Islamic University of Technology

Product Design I
IPE 4609

Lecture 09
Standardization – ISO 9001

M Nasim
 Bangladesh Standards and Testing Institution

• BSTI was established by the Government through an Ordinance

passed in July 1985.
• It is headed by an Additional Secretary to the Government.
• The primary activities of the BSTI are:
o Standardization of services and products;
o Introduction of the international unit system of weights and
measures;
o Promotion of quality assurance activities;
o Rendering testing facilities for services and products;
preparation, promotion and adoption of national standards.

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 International Organization for Standardization

• ISO is an international standard setting body composed of

representatives from various national standards organizations.
• Part of United Nations initiative - is a non-governmental
organization

Formation 23 February 1947

Type Non-governmental organization
Purpose International standardization
Headquarters Geneva, Switzerland
Membership 162 members
Official languages English, French, Russian

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 Why ISO Standards?

• Overall, ISO standards play a vital role in promoting quality, safety,

innovation, and sustainability across industries and sectors,
contributing to global trade, economic development, and societal
well-being.
• There are several reasons why ISO standards are widely adopted
and valued:
ü Global Acceptance: ISO standards are developed through a
consensus-based process involving experts from around the
world, representing various industries, governments, and other
stakeholders. As a result, ISO standards are universally
accepted and recognized across different countries and
regions.

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Why ISO Standards?

ü Quality Assurance: ISO standards provide a framework for

quality management systems (e.g., ISO 9001) that help
organizations ensure consistency, reliability, and excellence in
their products and services. Adhering to ISO quality standards
can enhance customer satisfaction, improve processes, and
drive continuous improvement.
ü Market Access: Compliance with ISO standards can facilitate
market access by demonstrating a commitment to quality,
safety, and environmental responsibility. Many customers,
especially in business-to-business transactions, require
suppliers to be ISO certified as a prerequisite for doing
business.

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Why ISO Standards?

ü Risk Management: ISO standards offer guidelines and best

practices for managing various risks, including those related
to information security (ISO 27001), environmental
management (ISO 14001), and occupational health and safety
(ISO 45001). Implementing ISO standards can help
organizations identify, assess, and mitigate risks effectively.
ü Legal and Regulatory Compliance: Compliance with ISO
standards can help organizations meet legal and regulatory
requirements in various domains, including quality
management, environmental protection, and occupational
health and safety. ISO standards often serve as a reference for
regulatory authorities when developing regulations and
standards.

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 Stages in the development process of an ISO standard
Stage Document Name

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Popular Standards
Sta
geISO Quality management
9000document
Associated
Stage
coISO
name14000 Environmental management
de
ISO 3166 Country codes
ISO 26000 Social responsibility
ISO 50001 Energy management
ISO 31000 Risk management
ISO 22000 Food safety management
ISO 27001 Information security management
ISO 45001 Occupational health and safety
ISO 37001 Anti bribery management systems
ISO 13485 Medical devices

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Position of ISO (and some other) Standards

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 ISO 9001 Standard

• ISO 9001 is for quality management.

• Quality refers to all those features of a product (or service) which
are required by the customer.
• Quality management means what the organization does to ensure
that its products or services satisfy the customer's quality
requirements and comply with any regulations applicable to those
products or services.
• Quality management also means what the organization does to
enhance customer satisfaction, and achieve continual improvement
of its performance.

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ISO 9001 Process Approach
Continual Improvement of the Quality
Management System

Customer Satisfaction
Management
Responsibility
Requirements

Resource Measurement,
Management Analysis,
Improvement
Customer

Product
Realization Product
Inputs Outputs

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 Applicability of ISO 9001

• ISO 9001 is applicable to organizations of all sizes and industries,

including manufacturing, services, healthcare, education, and
government.
• Any organization that wants to demonstrate its commitment to
quality management and meet customer requirements can benefit
from implementing ISO 9001.
• ISO 9001 is particularly relevant for organizations that:
• Want to enhance customer satisfaction and loyalty.
• Seek to improve operational efficiency and effectiveness.
• Wish to reduce waste, errors, and defects in products or services.
• Need to meet regulatory requirements or industry standards.
• Aim to increase competitiveness in the marketplace.
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 Quality Management Principles of ISO 9001

• The seven quality management principles outlined in ISO 9001 are

fundamental guidelines for organizations to follow in order to
achieve effective quality management.
• These principles serve as a foundation for the development,
implementation, and improvement of a quality management system
(QMS).

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 Quality Management Principles of ISO 9001

1) Customer Focus: Organizations should understand and meet the

current and future needs of customers, strive to exceed their
expectations, and enhance customer satisfaction.
2) Leadership: Leaders within the organization should establish a
clear vision and direction for quality, create unity of purpose and
direction, and actively engage employees in achieving quality
objectives.
3) Engagement of People: Employees at all levels should be
competent, empowered, and engaged in contributing to the
organization's success. Providing opportunities for involvement,
empowerment, and recognition enhances employee motivation
and performance.

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 Quality Management Principles of ISO 9001

4) Process Approach: Managing activities and resources as

processes helps organizations achieve their desired outcomes
efficiently. Identifying, understanding, and managing interrelated
processes as a system leads to improved performance and
effectiveness.
5) Improvement: Continual improvement is essential for enhancing
organizational performance and achieving objectives. Regularly
evaluating performance, identifying opportunities for
improvement, and implementing corrective and preventive actions
drive ongoing enhancements in quality.

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 Quality Management Principles of ISO 9001

6) Evidence-Based Decision Making: Effective decisions are based

on the analysis of data and information. Organizations should rely
on reliable evidence to make informed decisions that contribute to
achieving desired outcomes and improving performance.
7) Relationship Management: Successful organizations understand
and manage their relationships with relevant interested parties,
including customers, suppliers, employees, and other
stakeholders. Building and maintaining positive relationships
fosters collaboration, trust, and mutual benefit.

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Main Quality System Clauses of ISO 9001:2015

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