Awareness Session

Business Excellence

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 Introduction

Why ISO Certification is required?

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 Introduction
International Organization for Standardization
• An independent, non-governmental international organization with a
membership of 162 National Standards Bodies.

ISO Publication
• ISO has published more than 20,500 International Standards related
documents, covering almost every industry, from technology, to food safety,
to agriculture and healthcare.
• ISO International Standards impact everyone, everywhere.
Head Quarters
Geneva, Switzerland

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 Introduction
History of ISO 9001

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 Quality Management Principles

Customer Focus

Relationship Management Leadership

Quality
7Principles
Evidence based decision
Management
making People Engagement

Improvement Process Approach

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 Core Concepts of ISO 9001:2015

Identify the PROCESSES

3 Concepts Processes
needed to achieve the
planned results

Continually monitor the RISKS

(Risk based thinking) P
! A D Manage the Processes and
- Understanding ‘Cause and C the system using PDCA
Effect’
Risk PDCA

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 ISO 9001:2015 – The Structure

PLAN DO CHECK ACT

4
5
CONTEXT 6 7 8 9 10
PERFORMANCE
OF THE LEADERSHIP PLANNING SUPPORT OPERATION IMPROVEMENT
EVALUATION
ORGANIZATION

Understanding Operational planning &

Actions to Monitoring, Non conformity
the Leadership & Resources control
address risks & measurement & corrective
organization Commitment Determination of
opportunities analysis & actions
and its context Competence requirements for evaluation
Needs & Quality product & services
Quality Policy
expectations Objectives & Internal audit Continuous
Awareness Design & development
of interested planning improvement
Roles, of products & services
parties Management
responsibilities Communication
& authorities Planning of Control of externally review
Scope of the
changes proc. prod. & services
QMS Documented
information Production & service
QMS & its provision
processes
Clause 1 SCOPE Release of products &
service
Introductory clauses Clause 2 NORMATIVE REFERENCE Non conforming
processes prod. &
Clause 3 TERMS & DEFINITIONS services
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 Core Concepts of ISO 9001:2015 - Process

Identify the PROCESSES

3 Concepts Processes
needed to achieve the
planned results

Continually monitor the RISKS

(Risk based thinking) P
! A D Manage the Processes and
- Understanding ‘Cause and C the system using PDCA
Effect’
Risk PDCA

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 Core Concepts of ISO 9001:2015 - Process

Simple Process

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 Core Concepts of ISO 9001:2015 - Process

Systematic Process

Periodicity Measures

Feedback

Process Owner

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 Core Concepts of ISO 9001:2015 - Process

SIPOC Methodology

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 Core Concepts of ISO 9001:2015 - Process
EPM Document Structure

EPM Structure
L1 Process: Enterprise level process.
Focus on governance. Will not be
audited. KPIs to be tracked. L1
L2 Process: Connector between L1
& L3. Logical grouping for
management. Will not be audited. L2
KPIs to be tracked.

L3 Process: Operating level

processes. Will be audited. KPIs to be L3
tracked. SIPOC
SOP: Standard Operating Procedure.
Sub Process to L3. Will be audited. No SOP
SIPOC and KPIs.

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 Core Concepts of ISO 9001:2015 - Process
EPM Structure

16 L1

56 L2 level

193 L3 level Process mapping is being done

at this level.
The status report is about
127 SOP 193 + 127 = 320 processes
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 Core Concepts of ISO 9001:2015 - Process
EPM Architecture
Process Architecture in Tata Projects

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 Core Concepts of ISO 9001:2015 - Process
Process Document Structure in EPM
I. Summary Sheet II. Flow chart
• Objective / Intent
• Stakeholders
• Flow chart
• Scope • Activity description
• MIS • Activity Ownership L3 Process
• Dispute Resolution

III. Documents IV. SIPOC

• Supplier-Input-Output-
• Reference Documents Customer
• Formats / templates • Effectiveness – Efficiency
measures
• Review

I. Process II. Documents Standard

• Objective / Intent • Reference
Operating
• Activities with Documents
timelines • Formats / templates
Procedure

