ISO 9001-2015 QMS Awareness Training Presentation

Quality Management
ISO 9001:2015 System

Awareness Training

ISO 9001:2015 Awareness Training
Introduction
 Self Introduction
 Introduction from the participants

Objective
 Understand What is ISO 9001:2015
 Structure of ISO 9001:2015 Standard
 Requirements of ISO 9001:2015
 Implementation Methodology
My Current Knowledge
 What is ISO 9001 ?
 Why do companies implement ISO 9001 standard?
 What is quality ?
 Identify one most important parameter in your

process / organization you want to improve.
What is ISO 9001:2015?

What is ISO?
 Greek word which means “EQUAL”
 International Organization for Standardization
 Based in Geneva - Switzerland
 Global federation of more than 140 countries
 Define, draft, publish and revise standards
 Company → Certification body → Accreditation body → IAF

What is ISO 9001?
• ISO 9001 QMS (Quality Management System) ensures

consistency in business operations.
• Ensure customer satisfaction through continual improvement

in business processes / quality of product / services.
• Manage business risks effectively.
• Process based & measurable management system which

seamlessly merges with other system of the organization.
Evolution of ISO 9001

What is Quality?
 Each Participant to define “QUALITY”

What is Quality?
 Fitness for use
 Conformance to standard
 Totality of features and characteristics of a product

or service that bear on its ability to satisfy stated
and implied needs………
Stated Needs of the Customer

Implied Needs of the Customer

What is Quality Management System?
A formal methodology of
defining, documenting,
executing, monitoring and
improving various processes
of an organization to meet
stated and implied needs of
the customers and
stakeholders (interested
parties).
QMS is based on 7 Quality Management Principles

Quality Management Principles

Why ISO 9001 ?
Performance
People Process &
Productivity
• Enhanced risk management
• Bringing performance oriented work culture in the organization

Why ISO 9001 ?

Structure of ISO 9001:2015
 Based on Annex SL (HLS)

 An uniform high level structure common to all
management system standards from 2012 onwards.
 Consists of 10 clauses
 Requirements are from clause 4 to 10

ISO 9001:2015 Structure

ISO 9001:2015 Standard & PDCA

QMS – A Strategic Initiative
 ISO 9001:2015 must be considered as a strategic

decision to help an organization improve overall
performance.
 Must be led by Top Management
 Ensures QMS is everybody’s responsibility
 Align with other management systems of the

organization seamlessly.
ISO 9001:2015 Requirements

4. CONTEXT OF THE ORGANIZATION

Understand Context of the Organization
 Identify and define

 Business environment
 Organizational eco system
 Internal issues
 External issues
 Issues which are relevant to organization's purpose

and its strategic direction.
 Issues which will affect ability to achieve intended
results of QMS.
 Legal, technological, competitive, market, cultural,

social, economical can be example of external issues.
 Values, culture, knowledge, performance etc. can be

example of internal issues.
 These issues can be positive or negative.
 Determine what kind of risk do these issues create and

how organization can address them.
 Monitor and review information about context.

Internal issues & their impact / related risk

• Stability of workforce • High receivables
• Staff retention • Reducing market share
• Overall strength of business to
• Impact of unionization
support funding needs
• Staff competency levels • Relationship with investors
• Contractual arrangements with customer • Credit terms available
• Service level agreements with
• Payment terms from customers
customers
• Manual system of working / no
• Culture within the organization
automation
• Legacy software / not adequate for • Aging machinery / equipment /
changed business processes assets
External issues & their impact / related risk

• Political environment • Economic situation
• Social environment • Technological advancement in product

/ service / industry
• Legal, statutory and regulatory • Operating Permits becoming tighter on
emission levels
• Competitive environment • The nature and impact of economy on
market
• Customer demographic • General levels of consumer
confidence -
• Customer expectation • Trade associations and lobbying
powers -
• Price volatility of raw material • Oil price impact on transportation
• Oil price impact on overall economy • Change in customer expectations



Needs & Expectations of

Interested Parties
 Interested Parties : Individual, group or an organization that
gets affected, has a potential to get affected or considers
themselves to be affected by the organization’s operations
(Stakeholders)
 Interested parties impact organization’s ability to consistently

provide products and services meeting customer’s
requirements and applicable statutory / regulatory
requirements.

