ISO 9001:2015
QUALITY MANAGEMENT SYSTEM
09 August 2023
Presented By: Mr. Ambadas Goli
1
ISO 9001:2015 (5th Edition)
ISO STANDS FOR
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION
 Non government organization established in 1947 , based in Geneva, Switzerland
 Has a membership of 160 national standards institutes from countries in all regions of the
world
 Why ISO 9001
 Global Recognition
 Improved Customer Satisfaction
 Improved the Efficiency & Effectives organisation processes.
 Periodic self & third party assessment
2
ISO 9001:2015 (5th Edition)
9001
IDENTIFICATION NUMBER OF THE STANDARD
2015
YEAR OF EDITION
3
TRANSITION PHASES OF ISO 9001
ISO 9001:1987
ISO 9001:1994
ISO 9001:2000
ISO 9001:2008
PROCEDURES
PREVENTIVE
ACTION
PROCESS
APPROACH &
PDCA
PROCESS
APPROACH,
PDCA
4
ISO 9001:2015
RISK BASED
THINKING
PREVENTIVE
ACTION
OTHER RELATED STANDARDS
There are many other standards in the ISO 9000 series that can help you reap the
full benefits of a quality management system and put customer satisfaction at the
heart of your business.
 ISO 9000 contains detailed explanations of the seven quality management
principles with tips on how to ensure these are reflected in the way you work. It
also contains many of the terms and definitions used in ISO 9001.
 ISO 9004 provides guidance on how to achieve sustained success with your
quality management system.
 ISO 19011 gives guidance for performing both internal and external audits of ISO
9001. This will help ensure your quality management system delivers on promise
and will prepare you for an external audit, should you decide to seek third-party
certification.
5
BENEFITS OF ISO 9001:2015
6
DEFINATIONS
 QMS : Organisational Structure , responsibilities , procedures & resources used to ensure
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products , process or services to satisfy stated or implicit need
Quality : The ability to satisfy the expectations of the customer
Quality Control : Defect Identification-activities to identify defects in actual products
Produced
Quality Assurance : Defect Prevention- Activities for ensuring quality in the process by which
products are developed
Process : Set of interrelated or interacting activities that use inputs to deliver an intended
result.
Non-conformity(NC) : Non-fulfilment of requirement.
Corrective Action : Action to eliminate the cause of a non-conformity to prevent its
recurrence"
Preventive Action: Action to eliminate the potential cause of a nonconformity to prevent its
occurrence"
Risk: The effect of uncertainty
Resource: Resource is the source of supply such as places, people or things which is useful or
can be transformed into more valuable and useful items
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QUALITY MANAGEMENT PRINCIPLES
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ISO 9001:2015-KEY POINTS
ISO 9001:2015
Number of clauses- 10 (High Level Structure)
Risk based thinking
No any mandatory requirement of MR (Replaced as Process Owners)
Evidence based decision making
TERMINOLOGY
Products and services
Documented information
Environment for the operation of processes
Monitoring and measuring resources
Externally provided products and services
9
HIGH LEVEL STRUCTURE(HLS)-10 CLAUSES
Purpose of HLS:
 Alignment of Management System
Standards.
 New Structure for Management System
Standards.
 Identical title & core text.
 Generic Basic Vocabulary.
 Common main structure, common subclauses, common terms & definition.
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PDCA CYCLE (Deming)
 PLAN : Establish the objectives of the system and its processes, and the
resources needed to deliver results in accordance with customers’ requirements
and the organization’s policies, and identify and address risks and opportunities.
 DO : Implement & control what was panned.
 CHECK : Monitor and (where applicable) measure processes and the resulting
products and services against policies, objectives, requirements and planned
activities, and report the results.
 ACT : Take actions to improve performance, as necessary.
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PDCA CYCLE (Deming)
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PROCESS APPROACH
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PROCESS APPROACH (EXAMPLE)
RISK
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SINGLE SUPPLY SOURCE
HIGH FRIEGHT COST
OPPORTUNITY
MULTIPLE SUPPLIER
DEVELOP NEARBY SUPPLIER
OUTPUTS
INPUTS
PROCEDURES
PURCHASE REQUISITION
MATERIAL SPECIFICATION
APPROVED SUPPLIER LIST
LEAD TIME
SUPPLIER CAPABILITY

PURCHASING
PROCESS
INTERELAATED ACTIVITIES
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STORAGE
INSPECTION & TESTING FACILITY
MANUFACTURING
FINANCE
VENDOR DEVELOPMENT
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RECIEPT OF MATERIAL AS
PER SPECIFICATION
ON TIME DELIVERY
REQUIRED QUANTITY
TEST CERTIFICATE
RISK BASED THINKING
RISK
Effect of uncertainty
UNCERTAINTY
 Lack of information - Quality of water in another pot?
 Poor understanding - How to do jump?
 Not sufficient knowledge - How much force is required?
 Consequence or likelihood - What if not able get in another pot?
RISK BASED THINKING
RISK
Effect of uncertainty
 Identify what the risks and opportunities are in your organization- this depends on
the context of your organization.
 Analyse and prioritize the risks and opportunities in your organization identify what is
acceptable and what is not.
 Plan actions to address the risks, can the risks be avoided, mitigated or eliminated?
 Take action and implement the plan to address the risks.
