UNIT II

QUALITY SYSTEM
 QUALITY SYSTEM STANDARDS

• A standard is a document that provides requirements,

specifications, guidelines or characteristics that can be used
consistently to ensure that materials, products, processes
and services are fit for their purpose.

• Standards provide the knowledge that organizations need

to succeed, and deliver it in concentrated form. They can
offer a set of powerful tools to make your organization
more innovative and productive.
Benefits of using standards
• Standards are a tried and tested way to work more
efficiently and effectively. They help organizations to
improve their performance, reduce their risk and help them
be more sustainable.

Improve Performance
• Success is all about how you perform at every level of your
organization. standards promote a culture of continual
improvement.
Reduce risk
• Businesses today simply can‟t afford to take an
improvised, reactive approach to risk. Using
standards can help you to identify your risks and
minimize them.
Who uses standards
• Organizations of all sizes use standards to
compete more effectively,
• Small businesses
• National and multinational business Government
How are standards made
• Standards are put together by groups of industry experts,
consumers, research organizations, government
departments and more, all working together.

Types of standards
• Standards all have the same basic purpose of setting out
agreed principles or criteria so that their users can make
reliable assumptions about a particular product, service or
practice.
However, they can vary in two major respects:
• the type of agreement
• the number of people, organizations or countries who were
involved in making the agreement.
• In some standards, the type of agreement essentially
amounts to advice and guidance; others are much more
prescriptive and set out absolute requirements that have to
be met if a user wishes to make a claim of compliance with
the standard
About ASTM
• ASTM, founded in 1898. The organization's headquarters is
in Pennsylvania,
• ASTM International formerly known as the American
Society for Testing and Materials (ASTM).

• Today, more than12 000 ASTM standards are used around

the world to improve product quality, enhance safety,
facilitate market access and trade, and build consumer
confidence.
• ASTM is a not-for-profit organization that provides a forum
for the development and publication of voluntary
consensus standards for materials, products, systems, and
services.

• ASTM‟s members, representing producers, users,

consumers, government, and academia from over 100
countries.
The standards produced by ASTM International fall into six
categories
• The Standard Specification, that defines the requirements
to be satisfied by subject of the standard.
• The Standard Test Method, that defines the way a test is
performed and the precision of the result. The result of the
test may be used to assess compliance with a Standard
Specification.
• The Standard Practice, that defines a sequence of
operations that, unlike a Standard Test Method, does not
produce a result.
• theStandard Guide, that provides an organized
collection of information or series of options that
does not recommend a specific course of action.
• theStandard Classification, that provides an
arrangement or division of materials, products,
systems, or services into groups based on similar
characteristics such as origin, composition,
properties, or use.
• theTerminology Standard, that provides agreed
definitions of terms used in the other standards.
The quality of the standards is such that they are frequently
used worldwide
• Other governments (local and worldwide) also have
referenced ASTM standards
• Corporations doing international business may choose to
reference an ASTM standard.
• All toys sold in the United States must meet the safety
requirements of ASTM F963, Standard Consumer Safety
Specification for Toy Safety, as part of the Consumer
Product Safety Improvement Act of 2008 (CPSIA). The law
makes the ASTM F963 standard a mandatory requirement
for toys while the Consumer Product Safety Commission
(CPSC) studies the standard's effectiveness and issues final
consumer guidelines for toy safety.
About ISO
• The International Organization for Standardization known
as ISO, is an international standard setting body
composedof representatives from various national
standards .
• Founded on 23 February 1947, the organization promotes
worldwide industrial and commercial standards. It is
headquartered in Geneva, Switzerland, and as of 2013
works in 164 countries.
• More than 100 of ISO‟s members are from developing
countries.
• ISO has more than 18 600 International Standards in its
currents portfolio and ISO‟s work programme ranges from
standards for traditional activities, such as agriculture and
construction, through mechanical engineering,
manufacturing and distribution, to transport, medical
devices, the environment, safety, information and
communication technologies, and to standards for good
practices and for services.
Auditing
• Two types of auditing are required to become registered to
the standard:
• Auditing by an external certification body (external audit)
and
• Audits by internal staff trained for this process (internal
audits).
• The aim is a continual process of review and assessment to
verify that the system is working as it is supposed to; to find
out where it can improve; and to correct or prevent
problems identified.
• Under the 1994 standard, the auditing process could be
adequately addressed by performing "compliance
auditing":
• Tell me what you do (describe the business process)
• Show me where it says that (reference the procedure
manuals)
• Prove that this is what happened (exhibit evidence in
documented records)
• The 2000 standard uses a different approach. Auditors are
expected to go beyond mere auditing for rote compliance
by focusing on risk, status, and importance. This means
they are expected to make more judgments on what is
effective, rather than merely adhering to what is formally
prescribed. The difference from the previous standard can
be explained thus
• Under the 1994 version, the question was broad: "Are you
doing what the manual says you should be doing?",
whereas under the 2000 version, the questions are more
specific: "Will this process help you achieve your stated
objectives? Is it a good process or is there a way to do it
better?"
Benefits of ISO International Standards
• ISO International Standards ensure that products and
services are safe, reliable and of good quality. For business,
they are strategic tools that reduce costs by minimizing
waste and errors, and increasing productivity. They help
companies to access new markets, level the playing field for
developing countries and facilitate free and fair global
trade.
 ISO 9000 FAMILY OF STANDARDS
ISO
• ISO stands for “International Organization for
Standardization.”
• It is a World wide Organization Established in 1946.
• Head office at Geneva, Switzerland.
• It has a membership of 158 national standards institutes
from countries large and small, industrialized and
developing, in all regions of the world.
• ISO develops only those standards that are required by the
market. This work is carried out by experts coming from the
industrial, technical and business sectors which have asked
for the standard, and which subsequently put them to use.
Philosophy Behind ISO 9000
• Everything is done through processes.
• Bad Processes result into bad Quality.
• Are your processes under control?
• Are the results satisfying?
• If not – improve the process.
• Is the Process documented?
• Write down process steps clearly.
• The Goal is preventing defects.
KEY PRINCIPLES IN STANDARD DEVELOPMENT
1. ISO standards respond to a need in the market
2. ISO standards are based on global expert opinion
3. ISO standards are developed through a multi-stakeholder
process
4. ISO standards are based on a consensus

