resources, training and
authority to act with accountability;
— inspire, encourage and recognize the contribution of people.

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
...\..\..\..\Common component\US Japan quality.docx..\..\..\..\Common component\Matsushita.pptx
Key benefits
— 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 activities;
— enhanced personal development, initiatives and creativity;
— enhanced people satisfaction;
— enhanced trust and collaboration throughout the organization;
— increased attention to shared values and culture throughout the
organization

Engagement of people
Possible actions
— communicate with people to promote understanding of the
importance of their individual contribution;
— promote collaboration throughout the organization;
— facilitate open discussion and sharing of knowledge and
experience;
— empower people to determine constraints to performance and to
take initiatives without fear;
— recognize and acknowledge people’s contribution, learning and
improvement;
— enable self-evaluation of performance against personal
objectives;
— conduct surveys to assess people’s satisfaction, communicate
the results and take appropriate actions.

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

Process approach
Key benefits
— enhanced ability to focus effort on key processes and
opportunities for improvement;
— consistent and predictable outcomes through a system of
aligned processes;
— optimized performance through effective process
management, efficient use of resources and reduced
cross-functional barriers;
— enabling the organization to provide confidence to
interested parties related to its consistency, effectiveness
and efficiency.

Process approach
Possible actions
— define objectives of the system and processes necessary to achieve them;
— establish authority, responsibility and accountability for managing
processes;
— understand the organization’s capabilities and determine resource
constraints prior to action;
— determine process interdependencies and analyse the effect of
modifications to individual processes on the system as a whole;
— manage processes and their interrelations as a system to achieve the
organization’s quality objectives effectively and efficiently;
— ensure the necessary information is available to operate and improve the
processes and to monitor, analyse and evaluate the performance of the
overall system;
— manage risks which can affect outputs of the processes and overall
outcomes of the QMS.

Process
Set of interrelated or interacting activities that use
inputs to deliver an intended result
Note
– Whether the “intended result” of a process is called output,
product or service, depends on the context of the reference.
– Inputs to a process are generally the outputs of other
processes and outputs of a process are generally the inputs
to other processes.
– The systematic identification and management of the
processes employed within an organization and particularly
the interactions between such processes is referred to as the
“process approach”

16
Process
Procedures
(specified way to carry out an activity or a
process- can be documented or not)
Inputs intended result

PROCESS
(output, product,
service)
Resources
Monitoring, measurement, analysis, evaluation

(before, during and after processes )

Process approach
Process
network
Require
Define ments
d are met
requir
ements

Benefits of Process Approach

Process Approach
1 2 3 4
KPI
KPI
KPI
KPI
KPI KPI KPI

Management
Traditional by process
management

Improvement
Successful organizations have an ongoing focus on
improvement
Key benefits
— improved process performance, organizational capability and
customer satisfaction;
— enhanced focus on root cause investigation and determination,
followed by prevention and corrective actions;
— enhanced ability to anticipate and react to internal and external
risks and opportunities;
— enhanced consideration of both incremental and breakthrough
improvement;
— improved use of learning for improvement;
— enhanced drive for innovation

Improvement
Possible actions
— promote establishment of improvement objectives at all levels
of the organization;
— educate and train people at all levels on how to apply basic
tools and methodologies to achieve improvement objectives;
— ensure people are competent to successfully promote and
complete improvement projects;
— develop and deploy processes to implement improvement
projects throughout the organization;
— track, review and audit the planning, implementation,
completion and results of improvementprojects;
— integrate improvement consideration into development of new
or modified products and services and processes;
— recognize and acknowledge improvement.

Evidence-based decision making
Decisions based on the analysis and evaluation of data
and information are more likely to produce desired
results.
Key benefits
— improved decision making processes;
— improved assessment of process performance and ability to
achieve objectives;
— improved operational effectiveness and efficiency;
— increased ability to review, challenge and change opinions and
decisions;
— increased ability to demonstrate the effectiveness of past
decisions.

Relationship management
For sustained success, organizations manage their
relationships with interested parties.
Key benefits
— enhanced performance of the organization and its interested
parties through responding to the opportunities and constraints
related to each interested party;
— common understanding of objectives and values among
interested parties;
— 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.