 Check the effectiveness of your plan
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RISK ANALYASIS EXAMPLE

Purchasing Process :
 RISK- Single Source Supplier
• Single Source supplier is wiped out by Natural disaster
 What is the impact?
• You are shut down.
 What is the likelihood?
• Unlikely
 How do you mitigate the risk?
• Find another supplier
• Revise product design to allow other options
• Purchase insurance that covers business interruption
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PROCESS APPROACH – PDCA - RISK ANALYSIS
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IN ISO 9001:2015 VERBAL FORM USED ARE
 “shall” indicates a requirement
 “should” indicates a recommendation
 “may” indicates a permission
 “can” indicates a possibility or a capability
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1. SCOPE
ISO 9001:2015 standard specifies requirements for a quality management system when an
organization:
A) Needs to demonstrate its ability to consistently provide products and services that meet
customer and applicable statutory and regulatory requirements
B) Aims to enhance customer satisfaction through the effective application of the system,
including processes for improvement of the system and the assurance of conformity to
customer and applicable statutory and regulatory requirements.
All the requirements of this International Standard are generic and are intended to be
applicable to any organization, regardless of its type or size, or the products and services it
provides
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2. NORMATIVE REFERENCES
The following documents, in whole or in part, are normatively referenced in this
document and are indispensable for its application. For dated references, only the edition
cited applies. For undated references, the latest edition of the referenced document
(including any amendments) applies.
The committee responsible for this document is Technical Committee
ISO/TC 176
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3. TERMS & DEFINATION
For the purposes of this document, the terms and definitions given in ISO 9000:2015 apply
22
4. CONTEXT OF ORGANIZATION
Context: The set of circumstances or facts that surround a particular event, situation etc.
 Address the internal & external issues:
• Determine the internal Issues
• Determine the external Issues
• Monitor & review these issues on regular basis
That affects the performance
(Intended Output)
External Issue
Internal Issue
Stringent Legal Compliances
High Cost of Compliance
Rapid Change in Technology
Lack of skilled Manpower
High Competition
Lack of awareness
Poor availability of resources
High employees turnover
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4. CONTEXT OF ORGANIZATION
 Understanding the need & expectations of Interested Parties (IPs):
• Interested Parties: Person or organisation that can affect, be affected by, or perceive
itself to be affected by a decision or activity.
Internal Interested Parties
External Interested Parties
EMPLOYEES
MANAGEMENT
TEAM
CONSUMERS
INTERNAL
INTRESTED
PARTIES
EXTERNAL
INTRESTED
PARTIES
TOP
MANAGEMENT
CONTRACTORS
REGULATORS
COMMUNITY
UNIONS
SUPPLIERS
COMPITITORS
BOARD OF
DIRECTOR
MEDIA
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4. CONTEXT OF ORGANIZATION
 Understanding the need & expectations of Interested Parties:
• Need: Necessity or obligation
• Expectations: A strong belief (associated with need)
Interested
Parties
Needs
Customers
products/services
as per
specification
Employees
Livelihood and fair
compensation
Regulatory
Compliance with
laws and
regulations
Expectations
• Timely delivery of high quality products/services
• Clear and effective communication throughout the customer journey
• Prompt resolution of customer complaints.
• Access to training programs and resources for skill enhancement and career
advancement
• Opportunities for promotion and professional growth
• Job security and stability through fair employment practices and policies.
• 100 % Compliance
• On time compliance
• Transparency of data or information
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4. CONTEXT OF ORGANIZATION
 Understanding the need & expectations of Interested Parties:
Interested
Parties
Regulatory
Needs
Expectations
Internal Issues
Compliance with
environmental
laws and
regulations
•100 % Compliance
• Non availability of skilled man
power
• Frequent changes in
rules & regulation
• Non availability of re-sources
• Stringent compliance
requirement
• On time
compliance
• Transparency of
data or information
External Issues
• Limitation of budget
• Delayed information
• Poor understanding of
requirement
•Poor communication with team
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4. CONTEXT OF ORGANIZATION
External Issues - Risk, opportunity, monitoring and control
Sr.
No.
External issues
Risk
Stakeholders
Monitoring and review
Responsibility
Opportunity
1.
Very limited project in
market to bid
Loss of business
Sales
Achievement of
budgetedsales from
new markets
Head Sales &
Proposal
2.
Impact of statutory
compliances –labour,
licenses,
 Penalty
 Non
Projects, HR
Maintain updated
statusspecific for
site location
Head HR &
Administration,Head
Projects
 Improved
Changes in applicable
Pollution control board
norms
Up gradation ,
validation of
technology
Loss of business
Projects, HR
Review scope
requirements
Head Sales
 Improved new business
Loss of business
Sales
Achievement of
sales withnew
technology
Maintain margin
Head Sales &
Proposal
Improved new business
Head Sales
&Proposal /CEO
Improved business
CEO,
All Function
Heads
Business continuity
Head Sales &
Proposal, Head
Finance
New business withimproved
margins
3.
4.
compliance
5.
Currency fluctuations
Low Sales realizations
Sales
6.
Unforseen events
Resource loss
Organization
 Emergency
preparednessplan
 Adequate
insurance
coverage
7.
Awareness of Forex in
customer country
Low margins
Sales, Finance
Maintain updated
status inclient
country
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Improved new business
compliance
adherence
 Reduce penalty
costs
with pricemargins
4. CONTEXT OF ORGANIZATION
Internal Issues - Risk, 0pportunity, Monitoring and Control
Sr.