• ISO 9000 FAMILY

• ISO technical committee ISO/TC 176,develops Quality
management and quality assurance, which is responsible
for developing and maintaining the ISO 9000 family.
• ISO 9001:2008 - sets out the requirements of a quality
management system
• ISO 9004:2009 - focuses on how to make a quality
management system more efficient and effective

• ISO 19011:2011 - sets out guidance on internal and external

audits of quality management systems.

• ISO 9000 is a series of standards, developed and published

by the International Organization for Standardization (ISO),
that define, establish, and maintain an effective quality
assurance system for manufacturing and service industries.
• The ISO 9000 standard is the most widely known and has
perhaps had the most impact of the 13,000 standards
published by the ISO. It serves many different industries
and organizations as a guide to quality products, service,
and management.

• The ISO 9000 standards are not rules, but merely a set of
guidelines that organize their processes and make it more
cost effective
ISO 9000:2005
• ISO 9000 standard provides the fundamentals and
vocabulary used in the entire ISO 9000 family of standards.

• It sets the stage for understanding the basic elements of

quality management as described in the ISO standards.

• ISO 9000 introduces users to the eight Quality

Management Principles as well as the use of the process
approach to achieve continual improvement.
ISO 9001:2008
• ISO 9001 is used when you are seeking to establish a
quality management system that provides confidence in
your organization‟s ability to provide products that fulfill
customer needs and expectations.

• The requirements in four of the sections are applicable to

all organizations – Quality management system,
Management responsibility, Resource management and
Measurement, analysis and improvement.
ISO 9001
• With over 1,000,000 organizations currently certified to the
standard globally, it is the fore leader in not only quality
management systems, but within all management systems.

• The QMS standard is adaptable to any size of company;

large or small; multinational or local; public or private; as it
offers the same scalable benefits for each organisation.
• The overall objective of the standard is to help companies
meet statutory and regulatory requirements relating to the
product while achieving excellence within their customer
service and delivery. It can also grow market share, driving
costs do

ISO 9001 ACCREDITATION

• Certification Europe is an accredited certification body
which provides International Organization for
Standardization (ISO) management system certification and
inspection services to organizations globally.
• Accreditation is the process by which a certification body is
recognized to offer certification services. In order to
become accredited, Certification Europe is required to
implement a quality management system which meets
international standards.