Relationship management
Possible actions
— determine relevant interested parties and their relationship with the
organization;
— determine and prioritize interested party relationships that need to
be managed;
— establish relationships that balance short-term gains with long-term
considerations;
— gather and share information, expertise and resources with relevant
interested parties;
— measure performance and provide performance feedback to
interested parties to enhance improvement initiatives;
— establish collaborative development and improvement activities with
providers, partners and other interested parties;
— encourage and recognize improvements and achievements by
providers and partners.

Quality management system
Management system
Set of interrelated or interacting elements of an
organization to establish policies and
objectives and processes to achieve those
objectives
Quality Management System
Part of a management system with regard to
quality
(ISO 9000-2015)

ISO 9000 standard series
Quality management
system
ISO 9004:2018 ISO 9001:2015 ISO/TS 9002:2016
Guide for
QM Guide Requirements implementing ISO
9001:2015
ISO 9000:2015
Fundamentals
and vocabulary
ISO 100XX
26
ISO introduction
..\..\..\Data\latest\iso_in_figures_2014.pdf

ISO introduction
(31/12/2017)
161 NATIONAL STANDARDS BODIES
122 MEMBER BODIES

37 CORRESPONDENT MEMBERS
2 SUBSCRIBER MEMBERS
22144 standards and standard type documents

Relationship with ISO 9004
• ISO 9001 & ISO 9004 - consistent pair
• Designed to complement each other
• ISO 9001 can apply for certification or contractual purposes
and focuses on effectiveness
• ISO 9004 aims on improving performance and efficiency
• ISO 9004 should be regularly used throughout the
organization to lead beyond the basics of ISO 9001 and
improve the QMS.

3 core concepts…………
• Identify the processes needed to achieve the planned
results
• Continually monitor the risks (“Risk-based thinking”)
• Manage the processes and the system using “PDCA”

The PDCA Cycle for
improvement is the P-D-C-A Cycle
cornerstone of all
Management Systems
ACT PLAN
take actions to establish the objectives
improve performance How to achieve (procedure)
Act Plan
What, Who
When, Where,
How
CHECK Check Do
monitor and measure DO
processes and the implement what
resulting products and was planned
services against plan

As your Management Systems mature, effective use
of the PDCA Cycle will ensure continual improvement

Process approach
Process
network
Define Require
d ments
requir are met
ements

Need for Alignment of
management system standards!
ISO Joint Technical Coordination Group (“JTCG”):
• Joint vision for management system standards
• High level structure for all ISO management systems
standards
• Identical sub-clause titles under the high level structure
• Generic core vocabulary for management system
standards
• Aim is to make life easier for those who wish to have a
“single management system”

Annex SL – Appendix 2
General requirements of MSS are mentioned in Consolidated
ISO Supplement to the ISO Directives, Part 1 (Procedures
specific to ISO), Annex SL (normative) Proposals for
Management System Standards, SL.8 Guidance on the
development process and structure of an MSS plus
Appendices 2-4 (from now called “Annex SL”)
ISO 9001.2015\Annex-SL-Whitepaper.pdf

General requirements in“Annex SL”

“Annex SL” High Level Structure
• Incorporates the recommendations of the JTCG work

• Defines the common structure and format for all new ISO
management system standards and revisions to existing
standards
• Common text (approx 30% or more of each standard will
be identical text)
• Significant impact on future revisions of ISO 9001 and ISO
14001

Introduction
ISO 9001: 2015

Some key changes
• Complete reformatting to align with “Annex SL”

• “Products and services” instead of “product”
• More emphasis on addressing “risks & opportunities”,
elimination of the term “preventive action”, the concept still
remains, and is reinforced throughout the standard
• “External provision of products and services” instead of
“purchasing” and “outsourced” processes
• Documented information instead of “document” and
“record”
• Elimination of specific requirements (Quality Manual,
Management representative)

Structure of ISO 9001:2015
Structure of ISO 9001:2015

Purpose
Specify requirements for a quality management
system when an Organization
a) needs to demonstrate its ability to consistently
provide product or service that meets customer and
applicable statutory and regulatory requirements, and
b) aims to enhance customer satisfaction through the
effective application of the system, including
processes for improvement of the system
Effectiveness = “Ability to achieve planned results”
Efficiency = “Achieve planned results against resources”
Pho Duc Tru 2009-2

Scope of application
All organizations, regardless of type,

size and product and service provided.

4 Context of the organization
• Understanding the organization and its context

• Understanding the needs and expectations of interested parties
• Determining the scope of the quality management system
• Quality management system and its processes......