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 Core Concepts of ISO 9001:2015

Identify the PROCESSES

3 Concepts Processes
needed to achieve the
planned results

Continually monitor the RISKS

(Risk based thinking) P
! A D Manage the Processes and
- Understanding ‘Cause and C the system using PDCA
Effect’
Risk PDCA

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 Core Concepts of ISO 9001:2015 - PDCA Cycle
PDCA Cycle in EPM

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 Core Concepts of ISO 9001:2015 - PDCA Cycle
PDCA Cycle in ISO 9001:2015

4. Context of the Organization

10. Improvement
ACT 5. Leadership
6. Planning
7. Support

PLAN
ISO
9001:2015
CHECK
9. Performance Evaluation

DO
8. Operation

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 Core Concepts of ISO 9001:2015

Identify the PROCESSES

3 Concepts Processes
needed to achieve the
planned results

Continually monitor the RISKS

(Risk based thinking) P
! A D Manage the Processes and
- Understanding ‘Cause and C the system using PDCA
Effect’
Risk PDCA

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 Core Concepts of ISO 9001:2015 - Risk thinking
Risk Based Thinking - What should we do?

• Analyze and prioritize the risks and opportunities in the organization

– what is acceptable?
– what is unacceptable?
• Plan actions to address the risks
– how can I avoid or eliminate the risk?
– how can I mitigate the risk?
• Implement the plan – take action
• Check the effectiveness of the actions – does it work?
• Learn from experience – continual improvement

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 ISO 9001:2015 – The Structure

PLAN DO CHECK ACT

4
5
CONTEXT 6 7 8 9 10
PERFORMANCE
OF THE LEADERSHIP PLANNING SUPPORT OPERATION IMPROVEMENT
EVALUATION
ORGANIZATION

Understanding Operational planning &

Actions to Monitoring, Non conformity
the Leadership & Resources control
address risks & measurement & corrective
organization Commitment Determination of
opportunities analysis & actions
and its context Competence requirements for evaluation
Needs & Quality product & services
Quality Policy
expectations Objectives & Internal audit Continuous
Awareness Design & development
of interested planning improvement
Roles, of products & services
parties Management
responsibilities Communication
& authorities Planning of Control of externally review
Scope of the
changes proc. prod. & services
QMS Documented
information Production & service
QMS & its provision
processes
Clause 1 SCOPE Release of products &
service
Introductory clauses Clause 2 NORMATIVE REFERENCE Non conforming
processes prod. &
Clause 3 TERMS & DEFINITIONS services
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 ISO 9001:2015 - Key Changes
Three major changes
• Understanding the organization and its context
• Business Environment (Internal & External
issues)
• Understanding the needs and expectations of
interested parties
• All interested parties, as appropriate
• Risk based thinking - Risk & Opportunities
• Earlier Preventive action has been
considered as part of planning
Moving towards Business Excellence
framework
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Other changes
• Changes in Structure
• 10 Clauses has been introduced (In 2008
standard total clauses are 8)
• Strengthened Leadership
• The commitment to quality through strong and
visible leadership is strengthened
• Management Representative not required
• No more quality manual required
• However, the documentation requirement is still
part of the standard.
• Adoption of Knowledge Management
 Clause No. 01 - Scope
a) Consistently provide product that meets customer and
applicable statutory and regulatory requirements

b) aims to enhance customer satisfaction through the effective

application of the system

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 Clause No. 02 – Normative Reference

ISO 9000:2005, Quality management systems — Fundamentals and

vocabulary
ISO 9000:2005, Quality management systems — Fundamentals and
vocabulary

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 Clause No. 03 – Terms and definitions
For the purposes of this document, the terms and definitions given in
ISO 9000:2015 apply.

Throughout the text of this International Standard, wherever the term

“product” occurs, it can also mean “service”. 9000:2005, Quality
management systems — Fundamentals and vocabulary

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 Clause No. 04 – Context of the organization
4.1 Understanding the organization and its context
Organization shall:
• Determine external and internal issues that are relevant to purpose and strategic direction and
that affect ability to achieve the intended result (s) of QMS.
• Monitor and review the information about these external and internal issues.

