ISO 9001:2015 QMS Briefing

&
Road Map of Implementation
to Top Management Team
At Hub Level

Prepared by – Abel K.
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What is ISO?
 The International Organization for Standardization.

Established in 1947
 Headquarters in Geneva.
 It is a non-governmental body.
 Members (>160) have equal voting rights.

Approximately 21,000 standards, and

— Are consensus based
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 Some of Popular ISO Management System
Standards
Standard Description No. of certificates
(2016)

ISO 9001 Quality Management System 1106356

ISO 14001 Environmental Management System 346189

ISO 50001 Energy Management System 18976

ISO 27001 Information Security Management 33290

System
ISO 22000 Food Safety Management System 32139
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 Potential benefits

 Consistently provide products and services that meet customer and

applicable statutory and regulatory requirements
 Focus on achieving planned results
 Improved risk control
 Better process control leading to improved results
 Improved customer satisfaction
 Customer retention and loyalty
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 Improved image and reputation
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 Potential benefits

• Fewer rejects, therefore less repeated work and warranty costs;

• Errors rectified at the earliest stage, and not repeated;
• Improved utilization of resources/budget;
• Increased productivity;
• Continual improvements;
• Increased profit & company growth
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 Potential benefits


Improved management confidence;

 Improved awareness of company objectives;

 Improved communications;

 Roles, responsibilities & authorities are adequately defined;

 Improved traceability to root causes of quality problems;

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 Origin & Revision Status of ISO 9001
 Quality Assurance : First Release
ISO 9001:1987

 Minor Change
ISO 9001:1994

 Process Approach
ISO 9001:2000  Major Change

 Minor Change
ISO 9001:2008

 High Level Structure (Annex SL)

ISO 9001:2015  Major Change

SABY Management Consulting 8

QMS Principles

ISO 9001:2015 is built on seven Quality Management Principles (QMPs) that guide organizations in achieving

consistent quality and customer satisfaction. & are the foundation for an effective QMS Implementation

1.Customer Focus – Understanding and meeting customer needs while striving to exceed expectations.

2.Leadership – Leaders must create a culture that supports the QMS and drives quality improvement.

3.Engagement of People – Involving employees at all levels ensures better performance and innovation.

4.Process Approach – Managing activities as processes improves efficiency and consistency.

5.Improvement – Continual enhancement helps organizations adapt to challenges and seize opportunities.

6.Evidence-Based Decision Making – Using data and factual analysis ensures informed, effective choices.

7.Relationship Management – Building strong relationships with suppliers and stakeholders strengthens

business success.
 Quality Management Principles

1.Customer 3. Engagement
focus of People

4. Process
7. Relationship 2. Leadership approach
management

6. Evidenced-
based 5. Improvement
decision
making
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ISO 9001:2015 10 clauses,
with the first three providing background information and the remaining seven outlining the Quality Management
System (QMS) requirements. Here’s a breakdown:
1.Scope – Defines the applicability of the standard.
2.Normative References – Lists related documents for reference.
3.Terms and Definitions – Establishes key terminology.
4.Context of the Organization – Understanding internal/external factors affecting QMS.
5.Leadership – Emphasizes management commitment.
6.Planning – Focuses on risk assessment and setting objectives.
7.Support – Covers resources, infrastructure, and training.
8.Operation – Details execution of processes for quality output.
9.Performance Evaluation – Monitors QMS effectiveness through audits and reviews.
10.Improvement – Ensures continuous enhancement of QMS processes.
Clouse 1 - Scope
The Scope of ISO 9001:2015 is outlined in Clause 1. It defines the standard’s applicability to organizations that

want to establish, implement, maintain, and improve a Quality Management System (QMS). The key aspects

covered include:

•Customer Satisfaction – Ensuring products and services consistently meet customer and regulatory requirements.

•Process Approach – Establishing an effective framework for managing business processes.

•Continuous Improvement – Supporting ongoing enhancement of quality and efficiency.

•Applicability to Any Industry – Can be applied to any organization, regardless of size, sector, or geographic

location.

This clause essentially sets the foundation for how ISO 9001:2015 can be used universally by organizations aiming

for quality excellence.

