Group Members

NADEEM TAHIR (15081598-106)

MUHAMMAD USMAN (15081598-100)
MUHAMMAD ATIF (15081598-070)
HASSNAIN ALI (15081598-066)
 Introduction to
Quality Management
System
Quality Management

 What does the term quality mean?

Fit for use
Conformance to requirements
Achieve customers req.
Follows standards
Dimensions of Quality

 How do people evaluate quality?

 Performance - main characteristics of the
product/service

 Special features - extra characteristics

 how well product/service

Conformance -
conforms to customer expectations
 Reliability - consistency of performance
The Consequences of Poor Quality

 Loss of business
 Liability
 Productivity (rework, defective output that must be
scrapped)
 Costs (rework, scrap, warranty cost, etc.)
 QMS

A quality management system (QMS) is defined as a formalized

system that documents processes, procedures, and responsibilities
for achieving quality policies and objectives.
A QMS helps coordinate and direct an organization’s activities to
meet customer and regulatory requirements and improve its
effectiveness and efficiency on a continuous basis.
Quality management systems serve
many purposes, including:

 Improving processes
 Reducing waste
 Lowering costs
 Facilitating and identifying training opportunities
 Engaging staff
 Setting organization-wide direction
ISO 9000 Standard of Series

 ISO 9000:2005
 fundamentals and related concept of QMS

 ISO 9001:2008
 Follows standards
 Customer Conformance
 Regulatory
 Organizations requirements owns
The ISO 9000 Series Standards

ISO 9000 series standards, briefly,

require firms to document their quality-
control systems at every step (incoming
raw materials, product design, in-
process monitoring and so forth) so
that they will be able to identify those
areas that are causing quality
problems and correct them.
The ISO 9000 Series Standards

 ISO 9001, 9002, and 9003

 This series is used in contractual situations.
 9001 is for- addresses design/development, production,
installation, and service
 9002 deals only with production and installation
 9003 deals only with final testing and inspection
 ISO 9004:2000

 ISO 9004:2000
 Guideline for performance improvements

 Sector specific standard

 ISO/TS 16949 for automotive suppliers
 TL 9000 for telecommunication forum e.g. motorola
 Organizations requirements owns
ISO 9004 Series

 ISO 9004
 Internal standard that lists essential elements of a
quality system including management
responsibilities, marketing, procurement,
corrective action, human resource management,
product safety, and the use of statistical methods.
 Designed to help companies identify
improvement opportunities
ISO 9000 Registration Process

 When an organization feels that its quality

system is good enough, it may ask an
accredited registrar or other third party audit
team for pre-assessment.
ISO 9000 Registration Process

 When the registrar is satisfied with the

favorable recommendation of the audit team,
it grants registration and issues a registration
document to the company.
 Process based QMS

 Understanding and fulfilling the requirements

 The need to consider processes in terms of value added
 Obtaining results of process performance and
effectiveness
 Continual improvements of process based on objective
measure
Process Based QMS
 Management Responsibility

• Management Commitment
• Customer Focus
• Quality Policy
• Planning
• Responsibility, Authority and Communication
• Management Review
 Resource Management

• Provision of Resource
• Human Resource
• Infrastructure
• Work Environment
Implementation of QMS

• Top Management Commitment

• Appoint the Management Representative
• Awareness
• Appoint an Implementation Team
• Training
• Time Schedule
• Select Element Owners
 Implementation of QMS (Cont…)

• Review the Present System

• Write the Documents
• Install the New System
• Internal Audit
• Management Review
• Pre-assessment
• Registration
Top Management Commitment

 Implementing quality system that meet full support

of upper management
 CEO must be willing to allocate the resources for
achieving certification
 Critical for success
Appoint the Management Representative

 Commitment has been made already now make a

team which approach and treat quality standards.
 This team is responsible for implementing quality and
maintaining quality
 This team will contact every person which is involved
in this process
Awareness

