Chapter:1 Overview of ISO 9001: 2015 Quality Management System

1.0 Background of the new standards

The rules of the International Organisation for Standardisation (ISO) require that all standards
are reviewed every five years to ensure that they reflect the best practice in the particular
subject and take into account any lessons that have been learnt during the application of the
standard. The outcome of these reviews is that standards are confirmed, revised or
withdrawn.
Every organization would like to improve the way it operates, whether that means increasing
market share, driving down costs, managing risk more effectively or improving customer
satisfaction. A quality management system gives you the framework you need to monitor and
improve performance in any area you choose.

ISO 9001 is by far the world‟s most established quality framework, currently being used by
over three-fourth of a million organizations in 161 countries, and sets the standard not only for
quality management systems, but management systems in general.

It helps all kinds of organizations to succeed through improved customer satisfaction, staff
motivation and continual improvement.
ISO 9000 series of standards

ISO 9001 is one of a series of quality management system standards. It can help bring out the
best in your organization by enabling you to understand your processes for delivering your
products/services to your customers. The ISO 9001 series of standards consist of:
 ISO 9000 – Fundamentals and Vocabulary: This introduces the user to the concepts
behind the management systems and specifies the terminology used.
 ISO 9001 – Requirements: This sets out the criteria you will need to meet if you wish to
operate in accordance with the standard and gain certification.
 ISO 9004 – Guidelines for performance improvement: Based upon the eight quality
management principles, these are designed to be used by senior management as a
framework to guide their organizations towards improved performance by considering the
needs of all interested parties, not just customers.
2.0 Why ISO 9001?
ISO 9001 is a useful tool because it:
1. Supports export.
2. Provides confidence to customers.
3. Reduces wasted efforts and resources.
4. Gives a pathway to Total Quality Management.
5. Removes inter-departmental hassles.
6. Assures Top Management‟s commitment and involvement.
7. Involves all functions, all departments at all levels.
8. Sets out a disciplined way of working.
9. Builds structure for Quality Management according to needs.
10. Is preventive, rather than curative.
11. Works as a Strategic business tool.
12. Enhances return on investment.

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Chapter:1 Overview of ISO 9001: 2015 Quality Management System

3.0 Why not ISO: 9001? (For whom ISO: 9001 is not a useful tool)
ISO 9001 is not useful for those who:
1. Do not want to spend money.
2. Believe in monopoly supplier.
3. Do not want to export.
4. Do not care for customers.
5. Have unlimited resources.
6. Do not believe in involving people.
7. Do not want to train employees.
8. Enjoy fire fighting and quick fixes.
9. Believe that quality does not pay.
10. Do not want to commit anything on paper.
11. Expect miracles to overcome challenge.
12. Have other sources of income and don't want to grow.

4.0 Benefit of ISO 9001

The benefits of ISO: 9001 are summarized below:

 Competitive advantage
ISO 9001 should be led by top-management, which ensures that senior management
takes a strategic approach to its management systems. Our assessment and
certification process ensures that the business objectives are constantly fed into your
processes and working practices to ensure that you maximise your assets.
 Improves business performance and manages business risk
ISO 9001 helps your managers to raise the organization‟s performance above and
beyond competitors who aren‟t using management systems. Certification also makes it
easier to measure performance and better manage business risk.
 Attracts investment, enhances brand reputation and removes barriers to trade
ISO 9001 certification will boost your organization‟s brand reputation and can be a
useful promotional tool. It sends a clear message to all interested parties that this is a
company committed to high standards and continual improvement.
 Saves you money
Evidence shows that the financial benefits for companies that have invested in and
certified their quality management systems to ISO 9001 include operational
efficiencies, increased sales, higher return on assets and greater profitability.
 Streamlines operations and reduces waste
The assessment of your quality management system focuses on operating processes.
This encourages organizations to improve the quality of products and the service
provided and helps to reduce waste and customer complaints.
 Encourages internal communication and raises morale
ISO 9001 ensures that employees feel more involved through improved
communication. Regular assessment visits can highlight any skills shortages sooner
and uncover any teamwork issues.

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 Chapter:1 Overview of ISO 9001: 2015 Quality Management System

 Increases customer satisfaction

The „Plan, Do, Check, Act‟ structure of ISO 9001 ensures that the needs of the
customer are being considered and met.

The above benefits can be summarized as internal / intrinsic benefits and external /
extrinsic benefits of ISO: 9001 certification, as listed below.

4.1 INTERNAL BENEFITS:

 Improved quality (reduction in waste, rework, scrap, less complaints, etc.)