Relevant Document & Process

1. Strategy Document (STRAP)

2. SWOT Analysis
3. PESTLE Analysis

Strategy Development Process

(EPM No.: 01.01.02)
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 Clause No. 04 – Context of the organization
4.2 Understanding the needs and expectations of interested parties
• Organization shall:
• Determine the interested parties and their requirements that are relevant to the QMS.
• Monitor and review the information about these interested parties and their relevant
requirements.

Customers Suppliers / Vendors

• VoC • Voice of Vendors
Some of the tools
• Customer Satisfaction • Vendor Satisfaction Survey
Survey available • Vendor interactions
• Contract documents
Employees Government Community
• Employee Engagement • Regulatory scanning • Community need survey
Survey • Interaction with Govt. • Interaction with NGOs
• Employee touch points officials
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 Clause No. 04 – Context of the organization
4.3 Determining the scope of the QMS
Organization shall determine the scope;
• Boundaries and applicability of the QMS
The scope shall be available and maintained as documented information.

Design, Engineering, Procurement and Construction of Projects of Urban Infrastructure

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 Clause No. 04 – Context of the organization
4.4 Quality management system and its processes
Organization shall determine:
• Processes, interactions and improvement (incl. criteria, methods,
monitoring, measurements and KPIs)
• Resources and their availability
• Address risk and opportunities as per the requirements of cl. 6.1
Maintain documented information to support the operation of its processes
and retain the process documents.

For Processes and Process Interactions, KPIs: For Resources:

Process based management (EPM No. 02.01.01)
For Process Improvements:
a) Internal Audit process (EPM No. 03.02.02)
b) Process based management (EPM No. 02.01.01)
c) System Audits
AOP process (EPM No. 11.03.07)
For Risk & Opportunities:
a) Internal Audit process (EPM No. 03.02.02)
b) Enterprise Risk Management Process (EPM No. 03.04.01)
c) Project Risk Management Process (EPM No. 03.04.02)

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 Clause No. 05 – Leadership
5.1 Leadership and commitment
Top management shall demonstrate leadership and commitment by;
o Taking accountability for effectiveness of QMS (Ensure QMS achieves
intended results)
o Promoting the use of process approach and risk-based thinking,
Improvements
o Ensure address the risk and opportunities, enhancement of customer
satisfaction
o Ensure required resources are provided

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 Clause No. 05 – Leadership
5.2 Policy
5.2.1 Establish the quality policy

5.2.2 Communicate the quality policy

o Be communicated, understood and applied within the
organization
o Available to relevant interested parties
Available and maintained as documented information

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 Clause No. 05 – Leadership
5.3 Organizational roles, responsibilities and authorities
Ensure the responsibilities and authorities for relevant roles are assigned,
communicated and understood within the organization.

• Schedule of Powers (SoP)

• Job Descriptions (JDs)
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 Clause No. 06 – Planning
6.1 Actions to address risks and opportunities
6.1.1 Determine the risks and opportunities by considering internal & external
issues (4.1) and interested parties requirements (4.2)
6.1.2 Actions to address risks and opportunities
o Integrate and implement the actions into processes
o Evaluate the effectiveness of these actions

a) Internal Audit process (EPM No. 03.02.02)

b) Enterprise Risk Management Process (EPM No. 03.04.01)
c) Project Risk Management Process (EPM No. 03.04.02)
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 Clause No. 06 – Planning
6.2 Quality objectives and planning to achieve them
6.2.1 Establish quality objectives at relevant functions, levels and processes.
6.2.2 The organization shall determine action plans;
o What will be done
o What resources will be required
o Who will be responsible
o When it will be completed
o How the results will be evaluated

The organization shall maintain documented information on the quality objectives

• Strategy Deployment
• PMS
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 Clause No. 06 – Planning
6.3 Planning of changes
The organization shall consider;
o The purpose of the changes and their potential consequences
o The integrity of QMS
o The availability of resources
o The allocation or reallocation of responsibilities and authorities

a) Process Based Management (EPM No. 02.01.01)

b) Management Reviews
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 Clause No. 07 – Support
7.1 Resources
The organization shall determine and provide the resources;
o People
o Infrastructure
o Environment for the operation
o Monitoring and measuring resources
o Organizational knowledge (internal resources and external sources)
• The organization shall retain appropriate documented information as evidence of fitness purpose of the
monitoring and measurement resources.
• The knowledge shall be maintained and be made available to the extent necessary.