No.
1
Internal issues
Risk
Stakeholders
 Penalty
2
(Workmen
compensation policy)
Delay / non receipt of
Workmen Contract Act
certificate
3
Product failure at site
 Resource loss
4
Awareness of terms and
conditions – taxation,
duties applicable (state
wise)
 Low margins
Unaware of new
technologies in market
Loss of business
Liquidated damages
due to delay in project
execution
Delay in engineering
document preparation
Loss of margins
Projects,
Finance
Delayed
approvals
Engineering,
Proposal
5
6
7
Projects, HR
 Non compliance
Monitoring and review
 Maintain updated status
specific for site location
 No. of instances of delay in
 Non compliance
receipt of certificate
Projects
No. of failures reported
QC
No. of vendors supplying
Purchase Proposal
products resulting in failures
No. of instances of non
Proposals,
Projects, Accounts compliances
Proposals
 No. of new technologies
identified
 Achievement of sales with
new technologies
 No. of instances damages
incurred
 Value of damages
Timely preparation of
engineering documents as per
MDL
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Responsibility
Head HR &
Administration,Head
Projects
Head Projects
Head QC Head
PurchaseHead
Sales & Proposal
Head Projects, Head
Finance
Head Sales &
Proposal
Head Projects,
Head Finance,
CEO
Head
Engineering,
Head Sales &
Proposal
Opportunity
 Improved
compliance
adherence
 Reduce penalty costs
Customer satisfaction
 Improved
compliance
adherence
 Improved margins
Improved new business
Improved business with
margins
On time project
completion
4. CONTEXT OF ORGANIZATION
Interested parties - Risk, Opportunity, Monitoring and Control
Interested
parties
Customer
Vendor
Third party
inspection
(TPI)
Identify Needs &
expectations
Risks
Stakeholders
Customer
dissatisfaction
Organization
Scope clarity of purchase
order alongwith approved
documents and payment
terms
Non fulfillment
of contract
requirements
Purchase,
Projects,
Design
 Clear purchase order
 Advance intimation
Non fulfillment
of contract
requirements
Project
QC
 Timely submission of
documents
 Timely deliveries
 Quality of products
 Good workmanship
 Timely execution
 After sales support
for inspection
Monitoring and review
 On time completion of
deliveries
 On time submission of
documents
 No. of complaints of
quality
 No. of complaints of
workmanship
 On time after sales
support provided
 delays in payments
 No. of Purchase Orders
without scope clarity
 No. of purchase order
 submitted without approved
documents
 No. of incorrect
Purchase Orders
submitted
 Instances of delay in
intimation of inspection
 No. of delay in
payments
 On time coordination
with client
 Approved document
with quality plan
 Timely
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Responsibility
Opportunity
Head Projects
Head Sales &
Proposal
Improved business
margins
Head Purchase,
Head Projects,
Head
Engineering
Cost reductions
Head Projects,
Head QC
Improved
business
4. CONTEXT OF ORGANIZATION
 Understanding the need & expectations of Interested Parties:
1. Determine Relevant
Interested Parties
4. Monitoring & Review
Of Needs &
Expectations On
Regular Basis
2. Determine Relevant
Needs & Expectations
3. Determine Which
Needs & Expectations
Are Compliance
Obligations
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4. CONTEXT OF ORGANIZATION
 Determining the Scope of Management System:
When determining this scope, the organization shall consider:
• External & internal
issues
• Requirement of relevant
interested parties
• Product & Services
• Physical & Functional
Boundaries
The scope of the organization’s quality management system shall be:
• Available at point of use
• Maintain as documented
information
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• Justify for any non
applicability
4. CONTEXT OF ORGANIZATION
 Management System & Processes:
 PROCESS : Set of interrelated or interacting activities that use inputs to deliver an
intended result (Output)
 PROCEDURE : Set of activities, in sequence, from input to output
EX: Purchase Order Creation
INPUT
Purchase Requisition
OUTPUT
Purchase Order
INTENDED OUTCOME
Right material in right time
PROCESS INDICATOR
Converting PR into PO within required
days
ACTIVITIES:
Purchase
Requisition
(INPUT)
Enquiry to
Vendors
Quotation
Comparative
Statement
Technical
Approval
Negotiation
Budget
Approval
PO Preparation &
Preparation
Review &
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PO
Review
PO Release
(OUTPUT)
4. CONTEXT OF ORGANIZATION
4.4 Quality Management & its Processes:
Supplier, Input, Process, Output, Customer (SIPOC) Sheet
Department- QA
Input from
Input
(S)
(I)
RM Suppliers Material, QA report
Production
Control plan /
Drawings / WI
Production
Dispatch plan,
Materials from
Production, Control
Plan
Process/Sub
Process
(P)
Resources
Inward
Inspection
Measuring
instruments,
manpower,
communication
facility
Inprocess
Inspection
Measuring
instruments,
Inspector
Final
Inspection
Measuring
instruments,
manpower,
communication
facility
Output
Output to
(O)
(C)
QA report
Stores ,
production
Control
Measurement
Monitoring
Receiving Inspection
report, Work
Instruction/SOP
No of incidents of
incoming material
rejection in production
Daily
In-process PPM
Daily Monitoring
Final PPM
Daily Monitoring
Setup Approval
Setup Approval Report,
Report, In-process
In-process inspection
Inspection report, Production
report, In-process
In-process Rejection
Rejection report,
report.