 Process will be effective when all members giving

inputs
 This is possible only when everyone knows quality
standards
 They know their day by day operations
 Held training sessions
Appoint an implementation team

 This team should include all level of representatives

 Implementation team assembled projects
 Team should identify the QMS process
 Project should be accessible to all employees
Training

 Implementation team and supervisors should be

trained
 This can happen by sending trainer to organizations
 Held seminars for this purpose
Time Schedule

 Develop a time schedule for implementation

 The time frame will vary depending upon size
 Divide the time frame in manageable units
 Be sure for small victory
Select Elements owners

 Select owner for every element

 Owners will me member of implementation team
 Owner can be assign more than one elements
 Owner can select a team
 The more involved more the system effective
Review the present system

 Preview the present quality system

 Copies all the manual
 Documents are stored in elements
 These activities are helpful for gap analysis between
quality
Write the documents

 Prepare written quality policy

 Combine into one document
 Write instructions of work
 In this process every employee is involved
 Avoid too much documentation
Install the new system

 Integrate the policy

 Work instruction for organization
 Document what is being done
Internal Audit

 Conduct Internal audit for quality

 Ensure working is effectively
 Do Minor corrections if needed
Management Review

 Conduct management review

 Management review id used for achieving quality
goals
 Revise system as needed
Pre-assessment

 This step is optional

 If working well no need of it.
Registration

 It includes cost time and customer acceptance

 This step has three parts
 Choosing a registrar
 Submit application
 Conduct the registrar system audit
 Documentation

THE MOST IMPORTANT PURPOSE OF

DOCUMENTATION IS T PROVIDE GUIDELINES TO
INTERNAL QUALITY MANAGEMENT .
Documentation tiers..

 Policy
 Procedure
 Work instructions
 Records or proofs
All documentation moves
from one level to other in descending order,
change in one can effect upper level as well
as lower level if not properly designed.
 Policy

 It is the first level of documentation .

 It defines what will be done and why.
 Quality policy manual should be clear, precise, and
easy to understand.
 Each element should be addressed individually.
 It should of one or less than one page.
 Procedure

 This is second level of documentation.

 Procedure describe the methods that will be used
to implement and perform above stated policies.
 It define who , when ,where.
 More detailed than policies.
 Procedure should be easily understandable.
 It is not mandatory for all organization but its
absence can effect the activity,some organization
combine it with policy.
 Work Instructions

 It defines how it will be done.

 Most detailed than others in hierarchy.
 Work instruction may be in the form of drawing ,
photograph, videos, or specific job function.
 All the employee can take part In writing the work
instruction.
 Employee participation ensure that future
improvement will b suggested.
 Documentation specialist is necessary to do actual
writing.
 Not every task require work instruction.
Records or proof

 It is the way of documenting the policies

,procedure, and work instruction.
 Provide traceability of action taken on specific
product.
 Records may be stamps of approval , signature and
dates .
Document Development

 To begin creating ,documenting implementation

team need to gather all the policies ,procedure and
work instruction.
 Documentation should be reviewed .if it does not
pertain tto any element it should be set aside.
 Involve more people in creating the document and
assign responsibilities to each
 After completing document implementation team
become reviewing team.
Writing the document

 First step is to create format. (iso 9901).

 Document must be easy and concise.
 Use paragraph numbering system
 Address each idea in one paragraph.
 Write to an eighteen grade reading level.
 Write what you are doing instead of what you ought
to doing.
 Use flow charts
Internal Audits

 The purpose of an internal audit is to systematic

and independent assess the effectiveness of any
organization’s quality management system and its
overall performance Internal audit demonstrate the
compliance with a planned arrangements’, e.g. the
QMS and how its processes are implemented and
maintained
Objectives

 i. Examining the system of internal check.