• Certification Europe is audited annually to ensure its

services meet the exact requirements of the relevant
accreditation standards.
ISO 9004:2009
• ISO 9004 is used to extend the benefits obtained from ISO
9001 to all parties that are interested in or affected by your
operations.
• ISO 9001 and ISO 9004 are compatible and can be used
separately or in combination to meet or exceed
expectations of customers and interested
• ISO 9004 gives guidance on a wider range of objectives of a
quality management system than does ISO 9001,
particularly in managing for the long-term success of an
organization.
• ISO 9004 is recommended as a guide for organizations
whose top management wishes to extend the benefits
of ISO 9001 in pursuit of systematic and continual
improvement of the organization‟s overall
performance
ISO 19011:2011
• ISO 19011 covers the area of auditing of quality
management systems and environmental management
systems.
• It provides guidance on the audit programmes, the
conduct of internal or external audits.
• ISO 19011 provides an overview of how an audit
programme should operate and how management system
audits should take place
• It is applicable to all organizations needing to conduct
internal or external audits of quality and/or environmental
management systems or to manage an audit programme.
• It will help user organizations to optimize and facilitate the
integration of their management systems and, in facilitating
a single audit of its systems, will streamline the audit
processes, reduce duplication of effort.
• Use sector specific and general guidance
• Obtain guidance on specific topics within the quality
management system
• Do you need to demonstrate conformance
• Undergo independent audit
• Continue to improve your business.

ISO 14001
• The ISO 14001 Environment Management System (EMS)
standard is an internationally recognized environmental
management standard which was first published in 1996.
• ISO 14001 is part of the ISO 14000 series and forms the
cornerstone of the family of standards.

• It is a systematic framework to manage the immediate and

long term environmental impacts of an organisation‟s
products, services and processes.

• ISO 14001 environmental certification provides a

framework for best environmental management practice
and help organizations to the following,
• minimize their environmental footprint
• diminish the risk of pollution incidents
• provides operational improvements
• develop their business in a sustainable manner

BENEFITS OF THE ISO 14001

• Identify cost savings with greater emphasis on resource, waste and
energy management
• Develop the corporate image and credibility
• Quantify, monitor and control the impact of operations on the
environment, now and in the future
• Ensure legislative awareness and compliance.
• This International Standard is based on the methodology
Plan-Do-Check-Act (PDCA).
• Plan: establish the objectives and processes necessary to
deliver results in accordance with the organization's
environmental policy.
• Do: implement the processes.
• Check: monitor and measure processes against
environmental policy, objectives, targets, legal and other
requirements, and report the results.
• Act: take actions to continually improve performance of the
environmental management system
ISO 20000-1
• ISO 20000-1 is the international standard for quality
management specifically focused around IT service
management.
• An increasing number of organizations are implementing an
IT Service Management System (ITSMS), based around ISO
20000 as a solution to this business requirement.

Benefits of ISO 20000-1:

• Improving corporate image and credibility
• Greater understanding of roles and business objectives
• Consistency in the delivery of your service or product
ISO 22301:2012
• ISO 22301:2012 is a Societal Security-Business Continuity
Management Systems.
• Business Continuity Management (BCM) has been
developed to protect companies from the risks associated
with company outages which can occur due to unexpected
disruptions or disasters.
• Disruptions to your business can result in revenue loss, data
risk breakdowns and failure to deliver normal client
services as per service level agreements (SLA‟s).
• Our mantra is be prepared for potential incidents, assess
the potential threats, and develops a contingency plan
which ensures that your company continues to function
and provide a first class service to clients at all times.
Implementing a strong Business Continuity Management
System (BCMS) will aid your organization in quickly
recovering from a disaster or disruption.
Benefits of ISO 22301:
• Maximize quality and efficiency
• Competitive advantage
• Organizational improvement
• Maintain Optimum Client Delivery levels
CONTINUAL IMPROVEMENT
Continual improvement means step by step
improvement. If the customer complains are
reduced from 200 in a month, to 50 in a
month, that is continual improvement. If the
defects are reduced from 100 to 10, this is
continual improvement.
WHO CAN ADOPT ISO
• Even small construction company can adopt requirements
of ISO 9000 standards. The minimum requirements are,
making a Quality Manual, specifying method statements &
monitoring the processes. You may be a 10 people
company or less, still you can maintain ISO 9000 standards
and get yourself certified.
STEPS IN IMPLEMENTING ISO
• Identify what goals you want to achieve
• Identify what others expect of you
• Establish your current status
• Obtain information about the ISO 9000 family
• Apply the ISO 9000 standards in your management system
• Use sector- specific and general guidance
• Obtain guidance on specific topics within the quality
management system
• Undergo independent audit
• Continue to improve your business.
 QUALITY RELATED TRAININGS
Quality training