Final Inspection Quality
Dispatch plan, Control plan, SOP,
WI
Final Inspection
Report, PDIR
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5. LEADERSHIP
5.1.1 Leadership & Commitment : Top Management shall
 Take accountability for effectiveness of QMS
 Define policy & Objectives
 Communicate importance of requirements of QMS
 Integration of QMS requirements into business process
 Use of process approach & risk based thinking
 Engage, direct & support persons to contribute to the effectiveness of QMS
 Provide resources & promote continual improvement
 Ensure that QMS achieved its intended outcome
 Support other management roles to demonstrate their leadership
TOP MANAGEMENT
DEFINE POLICY
PROVIDE
RESOURCES
SET OBJECTIVE
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MANAGEMENT
REVIEW
5. LEADERSHIP
5.1.2 Customer Focus :
Top management shall demonstrate leadership and commitment with respect to customer
focus by ensuring that:
a) Customer requirements & applicable statutory and regulatory requirements are
determined, understood and consistently met
b) The risks and opportunities that can affect conformity of products and services and the
ability to enhance customer satisfaction are determined and addressed
c) The focus on enhancing customer satisfaction is maintained
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5. LEADERSHIP
5.2 Quality Policy :
 Policy- Intention & direction of an organization as formally expressed by top management
Top management shall establish, implement and maintain a Quality Policy that :
1) Appropriate to context of the organization & Support its strategic direction
2) Provide basics to the objectives
3) Commitment to continual improvement
4) Commitment to satisfy applicable requirement (Related to Product / Service)
Quality Policy Shall be :
1) Maintain as documented information
2) Communicate & understood within organization
3) Available to relevant interested parties
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5. LEADERSHIP
QUALITY POLICY
Ion Exchange Projects & Engineering Management is committed to sustain and enhance
satisfaction of its customers, interested parties and to exceed their expectations by
 Continuous endeavours to process and service improvements through standardization, value
engineering and reengineering.
 Being responsive to the external and internal issues which influence our origination
performance.
 Installing a culture of risk based thinking in the organisation.
 Establishing quality objectives in line with strategic direction of the organization.
 Ensuring effective implementation and continuous improvement of quality management
system though periodic reviews
 Monitoring & measuring the achievement of quality objectives and processes for increased
efficiency and productivity
 Achieving employee satisfaction by providing resources, training and healthy work
environment.
 Ensuring compliance to the applicable statutory and regulatory requirements.
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5. LEADERSHIP
5.3 Organizational roles, responsibilities and authorities :

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
Role: Designation or Position
Responsibilities: The duty assigned to a position
Authority: Power assigned to a position
Top management shall ensure :
1) Different roles are defined
2) Responsibilities and authorities are assigned
3) Communicated & understood
4) Assigning responsibility & authority for reporting on performance of the management
system
5) Assigning responsibility & authority for reporting on opportunities for improvement
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6. PLANNING
6.1 Actions to address risks and opportunities
Sr.
No
Risk
Impact resulting
failure
Are current
controls
adequate
Y/N
Current controls
Additional controls required
Opportunity
PROJECTS
1
No scope clarity in
customer
requirements eg.
termination points
/MOC/detailed
specifications of
material &
equipment, statutory
requirement of
Project & Project site.
 MOC change
 Delay in
engineering.
 Delay in Handing
over the plant.
 Cost implication.
 Delay in execution
 Identify gaps in specifications/scope
and get resolution from Proposal or
decide
 Extra claim to be submitted to client
for identified cases.
 Review with seniors (Head – Field,
Logistic, Stores, Project, Finance &
Procurement).
 Review of Techno
commercial prior to
bidding.
 Review of Techno
commercial before LOI.
