SESSION – 14

TOTAL
QUALITY
MANAGEMENT
By:
Zahid Hussain
MS-Total Quality Management
Lead Auditor 5-S
IRCA Lead Auditor ISO-9001-2000
IRCA Lead Auditor ISO-14000-2004
IRCA Lead Auditor OHSAS 18000-2007
B. Sc Engineering (Chemical)
PCBA–UCP
 Introduction

Accreditation
Body

Certification .
Body
/Registrar
 Introduction

International Association of Accreditation bodies to promote

Accreditation confidence and consistency in ISO-9001 accreditation
and certification process.
Forum (IAF)
Accreditation Provide confidence that certification body is competent
Body enough to issue ISO 9001 certificate. Accreditation
mark appear on certificate.
Certification Conduct an audit ( Third body audit) to see the
Body /Registrarconformity of organization as per ISO-9001.& issue
certificate if conformity is found.

Your supplier Organization supplying you goods . You can conduct 2nd
party audit to see the conformity to ISO QMS.
You You are purchasing goods and now safe to get quality
product.
 ISO
• International Organization
for standardization
•A network of national
standard institute of more
than 150 countries.
• Central office in Geneva
Switzerland, that coordinates
the system and publish the
standards.

• The name, "ISO" is derived from the Greek word "isos"

meaning "equal".
• The relation to standards is that if two objects meet the
same standard, they should be equal.
 Definitions
ISO 9000
• Series of standards on quality management and assurance.
• Applicable to all types and sizes of organizations.
• Prevents “non-conformity” at every stage, from design to after-
sales-services.
• ISO-9000 is a certificate awarded by independent
auditors, attesting that your organization has met the
quality management requirements determined by ISO-
9000.
• It is frame work for showing to customer how we
produce , test product, train employees , keep records,
and
ISO fixQuality
9000: defects. Etc. & Assurance Standards; GUIDELINES for
Management
Selection & Use
ISO 9001: Model for Quality Assurance in Design, Development, Production,
Installation and Servicing
ISO 9002: Model for Quality Assurance in Production, Installation and Servicing
ISO 9003: Model for Quality Assurance in Final Inspection and Testing
ISO 9004: Quality Management and Quality System Elements – GUIDELINES
ISO-9001 and 9004 are designed to constitute a “consistent pair “ of standards.
 Benefits of ISO
Product Cost Reduction
 Better process control & internal operational efficiency
 Better documentation of processes
 Greater Employees quality awareness
As the result
 Reduction in product scrap, rework and rejection,
 Time is saved.
Consistency in Quality
 Quality Constantly Measured
 Preventive approach to deal with potential threats to quality.
As the result
 The defect rate decreased.
 Improve product reliability,
 Avoid the penalties for quality failure.
 Market share increased with access to new market.
 Benefits of ISO
Others
 Customer Demand for ISO Registration.
 Customer satisfaction through documented procedures
 Competitive price offer due to low cost of product
 Purchase of good quality raw materials to produce
quality products.
 Good practices through following other ISO series like
14000, 22000, 27000 and so on.
 Documented Procedure are easier for new employee to
follow.
 Training enhance the skill, result the profitability.
 Continual Improvement is followed by the setting of
objectives & Goals, targets achievements, Collection /
Analysis of data and Management Review.
 Definitions
• Standard ; A standard is a document. It is a set of rules
that control how people develop and manage materials,
products, services, technologies, processes, and systems.
• Audit: An independent documented activity in accordance
with written checklists and procedures to verify, by
examination and evaluation of objective evidence that
applicable elements of the QMS have been developed,
documented and effectively implemented in accordance with
the specified requirements.
First Party: (Internal Audit), Second Party:( External Audit)
Third Party Assessment, Nonconformance: Major-
Minor non conformance, Existing , potential non
conformance, CAPA Request, Gap analysis
Overview of
ISO Continual Improvement of
ISO 9001 Model
9001:2008
CUSTOMERS the Quality Management System

5.Management

CUSTOMERS
Responsibility
Quality Management

Satisfaction
6. Resource 8. Measurement
Analysis and
Management
Improvement

System

Requirements 7. Product
Consumption
Realization Product
KEY
Value Added Model of a Process Based
Activities Quality Management System
 System Requirements / Structure of the
Standard
4 Quality 5 Management 6 Resource 7 Product 8 Measurement
Manageme Responsibility Management Realization Analysis &
nt System improvement

Management
General Provision of Planning General
Commitment
requirements resources

Customer focus Customer Monitoring &

Human
Documentation related measurement
resources
Requirements processes
Quality policy
Infrastructure Control of NCR
Design &
s development
Planning Analysis of data
Work
environment Purchasing
Responsibility, Improvements
authority &
communication Production &
service
provision
Management
Reviews
 Definitions
• Document is information with its supporting
medium.
Record is a document stating results achieved or
providing evidence of activities performed.
• All records are documents, but not all documents
are records. A written procedure is a document, but
not a record.
• A record is just a special type of document. A blank
form with no data is a document. Once data is
entered on the form, it may become a record.
 What is a Document?
ISO 9000:2008 definition:
Document: Information and its supporting medium.

