ISO 9001:2015

Quality Management Systems

Topics

• What is a Quality Management System (QMS)?

• Why a QMS is important to an organization and its benefits?

• An overview of ISO 9001, terms and definitions.

• The main requirements of ISO 9001

Module 1. Recognize the benefits of a QMS
What is a Management System?
A management system is the way in which an organization manages the inter-related parts of its
business in order to achieve its objectives. These objectives can relate to a number of different topics,
including product or service quality, operational efficiency, environmental performance, health and safety
in the workplace and many more.

What is Quality Management System (QMS)?

A Quality Management System (QMS) is a framework that allows that allows an organization to be more
efficient, ensure customer satisfaction and continually improve its performance.

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Why do you need a Quality Management System?
• Deliver consistent products and services
• Meet customer’s expectations
• Guarantee the quality of products and services.
• Implementation of best practices and process
improvement
• Effective and efficient production

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Quality Management System
A Quality Management System is based on Plan Do Check Act (PDCA) principles, an intuitive process
and an efficient documentation structure.
Review and
Improvement
• Data is accurate and accessible
and enables the business to
make decisions to manage risk
and improve performance.
Monitoring and
Checking
• Audits and inspections ensure
the effectiveness of the
Management System and
provide a comprehensive
picture of its performance.
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Planning
• Expectations and requirements
are established based on risk
and need.
• Processes and documents are
developed to meet these
expectations.
Implementation
• Work is conducted in a
safe ,culturally and
environmentally sound
manner.
QMS Benefits
• Assess the overall context of your organization to define who is affected by your work and what they
expect from your organization.
• Ensure customer satisfaction
• Reduce waste, increase efficiency and reduce internal costs.
• Competitive advantage – Increase market share
• Meet compliance requirements.
Module 2. Annex SL – ISO High Level
Structure
ISO Standard for Management Systems
What is Annex SL?
• High-level structure created by ISO.
• Provide a universal high-level structure, identical core text,
and common terms and definitions for all management
system standards.
• Reduction in potential conflict between different systems
• Facilitate integration of management systems.
• Improve understanding of requirements.
ISO 9001: Quality Management Systems -
Requirements
Organizations that implement an effective QMS benefit from:
• Stakeholder and customer confidence.
• Improved risk management.
• Operational effectiveness and efficiency.

• A Quality Management System is what ensures a business' products or services meets a certain
level of quality; that is, they are reliable, safe, consistent, meet customer expectations,
continuously improve and comply with the law.

Meet Customer’s expectations and ensure

their satisfaction !
ISO 9000 Family
The ISO 9000 family standards corresponds to all the management best practices benchmarks associated
with quality this includes, but not limited to:

• ISO 9000 Quality Management Systems - Basic Principles and Vocabulary

• ISO 9001 Quality Management Systems - Requirements
• ISO 9004 Quality Management Systems - Guidelines
• ISO 19011 Guidelines for auditing Management Systems
ISO 9001 Structure
1. Scope
2. Normative references
3. Terms and definitions
4. Context of the organisation
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance Evaluation
10. Improvement
Terms and Definitions
• Documented Information: information required to be controlled and maintained by an
organisation and the medium on which is contained.

• Products and Services: outputs and objects of the processes within the management system.

• Organizational Knowledge: required knowledge to maintain processes operations and improve

the quality of products and services.

• Risk-based Thinking: prioritize and treat processes based on their level of risk to affect the
outcomes of the QMS.
Module 3. Quality Management Principles
Quality Management Principles

1. Customer Focus
2. Leadership
3. Engagement of people
4. Process approach
5. Improvement
6. Evidence-based decision making
7. Relationship management
Customer Focus
Why?
• 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
Leadership
Why?
• Understanding and motivation
towards quality objectives
• Better coordination of the
organization’s processes
• Activities are evaluated, aligned
and implemented in an unified way
• 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
Engagement of People
Why?
• Motivated, committed and involved
people.
• 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 value and
culture throughout the organization
Process Approach

Input Process Output

Why?
• 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 as to its
consistency, effectiveness and efficiency
Processes in your organization

• Core: activities that customers are willing to pay for because they add value to the product
or service.
• Management/Governance: activities that involve strategic planning and decision making.
• Support: activities that provide resources and assist with the achievement of desired
outcomes.
• Verification: activities that measure and gather data, analyze and improve the overall
business and quality management system’s performance.
Process Mapping
• Process mapping is the first stage to document a process.
• The SIPOC approach is the first step to map a process.
• Activities and task can always be subdivided into sub-processes.
• Some of the Sub process Mapping Techniques includes:
– Flow chart
» Level 1 – high-level core steps of a process listed in six
steps or less.
» Level 2 – drills down from the core steps and
describes the steps involved in a process at the next
level.
» Level 3 – describes the step-by-step details of a
process.
– Deployment Charts / Swim lane Map

