MMVA ZG 522 Total Quality

Management
BITS Pilani
QMS –ISO:9001
 Agenda
• Module 1
– International Organization for Standardization and Quality
Management Systems
• Module 2
– Principles of QMS
• Module 3
– Overview of ISO-9001.
• Module 4
– Clauses in ISO 9001
• Module 5
– Process Approach
– PDCA
– Risk Based Thinking/Management

2
• Begin Module 1

International Organization for Standardization

and
Quality Management Systems.

3
 INTERNATIONAL ORGANIZATION FOR STANDARDIZATION-1

• Started in 1947- with ONLY 25 member countries.

• FUTURE of INTERNATIONAL STANDARDIZATION
• Acronym used is ISO -derived from the Greek
isos (aaisoj) meaning equality/harmony
• The International Organization for Standardization (ISO)
is a Worldwide federation of the national standards
organizations of member countries and provides:
– Standards for products, tests for industrial, commercial and public use
e.g ISO 6893:2016 Wood-based panels – Particleboard; ISO 404:2013 Steel and steel
products -- General technical delivery requirements.
– Standards for systems and processes.
Many guidelines, vocabulary are also called standards (as we shall see for ISO-9000
and 9004) though these are not STANDARDS per se.

4
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION-2

• NOW:
• 162+ member bodies; headquarters at Geneva.
• About 22500 standards so far.
• Technical committees
Sub committees and work groups
• Draft International Standards--
To member bodies for approval
• At least 75 % approval for acceptance by ISO council.
• Technical specification for 3 years (TS)
• Protocol for review every 5 years
• In short named as ISO (pronounced aaiso).
• INDIA IS ALSO A MEMBER.
 ISO 9000
Family of standards
• ISO 9000 family of standards were originally developed by Int. Stds. Org. in 1987 as
the first quality management system standard.
• This was in contrast to the PRODUCT STANDARDS till then developed by all
standard bodies across the world.
• -Family of standards because it contained and contains more than one standard.
• REVISION HISTORY;
• 1st made in 1987 (ISO-9000, 9001, 9002, 9003, 9004) +10011 series
Strategy for revision taken up by ISO(aaiso) in 1990, resulted in following revisions:
• 1994 revision
• 2000 (ISO-9000,9001, 9004) +14010/11/12
• 2008 (ISO-9000,9001, 9004) +19011:2002+ guidance documents
• 2015 (ISO-9000,9001, 9004) +19011:2011+ guidance documents

6
 ISO-9000 FAMILY (as of now :2015)
ISO-9000:2015
Quality Management systems-Fundamentals & Vocabulary
ISO-9001:2015
Quality Management Systems-Requirements
ISO-9004: 2018
Quality Management- Quality of an organization –Guidance to
achieve sustained success
ISO-19011:2011
Guidelines for Auditing Quality Management Systems
Note:
ONLY one ‘standard’ i.e ISO-9001:2015; others are supporting
guidelines.

*CERTIFICATION IS POSSIBLE ONLY AGAINST ISO-9001.

7
 Management System v/s Quality
Management System
• A management system is the framework of policies,
processes and procedures used by an organization to ensure
that it can effectively manage the tasks required to achieve its
objectives for a specific system.
• Quality Management system is a management system for the
management of QUALITY in totality.
• A standard is a prescriptive document related to a
product/system/process.
• ISO (aaiso) has developed and is developing, management
system standards for various sectors/functions.
• Quality management system standards are such standard for
QUALITY MANAGEMENT in the organization.
8
Many Management system and Quality Mngmt.
System standards & guidance documents,

ISO-14001-2015 Environment Management System

ISO-21000-FDIS Educational Management systems (2018)
ISO 27010-2015 Information security management
ISO 22000-2015 Food safety management. (2018)
ISO-13485-2016 Medical devices — Quality management
systems — Requirements for regulatory purposes.
ISO-15378-2017 Primary packing for medicinal products.
ISO 45001:2016 Occupational health and safety management systems
++
Many other standards are under revision.

