Preview

of

TRAINING HANDBOOK
ON
'ISO 9001:2015 QMS AWARENESS'

Trainer, Editor and Publisher

KESHAV RAM SINGHAL
Email - [email protected]

KESHAV RAM SINGHAL

117, Jeevan Vihar Colony,
Anasagar Circular Road,
Ajmer - 305004, India

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A Training Handbook on 'ISO 9001:2015 QMS Awareness'
(For Private Circulation Only)

© Keshav Ram Singhal

Please note that the document 'ISO 9001:2015 QMS' standard is a copyright publication of
'International Organization for Standardization' (ISO) that can be obtained from ISO
headquarters or from the national standards organization member of ISO. In India, Bureau of
Indian Standards (BIS) is the member of ISO.

Please note that this Training Handbook should not be used as a substitute of ISO 9001:2015
QMS standard.

No part of this training handbook may be reproduced or distributed without permission from
the trainer.

First Edition
October 2015

The objective of this publication is to train people and create awareness.

Training Support Contribution Per Participant

For participant residing within India

Training Handbook (without evaluation of participant) - Rs. 500
Training Handbook and Evaluation - Rs. 750 (Certificate of successful completion will be
provided to successful candidate.)

For participant residing outside India

Training Handbook (without evaluation of participant) - US $ 20

20% of the Training Support Contribution received from participants will be transferred to 'Singhal
Institute for Training and Education Trust' for its activities.

Training Handbook (soft copy) is sent by email to the outstation participant.

Training Support Contribution

should be
Electronically transferred (NEFT) or Deposited to
Savings account no. 389202010006503 of 'KESHAV RAM SINGHAL'
with Union Bank of India, Naya Bazar Branch, Ajmer - IFS Code - UBIN0538922,
with information by email
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[email protected]
or
[email protected]

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Contents
# 01 - An introduction on 'ISO 9001:2015 QMS Awareness' Training

# 02 - Introduction - Historical background, Standard Development Timeline for ISO

9001:2015

# 03 - Overview - Foreword, Introduction, QMS - Requirements Clauses, Scope,

Normative references, Terms and definitions

# 04 - Context of the organization

# 05 - Leadership

# 06 - Planning

# 07 - Support

# 08 - Operation

# 09 - Performance evaluation

# 10 - Improvement

# 11 - Transition Planning

# 12 - Developing and Implementing ISO 9001:2015 QMS

# 13 - Risk-based Thinking - An integral part of ISO 9001:2015 QMS

# 14 - ISO 9001:2015 QMS - Understanding the process approach and PDCA

# 15 - ISO 9001:2005 - Quality Management Principles

# 16 - Change Management in ISO 9001:2015

# 17 - Adding Value to the Audit

# 18 - Post-training test details

ISO 9001:2015 QMS is a standard that sets out the requirements for a quality
management system. The standard helps organizations be more efficient and improve
customer satisfaction.

Using ISO 9001:2015 QMS standard can increase productivity and efficiency, thus
lowering the cost of an organization.

Certification is not a requirement of ISO 9001:2015 QMS standard, however getting

certified to the standard can enhance your organization's reputation attracting new
customers.

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# 01
An introduction on 'ISO 9001:2015 QMS Awareness'
Training

AN OPPORTUNITY TO LEARN AND UPDATE

YOUR KNOWLEDGE ON 'ISO 9001:2015 QMS AWARENESS'

LEARNING OBJECTIVES
UNDERSTAND THE IMPACTS OF NEW STANDARD ON YOUR QMS

After attending the training you will be able to understand KEY CHANGES that affect your
organization and your quality management system implementation, including the following -
Structure and terminology
Context of the organization
Risk-based thinking
Organizational knowledge
Role of top management
Management representative's role?
Documentation impact and requirements for documented information
Internal audit requirements
Understanding ISO 9001:2015 QMS requirements
Transition planning guidance
Implementation guidance
Quality management principles
Change management
Adding value to the audit

WHY SHOULD YOU ATTEND?

