QMS 9001-2015 Quality Management System BASIC

To enable the participants to understand the basics of Quality Management System is all about

1. QUALITY MANAGEMENT SYSTEM
ISO 9001: 2015

2. 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

3. Section I
Basic Concepts: Quality

4. 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)

5. What Is Quality?
QUALITY IS CONSISTENCY
OR
ABSENCE OF VARIATION
OR
DOING RIGHT THE FIRST TIME
OR
CUSTOMER SATISFACTION
OR
MEETING SPECIFIED REQUIREMENTS

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





QC-1

Process
A
QC-2

Process
B
QC-3

Process
C
QC-4

7. 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.

8. 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.

9. 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.

10. Quality Management (QM)
Quality Management includes all the coordinated activities to
direct and control an organization with regard to quality

11. 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

12. Cost of Quality




Cost of
Poor
Quality
(CoPQ)


Cost of
Quality


Cost of
Good
Quality
(CoGQ)

13. Cost of Quality (CoQ)

14. 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
FAILURE COST
1. Scrap & Rework
2. Re-testing
3. Downtime
4. Delays
EXTERNAL FAILURE
COST
1. Warranty Costs
2. Customer Complaints
3. Loss of Business
4. Returned Material / Products

15. Quality Management Principles










Quality Principles



4. Process
Approach

16. Quality Management Principles



Quality Principle Benefits Applicable Clause
Customer Focus 1. Increased Customer Loyalty Leading to repeat business
2. Increased Revenue & Market Share
5.1.2
Customer Focus
Leadership 1. Motivation of people towards achievement of goals.
2. Providing people with required resources, training and
empowerment.
5.1
Leadership &
Commitment
Engagement of
People
1. Motivation, Commitment and involvement, of people.
2. Accountability of their performance
7.1.2
People
Process Approach 1. Lower costs & shorter cycle times through effective resource
management.
2. Focusing on factors (resource, methods & material) that will improve
key activities.
4.4.1
QMS & Its Processes

17. Quality Management Principles



Quality Principle Benefits Applicable Clause
Improvement 1. Performance advantage through increased organizational abilities.
2. Flexibility to react quickly to opportunities.
10
Improvement
Evidence based
Decision Making
1. Informed Decisions
2. Making decision and taking action based on factual analysis.
9.1.3
Improvement
Relationship
Management
1. Increased ability to create value for both parties.
2. Clear and open communication
3. Optimization of cost and resources.
8.4
Control of externally
provided product and
service

18. Section II
ISO 9001:2015 Requirements

19. ISO 9001:2015 Structure


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

4.1 Understanding
the organization &
its context

5.1 Leadership &
Commitment
6.1 Action to
address Risk &
Competence

7.1 Resource

8.1 Operational
planning & control
9.1 Monitoring,
measurement,
analysis and
evaluation

10.1 Nonconformity
& Corrective action


4.2 Understanding
Needs &
Expectations of
interested Parties


Scope of QMS



Quality Management
System

5.2 Quality/ Policy


5.3 Organizational
roles,
responsibilities &
authorities
6.2 Quality
Objectives


6.3 Planning of
changes

7.2 Competence



7.3 Awareness



7.4 Communication

8.2 Requirements for
products & service


8.3 Design &
Development


8.4 Control of
Externally Provided
products/ Service

9.2 Internal Audit



9.3 Management
Review
10.2 Continual
Improvement

7.5 Documented
Information
8.5 Product & Service
Provision


8.6 Release of
Product& Service



8.7 Control of NC

20. Clause 4
Context of the Organization

21. Evaluation of the
Organization
 Type of the Organization.
 Purpose of the Organization.
 Size of the Business.
 Business Resources.
 Business Model.
 Business Boundaries.
 Business Opportunities.
 Business Operations.
 Business Issues.
 Interested Parties Requirements.
 Business Management.

22. Type of the
Organization
(Scope)




 Profitable.
 Charity.
 Public.
 Private.
 Corporate.
 Business sector.

23. Purpose of the
Organization
(Scope)




 Products and services.
 Mission.
 Vision.
 Policies.
 Objectives.
 Values.
 Culture.

24. Size of the
Business
(Scope)





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

25. 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.

26. Business
Model
(Scope)
 Brokerage.
 Crowdsourcing.
 Freemium.
 Leasing.
 Negative operating cycle.
 Pay as you go.
 Reverse auction.
 Product to service.
 Subscription.

