Unit 3

ISO & Quality Manual

Introduction to quality systems
To provide good quality products
As per definition of ISO, “The quality system is the organizational structure, responsibilities,
procedures, processes and resources for implementing quality management.”
It involves phases from initial identification to final satisfaction of requirements and customers’
expectations.

Quality system ensures that:

1.The system is well understood and effective
2. Products and services satisfy customers requirements
3. Emphasis to problem prevention, rather than detection after occurrence.

Need for ISO 9000 and other quality system

To provide good quality products and services
To assure quality one has to ensure the quality
And for effective quality assurance system requires a well-defined quality system standard.
Quality and standardization are two important pre-requisites for organization to establish in this
competitive market.
Thus, quality will begin with standards.
So, every increasing demand of providing better quality led to development of quality standards
like ISO 9000.

Objectives of ISO 9000 quality system

1. Achieve, maintain and seek to continuously improve quality of products and services
2. Improve quality of operations to meet customers as well as stake holders stated and
expected needs
3. Provide confidence to management that quality requirements are fulfilled
4. Provide confidence to stake holders
5. Provide confidence to overall organization quality system requirements are fulfilled.

Benefits of ISO certification

Companies going for ISO certification because of following benefits:
1. Solid foundation for improvement, consistency and profitability
2. Good platform for continuous quality improvement
3. Status symbol for company
4. Increases potential market share.
5. Improves employee’s morale and ensures total involvement
6. Ensures customer satisfaction
7. Ensures confidence within all stake holders in company including suppliers, investors and
shareholders etc.
8. Fulfills the mandatory requirements of entry as a supplier to export products overseas.
9. Improves documentation, operating standards and house keeping
10. Reduce wastage and reduction in cost of production.
What is ISO?
ISO i.e. "International Organization for Standardization” is an association of National standard
bodies of more than 180 countries.
ISO was formed in 1987 and at Geneva, Switzerland.
It is an specialized international agency for standardization with objective of co-ordination and
unification of international standards.
ISO promotes the development of standardization and related activities in the world with a view
to facilitate international trade of goods and services, and developing cooperation within nations
regarding intellectual, scientific, technological and economic activities.
By 2015, ISO had published over 15,000 standards.

Introduction to IS0 9000

ISO 9000 family of standards is related to quality management systems.
It is designed to help organizations ensure that they meet the customer needs and other statutory
and regulatory requirements of QMS.
ISO 9000 is applicable in public as well as private sector

Family of ISO 9000 standards

ISO Quality Management systems: Provides information about concepts and
9000: Fundamentals and Vocabulary vocabulary used in other two standards.
2005 Serves as reference for ISO 9001: 2008
ISO Quality Management systems: Provides requirements to achieve
9001: requirements certification.
2008 Used for registration and certification of
standards
ISO Quality Management systems: Provides guidelines to companies
9004: Guidelines for performance applying beyond ISO 9001: 2008.
2009 improvement Helps to meet customer requirements as
well as checks performance
improvement

Introduction to ISO-9001
It insures manufacturing products according to the standards.
Improve the performance of process
Increase the satisfaction of customers.
Implementation of statutory and regulatory requirements related to products or services.
ISO standards are revised continually by standing technical committees and advisory groups.

Quality Management Principles

These 8 principles are set of comprehensive and fundamental rules for leading and operating an
organization.
1. Customer Focus
2. Leadership
3. Involvement of people
4. Process Approach
 5. System Approach
6. Continual improvement
7. Fact-based decision making
8. Mutually beneficial supplier relationships

Principle 1- Customer Focus

Organizations should understand current and future customer needs, meet customer requirements
& strive to exceed customer expectations.
Provide better service and take care of customer satisfaction.
Steps in Application of Principle are:
Researching and understanding customer needs and expectations.
Communicating customer needs & expectations within organization.
Measuring customer satisfaction level and acting on the results
Systematically managing customer relationships.
Key Benefits:
Increased revenue and market share
Resources used effectively to enhance customer satisfaction
Improved customer trust leading to repeat business.