N
 Incur LD
 Cost reduction
 Cost controls
 Support delayanalysis and
delivery extension
 Updated vendor list (internally
2
Non availability
ofsufficient
vendor options
 Cost implication
 Delayed delivery
 Quality issues
 Alternate vendor
credentials are sent and
approved through
customer
approved by IEI) to be quarterly
circulated to proposal for making part
of new bids
 Still, any additional vendor
approval to be expedited
N
 Establish Approval protocol with
 Master drawing list with
3
Delay in Engineering
document approval
from customer
 Resource loss
 Cost implication
 LD cases
customer to fit in with L2 schedule
monitoring
 Project review meetings
with focus on Engineering
 Cost control
 Timely delivery
 Better quality control
 L2 schedule to be monitored to avoid
N
slippages Maintain documentary evidence
of delays from customer
 Force approval across the
 Follow up for timely Pos
and vendor
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Project completion ontime
Timely delivery
Cost control
6. PLANNING
6.2 Quality objectives and planning to achieve them:
 Objective : Something aimed to achieve
 Target : Measurable part of the objective
The Quality Objective shall be:
 Consistent with policy
 Measurable
 Monitored on regular basis
 Communicate
 Update as appropriate
 Maintain documentation
40
6. PLANNING
6.2 Quality objectives and planning to achieve them
Sources of setting objective:
 Product & Service
 Legal & Other
 Risk & Opportunity
Planning to achieve objective:
 What will done
 What resources will be required
 Who will be responsible
 When it will be completed
 Update as appropriate
 How the results will be evaluated
41
6. PLANNING
6.2 Quality objectives and planning to achieve them
Specific
Measurable
Achievable
42
Relevant
Time Based
6. PLANNING
6.2 Quality objectives and planning to achieve them:
Examples: Quality Objective
 To increase sales turn over 15 Cr/Month to 25 Cr/Month by March 2024
 To improve OEE from 60% to 85% by by March 2024
 To reduce water consumption from 50 KL/MT to 30 KL/MT by by March 2024
 To reduce NC product generation from 5 % to 1 % by by March 2024
 To generate waste generation from 20 Kg/MT to 5 Kg/MT by by March 2024
 To develop 5 new vendors from domestic market by by March 2024
 To achieve Zero accident by by March 2024
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6. PLANNING
6.3 Planning of changes :
When the organization determines the need for changes to the quality management
system, the changes shall be carried out in a planned manner (4.4)
The organization shall consider:
Identify the need for change
Identify purpose of change & its Consequences
Ensure QMS Integrity
Assign resources
Identify & communicate changes & responsibilities
Implement the changes
Ensure effectiveness of changes implemented
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7. SUPPORT
7.1.1 & 7.1.2: General Resources & People
45
7. SUPPORT
7.1.1 & 7.1.2: General Resources & People
Man
Method
Machine
Resources
Measurement
Material
Mother Earth
Money
46
7. SUPPORT
7.1.3: Infrastructure- The organization shall determine, provide and maintain the
infrastructure necessary for the operation of its processes and to achieve
conformity of products and services
47
7. SUPPORT
7.1.3: Infrastructure-
Information Technology
Transportation
Utilities
Equipment-Hardware
Equipment-Software
Buildings
Communication Technology
48
7. SUPPORT
7.1.3: Infrastructure
PREVENTIVE MAINTENANCE
BREAKDOWN MAINTENANCE
49
PREDICTIVE MAINTENANCE
7. SUPPORT
7.1.4 Environment for the operation of processes :
The organization shall determine, provide and maintain the environment necessary
for the operation of its processes and to achieve conformity of products and
services. A suitable environment can be a combination of human and physical
factors, such as:
 Social (e.g. non-discriminatory, calm, non-confrontational)
 Psychological (e.g. stress-reducing, burnout prevention, emotionally protective)
 Physical (e.g. temperature, heat, humidity, light, airflow, hygiene, noise)
50
7. SUPPORT
7.1.4 Environment for the operation of processes :
51
7. SUPPORT
7.1.4 Environment for the operation of processes :
52
7. SUPPORT
7.1.5.1 Monitoring and measuring resources : General
The organization shall ensure that the resources provided


Are suitable for the specific type of monitoring and measurement activities being
undertaken
Are maintained to ensure their continuing fitness for their purpose
The organization shall retain appropriate documented information as evidence of fitness
for purpose of the monitoring and measurement resources
53
7. SUPPORT
7.1.5.1 Monitoring and measuring resources : General
Gold Shop
Vegetable Shop
Highly Precise
Highly Accurate
Less Precise
Less Accurate
54
7. SUPPORT
7.1.5.2 Measurement Traceability
Suitable Type
Fit For
Measurement
Re-Calibrate
when Repaired
Safeguard From
Adjustment
Acceptance
Criteria
Identification
55
Frequency Of
Calibration
7. SUPPORT
7.1.6 Organizational Knowledge:
The organization shall determine the knowledge necessary for the operation of its
processes and to achieve conformity of products and services
Organizational knowledge can be based on:
 Internal sources (e.g. intellectual property; knowledge gained from experience; lessons
learned from failures and successful projects; capturing and sharing undocumented
knowledge and experience; the results of improvements in processes, products and
services)
 External sources (e.g. standards; academia; conferences; gathering knowledge from
customers or external providers)
56
7. SUPPORT
7.2 Competence:
57
7. SUPPORT
7.2 Competence:
Education
Training
Skill
58
Experience
7. SUPPORT
7.2 Competence:
• Identify People who affect requirements
• Define minimum level of competency
• Check actual competency against minimum requirement
• Determine gap in competency (Training need & Identification)
• Prepare Training Plan
• Conduct training as per plan & check effectiveness
• Check & verify the effectiveness of training taken
• Update the Actual competency level
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7. SUPPORT
7.3 Awareness: The organization shall ensure that persons doing work under the
organization’s control are aware of
• Quality Policy
• Relative Quality Objectives
• Employees contribution for effectiveness of QMS & improved
Performance
• The implication of not confirming to QMS requirements
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7. SUPPORT
7.4 Communication: The organization shall determine the internal and external communications
relevant to the quality management system, including:
Ex- HR Policy
How
 What to communicate- HR Policy
With
Whom
What
 When to communicate- @ Joining
Communication
 How to communicate- Induction Training
Who
 Who will communicate- HR Department
When
 With whom to communicate- New Joining
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7. SUPPORT
7.5 Documented Information:
Documented Information- Examples












Scope
Policy
Objectives
Risk & opportunity
Compliance Register
Quality Manual
Procedures
Work Instructions
Checklists
Vendor List
Production Report
Calibration Report
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7. SUPPORT
7.5 Documented Information: Documented information shall be
• Indentified (Title, Date, Author, Document number, Revision Number)
• Storage & Preservation, including preservation of legibility
• Control of changes
• Retention & disposition
• Available at point of use
• Protected from loss of confidentiality
• Control of distribution of external origin documents
63
7. SUPPORT
7.5 Documented Information:
Retrieval
Disposal
Documented
Information
Retention
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Access
8. OPERATION
8.1 Operational planning and control:
The organization shall plan, implement & control the processes by:
 Establishing criteria for the processes & the acceptance of products and service