4.1 Understanding the organization
and its context
This clause requires the organization to consider potential
factors which can impact on the management system, in terms
of its structure, scope, implementation and operation.
Impacting factors can be of internal or external nature, and are
wide-ranging;
• External factors can arise from legal, technological, competitive,
market, cultural, social and economic environments, whether
international, national, regional or local.
• Internal factors may be related to values, culture, knowledge
and performance of the organization.


4.2 Understanding the needs and
expectations of interested parties
• determine the interested parties that are relevant to the

QMS,
• determine the related requirements of these interested
parties that are relevant to the QMS”
• monitor and review the information about these
interested parties and their relevant requirements
ISO 9001:2015 focuses attention on those interested parties

that can impact the organization’s ability consistently
provide conforming products and services

Interested parties could include:
• Employees
• Contractors
• Clients/Customers
• Suppliers
• Regulators
• Shareholders
• Neighbours
• Non-Governmental Organizations (NGOs)
• Parent organizations


4.3 Determining the scope of the QMS
The organization shall determine the boundaries and
applicability of the QMS to establish its scope.
Must consider
• the external and internal issues referred to in 4.1,
• the requirements referred to in 4.2
• products and services provided.
ISO 9001:2015 includes comments that:

 All requirements are applicable
 If a requirement cannot be applied, it must

• not affect the ability to provide conforming product
• be justified

4.4 Quality management system and
its processes
• Establish, implement, maintain and continually improve a
quality management system including the processes
needed and their interactions
• Determine the processes needed for the quality
management system and their application throughout
the organization
• How to control of processes
• maintain documented information ;
• retain documented information

4.4 Quality management system and
its processes

Documentation structure
Quality policy,
objectives
Quality manual
1
Procedures
2
Work instructions,
3 specifications, standards,
forms, …
4 Records
A “documented system” – NOT a “system of documents”

5. Leadership
• Leadership and commitment
• Quality Policy
• Organizational roles, responsibilities and authorities

5.1 Leadership and commitment
Leadership with respect to the QMS

• leadership is not so much about actions but the thinking
that leads to action.
• Demonstrating leadership with respect to the QMS
means adopting a way of thinking about quality and how
requirements for quality are met. It also involves
exhibiting behaviours that influence the actions of its
employees in a non-coercive way towards the
achievement of customer satisfaction

“Top management shall demonstrate leadership and commitment with
respect to the quality management system by
– taking accountability of the effectiveness of the QMS;
– ensuring policy and objectives are compatible with strategic direction
– ensuring the quality policy is communicated, understood and applied
– ensuring integration of the QMS requirements into business processes
– promoting awareness of the process approach;
– communicating importance of effective quality management and of
conforming to the QMS requirements;
– ensuring that the system achieves its intended results
– engaging, directing and supporting persons to contribute to the
effectiveness of the QMS;
– promoting continual improvement
– supporting other relevant management roles to demonstrate their
leadership as it applies to their areas of responsibility.”

• Top management is also required to ensure that:
– customer requirements and applicable statutory / regulatory
requirements are determined and met;
– the risks and opportunities that can affect conformity of products
and services and the ability to enhance customer satisfaction
are determined and addressed;
– the focus on consistently providing products and services that
meet customer and applicable statutory and regulatory
requirements is maintained;
– the focus on enhancing customer satisfaction is maintained.

The road to commitment

5.2 Quality policy
“Top management shall establish a quality policy that:

• is appropriate to the purpose of the organization,
• provides a framework for setting quality objectives;
• includes a commitment to satisfy applicable requirements, and
• includes a commitment to continual improvement of the quality
management system
The quality policy shall

 be available as documented information
 be communicated within the organization
 be available to interested parties, as appropriate

Policy & Objectives (example)
Policy – Defect free product, on time to the customer at a reasonable
price and continually improving all processes in accordance with the
requirements.
Organizational objective – 98% on time to customer promise date

Process objectives established to meet organizational goal
– Order review processes – all orders processed within 2 days of receipt
– Warehouse process – 100% compliance with FIFO, 18 inventory turns
– Maintenance Process – 97% uptime, no past due scheduled items
– Purchasing process – 95% of tier 1 suppliers on time and within
window
– Production Scheduling – all shop routers completed within 1 day of
receipt and all orders scheduled to be completed 2 days prior to
required ship date

5.3 Organizational roles, responsibilities
and authorities
• The responsibilities and authorities for relevant
roles are assigned, communicated and understood
• Assign the responsibility and authority for:
– ensuring that the quality management system conforms to the re
quirements of this International Standard;
– ensuring that the processes are delivering their intended outputs;
– reporting on the performance of the quality management system
and on opportunities for improvement to top management;
– ensuring the promotion of customer focus
– ensuring that the integrity of the quality management system is m
aintained when changes to the quality management system .