Principle 2- Leadership
Leaders establish unity and give direction of the organization.
Role models for implementation of policies and value.
Characteristics of Successful Leaders:
Give attention to external and internal customers
Provide training, and create healthy work environment
Emphasize improvement rather than maintenance.
Emphasize defect prevention.
Encourage collaboration rather than competition.
Continually try to improve communications
Choose suppliers on the basis of quality, not price.
Key Benefits:
Sub ordinates motivated towards organization's goals and objectives
Miss-communication will be minimized.

Principle 3 - Involvement of People

Quality is achieved by involving people across all levels of the organization as well as giving then
responsibility for quality.
Steps in Application of this Principle are:
Accept ownership and responsibility to solve problems.
Actively seek opportunities to make improvements, and enhance competencies, knowledge and
experience.
Freely share knowledge & experience in teams.
Focus on the creation of value for customers.
Be innovative in furthering the organization's objectives.
Make people enthusiastic & proud to be part of organization.
Key Benefits:
Motivated, committed and involved people in organization.
Innovation and creativity in furthering the organization's objectives.

Principle 4- Process Approach

A desired result is achieved more efficiently when activities and related resources are managed as
a process.
System of interrelated processes has to be identified, properly understood and managed to enhance
effectiveness and ensure efficient effectiveness of the organization.
To apply a process approach you have to decide what the tasks are, how and where they relate,
what resources and inputs you need, and how to do things in order to arrive at the result you want.
Key Benefits:
Lowers the costs and shorten the cycle times
Improved, consistent and predictable results.

Principle 5-System Approach to Management

Identifying, understanding and managing the multiple processes together as a system leads to
greater efficiency.
Helps in understanding the interrelation of business elements.
Steps in Application of this Principle are:
Define the system by identifying the processes that affect a given objective.
Structure the system to achieve the objective in efficient way.
Understand the interdependencies among the processes
Evaluate & estimate the resource requirements, establish resource constraints prior to action.
Key Benefits:
Integration and alignment of the processes will achieve the desired results
Ability to focus effort on the key processes

Principle 6-Continual Improvement

Continual improvement of the organization's overall performance should be a permanent objective.
There is increased ability to embrace new opportunities, organizational flexibility and improved
performance.
Steps in Application of this Principle are:
Use basic improvement concepts for incremental improvement.
Use periodic assessments
Continually improve the efficiency & effectiveness of all processes.
Promote Prevention Based Activities
Provide training using tools of continual improvement such as the PDCA cycle, problem solving,
and process innovation.
Key Benefits:
Improvement in organizational capabilities
Flexibility to react quickly to opportunities

Principle 7 - Factual Approach to Decision Making or Fact Based Decision Making

Effective decisions are based on the analysis of data and information and not on personal or
situational thinking
TQM requires that an organization continually collect and analyze data in order to improve
decision making accuracy, and allow prediction based on past history.
Steps in Application of this Principle are:
Take measurements and collect relevant information.
Check data is accurate, reliable and accessible.
Analyze the data and information using valid methods.
Make decisions and take action based on the results of logical analysis
Key Benefits:
Informed decisions.
An increased ability to demonstrate the effectiveness of past decisions

Principle 8- Mutually Beneficial Supplier Relationships

Strong relationship between the supplier and organization will enhance productivity and encourage
seamless working practices.
It will benefit as optimization of costs and resources
Steps in Application of this Principle are:
Identify and select key suppliers.
Establish supplier relationships.
Create clear and open communications.
Initiate joint development and improvement of processes.
Jointly establish a clear understanding of customers' needs.
Share information and future plans
Key Benefits:
Increased ability to create value for both parties
Optimization of costs and resources.

