Assignment No.

Please write detailed notes at the following standards of Quality Management

System,after going through the course material, internet and other supporting
sources:
1- ISO 9001:2015: Quality Management Systems - Requirements.
2- ISO 9000:2015: Quality Management Systems - Fundamentals and
Vocabulary (definitions)
3- ISO 9004:2018: Quality Management - Quality of an Organization -
Guidance to Achieve Sustained Success (continuous improvement)

The International Organization for Standardization (ISO) is a non-governmental organization

whose role is to facilitate international coordination and the standardization of industrial
standards. These standards contribute to the development, manufacturing and delivery of
products and services that are more effective, safer and clearer. ISO performs systematic reviews
every 3-5 years to keep these standards up-to-date.

The revision process adjusts them to changes in the environment with the aim at improving
organization’s ability to offer products and services that meet customer’s requirements. ISO has
revised world’s leading Quality Management System (QMS), ISO 9001:2008 to ISO 9001:2015.

What is Quality Management System (QMS)?

Quality management system is defined as a set of interrelated or interacting elements to establish

policies, objectives, and processes to achieve those objectives with regard to quality.

QMS is part of the overall management system, based on a business risk approach, to establish,
implement, operate, monitor, review, maintain and improve quality.

ISO 9001:2015 specifies requirements to plan, establish, implement, operate, monitor, review,
maintain and continually improve a documented management system used to manage quality.
The requirements set in ISO 9001:2015 are generic, flexible and useful to all types of
organizations. Thus, this ISO Management System Standard can be aligned and integrated with
other Management Systems such as Energy Management, Business Continuity Management and
other management systems, due to their similar structure.
Quality management standardization evolves with ISO 9001:2015 by adding:

• Greater emphasis on process approach, risk management, monitoring performance and

metrics;

• Better focus on interested parties;

• More careful analysis of the context of the organization needed for ensuring quality
improvement;

ISO 9001 applies to all types and sizes of organizations that wish to:

1. establish, implement, maintain and improve a QMS;

2. assure conformity with the organization’s stated quality policy;

3. demonstrate conformity to others;

4. seek certification/registration of its QMS by an accredited third party certification body;

or

5. Make a self-determination and self-declaration of conformity with this International

Standard.

ISO 9001:2015 is the first quality management standard to be fully compliant with the new
guidelines from Annex SL (“High level structure and identical text for management system
standards and common core management system terms and definitions”). It has been developed
in response to standards users’ critics that, while current standards have many common
components, they are not sufficiently aligned, making it difficult for organizations to rationalize
their systems and to interface and integrate them. This means that ISO 9001 is integrated to the
high-level structure and common text that will make it totally aligned with all other management
systems once the related standards have also adopted the Annex SL guidelines.

Key clauses of ISO 9001:2015

Following the new structure of the Annex SL, ISO 9001 is organized into the following main
clauses:

Clause 1: Scope
Clause 2: Normative references
Clause 3: Terms and definitions
Clause 4: Context of the organization
Clause 5: Leadership
Clause 6: Planning for the quality management system
Clause 7: Support
Clause 8: Operation
Clause 9: Performance evaluation Clause
10: Improvement

Each of these key areas is listed and described below.

|| Clause 4: Context of the organization

The organization shall determine external and internal issues that are relevant to its purpose and
its strategic direction and that affect its ability to achieve the intended result(s) of its QMS such
as:

• issues arising from technological, competitive, market, culture, social, and economic
environments;

• issues related to values, culture, knowledge and performance of the organization;

• the identified needs and expectations of relevant interested parties;

• Applicable legal, regulatory and other requirements to which the organization subscribes.

Defining the scope of the QMS, taking into account the organization’s strategic objectives, key
products and services, risk tolerance, and any regulatory, contractual or stakeholder obligations
is also part of this clause

Clause 5: Leadership

Top management shall demonstrate leadership and commitment with respect to the quality
management system by:

• Taking accountability of the effectiveness of the quality management system;

• Ensuring that the quality policy and quality objectives are compatible with the strategic
direction and the context of the organization;

• Ensuring that the quality policy is communicated, understood and applied within the
organization;

• Ensuring the integration of the QMS requirements into the organization’s business
processes;

• Promoting awareness of the process approach;

 • Ensuring that the resources needed for the QMS are available;

• Ensuring that the QMS achieves its intended results;

• Engaging, directing, and supporting persons to contribute to the effectiveness of the

QMS;

• Promoting continual improvement;

• Ensuring that customer requirement and applicable statutory and regulatory requirements
are deter- mined and met;

Clause 6: Planning for the quality management system

This is a critical stage as it relates to establishing strategic objectives and guiding principles
for the QMS as a whole. The intent of the organization to treat the risks identified and/or to
comply with the QMS requirements can be expressed through the QMS objectives. The
quality objectives shall:

• be consistent with the quality policy;

• be measurable;

• take into account applicable requirements;

• be relevant to conformity of products and services and the enhancement of customer

satisfaction;

• be monitored, communicated and updated as appropriate.