ISO-9001 is the base for IATF 16949, AS 9100 and TL 9000:2016; the specific
sector QMS’s for automotive. Aerospace and telecommunication sectors.

9
 Generic Standard
• The ISO 9001 is a "generic QMS standards".
• "Generic" means that the same standards can be applied to
any organization:
-large or small,
-whatever be its product/service;
-whatever be the size –whether a one person organization
or a multi location, multi product organization like IBM;
-Whatever the complexity of operations;
-Governmental or non governmental
etc.

10
 End of Module 1
• Summary:
– ISO (aaiso)-the worldwide standards organization;
– ISO unifies standards for the world;
– Quality Management system standards are also
being developed and used worldwide.
– ISO-9000 family standards are a family of generic
standards for Quality management Standards.

11
Begin Module 2

Principles of QMS

12
 Quality Management Principles
• The revised ISO 9001:2015 is based on SEVEN (earlier eight)
quality management principles (QMP’s).

• It is important to understand the QMP’s to comprehend the

thoughts and the philosophy behind the QMS.

• These principles can be used by senior management as a

framework to guide their organizations towards improved
performance.

13
 QUALITY MANAGEMENT PRINCIPLES
(QMP’s)

- ISO 9000: 2015 has defined QMP,s in clause 2.3

- The Seven principles are:-

1. Customer Focus. 2. Leadership

3. Engagement Of People 4. Process Approach

5. Improvement 6. Evidence based Decision

Making
7. Relationship Management

LET US , BRIEFLY DISCUSS EACH ONE .

 Principle 1: Customer focus
• Organizations depend on their customers and therefore
should understand current and future customer needs,
should meet customer requirements and strive to exceed
customer expectations.
“Mahatma Gandhi’s quote”
• Key benefits:
- Increased revenue and market share obtained
through flexible and fast responses to market
opportunities.
- Increased effectiveness in the use of the
organization's resources to enhance customer
satisfaction.
- Improved customer loyalty leading to repeat
business.
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 Principle 1: Customer focus
• Applying the principle typically leads to:
- Researching and understanding customer needs and
expectations.
- Ensuring that the objectives of the organization are
linked to customer needs and expectations.
- Communicating customer needs and expectations
throughout the organization.
- Measuring customer satisfaction and acting on the
results.
- Systematically managing customer relationships.
- Ensuring a balanced approach between satisfying
customers and other interested parties (such as
owners, employees, suppliers, financiers, local
communities and society as a whole).
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 Principle 2: Leadership
• Leaders establish unity of purpose and direction of the
organization. They should create and maintain the internal
environment in which people can become fully involved in
achieving the organization's objectives.

• Key benefits:
- People will understand and be motivated
towards the organization's goals and objectives.
- Activities are evaluated, aligned and implemented
in a unified way.
- Miscommunication between levels of an
organization will be minimized.

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 Principle 2: Leadership
• Applying the principle typically leads to:
- Considering the needs of all interested parties
including customers, owners, employees, suppliers,
financiers, local communities and society as a whole.
- Establishing a clear vision of the organization's future.
- Setting challenging goals and targets.
- Creating and sustaining shared values, fairness and
ethical role models at all levels of the organization.
- Establishing trust and eliminating fear.
- Providing people with the required resources, training
and freedom to act with responsibility and
accountability.
- Inspiring, encouraging and recognizing people's
contributions. 18
 Principle 3: Engagement of people
• People at all levels are the essence of an organization and
their full involvement enables their abilities to be used for the
organization's benefit.
• Key benefits:
- Motivated, committed and involved people
within the organization.
- Innovation and creativity in furthering the
organization's objectives.
- People being accountable for their own
performance.
- People eager to participate in and contribute to
continual improvement.