ISO 9001 requirements

The ISO 9001 document is the set of requirements that organization must satisfy in order to achieve
ISO 9001 certification.
It has eight major clauses. They are:
1. Scope
2. Normative reference
3. Terms and definitions
4. QMS requirements
5. Management responsibility
6. Resource management
7. Product realization
8. Measurement, analysis and improvement
First three clauses are general clauses which provides information and remaining five clauses are
technical clauses and they are the actual requirements which organization must meet.

1. Scope
This clause specifies the requirements for adapting quality management system.
So that organization could provide product that meets customer requirements.
And enhance the customer satisfaction level by effective application of the system
2. Normative Reference
This clause consists the necessary concept & definition for QMS

3.Terms and Definition

All the definitions and terms given in ISO 9000:2000 are mentioned in this clause. E.g. Supplier,
Organization, Customer.

4. Quality Management System Requirements

Maintain proper documentation to ensure that a product or service fulfills customer requirements
specifically. It includes,
4.1. The QMS: It should be implemented, maintained & continually improved by the organization.
4.2. The Quality Manual: Also called organizational 'Rule book’. It includes scope of QMS, its
details and justifications for any exclusions in applying QMS.
4.3. The Control of Documents : Review & approve document before issue. Changes & current
revision status must be clearly identified.
4.4. Quality Records: The Records must be legible, readily identifiable & easily retrievable.
E.g.: mgt. review records, training records, purchase evaluation records, audit records, customer
complaints and other process related records.

5. Management Responsibility
This contains following sub-clauses:
Management Commitment: Top (senior) management must be fully committed for the
development & improvement of the QMS.
Customer Focus: Determine, fully understand and document customer requirements & ensuring
compliance with statutory laws.
Quality Policy: Ensure that process is appropriate for the purpose, understood by everyone and
reviewed for continued standard.
Planning: the managements quality objectives and quality policy.
Responsibility: of identifying and planning the activities and resources required to achieve quality
objectives
Management Representative: Appointing person for implementing an improvement through
QMS.
Management Review: Regular review to check, QMS is functioning continually and find areas
of improvement

6. Resource Management
This clause discusses regarding defining and availability of resources.
6.1. Provision of Resources: Provide resources to implement, maintain and improve the QMS.
Also to enhance customer satisfaction
6.2. Human Resources: Ensure employees are adequately competent & trained for assigned roles.
Maintain training records.
6.3. Infrastructure: Determine, provide & maintain infrastructure (which include bldg.,
workspace, equipment and supporting services) as per product requirement
6.4. Work Environment: Determine & manage the work environment (which include factors such
as noise, lighting, temperature, humidity and weather) as per product requirement
7. Product Realization
Organizations’ have to plan & develop the processes needed for:
7.1. Planning of product realization: Determine quality objectives & requirements for product
7.2. Customer-related processes: Determination of requirements related to the product: such
Post-delivery activities, maintenance activities etc.
7.3 Design and development: Update the plan as design and development progresses. Perform
Review, Verification and Validation of design.
7.4 Purchasing: Evaluate and select suppliers based on their ability to meet purchase
requirements.
7.5 Production and service provision: During servicing safeguard the customer property.
Preserve conformity of product during internal testing up to product delivery.
7.6 Control of monitoring and measuring devices: Measuring devices must be calibrated at
specific intervals. And maintain the Calibration records.

8. Measurement, Analysis and Improvement

It includes
8.1 Monitoring and measurements: Perform Internal audit to determine implementation of QMS.
Also find Customer satisfaction through feedback channels.
8.2 Control of nonconforming product by identifying and segregation.
8.3 Determine, collect and analyze appropriate data to demonstrate suitability and effectiveness of
the QMS.
8.4 Improvement:
Continual improvement of QMS through quality policy, objectives, audit results, analysis of data,
corrective / preventive actions and mgt. review.
Corrective action taken to find non-conformities and take corrective actions
Preventive action taken to avoid non-conformities which should be recorded & their effectiveness
is verified.