 Improved efficiency, productivity and effectiveness
 Improved level of motivation, co-operation, workmanship and quality awareness
 Improved communication and quality information and greater quality awareness
 Greater control of processes and activities throughout organisation
 An onward journey of improvement is possible on an on-going basis
 Better quality means more satisfied customers leading to increased business
prospects and better market image
 Competitiveness through cost reduction by eliminating waste and rework, and
scraping overtime
 Increased customer confidence
 Improved employee morale
 Improved cycle time
 Improved communication and quality of information.
4.2 EXTERNAL BENEFITS: -

 Competitive edge to the company in domestic as well as global market

 Worldwide recognition and credibility
 Quality to bid on new contracts
 Improved corporate quality image
 Tool for motivating suppliers to conform
 Reduction in customer audit
 Higher customer satisfaction and increased confidence among customers.

5.0 Overview of ISO 9001: 2015 standard

0 Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Context of organization
5 Leadership
6 Planning
7 Support
8 Operations
9 Performance evaluation
10 Improvement

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Chapter:1 Overview of ISO 9001: 2015 Quality Management System

5.1 Re-organized structure of ISO 9001: 2015 quality management

standard
The following parts have been reorganized in ISO 9001: 2015:

4. Context of the organization – addresses needs and expectations of interested

parties and scope of quality management system.
5. Leadership – addresses management commitment, policy, roles, responsibilities
and authorities.
6. Planning – includes risks, opportunities, objectives and plans to achieve them, and
the planning of changes
7. Support – includes resources, competence, awareness, communication and
documented information
8. Operation – includes planning and control, determining market needs, interaction
with customers, planning process, control of external provisions of goods/services,
production of goods, provision of services, release of goods/services and non-
conforming goods/services
9. Performance evaluation – includes monitoring, measurement, analysis and
evaluation, internal audit, and management review.
10. Improvement – addresses non-conformity and corrective action, improvement

5.2 What’s new in ISO: 9001-2015?

• Use of the High Level Structure (HLS).

• Increased emphasis on organizational context.
• Risk management is being added with focus on risk-based thinking. Identification
of risk and risk control is now a requirement.
• Standardized core text, structure and definitions enable organizations with multiple
management systems to achieve improved integration and implementation.
• Revisions allow ISO: 9001 to be more applicable by “service-based” organizations.
• Standardized core text, structure, definitions enable organizations with multiple
management systems to achieve improved integration and implementation.
• Major focus is on achieving value for organization and its customers. The customer
remains the primary focus.
• .Improved applicability for services.
• Fewer prescribed requirements.
• Boundaries of the QMS must be defined.
• The term „documented information‟ replaces „documents and records‟.
• The term „outsourcing‟ is replaced by „external provision‟.
• Increased leadership requirements.
• No requirement for a management representative.
• Objectives must include reference to who, what and when
• Planning of changes.
• Explicit reference to knowledge management.
• No need for a Quality Manual.
• Operational planning includes addressing risks.
• Greater emphasis on processes achieving requirements for goods or services and
customer satisfaction.
• Internal audits now require the consideration of related risks.
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 Chapter:1 Overview of ISO 9001: 2015 Quality Management System

• Management review to take into consideration strategic direction of the

organization.
• New concepts are being considered.
• A new common ISO format has been developed for use across all Management
System Standards.

5.3 Main Changes in ISO: 9001-2015

Context of organization
 Two new clauses 4.1 and 4.2 have been included.
 Clause 4.1 is in line with physical boundary of quality management system. The
criteria defined included activities and physical / locational boundaries. This also
supports the definition of scope (Clause 1)
 Concept of customer extended to interested parties. Organization may not consider
interested party if not relevant to the system. (It has no impact on organization‟s
ability to consistently provide products and services that meet customer and
applicable regulatory requirements or impact customer satisfaction.)
Risk-based approach
 In line with Clause 4.1 (context of organization)
 Clause 6.1 to determine risks associated with its context, products and services.
 Preventive action clause deleted, since risk-based approach is a preventive tool.
 Risk-based system reduces prescriptive and focuses on performance-based
requirements.
 Risk and opportunities need to be determined and addressed. However, formal risk
management or documented risk management process is not required.
Structure and responsibility
 In line with other management standards – 10 clauses.
 Exclusions deleted – no restriction of clause 7.
 The term „Products and services‟ replaces „products‟.
 „Documented information‟ replaces „documents, records‟.
 „External provider‟ replaces „supplier‟.
 „Externally provided products and services‟ replace „purchased product‟.
Outsourcing now formally included (instead of a note in clause 4.1).
 Quality management system documentation need not follow standard structure .
 All terms used in standard can be changed after definition.
5.4 Objectives of revisions in ISO standards
 Enhance an organization‟s ability to satisfy customers.
 Maintain relevance, provide integrated approach to organizational management,
and integrate with other management system standards.
 Reflect needs of all user groups and increasingly complex operating environments.
 Increase confidence in an organization's ability to provide conforming goods and/or
services.
 Enhance customer confidence in quality management systems based on ISO 9001.
 Set a consistent foundation for next 10 years.