• Trainings which are needed or required in an organisation

to meet the quality policy of the organisation.
• Training is mandatory for each person in an organisation
and so it should be given for everyone involved in the
project.
• A quality systems training program should facilitate the
achievement of an organization‟s mission, goals, and
objectives.
• Once the details of the quality systems training program are
established, they are documented in a training plan.
• To be properly aligned with the organization, the training
program should be developed with accurate information
and attention to the unique needs and constraints of the
organization.

• A quality systems training program may include a variety of

methods for helping employees attain specific levels of
knowledge, skills, and abilities (KSAs) to the job.

• Ultimately the quality systems training program should

ensure that all personnel have the necessary level of
experience or training to enable them to competently
perform designated tasks.
• Training needs will be specific to the tasks and
functions at each level of the quality system.
• Therefore, it is important that each level of an
organization be analyzed in terms of its training
needs and KSA requirements.
• An understanding of the typical tasks and
functions that occur at each level will help in
assessing an organization‟s quality-related
training needs.
BUILDING A QUALITY TRAINING PROGRAM
• UP-FRONT REVIEW
• ASSESSMENT
• ANALYSIS
• DEVELOPMENT
• CONSTRUCTION
• EVALUATING THE PROGRAM
• UP-FRONT REVIEW
The purpose of the up-front review is to:
1. Describe reasons for building a quality systems training
program,
2. Determine the best solution, and
3. Create a team and assign roles.
NEEDS ASSESSMENT
• A Needs Assessment is the process used to identify and
understand the particular quality-related training goals of a
specific job, team, organization, or agency. Identifying the
training goals helps to ensure that the quality systems training
program makes the best use of available resources.
• The needs assessment process involves identifying the gaps in
KSAs that an employee needs to perform his or her job.
• There are three basic steps to performing a needs assessment:

1. Decide which jobs to assess,

2. Identify the quality-related KSAs required to perform the jobs,
3. Determine the existing level of knowledge and experience.
ANALYZING THE NEEDS ASSESSMENT DATA
• Needs assessment information analysis is the process of
identifying the differences or gaps between what is needed
to perform a job and what performance criteria are
currently being met.

This process includes the following steps:

1. Compare existing skills and required skills and
2. Verify the results.
• DEVELOPING A QUALITY SYSTEMS TRAINING PROGRAM
• The purpose of the development stage is to create an
approach for meeting the quality systems training goals.

There are four steps:

1. Rank the training goals,
2. Define success,
3. Compare the current quality-related training resources to
training goals, and
4. Verify and document the results.
CONSTRUCTING THE QUALITY SYSTEMS TRAINING
PROGRAM
• The Construction phase puts together the conclusions
reached during the information collection and analysis
phases to attain the training goals.

The process of constructing the training program includes:

1. Create a time line for achieving each training goal,
2. Identify how each training goal will be met,
3. Identify redundancy, and
4. Identify roles and responsibilities.
EVALUATING THE QUALITY SYSTEMS TRAINING PROGRAM
• The last phase of building a quality systems training
program is evaluating the program to make sure it is
sufficient in scope and will meet he needs of its users.
• Evaluate the program to determine if it addresses training
needs and priorities.

The following two areas are important when evaluating a

training program:
• 1. Review the original request,

• 2. Review the training goals

 IMPLEMENTING A QUALITY SYSTEM
• A QMS can be defined as the managing structure,
responsibilities, procedures, processes, and management
resources to implement the principles and action lines
needed to achieve the quality objectives of an organization.