Steps of ISO 9001 Certification

Following are the Ten Steps to be followed for ISO 9001 Certification:
1. Identify key drivers
2. Obtain the standard and Purchase a copy of the standard
3. Define the strategy
4. Planning
5. Know processes
6. Determine training needs
7. Develop management system documentation
8. Implement Quality Management System
9. Consider a pre-assessment audit
10. Go for certification

1. Identify Key Drivers:

At senior management level, First of all find the key drivers i.e. main purpose behind implementing
a QMS. The main purpose may be to improve the performance of process, or a need for continual
improvement, or satisfying a specific customer requirement
2. Obtain the standard and Purchase a copy of the standard:
On website www.iso.org search for ISO 9000 family to find standard relating to particular sector.
In this case purchase document related to ISO 9001

3. Define the Strategy:

commitment of senior management is most important for successful implementation of QMS.
Maintain formal documentation as per ISO 9001 requirements. Decide the policy and objectives
for quality of process. And ensure that, requirements of the quality policy must be measureable
and there is scope for continuous improvements.

4. Planning to provide Resources for Developing the Quality Management System

Prepare project plan to identify needs and to measure the progress. And it should be periodically
reviewed by senior management and kept updated from time to time

5. Know the Processes

As per ISO 9001, prepare process map. This map will identify the key processes and indicate the
resources, controls, documentation and records needed to meet the customers' requirements. This
process map should be used, reviewed and updated regularly so that it can be finally included in
the Quality Manual.

6. Determine Training Needs

Different courses, workshops and seminars are organized to provide training to Team leaders,
employees and internal auditors. Also mention the benefits derived by conduction of training

7. Develop Management System Documentation

ISO 9001 requires documentation of policy, manual, procedures and records. There are six
documented procedures specifically required by ISO 9001 as well as those needed and identified
for the organization.

8. Implement the Quality Management System

Proper implementation of QMS is recorded by internal audits. A management review must also be
conducted to ensure the system's suitability, adequacy and effectiveness. The main review is a key
driver to demonstrate the effective implementation of the QMS. Any corrective and preventive
actions should be identified, progressed and recorded

9. Consider a Pre-assessment Audit

It will help to identify any gaps that exist between the requirements of the standard and the
organization's existing processes. This audit can be carried out at any stage and is independent of
the certification process. It is performed to fulfill tow requirements.
Stage 1: The purpose of the auditor visit is to check the readiness of the organization for full
assessment.
Stage 2: The purpose of the auditor visit is to confirm that the QMS fully conforms to the
requirements of ISO 9001:2008 in practice.

10. Go for Certification

Go for certification by approaching registrar or certification body (CB) who should be a member
of the International Accreditation Forum (IAF), and additionally need to be ISO 17021: 2015
certified i.e. eligible to provide certification

ISO 9001 DOCUMENTATTON REQUIREMENTS

ISO 9001: 2008 requires the following documents:
1.Quality Manual:
The quality manual defines how each requirement of the “standard” is applied in the company.
It is are mentioned in section 3.2.2. of ISO 9001: 2008
2. Quality Procedures:
It describe how certain key processes within the company must be performed, and who is
responsible for them.
Quality procedures and their content in given in sections 3.2.3, 3.2.4, 8.2.2, 8.3, 8.5.2, and 8.5.3
of ISO 9001: 2008
3. Quality Policy:
The quality policy will tell the role and intension of company in implementing quality and fulfilling
customer satisfaction. The content of the quality policy must fulfill the requirements given in
Section 5.3.
4. Quality Objectives:
The quality objectives define measurable goals of the company's quality management system.
quality objectives are given in Section 5.4.1.
5. Process Flowchart:
It gives the description regarding relation between various processes of QMS.
It is given in Section 3.2.2.
6. Work Instructions:
Work instructions describe in detail how particular tasks must be performed.
Work instructions are mentioned in section 7.5.1.
7. Records
Records are different from the documents. Generally Documents provide directions on how to
conduct business. Records, on the other hand, are evidence of things done
8. Forms are Optional
And good forms will provide many benefits like time savings to consistency. It will help in creating
the various records. The best forms even act as instructions as they guide the user through a work
process
9. Format and Content
As per ISO 9001: 2008 there is no particular format or layout for every document and form. This
documentation just to provide instructions on how to operate company's ISO 9001 QMS. The best
documentation format must be easy to understand and user-friendly

