Unit 3 Quality Management System

Contents:
 The evolution of quality management,
 ISO 9000: Family (Series) of standards and its implementation,
 Elements of ISO 9000,
 Principles of quality management systems,
 Internal audit,
 External audit,
 The surveillance or quality audit visit,
 Assessment of quality-management systems,
 Conformity assessment,
 Conformity Assessment Bodies (CABs).

The Evolution of Quality Management

What is Quality Management?
Quality management ensures that products and services consistently meet
customer expectations and regulatory requirements. Over time, different
approaches have evolved to improve quality.
Evolution Stages & Real-Time Examples:
🔹 Craftsmanship (Pre-1900s) – Products were made by skilled craftsmen
who ensured high quality.
 Example: Handmade Swiss watches were crafted by expert
watchmakers with precise attention to detail.
🔹 Industrial Revolution (1900s–1920s) – Mass production started, leading to
the need for standardized quality checks.
 Example: Henry Ford’s assembly line improved production efficiency
but required quality inspections to maintain consistency.
🔹 Statistical Quality Control (1920s–1950s) – Introduced sampling methods
& statistical techniques.
 Example: During World War II, the U.S. Army used sampling
inspections for ammunition quality control.
🔹 Total Quality Management (TQM) (1950s–1980s) – Focused on
company-wide quality culture and continuous improvement.
 Example: Toyota Production System (TPS) emphasized lean
manufacturing and zero waste.
🔹 ISO 9000 & Six Sigma (1980s–2000s) – Standardized global quality
management practices.
 Example: Samsung adopted Six Sigma to reduce product defects and
improve manufacturing efficiency.
🔹 Industry 4.0 & AI in Quality Management (2000s–Present) –
Automation, AI-driven inspections, and IoT optimize quality.
 Example: Tesla’s automated production line uses AI to detect micro-
defects in electric vehicle batteries.

ISO 9000: Family (Series) of Standards and Its Implementation

What is ISO 9000?
ISO 9000 is a set of international quality management standards developed
by the International Organization for Standardization (ISO) to help
businesses improve processes and customer satisfaction.
Key ISO 9000 Standards:
Standard Purpose Example of Implementation

Basic principles &

Used as a guideline for setting up quality
ISO 9000 terminology of quality
management systems (QMS).
management.

Example: McDonald's follows ISO 9001

Specifies requirements
ISO 9001 to ensure food safety and consistency
for a QMS (certifiable).
across all outlets.

Provides guidance on
Example: Airbus uses ISO 9004 to
ISO 9004 improving QMS
enhance aircraft manufacturing processes.
performance.

ISO Guidelines for quality Example: Coca-Cola’s bottling plants

19011 auditing. undergo regular ISO 19011 audits to
Standard Purpose Example of Implementation

ensure beverage quality.

Elements of ISO 9000

ISO 9000 is based on 7 Key Quality Principles:
Customer Focus – Understanding and meeting customer needs.
 Example: Amazon’s return policy enhances customer trust.
Leadership – Strong leadership to drive quality culture.
 Example: Tesla’s CEO prioritizes AI-driven quality improvements in
car production.
Engagement of People – Employees contribute to quality improvement.
 Example: Toyota’s “Kaizen” approach allows workers to suggest
process improvements.
Process Approach – Managing activities as processes for efficiency.
 Example: BMW optimizes assembly line processes to ensure defect-free
production.
Continuous Improvement – Ongoing efforts to enhance quality.
 Example: Google’s software updates continuously refine products like
Android OS.
Evidence-Based Decision Making – Using data to drive quality improvements.
 Example: Pfizer uses AI and data analytics to improve pharmaceutical
quality control.
Relationship Management – Working with suppliers for consistent quality.
 Example: Apple ensures supplier compliance with ISO 9000 for high-
quality iPhone components.
Implementation of ISO 9000 – Step-by-Step Example:
🔹 Step 1: Planning – Identify quality objectives.
 Example: A car manufacturer sets a goal to reduce defective engine
parts by 10%.
🔹 Step 2: Process Mapping – Define company workflows.
 Example: Airbus documents every step of aircraft assembly to ensure
compliance.
🔹 Step 3: Training Employees – Educate teams on ISO standards.
 Example: A hospital trains its staff on patient safety procedures under
ISO 9001.
🔹 Step 4: Implementation & Monitoring – Apply standards and measure
performance.
 Example: A pharmaceutical company tracks medicine potency to
maintain consistency.
🔹 Step 5: ISO Certification Audit – External auditors verify compliance.
 Example: Nestlé undergoes ISO audits to maintain food safety
certification.