ISO 9001:2008 QMS certified organizations are required to comply with major change to ISO
9001:2015 QMS standard. Understanding what is different is the first step in implementing
the revised standard. You will require to ensure that the requirements mentioned in ISO
9001:2015 QMS standard are implemented in your organization before recertification.

WHO SHOULD ATTEND?

- Top, middle and junior management executives
- Personnel involved in QMS implementation
- Internal auditor
- Any individual

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TRAINER
Keshav Ram Singhal

You will learn from an expert professional and well known writer, who will help you
understand the changes and what they mean to you and your organization.

Trainer's Profile can be seen at (i) https://in.linkedin.com/in/krsinghal (ii) http://profile-

keshavramsinghal.blogspot.in/.

You may visit the blog on 'Quality Concepts and ISO 9001:2008 QMS Awareness'
(total hits more than 275,000) at http://iso9001-2008awareness.blogspot.in/.

You may visit the blog on 'Quality Concepts and ISO 9001:2015 QMS Awareness'
(total hits more than 4,500) at http://qmsawareness.blogspot.in/.

MODES OF TRAINING
(i) Face-to-face Training
One day (eight hours) duration
For Single Participant
Participant can visit Ajmer with prior appointment.
Training material (hard copy) will be provided. Face-to-face training fee Rs. 2,000.

(ii) Group Training

One day (eight hours) duration
For a group consisting 2 to10 participants
Interested participants can visit Ajmer with prior appointment.
Training material (hard copy) will be provided. Fee according to the size of the group.

(iii) In-house Training

One day (eight hours) duration
At Your Place
Sponsoring organization can call the trainer to conduct training programme.
Training material (hard copy) will be provided.
Sponsoring organization needs to arrange venue, photocopy facility and also staying
arrangement for the faculty. Fee according to the number of trainees.

(iv) Distance Training

For people interested to learn at their home/place. The learner can study and learn
whenever he/she wants, wherever he/she wants. Training material and assignments will be
sent by email. Learning registration will be valid for one month. During this period, the
participant can send his/her queries to the trainer by email, which will be replied. Training
contribution mentioned on page 2.

Evaluation optional at end of the training.

Certificate will be provided to successful candidates.

New skills and knowledge makes a learner more valuable.

Contact by email with your requirements and learner's details (name, profession,
address, phone/mobile, email id) to:
[email protected]
[email protected]

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# 02
Introduction
Historical Background

ISO 9001/2/3 standards series first published in 1987 and then revised in 1994.
Major revision in 2000 with publication of ISO 9001:2000 QMS Standard on 15 December
2000
Fourth edition – ISO 9001:2008 QMS Standard published on 15 November 2008.
Fifth edition – ISO 9001:2015 QMS Standard published on 15 September 2015

More than 25 years journey completed by ISO 9001 QMS, since it was first published in
1987.

International Organization for Standardization (ISO) is the largest developer and publisher of
international standards. It is an independent, non-governmental membership organization,
having a membership of 162 member countries (as on 15 November 2015). Standard
development work in ISO is done by ISO Technical Committees comprising experts
nominated by their standards body or liaison organization. ISO/TC 176 is the ISO Technical
Committee number 176 for Quality Management and Quality Assurance. ISO/TC 176/SC2 is
the subcommittee responsible for ISO 9001 and ISO 9004 standards, among others.

Standard Development Timeline for ISO 9001:2015

May-June 2012 - Proposal stage

June-October 2012 - Preparatory stage
June-September 2013 - Committee stage
ISO/CD 9001 released on 03 June 2013
May-October 2014 - Enquiry stage (DIS)
ISO/DIS 9001 voting started on 10 July 2014 and ended on 10 October 2014.
July 2015 - Approval stage (FDIS)
ISO/FDIS 9001 voting started on 09 July 2015 and ended on 09 September 2015.
80 countries voted on ISO/FDIS 9001 - 75 votes in favour, 5 abstentions, no negative vote.
15 September 2015 - Publication date of ISO 9001:2015 QMS standard.
23 September 2015 - ISO released press note 'ISO 9001:2005 - Just published!' on its
website

Why new version?