CONCEPT OF CONFORMITY AND NON-CONFORMITIES

Conformance Non-Conformity
It refers to fulfillment of requirements of ISO It refers to failure to comply with
9001 standards. requirements of ISO 9001 standards

Types of Non-Conformity
 Major Non-Conformance Minor Non-Conformance:
A deficiency that reduces the A minor deficiency that does not affect the
effectiveness of the QMS. effectiveness of the QMS.
Examples: Examples:
1. An element of ISO 9001 not 1. One or a few individuals do not use a
implemented. procedure correctly.
2. Procedures not developed or not 2. Procedure needs minor changes to be
implemented. effective.
3. Failure to take corrective or 3. One or a few records incomplete.
preventive action.
4. Several minor non-conformance.

CONCEPT OF INTERNAL CUSTOMERS AND EXTERNAL CUSTOMER

1. Internal Customers
Internal customers are the people in the same company or perhaps a partner that provides services
in order to deliver company's products or services.
An internal customer is any member of organization who relies on assistance from another to fulfill
its job duties.
For example: sales representative needs assistance from a customer service representative to place
an order.
Significance of Internal Customer
Internal customers is not purchasing the products or services offered by their employer. But the
internal customer relationship with other departments plays a key role in the business success.
For example, the salesperson who does not work well with customer service department, may have
greater difficulty in placing orders or obtaining answers to his external client's questions, resulting
in a poor level of service.
Strained internal relationships can adversely affect company morale and overall business.

2. External Customers
An external customer is one who uses company's products or services but is not part of the
organization.
For example: In retail store, an external customer is an individual who enters the store and buys
merchandise.
Significance of External Customer
External customers are essential to the success of any business, as they provide the revenue through
their purchases that the enterprise needs to survive.
Satisfied external customers often make repeat purchases as well as refer the company to other
people and encourage them to purchase your product.
A customer who suffers through a negative experience with a company, such as being treated
rudely by an employee, can also hinder a business by discouraging others from for purchasing
from your company.

BENEFITS OF IMPLEMENTATION OF ISO 9000 QMS

Most important advantage is that Quality is maintained.
It provides Opportunity to compete with larger companies.
More time and efforts spent in order to achieve customer focus.
It gives confirmation to stake holders that company is committed to quality.
It will facilitate trade and increased market opportunities.
IT helps to increase customer confidence and satisfaction.
QMS includes efficient ways of working which will save time, money and resources.
The improved operational performance will cut errors and increase profits.
QMS will motivate and engage staff with more efficient internal processes.
It will improve financial results.

Negative aspects of ISO 9000

Extra time and money involved in the ISO registration process.
There may be Distraction simultaneously applied from other quality programs
A lot of work is involved in implementation of QMS

Quality Manual
A Quality Manual is the main, top-level document which is used to establish the ‘quality policies’
and ‘objectives’ of an organization.
Quality manual includes company’s quality policy and goals, detailed description of its quality
control system which further includes staff roles and relationships, procedures, systems and
resources that are required to produce good quality products and services
It is said to be heart of organization's QMS and describes interrelationships between: Process,
quality procedures and work instructions.
It is the official document produced by company which describes the operating of Quality
management system in company

What will a Quality Manual provide to a Company?

It provides evidence of what specific controls are required to be implemented to ensure the
product or service quality.

Who will benefited by using quality manual?

