QUALITY MANAGEMENT SYSTEM

ISO 9001: 2015

Presented By: Hassan Faraz
Sequence

• Section – I: Basic Concepts: Quality

– Quality, Quality Assurance & Quality Control etc.
– Cost of Quality
– Quality Management
– Quality Management Principals

• Section – II: ISO 9001:2015 Requirements

– Clause by Clause (Clause 4 to 10)

• Section – III: Hazard Identification, Risk Assessment & Controls

Section I
Basic Concepts: Quality
What Is Quality
Quality Is Conformance To Agreed Requirements

How well requirements of the customer being met.

(Good Quality)
How bad requirements of the customer being met.
(Poor Quality)
What Is Quality?
QUALITY IS CONSISTENCY
OR

ABSENCE OF VARIATION
OR

DOING RIGHT THE FIRST TIME

OR

CUSTOMER SATISFACTION
OR

MEETING SPECIFIED REQUIREMENTS

What Is Inspection or Testing
To Check Whether Product / Service Has Passed The
Acceptance Criteria.

QC-1 Process
QC-2 Process QC-3 Process QC-4
A B C
Quality Control (QC)
Operational techniques and activities that are
used to fulfill requirements for quality.
Quality Control is a Reactive approach. And it is
used to verify the quality of output.
Quality Assurance (QA)
“A part of quality management focused on providing
confidence that quality requirements will be fulfilled”

Quality Assurance is a Preventive approach, & it is used to

managing for desired outputs.
 Quality Assurance (QA)

4 M’s
 MAN: Training & Competence
 METHOD: Defined & Documented, Work Study,
Resource Optimization
 MACHINE: Calibrated, Preventive Maintenance
(Preventive vs Breakdown) , Utilization
 MATERIAL: As per defined Specs.
Quality Management (QM)
Quality Management includes all the coordinated activities to
direct and control an organization with regard to quality
 Cost of Quality (COQ)
• Cost of Quality ("COQ") is a measurement used for assessing the waste or
losses from some defined process

• OR

• Cost of quality is the amount of money a business loses because its product
or service was not done right in the first place.

• OR

• Variation / Inconsistency
 Cost of Quality
Cost of
Poor
Quality
(CoPQ)

Cost of
Quality
Cost of
Good
Quality
(CoGQ)
Cost of Quality (CoQ)
 COST of QUALITY
APPRAISAL COST
1. Inspection and Testing
2. Calibration of Equipment
3. Inspection of Purchased Goods
4. Quality Audit
PREVENTION COST
1. Quality & Process Planning
2. Preventive Maintenance
3. Training & Education
4. Supplier Evaluation

INTERNAL EXTERNAL FAILURE

FAILURE COST COST
1. Scrap & Rework 1. Warranty Costs
2. Re-testing 2. Customer Complaints
3. Downtime 3. Loss of Business
4. Delays 4. Returned Material / Products
Quality Management Principles

Quality Principles

4. Process
Approach
 Quality Management Principles
Quality Principle Benefits Applicable Clause

Customer Focus 1. Increased Customer Loyalty Leading to repeat business 5.1.2

2. Increased Revenue & Market Share Customer Focus

Leadership 1. Motivation of people towards achievement of goals. 5.1

2. Providing people with required resources, training and Leadership &
empowerment. Commitment
Engagement of 1. Motivation, Commitment and involvement, of people. 7.1.2
People 2. Accountability of their performance People
Process Approach 1. Lower costs & shorter cycle times through effective resource 4.4.1
management. QMS & Its Processes
2. Focusing on factors (resource, methods & material) that will improve
key activities.
 Quality Management Principles
Quality Principle Benefits Applicable Clause

Improvement 1. Performance advantage through increased organizational abilities. 10

