GE3752 – Total Quality Management

Unit – 5
Introduction:
• ISO 9000 is a set of five world-wide standards.
• ISO stands for International Organization for Standardization.
• ANSI stands for American National Standards Institute.
• Quality system is defined by ANSI as the collective plans, activities and events.
• Quality system is defined by ISO as the organizational structure, responsibilities,
procedures, processes and resources.

Benefits of ISO Registration:

• Management Commitment
• Prepare the workmen for change
• Selection of appropriate model
• Study the selected model
• Set up steering
• Arrange training of leaders and co-ordinators
• Prepare a checklist
• Take correction action
• Apply for Registration
• Grant of licence

ISO 9000 Series of Standards:

• Quality
• Inspection
• Reliability
• Grade
• Quality Policy
• Quality Management
• Quality Loop
• Quality Assurance
• Quality Control
• Quality System
• Quality Plan
 • Quality Audit
• Quality Surveillance
• Quality system review
• Design review
• Traceability
• Concession waiver
• Product liability, service liability
• Defect
• Non-conformity
• Production permit, Deviation permit
• Specification
• Quality management and Quality Assurance Standard

Sector (Implementation):
• TQM implementation in manufacturing and service sectors:
➢ Quality as leadership at Perfect Machine Tools (PMT).
➢ Quality in manufacturing best practices – Ranbaxy Laboratories.
➢ Quality as After sales service – Thermax Ltd.
➢ Quality as marketing – Unilever Ltd.
➢ Quality as service – HDFC bank.
➢ Quality as HRD - Infosys.
i) PMT – 1966 – Exporting botts, screws, wiremills.
ii) Ranbaxy Laboratories – 1961 – Make conglomerate.
iii) Thermax – INR 5516 crore company
iv) Unilever – Consumer good company
v) HDFC – 76286 employees

Specific Standards:
• Quality management standards are details of
➢ Requirements
➢ Specifications
➢ Guidelines
➢ Characteristics that produces products
➢ Services and processes
• They should consistently meet inorder to ensure
 ➢ their quality matches expectations
➢ they are fit for purpose
➢ they meet the needs of their users
• Specific quality standards are
➢ Standards of design
➢ Appearance
➢ Quality for the licensed services
➢ Facilities
➢ Business materials
➢ Advertising materials
• Some of the specified quality standards are
➢ Applicable water quality standards
➢ Reliability standards
➢ Water quality standards
➢ National Ambient Air Quality Standards

AS 9100:
• AS 9100 is the internationally recognized quality management standard specifically
written for the aerospace industry.
• It is based on the ISO 9001 quality management system (QMS) standard.
• AS 9100 is an aerospace standard (AS) designed to achieve high-quality in the aviation,
space and defense industry.
• AS 9100 standard is based on ISO 9001 Quality Management System.
• There are 10 clauses with supporting sub-clauses.
• AS 9100 certification must be issued by CBs accredited to the AS standards by a body
recognized by the International Aerospace Quality Group (IAQG).
• AS 9100 is an SAE document developed by working Group II of ISO TC 20 and
supported by the international aerospace quality group.
• AS 9100 also addresses civil and military aviation requirements.
• ISO 9100 is a quality management system standard.
• AS 9100 is a Aerospace standard.
TS 16949:
• It is the globally recognized quality management standard for the automotive industry.
• It defines the quality management system requirements for the design and development,
production.
• It brings together standards from across Europe and US.

Requirements:
• Demonstrate its ability to consistently provide products.
• To meet customer.
• Applicable statutory.
• Regulatory.
• Product safety requirements.
• The latest version of this standard is IATF 16949:2016 and is titled Quality
Management Systems.
• ISO/TS 16949 replaced by IATF 16949.

Documents Required:
• Quality policy
• QMS documentation
• Documentation for management of product safety related products and manufacturing
processes.
• List of authorities and their responsibilities.