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SIPOCR Model
Organization Process Map
MANAGEMENT PROCESS

Strategic Management
Planning Review

Finance and
Administration ACT Lessons Learned
SUPPORT PROCESS

VERIFCATION PROCESS
Procurement
CONTINOUS
PLAN CHECK Auditing
IMPROVEMENT

HSEQ

Performance
DO Evaluation
Human Resources

CUSTOMER REQUIREMENTS CUSTOMER

SATISFACTION

Business
INPUT Design & Installation & OUTPUT
Development Fabrication
Engineering Delivery
Improvement
Why?
• Improved process performance, organizational
capabilities 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
Evidence-based decision making
Why?
• 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
Why?
• Enhanced performance of the
organization and its interested parties
through responding to the opportunities
and constraints related to each interested
party
• Common understanding of goals 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 goods and
services
Module 4. ISO 9001 Requirements
Section 4 – Context of the Organisation
• Identify internal and external issues that can affect an organisation ability to achieve its intended
outcomes.
 Internal: organisational structure/change, resources, budget, knowledge loss, morale, ageing
workforce, silo processes, technology, work environment, culture.
 External: Regulatory changes, customer OSH requirements, cultural changes, social changes,
economic slowdown, natural surroundings, technological change, new partners/competitors,
market conditions, subcontractors.
Section 4 – Context of the Organisation
• Identify needs and expectations of interested parties.
 Person or organisation that can affect, be affected by, or perceive itself to be affected by the
activities of the organisation.

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Section 4 – Context of the Organisation
• Define scope and boundaries of the Management System in line with business objectives.
• Must include the activities, products and services that are within your control or influence.

Out of Scope

In Scope
Section 4 – Context of the Organisation
• Define processes and their interactions, within the QMS.
Section 5 – Leadership
• Top management accountability and involvement.
 A Management Representative is no longer required under the management system.
• Integrate the requirements of management system into the organisation’s business processes.
• Promote the use of the process approach and risk-based thinking.
• Be accountable for the effectiveness of the management system and ensure it achieves its intended
results.
• Promote improvement.
• Maintain customer focus.

How to demonstrate leadership and commitment?

• Walk the talk - Quality is a priority in all business decisions and lead by example
• Active support and feedback
Section 5 – Leadership
Align strategic direction, policy and objectives – Quality Policy must be available as documented
information.

Assign and communicate roles, responsibilities and authorities – maintained as documented information.
• Top Management can assign responsibilities and authorities for the Quality Management System, but cannot
delegate accountability, which remains with top management.
Section 6 – Planning
• Risk based thinking

• Identify risk and opportunities – Taking into consideration the organisation’s context and needs and
expectations of interested parties.

• Plan actions to address the risk and opportunities and integrate actions into business processes. Plan
how to evaluate actions.

• Assess Quality risks and opportunities .

Section 6 – Planning
Determine objectives of the quality management system and plan to achieve them.
 Measurable, monitored, communicated and aligned to the Policy.
 Must maintained and retained documented information.

Objective Target Method – Plan to achieve Deliverable Responsible Due Date

Customer Increase 5% • All products should have an • Lead and Lag Indicators Quality December
Satisfaction against Inspection and Test Plan.  Customer Satisfaction Rate Manager 2019
previous • Conduct Factory Acceptance  Price of Non-Conformance
year results. Test • Monthly Customer
• Provide Total Quality Satisfaction Reports
Management Training • Training Records
• Conduct weekly fabrication • Meeting Minutes
meeting
Section 7 – Support
• Resources
• People
• Infrastructure
• Work Environment.
• Monitoring and Measuring resources
• Organizational Knowledge
Section 7 – Support
• Competence
• Awareness
• Communication
Section 7 – Support

• The level of documented information needed for the processes needs to be determined by the
organization.
• ISO 9001 does not define format or content, nor mandatory documented procedures or manuals.
• Processes are documented in Procedures.
• Document Development and Control. Po
lic
y
Procedures

Work Instructions

Forms
Section 8- Operation
• Operation Planning and Control
• Requirements for products and services
• Design and development of products and services
Section 8- Operation
• Control of externally provided processes, products and services
• Product and services provision
• Release of products and services
• Control of nonconforming outputs (process, product, service).
Section 9 – Performance Evaluation
• Determine what, how and when things are to be monitored, measured, analysed and evaluated.
 Monitoring – Performance Indicators and Operational Metrics
 Customer Satisfaction
 Internal Audit
 Management Review

• Review information, including trends and indicators on the effectiveness of actions taken to address risks
and opportunities.

• Effectiveness evaluation.
Section 10 – Improvement
• Nonconformity and corrective action

• Continual improvement
Practical Tips for implementation
• Conduct a gap analysis to understand your current situation

• Involve key functions and top management from the beginning – Educate them and take them in the
journey

• Establish an implementation plan with realistic milestones

• Less is more – Keep it simple