2. Flexibility to react quickly to opportunities. Improvement

Evidence based 1. Informed Decisions 9.1.3

Decision Making 2. Making decision and taking action based on factual analysis. Improvement
Relationship 1. Increased ability to create value for both parties. 8.4
Management 2. Clear and open communication Control of externally
3. Optimization of cost and resources. provided product and
service
 Section II

ISO 9001:2015 Requirements

 ISO 9001:2015 Structure
4. Context of the 9. Performance 10. Continual
Organization 5. Leadership 6. Planning 7. Support 8. Operations Evaluation Improvement

6.1 Action to 9.1 Monitoring,

4.1 Understanding 8.1 Operational measurement, 10.1 Nonconformity
5.1 Leadership & address Risk & 7.1 Resource planning & control & Corrective action
the organization & analysis and
Commitment Competence
its context evaluation

10.2 Continual
4.2 Understanding 6.2 Quality 8.2 Requirements for
7.2 Competence products & service 9.2 Internal Audit Improvement
Needs & Objectives
5.2 Quality/ Policy
Expectations of
interested Parties

6.3 Planning of 8.3 Design & 9.3 Management

5.3 Organizational 7.3 Awareness Development
changes Review
roles,
Scope of QMS
responsibilities &
authorities

8.4 Control of
7.4 Communication Externally Provided
products/ Service
Quality Management
System

7.5 Documented 8.5 Product & Service

Information Provision

8.6 Release of
Product& Service

8.7 Control of NC
 Clause 4
Context of the Organization
  Type of the Organization.
 Purpose of the Organization.
Evaluation of the  Size of the Business.
Organization  Business Resources.
 Business Model.
 Business Boundaries.
 Business Opportunities.
 Business Operations.
 Business Issues.
 Interested Parties Requirements.
 Business Management.
 Type of the
Organization
(Scope)

 Profitable.
 Charity.
 Public.
 Private.
 Corporate.
 Business sector.
Purpose of the
Organization
(Scope)

 Products and services.

 Mission.
 Vision.
 Policies.
 Objectives.
 Values.
 Culture.
 Size of the
Business
(Scope)

 Number of employees.
 Management sites.
 Functional sites.
 Complexity of the processes
(technology, employee).
 Business
Resources
(Scope)

 Human resources.
 Infrastructure, including
buildings, utilities, process
equipment, monitoring and
measurement equipment, work
environment & raw materials.
 Documented information.
 Knowledge of the organization.
  Brokerage.
 Crowdsourcing.
 Freemium.

Business  Leasing.
Negative operating cycle.
Model 

 Pay as you go.

(Scope)
 Reverse auction.
 Product to service.
 Subscription.
Business Boundaries
 Location.
 Facilities (e.g. production sites) including
remote facilities which are part of the Quality
Management System.
Business
Opportunities
 Launching new products and services.
 Opening new market.
 Addressing new customers.
 Building partnership.
 Adoption of new technology.
 Fostering new practices or standards.
 Other possibilities to address customer
needs.
 Business Operations

Marketing Sales Design Purchase Production Inspections Product Release

Preservation Documentation/Invoicing Transportation Delivery Payment

After sale service Recycling Disposition

 4 Understanding Organization & its
Context
1. External and internal issues that are relevant to its purpose and
its strategic direction
2. Needs & expectation of interested parties
3. Scope of Quality Management System
4. Quality management system
4.1 Understanding Organization & its
Context
External Issues Internal Issues
• Political • Technology
• Law & Order • Financial
• Legal & Regulatory • Products and services
• Technological • Strategic direction
• Economic • Culture
• Natural • People
• Competitive context • Knowledge
(International, • Processes
national, regional or • Systems
local)
 SWOT ANALYSIS
An ideal tool to meet the requirements of 4.1 clause.