TL9000:
• To meet the supply chain quality requirements.
• Establish and maintain a common set of QMS requirements.
• Faster a system that protects the integrity and use of ICT hardware software and
services.
• Define effective cost and performance based measurements.
• Drive continual improvement.
• It is a two part Quality management system.
• It is based on reliability of product.
• TL9000 stands for Telecom Quality Management System.
• It is a unique extension to ISO 9001: 2015.
Benefits:
• Overall cost reduction
• Increased competitiveness
• Enhanced customer organization
• Supplier relationships
• Continual improvement

Documentation of TL9000:
• Registration Guidance
• Migration path
• Category selection
• Late data submission process
• Guidance for communication with customers
• Design and development process
• Supplemented measurements
• Sustainability Assessment
• Document design for guidance
• Security resources guidance

ISO 9001 Requirements Implementation Documentation:

Elements:
• Management responsibility
• Quality systems
• Product identification and traceability
• Inspection and testing
• Inspection measuring and test equipment
• Inspection and test status
• Control of nonconforming product
• Handling storage packing and delivery
• Document control
• Quality records
• Training
• Statistical methods
 • Corrective action
• Process control
• Purchasing
• Control review
• Internal quality audits
• Design control
• Servicing

Benefits of ISO 9001:

• Increase income revenues
• Improved control
• Improved quality
• Improved supply

Requirements of ISO 9001:2008:

• Need to demonstrate its ability
• Aims to enhance customer satisfaction
• Improve the performance of process
• Satisfaction of customers
• Attention to resource management
• Better management control

Documentation:
• Greater emphasis on building a management system.
• A requirement that those at the top of an organization be involved and accountable
• Risk based thinking throughout the standard
• Less perspective requirements for documentation.
• Alignment with other key management system standards.

ISO 9001 : 2015 – Requirements:

• Needs to demonstrate its ability
• To consistently provide products
• To enhance customer satisfaction
• Includes process for the improvement of the system
• They are generic and an intended to be applicable to any organization.
Auditing:
• There are two types of audits:
i) Internal Audit – First party audit
ii) External Audit – Second party audit, Third party audit

Internal Audits:
• It is a first part audit.
• It can be carried out within a particular area or function against a specific job.
• It is performed on a continual basis by the organization.

Registration of Internal Audits:

• The purpose of registration of a document is to give notice to the world of a certain
property document having been executed.
• Stages of registration (steps information of a company)
i) Promotion stage
ii) Incorporation stage
iii) Commencement of Business stage

External Audits:
Second Party Audit:
• It is generally known as supplier quality assurance audits.
• To ensure the level of confidence for the purchasing organization.

Third Party Audit:

• Conducted by a recognized certifying agency.
• Types: System Audit, Process Audit, Product Audit, Compliance Audit

Environmental Management System:

• ISO 14000
• ISO 14001

ISO 14000 Series Standards:

➢ Organization Evaluation Standards
➢ Product Evaluation Standards
Organizational Evaluation Standards:
• These standards focus on how an organization manages its overall environmental
responsibilities.
• The main standard in this category is ISO 14001, which provides the criteria for an
effective environmental management system (EMS).
• It contains:
i) Environmental Management System (EMS)
ii) Environmental Auditing (EA)
iii) Environmental Performance Evaluation (EPE)

i) EMS:
ISO 14001:
• ISO 14001 requires organizations to establish, implement, maintain, and improve an
EMS.
• This ensures they are continuously improving their environmental performance.
• ISO 14001 is the main standard that provides the framework for establishing an
Environmental Management System (EMS).
• It outlines requirements that organizations can follow to reduce their environmental
impact while achieving compliance with applicable regulations.
• Organizations must create an environmental policy that reflects their commitment to
sustainable practices.

ISO 14004:
• ISO 14004 provides additional guidance to help organizations implement and maintain
an EMS according to the requirements of ISO 14001.
• Offers more detailed advice on EMS design and implementation.
• Provides insights into aligning the EMS with other organizational systems.
• Focuses on broader support techniques like training and communication for successful
implementation.

ii)EA:
ISO 14010:
• ISO 14010: Guidelines for Environmental Auditing.
• This standard provides the general principles of environmental auditing, defining the
processes and guidelines for conducting audits effectively.
ISO 14011:
• ISO 14011: Guidelines for Auditing Environmental Management Systems.
• ISO 14011 focuses specifically on auditing an organization’s EMS (as per ISO 14001).
• It outlines the procedures for conducting internal and external audits, providing a
structured approach to evaluating EMS effectiveness.

