Quality Management System:

 A system designed to manage quality through quality

assurance in design,,development,production,installation
and servicing.
 Ex: ISO: International Organisation for standardization.
Origin:

 Second World War: Pressure for quality from

the military.
 Result: 05 series of Military of Defense (MoD)
quality standards & Allied Quality Assurance
Publication series of NATO (North Atlantic
Treaty Organization)
 ISO (International Organization for Standardization) :
worldwide federation of national standards bodies, at present
comprising 176 members, one in each country.

 Object :To promote the development of standardization and

related activities in the world with a view to facilitating
international exchange of goods and services.
 To develop cooperation in the spheres of intellectual,
scientific, technological and economic activity.

 The results of ISO technical work are published as

International Standards.
 
ISO 9000

 It is a family of quality management & quality

assurance standards developed by the
International Organisation for Standardization.
 It consists of 17 different Standards.
 Quotable standards:( Which can be Audited
Against) : ISO 9001,9002 & 9003.
 Other Series are guidelines.
 ISO 9002 & 9003 are sub sets of ISO 9001.
ISO 9001
 Quality System - Model for quality assurance in
Design,development,production,installation & servicing.

 Most comprehensive model of quality systems offered by ISO.

 It specifies the quality system requirements for use where a

supplier’s capability to design & supply confirming product needs to
be demonstrated.

 The requirements specified are aimed primarily at achieving

customer satisfaction by preventing non conformity at all stages
from design through to servicing.
Situational Application of ISO 9001:
 Applicable when design is required and the
product requirements are stated principally in
performance terms or they need to be
established
 Confidence in product conformance can be
attained by adequate demonstration of
supplier’s capabilities in
design,development,production, installation &
servicing.
Contents of ISO 9001:
 It has 20 clauses which stipulates the conducts for a good
quality management system.
 These clauses can be grouped under the following business
functions of an organization:
1. Key Elements of Quality Management System: (Policy,
Management & Control, Records, Audit & Review,
Corrective actions)
2. Meeting Customer Requirements
3. Control over external factors
4. Control over internal factors
5. Demonstrating Conformance
6. Preserving product quality
7. After Sales
Win Win Situation ( Benefits to the Company & Customers)

 Benefits to the Company:

 Increased productivity & efficiency
 Reduced waste
 Reduced time to rework re check by the customers
 Improved profitability & performance
 Gained marketing advantages
 Established quality image &trust
 Increased overall business.
 Benefits to the Customers:
 Increased fitness for use.
 Increased satisfaction
 Saved Time to recheck work done
 Increased confidence & Trust
 Saved time to search for and select suppliers
 Reduced cost
 Ex: Collapsing of 12 Storey luxurious
residential block (Highland Towers) in 1993.
 Clause 4.19 of ISO 9001:
 Clarification of servicing responsibilities of Architect,
contractor & sub contractors
 Validation of designing & function
 Training of Servicing personnel
 Feedback of information collected on improved
building & service design.
Quality Audit:
 It is a systematic & Independent examination to
determine whether quality activities and related
results comply with planned arrangements & whether
these arrangements are implemented effectively and
are suitable to achieve objectives.
 There are three general classifications of quality
audit.
Types of Quality Audit:

 First Party Audit : (Internal Quality Audit)