Interested Parties

Interested Parties
 Identity all relevant interested parties
 Identify needs and expectations of interested

parties.
 Impact in case they are not fulfilled / associated

risk.
 Regularly monitor and review information about

interested parties and their relevant requirements.
Example Needs & Expectations
Interested Party – Employees

 Needs & Expectations:
1. Professional & progressive work environment
2. Salary on time
 Impact if the needs and expectations are not

fulfilled:
1. Low employee morale
2. Reduced productivity
3. High employee turnover and poor staff retention
Example Needs & Expectations

Interested Party – Customers
 Needs & Expectations:
1. Ontime delivery
2. KPI adherence, Fulfilment of contractual deliverables
3. Good product/service quality
4. Customer support before, during and after purchase
 Impact if the needs and expectations are not fulfilled:
1. Loss of customer
2. Low customer retention / repeat purchase
3. Loss of market share
Scope of QMS
 Boundary of the QMS
 Locations, business divisions, services/product

category etc.
QMS & it’s Processes
What is a process?
Process
A set of interrelated activities that convert an input into an output

Identify Processes in your Dept.

Recruitment
Induction
HR Training
Performance
Appraisal
Exit
Process A
XYZ LTD
Operations
Process B
Purchase
Marketing
IT
How to define Process?
 Process A:
1. Process Input
1. Supplier, What is the input, How does input come /
Input Format
2. Procedure
3. Responsibility & Authority
4. Resources Required
5. Associated Risk
6. Process Output
1. Customer, What is the output, Output format
7. Process effectiveness parameters / performance
indicators
Example - Processes
 Management
Risk management, internal audit, management review, non-conformity
management, resource / budget planning and management
 HR
Recruitment, induction, training, performance appraisal, salary management, leave
management, exit
 Sales
Enquiry management, tender participation
 Purchase
Supplier accreditation, purchasing, supplier re-evaluation
 Operations/production/service
Service planning, service delivery, project planning, change management,
production planning, incoming inspection, final inspection, preventive
maintenance, calibration, software development, installation, logistics, customer
complaint management, outsourcing management
5. LEADERSHIP
Leadership and Commitment
 Top Management shall demonstrate leadership and

commitment:
• there is an emphasis on leadership, not just
management
• has to have greater involvement in the management
system
Quality Policy
 Commitment towards customer, employees,

continual improvement, applicable requirements.
 Quality Policy to be maintained as a documented

information
 Quality Policy to be communicated, understood and

applied within the organization.
 Quality Policy to be made available to relevant

interested parties.

Example – Quality Policy
XYZ
Organizational Roles, Responsibilities

and Authorities
 Top Management must define the structure, hierarchy, and
lines of reporting
 Must ensure that the duties, responsibilities, and authority of

all personnel are defined and communicated
6. PLANNING
Risks and Opportunities
 Identify risks and opportunities considering context

of the organization, interested parties, products and
services, processes etc.
 Address these risks so that :

 QMS can achieve desired results.
 Enhance desirable effects.
 Undesired effects can be prevented or reduced.
 Improvement can be achieved.
Risks and Opportunities
 Make plan actions to address the risks
 Integrate and implement these actions into QMS.
 Evaluate effectiveness of the actions taken.


Risk Management Framework

Risk Categorization
Risks & Opportunities - Example

 Risks:
 Old IT system resulting in loss of productivity
 No formal supplier accreditation process resulting in selection of bad suppliers and delay
in delivery of products / services
 No review of generated proposals by the manager before sending to the client resulting in
mistakes and lost of potential business opportunities.
 Reliance on only one supplier for mission critical raw material.
 Political instability in XXX region where company has 65% of the customer base
 New entrants in the market with better innovation.
 Changing regulatory requirements
 Constant increase in fuel prices has resulted in 20% increase in logistics costs and exports
unviable
 Opportunities:
 Launch of a new product/service resulting in higher market share
 Work flow augmentation resulting in cost optimization
Quality Objectives
 Establish SMART quality objectives.
Quality Objectives - Examples

 To improve sales revenue from XXXXX to YYYYYY by December 2022
 To provide a minimum of 20 hours of training to all the employees in

the year 2022
 To reduce customer complaints from X to Y by December 2022.
 To enhance customer satisfaction level form 90% to 95% by December

2022
 To improve online delivery performance from 80% to 90% by December

2022
 To reduce procurement cost per dollar earned from 35% to 30% by

December 2022
Quality Objectives Planning
 Make plan to achieve quality objectives considering:

 What to do
 What resources are required
 Responsibilities
 Timeliness
 How to evaluate results
Quality Objectives Tracking
 Track achievement against quality objectives and

take necessary actions.
7. SUPPORT
Competence , Awareness ,
Communication
 Competence
- Ensuring appropriate education, training, skills and
experience of all persons in the organization
 Awareness
- Ensuring all persons in the organization are aware on any
significant information about the QMS
 Communication
- The organization must decide what, when, with

whom, and how we will communicate both internally and externally
HR Related Documents
 Organization chart
 Roles, Responsibility & Authority for all the positions as per

the organization chart.
 Ideal competence identification for various positions.
 Competence Gap identification between ideal competence

and existing competence.
 Training calendar
 Training attendance records
 Training effectiveness evaluation records

Resources
 Control of Monitoring and Measurement Resources
- List of monitoring and measurement resources
- Proof of fitness, accuracy and suitability of monitoring
and measurement resources.
- Identification of calibration frequency wherever required
- Calibration Records
Documented Information
Terminologies
 Document
 Document can be changed (manual, SOP, work
instructions, flow charts, blank forms/templates, design,
codes, drawings etc.)
 Records
 Records can not be changed (when you fill in data into the
forms or templates or checklist, they become record)
Document Change Control

 A formal form to request change in the document
 A user raises a change request and sends it to the document controller
 Requested change(s) gets reviewed and approved by an appropriate authority
 Once approved, decision is communicated to the document controller and the

requester.
 Document controller in coordination with change requester / HOD / Top

Management carries out the change
 New document gets approved by an appropriate authority
 Revised document is issued to the user with updation of version no and effective
date on the document.
 Master list of document is updated to reflect relevant changes.

8. OPERATION
Requirements for Products and Services

Sales / Marketing / Business Development Related Documents
 Customer enquiry details
 Identification of legal / statutory / regulatory requirements

for customer enquiry.
 Some kind of document to check whether before accepting

order from the customer whether internal discussions took
place to determine company’s capability to meet customer
requirements.
 Customer perception determination, customer feedback &

it’s analysis
Design and Development of

Products and Services
Design & Development Related Records
 Design & Development Plan
 Design & Development Input
 Design & Development Control (Review, Verification

& Validation)
 Records of Design & Development Changes

Control of Externally Provided Processes,

Products and Services
Purchase / Procurement / Outsourcing Related Documents
 Supplier Accreditation, Registration & initial supplier evaluation – i.e.
details on the basis of which a supplier was selected.
 List of Approved Suppliers
 Supplier Re-evaluation
 Purchase Orders
 Incoming Inspection Plan and Incoming Inspection Records for

purchased products / services.
Production and Service Provision

 Plan for product or service realization i.e. what will be the
input, what will be the processing, what parameters will be
checked and who will approve final delivery of the product or
service.
 Production / service delivery plan.
 In process / final inspection quality plan / record.
 SOPs and Work Instructions / method statements wherever

required for important processes during product / service
realization.
Identification and Traceability

 Physical tags, Barcode Labels, Lot Numbering (Manufacturing Date)
Expiration Date if necessary
Preservation
 Include identification, handling, contamination control, packaging,
storage, transmission or transportation, and protection.
 Stock Rotation Methods such as First-In First-Out (FIFO)


Maintenance & Asset Management
 Preventive maintenance plan & records
 Breakdown maintenance records
Customer / External Provider Property

 Any material, components, tools, drawings, specifications, software,
equipment, premises, intellectual property, personal data etc. which
belongs to either customer / external provider to be controlled.
 If incorrectly used, lost, damaged or found unsuitable for use, it has to

be reported back to the external provider / customer and required
records maintained.
Release – Post Release
 Release authority for product / service / project
 Post release details
 Traceability related records
 Customer satisfaction if post release services are provided

Control of Nonconforming Outputs

 What is nonconformity?
 Deviation against customer requirements
 Deviation against internal QMS requirements of the organization
 Deviation against applicable legal / statutory / regulatory
requirements
 Deviation against ISO 9001 standard
 Noncompliance can be against process (internal / outsourced),

product or service (provided by external provider / produced
by the organization )
Control of Nonconforming Outputs
For every non-conformity / deviation / complaint ensure

the following:
 Correction – Immediate action / containment
 Root Cause Analysis – The reason
 Corrective Actions – Stop reoccurrence. Based on root cause
 Evaluation of effectiveness of corrective actions