Strengths
• Highly competent middle management
• Less emissions due to clean technology
Weakness
• Capacity of product testing laboratory is not
as per production volume
• Labor is not aware of environmental issues
related to their activities

Opportunities Threats
• Government is funding the certification • Some competitors have less cost of
process for exporters production
• Solid waste recycling plant set by Govt. can • Environmental Protection Agency is revising
be utilized. the parameters of industrial effluent
4.2 Needs and Expectation of
Interested Parties
The interested parties includes;
• Direct customers
• End Users
• Employees
• Suppliers, Distributers, Retailers, or any other involved in supply Chain
• Regulators
• Any other relevant interested parties
Interested Parties Requirements

Interested parties

Owners Bankers Customers Competitors Suppliers

Leaders Organization Society Community

Interested parties’ Interested parties’

needs expectations
 4.2 Needs and Expectation of Interested
Parties
Interested Requirements of Needs and Expectations
Parties QMS
Manager Human Provision of 1. To provide required manpower within the specified budget.
Resource required Human 2. To ensure that employees working in the premises are competent.
Resources 3. To provide necessary trainings identified in TNA, to enhance the awareness
levels.
Quality Assurance To Minimize Non- 1. Establish quality assurance program to reduce rejections and improve
Dept. compliance effectiveness
2. To identify quality issues, analyze them and take corrective actions.
3. To ensure that employees are aware of quality requirements.
4. Maintain documented information to assure quality.
5. To ensure that equipment are at their optimum condition to give desired
results.
Business Management

 Business process inputs.

 Business processes.
 Business process outputs.
Business Process Inputs
Customers
requirements

Interested Statuary
Business
parties’ Regulatory
requirements process Requirements
inputs

Applicable
technical Contractual
standards and Requirements
codes
Business Management Process
Provide
Management Leadership
Processes

Effectiveness Planning To develop

Improvement Processes
Efficiency processes Business Plans
Profitability
Sustainability Business
Management
Processes

Performance Control Support To provide

measurement processes Processes Resources

Operation
Processes Management
of operations
Business Process Outputs
Business
growth

Improved
Profitability
Business Business
process
outputs

Interested
parties Sustainability
Satisfaction
Strategic Direction & Integration
Business Objectives Business Strategy
Intended Business
Intended Business
Results
QMS Objectives QMS Strategy

Strategic Direction

Internal External
Competitors Focus Supplier Focus
Customer Focus Customer Focus

Business Business
Business Objectives Gross/Net Profit Business Growth
Continuity Accountability

QMS Objectives Meeting Customer Meeting Legal Product and Service Customer
Requirements Requirements Conformity Satisfaction
4.3 Scope of QMS
While determining scope of QMS*, must consider;

a. The external and internal issues;

b. The requirements of relevant interested parties
c. The products and services of the organization.
4.4 QMS & Its Processes
Determine Required Inputs and Desired Outputs

Determine Sequence & Interaction of each process

Determine acceptance criteria & Monitoring process

Determine Resource needed

Assign responsibilities

Address Risks and Opportunities

Analysis, Evaluation & Improvement

Context of Organization (Clause 4)
Context of the Internal & external issues
Maintain Organization
documented Clause 4.1
information to
support the
process of its
operations
Requirements and
Quality Context of the expectations of
Management Requirements of the interested
System and its Organization Interested Parties
Retain documented parties
Processes Clause 4 Clause 4.2
information to have
Clause 4.4
confidence that
processes have been
carried out as per the
planned
arrangements
Determining the
Scope of Quality
Management
Maintain System
documented scope Clause 4.3
of QMS
Clause 5
Leadership
5.1 Leadership and Commitment
1 Communication
• Communicating the Importance of QMS, Policy and objectives

2 Customer Focus
• Ensuring that customer requirements are determined, communicated and met.

3 Provision of Resources
• Management shall determine and provide the necessary resources for the QMS.
5.2 Quality Policy
Policy shall ensure that it;

• Is appropriate to the purpose of the organization

• shows top management commitment
• Provides framework for establishing and reviewing Quality Objectives
• Approved
• Communicated
• Reviewed
5.3: Organizational Roles,
Responsibilities and Authorities
• Defined Organizational Structure
• Defined responsibilities
• Defined authorities
• Communication of responsibilities and authorities