INFORMATION: MEDIUM:
 Procedure  Paper
 Specification  Electronic
 Record  Photographic
 Drawing  Magnetic
 Report  etc.
 Standard

 DOCUMENTATION CAN BE IN ANY FORMAT OR

MEDIUM.
 Objectives of Documentation
 Communicate Information
– Means to transmit and communicate information
– Type and amount depend on:
 grade of formality of communication system
 level of communication skill
 Organizational Culture
 Nature of product and process
 Evidence Conformity
– Provide evidence that what has been planned has
been achieved
 Share Knowledge
– communicate and preserve the organization’s
Know–How
 Technical Specifications
 Manufacturing Technology
 Extension of Documentation
The extent of the QMS documentation can vary from one
organization to the other because of:
a) Size of the organization and type of its activities
b) Complexity of its processes and interactions
c) Competence of personnel
 Control of Documentation
Ensure that General Rule:
document is and The right document must be
remains legible & available at the right time at right
readily identifiable place
Define Needed Develop Review &
Issue to
Document Document Approve
Points of use
Prior to issue

Identify Revision Update Change

Status
Document the Doc

Identify Obsolete, if previous

If Retained doc available

Documents required by the QMS shall be controlled. Prevent

Unintende
(ISO 9001:2008)  (Clause 4.2.3) d Use
 Documentation Structure
Vision
TYPICAL STRUCTURE Mission
Quality
Policy

Level–1: Quality Manual

Scope, Exclusion,
1
Description of processes
interrelationships

Level–2: Procedures 2
Documentation of process
activities could include work
instructions
3
Level–3: Standardized Forms
Convertible into records
External Documents 4
Customer Specifications,
etc.
Level–4: Records
Evidence of conformance
 Quality Policy
 is the statement which defines or describes
an organization's commitment towards
quality.
 Quality Policy should be
– developed and authorized normally by Top
Management in consultation with senior
executives and management
– understood and implemented at all levels in the
organization,
– and be relevant to the organizational goals and
the needs and the expectations of its customers.
 Quality Manual
ISO 9000:2008 Definition: “Document specifying the QMS of an
organization”
 Quality manual is the first step in building a Quality Management
System.
 At a minimum, the Quality Manual is required to address the applicable
ISO Series that the company plans to become registered against. ISO
9001:2008.

 The Quality Manual must include: (ISO 9001:2008 – 4.2.2)

– Scope of QMS including details and justification of exclusions
– Documented procedures for QMS or Reference to them
– Description of the interaction between processes of QMS

 The Quality Manual could also include:

– A description of the organization
– The Quality Policy
– Global Quality Objectives
– The Structure of the Organization

 Quality Manual Structure:

– Three possible formats or structures:
 By Clauses
 By Functions
 Others
 Structure Of Typical
Procedure
 There is no set pattern of a procedure, but it should
clearly spell out the “5 W’s”-1H --- Why, What, Where,
Who, When, hoW
 Typically a Procedure is arrange as follows:
1. PURPOSE:
– Setting out the objectives of the process described in the
procedure;
1. SCOPE:
– Defining the areas of application and exclusions;
1. PERSON RESPONSIBLE:
– Assigning responsibility to specified person (s);
1. PROCEDURE:
– Listing, Step by Step, What needs to be done and by whom;
1. RECORDS:
– Identifying the records to be generated by applying the
procedure;
 Documented Procedures
PROCEDURE (ISO 9000:2008 Definition):
“Specified way to carry out an activity or a process”

 ISO 9001:2008 requires the following “documented

procedures”:
– Control of Documents (4.2.3)
– Control of Records (4.2.4)
– Internal Audit (8.2.2)
– Control of Nonconforming Products (8.3)
– Corrective Actions (8.5.2)
– Preventive Actions (8.5.3)

PLUS:
“Documents needed by the organization…”
QUESTION
S