• A Quality Management System can be seen as a complex

system consisting of all the parts and components of an
organization dealing with the quality of processes and
products. It is very easy to simply concentrate on the detail
of the documentation process. However, a modern QMS is
much more than this in doing
1. better service to users and customers
2. reduction of waste and rework
3. helping staff in all areas to „do it better‟
Objective of QMS
• Customer focus – actively reviewing customer needs
through dialogue; making customers aware of new
products and services; ensuring the organization is aware of
customer needs; corrective action when the service fails to
meet expectations.
• Continual improvement – of products, services, working
environment, staff development, and management and
production processes.
• Reduced waste – a reduction in wasted products, repeated
or corrective work and unnecessary processes.
Quality Management Implementation steps:
• Commitment from Top Management
• Establishing an Implementation Team
• Conducting ISO 9000 Awareness Programs
• Providing Training
• Conducting an Initial Status Survey
• Creating a Documented Implementation Plan
• Developing a Quality Management System
• Control of Documents
• Internal Quality Audit
• Reviewing by Management
• Assessment by Audit
• Certification and Registration
• Continual Improvement
ISO 9001 requirements are based on eight quality
management principle. Prior steps to ISO 9000
Certification
1. Hire Quality Management Consultant
2. Conduct Gap Analysis
3. Establish Quality Policy
4. Company Wide Quality Seminar
5. Prepare Quality Manual (electronic records)
• Quality Policies
• Quality Objectives
6. Quality Training for ALL
7. Appoint Lead Auditors
8. Contract Registrar should be elected
9. Conduct Internal Audits
Benefits of QMS
In "Good reasons for implementing a QMS" (CERCO
SWGA, 1999), a number of direct benefits of a QMS are
stated:
• improved customer satisfaction
• improved quality of products and services
• workers‟ satisfaction and more commitment to the
organization
• better management and a more effective organization
• improve relations with suppliers
• improved promotion of corporate image.
Risk of implementing QMS
• Short-term increase in production costs during training and
implementation of the QMS
• Dissatisfaction of staff because of new methodology e.g.
resistance to change and perceived risk of exposure
• Another set of rules and papers without actual results e.g.
documents that reflect what management think is
happening, not what is happening.
 THIRD PARTY CERTIFICATION
• Third-party certification means that an independent
organization has reviewed the manufacturing process of a
product and has independently determined that the final
product complies with specific standards for safety,
quality or performance.
• Third-party certification programs differ greatly from one
another, depends on the type of program and its
comprehensiveness.
• 4 certification for NACCB accreditation:
• (National Accreditation Capital for Certification Bodies)
• Certification of quality management systems
• Product conformity certification
• Product approval
• Certification of personal engaged in quality verification
• Methods used in third-party certification programs
• Type-testing/Initial Inspection – This method works to
determine if the manufacturer‟s design specifications can
produce a product that conforms to a particular standard.
Products from a preproduction run are inspected and/or
tested, but this method provides no information on whether
products from an actual production run also consistently
meet the specification.
• Surveillance of the Manufacturing Process – Assessment of
a manufacturer‟s materials, production and control
processes can, at relatively low cost, provide assurance that
the manufacturer‟s quality control procedures are
adequate.
• Audit-Testing – In this procedure, test samples are selected
at random from the marketplace. Extensive testing is
usually required to provide adequate assurance that
products meet the referenced standard.
• Field Investigations – Alleged failures of products during
actual use are investigated to determine the cause of
failure and to suggest appropriate corrective action.
• Batch-testing – A sample of products is selected from a
production batch and tested for conformance to the
standard. Batch testing is used in many certification
programs for building products.
• 100 Percent Testing – In this method, each individual
product is tested to determine if it meets the designated
standard. If the testing procedures are adequate, the
procedure provides the highest possible level of assurance
that the product conforms to a particular standard.
• Many certification programs rely on two or more of these
methods for their approval process.
• The choice of methods depends on the needs of both the
buyer and the seller and on the nature of the product.
CERTIFICATION MARKS
• A certification mark is defined as “a sign or symbol owned
or controlled by the certification body that is used
exclusively by the third-party certification program to
identify products or services as being certified and is
registered as a certification.
• A certificate of conformity, on the other hand is “A tag,
label, nameplate, or document of specified form and
contents, affixed or otherwise directly associated with a
product or service on delivery to the buyer, attesting that
the product or service is in conformity with the referenced
standards or specifications.”
• In addition, the certificate of conformity
should contain information on:
• (1) The lot, batch or other production
information to allow traceability to the
production source and time of production.
• (2) The date when the certificate was issued.
• (3) The officer of the company responsible for
its issuance.
• To determine which standard, certification, or rating system
should be used:
• A first-party assessment is one that comes directly from an
organization that is associated with the entity making the
claim or who may benefit from the claim.
• A second-party assessment is performed by an interested
party such as a trade association.
• A third-party assessment is conducted by an independent
party that has no financial interest or ties to the outcome
of the assessment.