 ISO 9000 firm (Registered or to be registered)
regularly does its audit internally to ensure that
the quality management system is implemented
effectively.
 Done by few trained people from each
department at least once every 6 months.
 2nd Party Audit: (Vendor Quality Audit): A
firm audits suppliers who may or may not be a
registered firm.
 In accordance with procedures in the
purchaser’s quality manual
 Should be communicated to the suppliers well
before the commencement of the 2nd party
audit.
 3rd party audit: (Adequacy, Compliance or
Surveillance audit)
 Carried out by certified agencies
 Mock audit (Adequacy audit)
 Actual Audit : (Compliance audit)
 Twice a year audit takes place to ensure that the
system is running effectively & to renew the
certificate annually. (Surveillance Audit)
How to Facilitate Audit?
 The need for quality audit
 Elements of successful interviews
 Preparing for the interview
 Conducting the interview
 Relation Auditor – auditee
 Formulating questions
 Repeating
 Advice on how to ask questions
 Auditor’s Behavior
 Where to start
 How much time should be spent
 The Report
 Presentation of Audit Report
Hints for the Auditees:
 Make sure you know well in advance as to
when the audit will take place.
 Request any documentation relating to the
audit procedure.
 Do not try to hide your weaknesses, do not
volunteer information.
 Rehearse an audit : Conducted by an
independent outside source.
 Finally try not to crowd the auditors.
Why are ISO 9000 & Quality Audit
needed?
 ISO 9000 : demonstrates that companies are in
control of their business and have proved it to a
certification body.
 Companies should implement a quality system
based on ISO 9000
 To maintain contracts with existing customers
 Due to pressure from large customers
 To use the constraints of the standard to prevent
scrap,
 To reduce auditing of the quality system by
customers.
Inappropriate reasons for implementing
the standard:
 To make reference to the standard on
company letter head paper
 To get the kitemark symbol on the
company’s product
 To enforce discipline on employees
 To retain existing customers
How to implement ISO 9000
 Top management Commitment
 Establish Implementation team
 Assess Current Quality System status
 Create a Documented Implementation plan
 Provide Training
 Create Documentation
 Document Control
 Monitor Progress
 Review Pitfalls to effective implementation
Benefits of Implementing ISO 9000
 BSI is first class marketing tool
 Proof of Quality & Technical Expertise
 Saves everyone's money & Time
 Company will improve its quality performance
 Confidence through Surveillance
 The company’s name will appear in the BSI
buyer guide
 Increasing help to public in export markets.
ISO 14000:
 ISO 14000 is the general term used for ISO 14000 family of standards.
 ISO 14001:1996 `Environmental Management Systems – Specifications
with Guidance for use’ is a standard published by International Organization
for Standardization (ISO) and adopted by BIS as IS/ISO 14001:1996.
 IS/ISO 14001:1996 is the exact replica of ISO 14001:1996. This standard
provides for the framework for the Management System for an organization
to meet its Environmental obligations reliably and consistently.
 IS/ISO 14001:1996 is the only certification standard in the IS/ISO 14000
family.
  
 IS/ISO 14001 is a requirements standard. It contains a set of requirements
to define the operation of the Environmental Management System. Since
the requirements are expressed in a general form, it has the flexibility to be
applied to any organization.
What are the benefits of implementing
IS/ISO 14001:1996?
 Following are the benefits to an organization by
implementing IS/ISO 14001:1996:
 
 Provides framework for
 §         Pollution prevention and waste reduction
 §         Compliance with legislative and regulatory requirements
 Reduction in liability/risks
 Competitive advantage for `Green’ products Globally
 Creation of an improved community goodwill
 Improved environmental performance
  
 Assures customers of commitment to
demonstrate environmental management
 Improved Industry Government relations
 Helps in conservation of raw materials and
energy
 Reduces incidents that results in liability
HAZARDS ANALYSIS AND CRITICAL CONTROL POINT
(HACCP) IS 15000:1998

 Hazard Analysis and Critical Control Point

(HACCP) is a process control system designed
to identify and prevent microbial and other
hazards in food production.
 It includes steps designed to prevent problems
before they occur and to correct deviations as
soon as they are detected.
 Such preventive control system with
documentation and verification are widely
recognized by scientific authorities and
international organizations as the most effective
approach available for producing safe food.
Why HCCP?
 India is a signatory to WTO. The WTO Agreement on Sanitary and
Phytosanitary (SPS) makes it obligatory to adopt the standards,
guidelines and recommendations issued by Codex Alimentarius
Commission which advocates the adoption of HACCP.
 The Indian Standard on ‘Food Hygiene – Hazard Analysis and
Critical Control Point (HACCP) – System and Guidelines for Its
Application’ IS 15000:1998 is technically equivalent to the Codex
document on the subject.
 For food industry in India, adoption of HACCP is becoming
imperative to reach global standards, demonstrate compliance to
Regulations/Customer requirements besides providing safer food to
our millions.
Who can implement HACCP:
 HACCP enables the producers, processors,
distributors, exporters, etc, of food products to
utilize technical resources efficiently and in a
cost effective manner in assuring food safety.
 Food inspection too would be more systematic
and therefore hassle-free.
 It would no doubt involve deployment of some
additional finances initially but this would be
more than compensated in the long run through
consistently better quality and hence better
prices and returns.
 Mandatory for export from certain sectors of food
industry to some countries
 Pro-active system for assuring safe production
of foods
 Emphasizes prevention rather than inspection
 Addresses all types of Hazards-Microbiological,
Physical and Chemical
 Can be integrated into a more general quality
assurance plan
 Can be implemented in tiny, small, medium and
large scale enterprises
BENEFITS OF HACCP
 
 Reduces contamination
 Reduces recall/product destruction
 Provides market protection
 Provides preferred supplier status
 Demonstrates conformance to international
standards and regulations, and requirements of
overseas markets
 Transforms commodities into branded products
 International acceptance