Examples: Responsibility Matrix

Job Descriptions
Organizational Chart
Reference Documents

Quality Policy

Organizational Charts

Job Descriptions

Responsibility Matrix
 RISK
MANAGEMENT
 Risk &
Opportunities

 Risk is “the effect of uncertainties

on the objectives”
 Opportunity is “situation or
condition favourable for attainment
of a goal”
Risk Management
Process
• Context Establishment.
• Risk Assessment:
• Risk Identification.
• Risk Analysis.
• Risk Evaluation.
• Risk Treatment.

Based on ISO 31000.

Risk
Assessment
Risk assessment is the
overall process of risk
identification, risk analysis Risk
and risk evaluation. Risk Analysis
Identification

Risk Assessment includes:

1. Risk Identification. Risk Evaluation
2. Risk Analysis.
3. Risk Evaluation.
Risk
Identification
Risk identification is the
process of finding, recognizing
and describing risk.

Note: Risk identification

involves the identification of
risk source, event and their
potential consequences.

Note: Risk identification can

involve historical data,
theoretical analysis, informed
and expert opinions and
stakeholders needs.
Risk Analysis
The process to comprehend
the nature of risk and to
determine level of risk.

Example
Risk = Likelihood x
consequences
5 x 5 = 25
Risk
Evaluation
The process of comparing
the results of risk analysis
with risk criteria to
determine whether the risk
is acceptable or tolerable.
Risk Criteria:
Terms of reference against which
the significance of risk is
evaluated.
Risk Treatment
Process of selecting and applying controls to treat risk.

• Risk Avoidance
• The activity or condition that gives rise to the particular
risk should be avoided. Example: eliminating the risk source
or changing the process.
• Risk Reduction
• Reduce the risk by changing the likelihood or consequences
of the risks.
• Risk Acceptance
• Accepting the Risk. Retaining the risk by informed
decision.
• Risk Transfer
• The risk is transferred to another party that can most
effectively manage this particular risk depending on risk
evaluation.
Risk Based
Thinking Risk Based Thinking
 Risk-based problem solving QMS Processes,
(R&O identification). Policies
Information Assets
 Risk-based decision-making
(Actions to address R&O).
Data Value Creation
Business Processes, Assets

Information Wisdom

Knowledge
Clause 6
Planning
Actions to Address Risk
Mapping of all Processes & Activities

Identify the Potential Risks Associated with activities

Determining Probability and Consequence

Calculating Risk Factor

Identification of Mitigation plan

Implementation of Plan

Risk factor after Mitigation

Risk Consequence can be;
• Potential loss of contracts
• Potential Harm to user
• Inability to meet contract / terms and requirements
• Potential Violation of regulation
• Impact on company’s reputation
• Est. Cost of Correction
Risk Register
QUALITY OBJECTIVES
• Objectives must be SMART
MANGEMENT PROGRAM FOR N A TIO N A L FU EL CO RPO RA T IO N

OBJECTIVES
Management Program for Objectives & Targets

Rev#: 00 Issue Date: Document Code: NFC-FRM-005

OBJ NO: _____________ DEPARTMENT: ___________________________________ TARGET DATE: ___________________

OBJECTIVE: _______________________________________________________________________________________________________________

Responsible Resource Required

Sr. Action / Activity (Step by step) Target Date Current Status
Person (if any)
Give breakup of the objective in Specify Mention Resources may This column will be
form of activity for its suitable tentative be mentioned used to describe the
implementation person for completion here. status of the action
each action. date of
action

Objective Setting
Reference Documents

Risk Register & Risk Methodology

Quality Objectives

Management Program for Objectives

Clause 7
Support
7.1: Resource
• The organization shall;
• Determine the resources needed
• Provide the resource
• Maintain the resources

It includes;
• People
• Infrastructure
• Work environment (Physical conditions)
Organizational Knowledge
• Knowledge specific to the organization generally gained by
experiences.
1. Intellectual property
Internal
2. Knowledge gained from experiences. Sources
3. Lessons learned from past failures & successful projects
(CA Log, Incident Log)
4. Standards
External
5. Conferences Sources

6. Knowledge from customers or external providers

 7.2 COMPETENCE

• The organization shall ensure to have competent employees to

perform task related to QMS.