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Chapter:1 Overview of ISO 9001: 2015 Quality Management System

5.5 What was considered for revising the ISO standard?

International experts nominated by ISO member bodies looked at a number of items to
help guide revision activities:
 An extensive web-based user survey
 New quality concepts and ideas for inclusion in ISO 9001
 Revised quality management principles
 Formal interpretations of ISO 9001:2008
 Support and guidance notes
 Common terminology with other standards

5.6 What prompted revisions?

 Business and industry has changed.
 Greater diversity of ISO 9001 users and broader interests of users.
 Knowledge and technology developments.
Reasons for the changes:
 Decrease the emphasis on documentation.
 Increase the emphasis on achieving value for the organization and its customers.
 Increase the emphasis on risk management to achieve the objectives.

6.0 Steps for implementation of ISO 9001:2015 quality management

system
The global objectives of the implementation of ISO: 9001-2015 are: “Say what
you do” and “Justify what you do”

All the progressive units in India, which are in the export market today, have adopted
some system of obtaining the final product quality. However, in this system there are
generally a lot of rework and wastages. Experience of other industries in India and
outside India shows that extensive efforts on the part of each and every person in the
organisation are needed for upgrading the existing system to meet the requirements of
ISO: 9001 quality system. In revised ISO 9001: 2015 standard, approach of risk
identification and taking necessary actions are required.

The time required for installation of this system in any company may vary depending
upon their present status and work culture. The total cost includes the cost of
consultancy, fees of certifying body, resource requirement, etc., depending on
infrastructure available with the company‟s established system and complexity of work
involved.

The steps for implementation of this system are:

1. Conduct awareness programmes (Top + Middle + Bottom level).
2. Form a task force for documentation.
3. Prepare documents of quality system.
4. Implementation and train all personnel in the use of procedures and formats.
5. Train internal auditors.
6. Assess the system through an internal audit.
7. Take corrective actions for non-compliances.
8. Apply for certification.
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Chapter:1 Overview of ISO 9001: 2015 Quality Management System

9. Assess the system through second round of internal audit.

10. Avail pre-certification audit of certifying body.
11. Take actions on suggestions given by them.
12. Maintain and improve the system by third round of internal audit.
13. Final audit by certifying body.

Conclusion
Quality under ISO 9001 will not give any company the status of the best product producer.
But what it will give to the company is a more consistent product and a system of operation
that is totally oriented to the customers‟ needs. It will require a lot of hard work and a lot of
headaches, but ultimately it will pay in terms of Quality Assured product.

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Chapter:1 Overview of ISO 9001: 2015 Quality Management System

Annexure -1

Clarification of New Structure, Terminology and Concepts

1 Structure and terminology
The clause structure and some of the terminologies of this International Standard, in
comparison with ISO 9001:2008, have been changed to improve alignment with other
management systems standards.

The consequent changes in the structure and terminology do not need to be reflected in the
documentation of an organization‟s quality management system.

The structure of clauses is intended to provide a coherent presentation of requirements rather

than a model for documenting an organization‟s policies, objectives and processes. There is no
requirement for the structure of an organization's quality management system documentation to
mirror that of this International Standard.

Table: Major differences between terminologies of ISO 9001:2008 and ISO 9001:2015

ISO 9001:2008 ISO 9001:2015

Products Products and services
Exclusions Not used (See Annex -4 for clarification of applicability)
Documentation, records Documented information
Work environment Environment for the operation of processes
Purchased product Externally provided products and services
Supplier External provider

2 Products and services

ISO 9001:2008 used the term “product‟ to include all output categories. This International
Standard uses “products and services”. The term “products and services” includes all output
categories (hardware, services, software and processed materials).

The specific inclusion of “services” is intended to highlight the differences between

products and services in the application of some requirements. The characteristic of
services is that at least part of the output is realised at the interface with the customer. This
means, for example, conformity to requirements cannot necessarily be confirmed before
service delivery.

3 Context of the organization

There are two new clauses relating to the context of the organization: 4.1 Understanding the
organization and its context and 4.2 Understanding the needs and expectations of
interested parties. Together, these clauses require the organization to determine the issues
and requirements that can impact on the planning of the quality management system.