Clause 7: Support
The day-to-day management of an effective quality management system relies heavily
on using the appropriate resources for each task. These include having competent staff
with relevant (and demonstrable) training and supporting services, awareness and
communication. This must be supported by properly managed documented information.

Both internal and external communications of the organization must be considered in

this area, including the format, the content and the proper timing of such
communications.

The requirements on the creation, update and control of documented information are
also specified in this clause.
Clause 8: Operation

After planning the QMS, an organization must put it into operation. This clause includes:
 Operational planning and control: This activity includes implementation of plans and
processes that lead the organization towards meeting the quality management system
requirements. Additionally, this clause requires from organizations that they establish
controls which help in preventing any deviation from the quality policy, objectives, and legal
requirements.

After the requirements have been established, the organization should control the planned
changes and review the unintended changes to mitigate any adverse effect. All the processes
within the organization, including outsourced processes should be controlled.

Clause 9: Performance Evaluation

Once the QMS is implemented, ISO 9001 requires permanent monitoring of the system as
well as periodic reviews to:

• demonstrate conformity of products and services to requirements;

• assess and enhance customer satisfaction;

• ensure conformity and effectiveness of the quality management system;

• demonstrate that planning has been successfully implemented;

• assess the performance of processes;

• assess the performance of external providers

• Determine the need or opportunities for improvements within the quality management
system.

Clause 10: Improvement

Continual improvement can be defined as all the actions taken throughout the organization to
increase effectiveness (reaching objectives) and efficiency (an optimal cost/benefit ratio) of
processes and controls to bring increased benefits to the organization and its stakeholders. An
organization can continually improve the effectiveness of its management system through the
use of the quality policy, objectives, and audit results, analysis of monitored events, indicators,
risk analysis, corrective actions and management review.
ISO 9000:2015
Scope

This International Standard describes the fundamental concepts and principles of quality
management which are universally applicable to the following: organizations seeking
sustained success through the implementation of a quality management system; — customers
seeking confidence in an organization’s ability to consistently provide products and services
conforming to their requirements; organizations seeking confidence in their supply chain that
product and service requirements will be met; organizations and interested parties seeking to
improve communication through a common understanding of the vocabulary used in quality
management; organizations performing conformity assessments against the requirements of
ISO 9001; providers of training, assessment or advice in quality management; developers of
related standards. This International Standard specifies the terms and definitions that apply to
all quality management and quality management system standards developed by ISO/TC
176.

Fundamental concepts and quality management principles

General

The quality management concepts and principles described in this International Standard
give the organization the capacity to meet challenges presented by an environment that is
profoundly different from recent decades. The context in which an organization works today
is characterized by accelerated change, globalization of markets and the emergence of
knowledge as a principal resource. The impact of quality extends beyond customer
satisfaction: it can also have a direct impact on the organization’s reputation.

Fundamental concepts

Quality

An organization focused on quality promotes a culture that results in the behaviour, attitudes,
activities and processes that deliver value through fulfilling the needs and expectations of
customers and other relevant interested parties. The quality of an organization’s products and
services is determined by the ability to satisfy customers and the intended and unintended
impact on relevant interested parties. The quality of products and services includes not only
their intended function and performance, but also their perceived value and benefit to the
customer.

Quality management system

A QMS comprises activities by which the organization identifies its objectives and
determines the processes and resources required to achieve desired results. The QMS
manages the interacting processes and resources required to provide value and realize results
for relevant interested parties. The QMS enables top management to optimize the use of
resources considering the long and short term consequences of their decision. A QMS
provides the means to identify actions to address intended and unintended consequences in
providing products and services.

Context of an organization Understanding the context of the organization is a process. This

process determines factors which influence the organization’s purpose, objectives and
sustainability. It considers internal factors such as values, culture, knowledge and
performance of the organization. It also considers external factors such as legal,
technological, competitive, market, cultural, social and economic environments. Examples of
the ways in which an organization’s purpose can be expressed include its vision, mission,
policies and objectives.