Competence Experience Skills Training Education

7.2 COMPETENCE
• The organization shall provide training to achieve the necessary
competence and evaluate the effectiveness of the actions taken

Identify Training Needs

Provide Training

Evaluate Training Effectiveness

Maintain Records of Training

7.3: Awareness
• Persons doing work under the organization’s control
shall be aware of;

1. Quality policy
2. Their roles in the QMS
3. Requirements for organizations
7.4: Communication
•Establishment of system for both internal or external
communication
Examples:
• Inter office notes
• Inter office memo
• Organizational Policies
• Compliance board
• Notice board
• Meetings
• Trainings and electronic mails etc.
7.5: Documented Information

Creation Identification Classification Modification

Adequate
Approval Distribution Archiving
Use

Disposal

A procedure must be established to manage the document lifecycle.

Reference Documents

Training Records

Calibration Records

Organizational Knowledge

Inter Office Memo

Quality Documents & Records

 Clause 8
Operations
8.1: Operational Planning and
Control
INCLUDES:

• Determine requirements of products & services

• Establish acceptance Criteria

• Determine Resources needed to achieve conformity

• Implementing Controls as per specified acceptance Criteria

• Maintain Documented Information

8.2.1. Customer Communication
• The company communicates with customer
regarding information related to:

• Product specifications
• Order and contract requirements
• Customer feedback System (Improvement Suggestions)
• Customer complaints System (Nonconforming Product, Late
Delivery / Responses, Poor packaging, others.
8.2.3 Review Of Requirements
Related To Product
Review of Requirements

• Define and review Customer Requirements

• Analyze Organizational ability to meet the requirements

• Resolve Differences & conflicts

• Review of Contracts

• Maintain Documented Information

Clause 8.3: Design and Development of
Product or service
Design & Development Planning

Design & Development Inputs

Design & Development Control

Design & Development Outputs

Design & Development Changes

8.4 External provision of Good &
Service
1. Define purchase requirements

2. Product acceptance criteria

3. Inspection of purchased product

4. Conformance with purchase information

5. Criteria for supplier selection

6. Evaluation and Re-evaluation of suppliers

8.5 Control of Product & Service
Provision
• Product Planning & Specification

• Availability of Work Instructions

CONTROLS

• Use of Suitable Equipment

• In Process Monitoring

• Availability of monitoring equipment

• Maintenance of equipment

• Production & Service provision records

Clause 8.5.2: Identification &
Traceability

Inspection & Testing

Identification Traceability Status

Article #/Model #/ Lot #/Batch #/ Tags/Stickers/Trays for

Item #/Design # Serial #/Mfg. date rejected/reworked items
8.5.3: Property belonging to customer
& external providers
• It Includes;
• Materials, components, tools and equipment, premises, intellectual
property and personal data.

When the customer’s property is Lost, damaged or found to be unsuitable

for use;

1. Report this to the customer or external provider

2. Retain documented information on what has occurred.
8.5.4: Preservation

Identification

Handling

Contamination Control

Packaging & Storage

Protection

Transmission or Transportation
 Clause 8.5.5: Post delivery activities:
• The extent of post-delivery are based on;
• Potential undesired consequences associated with its products and
services;
• Nature, use and intended lifetime of its products and services;
• Customer requirements;

Post-delivery activities can include;

1. Warranty provisions,
2. Maintenance services,
3. Supplementary services such as recycling or final disposal.
 8.6: Release of product and Service
The organization shall retain the documented information on the
release of product and service showing;

1. Evidence of Conformity
with acceptance criteria

2. Traceability of person
RELEASE SLIP
authorizing the release Date
Product
Batch #
Batch Size
Remarks
Released By
8.7 Control Of Non Conforming
Product
a. Correction;

b. Segregation, containment, suspension of provision of products

and services;

c. Informing the customer;

d. Obtaining authorization for acceptance under concession.