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Principle 3: Engagement of people
• Applying the principle typically leads to:
- People understanding the importance of their
contribution and role in the organization.
- People identifying constraints to their performance.
- People accepting ownership of problems and their
responsibility for solving them.
- People evaluating their performance against their
personal goals and objectives.
- People actively seeking opportunities to enhance
their competence, knowledge and experience.
- People freely sharing knowledge and experience.
- People openly discussing problems and issues.

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 Principle 4: Process approach
• A desired result is achieved more efficiently when
activities and related resources are managed as a
process.
• Key benefits:
- Lower costs and shorter cycle times
through effective use of resources.
- Improved, consistent and predictable
results.
- Focused and prioritized improvement
opportunities.

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 Principle 4: Process approach
• Applying the principle typically leads to:
- Systematically defining the activities necessary to obtain
a desired result.
- Establishing clear responsibility and accountability for
managing key activities.
- Analyzing and measuring of the capability of key
activities.
- Identifying the interfaces of key activities within and
between the functions of the organization.
- Focusing on the factors such as resources, methods, and
materials that will improve key activities of the
organization.
- Evaluating risks, consequences and impacts of activities
on customers, suppliers and other interested parties.

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 Principle 5: Improvement
• Continual improvement of the organization's overall
performance should be a permanent objective of the
organization.
• Key benefits:
- Performance advantage through
improved organizational capabilities.
- Alignment of improvement activities at all
levels to an organization's strategic intent.
- Flexibility to react quickly to opportunities.

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 Principle 5: Improvement
• Applying the principle typically leads to:
- Employing a consistent organization-wide
approach to continual improvement of the
organization's performance.
- Providing people with training in the methods
and tools of continual improvement.
- Making continual improvement of products,
processes and systems an objective for every
individual in the organization.
- Establishing goals to guide, and measures to track,
continual improvement.
- Recognizing and acknowledging improvements.

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 Principle 6: Evidence based decision
making
• Effective decisions are based on the analysis of data
and information
• Key benefits:
- Informed decisions.
- An increased ability to demonstrate the
effectiveness of past decisions through
reference to factual records.
- Increased ability to review, challenge
and change opinions and decisions.

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 Principle 6: Evidence based decision
making
• Applying the principle typically leads to:
- Ensuring that data and information are
sufficiently accurate and reliable.
- Making data accessible to those who
need it.
- Analyzing data and information using
valid methods.
- Making decisions and taking action
based on factual analysis, balanced
with experience and intuition.

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Principle 7: Relationship Management
• Sustainability of organisation depends on reliable and
participation by all interested parties in the company’s
growth and meeting of objectives.
• Determine relevant interested parties and their relationship
with the organisation.
• Determine and Prioritize relationships that need to be
managed.
• Share information and plans.
• Develop collaborative approach.
• Recognize, reward and share benefits

27
 Principle 7: Relationship Management …2
• Measure, guide and share feedback to partners; share the
assessment criteria.
• Applying the principle typically leads to:
– Enhanced overall company ‘s performance
– Capability to create value to customers.
-- Capability to manage risks and competition
-- Stable supply chain resulting in consistent flow of products
and services. .

28
 End of Module 2
• SUMMARY
Brief explanation of the 7 QMP’s.
Understanding of QMP’s reinforces the spread f the
QMP’s throughout the system.

29
Begin Module 3

OVERVIEW OF ISO-9001

30
 OVERVIEW OF ISO-9001
• INTRODUCTION (from standard)
• General ---The adoption of a quality management system is a
strategic decision-to improve its (organization’s) overall
performance and provide a sound basis for sustainable
development initiatives.
• THE POTENTIAL BENEFITS of implementing this QMS :
– a) the ability to consistently provide products and services that meet
customer and applicable statutory and regulatory requirements;
– b) facilitating opportunities to enhance customer satisfaction;
– c) addressing risks and opportunities associated with its context and
objectives;
– d) the ability to demonstrate conformity to specified quality
management system requirements…
….(not necessarily to product standards)

31
 Essential approaches/tools
for QMS

• PROCESS APPROACH/MANAGEMENT
• RISK BASED THINKING
• PDCA-Plan, Do, Check and Act

32
 Main Clauses of ISO 9001:2015
• Clause 4—Context of the organization +.
• Clause 5---Leadership
• Clause 6- Planning.
• Clause 7- Support.
• Clause 8- Operation.
• Clause 9--Performance evaluation.
• Clause 10-Improvement

Each MAIN clause has sub clauses.