In the year 2000, there was major revision to ISO 9001 QMS standard. Since then business
needs and expectations have changed significantly, such as, the emergence of new
technologies, more demanding customers, more complex supply chains, more awareness of
the need for sustainable development initiatives. Last version of ISO 9001 was published in
2008 with minor revision to the year 2000 version. All ISO standards are reviewed every five
years to establish if a revision is required to keep the standard current and relevant for the
users.

Key feature changes

- New version is developed on the basis of seven QMPs, old version was developed on the
basis on eight QMPs

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- New version has ten clauses, old version has eight clauses,
- New version does not state any mandatory procedures, instead it requires certain
documented information to maintain and retain.
- The term 'documented information' replaces the terms 'document' and 'record'.
- Adoption of the high level structure as set out in Annex SL of ISO Directives
- Introduction of risk-based thinking to support and improve understanding and application of
the process approach
- Process approach strengthened and more explicit
- With introduction of risk-based thinking, concept of preventive action now addressed
throughout the standard by risk identification and mitigation
- Greater focus on customer and on achieving product/service conformity
- Control of externally provided products and services replaces purchasing and outsourcing
- Fewer prescriptive requirements in the new version
- Greater flexibility with documentation
- Improved applicability for services and non-manufacturing users
- Boundaries for the QMS need to be defined
- Emphasis on clear understanding of the organization's context
- More emphasis on leadership role
- Increased emphasis on seeking opportunities for improvement

Structure and terminology

ISO 9001:2015 QMS standard has used high level structure, as set out in Annex SL of ISO
Directives. Some of the terminology of ISO 9001:2015 QMS standard, in comparison with
the earlier version (ISO 9001:2008 QMS standard), have been changed.

Some of the changes are as under:

(i) The term 'product' or 'products' (used in ISO 9001:2008 QMS standard) is now 'product
and service' or 'products and services' in ISO 9001:2015 QMS standard.
(ii) The term 'exclusion' (used in ISO 9001:2008 QMS standard) is not used in ISO
9001:2015 QMS standard.
(iii) The term 'management representative' (used in ISO 9001:2008 QMS standard) is not
used in ISO 9001:2015 QMS standard.
(iv) The terms 'documentation', 'quality manual', 'documented procedures' and 'records'
(used in ISO 9001:2008 QMS standard) have been replaced by the term 'documented
information' in ISO 9001:2015 QMS standard.
(v) The term 'work environment' (used in ISO 9001:2008 QMS standard) is changed to the
term 'environment for the operation of processes' in ISO 9001:2015 QMS standad.
(vi) The term 'monitoring and measuring equipment' (used in ISO 9001:2008 QMS standard)
is now 'monitoring and measuring resources' in ISO 9001:2015 QMS standard.
(vii) The term 'purchased product' (used in ISO 9001:2008 QMS standard) is replaced by the
term 'externally provided products and services' in ISO 9001:2015 QMS standard.
(viii) The term ' supplier' (used in ISO 9001:2008 QMS standard) is replaced by the term
'external provider' in ISO 9001:2015 QMS standard.

Participant should note that there is no requirement in ISO 9001:2015 QMS standard for its
structure and terminology to be applied to the documented information of an organization's
quality management system. There is no requirement for the terms used by an organization
to be replaced by the terms used in ISO 9001:2015 QMS standard to specify QMS
requirements. Organizations are free to choose to use terms which suits them and their
operations. They can use the earlier used terms, such as, 'document', 'record', 'documented
procedure', 'supplier' etc. in their QMS documented information.

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Abbreviations used in this Training Handbook

DIS - Draft International Standard

D&D - Design and development
FDIS - Final Draft International Standard
FMEA - Failure Modes and Effect Analysis
ISO - International Organization for Standardization
PDCA - Plan-Do-Check-Act
QMP - Quality Management Principle
QMPs - Quality Management Principles
QMS - Quality Management System

Some Meanings

Legal = Statutory and regulatory

Establish = Set-up on a permanent basis, install, or create

Determine = Ascertain or establish exactly (with certainty) by research, examination or

calculation

Maintain documented information = Maintain document(s) or documented procedure(s). The

term 'maintain documented information' also include the possibility of retaining documented
information.