 Determine resources needed to achieve conformity to the product and service requirements
 Implementing control of the processes in accordance with the criteria
Department
Maintenance
QC
Activities
• Breakdown Maintenance
• Preventive Maintenance
• Calibration of Instruments
• Incoming Material Inspection
Purchase
• Vendor development & evaluation
• Procurement
Marketing
• Enquiry handling
• Customer Satisfaction survey
Production
• Manufacturing
• Handling of NC Product
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8. OPERATION
8.1 Operational planning and control:
 Determining, maintaining and retaining documented information to the extent necessary
 To have confidence that the processes have been carried out as planned;
 To demonstrate the conformity of products and services to their requirements
 The output of this planning shall be suitable for the organization’s operations
 The organization shall control planned changes and review the consequences of
unintended changes, taking action to mitigate any adverse effects, as necessary
The organization shall ensure that outsourced processes are controlled
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8. OPERATION
8.2.1 Customer Communication:
Product
Boucher
Enquiry
Handling
Complaint
& Feedback
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Customer
Property
Risk
Assessment
8. OPERATION
8.2.2 & 8.2.3 Determine & review the requirements for products and services:
a) the requirements for the products and services are defined, including:
1) any applicable statutory and regulatory requirements
2) those considered necessary by the organization
b) the organization can meet the claims for the products and services it offers
Product
• Product Name, Grade / Quality, Quantity
Delivery
• Location, Date of Delivery, Vehicle for delivery
Packing
• Labelling instruction, Packing Material
Post Delivery
Services
Other T&C
CUSTOMER REQUIREMENT
CUSTOMER DOES
NOT DEFINE
• Installation, Testing, Commissioning, Warranty
• Commercial terms, Legal obligations, Disposal Requirements
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EVERY
REQUIREMENT
8. OPERATION
8.2.4 Changes to requirements for products and services:
CHANGES BY
CUSTOMER
CHANGES IN
INTERNAL
DOCUMENTS
ACKNOWLEDGMENT
TO CUSTOMER
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MAKE PEOPLE
AWARE ABOUT
CHANGES
8. OPERATION
8.3 Design & Development of Product & Services:
The organization shall establish, implement and maintain a design and development process
that is appropriate to ensure the subsequent provision of products and services.
• Design & Development Planning
• Design & Development Input
• Design & Development Controls
• Design & Development Output
• Design & Development Changes
The organization shall retain documented information on D&D changes, result of reviews,
authorization of changes & action to prevent its adverse impacts.
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8. OPERATION
8.4 Control of externally provided processes, products and services:
The organization shall ensure that externally provided processes, products and services
conform to requirements.
Confirmation of
Requirements
Externally Provided
Product
Externally Provided
Processes
(Raw Material)
(Outsource Activity)
Raw Material become part
of product
Out-sourced activity is
performed on part of
product
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Externally Provided
Service
(Third Party Inspection /
Calibration)
3rd Party Activity
8. OPERATION
8.4 Control of externally provided processes, products and services:
Define criteria for selection
Selection of Vendor
Monitor the performance of Vendor
Re-evaluate on regular basis
Initiate action based on evaluation result
Maintain record of evaluation & action taken
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8. OPERATION
8.4.3 Information for external providers: The organization shall communicate to external
providers its requirements for
• Product & Services
• Specification / Acceptance criteria
• Method of approval
• Delivery requirements -Quantity, Date, Location, Packing
• Competency Requirements
• Communication at various stages
• Verification & verification at supplier end
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8. OPERATION
8.4.3 Information for external providers: The organization shall communicate to external
providers its requirements for
Product & Services
Specification / Acceptance criteria
Method of approval
Delivery requirements -Quantity, Date, Location, Packing
Competency requirements
Communication at various stages
Verification & verification at supplier end
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8. OPERATION
8.5.1 Control of production and service provision: The organization shall implement
production and service provision under controlled conditions. Controlled conditions shall
include, as applicable:
• Availability of document that define Product or Service characteristics
• Availability of document that define Product or Service requirements
• Availability of suitable measuring / monitoring resources
• Monitoring & measurement planning
• Use of suitable infrastructure & environment for the operation
• Implementation of actions to prevent human errors
• Appointment of competent manpower
• Validation & periodic re-validation of the ability to achieve planned results
• Implementation of release, delivery & post delivery activities
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8. OPERATION
8.5.1 Control of production and service provision:
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8. OPERATION
8.5.2 Identification & Traceability:

The organization shall use suitable means to identify outputs when it is necessary to
ensure the conformity of products and services

The organization shall identify the status of outputs with respect to monitoring and
measurement requirements throughout production and service provision

The organization shall control the unique identification of the outputs when traceability is
a requirement, and shall retain the documented information necessary to enable
traceability
Raw
Material
Maintain Record Of Batch Number / Lot number
Product Traceability
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Final
Product
8. OPERATION
8.5.3 Property belonging to customers or external providers:
 The organisation shall
• Exercise Care When
belonging to organisation
• Identify, verify, protect &
safeguard during use
• Return to customer /
External provider
 Organisation shall inform to customer / external provider & maintain record when gets
• Lost
• Damage
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• Not suitable
8. OPERATION
8.5.4 Preservation:
The organization shall preserve the outputs during production and service provision, to
the extent necessary to ensure conformity to requirements
 Preservation can include:

Identification

Handling

Contamination Control

Packaging & Storage

Transportation

Protection
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8. OPERATION
8.5.5 Post Delivery Activities:
To determine extent of Post delivery activities required, organization shall consider :
Statutory and regulatory requirements
The potential undesired consequences associated with its products and services
The nature, use and intended lifetime of its products and services
Customer requirements
Customer feedback
80
8. OPERATION
8.5.5 Post Delivery Activities:
Post-delivery activities can include
Actions under warranty provision
Contractual Obligations- Maintenance Services, Installation, Commissioning etc
Supplementary Services- Recycling / Final Disposal
Installation
Commissioning
Demonstration
Maintenance /
Repair
Market Return
Feedback
Complaint
Handling
Servicing
Product Recall
Recycling
Disposal
Legal & other
requirement
81
8. OPERATION
8.5.6 Control of Changes:
 The organization shall review and control changes for production or service provision, to the
extent necessary to ensure continuing conformity with requirements.