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 Clause No. 07 – Support
7.1 Resources
a) AOP (EPM No. 11.03.07)
b) Engineering work & resource planning (EPM No. 05.01.02)
c) Project Resource Planning (EPM No. 08.01.03)
d) Manpower / workforce planning (EPM No. 10.01.01)
e) IT Planning & Control (EPM No. 12.01)
f) Procurement of IT Hardware & Software (EPM No. 06.02.03 / SOP-02)
g) T&P Management (EPM No. 08.04.03)
h) Admin Site Facilities Process (EPM No. 10.04.01)
i) Office Facilities Management (EPM No. 10.04.05)
j) HIRA (EPM No. 13.02.01)
k) Site Establishment Process (EPM No. 09.01.03)
l) Management of Organization knowledge (EPM No. 02.02.01)
m) Knowledge Management Process (EPM No. 05.01.07)
n) Innovation (EPM No. 02.02.02)

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 Clause No. 07 – Support
7.2 Competence
The organization shall determine;
o Necessary competence of person(s) based on appropriate education,
training or experience
o Take actions to acquire the necessary competence, and evaluate the
effectiveness
The organization shall retain appropriate documented information as
evidence of competence.

a) Training Design & Execution (EPM No. 10.02.02)

b) PMS
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 Clause No. 07 – Support
7.3 Awareness
The organization shall ensure the awareness of;
o Quality policy
o Relevant quality objectives
o Contribution to the effectiveness of QMS, including the benefit of improved performance
o Implications of not conforming with QMS requirements

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 Clause No. 07 – Support
7.4 Communication
The organization shall determine the internal and external communication
including;
o On what it will communicate
o When to communicate
o With whom to communicate
o How to communicate
o Who communicates

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 Clause No. 07 – Support
7.4 Documented information
• Creating and updating;
o identification and description, review and approval

• Control of documented information;

o distribution, access, retrieval and use, storage and preservations,
control of changes, retention and disposition.

Documented information retained as evidence of conformity shall be protected from

unintended alterations.

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 Clause No. 08 – Operation
8.1 Operational planning and control
The organization shall
• plan, implement and control the processes needed to meet the requirements
• ensure that outsourced processes are controlled

The organization shall retain 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

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 Clause No. 08 – Operation
8.1 Operational planning and control
• Bid Risk Assessment & Mitigation (EPM No. 04.01)
• Estimation & Proposal (EPM No. 04.02)
• Procurement Planning (EPM No. 06.02.01/SOP-1)
• Customer Kick off meeting (EPM No. 08.01.01/SOP-1)
• Project L2 Schedule Preparation Process (EPM No. 08.01.02)
• L2 Schedule updation (EPM No. 08.02.01)
• Project Resource Planning Process (EPM No. 08.01.03)
• Preparation of Control Budget Process (EPM No. 08.01.04)
• Preparation of project financials Process (EPM No. 08.01.05)
• Contract Signing Process (EPM No. 08.02.03/SOP-1)
• Approval of QAP/FQP/Procedures (EPM No. 08.03.01)
• Construction schedule & resource Planning Process (EPM No. 09.01.01)
• Cost Monitoring (CTC) (EPM No. 08.02.02)

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 Clause No. 08 – Operation
8.2 Requirements for products and services
8.2.1 Customer communication;
o enquiries, contracts or orders, including changes, customer
feedback on products and services, including customer
complaints, handling or controlling customer property
8.2.2 Determining the requirements for products and services
8.2.3 Review of the requirements for products and services
8.2.4 Changes to requirements for products and services

The organization shall retain documented information, as applicable

a) on the results of the review
b) on any new requirements for the products and services

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 Clause No. 08 – Operation
8.2 Requirements for products and services