 ii. Checking arithmetical accuracy of management,
verifying posting, costing, balancing etc.
 iii. Verifying the authenticity and validity of system.
 iv. Confirming the existence and value of assets and
liabilities.
 v. Verifying whether all the basic requirements are
fulfilled or not.
Subsidiary Objectives Of Audit

 i. Detection and prevention of errors

 Errors are those mistakes which are committed due
to carelessness or negligence or lack of knowledge
or without having vested interest. Errors may be
committed without or with any vested interest. So,
they are to be checked carefully. Errors are of
various types. Some of them are:
 * Errors of principle
 * Errors of omission
 * Errors of commission
 * Compensating error
Continued…

 ii. Detection and prevention of frauds

 Frauds are those mistakes which are committed
knowingly with some vested interest on the direction of
top level management. Management commits frauds
to deceive tax, to show the effectiveness of
management, to get more commission, to sell share in
the market or to maintain market price of share etc.
Detection of fraud is the main job of an auditor. Such
frauds are as follows:
 * Misappropriation of cash
 * Misappropriation of goods
 * Manipulation of accounts or falsification of accounts
without any misappropriation
Continued…

 iii. Under or over valuation of stock

 Normally such frauds are committed by the top
level executives of the business. So, the explanation
given to the auditor also remains false. So, an
auditor should detect such frauds using skill,
knowledge and facts
Auditor

 Audits should be performed by the qualified

individuals who have received training in
auditing principles and prcedures.
The 5 Characteristics of an
Auditor

 1. Have the Required

Experience
 Certifications are key academic qualifications for an
auditor. An auditor should have the required
knowledge on accounting, business and taxation
law. It is also necessary that he or she has computer
operation skills because most of the operations will
require one.
Continued…

 2. Ability to Make Independent

Decisions
 An auditor’s decision should not be wavered or
influenced by anyone. Their actions, decisions, and
reports should be as a result of careful analysis of the
company’s operations. They should not have any
personal interests or favoritism.
Continued…

 3. Auditors Have the Ability

to Understand Different
Business Needs
 Another characteristic of an auditor is the ability to
work with different company setups. To come up
with a successful audit, they must first understand
what the business entails.
Continued…

 4. Trustworthy
 An auditor should be trustworthy and decisive. They
should not share company information with third
parties. Sometimes, auditors come across sensitive
information. They should only disclose this to the
concerned parties.
Continued…

 5. Effective Communication
Skills
 An auditor cannot be effective if they have not
mastered excellent communication skills. They
should be assertive and at the same time have
people skills. They can be a skilled auditor when it
comes to compiling reports, but if they cannot
convincingly communicate when called upon to
present their work, the effort will be futile. They
should be patient and have skills to elaborate points
to the satisfaction of the auditee.
Audit Techniques

 Evidences are very important for an Auditor to form

an opinion regarding financial statements. If Auditor
fails to collect proper evidence, it will reduce the
reliability of audit report. The method of collecting
evidence is called audit technique. Following are a
few important audit techniques:

 Examination of documents
 Observation of activities
 Interviews
Examination of documents

 Auditor should start with the quality manual to

determine that the policies covers the QMS
Standards, and they are controlled.

 The documents are examined in a systematic

manner. e,.g, make transactions in the system
 Document Control: ensures that documents are
identified with a title, revision date, and responsible
owner.
Observation of activities

 It requires an aptitude for details. E.g,

 to evaluate the reservation of product element the

auditor would observe identification, handling,
packaging, storing and protection of the product.
Interviews

 It is the toughest task in Audit is collecting of

evidences by interviewing the employee or auditee.
 Perform open conversation
 Perform close conversation
 Yes/No Questions
Procedure

 It is the thing where an auditor shows how much

work is done and in which way it is done
 It contains the audit schedule
REGISTRATIOON

 Quality registration is the assessment audit of a

quality system by a third party, known as a registrar.
 Two Parts
 Selecting a registrar
 Registration Process
Selecting a registrar

 Qualification & Experience

 Certificate Recognition
 The Registration Process
 Time & Costs
 Auditor qualification
Registration Process

 Application of registration
 Document Review
 Pre-assesment
 Assessment
 Registration
 Follow-ups