Retain documented information =Retain record(s)

Information = Not necessary to be documented information. It is for the organization to

decide whether or not it is necessary or appropriate to maintain documented information.

# 03
Overview
Foreword
Foreword in the standard provides information about ISO and the procedure used to develop
ISO9001:2015 QMS standard.

Committee responsible for the development of ISO 9001:2015 QMS - ISO/TC 176, Quality
management and quality assurance, subcommittee SC 2, Quality systems

ISO 9001:2015 is the fifth edition of ISO 9001 QMS standard and it replaces the fourth
edition, ISO 9001:2008 QMS standard.

Introduction
Introduction provides general introduction on QMS, seven quality management principles,
process approach including PDCA cycle and risk-based thinking, and relationship with other
management system standards.

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Para 0.1 - General

Adoption of QMS is strategic decision for an organization. QMS helps the organization to
improve all round performance and it also provides a sound basis for sustainable initiatives.

Potential benefits of implementing QMS are many including (i) ability to provide
product/service that meets customer and applicable legal requirements, (ii) more
opportunities to enhance customer satisfaction, (iii)addressing risks and opportunities, (iv)
ability to demonstrate conformity to requirements.

ISO 9001:2015 QMS standard can be used by internal and external parties.

ISO 9001:2015 QMS standard employs process approach including PDCA and risk-based
thinking.

Para 0.2 - Quality management principles

Seven QMPs are (i) Customer focus, (ii) Leadership, (iii) Engagement of people, (iv) Process
approach, (v) Improvement, (vi) Evidence-based decision making, and (vii) Relationship
management.

Para 0.3 - Process approach

ISO 9001:2015 QMS standard promotes adoption of process approach. Organization, using
process approach (managing organization's processes as a system as a whole) along with
PDCA cycle and risk-based thinking brings, takes advantages of opportunities and prevent
undesirable results.

ISO 9001:2015 QMS standard is now compliant with Annex SL Directives and aligned with
other management systems standards, such as ISO 14001, ISO 27001, ISO 20000, ISO
22301 etc.

QMS - Requirements Clauses

Clause 1 deals with scope

ISO 9001:2015 QMS standard specifies requirements for a QMS

Requirements are generic and applicable to any organization regardless of its type, size and
product/service

Clause 2 deals with normative references

Normative reference document mentioned - ISO 9000:2015, Quality management systems –

Fundamental and vocabulary

Clause 3 deals with terms and definitions

Terms and definitions as given in ISO 9000:2015 apply

Clause 4 to 10 deal with requirements of QMS

Clause 4 – Context of the organization

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This clause deals with the understanding of organization and its context, needs and
expectations of interested parties (stakeholders), scope of the organization's QMS, QMS
and QMS processes that describes how to establish, implement, maintain and improve QMS
in a summarized way. This clause requires understanding a broader view of the
organization's business and its interested parties.

4.1 - Understanding the organization and its context

4.2 - Understanding the needs and expectation of interested parties
4.3 - Determining the scope of the QMS
4.4 - QMS and its processes

Clause 5 – Leadership

This clause deals with the requirements for the top management that describe what their
roles should be. Leadership is the central theme of the QMS and PDCA cycle that is applied
to QMS.

5.1 - Leadership and commitment (5.1.1 - General, 5.1.2 - Customer focus)

5.2 - Policy (5.2.1 - Establishing the quality policy, 5.2.1 - Communicating the quality policy)
5.3 - Organizational roles, responsibilities and authorities

Clause 6 – Planning

This clause deals with requirements related to risk and opportunities, quality objectives and
planning to achieve them and planning of changes. This clause has introduced risk-based
thinking in the QMS. This clause is the part of 'Plan' of PDCA cycle.