Principles of Quality Management Systems (QMS)

A Quality Management System (QMS) is a structured framework that
organizations use to ensure consistent product and service quality. ISO 9000
is based on seven key principles that drive effective quality management.
Real-Time Examples of QMS Principles:
1️Customer Focus – Organizations should prioritize customer needs and
satisfaction.
 Example: Amazon’s 1-day delivery policy focuses on enhancing
customer satisfaction and loyalty.
2️Leadership – Strong leadership establishes clear vision and quality culture.
 Example: Elon Musk’s focus on innovation at Tesla drives high-quality
electric vehicle production.
3️Engagement of People – Employees contribute to improving quality.
 Example: Toyota’s "Kaizen" philosophy allows workers to suggest
efficiency improvements in production.
4️Process Approach – Managing activities as interconnected processes
increases efficiency.
 Example: McDonald's follows a standardized burger-making process
to ensure consistency across global outlets.
5️Continuous Improvement – Organizations must always work to enhance
quality.
 Example: Google continuously updates Android OS to fix bugs and
improve user experience.
6️Evidence-Based Decision Making – Using data analysis for decision-making
improves accuracy.
 Example: Pfizer uses clinical trial data to refine medicine formulations.
7️Relationship Management – Maintaining good supplier relationships ensures
consistent quality.
 Example: Apple collaborates closely with TSMC to ensure high-quality
iPhone processors.

Internal Audit
What is an Internal Audit?
An internal audit is an organization’s self-assessment of its quality processes
to ensure compliance with standards like ISO 9001. It helps identify areas for
improvement before an external audit.
Real-Time Example of an Internal Audit:
🔹 Example: A hospital conducts an internal audit of its patient record
system to check compliance with ISO 9001 before an official health inspection.
🔹 Example: A car manufacturing company like Ford checks its production
line for defects before an external certification audit.
External Audit
What is an External Audit?
An external audit is performed by an independent third-party (such as ISO
certification bodies) to verify whether an organization complies with
international quality standards.
Types of External Audits:
1️Certification Audit – Conducted to obtain ISO certification.
 Example: Nestlé undergoes an ISO 22000 audit to certify food safety
compliance.
2️Supplier Audit – Performed by companies on their suppliers to ensure quality
standards.
 Example: Apple audits Foxconn to ensure ethical and quality
compliance in iPhone production.
3️Regulatory Audit – Conducted by government bodies for compliance with
legal regulations.
 Example: The FDA audits a pharmaceutical company to check for
drug safety compliance.

The Surveillance or Quality Audit Visit

What is a Surveillance Audit?
A surveillance audit is conducted periodically after ISO certification to
ensure ongoing compliance with quality standards.
Real-Time Example of a Surveillance Audit:
🔹 Example: A food processing company like PepsiCo undergoes annual
surveillance audits to maintain ISO 9001 and food safety certification.
🔹 Example: An airline like Emirates gets surveillance audits for safety
compliance from the International Air Transport Association (IATA).
Assessment of Quality-Management Systems (QMS)
What is QMS Assessment?
The assessment of a Quality Management System (QMS) evaluates whether
an organization’s quality policies, processes, and procedures meet international
standards like ISO 9001.
Real-Time Examples:
🔹 Automotive Industry (Toyota) – Toyota regularly assesses its QMS to
ensure all production lines maintain zero defects and adhere to ISO 9001 and
IATF 16949 (automotive quality standards).
🔹 Pharmaceutical Industry (Pfizer, Moderna) – Drug companies assess
their QMS through Good Manufacturing Practices (GMP) compliance
audits to meet FDA and WHO regulations.
🔹 IT Industry (Microsoft, Google) – Tech companies perform QMS
assessments to maintain ISO 27001 (Information Security) certification for
data security and privacy.

Conformity Assessment
What is Conformity Assessment?
Conformity assessment ensures that products, processes, or services comply
with specified standards or regulations before they reach consumers. This
includes testing, inspection, and certification.
Types of Conformity Assessments & Real-Time Examples:
First-Party Assessment (Self-Assessment by the Manufacturer)
 Example: Apple internally tests iPhone batteries for safety before mass
production.
Second-Party Assessment (Conducted by a Customer on a Supplier)
 Example: Walmart audits its suppliers to ensure they comply with food
safety and ethical sourcing standards.
Third-Party Assessment (Independent Certification or Government Body
Evaluation)
  Example: Tesla’s electric vehicles (EVs) undergo third-party safety
testing by Euro NCAP for crashworthiness and road safety certification.

Conformity Assessment Bodies (CABs)

What are Conformity Assessment Bodies (CABs)?
CABs are independent organizations that test, inspect, and certify products or
systems to ensure compliance with standards.
Examples of Major CABs & Their Functions:
🔹 Bureau Veritas – Conducts ISO 9001 audits for various industries like
shipping and construction.
🔹 UL (Underwriters Laboratories) – Certifies electrical appliances for
safety (e.g., UL certification for Samsung home appliances).
🔹 TÜV Rheinland – Tests and certifies automobile safety and emissions
compliance (e.g., European car manufacturers like BMW and Mercedes-Benz).
🔹 FDA (Food and Drug Administration) – Approves medications and
vaccines before they reach the public.
🔹 CE Marking (European Union) – Ensures medical devices, electronics,
and toys meet EU regulations (e.g., CE marking on Philips medical
equipment).