8.7 Control Of Non Conforming
Product

The documented information must be retained which;

a) describes the nonconformity;

b) describes the actions taken;
c) describes any concessions obtained;
d) identifies the authority deciding the action in respect
of the nonconformity
Reference Documents

Customer Feedback and Complaints

Supplier Evaluation forms

Acceptance Criteria

Corrective Action Forms

QC Reports & Release label

 Clause 9
Performance Evaluation
Customer Satisfaction
1. Customer surveys
2. Customer feedback (on delivered products and services)
3. Meetings with customers
4. Market-share analysis
5. Complaints
6. Warranty Claims
7. Dealer reports.
Analysis & Evaluation
• Conformity of products and services;
• Degree of customer satisfaction;
• Performance and effectiveness of the quality management
system;
• Effectiveness of actions taken to address risks and opportunities;
• Performance of external providers;
• Need for improvements to the quality management system.
9.2: Internal Audit
The organization shall conduct internal audits at planned intervals to review the
effectiveness of QMS.
The audit programme include;
9.3: Management Review
MRM consideration:
a) Status of actions from previous management reviews;
b) Changes in external and internal issues that are relevant to the quality
management system;
c) Effectiveness of the quality management system (Customer Satisfaction, NC,
Corrective actions etc.)

d) Audit results;
e) Performance of external providers;
f) Adequacy of resources;
g) Effectiveness of actions taken to address risks and opportunities
h) Opportunities for improvement.
Reference Documents

Customer Feedback and Complaints

Internal audit records

MRM Records

Analysis reports
 Clause 10
Improvement
Nonconformity & Corrective Actions
Nonconformity

Correction Corrective Action (CA)

Root Cause Analysis

Corrective Action Taken

Deal with Consequence

Review of Effectiveness

Update Risk & Opportunities

Maintain Documented Maintain Documented

Information Information
Continual Improvement
Quality
Management
Objective
Review
s

Correctiv Data
e Actions Analysis

Quality
Audits
Hazard Identification, Risk
Assessment and Controls
• Establish, implement and maintain procedures for ongoing hazard
identification, risk assessment and determining necessary controls.
• Take into account
• Routine and non-routine activities
• Activities of all persons having access to workplace
• Human behavior, capabilities and other human factors
• Hazards outside of workplace but under control of organization
• Infrastructure, equipment and materials at workplace
• Design of workplace, processes etc.
Hazard
• Source, situation, or act with a potential for harm in terms of human injury or ill
health, or a combination of these.
Types of Hazards
• Following are major types of hazards;
• Physical

• Chemical

• Biological

• Psychological

• Ergonomic
Physical Hazards
• Physical Hazards include;
• Noise
• Vibration
• Lighting
• Electrical
• Heat / Cold
• Dust
• Fire/Explosion
• Machine Moving Parts
• Working Space
Chemical Hazard
• Chemical Hazards include;
• Gasses
• Fumes
• Vapours
• Liquids
Biological Hazards
• Biological Hazards include;

• Infections (bacterial/viruses)
• Allergic Response
• Ingested (via contaminated food)
Psychological Hazard
• Psychological Hazards include;
• Shift work
• Workload
• Harassment
• Discrimination
• Stress
Ergonomic Hazard
• Ergonomic Hazards include;
• Tool design
• Equipment design
• Job and Task Design
• Workstation design
• Manual Handling