Interested parties The concept of interested parties extends beyond a focus solely on the
customer. It is important to consider all relevant interested parties. Part of the process for
understanding the context of the organization is to identify its interested parties. The relevant
interested parties are those that provide significant risk to organizational sustainability if their
needs and expectations are not met. Organizations define what results are necessary to
deliver to those relevant interested parties to reduce that risk.

People

People are essential resources within the organization. The performance of the organization
is dependent upon how people behave within the system in which they work. Within an
organization, people become engaged and aligned through a common understanding of the
quality policy and the organization’s desired results.

Competence

A QMS is most effective when all employees understand and apply the skills, training,
education and experience needed to perform their roles and responsibilities. It is the
responsibility of top management to provide opportunities for people to develop these
necessary competencies.

Awareness

Awareness is attained when people understand their responsibilities and how their actions
contribute to the achievement of the organization’s objectives.

Communication Planned and effective internal (i.e. throughout the organization) and
external (i.e. with relevant interested parties) communication enhances people’s engagement
and increased understanding of: the context of the organization; the needs and expectations
of customers and other relevant interested parties; the QMS.
Quality management principles

Customer focus

Statement The primary focus of quality management is to meet customer requirements and to
strive to exceed customer expectations.

Rationale Sustained success is achieved when an organization attracts and retains the
confidence of customers and other relevant interested parties. Every aspect of customer
interaction provides an opportunity to create more value for the customer. Understanding
current and future needs of customers and other interested parties contributes to the sustained
success of the organization.

Whether your business has a 50-year history or just opened last year, you need to make sure you
have a system of sustained success. ISO Q9004: Quality Management Systems–Managing for the
Sustained Success of an Organization “provides guidance to management for achieving sustained
success of any organization in a complex, demanding, and ever-changing environment.”

With organizations completing ISO 9001:2015 updating by the fall deadline, ISO 9004
readies to be reintroduced in an updated version. With these two updates in full swing, it
appears an opportune moment to compare these quality management system (QMS)
standards and offer insight into the ISO 9004 update.

ISO 9001:2015 vs. ISO 9004:2018

A common misconception is that ISO 9004 is a guideline for the implementation of ISO
9001. This is not the case. The standards have been designed to complement one another but
serve different purposes. That said, it is important to note that an organization can use ISO
9001 and 9004 simultaneously or independently of one another. The International
Organization for Standardization (ISO) website includes an excellent summary of the
differences between the ISO 9001 and 9004 standards. Here is a list of some of the key
components of each standard (found on https://www.iso.org/news/Ref2187.htm).

Purpose

ISO 9001 provides a framework for a systematic approach to managing an organization’s

processes so that their products or services are consistent and meet client expectations.

ISO 9004 is intended to help organizations extend the benefits of their quality management
system (QMS) to all interested parties, helping to give sustained success.

Certification

ISO 9001 is a requirements document that an organization can be certified against to

demonstrate conformance to its requirements.
ISO 9004 is not intended for certification. It is a guidance document on how to achieve
continuous improvement.

Focus

ISO 9001 is primarily a customer requirements standard, ensuring conformance to defined

customer requirements and ensuring effective response to customer feedback.

ISO 9004 focuses on meeting the requirements of customers and all other interested parties to
achieve sustained success.

Continual Improvement

In ISO 9001 continual improvement of the QMS is achieved mainly by performing

management reviews, internal/external audits and corrective/preventive actions.

ISO 9004 promotes self-assessment in order for organizations to identify areas of strength or
weakness and opportunities for either improvements or innovations, or both.

How is ISO 9004:2018 different from ISO 9004:2009?

While ISO 9001:2015 was a major revision, incorporating risk management throughout the
standard, it appears ISO 9004:2018 is closer to a maintenance revision.

On the ISO website, Nigel Croft, chair of ISO/TC 176/SC 2, the technical subcommittee in
charge of revising the standard, whose secretariat is held by BSI, ISO’s member for the U.K.,
is quoted as saying, “The new edition of ISO 9004 will build on, and improve the guidance
of, the previous 2009 version and will help organizations improve their overall performance
by releasing the full potential of their quality management system.”

Of significance to organizations is the inclusion of an enhanced self-assessment tool. The

tool was designed to assist organizations in assessing the level of maturity of the various
components of the QMS. After assessing their organizations, the quality improvement team
can identify and prioritize potential areas for improvement