6 Planning
• Actions to address risks & opportunities
• Quality objectives and planning to achieve them
• Planning of changes

6.1 Actions to address risks & opportunities
“determine the risks and opportunities that need to be addressed to

give assurance that the QMS can achieve its intended result(s)
prevent or reduce undesired effects achieve continual improvement.
Plan:
a) actions to address these risks and opportunities, and
b) how to integrate and implement these actions into the QMS
processes evaluate the effectiveness of these actions.”
Actions taken to address risks and opportunities shall be proportionate
to the potential impact on the conformity of products and services.

6.2 Quality objectives and planning
to achieve them

to achieve them
Establish quality objectives at relevant functions, levels and processes.
The quality objectives shall
 be consistent with the quality policy
 be measurable
 take into account applicable requirements
 be relevant to conformity of products and services and the

enhancement of customer satisfaction;
 be monitored
 be communicated, and
 be updated as appropriate.


to achieve them
When planning how to achieve its quality objectives, 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.”

6.3 Planning of changes
Where there is a need for change to the QMS this must be done in a
planned and systematic manner, considering:
• the purpose of the change and any potential consequences;
• the integrity of the QMS
• the availability of resources;
• allocation or reallocation of responsibilities and authorities.

7 Support Processes
• Resources
• Competence
• Awareness
• Communication
• Documented information

7.1 Resources
• The organization shall determine and provide the

resources needed for the establishment,
implementation, maintenance and continual
improvement of the QMS.
• Additional requirements:
– People
– Infrastructure
– Process environment
– Monitoring & measuring resources
– Organizational knowledge

7.2 Competence
• Determine the necessary competence of person(s) doing work
under its control that affects its quality performance,
• Ensure that these persons are competent on the basis of
appropriate education, training, or experience;
• Where applicable, take actions to acquire the necessary
competence, and evaluate the effectiveness of the actions taken
• Retain appropriate documented information as evidence of
competence.
• NOTE Applicable actions may include, for example: the provision of
training to, the mentoring of, or the re-assignment of currently
employed persons; or the hiring or contracting of competent
persons.”

7.3 Awareness
Persons doing work under the organization’s control
shall be aware of:
• the quality policy and relevant objectives
• their contribution to the effectiveness of the QMS, including the
benefits of improved quality performance
• the implications of not conforming with the QMS requirements.”

7.4 Communication
Determine the internal and external communications

relevant to the quality management system:
• what it will communicate;
• when to communicate;
• with whom to communicate;
• how to communicate;
• who communicates.

7.5 Documented information
• “Previously known as “documents and records”
• “Documents” need to be “maintained as documented information”
• “Records” need to be “retained as documented information
• How to control
– identification and description (title, date, author, reference number);
– format (language, software version, graphics), media ( paper, electronic);
– review and approval
– distribution, access, retrieval and use;
– storage and preservation,;
– control of changes (e.g. version control);
– retention and disposition

8 Operation
• Operational planning and control

• Determination of customer requirements
• Design and development of products and services
• Control of external provision of products and services
(Purchasing and outsourcing addressed together)
• Realization and provision of products and services
• Release of products and services
• Control of nonconforming products and services
• ..\..\..\diagram\QMS diagram 1 .docx
• (

8.1 Operational planning and control
“Plan, implement and control the processes 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 products and services
• establishing criteria for the processes and acceptance criteria
• determining the resources needed
• implementing the control of processes
• retaining documented information”
Control planned changes and review the consequences of unintended
changes, taking action to mitigate any adverse effects, as necessary
Outsourced processes are controlled.
..\..\..\diagram\QMS diagram 1 .docx

8.2 Determination of requirements for
products and services
8.2.1 Customer communication

Establish the processes for communicating with customers in relation to:
• information relating to products and services;
• enquiries, contracts or order handling, including changes;
• obtaining customer views and perceptions, including customer
complaints;
• handling or treatment of customer property, if applicable;
• specific requirements for contingency actions, when relevant

8.2 Determination of requirements for
8.2.2 Determination of requirements.

Process to determine the requirements for the products and services
to be offered to potential customers.
Ensure the organization has the ability to meet the defined
requirements and substantiate the claims for the products and
services it offers.