• Customer Engagement Process (EPM No. 14.01.01)

• VOC Mapping Process (EPM No. 14.01.02)
• Customer Satisfaction Survey Process (EPM No. 14.02.01)
• Customer Complaint Management Process (EPM No. 14.02.02)
• Customer Kick off meeting (EPM No. 08.01.01/SOP-1)
• Project L2 Schedule Preparation Process (EPM No. 08.01.02)
• Preparation and review of MOU and Agreement Process (EPM No. 08.02.03)
• Correspondence Management Process (EPM No. 08.02.10)
• Customer Assessment on Quality of works Process (EPM No. 08.03.04)
• Statutory Compliance Process (EPM No. 03.03.02)
• Estimation & Proposal Process (EPM No. 04.02)
• Tender risk assessment (Tend-1 & 2) (EPM No. 04.01.01)
• Proposal Engineering Process (EPM No. 04.02.01)
• Tend 3 Process (EPM No. 04.02.04)
• Detailed Order Intimation (DOI) Process (EPM No. 04.02.03)
• Engineering Change Management (EPM No. 05.01.05)
• Claims Management (EPM No. 08.02.12)
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 Clause No. 08 – Operation
8.3 Design and development of products and services
The organization shall establish, implement and maintain a design and development process;
• Design and development planning
• Design and development inputs
• Design and development controls
• Design and development outputs
• Design and development changes

The organization shall retain the documented information on design and development
o Inputs
o Controls
o Outputs
o Changes
o Results of review
o The authorization of the changes
o The actions taken to prevent adverse impacts
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 Clause No. 08 – Operation
8.3 Design and development of products and services

• Engineering Schedule Preparation Process (EPM No. 05.01.01)

• Value Engineering Process (EPM No. 05.01.03)
• Engineering Quality Control Process (EPM No. 05.01.04)
• Engineering Change Management Process (EPM No. 05.01.05)
• Engineering Document Management Process (EPM No. 05.01.06)
• Engineering Knowledge Management Process (EPM No. 05.01.07)
• Claims Management Process (EPM No. 08.02.03/SOP-4)

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 Clause No. 08 – Operation
8.4 Control of externally provided processes, products and services
• The organization shall determine the controls to be applied to externally provided processes, products
and services.
• The organization shall determine and apply criteria for the evaluation, selection, monitoring of
performance and re-evaluation of external providers.

8.4.2 Type and extent of control

8.4.3 Information for external providers

The organization shall retain documented information of these activities and any necessary action
arising from the evaluations.

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 Clause No. 08 – Operation
8.4 Control of externally provided processes, products and services

• Vendor Performance Evaluation Process (EPM No. 06.01.02)

• Project Procurement from HO/RO Process (EPM No. 06.02.01)
• CAPEX Procurement Process (EPM No. 06.02.03)
• Procurement of General & Administrative services Process (EPM No. 06.02.04)
• Logistics Management Process (EPM No. 06.02.05)
• Sub contractor subletting strategy Process (EPM No. 09.01.01/SOP-3)
• Sub contractors Contract Administration Process (EPM No. 09.01.05)
• Engineering Quality Control (EPM No. 05.01.04)
• Approval of QAP/FQP/Procedures (EPM No. 08.03.01)
• Inspection of supply items Process (EPM No. 08.03.02)

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 Clause No. 08 – Operation
8.5 Production and service provision
8.5.1 Control of production and service provision
8.5.2 Identification and traceability
8.5.3 Property belonging to customer or external providers
8.5.3 Preservation
8.5.4 Post-delivery activities
8.5.6 Control of changes

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 Clause No. 08 – Operation
8.5 Production and service provision

• Preparation of construction methodology Process (EPM No. 09.01.01/SOP-4)