Clause 2: Normative References

in ISO 9001:2015 specifies the documents that are essential for understanding

and applying the standard. In this edition of ISO 9001, there is only one

normative reference, which is:

•ISO 9000:2015 – Quality Management Systems – Fundamentals and

Vocabulary This document defines key terms and fundamental concepts related

to quality management. It helps organizations interpret ISO 9001 requirements

correctly.
Clause 3: Terms and Definitions
in ISO 9001:2015 provides essential terminology used throughout the standard. Instead of
listing definitions within the document itself, ISO 9001 refers to ISO 9000:2015, which contains
key terms related to Quality Management Systems (QMS).
Here are some important definitions from ISO 9000:2015:
•Quality – Degree to which a set of inherent characteristics meets requirements.
•Risk-based thinking – Systematic approach to identifying, assessing, and addressing risks in
QMS processes.
•Continual improvement – Recurring activity aimed at enhancing performance.
•Stakeholder – Any party impacted by an organization's quality performance.
•Nonconformity – Failure to meet a specified requirement.
 The common structure and ISO 9001:2015 additions
Plan Do Check Act
4 9
5 6 7 8
Context of Performance 10
Leadership Planning Support Operation
organization and Evaluation Improvement

4.1 7.1 8.1 9.1 10.1

5.1 6.1 Monitoring,
Understanding Actions to Resources Operational General
Leadership and measurement,
context address risks and planning and
commitment analysis and
opportunities 7.1.2 control
4.2 evaluation
Interested 5.2 People
10.2 Nonconformity and
parties Policy 6.2 See next slide 9.1.2 corrective action
Quality 7.1.3 Customer
objectives and Infrastructure satisfaction
4.3 5.3 planning
Scope Organizational
roles, 7.1.4
6.3 9.1.3 10.3
responsibilities Environment for
4.4 Planning of Analysis and Continual improvement
and authorities the operation of
QMS changes processes evaluation

