Quality is the best business plan: A QMS with the nitty gritties of ISO 9001:2015

Quality is the best business plan:
An overview of Quality Management
system with the Nitty Gritties of ISO
9001:2015
By
M.Youssef.K

M. Youssef K
Six Sigma Associates
M. Youssef K is an executive consultant & trainer with several qualifications. He is an
accomplished expert with over 10 years’ experience in the field of risk management, project and
program management, PRINCE 2, Agile, EVM, business process analysis and design, as well
as operational and organizational excellence
92-306-5252528
6sigmapk@gmail.com
https://pk.linkedin.com/in/projectmanagementpk
www.sixsigmaassociates.co.uk/sixsigma

What is a Quality Management
System?
Policies,
Processes
Procedures
System?

System?Required for planning and executing
business processes
To meet customer requirements
Accredited to International Standards
by a Registrar
ISO 9001:2015 is an example

It Requires …..
1. Leadership
2. Determination
3. Resilience
4. Commitment
5. Engagement

A Strategic Choice
 Effective Application of ISO 9000 QM
Principles = Financial & Economic benefits
 Financial benefit results from cost-effective
management practices within the
organization.
 Economic benefit results from improvements
in the overall worth and health of the
organization.

ISO 9001 Management Principles
1. Customer Focus
2. Leadership
3. People Involvement
4. Process Approach
5. Systems Approach
6. Continual improvement
7. Factual Approach to Decision Making
8. Mutually Beneficial Supplier Relationships

Derived Benefits of QMS
improved profitability, improved revenues, improved
budgetary performance,
reduced costs, improved cash flow, improved return
on investment,
increased competitiveness, improved customer retention
and loyalty, improved effectiveness of decision making,
optimized use of available resources,
heightened employee accountability, improved
intellectual capital, optimized, effective and efficient
processes,
improved supply chain performance, reduced time to
market,
enhanced organizational performance, credibility and
sustainability.

Realization of Benefits
INPUTS OUTPUTSPROCESS

The Inputs
1. Customer Focus
2. Leadership
3. People Involvement
4. Process Approach
5. Systems Approach
6. Continual improvement
7. Factual Approach to Decision Making
8. Mutually Beneficial Supplier Relationships

The Process
Assess requirements,
Plan activities,
Allocate appropriate resources,
Implement continual improvement
actions,
Measure results to determine
effectiveness,

Out put = Increased Productivity

The new ISO 9001:2015
The ISO 9001:2015

Introduction
A short overview of ISO 9001 in the world

The new ISO 9001:2015Introduction
A short overview of ISO 9001 in the world

The Framework
Standardize and effectively develop standards
Enhance alignment and compatibility of
standards
Useful for organizations which pursue multiple
standards
Some standards already under Common
Framework: ISO 22000, ISO 20001, ISO 50001
Under revision to the Common Framework: ISO
14001, ISO 27001, ISO 9001

The new ISO 9001:2015ISO 9001:2015
0. Introduction
1. Scope
2. Normative References
3. Terms and Definitions
4. Context of the Organization
5. Leadership
6. Planning
7. Support
8. Operations
9. Performance Evaluations
10.Improvement

Focus on risk based management
Senior management must be able to demonstrate an
understanding of business risks and how they could impact
on the ability to meet customer requirements. An effective
risk management process will be critical for successful
certification to the new version.
It must ensure the management system can achieve its
intended outcomes and achieve continual improvement.
Clause 6.1 Actions to address risks and opportunities, is
where this is covered and it addresses the ‘what, who, how
and when of risk management.

Objectives and measurement
The requirements around quality objectives have also been
made more detailed. They need to be consistent with the
quality policy, measurable (if practicable), monitored,
communicated, and updated as appropriate. They also
have to be established at relevant functions and levels.
Objectives should include plans on how to achieve them as
well as how the results will be evaluated.

The organization must determine who will be responsible
for the delivery of the objectives, resources required, what
needs to be done and by when.
So remember that when establishing quality objectives
organization needs to demonstrate how they plan to
achieve them. And remember that the objectives (results to
be achieved) – can be technical, strategic or operational.

Communication and awareness
Clause 7.3 Awareness is now a clause in its own right:
people working under an organization’s control should be
aware of the quality policy, objectives, their contributions to
QMS, implications of non-conformities etc. There is an
increased emphasis on awareness to ensure that everyone
knows the implications of not conforming to the
management system requirements.

Which leads into Clause 7.4 Communication – internal
and external communications are now a requirement. It’s
up to the organisations to decide what/who/when and how
they are communicating. Communication is important for
both internal and external stakeholders and an
organization must develop a communication plan. It is
important to decide who will own the communication and
ensure that they have the appropriate authority,
competencies and knowledge.
The communication plan can include a variety of mediums
including briefings, meetings, seminars, conferences and
newsletters.