• Preparation of Method statement for critical structures Process (EPM No. 09.01.01/SOP-5)
• Sub-Contractor Contract Administration Process (EPM No. 09.01.05)
• Client Billing Processes (EPM No. 09.01.06)
• Project Materials Management Process (EPM No. 06.03.01)
• Non Project Materials Management Process (EPM No. 06.03.02)
• Contract Management Process (EPM No. 08.02.03)
• Site Closure Process (EPM No. 09.01.07)
• Statutory Compliance Process (EPM No. 03.03.02)
• Inspection of supply items (EPM No. 08.03.02)
• Approval of QAP/FQP/Procedures Process (EPM No. 08.03.01)
• Quality Monitoring at Project Sites Process (EPM No. 08.03.03)
• Customer Assessment on Quality of works Process (EPM No. 08.03.04)

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 Clause No. 08 – 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;
• Evidence of conformity with the acceptance criteria
• Traceability to the person(s) authorizing the release

8.7 Control of nonconforming outputs

• Identify and control to prevent their unintended use or delivery.
• Take appropriate action based on the nature of the nonconformity

The organization shall retained documented information that:

• Describes the nonconformity
• Describes the action taken
• Describes any concession obtained
• Identifies the authority deciding the action in respect of the nonconformity
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 Clause No. 08 – Operation
8.7 Control of nonconforming outputs

• Site Closure Process (EPM No. 09.01.07)

• Contract Closeout Process (EPM No. 08.02.03/SOP-3)
• Inspection of supply items Process (EPM No. 08.03.02)
• Quality Monitoring at Project Sites Process (EPM No. 08.03.03)

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 Clause No. 09 – Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
The organization shall determine;
• What needs to be monitored and measured
• The methods for monitoring, measurement, analysis and evaluation to ensure valid results
• When the monitoring and measuring shall be performed
• When the results from monitoring and measurement shall be analysed and evaluated
9.1.2 Customer satisfaction – Monitor customer satisfaction

The organization shall retain appropriate documented information as evidence of the results.

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 Clause No. 09 – Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation

• Reviews on various parameters in ORM, PRM, BRM

• Customer Satisfaction Survey Process (EPM No. 14.02.01)
• Customer Engagement Process (EPM No. 14.01.01)
• Customer Complaint Management Process (EPM No. 14.02.02)
• Customer Assessment on Quality of works Process (EPM No. 08.03.04)

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 Clause No. 09 – Performance evaluation
9.2 Internal audit
The organization shall conduct internal audits at planned intervals.

The organization shall retain documented information as evidence of the implementation of the audit
programme and audit results.

1) Internal Quality Audit Process (QMD) (EPM No. 08.03.05)

2) Internal Audit process (EPM No. 03.02.02)

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 Clause No. 09 – Performance evaluation
9.3 Management review
The organization shall review the organization’s QMS at planned intervals.
9.3.2 Management review inputs
9.3.2 Management review outputs

The organization shall retain documented information as evidence of the results of management reviews

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 Clause No. 10 – Improvement
10 Improvement
The organization shall determine and select opportunities for improvement and implement any necessary
actions to meet customer requirements and enhance customer satisfaction.
10.2 Nonconformity and corrective action
10.3 Continual improvement
The organization shall continually improve the suitability, adequacy and
effectiveness of QMS.

The organization shall retain documented information as evidence of;

• The nature of nonconformities and any subsequent actions taken
• The results of any corrective actions

Process Based Management

(EPM No. 02.01.01)
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 Introduction

ISO 9001 and Business Excellence

QMS - Compliance Model Business Excellence - Improvement Model

ISO 9001 (TBEM | ISO 9004)

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ISO Manual in TPL NET

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EPM Documents in TPL NET

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EPM Documents in TPL NET

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EPM – ISO 9001 Integration

ISO

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 EPM – ISO 9001 Integration
EPM Structure QMS Structure
L1 Process: Enterprise level process.
Focus on governance. Will not be
audited. KPIs to be tracked. L1
L2 Process: Connector between L1
& L3. Logical grouping for
L2 Manual
management. Will not be audited.
KPIs to be tracked.

L3 Process: Operating level

processes. Will be audited. KPIs to be L3
tracked. SIPOC EPM Processes
SOP: Standard Operating Procedure.
Sub Process to L3. Will be audited. No SOP
SIPOC and KPIs.

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EPM – ISO 9001 Integration

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EPM – ISO 9001 Integration
Practice Recognition

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Any Questions !

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Thank You

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