Customers
Suppliers
Employees
The Company
ISO

Quality Manual Should Include:

(What are the requirements of QM):
Quality manual should include:
All the scope of the QMS with details and justification for any exclusions
The documented procedures or reference to them
A description of the interaction among the QMS

Format of Quality manual

There is no specific format. It is decided by organization which suits as per organization’s
objectives.
 Contents of Quality manual are:
1.Quality policy of organization
2. Explanation regarding documentation structure
3. Policy statements which clearly indicates organization’s intention to comply ISO 9001
requirements.
4. Policy statements should include:
a) what are functions of company operations
b) Who is responsible for implementation expectations?
c) When and where policies are applicable within organization
d) What is interdependence between functions and processes
5. References should be made to company’s operating procedures
6. Appointing management representatives responsible for quality within organization
7. A description regarding set-up of organization.

Primary Use of Quality Manual

To communicate management’s expectations in context with quality to organization
To demonstrate the organization’s efforts to meet the ISO 9001 requirements
IT helps to fulfill management’s expectations by performing: customer’s audit, internal audits and
ISO registrar audits.

Development of QM
Steps required for development of Quality manual (QM) are:
1. Make list of policies
2. Make list of operating procedures related to adapted policies
3. Draft the policies as per ISO 9001 requirements
4. Collect inputs from all departments
5. Identify the in-adequacies within quality system
6. Determine structure and format of manual
7. Publish first draft of manual
8. Do formal review, approval and finally publish it

BASIC OUTLINE OF QUALITY MANUAL:

1. Introduction
2. Policy and Objectives
3. Definitions
4. Quality System
5. Organization
6. Authority and Responsibilities
7. Compliance
8. Internal Review and Audit
9. Documentation and Change
10. Purchasing
11. Inspection and Testing
12. Training

Advantages of Quality Manual

 1. To prevent risks
2. To detect deviations
3. To correct errors
4. To improve efficiency
5. To reduce costs
6. To meet customer needs
7. To market company

CHECK LIST
Check list is a list of items or tasks for comparison, verification and other checking purposes.
A checklist can help to reduce failure by finding the potential limits of human memory and
attention.
It helps to ensure consistency and completeness in carrying out a task
Example: To do list.
Format of Checklist:
Checklists consists of list of items with small checkboxes in front of them. A small tick or
checkmark is drawn in the box after the item has been completed.

Checklist for Column Concreting:

1. Checking the Column before Concreting
1 Check Size as per the drawing
2 Check Arrangement of rings
3 Check Diagonals
4 Check Oiling of shuttering
5 Check Plumb and line
6 Check Level marking
7 Check Supports
8 Check Reinforcement cover

2. Checklist for Column while Concreting

Check quality of material
Check the proportion and mixing-of material
Check to ensure than six cube mould are cast from different batches
Check Availability of vibrator or labor for tamping
Check Availability of vibrator or labor for tamping
Check to ensure proper cover after concreting on top level
Check Casting of cubes and ensure proper numbering on cubes
 Check all the joints to ensure that no slurry flows from anywhere
Check the cleaning of mixing platform

3. Checklist for Column After Concreting

Check De-shuttering of columns after 36 hours
Check to submit de-shuttering report to higher authority
Finishing the honey combing carefully
Date of casting and column number to be written on each column
Hacking of column 50 nos. in 1 sq ft
Curing of columns to be done mini. 15 days, with wet cloth rapped
around them
Cubes to be removed next day, kept for curing with code no. and
testing of cubes on due dates

4. Checklist for Formwork Checking

The following checking should be done for formwork of RCC:
1 Check the Formwork is properly aligned
2 Check it is cleaned
3 Check it is oiled
4 Check inner face of formwork is smooth
5 Check if the formwork is water-tight
6 Check supports are properly placed and fixed
7 Check width and depth/height of formwork
9 Check foam is provided along the joint of steel formwork