ISO 14012:
• ISO 14012: Guidelines for Environmental Auditors.
• ISO 14012 focuses on the qualifications and competence of individuals performing
environmental audits.
• It ensures that auditors have the required knowledge, skills, and experience.

iii) EPE:
ISO 14031:
• ISO 14031 provides guidelines for evaluating an organization’s environmental
performance.
• It helps organizations track and assess their progress in meeting environmental goals
by using performance indicators.
• Use of EPE results for decision-making and continual improvement of environmental
processes.

Product Evaluation Standards:

• These standards deal with the environmental aspects of products across their lifecycle,
from raw material extraction to disposal.
• The key focus is on reducing the environmental impact of products.
• It contains:
i) Environmental Aspects in Product Standards (EAPS)
ii) Environmental Labels and Declaration (ELD)
iii) Life Cycle Assessment (LCA)

i) EAPS:
• Environmental Aspects in Product Standards focus on identifying and addressing
the environmental impacts of products across their entire life cycle.
• These aspects involve everything from the extraction of raw materials, manufacturing
processes, product use, and end-of-life disposal.
• The aim is to reduce environmental harm, increase resource efficiency, and minimize
waste.
Guide 64:
Guide 64 provides guidance for integrating environmental aspects into product
standards. It helps standard developers consider how products interact with the
environment.

ii) ELD:
• Environmental labeling is a way to communicate the environmental performance of
products to consumers.
• The ISO 14020 series outlines principles for environmental labels and declarations,
ensuring transparency and reliability in environmental claims.
• ISO 14020: Establishes general principles for environmental labeling, such as ensuring
that labels are clear, accurate, and not misleading.
• ISO 14021: Focuses on self-declared environmental claims (Type II labels), where
manufacturers voluntarily make claims about a product’s environmental impact (e.g.,
"recyclable," "biodegradable").
• ISO 14022: Provides guidelines for using symbols in environmental labeling, ensuring
that visual representations are consistent and easily understood.
• ISO 14023: Gives guidance on the testing and verification of environmental claims,
ensuring that they are based on measurable data.
• ISO 14024: Covers Type I environmental labeling, which involves third-party
certification. Products with Type I labels have been independently verified to meet
multiple environmental criteria.

iii)LCA:
• LCA is a method for evaluating the environmental impacts associated with all stages of
a product’s life.
• The ISO 14040 series provides comprehensive guidance on how to conduct LCAs.
• ISO 14040: Defines the framework and principles for conducting an LCA. It establishes
how to assess the environmental aspects of a product, from raw material acquisition to
disposal.
• ISO 14041: Focuses on inventory analysis, which involves collecting and quantifying
inputs (like energy and materials) and outputs (like waste and emissions) at each stage
of the product's life cycle.
• ISO 14042: Deals with impact assessment, where the data from the inventory analysis
is used to evaluate the product's environmental impacts, such as resource depletion,
pollution, and ecological harm.
 • ISO 14043: Provides guidelines for the interpretation of LCA results, helping
businesses understand what the data means and how to use it for making informed
decisions about product improvements and sustainability strategies.

Concepts of ISO 14001:

• Internationally agreed standard
• Sets out the requirements for an environmental management system
• It helps in improve their environmental performance
• Efficient use of resources
• Reduction of waste
• Gaining a competitive advantage
• Trust of stakeholders

Elements of ISO 14001:

• Environmental policy
• Planning
• Implementation
• Study and correct
• Management review
• Continuous improvement

Requirements of ISO 14001:

• Scope of the environmental management system.
• Environmental policy
• Evaluation of environmental risks
• Environmental objectives
• Plans for achieving
• Operational control procedures.

Benefits of EMS:
• Promote business
• Enhance business
• Keep the customer happy
• Keep the customer satisfied
• Increases income revenues
• Reduced habilities
• Added protection
• Improved control
• Improved quality
• Improved supply