27. Business Boundaries

 Location.
 Facilities (e.g. production sites) including
remote facilities which are part of the Quality
Management System.

28. 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.

29. Marketing Sales Design Purchase Production Inspections Product Release
Preservation Documentation/Invoicing Transportation Delivery Payment
After sale service Recycling Disposition
Business Operations

30. 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

31. 4.1 Understanding Organization & its
Context

External Issues
• Political
• Law & Order
• Legal & Regulatory
• Technological
• Economic
• Natural
• Competitive context
(International,
national, regional or
local)
Internal Issues
• Technology
• Financial
• Products and services
• Strategic direction
• Culture
• People
• Knowledge
• Processes
• Systems

35. 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
• Government is funding the certification
process for exporters
• Solid waste recycling plant set by Govt. can
be utilized.
Threats
• Some competitors have less cost of
production
• Environmental Protection Agency is revising
the parameters of industrial effluent

36. 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

37. Interested Parties Requirements




Interested parties








Owners Bankers Customers Competitors Suppliers


Leaders Organization Society Community










Interested parties’
needs
Interested parties’
expectations

38. 4.2 Needs and Expectation of Interested
Parties
Interested
Parties
Requirements of
QMS
Needs and Expectations
Manager Human
Resource
Provision of
required Human
Resources
1. To provide required manpower within the specified budget.
2. To ensure that employees working in the premises are competent.
3. To provide necessary trainings identified in TNA, to enhance the awareness
levels.
Quality Assurance
Dept.
To Minimize Non-
compliance
1. Establish quality assurance program to reduce rejections and improve
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.

39. Business Management

 Business process inputs.
 Business processes.
 Business process outputs.

40. Business Process Inputs



Customers
requirements








Interested
parties’
requirements
Business
process
inputs
Statuary
Regulatory
Requirements







Applicable
technical
standards and
codes

Contractual
Requirements

41. Business Management Process
Management
Processes


Provide
Leadership



Effectiveness
Efficiency
Profitability
Sustainability
Improvement
processes



Business
Management
Processes
Planning
Processes
To develop
Business Plans


Performance
measurement

Control
processes
Support
Processes
To provide
Resources




Operation
Processes

Management
of operations

42. Business Process Outputs



Business
growth






Improved
Business Business
process
outputs
Profitability








Interested
parties
Satisfaction

Sustainability

43. Strategic Direction & Integration




Intended Business
Business Objectives


QMS Objectives
Business Strategy


QMS Strategy

Intended Business
Results




Strategic Direction




Internal
Customer Focus
Competitors Focus Supplier Focus
External
Customer Focus



Business Objectives
Gross/Net Profit Business Growth
Business

Continuity
Business
Accountability




QMS Objectives
Meeting Customer
Requirements
Meeting Legal
Requirements
Product and Service
Conformity
Customer
Satisfaction

44. 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.

45. 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

46. Context of Organization (Clause 4)




Maintain
documented
information to
support the
process of its
operations








Quality
Context of the
Organization
Clause 4.1





Context of the
Internal & external issues






Requirements and
expectations of

Retain documented
information to have
confidence that
processes have been
carried out as per the
planned
arrangements









Maintain
Management
System and its
Processes
Clause 4.4
Organization
Clause 4





Determining the
Scope of Quality
Management
System
Requirements of
Interested Parties
Clause 4.2
the interested
parties
documented scope
of QMS
Clause 4.3

47. Clause 5
Leadership

48. 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.

49. 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

50. 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

51. Reference Documents







Quality Policy



Organizational Charts



Job Descriptions



Responsibility Matrix

52. RISK
MANAGEMENT

53. Risk &
Opportunities

 Risk is “the effect of uncertainties
on the objectives”
 Opportunity is “situation or
condition favourable for attainment
of a goal”

54. Risk Management
Process
• Context Establishment.
• Risk Assessment:
• Risk Identification.
• Risk Analysis.
• Risk Evaluation.
• Risk Treatment.
Based on ISO 31000.

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


Risk Assessment includes:
1. Risk Identification.
2. Risk Analysis.
3. Risk Evaluation.
Risk Analysis
Risk
Identification
Risk Evaluation

56. 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.

57. 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

58. 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.

59. 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.