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Chapter:1 Overview of ISO 9001: 2015 Quality Management System
The scope of the standard states, in part, that this International Standard is applicable
where an organization needs to demonstrate its ability to consistently provide products and
services that meet customer and applicable statutory and regulatory requirements and aims
to enhance customer satisfaction. No requirement of this International Standard can be
interpreted as extending that applicability without the agreement of the organization.

4 Risk- based thinking

This International Standard requires the organization to understand its context (see clause
4.1) and determine the risks and opportunities that need to be addressed (see clause 6.1).

One of the key purposes of a quality management system is to act as a preventive tool.
Consequently, this International Standard does not have a separate clause or sub- clause
titled 'Preventive action‟. The concept of preventive action is expressed through a risk-based
approach to formulating quality management system requirements.

The risk-based approach to drafting this International Standard has facilitated some
reduction in prescriptive requirements and their replacement by performance-based
requirements.

5 Applicability
Where a requirement can be applied within the scope of its quality management system, the
organization cannot decide that it is not applicable. Where a requirement cannot be applied (for
example where the relevant process is not carried out) the organization can determine that the
requirement is not applicable. However, this non-applicability cannot be allowed to result in
failure to achieve conformity of products and services or to meet the organization‟s aim to
enhance customer satisfaction.

6 Documented information
As part of the alignment with other management system standards, a common clause on
'Documented Information' has been adopted without significant change or addition (see
7.5). Where appropriate, text elsewhere in this International Standard has been aligned with its
requirements. Consequently, the terms “documented procedure” and “record” have both been
replaced throughout the requirements text by “documented information”. So the major focus in
the ISO/DIS 9001: 2015 is to reduce documentation and only few places requirements of
documented information is requested.

7 Organisational knowledge
Clause 7.1.5 Organisational knowledge addresses the need to determine and maintain the
knowledge obtained by the organization, including by its personnel, to ensure that it can
achieve conformity of products and services.

The process for considering and controlling past, existing and additional knowledge needs
to take account of the organization‟s context, therefore, it is advisable to make the knowledge
library to gain good and bad experience of the past and share the same with all concerned
persons.

8 Control of externally provided products and services

Clause 8.4 Control of externally provided products and services addresses all forms
of external provision, whether it is by purchasing from a supplier, through an arrangement with
an associate company, through the outsourcing of processes and functions of the organization
or by any other means.

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Chapter:1 Overview of ISO 9001: 2015 Quality Management System
The organization is required to take a risk-based approach to determine the type and extent
of controls appropriate to particular external providers.

Annexure -2

Some facts about ISO and messages from ISO 9001:2015

 ISO is International Organization for Standardization.

 ISO is based on the Greek word ISO, which means “equal” or standardization, as the
universal short form of its name.
 ISO is an independent Non-Government Organization; its head-quarter is in Geneva –
Switzerland.
 ISO is a system management certificate not a product certificate.
 ISO is made up of 160 National Standards Bodies (“NSBs”)
 All standards are based on international consensus.
 ISO 9001 is a quality management system standard.
 ISO 9001 standard focus on quality principle, process approach – SIPOC with PDCA,
risk-based thinking and relation with other management system standards.
 ISO standards are usually developed by its Technical Committees (“TCs”) and Sub-
committees (“SCs”)
 ISO/TC176/SC2 (Quality Systems) is responsible for ISO 9001.
 ISO 9001:2015 was published on15th September 2015.

Messages from ISO 9001:2015 Standard

Message in four lines( ISO 9001:2015 )

• Plan what you do (resources / objectives / activities / controls / procedures)
• Do what you say (deploy and confirm with plan)
• Check what you do (measure and monitor for conformity and effectiveness of system)
• Act (analyze / review / decide / change / improve effectiveness)
Message in one line (1994)
• Do right thing, first time, every time to achieve consistent quality.
Message in one line (2008)
• Continual improvement is the way of life.
Message in five lines (2008)
• Plan what you do
• Do what you say
• Record what you do
• Check the difference
• Act on the difference

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 Chapter:1 Overview of ISO 9001: 2015 Quality Management System

Annexure -3

Basic Process Model of ISO: 9001-2015

Any activity or set of activities that uses resources to transform inputs to outputs can be
considered as a process. Outputs from one process are typically inputs for other processes.

Overall aim of ISO: 9001-2015 standard is to add value by planning and controlling processes.

Schematic Representation of Process Approach

• Top management processes include, for example, planning, allocation of resources,

management review, etc.
• Realization processes include, for example, customer related processes, design and
development, product realization, etc.
• Support processes include, for example, training, maintenance, etc.

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