The organization shall retain documented information describing the results of the review of
changes, the person(s) authorizing the change, and any necessary actions arising from review.
Man
Machine
Measurement
6M
Material
Method
Mother Earth
82
8. OPERATION
8.6 Release of products and services:
 The organization shall implement planned arrangements, at appropriate stages, to verify
that the product and service requirements have been met.
 The release of products and services to the customer shall not proceed until the planned
arrangements have been satisfactorily completed, unless otherwise approved by a relevant
authority and, as applicable, by the customer.
Final Product
OK
Meets
Requirements
Under Deviation
Need Customer Approval
Release of the Product
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8. OPERATION
8.6 Release of products and services:
 The organization shall retain documented information on the release of products and services.
The documented information shall include
1. Evidence of conformity with the acceptance criteria
2. Traceability to the person(s) authorizing the release
84
8. OPERATION
8.7 Control of non-conforming Outputs:
 The organization shall deal with nonconforming outputs in one or more of the following
ways
• Correction
• Segregation, containment, return or dispose
• Informing to customer
• Obtaining authorization for acceptance under concession
Conformity to the requirements shall be verified when nonconforming outputs are corrected
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8. OPERATION
8.7 Control of non-conforming Outputs:
 The organization shall retain documented information that:
1
2
• Describes the actions taken
• Describes the non-conformity
• Describes the concession
obtained
• Identify the person authorised
to decide the action against NC
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NON-CONFIRMITY (NC) & CORRECTION
Non- Conformity (NC):
Non-fulfilment of requirement
Examples1. Complaint from the Customer
2. Deviation of effluent discharge quality / quantity
3. Fire event in the factory
4. Rejection of product by quality control
Correction:
Action to eliminate the NC
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ROOT CAUSE ANALYSIS
ROOT CAUSE ANALYSIS
Is the process of discovering the root causes of problems in order to identify appropriate
solutions. There are number of RCA tools.
 Fault Tree Analysis
 Cause & effect diagram
 Brainstorming
 Pareto Analysis
 Tree Diagram
 Process Map
 5 Why analysis
 Scatter Diagram
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PREVENTIVE ACTION AND CORRECTIVE ACTION
Preventive Action:
Action to eliminate the potential cause of a nonconformity to prevent its occurrence
PREVENTIVE
CORRECTIVE
Corrective Action:
Action to eliminate the cause of a nonconformity to prevent its recurrence
89
9. PERFORMANCE EVALUATION
9.1.1 Monitoring, Measurement , Analysis and Evaluation : General
 Monitoring: Process to determine the status of a system or a process or an activity
(Qualitative term)
 Measurement: Process to determine value .
(Quantitative term)
 Analysis: A set of technique to examine trend & make conclusion based on trend
 Evaluation: The action to compare process output against set criteria in order to determine
conformity.
90
9. PERFORMANCE EVALUATION
9.1.1 Monitoring & Measurement , Analysis and Evaluation : General
Quality
What to Monitor & Measure
When to Monitor & Measure
How to Monitor & Measure
• pH
• After Distillation
• pH Meter
• Colour
• TDS
• Physical
• Every Hour
• Comparison
• Acid Value
• Purity
•Titration
• Before Dispatch
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• Test Certificate
9. PERFORMANCE EVALUATION
9.1.2 Customer Satisfaction:
Customers perceptions of the degree to which their needs and expectations have been fulfilled.
 Examples of monitoring customer perceptions can include:
Surveys
Market Share
Analysis
Feedback
Customer
Satisfaction
Dealers Report
Customer
Meet
Customer
Complaint
Warranty
Claims
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9. PERFORMANCE EVALUATION
9.1.2 Customer Satisfaction:
.