33
 Sequence and interaction of QMS processes at macro level

Context & needs

of interested
parties cl 4. Leadership &
Planning cl 5 & 6

Performance
Customer Evaluation Improve
requirements Support cl 7 Cl 9 ments
Cl 10

Operations cl 8
Products &
services as
required

34
 Specific to
2015 version of ISO-9001
• Context of the organization; needs of Interested parties .
• Explicit requirements from management/leadership.
• Increased focus on “roles/responsibilities/authority” and
“Quality Objectives”
• RISK BASED THINKING-Replaces preventive action
• Organizational knowledge
• Management representative & quality manual-not mandatory.
• Reorganization of clauses /sub clauses.
Focus on PDCA and the process approach is continued.
Etc.

35
 Flexibility in ISO-9001:2015
Provides flexibility to:
• Design your OWN structure of QMS.
• Prepare your OWN documentation….Value
except some mandated requirements.
• Adopt and follow your OWN terminology
(and define the same).
(e.g purchase v/s externally supplied)
Etc.

36
 End of Module 3

Summary:
Why, when of ISO-9001;
Three underlying approaches-process, risk, PDCA
7 clauses and their interaction;
Flexibility….

37
 Begin Module 4

-Explanation of each
Clause of ISO-9001:2015

38
 ISO-9001 –by whom and when
• 1 Scope
• This Intern. Std. specifies requirements for a quality management system
when an organization needs to demonstrate its ability to consistently
provide products and services that meet:
Customer requirements &
applicable statutory and regulatory requirements,
and (THE ORGANIZATION)
aims to enhance customer satisfaction through the effective application
of the system, ----- -- -------.
• 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.
• contd…………

39
 ISO 9001:2015
7 CLAUSES –No. 4 to 10
At A Glance
ISO-
9001:2015

Cl. 4 Cl. 5 Cl. 7

Cl.9
Context of Leadership Performance
Support
the evaluation
organization
Cl. 6 Cl.8
+ Operation
Cl.10
Planning Improvement

7 clauses, each representing a group of generic

processes applicable to any type of organization.

40
 Clause 4 at a glance

4. Context of
organization +

4.1 4.2 4.3 4.4

Understanding the Understanding the Determining QMS & its
Organization & its needs & expectations the Scope of processes
context of interested parties QMS

Cl. 4.1 ORGANIZATION & ITS CONTEXT Understanding

CL. 4.2 NEEDS & EXPECTATIONS OF

INTERESTED PARTIES. Understanding

Cl. 4.3 SCOPE OF THE QMS Determining

Cl. 4.4 QMS & ITS PROCESSES Summarizes the entire process of
establishing, implementing,
maintaining and improving the QMS

41
 Clause 5 at a glance
QMP’s 4 and 5 (process management and
improvement are related to all clause.)

Cl. 5
Leadership

5.1 Leadership 5.2 Establishing

& commitment Quality policy
5.3 Organizational roles;

responsibilities & authorities,

Communicating
the Quality communicating & ensuring the
5.1.1 5.1.2 Policy understanding thereof
Demonstrating Demonstrating
leadership & Customer
committment focus

42
 Clause 6 at a glance

Cl. 6
Planning

6.1
6.2
Actions to 6.3
Quality objectives
address risks & Planning of
& planning to
opportunities. changes
achieve them.