7.1.5 9.2
Monitoring and Internal audit
measuring
ISO/TC 176/SC 2/ N1282

resources
9.3
7.1.6 Management
Organizational review
knowledge

7.2
Competence

7.3
Awareness

7.4
Communication

7.5
Documented
information
Clause 4: Context of the Organization
in ISO 9001:2015 emphasizes the importance of understanding internal and external factors
that can impact the organization's Quality Management System (QMS). This clause requires
organizations to:
1.Identify Internal and External Issues
1. Internal: Company culture, values, processes, resources. Vision .Mission ( SW)
2. External: Market trends, regulations, competition, economic factors.(OT , PESTEL)
2.Understand Stakeholder needs & Expectations
1. Customers, suppliers, employees, regulators—all these parties influence the QMS.
3.Define the Scope of the QMS
1. Organizations must determine the boundaries and applicability of their QMS.
4.Implement a Process-Based Approach
Clause 5: Leadership
in ISO 9001:2015 highlights the role of top management in ensuring the success of a Quality Management
System (QMS). The key requirements include:
1.Commitment to Quality
1. Leaders must take responsibility for the effectiveness of the QMS.
2. Quality objectives should align with the organization's strategy.
2.Customer Focus
1. Ensuring that customer needs and expectations are met.
2. Addressing risks and opportunities that impact customer satisfaction.
3.Establishing a Quality Policy
1. Creating and communicating a policy that drives continuous improvement.
2. Making the policy available to all employees and relevant stakeholders.
4.Roles and Responsibilities
1. Leaders must define and delegate responsibilities clearly.
Clause 6: Planning
in ISO 9001:2015 focuses on ensuring that organizations proactively plan their Quality
Management System (QMS) for effectiveness and continuous improvement. Key aspects
include:
1.Addressing Risks and Opportunities
1. Identifying risks that could impact product quality or customer satisfaction.
2. Implementing preventive actions to mitigate potential issues.
2.Setting Quality Objectives
1. Establishing measurable objectives that align with the company’s strategy.
2. Ensuring objectives are regularly reviewed and updated.
3.Planning Changes
1. Managing changes systematically to avoid disruptions to the QMS.
Clause 7: Support
in ISO 9001:2015 ensures organizations have the necessary resources to maintain an effective Quality Management System (QMS). This
clause covers:
1.Resources
1. Organizations must provide people, infrastructure, and technology to support quality processes.
2. Includes management of external providers and suppliers.
2.Competence
1. Employees must have the skills and knowledge needed for their roles.
2. Training and development should be regularly assessed.
3.Awareness
1. Staff must understand their role in achieving quality objectives.
2. Communication ensures employees are aligned with the QMS.
4.Communication
1. Clear internal and external communication ensures effective QMS implementation.
2. Information should be timely and accessible.
5.Documented Information
1. Proper documentation of processes, policies, and records is required.
2. Must ensure documents are controlled, accessible, and up-to-date.
Clause 8: Operation
in ISO 9001:2015 outlines the processes necessary for producing quality goods and services while meeting customer requirements. The key aspects include:
1.Operational Planning and Control
1. Organizations must plan and control operational processes effectively.( Citizen Charter / Service Standard )
2. This includes defining criteria for product and service acceptance.
2.Requirements for Products and Services
1. Ensuring customer requirements are understood and met.
2. Reviewing contracts and agreements to prevent misunderstandings.
3.Design and Development ( Not applicable at EPSS Contest )
1. If applicable, organizations must establish a structured design and development process.
2. Includes defining inputs, outputs, controls, and validation measures.
4.External Provider Management
1. Controlling and monitoring suppliers and subcontractors.
2. Ensuring procured goods and services meet quality requirements.
5.Production and Service Provision
1. Managing operations to maintain consistency, traceability, and compliance.
2. Includes proper equipment calibration, process validation, and material handling.
6.Control of Nonconforming Outputs
1. Defining processes for identifying and correcting defective products or services.
2. Taking appropriate corrective action to prevent future nonconformities.
Clause 9: Performance Evaluation
in ISO 9001:2015 ensures organizations systematically monitor, measure, analyze, and evaluate
their (QMS) to improve effectiveness. The key requirements include:
1.Monitoring, Measurement, Analysis, and Evaluation
1. Organizations must define what to monitor and how to measure performance.
2. This includes tracking key quality indicators, customer feedback, and operational
efficiency.
2.Internal Audits
1. Conducting audits to ensure QMS compliance and effectiveness.
2. Identifying areas for improvement through systematic reviews.
3.Management Review
1. Top management must periodically evaluate QMS performance.
Clause 10: Improvement
in ISO 9001:2015 focuses on ensuring continuous enhancement of the Quality Management
System (QMS). Key aspects include:
1.Reacting to Nonconformities and Taking Corrective Actions
1. Identifying issues that negatively impact product quality or customer satisfaction.
2. Implementing corrective actions to prevent recurrence.
2.Continual Improvement
1. Organizations must regularly evaluate and improve their QMS.
2. Enhancements should be based on data analysis, audits, and stakeholder feedback.
3.Driving Innovation and Performance Enhancement
1. Encouraging efficiency and effectiveness in operations.
2. Leveraging new technologies, best practices, and lessons learned.
 • Top Management Briefing
• Roles and Responsibility/QMS task force
• Determining Scope of the QMS
Initia • Review existing documents (BPR, SOPs, etc.) to streamline with QMS Requirements
tion

• Training of QMS taskforce on ISO 9001:2015 requirements

• determining context of EPSA and processes and their interaction, establishing the
Developme Quality policy) and objectives, identify risks and opportunities, Resources needed
for the QMS, stakeholder /interested parties analysis and finalize the draft
nt implementation plan with timelines etc...
• Establishing documented information needed for the QMS

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 ISO 9001:2015 QMS Road Map
• launching the QMS implentation
• Awareness training of relevant staffs on the established system
• Relevant SOP training to staff
Imple • implementation and follow-up of risk mitigation plans, objectives and KPIs
menta
• Change management
tion

• Training of selected staffs on internal audit and conduct internal audit

Perf
• Customer satisfaction
orma
• Monitoring and measuring of processes
nce
• Management review
Eval
uatio
n
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ISO 9001:2015 QMS Road Map

• Corrective action based on

certification audit if needed
• Customer satisfaction, M&M, internal
Maintenance audit, management review
and continual •
improvement Identify improvement areas
• preparation for yearly surveillance
audit

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THANK YOU

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