Less Question & Easy to Understand
Expect Answer in Rating
Person name who gives the rating
Frequency
Compile data & information
Analysis & identify opportunity
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9. PERFORMANCE EVALUATION
9.1.3 Analysis & Evaluation:
The organization shall analyze and evaluate appropriate data and information arising from
monitoring and measurement. The results of analysis shall be used to evaluate
• Conformity of product & services
• Degree of customer satisfaction
• Performance & effectiveness of QMS
• Effectiveness of planning implemented
• Effectiveness of action for risk & opportunity
• Effectiveness of action for risk & opportunity
• Need for improvements to the QMS
94
9. PERFORMANCE EVALUATION
9.1.3 Analysis & Evaluation:
DEPARTMENT
PRODUCTION
QUALITY
MAINTAINANCE
PURCHASE
SAFETY
PERFORMANCE INDICATOR
PRODUCTION PLAN VS ACTUAL
OVERALL EQUIPMENT EFFECTIVENESS (OEE)
CUSTOMER COMPLAINTS
REJECTION PPM
PM PLAN VS ACTUAL
MTBF , MTTR
SUPPLIER REJECTION PPM
ON TIME DELIVERY (LEAD TIME)
LOST TIME INJUREY
REPORTED INCIDENTS
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Audit
AUDIT
Systematic, independent and documented process for obtaining objective evidence &
evaluating it objectively to determine the extent to which audit criteria are fulfilled
Obtaining evidences
Evaluating audit criteria
Determining extent of requirements
FULFILLED
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Types of Audit
TYPES OF AUDIT
First Party
Audit
Second Party
Audit
Third Party
Audit
INTERNAL AUDIT
SUPPLIER AUDIT
CERTIFICATION AUDIT
97
9. PERFORMANCE EVALUATION
9.2 Internal Audit:
INTERNAL AUDIT: Internal audit is an audit conducted by auditors who are employed by the
organization being audited but who have no vested interest in the audit results of the area
being audited.
WHY TO CONDUCT INTERNAL AUDIT
The organization shall conduct internal audits at planned intervals to
 Confirm :
 Organizational own requirements for its QMS
 Requirements of QMS
 Effectively implement & maintained the QMS
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9. PERFORMANCE EVALUATION
9.2 Internal Audit: The organization shall:
• Plan, Implement & maintain audit programme
• Define audit criteria & scope of audit
• Select auditors & conduct audit
• Audit result are reported to relevant Management
• Take appropriate correction & corrective actions in defined time interval
• Retain documented information as evidence of effective implementation
of audit programme & the audit results
99
9. PERFORMANCE EVALUATION
9.3 Management Review : General
Top management shall review the organization’s QMS, at planned intervals, to ensure its
continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the
organization
WHO
Top Management
WHEN
Planned Interval
WHY
Ensure continuing suitability, adequacy & effectiveness
100
9. PERFORMANCE EVALUATION
9.3.2 Management Review Input
The management review shall be planned and carried out taking into consideration :
The status of actions from previous management reviews
Changes in external and internal issues that are relevant to the quality management
system
The adequacy of resources
The effectiveness of actions taken to address risks and opportunities
Opportunities for improvement
101
9. PERFORMANCE EVALUATION
9.3.2 Management Review Input:
The management review input shall consider performance and effectiveness of the QMS:
• Customer satisfaction & feedback from all the interested parties
• The extent to which quality objectives have been met
• Process performance & conformity of products & services
• NC & Corrective actions
• Monitoring & measurement result
• Audit results
• Performance of external provider
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9. PERFORMANCE EVALUATION
9.3.3 Management Review Output:
The outputs of the management review shall include decisions and actions related to:
Management Review Output
Opportunity
for
Improvement
Need of
Change in
QMS
Resource
Needed
The organization shall retain documented information as evidence of the results of management
reviews
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10. IMPROVEMENT
10.1 Improvement: General
The organization shall determine and select opportunities for improvement and implement
any necessary actions to meet customer requirements and enhance customer satisfaction.
These shall include:
2
1
• Current product & services
• Future needs & expectations
• Correcting, preventing or
reducing undesirable effects
• Improve the performance &
effectiveness of QMS
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10. IMPROVEMENT
10.2 Non-conformity & corrective action:When a nonconformity occurs, including any arising
from complaints, the organization shall
• Take action to control & correct it
• Deal with consequence
• Analyse & determine the cause(s) of NC
• Determine if similar NC have occurred or could potentially occur
• Take corrective action
• Review the effectiveness of corrective action taken
• Update risk & opportunities if necessary
• Change in QMS if necessary (Update relevant document & provide training)
• Communicate lesson learnt with relevant interested parties
• Retain documented information as evidence of NC & result of corrective action taken
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10. IMPROVEMENT
10.2 Non-conformity & corrective action: Example
Non conformity (NC)
Correction
Corrective Action
Non fulfillment of the
requirement
Action to eliminate the
NC
Action to eliminate the cause
of NC (Detected)
Fire Incident (NC)
Use of power
extinguisher
Investigation of fire incident
resulting detection of mouse as
root cause
Root cause- Mouse
Corrective Action taken:
a) Cage to catch mouse
b) Pest control
c) Sealing Wholes
d) Cat
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10. IMPROVEMENT
 10.3 Continual improvement : In a continual improvement approach, there will be
phases where there will be improvements and a break to evaluate the success, after
which further improvements are made.
 The organization shall continually improve the suitability, adequacy and effectiveness of
the quality management system.
 As part of continual improvement organisation shall consider:
• Audit findings
• Corrective Action
• Result of analysis & evaluation of (Clause 9.1.3)
• Output of Management Review Meeting
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10. IMPROVEMENT
108
THANK YOU
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