6.1 - Actions to address risks and opportunities

6.2 - Quality objectives and planning to achieve them
6.3 - Planning of changes

Clause 7 – Support

Resources needed for QMS and to be provided is the subject matter of this clause. This
clause also deals with requirements of documented information, what and how need to
maintain and retain. This clause is part of 'Do' of PDCA cycle.

7.1 - Resources (7.1.1 - General, 7.1.2 - People, 7.1.3 - Infrastructure,7.1.4 - Environment

for the operation of processes, 7.1.5 - Monitoring and measuring resources, 7.1.6 -
Organizational knowledge)
7.2 - Competence
7.3 - Awareness
7.4 - Communication
7.5 - Documented information (7.5.1 - General, 7.5.2 - Creating and updating, 7.5.3 - Control
of documented information)

Clause 8 – Operation

Doing is described in this clause that relates to organizational operational processes. This
clause is part of 'Do' of PDCA cycle.

8.1 - Operational planning and control

8.2 - Requirements for products and services (8.2.1 - Customer communication, 8.2.2 -
Determining the requirements for products and services, 8.2.3 - Review of the requirements
for products and services, 8.2.4 - Change to requirements for products and services)

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8.3 - Design and development of products and services (8.3.1 - General, 8.3.2 -Design and
development planning, 8.3.3 - Design and development inputs, 8.3.4 - Design and
development controls, 8.3.5 - Design and development outputs, 8.3.6 - Design and
development changes)
8.4 - Control of externally provided processes, products and services (8.4.1 - General, 8.4.2
- Type and extent of control, 8.4.3 - Information for external providers)
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 customers or external
providers, 8.4.4 - Preservation, 8.4.5 - Post-delivery activities, 8.5.6 - Control of changes)
8.6 - Release of products and services
8.7 - Control of nonconforming outputs

Clause 9 – Performance evaluation

This clause deals with requirements of monitoring, measurement, analysis and evaluation.
Internal audit and management review requirements are part of this clause. This clause is
part of 'Check' of PDCA cycle.

9.1 - Monitoring, measurement, analysis and evaluation (9.1.1 - General, 9.1.2 - Customer
satisfaction, 9.1.3 - Analysis and evaluation)
9.2 - Internal audit
9.3 - Management review (9.3.1 - General, 9.3.2 - Management review inputs, 9.3.3 -
Management review outputs)

Clause 10 – Improvement

This clause deals with nonconformity, corrective action and continual improvement. This
clause is part of 'Act' of PDCA cycle.

10.1 - General
10.2 - Nonconformity and corrective action
10.3 - Continual improvement

Annex A

This Annex A is Informative and provides clarification on new structure, terminology and
concepts. This Annex is helpful in understanding the requirements of the standard.

Annex B

This Annex B is also informative and describes details of other international standards on
quality management and quality management systems developed by ISO/TC 176. The
organization can use other international standards, if organization chooses to progress
beyond requirements mentioned in ISO 9001:2015 QMS standard. Guidance or
requirements mentioned in other international standards listed in Annex B do not add to, or
modify, the requirements of ISO 9001:2015 QMS standard.

Bibliography

In the end of the ISO 9001:2015 QMS standard, bibliography is provided.

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# 04
Context of the organization
(4.1) Understanding organization and its context
Determine - Internal and external issues (positive and negative factors or conditions)
relevant to organization's purpose, strategic direction and that can affect organizational
ability to achieve intended results.

Monitor and review - Information about the determined external and internal issue (positive
and negative factors or conditions)

Clarification -
(i) There are many issues that can make easier the understanding the external context of the
organization. Such issues may arise from legal, technological, competitive, cultural, social
and economic environments and that can be global, national, regional or local.
(ii) There are many issues that can make easier the understanding the internal context of the
organization. Such issues may relate to the organization's values, culture, knowledge and
performance.

(4.2) Understanding the needs and expectations of interested

parties
Determine - (i) Interested parties relevant to the organization's QMS, and (ii) Requirements
of the determined interested parties that are relevant to the organization's QMS.