43
 Cl. 7. RESOURCES AND SUPPORTS
•
RESOURCES cl. 7.1

People Infrastructu Environment Org. knowledge

Mtrg &
7.1.2 re 7.1.3 7.1.4 7.1.6
msrg.
resources
7.1.5

Supports—cl 7.2 to 7.5

Cl. 7.2 Cl. 7.3 Cl. 7.4 Cl. 7.5

Competence Awareness Communication Documented information

PROCESSES to—determine, provide and maintain EACH of the above-about 27

processes/sub-processes with interaction as in previous slide.

44
Clause 8; at a glance-OPERATIONS Module 8.5

All sub-clauses may

45
Clause 9; Measurement, analysis, evaluation

Internal audit and management review processes interact

with every other process of QMS and also with each other. 46
 CL 10-IMPROVEMENT

• IMPROVEMENT
• Ref. Clause 1.b -Scope (of QMS –Requirements)
Need of
“Enhancement of customer satisfaction through the effective application of the
system including processes of improvement of the system---------”

is one of the two main requirements from this QMS;

the other being “the need to demonstrate consistent compliance to all

requirements”.
THIS COMPLETES THE 7 CLAUSES.

47
 What now
• The organization which wants to implement has to understand and apply each
clause/sub-clause to the organization. Some of the clauses/sub-clauses may not be
applicable.
• The organization has to design and implement processes/procedures for the
applicable ones, including maintaining the necessary reports/records.
• Thus, the system shall be unique to every organization as per its needs,
requirements and objectives.
• The system can be documented as per clause no. 7.5 or in any way as decided by
the organization (flexibility).
• Implementation is verified through internal audits and management reviews.
Clause no.s 9.3 and 9.4.
• After reaching a satisfactory level, the external certifying agency can be engaged
to audit the system (If required by the organization). If the agency finds the system
adequate, the organization is certified to ISO-9001:2015.
• The audits by external agency (and also the internal audits) shall continue in a
planned manner to ensure that the system is running satisfactorily.
** **
48
 End of Module 4
Summary :
• The brief explanation of the clauses given here:
– Is only for understanding what is required;
– But will not be adequate for implementation
• Implementation needs thorough understanding as
per the organization’s UNIQUE requirements.
• Implementation should place the company on the
track for:
– Continual improvement of customer satisfaction.

49
 Begin Module 5

– Process approach
– Risk based thinking/management
– PDCA

50
 PROCESS APPROACH

All work gets done through processes only.

No activity by itself can give a result and/or an output.
An activity can contribute towards a result only along with other
sequential, inter-related or interacting activities.

Definition of ‘process’
Set of
interrelated or interacting activities
that use inputs to deliver an intended result.

Output of one process may be the input to the next process.

interrelated or interacting processes/sub processes.

51
 Schematic representation of a Module 4a
process
EFFECTIVENESS
EFFECTIVENESS
PROCEDURE* OF
OFPROCESS
PROCESS==
Ability
Abilitytotoachieve
(“Specified way to carry out an activity or a desired
achieve
desiredresults
results
process” - may be documented or not) (Focus
(Focus ofISO
of ISO
9001:2000)
9001:2000)

Supplier Input PROCESS Output

PRODUCT Customer
(Includes
(“Set of interrelated
Resources) or interacting activities”) (“Result of a
process”)

EFFICIENCY
EFFICIENCYOF OF
MONITORING AND PROCESS
PROCESS==
MEASUREMENT OPPORTUNITIES Results
Resultsachieved
achieved
(Before, during and after the process)
vs
vsresources
resourcesused
(Focus
used
(FocusofofISO
ISO
Characteristics
9004:2000)
9004:2000)
* Note – This is the definition of “procedure” given in ISO 9000:2000.
This does not necessarily mean one of the 6
“documented procedures” required by ISO 9001:2000

Characteristics

Quantitative Qualitative

52
 PROCESS (contd.)

INPUTS PROCESS OUTPUTS

SUPPLIERS INPUTS PROCESS OUTPUTS CUSTOMERS

 PROCESS approach
• 0.3. Process approach (from ISO-9001:2015)
• The process approach involves the systematic definition and
management of processes, and their interactions, so as to
achieve the intended results in accordance with the quality
policy and strategic direction of the organization.
• Management of the processes and the system as a whole can
be achieved using the PDCA cycle (see 0.3.2) with an overall
focus on risk-based thinking (see 0.3.3) aimed at taking
advantage of opportunities and preventing undesirable
results.