Nonconformity Examples
 Rejection of product/service by the client due to quality issues
 Delay in product/service delivery
 Raw materials/products supplied by the suppliers are out of

specification and rejected by the QA team
 Customer complaints about unprofessional attitude of the

service technician during the onsite service.
Nonconformity Examples
Non-Conformity: Customer compliant about damaged

product received.
 Correction: Replace the product or offer refund
 Root Cause Analysis: Poor packaging. Packaging material is not

able to withstand the product weight.
 Corrective Action: Improve packaging to ensure it can sustain

the product weight and during transit the product does not get
damaged.
9. PERFORMANCE EVALUATION
Monitoring, Measurement,
Analysis and Evaluation
 determine what needs to be monitored and measured, how,
and when, as well as when the results to be analyzed
 Customer Satisfaction
 Monitor customer’s perceptions of the degree to which
their needs and expectations have been fulfilled
 Customer Satisfaction Survey
 Customer Feedback
 Issuance of Supplier Performance Evaluation
Internal Audit
 Conduct internal audits at planned intervals to determine:

 If QMS is effectively implemented and maintained
 QMS conforms to:
 Requirements of the organization
 Requirements of the ISO 9001 standard
 Requirements of the customers / interested parties
 Internal audit annual program

 Internal audit plan/schedule
 Internal audit report / summary / non-conformity report
Management Review
 Conducted at a regular interval
 Evaluate effectiveness, adequacy and suitability of the QMS
 Chaired by Top Management and attended by other Senior

Management
 Review Input (agenda) & review output (minutes/ action

plan/resources needed/improvement in QMS).
Management Review
 Standalone QMS specific Management Review
 Combine with other business reviews meetings.

Management Review Input
 Status of last Management Review Meeting
 Changes in context of the organization (external and internal issues)
 Changes in needs and expectations of the interested parties
 Effectiveness of the actions taken to address risks and opportunities
 New potential opportunities for improvement
 Adequacy of resources
Management Review Input

 Performance, effectiveness, trends and indicators for:
 Nonconformities and corrective actions
 Monitoring and measurement of process / products /
services
 Internal / external / customer / interested party audit results
 Customer satisfaction and feedback from interested parties
 Extent to which quality objectives have been met
 Customer complaints
 Performance of external providers
 Adequacy of resources
 Process performance and products / services conformity
10. IMPROVEMENT
Nonconformity and Corrective Action

Continual Improvement
 Determining, selecting and implementing opportunities for

improvement
 Provision of corrective action for any nonconformity or arising

from complaints
 Continual improvement for the suitability, adequacy and

effectiveness of the QMS
ISO 9001 Documentation Requirements

Success Factors
 Simple
 Employee Friendly
 Non-complicated, non-bureaucratic
 Lean & agile
 Focus on benefits and improvements
 Involvement and participation of everybody

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Quality Management

ISO 9001:2015 System

 Introduction from the participants

 Understand What is ISO 9001:2015

 Structure of ISO 9001:2015 Standard

 Requirements of ISO 9001:2015

 What is ISO 9001 ?

 Why do companies implement ISO 9001 standard?

 Identify one most important parameter in your

What is ISO 9001:2015?

 Greek word which means “EQUAL”

 International Organization for Standardization

 Based in Geneva - Switzerland

 Global federation of more than 140 countries

 Define, draft, publish and revise standards

 Company → Certification body → Accreditation body → IAF

What is ISO 9001?

• ISO 9001 QMS (Quality Management System) ensures

• Ensure customer satisfaction through continual improvement

• Manage business risks effectively.

• Process based & measurable management system which

Evolution of ISO 9001

 Each Participant to define “QUALITY”

 Fitness for use

 Totality of features and characteristics of a product

Stated Needs of the Customer

Implied Needs of the Customer

What is Quality Management System?

QMS is based on 7 Quality Management Principles

Quality Management Principles

Why ISO 9001 ?

• Enhanced risk management

• Bringing performance oriented work culture in the organization

Why ISO 9001 ?

Structure of ISO 9001:2015

 Based on Annex SL (HLS)

 Requirements are from clause 4 to 10

ISO 9001:2015 Structure

ISO 9001:2015 Standard & PDCA

QMS – A Strategic Initiative

 ISO 9001:2015 must be considered as a strategic

 Must be led by Top Management

 Ensures QMS is everybody’s responsibility

 Align with other management systems of the

ISO 9001:2015 Requirements

4. CONTEXT OF THE ORGANIZATION

Understand Context of the Organization

 Identify and define

 Issues which are relevant to organization's purpose

Understand Context of the Organization

 Legal, technological, competitive, market, cultural,

 Values, culture, knowledge, performance etc. can be

 These issues can be positive or negative.

 Determine what kind of risk do these issues create and

 Monitor and review information about context.

Internal issues & their impact / related risk

External issues & their impact / related risk

• Social environment • Technological advancement in product

• Oil price impact on overall economy • Change in customer expectations

Understand Context of the Organization

Understand Context of the Organization

Needs & Expectations of

 Interested parties impact organization’s ability to consistently