8.2.3 Review of the requirements
Ensure that it has the ability to meet the requirements for

products and services to be offered to customers.
Conduct a review before committing to supply products and
services to a customer, to include:
– requirements specified by the customer, including the requirements
for delivery and post- delivery activities;
– requirements not stated by the customer, but necessary for the
specified or intended use;
– requirements specified by the organization;
– statutory and regulatory requirements applicable;
– contract or order requirements differing from those previously
expressed.

8.3 Design and development of
• Establish, implement and maintain a design and development process
that is appropriate to ensure the subsequent provision of products and
services
• Design and development planning
• Design and development inputs
• Design and development controls
• Design and development outputs
• Design and development changes

8.4 Control of externally provided
processes, products and services
8.4.1 General
Ensure that externally provided processes, products and services conform
to requirements.
Controls to be applied to externally provided processes, products and
services when:
a) products and services from external providers are intended for
incorporation into the organization’s own products and services;
b) products and services are provided directly to the customer(s) by
external providers on behalf of the organization;
c) a process, or part of a process, is provided by an external provider as a
result of a decision by the organization.
Determine and apply criteria for the evaluation, selection, monitoring of
performance, and re-evaluation of external providers, based on their ability
to provide processes or products and services in accordance with
requirements
8.4.2 Type and extent of control
Ensure that externally provided processes, products and services do not
adversely affect the organization’s ability to consistently deliver conforming
products and services to its customers.
 externally provided processes remain within the control of its quality
management system;
 define the controls to external provider and resulting output;
 take into consideration:
− the potential impact of the externally provided processes, products and services
on the organization’s ability to consistently meet requirements;
− the effectiveness of the controls applied by the external provider;
 ensure that the externally provided processes, products and
services meet requirements

8.4.3 Information for external providers
• Ensure the adequacy of requirements prior to their communication
to the external provider.
• Communicate to external providers its requirements for:
a) the processes, products and services to be provided;
b) the approval of:
1) products and services;
2) methods, processes and equipment;
3) the release of products and services;
c) competence, including any required qualification of persons;
d) the external providers’ interactions with the organization;
e) control and monitoring of the external providers’ performance to be
applied by the organization;
f) verification or validation activities performing at the external providers’
premises.

8.5 Production and service provision
8.5.1 Implement controlled conditions for production and
service provision, including delivery and post-delivery
activities:
– definition of the product and service characteristics (documented);
– activities to be performed and results to be achieved (documented);
– monitoring and measurement activities
– use and control of suitable infrastructure and process environment;
– availability and use of suitable monitoring and measuring resources;
– competence and, where applicable, required qualification of persons;
– validation, and periodic revalidation, of “special processes”;
– formal release of products and services, delivery and post-delivery
activities.
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8.5 Production and service provision
8.5.2 Identification and traceability

8.5.3 Property belonging to customers or external providers
8.5.4 Preservation
8.5.5 Post-delivery activities – Consider:
− risks associated with the products and services;
− nature, use and intended lifetime
− customer feedback;
− statutory and regulatory requirements.
8.5.6 Control of changes review and control unplanned changes essential
for production or service provision to ensure continuing conformity
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8.6 Release of products and services
Implement planned arrangements, at appropriate stages, to

verify that the
– product and service requirements have been met.
– the release of products and services to the customer shall not
proceed until the planned arrangements have been completed,
unless otherwise approved by a relevant authority/customer.
• (

8.7 Control of nonconforming outputs,
• Outputs that do not conform to their requirements are
identified and controlled
• Take appropriate action based on the nature of the
nonconformity and its effect
• Nonconforming products and services detected after
delivery
• Deal with nonconforming outputs
• (

9 Performance evaluation
• Monitoring, measurement, analysis and evaluation
• Internal Audit
• Management review
• (

9.1 Monitoring, measurement, analysis
and evaluation
Determine:
• what needs to be monitored and measured
• methods for monitoring, measurement, analysis and
evaluation, as applicable, to ensure valid results
• when the monitoring and measuring shall be performed
• when the results from monitoring and measurement shall
be analysed and evaluated.
Retain appropriate documented information.
Evaluate the quality performance and the effectiveness of
the QMS
• (

Analysis of Data & Measurement
Food for Thought:

• Consider all the records and data that you collect and
store in your company...
• How are each of these used for analysis, training, and
improvement purposes?
• If you can’t answer this question for nearly every record
you spend time and money collecting then why do you do
it?