Monitor and review - Information about the determined interested parties and their
determined requirements

Clarification -
(i) Interested parties = Persons/organizations that can affect, be affected by, or perceive
themselves to be affected by a decision or activity.
(ii) Examples of interested parties - Customers, owners, employees, workers on contracts,
contractors, suppliers, bankers, unions, partners, society, competitors, opposite pressure
groups etc.
(iii) Why there is a requirement to understand the needs and expectations of interested
parties? Because interested parties' needs and expectations can have an effect or potential
effect on the organization's ability to consistently provide products/services that meet (fulfill)
customer and applicable legal requirements.

(4.3) Determining the scope of the QMS

Consider - (i) External and internal issues as determined in 4.1, (ii) Requirements (needs
and expectations) of the interested parties as determined in 4.2, (iii) Organization's products
and services.

Determine - (i) Boundaries and applicability of the QMS by considering the above and this
process will establish the scope of the QMS, (ii) If any requirement of ISO 9001:2015 QMS
standard is not applicable to the scope of the organization's QMS, then provide justification.

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Apply - All requirements of ISO 9001:2015 QMS standard, if applicable within the
determined scope of the organization's QMS. In case any requirement of ISO 9001:2015
QMS standard is not applicable to the scope of the organization's QMS, then justification
needs to be provided.

Maintain documented information - Organization's QMS scope, stating types of

products/services covered and the justification if any ISO 9001:2015 QMS standard
requirement not applicable to the scope.

Make available - The documented information that states determined scope of the
organization's QMS

Important Point - Conformity to ISO 9001:2015 QMS may only be claimed if determined
requirements as not being applicable do not affect the organization's ability/responsibility to
ensure the conformity of organization's products/services and the enhancement of customer
satisfaction.

Clarification - ISO 9001:2015 QMS standard does not use the term 'exclusion' or refer to
'exclusions' in relation to the applicability of the standard's requirements to the organization's
QMS. It is for the organization to review the applicability of ISO 9001:2015 QMS standard's
requirements due to (i) the organization's size, (ii) the organization's complexity, (iii) the
management model adopted by the organization, (iv) the range of organization's activities,
and (v) the nature of risks and opportunities the organization encounters. However, please
note that conformity to ISO 9001:2015 QMS may only be claimed if determined requirements
as not being applicable do not affect the organization's ability/responsibility to ensure the
conformity of organization's products/services and the enhancement of customer
satisfaction.

(4.4) QMS and its processes

Establish, implement, maintain and continually improve - Organization's QMS, including
the processes needed and their interactions, in accordance with ISO 9001:2015 QMS
standard's requirements.

Determine - (i) Processes needed for the QMS and their application throughout the
organization, (ii) Inputs required and output expected from determined processes, (iii)
Sequence and interaction of determined processes, (iv) Criteria and methods as well as
monitoring, measurements and related performance indicators needed for effective
operation and control of the determined processes, (v) Resources needed for the
determined processes

Ensure - Availability of the determined resources needed

Assign - Responsibilities and authorities for the determined processes

Apply - Determined criteria and methods and also monitoring, measurements and related
performance indicators needed for effective operation and control of determined processes

Address - Risks and opportunities (as determined in 6.1)

Evaluate - Determined processes (to ensure achieving intended results)

Implement - Any changes needed (to ensure achieving intended results)

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Improve - (i) Determined processes, (ii) QMS

Maintain documented information - That support the operation of organization's

processes

Retain documented information - That provide confidence that the processes being
carried out as planned

Only informative contents of the Training Handbook is

available free. To view full contents of the Training
Handbook, please provide the Training Support
Contribution.

# 18
POST-TRAINING TEST
If you wish to have your assessment on 'ISO 9001:2015 QMS Awareness Training', you can
appear in the post-training test.

For distance training participant, post-training test paper is sent by email.

Upon successful completion of the course, the participant will receive softcopy of the
certificate.

Passing score - 75% or more

Participant can also reappear in the post-training test, if he could not score the passing score,
for which he/she will be sent assessment questionnaire again. No fee charged for the
reassessment.

Evaluation optional at the end of the training.

Certificate will be provided to successful candidates.

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