54
 PDCA
• PDCA- means the cycle of four steps viz. Plan, Do, Check and Act -a
model for systematically carrying out change/improvement.

Plan
Determine
goals , targets
and methods

Act
Take necessary Do
follow up Implement
action starting work plan
with plan

Check
Examine
results

55
 PDCA cycle
• 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 what was planned;
• 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.
56
 RISK BASED THINKING/RISK
MANAGEMENT
• Part of all processes at all levels.
• The word “risk” now appears 46 times in ISO 9001:2015.
• Concerns every manager.
• So establish a methodology to:
-Identify risks;
-Evaluate and prioritize the risks identified;
-manage (plan & implement actions) as prioritized;
-verify the actions and the results;
-standardize the changed procedure.
(As per need of the organization and the situation).

57
 RISK BASED THINKING/RISK MANAGEMENT
• Risk-based thinking is essential for achieving
an effective quality management system.
• This ensures that potential risks of failure are
identified and managed so as to eliminate,
reduce, control the risks of failure.
• Thus PREVENTIVE ACTIONS are taken during
planning stage itself.
• FMEA (already discussed) is an important and
effective tool for most of the situations.

58
 Risks -examples
1. A new product under development required a communication module
which would interact with the entire assembly.
• The known (and trusted) brand’s module was not available.
• It could be designed in house but time and cost estimates were too high to be
considered (specially the delay in market entry).Severity very high so discarded.
• Another supplier was located in China.
• This supplier had recently introduced this product while its other products had a
reputation of LOW failure rates.
• So severity was NOT high, (assumed)
• Occurrence was taken to be LOW (based on other products),
• Detectability was low.
• The risk was accepted and order placed.

59
 Risks -examples
• 2. A supplier was receiving high complaints of failure on site.
• The failure was analysed and the root cause was found to be poor resin quality.
(one specific batch from a specific supplier). The problem created a HIGH
uncertainty on the life of the product i.e the severity was high; occurrence was in
question mark and detectability was low.
• 45 products were supplied from this lot of the resin and 10 had already failed. 5
more were in stock.
• RISK
– Wait for failures at site and then re-work/replace the product. (Cost, failure to
perform at customer’s place during the period of action, loss of reputation;
possibility of loss of future business). Overall severity HIGH, occurrence –HIGH
( so far 10/45=about 22 %), detectability (before failure is VERY LOW.
• Cannot be accepted, so recall the products and replace; carry out
rework/rectification.(Cost, performance assurance; reputation).

60
 End of Module 5
Summary:
1. All work is carried out through processes.
2. Process management needs to result in
effectiveness and efficiency of processes.
3. PDCA is a method/tool/process to manage
improvement/rectification projects.
Improvement projects lead to continual
improvement.
4. Risk management can lead to ZERO defects.

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 Overall Summary-1
• In this session the current QMS (Quality Management System) standard
i.e ISO-9001;2015 developed by the International Organization for
standardization has been discussed.
• ISO-9001 is a family of 4 generic Quality management system standards
while there are, also QMS’s and other MSS’s (Management System
Standards) by ISO for specific sectors.
• ISO-9001:2015 has seven main clauses. Each clause has various sub-
clauses each of which defines the requirements to be complied. All
requirements may not be applicable to an organization.

62
 Overall Summary-2
• Process approach, PDCA and Risk Management are integral to ISO-
9001:2015.
• General
– ISO is a worldwide quality management standard that requires suppliers to
standardize their Quality related processes as specified in the standard. This
is EXPECTED to improve the consistency of quality of the product and
services and hence improve the customer satisfaction.
** ** ** **

63