9.2 Internal audit
• Conduct internal audits at planned intervals
• Shall
• plan, establish, implement and maintain an audit programme(s);
• define the audit criteria and scope for each audit;
• select auditors and conduct audits to ensure objectivity and the
impartiality of the audit process;
• ensure that the results of the audits are reported to relevant
management;
• take appropriate correction and corrective actions;
• retain documented information

9.3 Management review
• Top management review the organization’s quality
management system
• Management review inputs
– the status of actions from previous management reviews
– changes in external and internal issues
– information on the performance and effectiveness of the QMS
– the adequacy of resources;
– the effectiveness of actions taken to address risks and opportunities
– opportunities for improvement
• Management review outputs: decisions and actions related to
– opportunities for improvement;
– any need for changes to the quality management system;
– resource needs.

10 Improvement
Determine and select opportunities for improvement and
implement any necessary actions
Nonconformity and corrective action
• react to the nonconformity
• evaluate the need for action to eliminate the cause(s) of the
nonconformity
• implement any action needed;
• review the effectiveness of any corrective action taken;
• update risks and opportunities determined during planning,
• make changes to the quality management system,
Continual improvement
• continually improve the suitability, adequacy and effectiveness of
the quality management system.

Why is ISO 9001 so popular?
The scope of the Standard specifies requirements
intended to:
• demonstrate organization’s ability to consistently
provide product meeting customer & applicable
regulatory requirements
• enhance customer’s satisfaction through effective
application of the system including processes for its
continual improvement and assurance of conformity
to customer and applicable regulatory requirements

Why is ISO 9001 so popular?
• Significantly less emphasis on procedures and
records.
• Significantly more emphasis on management
involvement and a system that works to achieve the
goals of your business.

Benefits of the ISO 9001
There are obvious internal benefits
– Competitive Advantage
– Commitment to detail for the scope; ie: quality, security, services, etc
– Better employee engagement through training, communication and
accountability
– Formalized & repeatable processes
– Accountability at all levels
– Ongoing internal and external audits ensure weaknesses are
identified and improvements are completed
– Better governance and management of suppliers and outsourced
processes
– More efficient ability to change
– Reduction in duplicate effort

Customer Benefits
ISO 9001 certified companies queried
• 75% improved their levels of customer satisfaction and

loyalty
• 75% booster their operational performance
• 71% acquired new customers and retained existing ones.
• 55% achieved cost savings
» Source: BSI Excellerator Research 2011

Reducing Risk
• 85% of information security (ISO 27001) clients built
stakeholder confidence
• 79% experienced faster recovery speeds from incidents
• 83% of business continuity (ISO 25999) clients reported
enhanced reputation as the key benefit
• 64% of health & safety clients reduced incidents while
49% made cost savings
• 99% of organizations meets their Information Security
objectives once they have implemented ISO 27001
Source: BSI Excellerator Research 2011 and Erasmus University Study

Organizational Benefits
• 64% attribute direct cost saving to ISO 14001

• 74% report improvements to their corporate
reputation
• 76% improve their compliance
• 61% report higher morale among staff
Source: BSI Excellerator Research 2011

QMS Model in ISO 9001:2015
4.1,4.2,4.3 Define 10. Improvement

context, stakeholders
and scope of QMS
Customer 5. Leadership Custo

and mers
stakehold
ers 4.4 QMS and
processes 9. Performance Satis
6. Planning
evaluation faction
Require
Product
ment Input 8. Operation Output &services
7. Support


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What is the quality?

Degree to which a set of

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Coordinated activities to direct and

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Inputs intended result

Monitoring, measurement, analysis, evaluation

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KPI KPI KPI

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161 NATIONAL STANDARDS BODIES

122 MEMBER BODIES

22144 standards and standard type documents

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• Incorporates the recommendations of the JTCG work

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ISO 9001: 2015

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• Complete reformatting to align with “Annex SL”

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Pho Duc Tru 2009-2

All organizations, regardless of type,

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• Understanding the organization and its context

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• determine the interested parties that are relevant to the

ISO 9001:2015 focuses attention on those interested parties

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ISO 9001:2015 includes comments that:

 If a requirement cannot be applied, it must

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