5. Checklist Reinforcement Checking:

Check steel are placed as per drawing
Check rebar are straight
Check the diameter of rebar
Check spacing of rebar
Check hooks and bends are placed as specified by Consultant
Check the lap length is accurate
 Check the clear cover
Check cover blocks are enough
Check the rebar are rust free
Check the rebar are crack free
Check the rods are tied properly with binding wire

6. Checklist for Concrete Pre-Placement Inspection

Sr. Check List Requirements Remarks
No.
1 Centre line As per drawing
2 Formwork and Staging As per drawing and in exact
plumb
3 Construction joint location As per drawing
4 Steel reinforcement diameter/spacing As per drawing
5 Cover to the reinforcement and overlap As per drawing
6 Shuttering Aligned as per drawing and in
plumb
7 Placement of water stoppers, if any As per drawing
8 Location of construction joint As per drawing
9 Water tightness of shuttering, if No water seepage allowed
required
10 Quality of water Potable and clean
11 Quality of materials As per specification

7. Checklist for Concrete Inspection During Placement

Sr. Check List Requirements Remarks
No.
1 Water cement ratio As per specification
2 Surface preparation by mortar bedding Fresh mortar
3 Slump testing As per requirement
4 Adequacy of vibration 40 mm and 60 mm needle
required
5 Segregation of aggregates Not allowed
 6 Removal of temporary Spacers and All to be removed
ties
7 Check for shuttering prop Not allowed
displacement/ settlement
8 Number of cubes taken for testing 3 numbers
with identification for RCC
>6 m3

8. Checklist for Post-Placement Inspection:

Sr. Check List Requirements
No.
1 Observation for honey combing Not allowed
2 Line and level As per drawing
3 Surface finish As per drawing
4 Cracks and air bubbles Not allowed
5 Method of curing As specified
6 Checked for stripping/ Removing of formwork/ Support Yes No NA
etc. after specified duration of stripping time
7 Checked for position of embedment Yes No NA
8 Repair and Finish all surface defects by specification/ Yes No NA
approved method
9 Structure of part of structure is alright and allowed for Yes No NA
subsequent activity / backfilling
10 Others, if any

QUALITY AUDIT
1. Quality audit is the process of systematic examination of a quality system carried out by an
internal or external quality auditor or an audit team.
2. It is an important part of organization's QMS also key element in the ISO quality system
standard.
3. Quality audits are typically performed at predefined time intervals and ensure that the institution
has clearly defined internal system monitoring procedures linked to effective action.
4. It can help determine if the organization complies with the defined quality system processes
and can involve procedural or results-based assessment criteria.
5. The purpose of a quality audit is to assess or examine a product, the process used to produce a
particular product or line of products or the system sup-porting the product to be produced.
6. A quality audit is different from financial audit such that the financial audit is done to verify the
integrity and accuracy of the accounting methods used within the organization. Whereas quality
audit done to study implementation of QMs within organization.

2. Types of Quality Audit

1. First Party (internal) Audit
It is also known as "Internal Audit", as it is usually performed by the organization upon itself.
It is an audit of the quality assurance programs which are going within its organizational
structure.
This audit provides feedback to management that the quality system is both implemented and
effective.
It is excellent tools for gauging the continuous improvement effort as well as measuring the
return on investment for sustaining that effort.

2. Second Party (External) Audit

Second party audits are usually performed by the customer upon its suppliers.
It is performed to determine whether the supplier can meet existing or proposed contractual
requirements or not.
Second-party audits tend to be more formal than first-party audits because its results could
influence the customer’s purchasing decisions.

3. Third Party Audit

It is conducted by independent regulatory authorities or certifying agencies.
This provides an assurance about compliances of requirements of QMS, standards, as also to
make sure that regulatory requirements are duly satisfied.
Third-party audits may result in certification, registration, recognition, an award, license
approval, a citation, a fine, or a penalty issued by the third-party auditors.