60. Risk Based Thinking
QMS Processes,
Policies
Information Assets
Data Value Creation
Information Wisdom
Knowledge
Thinking
Risk Based

 Risk-based problem solving
(R&O identification).
 Risk-based decision-making
(Actions to address R&O).

61. Clause 6
Planning

62. 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

63. 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

64. Risk Register

65. QUALITY OBJECTIVES
• Objectives must be SMART

66. Objective Setting
MANGEMENT PROGRAM FOR
OBJECTIVES




OBJ NO: DEPARTMENT: TARGET DATE:

OBJECTIVE:

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

67. Reference Documents










Risk Register & Risk Methodology




Quality Objectives




Management Program for Objectives

68. Clause 7
Support

69. 7.1 : Resource
• The organization shall;
• Determine the resources needed
• Provide the resource
• Maintain the resources
It includes;
• People
• Infrastructure
• Work environment (Physical conditions)

70. Organizational Knowledge



• Knowledge specific to the organization generally gained by
experiences.
1. Intellectual property
2. Knowledge gained from experiences.
3. Lessons learned from past failures & successful projects
(CA Log, Incident Log)
4. Standards
5. Conferences
6. Knowledge from customers or external providers




Internal
Sources





External
Sources

71. 7.2 COMPETENCE

• The organization shall ensure to have competent employees to
perform task related to QMS.









Competence Experience Skills Training
Education

72. 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

73. 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

74. 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.

75. 7.5 : Documented Information





Creation Identification Classification Modification






Approval Distribution
Adequate

Use

Archiving






Disposal


A procedure must be established to manage the document lifecycle.

76. Reference Documents






Training Records



Calibration Records



Organizational Knowledge



Inter Office Memo



Quality Documents & Records

77. Clause 8
Operations

78. 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

79. 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.

80. 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

81. 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

82. 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

83. 8.5 Control of Product & Service
Provision
• Product Planning & Specification

• Availability of Work Instructions

• Use of Suitable Equipment

• In Process Monitoring

• Availability of monitoring equipment

• Maintenance of equipment

• Production & Service provision records
CONTROLS

84. Clause 8.5.2: Identification &
Traceability





Identification Traceability
Inspection & Testing
Status








Article #/Model #/
Item #/Design #
Lot #/Batch #/
Serial #/Mfg. date

Tags/Stickers/Trays for
rejected/reworked items

85. 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.

86. 8.5.4 : Preservation






Identification


Handling


Contamination Control


Packaging & Storage


Protection


Transmission or Transportation

87. 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.

88. 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
authorizing the release
RELEASE SLIP
Date
Product
Batch #
Batch Size
Remarks
Released By

89. 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.

90. 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

91. Reference Documents






Customer Feedback and Complaints



Supplier Evaluation forms



Acceptance Criteria



Corrective Action Forms



QC Reports & Release label

92. Clause 9
Performance Evaluation

93. 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.

94. 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.

95. 9.2 : Internal Audit
The organization shall conduct internal audits at planned intervals to review the
effectiveness of QMS.
The audit programme include;

96. 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.

97. Reference Documents






Customer Feedback and Complaints



Internal audit records



MRM Records



Analysis reports

98. Clause 10
Improvement

99. 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
Information
Maintain Documented
Information

100. Continual Improvement




Management
Review
Quality
Objective
s







Correctiv
e Actions
Data
Analysis




Quality
Audits

101. 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.

102. Hazard
• Source, situation, or act with a potential for harm in terms of human injury or ill
health, or a combination of these.

103. Types of Hazards
• Following are major types of hazards;
• Physical
• Chemical
• Biological
• Psychological
• Ergonomic

104. Physical Hazards
• Physical Hazards include;
• Noise
• Vibration
• Lighting
• Electrical
• Heat / Cold
• Dust
• Fire/Explosion
• Machine Moving Parts
• Working Space

105. Chemical Hazard
• Chemical Hazards include;
• Gasses
• Fumes
• Vapours
• Liquids

106. Biological Hazards
• Biological Hazards include;

• Infections (bacterial/viruses)
• Allergic Response
• Ingested (via contaminated food)

107. Psychological Hazard
• Psychological Hazards include;
• Shift work
• Workload
• Harassment
• Discrimination
• Stress

108. Ergonomic Hazard
• Ergonomic Hazards include;
• Tool design
• Equipment design
• Job and Task Design
• Workstation design
• Manual Handling