Fewer prescriptive requirements
Much will be made of the fact that the new version of the
standard has no requirements for procedures but it does
have requirements for documentation. Clause 7.5
Documented Information deals with documented
information and is split into 3 sub-clauses – general,
creating and updating and control.

An organization must decide what information they wish to
retain, how these are updated and controlled and
adequately protected Clause 8 Operations includes:
Requirements for customer communication (from
information on products to contracts and invoicing)
Review of design and development changes
Information for external providers
Identification and traceability
Release of products and services now part of
operational controls
Non-conforming processes, outputs and product and
services

5. High Level Structure New Clause Numbers
1. Scope
2. Normative References
3. Terms and Definitions
4. Context of the Organization
4.1. Understanding the Organization and its context
4.2. Needs and expectations
4.3. Scope
4.4. Management system

The new ISO 9001:20155. Leadership
5.1. Management commitment
5.2. Policy
5.3. Roles, Responsibility and Authority
6. Planning
6.1. Actions to address risks and opportunities
6.2. Objectives and plans to achieve them
7. Support
7.1. Resources
7.2. Competence
7.3. Awareness
7.4. Communications
7.5. Documented Information

8. Operations
8.1. Operational planning and control
9. Performance evaluation
9.1. Monitoring, measurement, analysis and
evaluation
9.2. Internal audit
9.3. Management review
10. Improvement
10.1. Nonconformity and corrective action
10.2. Continual improvement

6. Some Requirements – Examples
4. CONTEXT OF THE ORGANISATION
4.1. Understanding the organization and its context
The organization must determine external and internal
issues relevant to its purpose and that affect its ability to
achieve the intended outcome(s) of its QMS.

4.2. Understanding the needs and expectations of
interested parties
The organization must determine interested parties
relevant to the QMS, and the requirements of these
interested parties
List of interested parties the organization must consider:
Direct customers
End users
Suppliers, distributors, retailers or others involved in
the supply chain
Regulators, and
Any other relevant interested parties

4.4. Quality management system
The organization must establish, implement, maintain and
improve a QMS, including the processes needed and their
interactions, in accordance with the requirements of this
standard
"Process approach" is maintained, and it will be embedded
in all ISO management system standards.

The new ISO 9001:20155.1. Leadership
Top management must demonstrate leadership and
commitment with respect to the quality management
system, by ...
Ensuring the integration of the QMS requirements
into the organization's business processes,
Promoting awareness of the process approach,
Supporting other relevant management roles to
demonstrate their leadership as it applies to their
areas of responsibility.
Top management must demonstrate leadership and
commitment with respect to customer focus.

The new ISO 9001:20156.1. Actions to address risks and opportunities
When planning for the QMS, the organization must
consider the issues... in 4.1 and the requirements ... in 4.2
and determine the risks and opportunities that need to be
addressed to:
Assure the QMS can achieve its intended outcome(s)
Prevent or reduce undesired effects
Achieve improvement
The organization must plan:
Actions to address these risks and opportunities, and
how to:
• Integrate and implement the actions into its OMS
processes and
• Evaluate the effectiveness of these actions

7.1. Resources
The organization must determine and provide the
resources needed for the OMS (establishment,
implementation, maintenance and improvement of the
OMS).
Resources may include:
Infrastructure (7.1.2 )
Process environment (7.1.3)
Monitoring (7.1.4 )
Knowledge (7.1.5)

The new ISO 9001:20158.1. Operational Planning and Control
The organization must plan, implement and control the
processes needed to meet requirements and to implement
the actions determined in 6.1, by:
Establishing criteria for those processes
Implementing the control of the processes in
accordance with the criteria
Keeping sufficient documented information to
demonstrate the processes have been carried out as
planned

The organization must control planned and review the
consequences of unintended changes, taking action to
mitigate any adverse effects, as necessary.
The organization must ensure the operation of a function
or process of the organization by an external provider is
controlled (outsourcing ).

The new ISO 9001:20158.4. Control of External Provision of Goods and
Services
The organization must ensure that externally provided
goods and services satisfy the specified requirements.
Note: These include outsourcing.

The new ISO 9001:20159. PERFORMANCE EVALUATION
9.1. Monitoring, measurement, analysis and evaluation
9.2. Internal audit
9.3 Management review

??
QUESTIONS
92-306-5252528
6sigmapk@gmail.com www.sixsigmaassociates.co.uk/sixsigma
https://pk.linkedin.com/in/projectmanagementpk
THANK YOU

Quality is the best business plan: A QMS with the nitty gritties of ISO 9001:2015

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Quality is the best business plan: A QMS with the nitty gritties of ISO 9001:2015